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The Future of Targeted Functional and Wellbeing Food and Drinks Innovation and clinical research across beauty, digestive, heart, brain and bone health Reference Code: BI00012-055
Publication Date: November 2010
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About the author Natasha Horton is an analyst in Business Insights’ Consumer Goods division. Previously she worked in
product development, specializing in private label convenience and ready-to-go foods for foodservice and
retail customers. She has worked on several projects analyzing NPD trends in food and drinks for leading
multinational clients and has a degree in Food Marketing and Business Economics from the University of
Reading.
Disclaimer Copyright © 2010 Business Insights Ltd
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or opinions expressed in this report by individual authors or contributors are their personal views and
opinions and do not necessarily reflect the views/opinions of the Publisher.
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Table of Contents
About the author 2
Disclaimer 2
Executive summary 9
Functional food and drinks: the overlap between food and pharma 9 Regulation, marketing and positioning 9 Growing audience for functional food 10 Bone and joint health 11 Brain and mental health 11 Digestive health 12 Heart health 12 Skin health and beauty 13
Chapter 1 Functional food and drinks: the overlap between food and pharma 14
Summary 14 Introduction 14 Definition of functional foods/nutraceuticals 15 The growth of the functional food and drinks market 16 Crossover between pharma and food 18 Food companies moving into the pharma space 18 Case Study: Nestlé 19 Case Study: Danone 20
Pharma companies moving into the food industry 20 Case Study: Abbott Nutrition 21
Chapter 2 Regulation, marketing and positioning 23
Summary 23 Introduction 23 Japan - FOSHU (Food for Specified Health Uses) 24 US-FDA and GRAS 26
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Europe 27 Article 13 health claim legislation 27 Types of claims 27 Nutrition claims 28 Functional well-established claims 29
Functional innovative claims 30 Article 13.5 30 Risk reduction and children’s health claims 31
Analysis of site specific claims submitted to EFSA 31
The future of health claims in Europe 33 Invest in R&D 34 Reduce product portfolio? 34 Withdraw health claim? 35
Chapter 3 Growing audience for functional food and drinks 36
Summary 36 Introduction 36 A shift to targeted functional foods 37 Quality of life 38 Growth of ‘middle-age’ 39
Self medication and the impact of nutrigenomics and nutrigenetics 41
Disease and patient targets 44 Incidence of health problems 44
Chapter 4 Bone and joint health 46
Summary 46 Introduction 46 NPD and innovation 48 Bone health 49 Key ingredients 49 Latest research on nutrition for bone health 51
Joint health 53 Key ingredients 53 Latest research on nutrition for joint health 54
The future of bone and joint health food and drinks 55
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Chapter 5 Brain and mental health 57
Summary 57 Introduction 57 NPD and innovation 58 Mood management 59
Preventing the onset of dementia 61
Alertness, intelligence and memory 62
Key ingredients 63 Latest research on nutrition for brain and mental health 64
The future of brain and mental health food and drinks 66
Chapter 6 Digestive health 68
Summary 68
Introduction 68 NPD and innovation 69 Gut health & IBS 70
Acid reflux 71
Key ingredients 71 Probiotics 72 Inulin 73 Prebiotics 73 Latest research on nutrition for digestive health 74
The future of digestive health food and drinks 76
Chapter 7 Heart health 77
Summary 77 Introduction 78 NPD and innovation 79 Lowering cholesterol 80
Lowering blood pressure 80
Key ingredients 80 Antioxidants 81
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Plant stanols and sterols 81 Soy 82 Latest research on nutrition for heart health food and drinks 83
The future of heart health food and drinks 85
Chapter 8 Skin health and beauty 86
Summary 86 Introduction 86 NPD and innovation 87 Skincare and anti-aging 89
Hair and nails 90
Key ingredients 91 Collagen 92 Latest research on nutrition for skin health and beauty 92
The future of skin health food and drinks 93
Chapter 9 Conclusions 94
The future of targeted functional food and drinks 94 The health claims struggle 94 Consumer understanding needs to be improved 95 Areas of misunderstanding 95 Claims should be concise and clear to avoid confusion 96
Successful marketing strategies 97 New/softer claims 98
New formats and delivery mechanisms 98
Connect with the consumer 98
Make claims clear, specific and benefit-focused 99
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Table of figures Figure 1: The role of food and pharmaceuticals in the healthcare continuum 19 Figure 2: Functional food regulation by country 24 Figure 3: A shift to targeted functional food and drinks 37 Figure 4: Life expectancy at birth, by region, 1990-2015 38 Figure 5: Growth by age group (% of total country population), 2000-2020 39 Figure 6: Top Care - Dietary Supplement - Women's 50+ Formula 40 Figure 7: Prevalence of disease versus forecast growth (%), 2008-2013 45 Figure 8: Share of bone health products launched (%) by category, 2007-2010 48 Figure 9: Abbott Ensure bone health drink 51 Figure 10: Share of brain and mental health products launched (%) by category, 2007-2010 59 Figure 11: iChill and MiniChill relaxation shots 61 Figure 12: Arizona green teas 62 Figure 13: Complan Memory drink 63 Figure 14: Share of digestive health products launched (%) by category, 2007-2010 70 Figure 15: Share of heart health products launched (%) by category, 2007-2010 79 Figure 16: Kashi Heart to Heart - Cereal - Warm Cinnamon Oat 82 Figure 17: Share of skin health and beauty products launched (%) by category, 2007-2010 88 Figure 18: R&D options for food and drinks companies 100
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Table of tables Table 1: Functional food and drinks sales ($m), 2002-2012 17 Table 2: Number of claims submitted to EFSA by site specific function 32 Table 3: Functional foods product launch analysis 32 Table 4: European self-medication pharmaceutical market (€m), 2007-2009 42 Table 5: Disease prevalence 2008 (% total population), growth in sufferer numbers (CAGR
2008-2013) and forecast suffers number 2013 (actual) 44 Table 6: Total osteoporosis prevalence and sufferer numbers in eight major countries, 2008-
2013 47 Table 7: Clinical trials for bone health, October 2010 52 Table 8: Clinical trials for joint health, October 2010 54 Table 9: Total Alzheimer’s prevalence and sufferer numbers in selected major countries and
regions, 2006-2013 58 Table 10: Clinical trials for brain and mental health, October 2010 65 Table 11: Prevalence of major GIT indications across the seven major markets (000s), 2008 69 Table 12: Clinical trials for digestive health, October 2010 74 Table 13: Estimated prevalence of cardiovascular disorders across seven major markets (000s),
2009 78 Table 14: Clinical trials for heart health ingredients, October 2010 83 Table 15: Oral beauty supplements consumer spending by category in Europe and the US ($m),
2000-2010 87 Table 16: Anti-Aging skincare sales by country ($m), 2008–2014 90
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Executive summary
Functional food and drinks: the overlap between food and pharma Nutraceuticals are substances that are extracted from foods and are used either to fortify other food
products in order to enhance their nutritional properties (functional food and drinks) or are taken as
dietary supplements in the form of pills, capsules of soft-gels.
The global consumption of functional foods and drinks increased by a compound annual rate of over
6% between 2003 and 2008, and growth is predicted to continue over the next three years.
Due to the dynamic nature and the significant opportunity and profit associated with producing a
successful functional ingredient/product, a number of and drinks companies have invested in
nutraceutical ingredients and processes to try to look/act more like a pharma company and move into
this space.
In September 2010 Nestlé announced plans to invest $500m into expanding its medical nutrition
business over the next decade in a bid to capture a slice of the growing market for foods to treat
chronic conditions such as diabetes and obesity.
Regulation, marketing and positioning Health claims have traditionally been attractive marketing tools because they have the potential to
influence consumers to purchase foods and drinks that support the physical and mental wellbeing.
Drugs are more tightly regulated than FOSHU products in Japan and therefore food ingredients,
FOSHU or not, are easier to get to market. Some food ingredients, such as CoQ10, were previously
classified as drugs but later reclassified as food ingredients.
The US does not define functional foods, nor does it have a regulatory system in place specifically for
them. Instead, functional foods may be regulated as conventional foods, food additives, dietary
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supplements, drugs, medical foods or foods for special dietary use depending on the health claims that
are made.
There are three main strategies that companies are adopting in reaction to the large number of
rejections from EFSA; invest in R&D, reduce product portfolio or withdraw the health claim.
Growing audience for functional food The aging population and the lack of consumer trust in some functional claims have also led to a shift
in the type of functional products consumers are demanding.
Increased health awareness and consumer confidence coupled with an aging population has driven
demand for products that improve the quality of life, have specific health benefits and can be used by
consumers to self-medicate.
The demand from the older generation will dramatically increase over the next four decades. Certainly
disease-focused targeting will improve, creating a clear demand for more personalized nutrition. The
demand for foods which offer health benefits and even promote disease prevention will become more
important in order to avoid the long term costs and issues associated with age-related chronic
conditions such as diabetes, obesity and cardiovascular disease.
The food industry, like the pharmaceutical industry, has recognized that ‘one size fits all’ approach is
not always applicable and nutritional recommendations could be improved by personalization, for
example with respect to metabolic disorders and cardiovascular diseases.
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Bone and joint health Soft drinks accounted for the highest share of bone and joint health drinks launched in 2010 with an
increase from 26.2% to 38.4%. This significant share is reflective of the move by multinationals
developing calcium-fortified juices and the arrival of mainstream calcium-fortified water in Europe.
In Europe there have been a number of dossiers submitted for bone health. An analysis of clinical trials
carried out to 2010 with links to bone health highlights the vast numbers (1,406), which have been
submitted for approval for calcium. 470 were found for Vitamin D.
The rise in the incidence of arthritis presents an opportunity for manufacturers to educate more
consumers as to the benefits of functional health products fortified with glucosamine or omega-3
compounds.
Future market opportunities outside of offering novel ingredients may be possible through collaboration
with pharmaceutical companies looking to offer adjunct therapies for joint diseases. Those utilizing
patented and clinically proven ingredients will be best placed for this approach.
Brain and mental health Alzheimer’s disease (AD) is the most common cause of dementia among people aged 65 and older.
The disease usually begins after age 60 and risk goes up with age. While younger people also may get
AD, it is much less common.
Soft drinks took the largest share of brain and mental health food and drinks in 2010 (62.2%) a slight
increase from its value in 61.0%. This has been driven by the energy drinks market, which is one of the
fastest growing categories in the soft drinks market.
Caffeine is one of the most frequently used ingredients in the functional food and drinks market as a
whole. For manufacturers targeting fatigue and stress (taking a break for a cup of tea or coffee is a
cultural habit for many people), caffeine is used as a primary ingredient to provide a perceived boost to
energy levels.
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Consumers in major markets have shown an increased interest in products which have benefits of
sustaining mental alertness and vitality. In the leisure sector, for example, Nintendo’s Brain Age
console game is marketed as ‘brain training’ for adults, with a ‘use it or lose it’ message.
New research was published in November 2010 suggesting that in addition to heart health benefits,
beetroot juice could improve blood flow to the brain and therefore join the fight against dementia.
Digestive health Good digestive health is closely related to the idea of bodily cleansing from the inside, and therefore, to
notions of purity within and the detoxification of the body.
In 2007, the leading category in terms of share of food and drinks products launched offering digestive,
defense and immunity health benefits was dairy, at 32.5%. Soft drinks were second place, with a 25.0
% share. By 2010, however, dairy’s share had reduced to 17.8% and soft drinks had increased to
31.1%.
There is increased demand from consumers who have no medical need to be concerned about
digestive health, but who find their lifestyle is improved or enhanced by the inclusion of gut health
products in their diet.
Cultural differences mean that the opportunities for probiotic food and drinks vary across the globe. The
initial roll-out of the Actimel brand in the US was not successful due to low consumer awareness of the
benefits of good bacteria and the fact that many Americans often associate bacteria with bad health
and disease.
Heart health Sales of heart health food and drinks are expected to grow by 37% between 2005 and 2010 in Europe
and the US, and the total market is expected to be worth $7.7bn by the end of 2010.
Bakery and cereals can easily be marketed as being formulated to offer targeted heart health benefits,
via ingredients such as plant sterols, whole grains and omega-3 and 6 and dairy can offer opportunities
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for manufacturers to formulate and market products offering preventive heart health benefits (via the
ingredients of omega-3 and 6, for example) to have heart health benefits.
There have been 194 dossiers submitted to EFSA for cholesterol. Food and drinks products that help
to lower cholesterol is a large area of innovation as consumers awareness about the impact of lifestyle
on conditions such as dyslipidemia has driven a demand for food and drinks that will prevent them from
suffering from these conditions in the future.
Many clinical studies have been performed to establish that phytosterols lower cholesterol and The
American Heart Association notes that daily intakes sterol/stanol of 2g achieves maximum effects and
the National Cholesterol Education Program Adult Treatment Panel states that ‘intakes of 2-3g per day
of plant sterol/stanol esters will reduce LDL cholesterol by 6 to 15%.
Skin health and beauty Sales of oral beauty supplements are expected to have a compound annual growth rate (CAGR) of 9%
between 2005 and 2010 in Europe and the US, and the total market is expected to be worth $2.3bn by
the end of 2010.
Herbs and botanicals which claim to have skin and beauty benefits and the increased popularity of
green tea have encouraged manufacturers to innovate in this area.
Consumer skepticism about the veracity of benefit claims made for cosmetic products is widespread,
and this is a potential barrier to manufacturers of food and drinks products claiming preventive skin and
beauty health benefits.
In the future, in the context of the ever higher symbolic value given to bodily appearance and sexual
attractiveness, along with population aging, skin health and beauty will remain a dominant trend. In
order to benefit from the future growth opportunities these cultural and demographic features of major
market countries present, food and drinks manufacturers will have to articulate convincingly for
consumers the precise ways a product provides ‘beauty from within’.
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Chapter 1 Functional food and drinks: the overlap between food and pharma
Summary Nutraceuticals are substances that are extracted from foods and are used either to fortify other food
products in order to enhance their nutritional properties (functional food and drinks) or are taken as
dietary supplements in the form of pills, capsules of soft-gels.
The global consumption of functional foods and drinks increased by a compound annual rate of over
6% between 2003 and 2008, and growth is predicted to continue over the next three years.
Due to the dynamic nature and the significant opportunity and profit associated with producing a
successful functional ingredient/product, a number of and drinks companies have invested in
nutraceutical ingredients and processes to try to look/act more like a pharma company and move into
this space.
In September 2010 Nestlé announced plans to invest $500m into expanding its medical nutrition
business over the next decade in a bid to capture a slice of the growing market for foods to treat
chronic conditions such as diabetes and obesity.
Introduction Nutraceuticals/functional food and drinks have had an influence in the development of the food and drinks
industry over the past five years. They have introduced new players into the market by demanding a more
research-focused approach to product development and has also caused some food and drinks
manufacturers to reappraise their brand portfolios. This chapter looks at the growth of the functional food and
drinks industry with a specific focus on the overlap between food and pharmaceutical companies, both of
which are investing in this market.
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Definition of functional foods/nutraceuticals There are a number of different subsets of functional food and drinks and the term functional food and drinks
is often seen as interchangeable with the term nutraceuticals.
Nutraceuticals and pharmaceuticals are related in that both are types of compounds that demonstrate
bioactive properties. Nutraceuticals are substances that are extracted from foods and are used either to
fortify other food products in order to enhance their nutritional properties or are taken as dietary supplements
in the form of pills, capsules of soft-gels. The clinical evidence supporting the development of nutraceutical
products varies widely; some have been tested with pharmaceutical rigor to demonstrate properties
beneficial to health, while for other the evidence to support such claims is slim.
Nutraceutical: bioactive compounds with properties beneficial to health that are often concentrated
extracts from fruits, herbs, seeds, specific lipids and vegetables. Nutraceuticals are often used to fortify
food products, creating functional foods, or can be taken as supplements;
Dietary supplement: A product that contains a vitamin, mineral, herb or other botanical, amino acid,
concentrate, metabolite, constituent, extract, or combinations of these ingredients (modified from the
Dietary Supplement Health and Education Act);
Medical food: A food intended for the dietary management of a disease or condition and consumed
under the supervision of a physician;
Cosmeceuticals: products that combine features of cosmetics and nutraceuticals;
Pharmaceutical: bioactive compounds intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease.
Medical foods must adhere to strict definitions in all markets. In the US, this definition is only applicable in
areas where it is well established that diet is fundamental to the management of a disease. Medical foods
can be oral, such as foods for metabolic conditions such as phenylketonuria or diabetes, or enteral foods for
use in hospitals.
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For the purposes of this report, functional food and drinks are defined in the following way:
"Functional food and drinks that provide benefits beyond basic nutrition by way of added
components and may prevent disease or promote health. These benefits can range from the
prevention of osteoporosis through calcium fortification, to the use of omega-3 in fats and
spreads to lower cholesterol levels and added ingredients in soft drinks that stimulate, or
promote muscle growth."
This report does not cover dietary supplements, such as vitamin, herb and food supplements, although
information on these is included in certain sections as an indication of growth potential in other related
categories. Although the scope of nutraceuticals reaches beyond these boundaries, these markets provide
the key focus as they are central to both sales and development of nutraceuticals within the sphere of food
and drinks. However, the report also contains information about other developments in nutraceuticals that
are influencing the category as a whole.
