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GLOBAL & LOCAL SCENARIOS OF HERBAL/PHYTOCHEMICAL INDUSTRY RAMLAN AZIZ PENGARAH INSTITUT PEMBANGUNAN BIOPRODUK UNIVERSITI TEKNOLOGI MALAYSIA AHLI, LEMBAGA PEMBANGUNAN HERBA MALAYSIA www.ibd.utm.my

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Page 1: Chapter 1 SKKK4313

GLOBAL & LOCAL SCENARIOS OF

HERBAL/PHYTOCHEMICAL INDUSTRY

RAMLAN AZIZ

PENGARAH

INSTITUT PEMBANGUNAN BIOPRODUK

UNIVERSITI TEKNOLOGI MALAYSIA

AHLI, LEMBAGA PEMBANGUNAN HERBA MALAYSIA

www.ibd.utm.my

Page 2: Chapter 1 SKKK4313

Health Related issues of the 21st Century Chronic disease is responsible for 60% (17 million) of all deaths worldwide with

80% deaths occur in developing countries.

Almost half of chronic disease deaths occur in people under the age of 70

The major risk factors for chronic disease are an unhealthy diet, physical

inactivity, and tobacco use

One billion adults are overweight and this figure estimated will surpass 1.5

billion by 2015 if no action is taken.

22 million children under five years old are overweight

Source: WHO. 2005 Statistic Data

WORLD HEALTH FACTS

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Source: WHO

Page 4: Chapter 1 SKKK4313

6 in every 100 Malaysians are diagnosed

with Diabetic related diseases

1 in every10 Malaysians have Kidney related diseases

1 in every 4 Malaysians faces the risk of

any Cancer

In every hour, there are 6 Malaysians are

hit by Stroke

Page 5: Chapter 1 SKKK4313

• More than 14.5 millions Malaysians

suffering from diabetes,

hypertension and high cholesterol

• High cholesterol topped the list with

6.2 millions people followed by

hypertension (5.8 millions) and

diabetes (2.6 millions). There are

also 2.5 millions people suffering

from obesity

• Statistics obtained from latest

National Health and Morbidity Survey

showed that the obesity rate had

tripled over the past 15 years,

growing from 4.4% in 1996 to

15.1% last year

• Diabetes and hypertension also

increased from 11.6% to 15.2% and

32.2% to 32.7% respectively from

2006 until 2011, adding that the

number of smokers also rose to

24.7% from 21.5% during the same

period.

Source: thestar online, 8 April 2012

Page 6: Chapter 1 SKKK4313

DEADLY DISEASES

The World Health Organization warns that cancer, heart

disease, stroke, diabetes, osteoporosis, arthritis, alzheimer’s,

obesity and other chronic conditions, which already kill more

than 24 million people a year, will impose increasing burdens

of suffering and disability on hundreds of millions of others.

Page 7: Chapter 1 SKKK4313

CANCER INCIDENCE By Clifton Leaf March 22, 2004 (FORTUNE Magazine)

>> $200 billion spent since 1970

>> 1.56 million papers

>> 150,855 experimental studies published on mice

>> 10.9 million new cases per year (1.5M in USA)

>> 6.7 million people die every year (563,700 in US)

Page 8: Chapter 1 SKKK4313

*Age-adjusted to 2000 US standard population

Source: 1950, Mortality Data – CDC/NCHS, NVSS, Mortality Revised

2002 Mortality Data: US Mortality Public Use Data Tape, 2002, NCHS, Centers for Disease Control and Prevention ,2004

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OBESITI

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UNHEALTHY DIET

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2010 Ref: Lek 2005, NST 2004, Hill S 2010

UPWARD SPIRAL OF HEALTHCARE COST

Price of medicines increases 5-15% every year

‘We eat to die’ (bad quality and big quantity) as

compared to citizens of poor countries who died

because of lack of food

Go for prevention rather than cure

GOVERNMENTEXPENDITUREONMEDICINE

RM 300 Million

RM 900 Million

RM 1200 Million

0

200

400

600

800

1000

1200

1400

1995 2004 2010

Page 13: Chapter 1 SKKK4313

KURANGKAN

PENGGUNAAN GULA!!