The growth of the functional food and drinks market Functional products are one of the fastest growing areas of the food market. The global consumption of
functional foods and drinks increased by a compound annual rate of over 6% between 2003 and 2008, and
growth is predicted to continue over the next three years.
However, growth will be restricted by the implementation of Article 13 health claim legislation when the last
batch of claims is published in October 2011. The implication of the legislation is likely to result in a decline in
the number of products that make functional claims or a shift to food and drinks that make softer wellbeing
claims instead of hard, scientifically substantiated claims.
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Table 1: Functional food and drinks sales ($m), 2002-2012
2002 2007 2012 Growth 02-07 Growth 07-12France 637.2 807.9 980.4 4.9% 3.9%Germany 1,497.9 1,982.5 2,524.8 5.8% 5.0%Italy 768.2 1,138.1 1,525.2 8.2% 6.0%Netherlands 230.5 285.9 346.2 4.4% 3.9%Spain 449.3 641.1 813.7 7.4% 4.9%Sweden 157.5 250.9 317.7 9.8% 4.8%UK 1,667.9 2,103.3 2,533 4.7% 3.8%US 18,104.1 27,230.5 36,653 8.5% 6.1%Australia 516 657.7 840.8 5.0% 5.0%China 9,593.5 12,491.5 16,162.2 5.4% 5.3%Hong Kong 1,217.9 1,720.2 2,332.9 7.1% 6.3%India 1,511.6 1,940.5 2,408.9 5.1% 4.4%Japan 12,094.5 16,377.5 21,808.8 6.3% 5.9%New Zealand 108.6 132.6 170 4.1% 5.1%South Korea 1,647.2 2581 3,365.8 9.4% 5.5%
Source: Business Insights BUSINESS INSIGHTS
The US has the largest functional food and drinks market valued at $27,179 by the end of 2010. The
functional food and drinks market in the US is relatively mature although it is still growing; signaling to
manufacturers there is still a large opportunity to launch a product there. The variation in the uptake of
functional food and drinks has typically focused on two factors:
Consumer acceptance;
Regulation.
The size and growth of the Japanese functional food and drinks market has been driven by a less strict
regulatory market and a higher consumer acceptance of functional food and drinks.
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Crossover between pharma and food On the back of the growth of functional food and drinks, a number of food and drinks companies have
invested in ingredient and processes to try to look/act more like a pharmaceutical company and move into
this space more effectively. Undoubtedly this is easiest for larger food and drinks companies such as Nestlé
and Danone who are able to invest more in R&D for functional food and drinks. However, there are options
for smaller companies including outsourcing, joint ventures and in-licensing.
The consumer healthcare divisions of some of the major pharma companies are also investing in
nutraceuticals via a variety of routes. Some consumer health divisions directly compete with food and
ingredients manufacturers in the functional foods market. For example, McNeil Nutritionals markets Benecol
products which contain plant sterols and Abbott’s healthy living products compete in the functional food
market. However, other pharma companies’ consumer health divisions have opted to remain focused on
vitamin and mineral supplements (Bayer), infant and pediatric nutrition (Mead Johnson, Merck and Pfizer), or
medical foods (Abbott).
Food companies moving into the pharma space At present, the food industry is primarily targeting lifestyle-related diseases with functional foods. The
pharmaceutical industry is also targeting these same lifestyle disease growth markets, but from a different
standpoint and with different goals according to the differing roles of food and drugs, as shown in Figure 1.
Two key factors are leading to the convergence of the food and pharmaceutical industry sectors:
The increasing use of ingredients that claim to have health benefits and have subsequently been
studied in clinical trials to demonstrate these benefits;
The increasing scientific evidence for a link between diet and the cause or treatment of a number of
diseases.
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Figure 1: The role of food and pharmaceuticals in the healthcare continuum
Purpose
Health professional
Individual participation
Cost
Reduce risk
Treat disease
Low High
High Low
Low High
Fortified/functional food
Supplements Medical food Pharmaceuticals
PurposePurpose
Health professional
Health professional
Individual participationIndividual
participation
CostCost
Reduce risk
Treat disease
Low High
High Low
Low High
Fortified/functional food
Supplements Medical food Pharmaceuticals
Source: Business Insights BUSINESS INSIGHTS
Case Study: Nestlé
In September 2010 Nestlé announced plans to invest $500m into expanding its medical nutrition business
over the next decade in a bid to capture a slice of the growing market for foods to treat chronic conditions
such as diabetes and obesity. Luis Cantrell has been appointed to “pioneer a new industry between food and
Pharma.” Nestlé have also announced that it plans to develop products to combat diabetes, heart problems
and Alzheimer’s. However as Danone has invested in heavily in this area and has only recently begun to see
a significant payback it is thought it will take Nestlé a long time before it benefits from this investment
Regulators, including the European Food Safety Authority, have begun imposing tougher standards to
ensure any health-related claims are backed by science. Getting a claim through the tough EFSA regulation
process is an area of concern for many food and drinks companies and Nestlé plans to use this investment
to help to solve this problem:
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"The creation of Nestlé Health Science S.A. and the Nestlé Institute of Health Sciences is
the best way to focus our attention and organize our unique capabilities and competencies
to seize this promising business opportunity,” said Paul Bulcke, CEO of Nestlé. “The new
set-up will give us a pioneering and leading role in this entirely new industry, while at the
same time allowing us to keep the necessary focus on Nestlé's extremely important food,
beverages and nutrition business, as embodied by our binding promise of Good Food, Good
Life."
This investment signifies the high levels of investment that food and drinks companies are putting into
developing new and targeted functional food and drinks. The idea that this investment highlights the ‘overlap
between food and pharma’ has generated excitement from food and drinks and pharma companies alike with
Danone announcing shortly after Nestlé that it also plans to invest further in baby and medical nutrition.
Case Study: Danone
A further example of a food and drinks company investing heavily in functional food and drinks is Danone. In
October 2010 Danone announced plans to build an R&D centre dedicated to infant and medical nutrition in
The Netherlands after signing an agreement to purchase land on Utrecht Science Park.
Danone entered the medical and baby nutrition market through the acquisition of Numico in 2007. In 2009
turnover from medical and infant nutrition accounted for 26% of the companies €15bn turnover, growing
significantly from 2008.
Pharma companies moving into the food industry
A number of pharmaceutical companies have also invested in ingredients and technologies in a bid to target
the lucrative functional food and drinks market. They include:
In October 2010 Pharmaceutical firm Evolva extended a research deal with Abunda Nutrition. This
collaboration will enable Evolva to apply its synthetic biology expertise to the development of nutritional
ingredients;
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In March 2010, sanofi-aventis acquired Chattem Inc for $1.9bn. Chattem is a US based consumer
healthcare company that markets a variety of OTC drugs and nutraceutical products including garlic
based supplements to ‘support a healthy heart’, phytosterols and a melatonin-based sleep supplement;
Pfizer worked with UK company Phytopharm to develop a pharmaceutical Hoodia extract for weight
loss. Despite completing a number of Phase 2 trials, this collaboration was terminated by Pfizer when it
sold its Natureceuticals group in 2003. However in November 2010 Phytopharm confirmed it is in
negotiations to sell off the rights to branded hoodia weight management ingredient P57;
Bayer launched combination OTC pharmaceuticals and supplements (aspirin/phytosterol and
aspirin/calcium carbonate), although these were removed from the market in October 2008, a few
months after their launch, due to misleading labeling claims. Bayer also entered into a collaboration
with Neptune Technologies to develop a pharma-grade omega-3 product in June 2009;
GSK markets a high dose, pharmaceutical grade omega-3 fatty acid capsule for patients with high
triglyceride levels (Omacor/Lovaza) in the US. The company behind this drug, Pronova BioPharma,
continues to develop it for possible combination with a statin. Additional marketing partners for Lovaza
include Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others). Sales of
Lovaza generated more than $1bn in 2009.
Case Study: Abbott Nutrition
Abbott Nutrition is a division of Abbott Laboratories, which generated total revenues of $5.2bn in 2009. Its
businesses include infant and pediatric formulas, medical foods for special dietary needs (for example,
people with diabetes and liquids for tube feeding), and sports nutrition and nutritious snacks for adults and
children. The company has been in the market for medical foods for many years and has built expertise in
this area, but its entry into sports and convenience nutrition are more recent. Abbott purchased EAS in 2004
(for $320m) and entered into the more conventional healthy snack food market with the purchase of
ZonePerfect in 2003 (for $160m). Abbott has grown both of these product ranges since their purchase.
In addition to entering new areas of the nutrition market, Abbott aims to develop its business in emerging
markets and believes that increasing consumer demand in the international markets will drive strong growth
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for Abbott nutritional products. The company has declared its interest in the emerging markets of China,
Southeast Asia and Latin America, where increasing personal incomes and growing populations are driving
growth, particularly in the areas of infant nutrition.
As a result, Abbott opened a new pediatric nutrition manufacturing facility in Singapore in February 2009,
representing its largest investment in the nutritional sector to date ($300m). The company will also open a
nutrition science research and development center in Singapore, to focus on clinical trials and the
development of nutrition products tailored to Asian dietary needs. These investments in Singapore mirror
those made by Abbott’s pharmaceutical sector.
In addition, in July 2009 Abbott purchased Wockhardt, for $130m. Wockhardt markets infant formulas,
weaning foods and adult protein supplements. This also highlights the high level of investment that both
pharmaceutical based and food and drinks companies are making in the functional foods market.
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Chapter 2 Regulation, marketing and positioning
Summary Health claims have traditionally been attractive marketing tools because they have the potential to
convince consumers to purchase foods and drinks that support the physical and mental well-being.
Drugs are more tightly regulated than FOSHU products in Japan and therefore food ingredients,
FOSHU or not, are easier to get to market. Some food ingredients, such as CoQ10 were previously
classified as drugs but later reclassified as food ingredients.
The US does not define functional foods, nor does it have a regulatory system in place specifically for
them. Instead, functional foods may be regulated as conventional foods, food additives, dietary
supplements, drugs, medical foods or foods for special dietary use depending on the health claims that
are made.
There are three main strategies that companies are adopting in reaction to the large number of
rejections from EFSA; invest in R&D, reduce product portfolio or withdraw the health claim.
Introduction Historically, Japan has been a leading market in functional food and drinks. This is due to an extent to the
FOSHU regulation seen as ‘less strict’ regulation in Europe, and possibly the US, and high acceptance of
functional food and drinks by Japanese consumers. However, there has been a shift in the last 10 years and
the functional food and drinks markets in both Europe and the US have grown rapidly. In common with
Japan, growth in these markets has been driven by an increasing consumer acceptance of functional food
and drinks and consumers taking an active role in preventive health.
Health claims have traditionally been attractive marketing tools but more recently there has been a clear
shift towards specific disease risk reduction claims. This shift towards has also driven the demand from both
consumers and regulators for more substantiated clinically proven claims. In Europe Regulation No.
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1924/2006 was implemented in December 2006 to govern the substantiation of these claims. The regulation
on health claims continues to vary greatly by region. Figure 2 summarizes the regulation on functional food
and drinks.
Figure 2: Functional food regulation by country
EUKnown as: Article 13 Health Claim LegislationGoverned by: EFSAImplemented in: 2007
RussiaKnown as: Biologically active Food SupplementsGoverned by: Ministry of Health & Social DevelopmentImplemented in: 1997
CanadaKnown as: “Natural Health Products”Governed by: Food and Drugs AuthorityImplemented in: 2004
USKnown as: “Dietary SupplementsGoverned by: Food and Drugs AdministrationImplemented in: 1994 India
Regulation: Food Safety and Standards ActGoverned by:Effective from: 2006
AustraliaKnown as: Complementary MedicineGoverned by: Dept. of Health & AgeingImplemented in: 1991
JapanKnown as: FOSHUGoverned by: Japan Health and Nutrition Food AssociationImplemented in: 1991
EUKnown as: Article 13 Health Claim LegislationGoverned by: EFSAImplemented in: 2007
RussiaKnown as: Biologically active Food SupplementsGoverned by: Ministry of Health & Social DevelopmentImplemented in: 1997
CanadaKnown as: “Natural Health Products”Governed by: Food and Drugs AuthorityImplemented in: 2004
USKnown as: “Dietary SupplementsGoverned by: Food and Drugs AdministrationImplemented in: 1994 India
Regulation: Food Safety and Standards ActGoverned by:Effective from: 2006
AustraliaKnown as: Complementary MedicineGoverned by: Dept. of Health & AgeingImplemented in: 1991
JapanKnown as: FOSHUGoverned by: Japan Health and Nutrition Food AssociationImplemented in: 1991
Source: Business Insights BUSINESS INSIGHTS
Japan, Western Europe and the US have the most mature functional food and drinks markets. The regulation
across these three markets is quite diverse and is explained in more detail in the rest of this chapter.
Japan - FOSHU (Food for Specified Health Uses) Japan considers functional foods a separate category of food, Foods for Specified Health Use (FOSHU) was
created in 1991. Japan also has a regulatory framework for functional foods and allows health and disease
risk reduction claims on “qualified FOSHU” products based on scientific evidence. Foods that fall into
FOSHU have functional ingredients that specifically target the function and/or structure of the body and yet
they are clearly separated from drugs (Arai 2002).
The official definition of FOSHU is, according to the Japanese Ministry of Health Labor and Welfare:
25
“Foods containing ingredient with functions for health and officially approved to claim its
physiological effects on the human body. FOSHU is intended to be consumed for the
maintenance / promotion of health or special health uses by people who wish to control
health conditions, including blood pressure or blood cholesterol. In order to sell a food as
FOSHU, the assessment for the safety of the food and effectiveness of the functions for
health is required, and the claim must be approved by the MHLW.”
Food companies must follow specific processes in order to meet FOSHU criteria and each applicant is taken
on a case-by-case basis. The FOSHU process is rigorous and requires in-depth clinical trials on Japanese
natives with an estimated research cost of over $92,000 per product.
Drugs are more tightly regulated than FOSHU products in Japan and therefore food ingredients, FOSHU or
not, are easier to get to market. Some food ingredients, such as CoQ10 were previously classified as drugs
but later reclassified as food ingredients. Requirements for FOSHU approval include:
Effectiveness on the human body is clearly proven;
Absence of any safety issues (animal toxicity tests, confirmation of effects in the cases of excess
intake, etc.);
Use of nutritionally appropriate ingredients (e.g. no excessive use of salt, etc.);
Guarantee of compatibility with product specifications by the time of consumption;
Established quality control methods, such as specifications of products and ingredients, processes, and
methods of analysis (The Functional Foods Market in Japan).
By 2007 over 500 food products made it through the FOSHU application process. The health issues targeted
by FOSHU foods and ingredients include:
Gastrointestinal problems (oligosaccharides, dietary fiber, probiotics);
Hypercholesterolemia, or high blood cholesterol, (soy proteins, alginic acid, plant sterol/stanol esters);
26
Hypertension (gamma-aminobutyric acid, lactotoli peptides, wakame peptides, sardine peptides);
Hyperglycemia (guava polyphenols, indigestible dextrins);
Hypertriglyceridemia, or high blood triglycerides, (diacylglycerol, omega-3 fats, green tea catechin);
Mineral absorption (calcium citrate malate, casein phosphopeptide, heme-iron);
Dental health (xylitol, phospo acid oligosaccharides);
Bone health (soy isoflavones, fructooligosaccharides, vitamin K-2) (Ministry of Health, Labor and
Welfare).
This regulatory framework has increased consumer awareness of FOSHU and consumption of certain
products. In fact, gastrointestinal health products are the biggest FOSHU sellers in Japan and according to
the Ministry of Health, Labor and Welfare the total growth of FOSHU products has increased from $1bn in
1997 to over $6bn in 2006.
US-FDA and GRAS The US does not define functional foods, nor does it have a regulatory system in place specifically for them.
Instead, functional foods may be regulated as conventional foods, food additives, dietary supplements,
drugs, medical foods or foods for special dietary use depending on the health claims that are made.
The US FDA is reviewing comments on functional food regulation prior to changing the regulatory
framework. In 2006, the FDA took recommendations and comments on the ingredients, labeling and overall
regulatory framework in place for functional foods from the Government Accountability Office, the
International Life Sciences Institute, the Institute of Food Technologists and a citizens petition from the
Centers for Science in the Public Interest, an advocacy group
The Federal Food, Drug, and Cosmetic Act (FD&C) of 1938 provides for the regulation of all foods and food
additives. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the FD&C Act to
cover dietary supplements and ingredients of dietary supplements. Functional foods may be categorized as
27
whole foods, enriched foods, fortified foods, or enhanced foods. Labeling claims that are used on functional
foods are of two types:
Structure and function claims, which describe effects on normal functioning of the body, but not claims
that the food can treat, diagnose, prevent, or cure a disease (claims such as "promotes regularity,"
"helps maintain cardiovascular health," and "supports the immune system " fit into this category);
Disease-risk reduction claims, which imply a relationship between dietary components and a disease or
health condition.
Structure and function claims do not require preapproval by the FDA, and require much less stringent
scientific consensus than disease-risk reduction claims. Under the FD&C Act, structure and function claims
cannot be false or misleading. However, the law does not define the nature or extent of evidence necessary
to support these claims. To complicate matters, the evidence available to support structure and function
claims varies widely
Europe
Article 13 health claim legislation
In December 2006, the EU adopted Regulation No. 1924/2006 on the use of nutrition and health claims for
foods. This ruling specified definitions for specific nutrition claims (such as “low fat”). In addition, it
distinguishes between health claims based on existing and uncontroversial scientific evidence and novel
health claims that have insufficient evidence (Nutrition and Health Claims). This regulation helps ensure
consumer protection and fair competition within the food industry while stimulating innovation (Asp 2008).
Types of claims
The regulatory environments for health claims used to considerably vary among the EU member states, and
so did their definitions. With the European regulation no. 1924/2006, the European Commission (EC) created
a harmonized framework including standard terminologies.
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According to the new directive, claims are classified with respect to the function they state (nutritional content
versus health benefit function), the scientific evidence they are based on (general accepted science versus
new scientific insights), or the scope of health benefit they propose (reduction of a disease risk versus
support of a body function).
In order to clarify the scope of the European directive, a set of definitions is provided. Here, a claim is
generally defined as any message or representation, including pictoral, graphic, or symbolic representation
that provides information about a particular characteristic of a food (Article 2). A health claim is further
defined by the directive as
“any message that states, suggests, or implies that a relationship exists between a food
category, a food, or one of its constituents and health.”
Nutrition claims
Any claim that provides information on the beneficial and nutritional properties of a food is considered a
nutrition claim. These qualities could result from either the energy a foodstuff:
Provides;
Provides at a reduced or increased rate, or;
Does not provide;
As well as from the nutrient or other substances it;
Contains;
Contains at a reduced or increased rate, or;
Does not contain.
A key issue of the directive is to ensure the consumer understands the nutrition information provided by a
claim. Therefore, the EC approached the EFSA to reduce the plethora of claims that currently exist in the
member states, to a selection that can be easily comprehended by the average consumer and created a list
29
of applicable nutrition claims. It is provided in the annex of regulation no. 1924/2006 and includes the
following terms:
Low energy, energy-reduced, energy-free;
Low fat, fat-free, low saturated fat, saturated fat-free;
Low sugars, sugars-free, with no added sugars;
Low sodium/salt, very low sodium/salt, sodium-free/salt-free;
High fiber, high protein, high (vitamin/mineral name);
Increased/reduced (nutrient name);
Light, natural.
The authority encourages the use of the term “source of …” in case of vitamins and minerals while the
statement “contains…” shall apply to nutrients and other substances. The EC recently amended this list,
based on regulation No. 116/2010, for the application of claims concerning omega-3 fatty acids,
monosaturated fat, polyunsaturated fat, and unsaturated fat, which constitute an emerging field of ingredients
that impact the consumer’s health. Currently, the industry is seeking additional nutrition claims to be included
in the list.
Nutrition claims do not require legal authorization. When a claim is listed in the regulation, any company in
the food and drink industry can use it without further substantiation.
Functional well-established claims
Functional claims are such claims that refer to the beneficial effect of a food or food substance for bodily
functions, including:
Growth and development;
Psychological and behavioral functions;
Slimming and weight control, as well as satiety or reduction of available energy in the diet.
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In contrast to nutrition claims, all functional claims require approval by the EFSA. Serving as the basis for
EFSA’s evaluation process regarding the key requirements for a health claim to be approved, the regulation
1924/2006 distinguishes three types of functional claims. Their categorization is delineated by articles 13.1,
13.5, and 14 of the regulation, respectively).
Functional well-established claims, regulated by article 13.1 of the directive, are based on generally accepted
science. One of the most prominent examples is the role of calcium in the maintenance of strong bones and
teeth.
Once positively judged by EFSA and approved by the EC, these health claims will be compiled in a
community list that will be publicly accessible (estimated December 2012). Thus, accepted claims can serve
as a source for claims to be used by any company for respective food constituents. Functional well-
established claims are therefore also designated as “list claims”.
Companies from the food and drinks industry have submitted a total of more than 44,000 article 13.1 claims
to the EC via the EU member states. After condensation to 4,637 claims with related food constituents,
EFSA started their assessment with the ambitious goal of publishing the scientific opinions for all article 13.1
claims by January 2010 – a deadline laid down in article 13.3 of the directive – due to the fact that only one
tenth of the actual number of submitted claims were expected. Although batches numbers one and two,
composed of about 900 claims, were published in October 2009 and February 2010, respectively, EFSA is
still far from completing the claim list. Recent estimates suggest that it will not be completed before 2012.
Functional innovative claims
Article 13.5
Article 13.5 of the new European regulation on nutrition and health claims refers to functional innovative
claims. The basis for claims with this classification is newly developed scientific evidence. Because the
causality between the consumption of a food and its benefit for human well-being stated by functional
innovative claim lacks general scientific acceptance, their submission requires data from emerging science,
specifically proprietary investigational studies.
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EFSA is obliged to handle all innovative claims with respect to their proprietary data, therefore all claims
must be assessed on a case-by-case basis and the data will be protected for five years. However, it must be
noted that companies submitting an article 13.5 claim must explicitly express this intention in the application,
including an indication of the data provided by product-specific clinical studies.
Risk reduction and children’s health claims
Article 14 regulates the third type of functional claims, which are risk reduction claims, as well as claims that
refer to the development and health of children. A risk reduction claim is defined as a claim that states a
relationship between the consumption of a food or food constituent and a significantly reduced risk in the
development of a disease.
Although the reduction of a disease risk is intimately linked to the prevention of a disease, the legislation
excludes claims that feature the ability of a product to prevent, alleviate, or cure a disease.
Analysis of site specific claims submitted to EFSA
As part of the above health claim legislation, any companies wishing to make a nutrition or health claim on a
food or drink product were required to submit a dossier to the EFSA. Table 2 shows the number of dossiers
submitted to EFSA for each site specific function.
The number of health claims submitted for heart health was the largest. However a number of these claims
were made on antioxidants and there has been mass rejection of antioxidant claims in the first three batches
of results from EFSA, so it may not necessary relate to a positive outcome. The shift of innovation from bone
and joint health to brain and mental health is also apparent from the product launch analysis in Table 3. The
share of functional food and drink products targeted at bone and joint health has decreased and the share of
products targeted at brain and mental health has increased.
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Table 2: Number of claims submitted to EFSA by site specific function
Site specific function Number of dossiers submitted (Oct 2010)Bone health 96Brain and mental health 214Digestive health 135Heart health 285Skin health 66
Source: EFSA and Business Insights analysis BUSINESS INSIGHTS
There may be two significant reasons for this:
Firstly, brain and mental health is a very large area which covers some specific health benefits such as
intelligence but also ‘softer’ benefits such as stress and relaxation, for which there are a number of
different ingredients for which multiple dossiers have been submitted;
Secondly, some of the ingredients for bone and joint health have reasonably well substantiated clinical
evidence (i.e. calcium) and as a result the number of claims submitted will be reduced.
Products targeted at heart health and digestive health have also increased in share in NPD and there were
large amounts of dossiers submitted to the EFSA for all both areas.
Table 3: Functional foods product launch analysis
Target area 2007 2010Bone and joint health 33.7% 27.4%Brain and mental health 19.6% 23.3%Digestive health 9.6% 14.2%Heart health 9.6% 11.9%Skin health and beauty 27.5% 23.3%
Source: Product Launch Analytics BUSINESS INSIGHTS
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The number of claims submitted to EFSA can be compared to the amount of product launch activity targeted
at the specific areas. Bone and joint health has historically been the functional health area that the highest
share of functional food and drinks are targeted at. However in 2010 the share of bone health food and
drinks had decreased and products launched at brain and mental health had increased. If we compare this to
the number of dossiers submitted to EFSA it is apparent that there have been over twice the number of
dossiers submitted for brain and mental health then bone health.
The future of health claims in Europe
In October 2010 the EFSA released the third batch of opinions on the article 13.1 generic health claims. The
Parma-based agency – which is assessing all health claims submitted under the EU’s Nutrition & Health
Claims Regulation – published 808 opinions on 19th October of which just 75 were positive. This translated to
a success rate for the industry of just 9 percent.
The most of the successful claims related to essential vitamins and minerals, though there were also positive
opinions relating to dietary fibers and blood glucose control, bowel function and weight management. The
latest batch of Article 13.1 opinions – the third to be published so far – takes to 1,745 the number of claims
EFSA has assessed out of the 4,637 submitted by member states for inclusion on the so-called ‘Community
List’ of general function claims, which are to be made available for any company to use. The vast majority of
claims assessed so far have been rejected. There will be one further batch – in June 2011 – at which point
the European Commission will begin the process of writing all of the EFSA opinions into law.
In a statement regarding the latest batch, EFSA said: “EFSA’s NDA Panel issued unfavorable opinions on
many of the claims in this series due to the poor quality of the information provided to EFSA.
“Information gaps included for instance: inability to identify the specific substance on which
the claim is based (e.g. claims on dietary fiber without specifying the particular fiber); lack of
evidence that the claimed effect is indeed beneficial to the maintenance or improvement of
body functions (e.g. claims on renal ‘water elimination’); lack of precision regarding the
34
health claim being made (e.g. claims referring to terms such as ‘energy’ and ‘vitality’); or lack
of human studies with reliable measures of the claimed health benefit.”
Food and drinks, ingredients and pharma companies alike have to reassess their product claims and
dossiers to try to gain approval from EFSA. There are three main strategies that companies are adopting in
reaction to the large number of rejections from EFSA:
Invest in R&D;
Reduce product portfolio;
Withdraw health claims.
Invest in R&D
Due to the increased demands for scientific substantiation as the basis for claims on health benefits,
manufacturers will have to invest in research and development in order to provide the required human data.
A potential impact is the shift in a company’s budget from the marketing division to the science department to
ensure properly designed, well-conducted human clinical trials as the fundament for new product
development. Clearly, companies with the expertise and the resources to organize and conduct intervention
studies to prove the claimed health effects will be the winners from the new regulation. In contrast, small and
medium sized companies are at a disadvantage. Lacking some or all of funding, capability and expertise –
they are more likely to be forced down the licensing route – i.e. to buy in ingredients.
Reduce product portfolio?
In another scenario manufacturers will reduce their product portfolio to cope with the rising cost of research
and development. Instead of investing in a line of products with limited clinical research, they may focus on
scientific validation of health claims for a few featured products. This will drive up usage of contract research
organizations (CROs) to bring expertise to drive the creation, management and outcomes of intelligently
designed, human clinical trials. Despite being time-consuming and very costly, well-conducted, product-
specific trials are the key to successfully applying for health claim authorization.
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Withdraw health claim?
Because the majority of health claims have so far been deemed scientifically invalid and therefore must be
removed from shelves after the six month transition period, the European food and drinks landscape will
undergo radical changes. However, the conditions required to meet EFSA’s evaluation standards have not
been established for some food ingredients yet, and it is expected that soon there will only be few products
advertised with a handful of repetitive claims. A worst-case scenario would include food manufacturers
withdrawing products that feature health claims from the European market, which could have a drastic
impact on the financial performance of European health-oriented food manufacturers.
In April 2009 Danone withdrew the health claims it had submitted for Actimel and Activia, citing confusion
about what scientific evidence was required to substantiate the claims. The Actimel immunity claim was
resubmitted by Danone in February 2010 and its Activia gut health claim was re-entered late in 2009. Both
dossiers contained more than 10 probiotic, strain-specific clinical trials. In April 2010 (nearly a year to the day
that Danone first withdrew the claim) Danone pulled its claims from EFSA once again. It is unclear whether
Danone plans to resubmit the claims, however there is speculation that the gut health workshop which EFSA
is holding in December 2010 will give further insight into the future of immunity and gut health claim approval
in Europe, so Danone may wait for the result of this before resubmitting the claims.
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Chapter 3 Growing audience for functional food and drinks
Summary The aging population and the lack of consumer trust in some functional claims have also led to a shift
in the type of functional products consumers are demanding.
Increased health awareness and consumer confidence coupled with an aging population has driven
demand for products that improve the quality of life, have specific health benefits and can be used by
consumers to self-medicate.
The demand from the older generation will dramatically increase over the next four decades. Certainly
disease-focused targeting will improve, creating a clear demand for more personalized nutrition. The
demand for foods which offer health benefits and even promote disease prevention will become more
important in order to avoid the long term costs and issues associated with age-related chronic
conditions such as diabetes, obesity and cardiovascular disease.
The food industry, like the pharmaceutical industry, has recognized that ‘one size fits all’ approach is
not always applicable and nutritional recommendations could be improved by personalization, for
example with respect to metabolic disorders and cardiovascular diseases.
Introduction This chapter analyses the impact the global aging population amongst other factors, has had on the demand
for targeted functional food and drinks. The shift to targeted functional food and drinks has been driven by:
A growth in the number of consumers aged 40+ which has driven the market for targeted health
benefits that help them to look and feel younger for longer;
The increase in consumer awareness of health conditions and the drive to self-medicate;
37
The adoption of nutrigenomics and nutrigenetics.
Future opportunities for functional food and drinks that target specific diseases are also assessed in terms of
prevalence and growth to 2013. This analysis provides food and drinks manufacturers an insight into which
site specific areas will provide the most opportunity in terms of investment.
A shift to targeted functional foods There has been a shift in consumer behavior which in turn has had an impact on consumer demand for
functional food and drinks. The increased awareness of the impact of the diet on health has led to
consumers changing their behavior in regards to what they eat and the health benefits of it.
Figure 3: A shift to targeted functional food and drinks
Consumer confidence
Self-medication
Aging population Quality of life
Health awareness
Specificfunctional claims
-Increased number of consumers self-medicating-More emphasis on improving quality of life as consumers are living longer-Move to products with substantiated health claims
Consumer confidence
Self-medicationSelf-medication
Aging population
Aging population Quality of lifeQuality of life
Health awareness
Specificfunctional claims
-Increased number of consumers self-medicating-More emphasis on improving quality of life as consumers are living longer-Move to products with substantiated health claims
Source: Business Insights BUSINESS INSIGHTS
The aging population and the lack of consumer trust in some functional claims have also led to a shift in the
type of functional products consumers are demanding. The idea that people want to ‘look younger for longer’
is becoming more apparent as the aging population increases demand for products that provide them with
38
health benefits or ingredients that improve the quality of their life rather then stop them from suffering from
the effects of getting older.
Figure 3 highlights the shift in the functional food and drinks market. Increased health awareness and
consumer confidence coupled with an aging population has driven demand for products that improve the
quality of life, have specific health benefits and can be used by consumers to self-medicate.
Quality of life
Consumer demographics continue to change; the older population is growing at a considerably faster rate
than that of the world’s total population. In absolute terms, the number of older persons has tripled over the
last 50 years and will more than triple again over the next 50 years. According to the Department of
Economics and Social Division (DESA) Population Division, United Nations, “the percentage of older persons
is projected to more than double worldwide over the next half century. Although the highest proportions of
older persons are found in the more developed regions, this age group is growing more rapidly in the less
developed regions.”
Figure 4: Life expectancy at birth, by region, 1990-2015
50
55
60
65
70
75
80
1990 1995 2000 2005 2010 2015
Europe Asia Pacific Middle East & Africa North America
Age
50
55
60
65
70
75
80
1990 1995 2000 2005 2010 2015
Europe Asia Pacific Middle East & Africa North America
50
55
60
65
70
75
80
1990 1995 2000 2005 2010 2015
Europe Asia Pacific Middle East & Africa North America
Age
Source: Business Insights BUSINESS INSIGHTS
39
Demographic trends, in particular the aging of populations, are clearly the main driver of this market and this
will continue to be so into the future. While not all populations in all countries around the World are aging, in
general the pattern is clear. Longer life expectancy, better healthcare and improved nutrition are all helping
people to live longer. Figure 4 highlights how increased life expectancy has increased since 1990 and is
expected to continue this trend through to 2015. The chart clearly illustrates that in all regions of the World
there is a strong tendency towards increased life expectancy and that this pattern will continue over the next
five years.
Growth of ‘middle-age’
The result of this increase in life expectancy has been an explosion in the actual number of people aged 50
years old or more. The most apparent outcome of Figure 5 is the growth of the aging population. The growth
of the aging population has had a profound effect on the functional food and drinks industry in the last 10
years with a huge increase in the amount of products targeted at this age group.
Figure 5: Growth by age group (% of total country population), 2000-2020
France
Germany
Italy
Japan
Spain
Sweden
UK
US
70+ yrs60-69 yrs 50-59 yrs40-49yrs0-39 yrs
France
Germany
Italy
Japan
Spain
Sweden
UK
US
70+ yrs60-69 yrs 50-59 yrs40-49yrs0-39 yrs 70+ yrs60-69 yrs 50-59 yrs40-49yrs0-39 yrs 70+ yrs70+ yrs60-69 yrs 60-69 yrs 50-59 yrs50-59 yrs40-49yrs40-49yrs0-39 yrs0-39 yrs
Source: Business Insights BUSINESS INSIGHTS
40
In the more developed regions the proportion of older persons already exceeds that of children, and by 2050
it is expected to be double that of children. By 2050, the population of the less developed regions will have
the same percentage of persons aged 60 years and over as the more developed regions did in 2000.