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KEGEMUKAN

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FASTFOOD

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MAKANAN SEGERA = SEGERA MASUK KUBUR

FAST FOOD = FAST TO THE GRAVE

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TRADITIONAL

M O D E R N

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WELLNESS

INDUSTRY

SICKNESS

INDUSTRY

VS

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Introduction to Traditional Complementary

Medicine (T/CM)

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YOGA TRADITIONAL

CHINESE MEDICINE AYURVEDA

HYDROTHERAPY HOMEOPATHY REFLEXOLOGY

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AROMATHERAPY CHIROPRACTIC NATUROPATHY

TRADITIONAL

MALAY MEDICINE ACUPUNCTURE THAI MASSAGE

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TRADITIONAL COMPLIMENTARY THERAPY

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HISTORY OF HERBAL MEDICINES

EGYPT 2900 BC

MESOPOTAMIA 2600 BC

CHINESE 2000 BC

Collection of 800 prescription on 700

types of medicine (mostly plants)

First text recorded on diseases

symptoms

Emperor Shen Nong had tested the efficacy

of herbs on himself and also wrote 365 type

of medicine in a book called Ben Cao.

Amongst the popular herbs are Rhubarb

(Rheum), Ginseng and Cassia Bark

Page 28: Chapter 1 SKKK4313

ISLAM 8th Century

ANCIENT GREECE 300 BC

Theophrastus – Father of Botany

MEDICINE FORMULATION 2nd Century

GALEN – The person who introduced formulation

through mixing a few plants

The first Medicine Shop were introduced

Popular in Baghdad in 8th Century.

Herbs are from India, China and Persia

e.g: camphor, cassia, clove, cubeb, musk, nutmeg, ruhubarb,

sandalwood, senna and tamarind

HISTORY OF HERBAL MEDICINES

Page 29: Chapter 1 SKKK4313

MODERN MEDICINE 18th Century

IBN SINA 980 – 1037 AD

Avicenna, The “Persian Galen”

Pharmacist, Physicist, Philosopher and Diplomat

His writing on pharmaceutical well accepted by

western in 17th century

Pioneered by Shaker’s (1709) and commercialized

in 1870

HISTORY OF HERBAL MEDICINES

Page 30: Chapter 1 SKKK4313

"For every malady Allah has created he also

created its cure and one who acquires such

knowledge will benefit from it and one who

ignores it will forego such benefits" Hadith

Bukhari

ISLAMIC CONCEPT OF

WELLNESS

Page 31: Chapter 1 SKKK4313

WORLD’S HEALING POWERS

Chinese Herbalism

Ayurvedic

Western Herbalism

Homeopathic Remedies

Native Tribes of the Americas

Traditional Malay Medicine

Modern Herbalism

Antioxidant

Page 32: Chapter 1 SKKK4313

Definitions

• Complementary Medicine (CM) – Diverse practices and products that are not presently

considered to be part of conventional (modern) medicine

– Used together with conventional medicine

• Alternative Medicine – Medicine used in place of conventional medicine

• Traditional Medicine – Traditional medicine is based on theory, beliefs and

experiences that are indigenous to the different cultures, and that is developed and handed down from generation to generation.

• Integrated / Integrative Medicine – Medicine that combines mainstream medical therapies and

TCM therapies for which there is some high-quality scientific evidence of safety and effectiveness

Bomoh/ Witch

Doctor

Ayurveda

Chinese Sinseh

Page 33: Chapter 1 SKKK4313

Evolution of Integrated Medicine

Traditional Medicine

Modern Medicine

Medicine

Modern Medicine

Before 18th Century :

Traditional Medicine is the only form of Medicine in the

East.

Survival and Quality of Life dependent on Traditional

Medicine

19th Century

Influx of Modern Medicine

-noted for its ease and

effectiveness

Increasing popularity of TCM

21st Century

Efforts towards

Integration of

Modern and TCM

20th century

Integrated

Page 34: Chapter 1 SKKK4313

Integrated Medicine

“Integrated Medicine”

attempts to combine the best of both systems, but it is not just about adding a bit of acupuncture to the aspirin; it is about restoring an understanding of the patient, his or her attitudes, beliefs, personal history, and life situation to health care

Jack Czauderna, Centre for Institute of Integrated Medicine, Sheffield

Page 35: Chapter 1 SKKK4313

GLOBAL TRENDS

Traditional medicine has been fully integrated into the health

systems of China, North and South Korea and Vietnam

In western countries, growing numbers of patients rely on

alternative medicine for preventive or palliative care

In France, 75% of the population has used complementary

medicine at least once

In Germany, 77% of pain clinics provide acupuncture

The global market for traditional therapies stands at US$ 60

billion a year and is steadily growing

TRADITIONAL AND ALTERNATIVE MEDICINE

Page 36: Chapter 1 SKKK4313

HERBS then as Traditional and now a Complementary Alternative Medicine

Herbs and botanicals have been used for centuries for a variety of ailments.

Growing interest in alternative medicine and natural remedies to modern

medicines has led to a dramatic growth in the herbal market over the last decade.

But herbs increasingly finding application in a variety of foods being promoted on

a health platform.

(Leatherhead Food Research Association)

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WHAT IS PHYTOCHEMICAL?

From Greek word PHYTO = PLANT

Phytochemical refers to every naturally occurring chemical present in plants

Non-nutritive plant chemicals that have protective or disease preventive properties

Page 38: Chapter 1 SKKK4313

Definition of Herbs?

As defined by Merriam-Webster’s Dictionary:

‘Herb is a plant or parts of plant valued for its medicinal, savory or aromatic qualities’

' Tumbuhan atau bahagian tumbuhan yang bernilai dari segi perubatan, masakan atau haruman‘

Herb Society of America describe Herbs as :

‘Any plant that may be used for pleasure, fragrance

or physics’

' Mana-mana tumbuhan yang boleh digunakan

untuk tujuan hiburan, haruman atau fizik'

Page 39: Chapter 1 SKKK4313

PHYTOCHEMICAL – comes from the Greek word “Phyto” for plant. It refers to every

naturally occurring chemical presents in plants. Plant are also the source many modern

pharmaceutical (drugs). It is estimated that approximately one quarter drugs contain plant

extract or active ingredients obtained from plant substances.

COSMECEUTICAL – is the term used to describe cosmetic containing ingredients that

are bioactive, exerting effects on people. It is a blend of cosmetic and pharmaceutical

which has appeared only in the nineties. Examples are anti-wrinkles creams, baldness

treatments, moisturizers and sunscreens.

NUTRACEUTICAL – can be any substance that may be considered a food or part of a

food that provide medical and health benefits, including the prevention and treatment of

disease. Under this broad definition, nutraceutical might be isolated nutrients, dietary

supplements or diets, processed foods, herbal products or genetically engineered

“designer foods”.

Definition Of Terms

Page 40: Chapter 1 SKKK4313

LOCAL SCENARIO

SCOPE OF HERBAL INDUSTRY

Cosmetics/Cosm

eceuticals and

Toileteries

Essential Oils,

Flavours, Colours and

Fragrance

Healthcare/Nutraceuticals

Biopharmaceuticals Herbal/Traditional

Medicine

Pharmaceuticals

Insect Repellent,

Pesticides and

Household Items

HERBAL

PRODUCTS

INDUSTRY

Page 41: Chapter 1 SKKK4313

HERBAL INDUSTRY global

Page 42: Chapter 1 SKKK4313

VIETNAM INDONESIA

SINGAPORE

PHILLIPINES THAILAND

MALAYSIA ?