The demand from the older generation will dramatically increase over the next four decades. Certainly
disease-focused targeting will improve, creating a clear demand for more personalized nutrition. The demand
for foods which offer health benefits and even promote disease prevention will become more important in
order to avoid the long term costs and issues associated with age-related chronic conditions such as
diabetes, obesity and cardiovascular disease.
Figure 6: Top Care - Dietary Supplement - Women's 50+ Formula
Source: Company information BUSINESS INSIGHTS
Figure 6 shows the Top Care range of Dietary Supplement products launched in the US in September 2010
and includes Women's 50+ Formula and Men's 50+ Formula. The tablets are claimed to provide "memory
support, bone strength, joint health, breast health, heart and eye health." This product highlights the growth
in products that are targeted specifically at this age group and have site specific functional benefits.
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Self medication and the impact of nutrigenomics and nutrigenetics
The old adage “you are what you eat” is particularly pertinent today, with the global increase in metabolic
disorders (diabetes and obesity) alongside a much greater understanding of the genetic components of
health and disease. Through research into the genome (genetic code or DNA) and epigenome (factors that
influence gene expression without changing the genetic code) it is becoming clearer how our diet can affect
which genes are switched on and off and ultimately the state of our health and wellbeing.
According to the European OTC industry association, the AESGP, Europe’s total pharmaceutical market was
worth €196.2bn. The AESGP describes the self-medication pharmaceutical market as: all medicinal products
bought spontaneously by consumers without a medical prescription at public price level, including Value
Added Tax (VAT).
At a European level, self-medication accounted for a 12.4% share of the total pharmaceutical market in
2009. However, this proportion varies considerably from country to country, with self-medication
pharmaceutical products accounting for 36% of the pharmaceutical market in Russia.
The increasing amount of the total pharmaceutical market accounted for by self-medication products
highlight the shift by consumers to take more control of what they put into their bodies and subsequently their
medication. One form of self-medication is personalized nutrition which also encompasses Nutrigenetics and
Nutrigenomics. Personalized nutrition enables clients to tailor food and drinks and to some extent self-
medication based on their individual DNA.
Personalized nutrition is a subset of nutrigenomics which looks at how heritable genes predispose an
individual’s response to nutrition. Already a number of companies have begun to apply nutrigenomics in their
R&D programs to identify new ingredients with health benefits based on genetic readout such as WellGen.
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Table 4: European self-medication pharmaceutical market (€m), 2007-2009
At consumer price level (€m) As a percentage of the total
pharmaceutical market % 2007 2008 2009 2007 2008 2009Austria 300 308 307 7.5% 7.2% 7.5%Belgium 665 676 703 15.6% 15.1% 15.4%Bulgaria 158 192 203 26.5% 28.2% 25.7%Croatia 165 177 171 10.9% 10.6% 10.5%Czech Republic 437 529 515 25.8% 26.9% 32.4%Denmark 223 227 240 12.7% 13.0% 13.7%Finland 273 296 285 10.9% 11.2% 10.6%France 1,926 1,978 1,989 6.2% 6.6% 6.6%Germany 4,497 4,350 4,230 12.3% 11.6% 11.2%Greece 297 319 337 3.7% 3.7% 3.5%Hungary 287 331 327 13.9% 15.0% 15.8%Ireland 315 333 339 15.2% 14.8% 14.5%Italy 1,596 1,597 1,603 8.4% 8.5% 8.3%Netherlands 628 635 652 10.9% 11.0% 11.4%Norway 253 261 259 12.0% 12.5% 12.4%Poland 1,702 1,997 1,798 26.9% 26.8% 25.8%Portugal 226 229 233 6.7% 6.3% 6.5%Romania 458 477 453 23.2% 22.4% 20.8%Russian Federation 3,130 3,650 3,840 34.1% 31.5% 36.6%Slovak Republic 171 231 251 23.0% 25.1% 25.8%Slovenia 50 56 64 7.9% 8.3% 9.1%Spain 618 1,744 1,822 5.6% 10.9% 11.0%Sweden 367 371 355 9.2% 9.4% 9.7%Switzerland 566 602 651 16.3% 16.2% 16.2%United Kingdom 3,334 2,880 2,649 12.5% 12.2% 12.7%EU-27 18,954 20,017 19,614 10.6% 11.0% 10.9%Europe 22,815 24,447 24,276 11.8% 12.3% 12.4%
Source: AESGP BUSINESS INSIGHTS
43
The pharmaceutical industry has witnessed a growing popularity of personalized medicine and a similar
trend is emerging with personalized nutrition. Functional food and drinks manufacturers are turning to
nutrigenomics in the quest to personalize nutrition and gain recommendations for food, drinks and
supplements based on a person’s genetic profile.
In the human genome, there are approximately 3bn bases distributed among 23 chromosomes, but despite
the diversity observed in humans, this sequence is 99.99% invariant between individuals. The genetic code
is largely static: the genome itself does not change, but the information derived from it does. Interestingly,
only ~1.2-1.8% of the transcribed human genome is estimated to code for protein-coding genes, the
remaining DNA previously viewed as “junk” represents non-coding ribonucleic acids (ncRNAs) which can be
triggered by external factors (e.g. environment, diet) and are important in controlling how genes are
expressed (Mattick, 2009).
Nutrigenomics has the potential to impact various parts of the food chain including the genetic modification of
crops and animal feeds with enhanced nutrition (e.g. omega 3, PUFA), the development of nutrigenomic test
to monitor food safety and personalized nutrigenetics diagnostic tests and the identification of nutritional
supplements and nutrigenomic based products with health benefits.
Indeed, what we eat today can affect future generations as shifts in food sources and geographic locations
can alter gene expression through epigenetic changes. For example, research in Finland has linked infant
low birth weight to adult prevalence of coronary heart disease, diabetes, hypertension, stroke and even
osteoporosis. While we are not doomed by our prenatal and early nutritional exposures, they can have a
long-term effect and make us more vulnerable to disease (Barker, 2005).
The food industry, like the pharmaceutical industry, has recognized that ‘one size fits all’ approach is not
always applicable and nutritional recommendations could be improved by personalization, for example with
respect to metabolic disorders and cardiovascular diseases. Increasingly, consumers are taking more control
of their diets and placing a greater emphasis on disease prevention – providing new market opportunities for
44
the food and pharma industries. To this end, the food industry is showing a keen interest in nutrigenomics
and personalized diets.
Disease and patient targets A result of the increase in personalized nutrition and nutrigenomics has led to a huge opportunity for food
and drinks companies to develop functional food and drinks targeted at specific disease or therapy areas. A
quick way to see where the areas of opportunity are is to look at the prevalence certain diseases and the
clinical efficacy of the ingredients and products that have targeted at these areas.
Incidence of health problems
Table 5 shows the disease prevalence and growth in sufferer numbers of some of the diseases associated
with the more established functional food and drinks markets. It is evident that from this table that the
number of consumers suffering from heart health conditions is much higher then the rest of the conditions
analyzed highlighting a potentially large opportunity for heart health manufacturers.
Table 5: Disease prevalence 2008 (% total population), growth in sufferer numbers (CAGR 2008-2013) and forecast suffers number 2013 (actual)
2008 Prevalence CAGR 2008-13 Sufferers 2013 CVD 16.9% 1.7% 116,854,555Diabetes 8.8% 1.4% 60,076,995Dysphasia 8.9% 1.0% 59,250,309IBS 12.5% 0.6% 81,962,672Hypertension 30.0% 0.8% 199,079,691Osteoporosis 2.7% 2.2% 18,980,734
Source: Business Insights BUSINESS INSIGHTS
45
Hypertension offers the largest consumer audience to target
The chart highlights that the disease with easily the greatest prevalence and forecasted number of future
sufferers is hypertension. However, it is positioned in the bottom right quadrant of the diagram, indicating that
despite having a prevalence rate well above the average the growth rate of sufferer numbers in the future is
much less than will be seen in other areas. However, the very high prevalence rate means that despite
differences in growth rates this will still offer the largest consumer audience to target in 2013.
Figure 7: Prevalence of disease versus forecast growth (%), 2008-2013
CVDDiabetes
Dysphagia
IBS
Hypertension
Osteoporosis
0%
1%
1.5%
2%
2.5%
3%
3.5%
0% 10% 20% 30% 40%
2008 Prevalence
CA
GR
200
8-13
Sufferers 2013
CVDDiabetes
Dysphagia
IBS
Hypertension
Osteoporosis
0%
1%
1.5%
2%
2.5%
3%
3.5%
0% 10% 20% 30% 40%
2008 Prevalence
CA
GR
200
8-13
Sufferers 2013
Source: Business Insights BUSINESS INSIGHTS
The increase of functional food and drinks targeted at specific areas is evident by looking at NPD related to
the diseases and therapy areas highlights in Figure 7. Chapters 4-8 highlight the targeted approach that
functional food manufacturers are continuing to adhere to, both by disease specific area and the function of
the product.
46
Chapter 4 Bone and joint health
Summary Soft drinks took the highest share of bone and joint health drinks launched in 2010 with an increase
from 26.2% to 38.4%. This significant share is reflective of the move by multi-nationals developing
calcium-fortified juices and the arrival of mainstream calcium-fortified water in Europe.
In Europe there have been a number of dossiers submitted for bone health. An analysis of clinical trials
carried out to 2010 with links to bone health highlights the vast numbers (1406), which have been
submitted for approval for calcium. 470 were found for Vitamin D.
The rise in the incidence of arthritis presents an opportunity for manufacturers to educate more
consumers as to the benefits of functional health products fortified with glucosamine or omega-3
compounds.
Future market opportunities outside of offering novel ingredients may be possible through collaboration
with pharmaceutical companies looking to offer adjunct therapies for joint diseases. Those utilizing
patented and clinically proven ingredients will be best placed for this approach.
Introduction Although bone and joint conditions such as osteoporosis and arthritis have a variety of causes, including
genetic inheritance, types of food and drink consumed can play a part in reducing propensity to develop
conditions and the relief of symptoms. This means that there are market opportunities for manufacturers to
offer food and drinks products specially formulated to give individual consumers preventive health bone and
joint benefits according to their particular health concerns.
47
Table 6: Total osteoporosis prevalence and sufferer numbers in eight major countries, 2008-2013
2008 2013 CAGR 2008-13 Prev. 2008 Prev. 2013France 1,294,258 1,434,437 2.1% 2.0% 2.2%Germany 1,706,063 1,836,748 1.5% 2.1% 2.2%Italy 1,843,963 1,982,962 1.5% 3.2% 3.4%Netherlands 262,024 288,487 1.9% 1.6% 1.7%Spain 859,733 947,677 2.0% 2.1% 2.2%Sweden 185,635 202,150 1.7% 2.1% 2.2%UK 867,949 950,857 1.8% 1.4% 1.5%US 10,000,000 11,337,415 2.5% 3.3% 3.6%Overall 17,019,626 18,980,734 2.2% 2.7% 2.9%
Source: Business Insights BUSINESS INSIGHTS
With a growth in aging consumers, osteoporosis is a rising problem and consumers continue to look to
functional health products with ingredients such as calcium to provide benefits for their condition. Indeed,
calcium is the most utilized mineral in functional health products, from orange juices to soymilks, and the
prevalence of this health condition has contributed to the popularity of calcium-fortified products.
Figure 6 shows the prevalence of osteoporosis in eight major countries. Although (as with most major health
conditions) the prevalence is not increasing rapidly it is important to note that there is a CAGR of at least 2%
in all markets highlighting how significant the aging population is and the impact it will have on the number of
people that will suffer from osteoporosis in the next five years.
Due to the large increase in the number of people ages between 40-70 yrs in a number of countries, in line
with promoting product that help to make consumers look younger there are also a number of products that
help consumers to feel younger and delay the onset of age-related diseases such as osteoporosis. In May
2010 Ito En launched a product in Japan called Kurozu to Calcium Drin,k which company literature states
48
has FOSHU approval to claim that it contains substantial calcium which maintains the bone health and may
prevent osteoporosis. As the number of consumers living longer and therefore more likely to suffer from
osteoporosis increase it is likely there will be an increase in products that help to prevent osteoporosis and
other bone conditions or relieve conditions such as rheumatoid arthritis.
NPD and innovation Soft drinks took the highest share of bone and joint health drinks launched in 2010 with an increase from
26.2% to 38.4%. This significant share is reflective of the move by multinationals developing calcium-fortified
juices and the arrival of mainstream calcium-fortified water in Europe.
Figure 8: Share of bone health products launched (%) by category, 2007-2010
9.2% 9.3%
9.9% 5.8%
13.5% 23.3%7.8% 1.2%
3.5% 1.2%
26.2% 38.4%
29.8%20.9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010
Bakery and cereals
Confectionery
Dairy
Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
cts
laun
ched
9.2% 9.3%
9.9% 5.8%
13.5% 23.3%7.8% 1.2%
3.5% 1.2%
26.2% 38.4%
29.8%20.9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010
Bakery and cereals
Confectionery
Dairy
Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
cts
laun
ched
Source: Product Launch Analytics BUSINESS INSIGHTS
Dairy has continued to show substantial growth in the bone health market as the increased understanding of
calcium absorption and probiotic use may aid in future growth of the dairy industry. The popularity of
multifunctional health ingredients is becoming evident across all health channels and, as such, probiotics fit
nicely into this trend.
49
Bakery and cereals, confectionery and savory snacks all lost share from 2007-2010. Using typically
unhealthy carrier foods such as chocolate is still a relatively niche area as consumers tend to associate
functional benefits with the consumption of healthy food and drinks.
Bone health
Sales of bone health food and drinks grew by 30% between 2005 and 2010 in Europe and the US, and the
total market is expected to be worth $5.2bn by the end of 2010. One of the key reasons for the growth of the
functional bone health market is the increasing cost of treating bone health related diseases. In the US,
osteoporosis-related hip fractures result in estimated costs of $12.8bn to $17.8bn per year for medical care,
extended treatment facilities, and the value of lost productivity within the US. Rehabilitation and
institutionalization costs are about $5.1bn and $7.1bn, respectively and account for 40% of the estimated
total economic cost of osteoporosis-related hip fractures. The value of lost productivity due to missed work is
less than 1% of total economic costs, while the value of premature death accounts for 35.3%. Bone health
has always been a strong market and has evolved in line with scientific developments
Key ingredients
There are a number of other ingredients that currently make bone health claims including:
Ingredients with anti-inflammatory properties, including Aloe vera and Omega-3;
Calcium, a mineral important in the support of the structure of bones and teeth.
Vitamin D, which helps regulate the amount of calcium and phosphate in the body and so helps to keep
bones and teeth healthy;
Vitamin C, essential for the formation, growth, and repair of bone, tendons, and ligaments;
Vitamin E, believed to have anti-inflammatory properties and benefits for cartilage;
Vitamin K2, important for the functioning of calcium and thought to have benefits for osteoporosis;
Despite the alternatives an overwhelming number of bone health food and drinks continue to supplement
bone health products with calcium.
50
The role of calcium
In a study examining the impact of calcium on bone density and fractures in postmenopausal women,
researchers conducted a review of existing randomized trials in postmenopausal women that examined the
effect of calcium supplements or dietary calcium intake on bone mineral density (BMD) at several body sites,
as well as on number of fractures. Fifteen trials with 1,806 respondents were included in the regression
analysis. According to the Ministry of Health, Labor and Welfare, Calcium was more effective than placebo in
reducing bone loss after two or more years of treatment, and there was a trend toward a reduction in
vertebral fractures, but no clear relation between calcium intake and nonvertebral fractures.
Calcium citrate and calcium carbonate are the two most commonly used forms of supplemental calcium.
Calcium carbonate contains approximately 40% elemental calcium whereas calcium citrate contains
approximately 21% elemental calcium. Calcium absorption decreases as the amount of calcium consumed at
one time increases. Therefore, products formulated with calcium should include 500mg or less per serving
(Heaney et al. 1988). Calcium carbonate requires an acidic environment to be broken down and therefore
best absorbed. If taken in supplemental form, this type of calcium should be taken with a meal. If formulated
into a functional food or beverage, the person will not need to remember to eat food along with their
supplemental calcium. Calcium citrate can be absorbed if taken on an empty stomach or with food. Aside
from an acidic stomach environment, age and vitamin D status also affect calcium absorption (Heaney
1988).
Calcium can be formulated into drinks, lightly carbonated beverages, dried powders and foods. Scientists
advise taking calcium in at least two doses during the day as opposed to trying to meet all calcium needs at
one point in time, due to decreased absorption with doses over 500mg. This presents an opportunity for food
and beverage manufacturers to create products that help seniors meet their calcium needs without having to
take a supplement. When formulating calcium into foods, the following forms are typically used: citrate,
tartrate, phosphate, gluconate, sulfate or carbonate.
Abbott Laboratories have launched the Abbott Ensure brand of Bone Health Milk Shake nutritional drinks
(Figure 9) on the market in the USA in 2010. According to the company, "Ensure Bone Health has Caltrius
51
(tm), a triple blend that provides 50% of your daily value of calcium, vitamin D, and 10g of protein to help
build strong bones."
Figure 9: Abbott Ensure bone health drink
Source: Company information BUSINESS INSIGHTS
Danone pulls calcium fortified yogurt
However, it hasn’t all been good news for calcium fortified products. Danone trialed a calcium fortified bone
health yoghurt (Densia) in a small town in France. The trial wasn’t as successful as planned and after an
indifferent response from the target market Danone cancelled plans to roll the product out nationally. A
spokesman for Danone stated:
The response of consumers was did not meet our expectations so we decided not to move
forward with the roll-out,” she said.
The product has been rolled out successfully in Italy and Spain.
Latest research on nutrition for bone health
There are several countries that recognize the link between calcium and bone health with health content
claims including:
In the US the FDA permits food and beverages rich in calcium to carry a bone health claim;
52
The Australia New Zealand Food Regulation Ministerial Council allows nutrient content claims such as
“calcium is good for healthy bones and teeth”;
Japan permits a claim linking calcium to the development of healthy bones and teeth;
In Sweden, a health claim is allowed indicating that, “a nutritionally balanced diet high in calcium
reduces the risk of osteoporosis”.
In Europe there have been a number of dossiers submitted for bone health. An analysis of clinical trials
carried out to 2010 with links to bone health highlights the vast numbers (1406), which have been submitted
for approval for calcium. 470 were found for Vitamin D.
Table 7: Clinical trials for bone health, October 2010
Ingredient Number of clinical trials Calcium 1,406Vitamin D 470
Source: The Cochrane Library and Business Insights analysis BUSINESS INSIGHTS
In August 2009 EFSA accepted a health claim linking calcium and vitamin D to bone health in older women,
but said there was insufficient evidence to support the proposed dosage levels. The article 14 (disease
reduction) claim was submitted by Abtei Pharma Vertriebs, a GlaxoSmithKline company.
Information from EFSA states:
The dossier claimed that chewing tablets with calcium and vitamin D improves bone density
in women over the age of 50, and may reduce the risk of osteoporotic fractures and hip
fractures. The proposed dosages were 1000mg calcium and 800 IU vitamin D3.
53
EFSA agreed that submitted evidence demonstrated a cause and effect relationship between the
supplementation with calcium alone or calcium and vitamin D with a reduction in the loss of bone mineral
density (BMD) and the reduction in the risk of bone fractures in post-menopausal women.
However, it proposed a re-wording of the health claim, and also said that the information provided was
insufficient to establish conditions of use for the claims. The current opinion would apply to any calcium or
vitamin D product with a similar composition according to EFSA.
Joint health
The severity of arthritis and other joint health conditions which can be lessened with use of glucosamine,
omega-3 and other joint lubricating compounds has led to an increase in the number of products available
targeted specifically at joint health. The rise in the incidence of arthritis presents an opportunity for
manufacturers to educate more consumers as to the benefits of functional health products fortified with
glucosamine or omega-3 compounds
Key ingredients
Glucosamine, and N-acetyl glucosamine, naturally occurring sugars which are known to have anti-
inflammatory effects and are believed to benefit the health of cartilage;
Chondroitin, a naturally occurring sugar which is a structural element of cartilage;
Effects of glucosamine on joint health
Glucosamine is an amino monosaccharide, which acts by providing a key nutrient for the extracellular matrix
that makes up the structure of cartilage thereby aiding in its repair. The raw material for glucosamine is
extracted from chitin present in marine animals such as shrimp and crab. Since glucosamine is a precursor
for glycosaminoglycans, and glycosaminoglycans are a major component of joint cartilage, supplemental
glucosamine may help to prevent cartilage degeneration and treat arthritis. Its use as a therapy for
osteoarthritis appears safe, but there is conflicting evidence as to its effectiveness. A Cochrane 2005 meta-
analysis of glucosamine for osteoarthritis found that only "Rotta" preparations (including older studies) found
beneficial effects for pain and functional impairment. Additionally, allergies to some shellfish have driven the
search for more sustainable non-shellfish sources of glucosamine.
54
Chondroitin sulfate
Chondroitin sulfate (CS) is an essential component of the connective tissue extracellular matrix including
hyaline cartilage and providing its elasticity. Another beneficial property of CS is that it draws water into the
extracellular matrix maintaining the hydration status of joints. CS is usually manufactured from bovine or
porcine cartilaginous material including shark cartilage.
While it is a prescription or over-the-counter drug in 22 countries, chondroitin is regulated in the U.S. as a
dietary supplement by the Food and Drug Administration. As a result, in chondroitin sulfate supplements,
there are no mandatory standards for formulation, and no guarantee that the product is correctly labeled.
Latest research on nutrition for joint health
Calcium and glucosamine are the two most commonly used ingredients for food and drinks manufacturers
wishing to make joint health claims. A review of clinical trials into the use of both calcium and glucosamine
showed that there has been significant investment in trying to prove the efficacy of both ingredients although
the number of clinical trials for calcium is much lower then those submitted for bone health signaling that the
future of the bone and joint health market may lay in companies that make bone health rather then joint
health claims.
In September 2010 the British Medical Journal published a report that stated that the evidence from 10
clinical trials with 3,803 people with knee or hip osteoarthritis showed that there were no clinically relevant
effects of chondroitin, glucosamine, or their combination on perceived joint pain or on joint space narrowing.
Table 8: Clinical trials for joint health, October 2010
Ingredient Number of clinical trials Calcium 6Glucosamine 12Chondroitin 7
Source: The Cochrane Library and Business Insights analysis BUSINESS INSIGHTS
55
Professor Juni and his co-workers searched the literature for “large scale randomized controlled trials in
more than 200 patients with osteoarthritis of the knee or hip that compared glucosamine, chondroitin, or their
combination with placebo or head to head”. Of the 58 potentially eligible studies, only 10 met the inclusion
criteria. This provided the reviewers with data for 3,803 people with knee or hip osteoarthritis. All studies
used doses of at least 800 mg/day of chondroitin and at least 1500 mg/day of glucosamine.
Despite the apparent null effects, scientists state in the British Medical Journal that sufferers of osteoarthritis
may continue using the supplements due to the ‘perceived’ benefit on joint health.
“Some patients, however, are convinced that these preparations are beneficial, which might be because of
the natural course of osteoarthritis, regression to the mean, or the placebo effect,” state the reviewers, led by
Prof Peter Jüni from the Institute of Social and Preventive Medicine at the University of Bern in Switzerland.
In addition, the reviewers support the safety of glucosamine and chondroitin supplements and “see no harm
in having patients continue these preparations as long as they perceive a benefit and cover the costs of
treatment themselves”, they added.
The negative results of this highly publicized study may have had an impact on the number of claims
submitted for glucosamine to EFSA. The number of Article 13.1 health claim submissions received for
glucosamine was 15 in comparison to 201 for calcium.
The future of bone and joint health food and drinks It is clear that the joint and bone health market is still growing and with aging populations increasing, there is
likely to be increased demand for treatment options. Market opportunities outside of offering novel
ingredients may be possible through collaboration with pharmaceutical companies looking to offer adjunct
therapies for joint diseases. Those utilizing patented and clinically proven ingredients will be best placed for
this approach.
56
The next wave of nutraceutical solutions is likely to focus on a combination of biochemical pathways to aid
treatment. This is likely to include the traditional provision of concentrated nutrients for repair and prevention
but also nutrients for pain management and relief from inflammation.
57
Chapter 5 Brain and mental health
Summary Alzheimer’s disease (AD) is the most common cause of dementia among people aged 65 and older.
The disease usually begins after age 60 and risk goes up with age. While younger people also may get
AD, it is much less common.
Soft drinks took the largest share of brain and mental health food and drinks in 2010 (62.2%) a slight
increase from its value in 61.0%. This has been driven by the energy drinks market is one of the fastest
growing categories in the soft drinks market.
Caffeine is one of the most frequently used ingredients in the functional food and drink market as a
whole. Targeting fatigue and stress (taking a break for a cup of tea or coffee is a cultural habit for many
people), caffeine is used as a primary ingredient to provide a perceived boost to energy levels.
Consumers in major markets have shown an increased interest in products which have benefits of
sustaining mental alertness and vitality. In the leisure sector, for example, Nintendo’s Brain Age
console game is marketed as ‘brain training’ for adults, with a ‘use it or lose it’ message.
New research was published in November 2010 suggesting that in addition to heart health benefits,
beetroot juice could improve blood flow to the brain and therefore join the fight against dementia.
Introduction The prevalence of depression and other depressive symptoms is increasing worldwide and anti-depressants
are prescribed in growing quantities to treat the disorder.
Dementia is not one specific disease but is instead a group of symptoms that affect the brain. One common
aspect of dementia is memory loss, though as a stand-alone symptom memory loss does not signify
dementia. Some of the symptoms of dementia may include: difficulty with getting dressed or eating, loss of
control over emotions, inability to solve problems, agitation, seeing things that are not there and memory
58
loss. Dementia causes serious problems with two or more brain functions such as memory and language
(Medline Plus, NIH).
Alzheimer’s disease (AD) is the most common cause of dementia among people aged 65 and older. The
disease usually begins after age 60 and risk goes up with age. While younger people also may get AD, it is
much less common. Approximately 3% of men and women aged 65 to 74 years old suffer from AD, and
nearly half of those age 85 and older may have the disease. Table 9 highlights the prevalence in the seven
major markets.
Table 9: Total Alzheimer’s prevalence and sufferer numbers in selected major countries and regions, 2006-2013
Country 2007 2009 2013 Prevalence (m) (%) m (%) m (%)France 0.5 0.81% 0.51 0.82% 0.54 0.84%Germany 0.7 0.85% 0.74 0.88% 0.81 0.96%Italy 0.55 0.94% 0.58 0.98% 0.63 1.06%Spain 0.35 0.80% 0.37 0.84% 0.41 0.92%UK 0.46 0.76% 0.48 0.79% 0.52 0.84%EU6 2.57 0.83% 2.67 0.86% 2.9 0.92%US 2.75 0.90% 2.85 0.92% 3.06 0.95%Japan 1.31 1.02% 1.36 1.07% 1.49 1.17% Total 6.63 0.89% 6.89 0.92% 7.45 0.98%
Source: Business Insights BUSINESS INSIGHTS
NPD and innovation As with a number of the other areas of targeted functional food and drinks, soft drinks took the largest share
of brain and mental health food and drinks in 2010 (62.2%) a slight increase from its value in 61.0%. This
has been driven by the energy drinks market is one of the fastest growing categories in the soft drinks
59
market. The popularity of energy and anti-energy food and drinks has also continued to drive demand for
brain and mental health food and drinks.
Figure 10: Share of brain and mental health products launched (%) by category, 2007-2010
2.4% 5.4%7.3% 5.4%11.0% 4.1%
1.2%
61.0% 62.2%
17.1% 21.6%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010Bakery and cerealsConfectioneryDairy Ready meals
Savory snacks
Soft drinks
Other
1.4%
% s
hare
of p
rodu
cts
laun
ched
2.4% 5.4%7.3% 5.4%11.0% 4.1%
1.2%
61.0% 62.2%
17.1% 21.6%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010Bakery and cerealsConfectioneryDairy Ready meals
Savory snacks
Soft drinks
Other
1.4%
2.4% 5.4%7.3% 5.4%11.0% 4.1%
1.2%
61.0% 62.2%
17.1% 21.6%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010Bakery and cerealsConfectioneryDairy Ready meals
Savory snacks
Soft drinks
Other
1.4%
% s
hare
of p
rodu
cts
laun
ched
Source: Product Launch Analytics BUSINESS INSIGHTS
Mood management
Caffeine is one of the most frequently used ingredients in the functional food and drink market as a whole.
Targeting fatigue and stress (taking a break for a cup of tea or coffee is a cultural habit for many people),
caffeine is used as a primary ingredient to provide a perceived boost to energy levels. Some products within
the ‘mood food’ category are positioned to combat feelings of exhaustion and caffeine is a natural ingredient
relied upon by many manufacturers to provide this boost.
The main goal of using an energy drink is to get you through the day without feeling fatigue or tired. Until
recently, the only way most energy products achieved this was to provide a selection of stimulants, such as
caffeine. However, recently there has been a large shift in terms of innovation toward products that offer
relaxation instead of energy-boosting benefits.
According to an American Express/RoperASW Global Affluent Study, high income consumers in the US,
Australia and Japan are the most stressed out, while those in Hong Kong and Brazil are the least stressed.
60
Stress levels in these countries are directly related to working hours. Employed affluents report higher levels
of stress. Americans have the highest levels of stress (66%) and 82% of Americans are employed. Only 67%
of Brazilian affluents are employed and only 35% experience stress several times a week. Affluent
respondents in highly stressed countries spend more time engaged in activities such as housework, leisure
activities and working.
Stress and poor sleeping habits are often linked to feelings of lethargy and fatigue, and in order to overcome
such factors, a selection of new functional beverages are making headway into the functional foods market
(Figure 11). One of the most recent launches has been iChill (Figure 11) from Figueroa Brothers, which was
launched in late 2009 and markets itself as the "world’s first relaxation shot", building on the pioneers of the
market for relaxation, Dreamerz Foods and BD Blue Cow LLC. From its 7-Eleven distribution in 2009, iChill
has just announced several new distribution deals, including 650 Barnes & Noble locations, 200 Harris
Teeters, and 150 Smoothie Kings. This rapidly increasing popularity and acceptance by additional retail
channels suggests the emergence of an acceptance of and a willingness to try out relaxation products
among consumers.
61
Figure 11: iChill and MiniChill relaxation shots
Source: Company information BUSINESS INSIGHTS
Preventing the onset of dementia
With as many as 24m people worldwide afflicted with dementia, researchers are looking for correlations in
genetics, diet and environment.
Since many of these people live in low- and middle-income countries, the solution to reducing instances of
dementia may be a cost-effective one: more oily fish, according to a paper in the American Journal of Clinical
Nutrition.
Omega-3, 6 and 9 are essential fatty acids that have taken a prominent position in the functional food and
drinks industry over the past decade. Consumers recognize that consuming essential fatty acids (EFA) is
important as part of a healthy diet and there is growing understanding that fats can be divided into two
camps: good fats and bad fats (saturated fats, transfats etc).
Oily fish are rich in omega-3 long-chain polyunsaturated fatty acids, which some studies have suggested are
positively related to cognitive function in later life. A few studies have been less convincing that increased
meat consumption may be related to cognitive decline.
62
Green tea is heavily marketed for its health benefits and most recently, in March 2006, a study published in
the European Journal of Neuroscience, and one in the Journal of Nutrition in Japan, both claimed that green
tea could protect against age-related diseases such as Alzheimer’s. This combined with its antioxidant
properties has meant the appeal of the flavor is increasing with consumers in Europe and the US. The
Arizona Beverage Company launched a range of innovative green teas in the US and the UK. The Arizona
green teas come in a variety of flavors including, Asia plum green tea, diet green tea, green tea, honey green
tea, mandarin orange green tea, and two No Carb Ice Tea variants: blueberry green tea and white cranberry
and apple green tea.
Figure 12: Arizona green teas
Source: Company information BUSINESS INSIGHTS
Alertness, intelligence and memory
Consumers in major markets have shown an increased interest in products which have benefits of sustaining
mental alertness and vitality. In the leisure sector, for example, Nintendo’s Brain Age console game is
marketed as ‘brain training’ for adults, with a ‘use it or lose it’ message. In terms of food and drinks, products
which are high in omega-3 have proven attractive to consumers, in the context of proven links between
63
omega-3 fatty acids and the improvement of brain function in children and adults. Omega-3 can also slow
down the onset of dementia in adults, including Alzheimer’s disease. The success of these products
indicates potential growth opportunities for manufacturers of food and drinks products that claim to enhance
mental alertness, mental vitality and mental intelligence.
A new Complan Memory brand of Health Drink Mix was launched in May 2010 in Pakistan. Company
literature states it has 23 vital nutrients (including beetroot juice) in planned proportion along with five brain
chargers with extra brain power.
Figure 13: Complan Memory drink
Source: Company information BUSINESS INSIGHTS
Key ingredients
As there are a number of different functions of brain and mental health food and drinks there are a number of
ingredients associated with the varying aspects:
Caffeine, to boost energy;
Folic acid, or vitamin B9, essential to the healthy development of the brain of the fetus;
64
Phosphatidyl serine, a chemical compound that, according to the US Food and Drug Administration
(FDA) may reduce the risk of dementia in the elderly and may reduce the risk of cognitive dysfunction in
the elderly;
B vitamins, including B3 and B6, which may benefit mental alertness and clarity;
Alpha GPC (Alpha-glycerylphosphorylcholine), a naturally occurring substance derived from soy
lecithin and thought to contribute to improved mental focus and stimulation of cognitive function;
DHA, Omega-3 and ARA, fatty acids important for brain function;
Choline, a vitamin B-like chemical important for brain development in the fetus and in infants and which
may help to prevent aging-related memory loss;
DMAE, a naturally occurring substance which speeds up the production of the brain nutrient
acetylcholine;
Vinpocetine, derived from the periwinkle plant, and reported to have cerebral blood flow enhancing
effects and to improve memory;
Huperzine-A, derived from a Chinese moss plant, and said to have memory improvement benefits, via
its maintenance of levels of the brain nutrient acetylcholine.