• Global producer of mint,

citronella, eucalyptus, mint

and jasmine oil – flavors &

fragrances

• Becoming known globally -

strong support from

government on trade

exhibitions

• Target to produce medicines

indigenously by year 2010

• Set up Institute

MateriaMedica - an

integrated research center

• Organised large scale

cultivation for export

• Among the top 12 major exporting

country of medicinal plants

• Positioned as a major clinical trial

center: over 150 clinical trials a year

• Allocation of S$2 billion for herbal

research

• Known for Jamu traditional

medicines, e.g. MustikaRatu

exports to over 20 countries

around the world

• Major supplier essential oils:

ylangylang, patchouli and

citronella

• High priority in research

• Products have penetrated

Japanese market

Source: ICS UNIDO, 2003; Focus Group Discussions

Page 43: Chapter 1 SKKK4313

• Major markets are looking for new ingredients

• Increasing appreciation towards maintaining health with natural products versus curing disease with chemical drugs

Health concerns

• Increasing awareness about side effects of synthetic drugs, e.g. anti-biotic, pain killers

• Increasing cost of drugs and hospitalisation

Side effects of drug

• Upward trend of time tested traditional healing

• Scientific validation and quality products of traditional medicines

Higher confidence

• Herbal extracts and powders are comparatively cheaper than synthetic drugs and formulations

• Act as an alternate for those who cannot afford the synthetic drugs

Competitive pricing

• Growing middle income class

• Increasing aging population and related demands for health solutions: anti-aging, weight control, joint and bone health, cognition

Demographics

HERBAL INDUSTRY

GROWTH DRIVERS

Source: Burrill & Co 2007; Malaysian Herbal Industry Outlook 2004

Page 44: Chapter 1 SKKK4313

KEYMARKETDRIVERS

Increasing aging

population with

increasing

interest in

healthy living

An emphasis on

preventive

measures to

control health

care costs

An increase

consumer

interest in

alternative

medicines

Increased

acceptance

among doctors,

pharmacists

and other

health

professionals

Increasing

awareness

about adverse

effects of

synthetic drugs

Herbal extracts

and powder are

comparatively

cheaper than

synthetic drugs

Increase

demand of

HALAL based

products

Page 45: Chapter 1 SKKK4313

WELLNESS PARADIGM

PROACTIVE REACTIVE

TREATMENT PARADIGM

Complementary & Alternative Medicine $113.0

Spa $60.3

Healthy Eating/Nutrition/Weight Loss $276.5

Preventive / Personalized Health $243.0

Medical Tourism $50.0 Wellness Tourism $106.0

Workplace Wellness $30.7

Fitness & Mind Body $390.1

Beauty & Anti Aging $679.1

Total market

value

> USD1.9

trillion

Value in USD billions

Ref: Spas and the Wellness Market Synergies and Opportunities | May 2010, SRI International

ADAPTED From

Dr John W, Travis’s

Wellness Illness

Continuum

ESTIMATEDGLOBALMARKETFOR WELLNESSPRODUCTS

Page 46: Chapter 1 SKKK4313

HERBAL INDUSTRY IN

GLOBAL AND

MALAYSIA DEMAND

60

210

600

Global Demand for Herbal Products,

1997 - 2020

USD billion

1997 2006 2020

CAGR =

10.5%

0.6

3.1

9.4

1999 2009 2020

CAGR =

13.8%

Malaysian Demand for Herbal

Products, 1999 - 2020

USD billion

GLOBAL MALAYSIAN

Source: Burrill & Co 2007; Malaysian Herbal Industry Outlook 2004

Page 47: Chapter 1 SKKK4313

The world health care industry is driven by two dominant trends:

– Tremendous development of biotechnology industry

– More recognition, acceptance and use of Traditional Medicine as natural medicine, health food and food supplements at National, Regional and Global level.