Latest research on nutrition for brain and mental health
An analysis of clinical trials for bone and mental health are shown in Table 10. The number of clinical trials
for brain and mental health are a lot smaller then some of the other areas of targeted functional health. One
reason for this may be that because there are a number of different areas of brain and mental health which
makes it hard to track the specific clinical trials for all the areas. The number of dossiers submitted to EFSA
was the largest out of the targeted functional areas this report analyzes highlighting that this is still a key area
of innovation.
65
Table 10: Clinical trials for brain and mental health, October 2010
Ingredient Number of clinical trialsDHA 2Coenzyme Q10 5Vitamin A 5Folate 4Folic acid 2
Source: The Cochrane Library BUSINESS INSIGHTS
New research was published in November 2010 suggesting that in addition to heart health benefits, beetroot
juice could improve blood flow to the brain and therefore join the fight against dementia. Scientists at Wake
Forest University in the US (published in Nitric Oxide: Biology and Chemistry) decided to explore the
potential impact that beetroot juice could have on brain health.
“There have been several very high-profile studies showing that drinking beet juice can
lower blood pressure, but we wanted to show that drinking beet juice also increases
perfusion, or blood flow, to the brain,” said Daniel Kim-Shapiro, director of the Translational
Science Center at Wake Forest.
Improved blood flow to the brain is relevant to cognitive health and aging because poorer blood flow in the
brain among the elderly is believed to be linked to the onset of dementia. Beetroot is a high-nitrate food and
because in the body nitrate turns to nitrite, which has been found to help open blood vessels and improve
blood flow, the scientists decided to study its impact on blood flow to the brain.
According to a review on the study:
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The study consisted of taking a group of 14 adults aged 70 or over and for two days and fed half of
them a high nitrate breakfast that included 16 ounces of beetroot juice while the other half ate a low
nitrate breakfast;
After that an MRI scan was taken before the two groups swapped breakfasts for two days before
having another scan;
The MRI scans revealed that blood flow to the white matter of the frontal lobes, an area commonly
associated with dementia, was higher among those who had just had the high nitrate breakfast.
Research published in September 2010 also showed that supplementation with vitamin C could improve the
emotional state of hospitalized patients. The trial, published in the journal Nutrition, suggests that increasing
vitamin C levels in acutely hospitalized patients – who often have vitamin deficiencies – could improve mood
response scores by 34 percent.
"About one in five acute-care patients in our hospital have vitamin C levels so low as to be
compatible with scurvy," said lead researcher, Dr. John Hoffer, professor of medicine at
McGill University, Canada.
"Patients are rarely given vitamin supplements. Most physicians are simply unaware of the
problem. Subclinical deficiencies of vitamin C and D have each been linked to psychological
abnormalities, so we examined that aspect in our clinical trial," added Dr. Hoffer.
The future of brain and mental health food and drinks Within the mind and mood preventive health trend, there is an element of contradiction between drivers of
products offering boosts to performance in terms of cognitive energy, and drivers of products offering stress
and relaxation benefits. There is an offshoot of both prescribed and recreational drug practices, where
patients or users will vary their energy levels and mental states by using uppers and downers. Consumers
can seek in one set of circumstances to boost their cognitive energy with ‘up benefits’ (important in an
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examination, in a job interview, or just to get through a demanding day), whilst in another (at home, at night
or on holiday) may look for food and drinks products which offer them ‘down benefits’ (anti-stress, relaxation
and sleep-aiding benefits).
In short there are is very little evidence to support a number of brain and mental health claims. The low levels
of clinical trials highlights being carried out for the ingredients related to brain and mental health signifies this
is a functional area that is likely to see a large amount of claims discredited. The result of this is likely to be a
change in the type of brain and mental health claims. There will be shift to softer claims around the areas of
relaxation and wellbeing rather then the clinically substantiated areas of cognitive function and intelligence.
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Chapter 6 Digestive health
Summary Good digestive health is closely related to the idea of bodily cleansing from the inside, and therefore, to
notions of purity within and the detoxification of the body.
In 2007, the leading category in terms of share of food and drinks products launched offering digestive,
defense and immunity health benefits was dairy at 32.5%. Soft drinks were second place, with a 25.0 %
share. By 2010, however, dairy’s share had reduced to 17.8% and soft drinks had increased to 31.1%.
There is increased demand from consumers who have no medical need to be concerned about
digestive health, but who find their lifestyle is improved or enhanced by the inclusion of gut health
products in their diet.
Cultural differences mean that the opportunities for probiotic food and drinks vary across the globe. The
initial roll-out of the Actimel brand in the US was not successful due to low consumer awareness of the
benefits of good bacteria and the fact that many Americans often associate bacteria with bad health
and disease.
Introduction Consumers are increasingly aware that digestive health can have a key role in preventive health, including
skin health, immunity levels and energy levels as well as general feelings of bodily health. Good digestive
health is closely related to the idea of bodily cleansing from the inside, and therefore, to notions of purity
within and the detoxification of the body. Functional food and drinks that target digestive health problems
have been available for a number of years.
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Table 11: Prevalence of major GIT indications across the seven major markets (000s), 2008
Country GERD PUD IBS UC CD Prevalence Prevalence Prevalence Prevalence Prevalence (000s) (000s) (000s) (000s) (000s)France 19,418 742 3,092 74 68Germany 35,840 1,324 14,982 25 33Italy 5,297 589 7,180 71 59Spain 6,691 487 5,007 93 40UK 12,950 855 10,262 147 24EU5 80,196 3,998 40,523 409 224Japan 22,835 1,658 13,777 26 64US 127,607 5,469 43,143 729 547Total 230,637 11,125 97,443 1,164 835GERD- Gastroesophageal reflux disease PUD- Peptic ulcer disease IBS- Irritable Bowel Syndrome UC- Ulcerative colitis CD- Crohn's disease
Source: Business Insights BUSINESS INSIGHTS
NPD and innovation In 2007, the leading category in terms of share of food and drinks products launched offering digestive,
defense and immunity health benefits was dairy at 32.5%. Soft drinks were second place, with a 25.0 %
share. By 2010, however, dairy’s share had reduced to 17.8% and soft drinks had increased to 31.1%.
Dairy and soft drinks are leading categories in food and drinks products offering preventive digestive,
defense and immunity health benefits because:
Dairy products can readily be formulated to contain prebiotic and probiotic ingredients and antioxidants
with benefits for digestive, defense and immunity health;
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Soft drinks can easily be made from and/or flavored with natural and pure fruit and vegetable
ingredients, and can therefore be high in immune boosting vitamin and mineral content, and can
incorporate probiotics. Moreover, their high water content allows manufacturers to appeal to
consumers’ knowledge of hydration as an important element of a preventive digestive, defense and
immunity health diet, through aiding the flushing out of the body.
Figure 14: Share of digestive health products launched (%) by category, 2007-2010
7.5%15.6%
32.5% 17.8%
5.0%
2.2%
2.2%
25.0% 31.1%
30.0% 31.1%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010
Bakery and cereals
Dairy
Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
cts
laun
ched
7.5%15.6%
32.5% 17.8%
5.0%
2.2%
2.2%
25.0% 31.1%
30.0% 31.1%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010
Bakery and cereals
Dairy
Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
cts
laun
ched
Source: Product Launch Analytics BUSINESS INSIGHTS
Gut health & IBS
Food intolerance and the high incidence of irritable bowel syndrome (IBS) have driven consumers to look for
solutions in food. In the developed markets of the EU and US, incidence of IBS is high, ranging between
10% and 20% of the total population. The majority of these sufferers are female. There is also higher
demand from consumers who have no medical need to be concerned about digestive health, but who find
their lifestyle is improved or enhanced by the inclusion of gut health products in their diet.
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Acid reflux
The symptoms of GERD include heartburn (pyrosis), acid regurgitation, chest pain, sore throat and/or painful
swallowing, chronic cough, excessive salivation, and inflammation of the sinuses (sinusitis). With prolonged
irritation of the lower part of the esophagus from repeated reflux, the cells lining the esophagus may change,
potentially causing conditions such as Barrett’s esophagus to arise. Episodes of normal reflux typically occur
after meals, are brief and without symptoms, and rarely occur during sleep. Acid reflux becomes pathological
when an individual develops frequent symptoms or when the esophagus becomes damaged.
Key ingredients
Manufacturers market their food and drinks products as offering preventive digestive, defense and immunity
health and immunity benefits through highlighting key ingredients, and/or the naturalness of their formulation.
Key ingredients include:
Probiotic active bacterial cultures with immunity boosting benefits, such as Lp299v, Lactobacillus
bulgaricus, Bifidubacterium sp, bififobacterium lactis, and lactobacillus acidophilus;
Seed oil complex, with antioxidant properties to benefit the immune system;
Superfruits (such as maracuja and noni) and superplants (such as echinacea and milk vetch) which are
high in antioxidants to boost immunity;
The antioxidant vitamins C and E, with benefits for the health of the immune system;
Fiber, including chicory root, a prebiotic fiber to help regulate the digestive system;
Aquatic plants, such as chlorella and spirulina, high in protein and thought to aid detoxification
processes in the body;
Inulin.
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Probiotics
One of the main uses of probiotics is in the support of gut health as probiotics facilitate the fermentation of
non-digestible dietary residues. This fermentation process results in the production of short chain fatty acids,
which can play a role in glucose metabolism and potentially lower the glycemic response to a meal which
also has health implications for diabetics and weight control.
In 2006, Kraft introduced the health and wellness brand LiveActive, which is a range of pro and prebiotic
fortified functional foods ranging from cheese, cereals and snack bars. Kraft’s strategy was to invest heavily
in the education of consumers about probiotics through the use of TV, print and digital marketing. The
packaging of all LiveActive products carried the brand’s website, and encouraged consumers to sign up for
the “gut check” which provided information about how foods and lifestyles impact gut health. The brand also
made a bold claim: “One serving of great-tasting LiveActive Natural Cheese Snacks every day for 14 days
will help promote regularity – or we will refund you purchase price”.
Kraft also capitalized on consumer recognition and trust of fiber as an ingredient with digestive health
benefits. Product packaging clearly showed that the product contained probiotic and fiber and that it was
suitable for digestive health. The use of the probiotic bar as a format offered convenience to rival the daily
shot of Yakult, with the benefits of a new taste and texture.
After only two years on the market, Kraft’s attempt to enter and extend the US probiotic was put on hold.
Although the potential for success for Kraft was related to its expertise in formulation and distribution, some
key factors relating to the functional foods category were overlooked. The first factor behind the failure was
the choice of cheese as its probiotic launch platform. Although cheese is well known for its high levels of
calcium, it is also recognized as an indulgent calorie laden product. Dairy products such as yogurt are
perceived to have healthier nutrient profiles and as a result, consumers are more accepting of added
ingredients within them and the associated health messages.
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Inulin
One of the major drivers of change within the dairy nutraceuticals market has been the growing use of inulin.
Inulin is a sugar and fat replacer used as a bulking agent. When it is digested, there is no hydrolysis,
absorption or bacterial breakdown in the mouth, stomach or small intestine. Therefore, inulin contributes no
calories during the digestive process. However, colonic fermentation occurs when beneficial intestinal
bacteria, bifidobacteria, use inulin as a food source. Inulin and other fat replacers represent a major
progression for food manufacturers, helping to implement the low and light demands of the consumer with
the need to provide functional benefits as well.
Prebiotics
Prebiotics are non-digestible dietary ingredients such as fructo-oligosaccharides (FOS) that exert positive
influences on the host because they selectively stimulate growth and/or metabolic activities of bacterial
species in the colon with health promoting properties. Prebiotics also increase calcium absorption
independently of intake, probably because the acidification of the sites of absorption in the intestines makes
calcium more soluble and more easily absorbed.
The strongest evidence for the clinical effectiveness of probiotics has been in their use for the prevention of
symptoms of lactose intolerance, treatment of acute diarrhea, attenuation of antibiotic-associated
gastrointestinal side effects and the prevention and treatment of allergy manifestations. Researchers from
the Department of Pediatrics, University of Tartu, Estonia have recently evaluated the influence of the
probiotic Lactobacillus rhamnosus GG (LGG)-enriched formula on growth and fecal microflora during the first
6 months of life in normal healthy infants. One hundred and twenty healthy infants (up to 2 months) received
the LGG-supplemented formula or regular formula in a double-blind, randomized manner until the age of 6
months.
105 infants (51 in the LGG group) completed the study which showed that those who received the LGG-
supplemented formula grew better: changes in their length and weight at the end of the study were
significantly higher than those receiving regular formula. More frequent colonization of the health promoting
gut bacteria lactobacilli was found in the LGG group, 91% versus 76% at the end of the study. The authors of
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the study concluded that infants fed with the LGG-enriched formula grew better than those fed with regular
formula
The vast majority of US-based prebiotic containing products can be found in mainstream yogurts, nutrition
bars, and breakfast cereals. Consumer product/ingredient education will go a long way in expanding the
market. One such example of a successful entry into the US market for gut health includes the likes of
Kellogg’s Rice Krispies Multi-Grain breakfast cereal, and low carb energy bars.
Latest research on nutrition for digestive health
The regulations regarding gut health products are radically different across continents. In the United States,
there is neither a legal definition nor specific regulations regarding the marketing of probiotics, prebiotics or
synbiotics. In contrast, probiotic foods in Japan may be granted FOSHU (Foods for Specific Health Use)
status by the Japanese Department of Health, making them “legally recognized as foods that deliver direct
health benefits and eligible for direct health claims”. As such, the pro and prebiotic gut health market is worth
over $2.3bn in Japan (in the world market, 68% of fermented product consumption is in the Asia-Pacific
region, with South Korea and Japan accounting for 70% of consumption according to DEFRA, UK).
Table 12: Clinical trials for digestive health, October 2010
Ingredient Number of clinical trials Probiotic 16Prebiotic 7Bifidobacterium 357Lactobacillus 14Inulin 362
Source: The Cochrane Library and Business Insights analysis BUSINESS INSIGHTS
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In contrast to increased claims and scientific research in Europe, US policy is such that only indirect or so-
called “soft” health claims are utilized for pro and prebiotics. The Food and Drug Administration (FDA), has
allowed such claims as “contains acidophilus and bifidobacteria, which are considered normal inhabitants of
a healthy digestive system,” and “helps promote healthy digestion”.
The high number of negative opinions relating to gut health and the withdrawal of gut health and immunity
claims from leading players such as Danone has prompted EFSA to release a guidance document. Key
points in the dossiers that require further substantiation include:
Improved digestion or absorption of nutrients such as lactose and iron are physiological beneficial and
can form the basis of claims;
Maintenance of a normal immune function is physiologically beneficial but the effect must be defined in
a way such as ‘defends against pathogens/allergens’. ‘Boosts natural defenses’ claims are not specific
enough;
Reduction in the incidence of respiratory, gastrointestinal and urinary infections are valid outcome
measures for general immunity claims if matched by changes in immunological parameters such as a
reduction in allergens or pathogens;
Self reported allergy data is, “unreliable and insufficient for diagnosis of allergy.” Clinical and lab
measures should be shown in the same intervention studies;
Reductions in inflammation markers can be beneficial.
Similarly, the NDA pointed out that immune function biomarkers such as levels of lymphoid subpopulations;
responses of lymphocytes; phagocytic activity of phagocytes; lytic activity of natural killer cells and cytolytic T
cells; production of cellular mediators; immunoglobulin levels and delayed-type hypersensitivity responses
only had value as supportive evidence.
Cultural differences mean that the opportunities for probiotic food and drinks vary across the globe. The
initial roll-out of the Actimel brand in the US was not successful due to low consumer awareness of the
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benefits of good bacteria and the fact that many Americans often associate bacteria with bad health and
disease. In response, Danone educated US consumers about probiotics by launching a website aimed at
informing consumers about the benefits of healthy bacteria. In February 2004, Danone changed the Actimel
branding to DanActive as part of a re-launch for the US market. The drink is marketed on its immunity
benefits, rather than focusing on bacteria. Since then, the company has been more successful in the US
The future of digestive health food and drinks The future of digestive health food and drinks in terms of claims in the EU is still very unclear. A workshop
held by EFSA in December 2010 is likely to shed some additional light on the future of this area. In other
areas of functional food and drinks, probiotics are still a relatively buoyant market in Japan, the US and
Europe with consumers’ willingness to self-medicate in these areas a key driver. Probiotic containing dairy
products for digestive health, which represent established markets in the EU and Japan, are providing
opportunities for growth in the US market.
A positive for the future of targeted functional digestive health food and drinks is the high levels of clinical
trials taking place on ingredients with digestive health benefits. As stated previously in the chapter, the
market will be driven by consumers with no medical need to be concerned about digestive health, but who
find their lifestyle is improved or enhanced by the inclusion of gut health products in their diet. The inclusion
of probiotics in non-dairy based products such as bakery and cereal based products will also drive growth in
the functional digestive health market.
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Chapter 7 Heart health
Summary Sales of heart health food and drinks are expected to grow by 37% between 2005 and 2010 in Europe
and the US, and the total market is expected to be worth $7.7bn by the end of 2010.
Bakery and cereals can easily be marketed as being formulated to offer targeted heart health benefits,
via ingredients such as plant sterols, whole grains and omega-3 and 6 and dairy can offer opportunities
for manufacturers to formulate and market products offering preventive heart health benefits (via the
ingredients of omega-3 and 6, for example) to have heart health benefits.