Key Emerging Trends

Discerning consumers concern with:

- quality

- safety

- efficacy, &

- traceability of health products (Controlling product quality & safety in the entire supply chain & trading network, “FROM SEED TO SHELF”)

Increasing significant portion of herbal medicine taken as prophylactic/preventive rather than curative/remedy.

However, periodic negative press or concern regarding safety & efficacy of herbal medicine largely because of fraudulent claims & unscrupulous manufactures.

GLOBAL SCENARIO

Page 48: Chapter 1 SKKK4313

World Health Organization (WHO) consistently reported that 80% of the

world’s population depends on herbal medicine.

Tropical forests contribute 25% of the world’s medicinal products and

nearly half of the prescription drugs are plant derived.

The global herbal trend shows that herbal therapy enters the mainstream

medicine from 1970 -2000.

• Europe is the largest herbal products market

-USD 6 billion (led by Germany & France.

• Japan – USD 2.1 million

• Asia excluding Japan – USD 2.3 billion

• North America – USD 1.5 billion.

• Middle East countries become largely untapped

WHO – estimated USD 60 billion in 2003

MIGHT – market will reach USD 200 billion in 2008

World Bank – market to reach USD 5 Trillion in 2050

GLOBAL TRENDS

Page 49: Chapter 1 SKKK4313

GLOBAL TRENDS

•BIG BLOCKBUSTER DRUGS PULLED OUT FROM THE MARKET GAVE

INVESTORS CONCERN

•COST TO DO R&D AND TO BRING NEW DRUGS TO THE MARKET ARE

GETTING SO EXPENSIVE

•BIG PHARMA AND COSMETIC COMPANIES LOOKING AT TRADITIONAL HERBS

FOR CLUES FOR FUTURE LEAD COMPOUNDS

•COSTS TO TREAT CHRONIC DISEASES APPROACHING USD 1 TRILLION BUT

DO NOT DELIVER WHAT IS POSSIBLE. PEOPLE LIVING LONGER

BUT NOT HEALTHIER

Eg. IN MALAYSIA, COST OF MEDICINES INCREASES DRAMATICALLY

FROM RM228(1996), RM800(2004) TO RM1.2 BILLION (2006)

Page 50: Chapter 1 SKKK4313

USD 60b

USD 160b

USD 200b

USD 5 trillion

Source: World Bank

Global Market Value of Herbal Industry

Page 51: Chapter 1 SKKK4313

GLOBAL TRENDS

Traditional medicine has been fully integrated into the health

systems of China, North and South Korea and Vietnam

In western countries, growing numbers of patients rely on

alternative medicine for preventive or palliative care

In France, 75% of the population has used complementary

medicine at least once

In Germany, 77% of pain clinics provide acupuncture

The global market for traditional therapies stands at US$ 60

billion a year and is steadily growing

TRADITIONAL AND ALTERNATIVE MEDICINE

Page 52: Chapter 1 SKKK4313

MALAYSIAN SCENARIO

Page 53: Chapter 1 SKKK4313

Bioresources

Identification of suitable herbs

Strategic Analysis-core competencies

Strong Competencies

Strong Competencies

Product design & development

Primary processing Of herbs

(post-harvest Processing) New herbal

products marketing

End users

Natural Bioactive

Compounds

Development of Required herb for

Industry / New Herbal outlets

Commercial production of

Required herbs

Clinical research

Manufacturing Distribution

Weak Competencies

Weak Competencies

Weak Competencies

Weak Competencies

Weak Competencies

Weak Competencies

Weak Competencies

Ref : Malaysian Herbal Industry Outlook (Might)

Strong Competencies

Strong Competencies

Strong Competencies

Strong Competencies

Page 54: Chapter 1 SKKK4313

The total value of the domestic market for herbal and medicinal

plants is now estimated to reach up to RM4.55 billion.

TYPE VALUE (RM)

Flavour & Fragrance 1.60 billion

Pharmaceuticals/Nutraceuticals 0.95 billion

T/CM and Herbal Rremedies 2.00 billion

TOTAL 4.55 billion

Based on local T/CM and herbal industry growth rate at 10% annually, it

was estimated that the value of the industry was at RM 7.97 billion in 2006 *

*

LOCAL MARKET VALUE

( Source: MARDI, 1999 )

Page 55: Chapter 1 SKKK4313

WELLNESS

INDUSTRY

SICKNESS

INDUSTRY

VS

Page 56: Chapter 1 SKKK4313

KEY IMPORTANT TRAITS HERBAL INDUSTRY

NEED TO ADOPT IN ORDER TO GET MARKET

ACCEPTANCE AND GO GLOBAL

QUALITY

SAFETY

EFFICACY

TRACEABILITY

Page 57: Chapter 1 SKKK4313

PORTAL BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN (BPFK), KEMENTERIAN KESIHATAN MALAYSIA.

http://portal.bpfk.gov.my/index.cfm

Page 58: Chapter 1 SKKK4313

DUA KEISTIMEWAN: ‘BELI & MAKAN’ RACUN

Page 59: Chapter 1 SKKK4313
Page 60: Chapter 1 SKKK4313

Source : Annual Report 2011, Ministry of Health

CANNABIS FOR HEALTH (KETUM?)

Page 61: Chapter 1 SKKK4313

Agrochemicals

Cosmetics

Fine Chemicals

Nutraceuticals

Personal & Healthcare

Products

NP’s

Discovery &

Development

Opportunities

Pharmaceuticals

Page 62: Chapter 1 SKKK4313

Research & Development

- Raw Material

- Grading, Accreditation & Standards

- Scientists Evidence

- Technology / R & D

- Biotechnology

- Human Resource Development

- Training

- Education

- Skilled and Knowledgeable Human Resource

Bioresources

Natural bioactive

compounds

Identification of

Suitable herbs

Development of required herbs

for industry / new herbal entity

Product design &

development

Commercial production

of required herbs

Primary processing of herbs

(post-harvest processing)

Clinical research

New herbal products

Manufacturing

Marketing

Distribution

End user

Manufacturing

Marketing & Packaging

Ref : Malaysian Herbal Industry Outlook (Might)

- Technology / R&D

- Human Resource Development

Training

Education

Skilled and knowledgeable

Human Resource

- Awareness

Programme Through

Media / IT

- Packaging

- Advertising

- Technology / R&D

- Human Resource

Development

- Training

- Education

- Skilled and

knowledgeable

Human Resource

Page 63: Chapter 1 SKKK4313

Strengths Weaknesses

• Rich bio-diversity and associated traditional knowledge of herbs

• Unique and yet to be explored

• Strong research and scientific expertise; good botanists, biochemists, biologists

• GMP capabilities

• Strong government to drive growth

• Poor industrial infrastructure (extraction, monograph, toxicology labs)

• Low sustainability of production

• Low innovation capacities due to scattered funds and lack of facilities for clinical validation

• Consumer cynicism; lack of information on the benefits of Malaysian herbs

• Multiple competing stakeholders e.g. government and regulatory bodies

• Cumbersome and unfriendly regulations and policies

Opportunities Threats

• Growing international demand; trend for new/novel/natural healthy products

• Undiscovered herbs potentials

• Alliances/networks with international partners for better control of supply chain

• Create a unique Malaysia positioning through geographic indication protection

• Major player of tropical natural product

• Tainted products (heavy metals & spiked with illegal ingredients)

• Commoditisation of the functional food, cosmetics and personal care markets

• Increased regulations in target markets

• Lack of validation tests are threatening sustainability of production

• Biopiracy limits local innovation and exports

• Competitive from other established traditions e.g. India and China

• Malaysia has vast untapped potential in herbal products discovery and development

• The industry is still at its early stages; the Health & Wellness multi-sectorial segments have not been fully exploited

• Drug discovery program using the herbal products research and development platform has great potential

Malaysia is well positioned to promote the growth and

competitiveness of the herbal industry

Page 64: Chapter 1 SKKK4313

I believe that this has had a positive

effect, both domestically and

internationally. This brings us a step

closer towards transforming Malaysia

into a globally competitive investment

destination.