There have been 194 dossiers submitted to EFSA for cholesterol. Food and drinks products that help
to lower cholesterol is a large area of innovation as consumers awareness about the impact of lifestyle
on conditions such as dyslipidemia has driven a demand for food and drinks that will prevent them from
suffering from these conditions in the future.
Many clinical studies have been performed to establish that phytosterols lower cholesterol and The
American Heart Association notes that daily intakes sterol/stanol of 2g achieves maximum effects and
the National Cholesterol Education Program Adult Treatment Panel states that ‘intakes of 2-3g per day
of plant sterol/stanol esters will reduce LDL cholesterol by 6 to 15%.
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Introduction The range of conditions within cardiovascular disease is wide. The focus on treatment in cardiovascular
disease is twofold:
Firstly lowering the risk associated with cardiovascular risk factors in order to prevent an acute
cardiovascular event;
Secondly, delaying or preventing the onset of chronic cardiovascular disease.
The two most common risk factors are dyslipidemia and hypertension.
Table 13: Estimated prevalence of cardiovascular disorders across seven major markets (000s), 2009
Country Hypertension Dyslipidemia StrokeFrance 16,152 31,255 79Germany 29,405 54,103 127Italy 22,609 29,851 112Spain 20,147 10,273 89UK 23,214 28,987 102EU5 111,526 154,468 509US 102,758 159,641 745Japan 46,324 25,849 236Total 260,608 339,959 1,490
Source: Business Insights BUSINESS INSIGHTS
Due to the wider availability of health information, consumers are increasingly educated about heart health
issues and their prevention, including the ways in which one’s food and drink intake can affect blood
cholesterol levels, blood pressure, heart strength, and circulation. This means that there is a receptive
market, especially in the US, Germany and Italy, for food and drinks products that offer consumers
preventive heart health benefits through their ingredient formulation
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NPD and innovation Sales of heart health food and drinks are expected to grow by 37% between 2005 and 2010 in Europe and
the US, and the total market is expected to be worth $7.7bn by the end of 2010. The largest markets for
heart health food and drinks in 2005 were the US, with a value of $4.4bn and Germany, with a value of
$361m.
Figure 15: Share of heart health products launched (%) by category, 2007-2010
20.0% 15.8%
2.5%
20.0%18.4%
2.5%
2.6%5.3%
30.0% 28.9%
25.0% 28.9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010
Bakery and cerealsConfectionery
Dairy Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
cts
laun
ched
20.0% 15.8%
2.5%
20.0%18.4%
2.5%
2.6%5.3%
30.0% 28.9%
25.0% 28.9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010
Bakery and cerealsConfectionery
Dairy Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
cts
laun
ched
Source: Product Launch Analytics BUSINESS INSIGHTS
Figure 15 shows that historically soft drinks took the largest share of targeted heart health food and drinks
(30.0% share of the market in 2007) however the share declined to 28.9% in 2010 as other more innovative
categories gained share. Included in the other category, which gained share from 2007-2010 is sweet and
savory spreads which is a key area of innovation in heart health food and drinks due to the large number of
spreads that contain plant sterols and claim to have cholesterol reducing effects. Dairy and bakery and
cereals also take a large share of the heart health food and drinks market. Bakery and cereals can easily be
marketed as being formulated to offer targeted heart health benefits, via ingredients such as plant sterols,
whole grains and omega-3 and 6 and dairy can offer opportunities for manufacturers to formulate and market
products offering preventive heart health benefits (via the ingredients of omega-3 and 6, for example) to have
heart health benefits.
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Lowering cholesterol
Dyslipidemia is an abnormal amount of lipids (e.g. cholesterol and/or fat) in the blood. In developed
countries, most dyslipidemias are hyperlipidemias; that is, an elevation of lipids in the blood, often due to diet
and lifestyle. There have been 194 dossiers submitted to EFSA for cholesterol. Food and drinks products
that help to lower cholesterol is a large area of innovation as consumers awareness about the impact of
lifestyle on conditions such as dyslipidemia has driven a demand for food and drinks that will prevent them
from suffering from these conditions in the future.
To date there has been one Article 13.5 claim that has gained approval from EFSA.; Fruitflow from Provexis
successfully made a claim for lowering cholesterol. Provexis, have been tested with pharmaceutical rigor to
demonstrate properties beneficial to health, becoming the first company to win an approval for a European
Union article 13.5 (emerging and proprietary science health claim) for its Fruitflow, blood circulation-
benefitting tomato extract.
Lowering blood pressure
Hypertension (HTN) or high blood pressure is a chronic medical condition in which the systemic arterial
blood pressure is elevated. The US has the lowest prevalence rates of hypertension of the seven countries
profiled and has benefited from increased awareness of hypertension as a potentially harmful condition. This
has resulted in improvements in treatment rates and in lifestyle adjustments among the diagnosed population
of hypertension and borderline hypertension sufferers, and is likely to be playing an important role in
reducing the rate at which the prevalence of hypertension in the US is rising. As high blood pressure can to
some extent be managed by the diet there are a number of functional food and drinks that make claims that
they can help clients to maintain or reduce blood pressure.
Key ingredients
Manufacturers market products with heart health benefits within the site specific preventive health trend by
highlighting specific ingredients that actively promote optimum heart health. These include:
Whole grains (especially oats and wheat);
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L-Arginine, an amino acid, which is thought to have heart health benefits;
Plant sterols, such as Diminicol and Corowise, which lower cholesterol;
Soy, which lowers cholesterol;
Polyphenols, such as rutin (vitamin P), which can lower blood pressure;
Antioxidants, such as vitamins C and E, including from pomegranates, which reduce cholesterol;
Omega-3 and omega-6, fatty acids important for heart health;
Minerals such as magnesium, for heart health.
Antioxidants
Antioxidants are also believed to help reduce blood pressure and can be found in vitamin C and E as well as
in the increasingly popular family of “superfruits”; mangosteen, açaí, goji, blueberries, etc. Vitamins and
minerals with antioxidant properties play an important role in the fight against heart disease, as they help
with the prevention of oxidation of “bad” LDL cholesterol. Such oxidation is harmful since it leads to the
development of fatty deposits in blood vessels, which is a major contributing factor to heart attacks and
strokes.
Plant stanols and sterols
Plant stanols and sterols, also called phytosterols, are found in small quantities in plant sources including
fruits, vegetables, nuts, seeds, cereals, legumes and vegetable oils. These nutraceuticals have lower low-
density lipoprotein (LDL) cholesterol levels and are thought to work by inhibiting absorption of LDL.
Phytosterols are most often included in higher fat content products due to the ease with which they can be
processed. They were first introduced in margarines by Raisio in the 1990s, and licensed out to companies
including McNeil Nutritionals.
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Figure 16: Kashi Heart to Heart - Cereal - Warm Cinnamon Oat
Source: Company information BUSINESS INSIGHTS
Procter and Gamble received regulatory approval for Nutraphyl, a plant sterol for inclusion in yellow fat
spread, salad dressings, milk-type products, fermented milk-type products, soy drinks and spicy sauces in
June 2006.
Cargill has also launched a range of products with CoroWise plant sterols, including bread, fruit juice, a rice
drink, snack bars and cheese and major food retailers, such as Tesco in the UK and Albert Heijn in the
Netherlands, have included plant sterols from Forbes MediTech in their own-label foods. One example of a
novel product type launched in mid-2009 is a sterol-containing cracker from Kashi’s Heart to Heart line.
These crackers contain whole grains, antioxidants and are low in sodium.
Soy
Isoflavones belong to the phytoestrogen family, a group of plant compounds present in vegetables, fruits and
whole grains that have hormone-like effects on the human body. Past research has shown promising health
benefits of soy isoflavones in the area of cancer prevention and cardiovascular disease risk reduction.
In the US, soy products with targeted health benefits have grown significantly in popularity following the
FDA’s approval of health claims linking consumption of soy to a reduced risk of coronary heart disease. Soy
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products are beginning to enter the mainstream due to their popularity with consumers and many health
benefits.
Latest research on nutrition for heart health food and drinks
Many clinical studies have been performed to establish that phytosterols lower cholesterol and The American
Heart Association notes that daily intakes sterol/stanol of 2g achieves maximum effects and the National
Cholesterol Education Program Adult Treatment Panel states that ‘intakes of 2-3g per day of plant
sterol/stanol esters will reduce LDL cholesterol by 6 to 15%’
Analysis of clinical trials on the use of antioxidants to lower cholesterol (as at October 2010) revealed that
the largest number had taken place on antioxidants with the number of clinical trials on plant sterols and
sterols just over half the amount.
Table 14: Clinical trials for heart health ingredients, October 2010
Ingredient Number of clinical trials Antioxidants 102Plant stanols 53Plant sterols 3Soy 6
Source: The Cochrane Library and Business Insights analysis BUSINESS INSIGHTS
In September 2010 EFSA issued a negative opinion to a health claim submission linking soy protein and
reduced LDL cholesterol. While EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) recognized
reduced LDL cholesterol as a viable biomarker for reduced risk of heart disease, it said the 40-study strong
dossier failed to demonstrate causality. The NDA took issue with most of the 32 randomized controlled trials
and eight observational studies submitted in the article 14 disease reduction dossier because it said they did
not specifically test for soy protein but rather soy protein isolate or soyfoods that contained other
constituents.
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However according to EFSA, the main problem still lies in the wording of the claim: if companies either by
broaden or narrowthe definition of the active ingredient in question – there is still a good chance of being
able to support some kind of claim under one of the articles (13.1, 13.5 or 14) of the Regulation.
In October 2010 EFSA published its opinion on plant sterols and stanols:
The claimed effects are “cholesterol”, “cholesterol levels”, “cholesterol metabolism”, “heart
health and artery health because of LDL cholesterol maintenance”, “cardiovascular system”,
“cholesterol metabolism”, “effet sur le taux de cholestérol sanguin”, “heart health” and “helps
to keep normal cholesterol level”. The target population is assumed to be adults. In the
context of the proposed wordings, the Panel notes that the claimed effects refer to the
maintenance of normal blood cholesterol concentrations. The Panel considers that
maintenance of normal blood cholesterol concentrations is a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has been established between the
consumption of plant sterols and plant stanols and the reduction of blood cholesterol
concentrations.
The Panel considers that in order to bear the claim, a food should provide at least 0.8 g per
day of plant sterols/stanols in one or more servings. These amounts can be reasonably
achieved in the context of a balanced diet. The target population is adults. The
considerations regarding the food matrix expressed by the Panel in a previous opinion in
relation to the blood LDL-cholesterol lowering effect of plant sterols and stanols also apply to
the present opinion.
Two of the three article 14 cholesterol-lowering health claim opinions relating to plant sterols and stanols
were written into the European Union legislature in October 2009 – along with 19 other claims.
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The two approvals are for Raisio/McNeil Nutritional’s Benecol and Unilever’s pro.activ and mean the
companies’ products can continue making cholesterol-lowering claims that state:
“Plant stanol/sterol esters have been shown to lower/reduce blood cholesterol. High
cholesterol is a risk factor in the development of coronary heart disease.”
Danone’s Danacol has also been handed a positive opinion by the European Food Safety Authority (EFSA),
but has yet to pass through the European Commission and member state process and into the official
Community register of laws, as it was assessed by EFSA at a later date.
The future of heart health food and drinks One of the more surprising results of the two batches of health claim results from EFSA is the mass rejection
of physiological claims on antioxidants. In reaction to the mass rejection of antioxidants Coca-Cola released
a statement in November 2010 stating that it believes that polyphenols the new antioxidants. This will result
in a new and exciting area for companies wanting to make targeted heart health claims as it will provide a
way to continue to make heart health claims. A review of clinical trial meta-analyses from the Cochrane
library showed that there has been a large amount of activity and a number of clinical trials performed on
polyphenols with 2 related specifically to heart health.
The analysis of prevalence data shows a sizeable opportunity for food and drinks manufacturers in heart
health related products, especially in key markets in Western Europe, Japan and the US. This is reflected in
the high expected growth rates for heart health product sales for the period to 2010.
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Chapter 8 Skin health and beauty
Summary Sales of oral beauty supplements are expected to have a compound annual growth rate (CAGR) of 9%
between 2005 and 2010 in Europe and the US, and the total market is expected to be worth $2.3bn by
the end of 2010.
Herbs and botanicals which claim to have skin and beauty benefits and the increased popularity of
green tea have encouraged manufacturers to innovate in this area.
Consumer skepticism about the veracity of benefit claims made for cosmetic products is widespread,
and this is a potential barrier to manufacturers of food and drinks products claiming preventive skin and
beauty health benefits.
In the future, in the context of the ever higher symbolic value given to bodily appearance and sexual
attractiveness, along with population aging, skin health and beauty will remain a dominant trend. In
order to benefit from the future growth opportunities these cultural and demographic features of major
market countries present, food and drinks manufacturers will have to articulate convincingly for
consumers the precise ways a product provides ‘beauty from within’.
Introduction The fast growth of the skin health and beauty market can to some extent be attributed to the growth of the
aging population. The trend of ‘looking younger for longer’ has driven the demand for food and drinks that
have anti-aging effects to counteract the aging process. Alongside this, sales of oral beauty supplements are
expected to have a compound annual growth rate (CAGR) of 9% between 2005 and 2010 in Europe and the
US, and the total market is expected to be worth $2.3bn by the end of 2010. The largest markets for oral
beauty supplements in 2005 were the US, with a value of $741m and France, with a value of $223m.
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Table 15: Oral beauty supplements consumer spending by category in Europe and the US ($m), 2000-2010
2000 2005 2010 CAGR 00-05 CAGR 05-10Europe Skin only 231.3 500.2 777.7 16.7% 9.2%Hair only 45.8 79.2 115.2 11.6% 7.8%Nail only 22.5 35.3 47.6 9.4% 6.2%Multiple area 89.8 153 214.7 11.3% 7.0%Overall 389.4 767.6 1,155.2 14.5% 8.5%US Skin only 165 456.4 737.1 22.6% 10.1%Hair only 26.7 86.1 144.5 26.4% 10.9%Nail only 8.8 26.4 43.6 24.6% 10.5%Multiple area 98.6 173 247.5 11.9% 7.4%Overall 299.2 741.9 1,172.6 19.9% 9.6%
Source: Business Insights BUSINESS INSIGHTS
The current buzz words of cosmeceuticals, dermaceuticals, and biocosmetics are used to describe the
application of ingredients traditionally found in foods offering skin health benefit. nutricosmeceuticals, which
is a collaboration of the words nutrition, cosmetic and pharmaceutical and is often used to describe food and
drinks targeted at skin health. The shortened version used within the food and ingredient industry is
'nutricosmetic.'
NPD and innovation The growth of the skin health and beauty functional foods market has been driven by the growth of the ‘other’
category and the soft drinks category. The category driving the growth of the ‘other’ market is hot drinks.
Herbs and botanicals which claim to have skin and beauty benefits and the increased popularity of green tea
have encouraged manufacturers to innovate in this area. Adding antioxidants to coffee has also become
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popular with Nestle Espana, S.A. launching the new Nescafe Green Blend in April 2010. This product is said
to contain natural antioxidants of green coffee to protect from the effects of free radicals and skin aging.
Figure 17: Share of skin health and beauty products launched (%) by category, 2007-2010
6.1% 5.4%
9.6%4.1%
5.2%5.4%
5.2%
1.4%
3.5%1.4%
35.7% 40.5%
34.8% 41.9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010Bakery and cerealsConfectioneryDairy Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
ct la
unch
es
6.1% 5.4%
9.6%4.1%
5.2%5.4%
5.2%
1.4%
3.5%1.4%
35.7% 40.5%
34.8% 41.9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2007 2010Bakery and cerealsConfectioneryDairy Ready mealsSavory snacks
Soft drinks
Other
% s
hare
of p
rodu
ct la
unch
es
Source: Product Launch Analytics BUSINESS INSIGHTS
Dairy and soft drinks also increased in cosmeceutical products launches by 13.7% and 3.6%, respectively.
The dairy sector is being driven in part by the protein market including RTDs and powders which contain
active compounds from milk which can be beneficial as beauty aids when consumed as a drink. Examples
include the entrance of DMV’s milk extract lactoferrin into the skin care market offering a dairy sourced
ingredient option, and whey manufacturer Glanbia Nutritionals offers its brand of lactoferrin, Bioferrin, which
has anti-inflammatory and antibacterial properties that can be used to help treat skin imperfections.
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Skincare and anti-aging
Skincare is the biggest personal care sub-sector globally, although it remains heavily biased towards
females. Wrinkles, spots and acne, and dryness are causes of concern more for women than men, although
there are opportunities for manufacturers to specifically target men with a more ‘male’ perspective. Personal
care manufacturers are targeting concerns such as exposure to the sun when working outside, gardening or
playing sport, wrinkles around the eyes, bags under the eyes, and acne. In the UK, Hydro-Energizing Gel
has been introduced in April 2007 under the brand name ‘Janssen Opus Men’. The manufacturer states:
“Hydro-Energizing Gel helps skin appear more attractive and protects it from premature aging.” It is available
in 50ml pack and is manufactured by Janssen Cosmeceutical Care.