The Economic Transformation Programme is a

focused, inclusive and sustainable initiative that

will transform Malaysia into a high-income nation

by 2020.

Page 65: Chapter 1 SKKK4313

bottlenecks.

EPP1:

High value

herbal

products

"The NKEAs will have dedicated focus from the Prime Minister and will have fast-track

mechanisms to resolve disputes or bottlenecks”

Page 66: Chapter 1 SKKK4313

BIODIVERSITYOFMALAYSIA

One of the World’s

OLDEST rainforest

Estimated

15,000 known

plant species,

3,700 are

known to be

useful, 2,000

species with

medicinal

value and the

balance

remain largely

unexploited

Home to about

12% of all the

plant species on

earth, which has

not been fully

exploited and

cultivated

One of the 17

Megadiversity

countries

Page 67: Chapter 1 SKKK4313

MALAYSIAFORESTHERITAGE B

IOD

IVER

SIT

Y

10th In the World

4th In Asia

1200 spesies

with medicinal

values

15,000 flowering

plants

300sp mammals

700sp

birds

350sp

reptiles

165sp

amphibian

300sp fish

MILLIONS invertebrate

MICRO organism

Page 68: Chapter 1 SKKK4313

A case of “bio-piracy” : Lemba

Lemba (Curculigo latifolia)

Japan patents (18)

• Curculin, taste modifier composition, chewing gum,

composition for oral cavity, beverage

- Inventor & applicants: Japanese

US patents (8)

• Curculin, taste modifier composition, chewing gum

- Inventor & applicants: Japanese

Europe patents (3)

• Taste modifier composition, chewing gum

Inventor & applicants: Japanese

If we do not do anything, we will face the risk of losing our bio-diversity potentials

to others

Source: Biotropics Malaysia

Other countries are aggressively doing research and coming

up with new discoveries based on our local herbs:

Page 69: Chapter 1 SKKK4313

•To achieve GNI of RM2.2 billion by

2020

•To produce safe, high quality and

efficacious high-end herbal

products

•To strengthen the supplies across

the value chain

•To enhance R&D in herbs and to

secure the IPR from local herbs

Page 70: Chapter 1 SKKK4313

ENTRY POINT PROJECTS (EPPs) FOR AGRICULTURAL

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Page 72: Chapter 1 SKKK4313

+

Discovery & Identification of Herbal Targets

and IP

Devt of Pre & Post Clinical

Testing

Cultivation Primary Processing of

Herbs

Extract & Product Development

Internationall Marketing

& Distribution

Special Formulation &

GMP Manufacturing

Increase in value Increase in value +

This is due to concentrated efforts in the primary processing, cultivation and extraction, but not in other high-value add activities

Value Level of activities in Malaysia

Current Malaysia‘s scenario

Ideal curve

Page 73: Chapter 1 SKKK4313

19%

46% 35%

In the last 10 years, we have seen an increase in local products registration, but