In the US, more than 33m people annually seek treatment from dermatologists for skin complaints. The
number of people seeking skin anti-aging treatments in the future is expected to increase substantially as
media focus on anti-aging treatments intensifies and the population as a whole ages. Women, rather than
men are expected to drive this trend in the short term. However, sales of male grooming products have risen
sharply over the past five years. While there is undoubtedly a time lag, the issue of anti aging will also
become a sales feature for men in the next 5-10 years within the food market.
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Table 16: Anti-Aging skincare sales by country ($m), 2008–2014
US$m 2008 2011 2014 CAGR 08-11 CAGR 11-14United States 2,302 2,690 3,861 5.3% 11.8%France 513 570 608 3.5% 2.2%Italy 246 304 350 7.4% 4.8%Germany 201 232 256 4.9% 3.4%UK 134 151 166 4.0% 3.3%Europe total 1,830 2,129 2,360 5.2% 3.5%Japan 721 766 815 2.1% 2.1%South Korea 137 153 161 3.8% 1.8%Australia 49 57 60 4.8% 1.8%New Zealand 11 12 12 3.7% 1.1%Asia-Pacific total 1,695 1,880 2,048 3.6% 2.9%Total 5,827 6,699 8,270 4.8% 7.0%
Source: Business Insights BUSINESS INSIGHTS
The total anti-aging skincare market is set to see continued growth of around 7% over 2011–2014. This rapid
growth is due to the significant growth rates in the US as consumers start to turn away from the surgeon's
knife and look for natural options. The slowdown in the traditional skincare market (outside of the US) is in
direct response to consumer interest in alternative anti-aging options, including the emergence of beauty
foods and dietary supplements. The growth in this market may slow down due to the impact of the economic
downturn.
Hair and nails
Oral beauty supplements may be marketed as benefiting the skin, the hair or nails, or they may be marketed
as having multiple beauty benefits. In both the US and France, the importance of beauty as a concept is well-
established and longstanding, as indicated by the significance of, for example, the French cosmetic and
fashion industries and by the importance of cosmetic dentistry, and cosmetic surgery to consumers in the
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US. The US also has the highest levels of psoriasis and stress (which is linked to poor skin health) and
obesity of all the seven major markets. Germany, too, has a relatively high prevalence of the skin conditions
psoriasis and eczema, and relatively high levels of stress, which is linked to poor skin health. These country
profiles suggest that consumers in France, the US and Germany will be receptive to innovative food and
drinks products that aid in their desire to look good through offering skin and beauty wellness benefits.
The market data on oral skin beauty supplement spending indicates significant growth potential for food and
drinks products that claim to alleviate skin conditions, including those exacerbated by stress, and especially,
those that may improve the appearance of otherwise healthy skin, in terms of vitality and anti-aging. The
data suggests that products offering targeted benefits, for example, for the nails or the hair only, will be more
appealing to consumers than products offering multiple skin and beauty benefits. The UK is set to emerge as
the key market for oral beauty supplements between 2005 and 2010, offering growth opportunities for
manufacturers of food and drinks products that aid feelings of looking good through enhancing skin, nail and
hair health, and aiding weight control
Key ingredients
Manufacturers market products within the skin and beauty wellness trend by highlighting, especially, the skin
health and anti-aging benefits offered by key ingredients. These include:
Vitamins, especially vitamin E, widely recognized as benefiting the skin;
Aloe vera, derived from the plant and long recognized to have skin wellness benefits;
Polyphenols and other antioxidant compounds that counter skin aging by acting against the damage
caused by free-radicals, and the oxidation of certain body fats;
Berries, which have a high antioxidant content, including blueberries and goji berries;
Coenzyme Q10 (CoQ10), a vitamin-like antioxidant nutrient;
Soya, derived from beans, which has antioxidant properties;
L-cysteine, an amino acid with antioxidant properties;
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Royal jelly, a honey bee secretion widely thought to have anti-aging benefits;
Hyaluronic acid, via its skin lubrication and repair properties;
Collagen, elastin and ceramide, important for skin elasticity, strength and moisture.
Collagen
From the Greek kolla, the word collagen means "glue producer" and refers to the early process of boiling the
skin and sinews of horses and other animals to obtain glue. Collagen adhesive was used by the Egyptians
about 4,000 years ago, while Native Americans used it in bows about 1,500 years ago. If collagen is partially
hydrolyzed, the three tropocollagen strands separate to produce gelatin, which is used in many foods,
including flavored gelatin desserts. Along with soft keratin, it is responsible for skin strength and elasticity,
and its degradation leads to wrinkles that accompany aging. As collagen accounts for around 75% of our
skin, it is not surprising it has found its way into beauty products.
According to published research, orally administered collagen hydrolysate has been shown to be absorbed
intestinally and to accumulate in cartilage. However, in relation to beauty, 2009 has proved to be a pivotal
year with two trials showing that the oral intake of collagen significantly changes skin collagen content and
delivers an anti-aging effect.
In 2009, researchers carried out an animal trial on the ingestion of a collagen peptide on the skin damage
induced by repeated UVB irradiation. The ingestion of collagen peptide suppressed UVB-induced decreases
in skin hydration, hyperplasia of the epidermis, and decreases in soluble type I collagen. These results
suggest that collagen peptide is beneficial as a dietary supplement to suppress UVB-induced skin damage
and photoaging.
Latest research on nutrition for skin health and beauty
The beauty supplement, or nutricosmetic market, as it is sometimes known, has seen a large amount of
innovation. Innéov was set up as a joint venture between L’Oreal and Nestlé in 2003 and now has
subsidiaries in France, Germany, Austria, Belgium, Switzerland, Spain, Italy, Greece, Poland, Russia and
Brazil. Products include haircare, skincare, oral suncare and a specific range targeted at male hair loss.
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However, in April 2010 the the European Food Safety Authority (EFSA) health claims panel rejected a
submission by Laboratoires Innéov linking its proprietary blend with improved skin health.
In its article 13.5 emerging and proprietary science dossier, Innéov included reference to 29 scientific
publications, all but three of which EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said
were irrelevant to the proposed claim.
Many were deemed of no scientific import to the claim in question because the trials were conducted on
individual components of the Innéov blend, and not the whole blend which contained blackcurrant seed oil,
fish oil, lycopene, vitamin C, and vitamin E.
In September 2010 Unilever submitted a health claim dossier to EFSA for a skin health food supplement
composed of a similar formulation to the Innéov product. Unilever spokesperson Flip Dotsch said the
company was confident of its article 13.5 emerging and proprietary science dossier due to the quality of
science it possessed. One of the concerns is that the reason EFSA rejected the claims submitted by Innéov
was due to ingredient specific rather then formulation specific science. Unliver has claimed to have a
different ingredient formulation to Innéov so it will be interesting to see if Unilever is more successful.
The future of skin health food and drinks The future of the skin health food and drinks market will be driven by consumers concerns over aging and
the preference to stay younger for longer. Male consumers are also driving the market and sales of grooming
products targeted at men have risen sharply in the last five years. In order to benefit from the future growth
opportunities these cultural and demographic features of major market countries present, food and drinks
manufacturers will have to articulate convincingly for consumers the precise ways a product provides ‘beauty
from within’. Consumer skepticism about the veracity of benefit claims made for cosmetic products is
widespread, and this is a potential barrier to manufacturers of food and drinks products claiming preventive
skin and beauty health benefits.
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Chapter 9 Conclusions
The future of targeted functional food and drinks Detailed analysis of the six categories contained in this report provides insight into the key criteria for
success in the functional foods market and the future of targeted health claims. This chapter provides
guidance for manufacturers who either currently operates in, or looking to enter the functional foods market
by looking at key marketing strategies which drive success. The impact of Article 13 Health Claims is yet to
be finalized in Europe. However, it is already forcing food and drinks manufacturers to either substantiate the
claims they are already making or to look for slightly different ways to position their product so they are not
subject to the legislation.
The health claims struggle The health and wellness sector has been affected to a lesser extent than other areas by the global economic
downturn and opportunities for new product development continue to be driven by consumer demands.
Future growth will be driven largely by the economics of providing healthcare for an increasingly aging
population and the consequent focus on prevention instead of treatment, as well as the growing numbers of
consumers in emerging economies. Healthcare reform in the US, which was signed into law by President
Obama in March 2010, may add potential opportunities by increasing the focus on preventive healthcare in
an effort to reduce the potential spend on pharmaceuticals for the aging population in the future.
Both industries (food and pharma) face major challenges to develop new and approved products that can
prevent or reduce the risk of endemic, chronic and lifestyle related diseases. This report has highlighted
potential synergies and areas of common interest, including marketing methods and potential changes to
regulation, which could be explored by networks involving players from both sides.
Looking at the targeted functional food and drinks market it is apparent that the impact of the health claim
legislation in Europe is going to change the way food and drinks manufacturers develop a product in terms of
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both developing new products and marketing functional food and drinks and ingredients. Although the full
impact of the health claim legislation is yet to be felt possible outcomes include:
EFSA will lead to a division between manufacturers capable of investing in R&D and others;
Much heavier focus on partners;
Wins and losses for consumer trust;
Already certain manufacturers adopting a pharma/biotech led approach;
Much higher interest in the sector from pharma and biotech players, but who lack marketing expertise.
The impact of Article 13 Health Claims is yet to be finalized in Europe however it is already forcing food and
drinks manufacturers to either substantiate the claims they are already making or to look for slightly different
ways to position their product so they are not subject to the legislation.
Consumer understanding needs to be improved
Areas of misunderstanding
There are many areas of consumer misunderstanding about health and nutritional claims that inhibit future
growth. By no means are all of these areas of misunderstanding the fault of the industry, differences in
legislation by country and the sheer complexity of the area are responsible for much of the confusion, but
nonetheless marketers will need to take the lead in resolving them for their own brands at least – and the
more individual companies that do this the better for the industry as a whole.
The main areas of consumer misunderstanding can be summarized as:
A lack of a clarity regarding what product functions actually are – the wide variety of claims, scientific
language, the fact that some claims are qualified with terms like “may” and “can” and that claims can be
implied by the inclusion of a particular ingredient all create consumer confusion about the precise
benefits of either a product or a particular ingredient;
Consumers are unsure what protection authorities provide them – few consumers within a country are
aware of what the codes of practice for marketing products with health and nutritional claims are, and
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are therefore unsure what protection they are offered. Questions like “are these products safe?” and “is
the product guaranteed to work?” therefore remain unanswered in their minds;
A lack of understanding why there is not always a 100% clear scientific view about the efficacy of
products – to many consumers the sheer complexity and variance in how products with health and
nutritional claims can work is not common knowledge. And as consumers are often not nutritional
scientists, manufacturers should not expect them to understand. Consumers are willing to accept that
products work without having full knowledge of how they work (indeed many would not want to wish to
know full details) but do want a clear and largely unqualified scientific view about their efficacy.
However, reports and then counter-reports about an ingredient’s effectiveness undermine products in
consumers’ minds, at least in the short term, while media attention is focused on the topic. Until a
recognized consensus is reached consumers cannot reasonably be expected to solve the ambiguities
for themselves.
The consequence of these areas of misunderstanding are that claims must be properly, and preferably
independently, substantiated scientifically and that claims must also be clearly expressed in terms of their
benefits. However, more interested consumers must be able to find their way to scientific evidence
substantiating the claim if they so wish. This is the case even if the claim is implied, such as when a latest
“superfood” ingredient is prominently displayed on packaging implying that, because of the reported benefits
of the superfood are well known, its inclusion in the product therefore in some way makes it healthy.
Claims should be concise and clear to avoid confusion
Many consumers find the vast array of different claims, the way in which they are made (ranging from highly
scientific explanations to implied health benefits) and the fact that some are qualified, confusing. Perhaps
unsurprisingly research highlights that the most effective claims are those that are clear and concise. In a
review of 42, mainly American and European studies that included both qualitative and quantitative research,
the Agricultural University of Athens, Greece found that:
Consumers tend to prefer shorter health claims;
They also pay more attention to claims presented in prominent positions on packaging and messages;
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Finally, that disease risk reduction claims are found to be “more appealing and convincing”, especially if they
relate to an illness they may be suffering from.
All of the above sounds like common sense, which is true, but it is nonetheless challenging to simply and
clearly explain the benefits of products that might be highly complex. Focusing messages solely on health
benefits would be one possible solution, but consumers also do want to know that there is real, proven,
science behind claims. As such, a difficult balance needs to be found between communicating clear, simple
and compelling benefits on the one hand and scientifically robust claims on the other.
Similarly, it is also beneficial to limit the number of claims made in order to reduce the array of claims that
consumers have to understand or decipher. For example, more than 4,000 Article 13 claims have been
submitted to EFSA. Many of those claims could be found on the products in large format hypermarkets,
highlighting the vast array of claims consumers are bombarded with. Any reduction in this number would be
beneficial from a consumer’s point of view. Clearly, the industry cannot regulate the total number of claims in
circulation at any one time, but manufacturers can strive to ensure that their own portfolios feature a limited
number of clear and concise claims, and that the temptation to proliferate the number of claims for every new
product or ingredient is kept in check.
Successful marketing strategies As markets have developed, many health claims and nutritional additives have become commonplace,
commanding little if any premium. For example in the yogurt market, virtually all products, including those at
the budget end of the market now make probiotic claims. A vast number of products are being launched onto
the market on a daily basis.
Successful manufacturers have therefore had to search for new ways to deliver differentiated health benefits
and drive profitability, and there are a number of strategies which have proved successful:
New claims;
New delivery methods for ingredients;
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New delivery mechanics/new formats;
Connect with the consumer;
Make claims clear, specific and benefit-focused.
New/softer claims
New claims can include both those which launch a whole new market segment –for example the claims for
anti-aging and inner beauty in soft drinks made by companies such as Sipp and Vichy, and those which help
to differentiate in an already highly developed market. Whilst successful claims may be breakthrough, they
may also simply be a matter of rewording a current claim in a way that makes it more relevant or more
tangible to consumers.
New formats and delivery mechanisms
New formats and delivery mechanics can often be more easily achieved by smaller companies who do not
necessarily have the investment levels and scientific expertise required to generate new claims and new
ingredients. In addition, new formats can sometimes be less interesting to some of the huge multinational
corporations who are searching for high volume, mainstream, multi-country opportunities, resulting in less
competition for smaller companies who are willing to operate in a profitable niche.
Often these new developments in claims, ingredients or formats are created in close connection with
scientific specialists, and many of the large and successful manufacturers in this area fund and work closely
with a range of scientific bodies and experts. However, insightful consumer research is also important in
ensuring that claims are relevant and meaningfully expressed.
Connect with the consumer
The ability to market to the wellness consumer requires a keen understanding of purchasing motivators, and
the roles that products fulfill in their lives. Consumers often have personal and defined health goals and
standing out from competitors will require product differentiation and relevant messaging on how products
improve or make their life easier.
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Understanding consumer lifestyles (how they structure their working and family life) is a key issue as it
informs manufactures about the value of convenience, eating patterns and factors that create or break
purchasing habits. Other key factors include product format, pricing, packaging, as well as clearly
communicating the product benefits.
Marketing tactics should also be updated as a result of the new regulation and its effects. The consumer
attitudes chapter highlighted several areas which have direct consequences for marketing strategy and
tactics:
Consumers respond more positively to clear and specific claims and benefits than to general “wellness”
positioning;
Consumers are practical in their outlook and want to know about product benefits first and foremost,
not the details of the science (but want to know that the science exists and is robust);
Despite this, naming specific ingredients is nonetheless a powerful marketing tactic;
Consumers would like reassurance that products are safe.
Make claims clear, specific and benefit-focused
Refining claims down to the level where they are specific, clear and benefit-driven is much more difficult in
practice than it is in theory. Complex ideas, biological processes, supporting science and consumption
guidelines do not fit perfectly with short advertisements and limited space on product packaging. Expertise in
legislation is often another qualifier for success as making new claims can be a laborious process.
Unsurprisingly a number of joint ventures and collaborations are taking place between food and
pharmaceutical multinationals so that expertise can be shared as markets become more specialized.
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Figure 18: R&D options for food and drinks companies
Outsourcing
Joint ventures
In -licensing
Open innovation
Outsourcing
Joint ventures
In -licensingIn -licensing
Open innovation
Source: Business Insights BUSINESS INSIGHTS
Figure 18 highlights the four key ways a food and drinks company can develop successful R&D strategies.
An example of a successful partnership/joint venture was created in March 2008, when InterMed Discovery
signed a collaborative agreement with Cognis, that gave the ingredients’ company exclusive access to
selected potential active ingredients for specific applications in functional foods. In October 2008, Cognis
licensed its first active ingredient, for weight management, and in March 2009 Cognis licensed two further
active ingredients for weight management and heart health. Both weight management compounds have
shown promising in vitro and in vivo data, while the compound for heart health has demonstrated activity in in
vitro tests and preclinical studies are now planned.
Whether or not the new European directive 1924/2006/EC on nutrition and health claims, including EFSA’s
evaluation process, was able to achieve the objective of stimulating health innovations in the food and drink
industry, ensuring the consumers an increased selection of health promoting foodstuffs, and positively
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impacting public health, will be evaluated in the near future. In 2013, the European Commission will submit a
report to the European Parliament with an evaluation of the development of the food and drink market, in
respect to nutrition and health claims and how consumers understand them.