our products remain in the lower-end of the value chain

Local

1998 2009

4560

5540

Imported

100% = 5,019 20,071

Products registered with NPCB, MOH

Percent

88 GMP

manufac

-turers

175 Cosmeceuticals

Botanical Drugs

E.g. pegaga soap,

shampoo

E.g. pegaga tea, noni

juice, energy drink

E.g. pegaga

capsule, garlic,

ginseng

Nutraceuticals

Dietary supplements

Functional foods

Cosmetics and personal care

RM150 /

bottle

RM120 /

bottle

RM120 /

bottle

RM10 /

box

RM30 /

box

RM80 /

bottle

Malaysian natural products industry, 2007

Percent

Flavor and

fragrances

Pharmaceutic

als/

Nutraceuticals

*

Herbal

remedies

100% = USD 2.5 billion

* Nutraceutical products not based on Malaysian herbs

1 month

consumption

Status of the

current

Malaysian

herbal industry

Page 74: Chapter 1 SKKK4313

Hempedu Bumi

Misai Kucing Mengkudu Pegaga

Tongkat Ali

Halia

Kacip Fatimah

Mas cotek

Belalai Gajah

Rosel

Dukung Anak

18 SELECTED local HERBS to be developed into a global wellness products

Page 75: Chapter 1 SKKK4313

Lempoyang

Gelenggang Peria Katak

Sireh / Kaduk

Sambung Nyawa

Merunggai

Senduduk

Page 76: Chapter 1 SKKK4313

To embark on initiative to develop new high-value herbal products

High-Value Herbal Products

Misai Kucing Tongkat Ali Dukung Anak Kacip Fatimah Hempedu Bumi

Supporting

Initiatives

▪ Empowered to spearhead initiatives

▪ One-stop-centre on matters related to herbal industry

▪ Coordinate across all relevant ministries and agencies

▪ Promote smart partnerships between government and herbal industry

stakeholders

Key

Enabler

▪ Commercial cultivation based on contract

farming model

▪ Identified 1,400 ha in Kelantan, Terengganu and

Pahang

▪ Strengthening herbal extraction processing

facilities

▪ Production of high-quality extracts to open up

opportunities to develop wide range of

products

Herbal Cultivation

Park

Multi-Crop

Extraction Facilities

Establishment of Herbal Development Board / Office

B C

D

A

+6

HDO Herbal Development Office

Mengkudu Mas Cotek Roselle Halia Pegaga Belalai Gajah

Page 77: Chapter 1 SKKK4313

Crop Production &

Agronomy

Discovery

Standardization & Product

Development

Processing Technology

R&D Grant approved (RM22.45m)

• UPM

• FRIM

• UKM

• UM

• IPHARM

• MARDI

• UPM

• FRIM

• UTM

• FRIM

• UPM

• USM

• UPM

• TPM

• UTM

• UKM

• SIRIM

NKEA EPP#1 - AS AT SEPT 2013

56 R&D PAPERS APPROVED

Other grants approved (22.43m)

OECD MAD GLP lab status

TK/ TKDL

MONOGRAF

TK Malay / TKDL

IMR

Page 78: Chapter 1 SKKK4313

COMPANY PRODUCTS ON PRE-CLINICAL

TRIAL

PRODUCTS ON CLINICAL TRIAL

BIOALPHA INT. SDN. BHD. √

NATURECEUTICALS SDN. BHD. √

PHYTO BIZNET SDN. BHD. √ √

ANING RESOURCES SDN. BHD. √

NATURAL WELLNESS BIOTECH (M) SDN. BHD. √

NOVA LABORATORIES SDN. BHD. √ √

BIOTROPICS MALAYSIA BERHAD √ √

THE MITOMASA SDN. BHD. √

NKEA EPP#1 ANCHOR COMPANIES : PRODUCTS

ALREADY UNDERGOING PRE-CLINICAL & CLINICAL

TRIALS

HDO Herbal Development

Office

PHYTO IZNET

Page 79: Chapter 1 SKKK4313

www.ibd.utm.my

> 1Million of substances

10000 substances

20 substances

10 products

1 product

0 5 10 15 20

Research

phase

Pre clinic

phase Clinic phase Commercialisation

Active molecule

determination

Patent

Tests on animal

Efficiency

Tolerance

Production of

Active substance

Galenic form

Phase 1

Test on healthy volunteers

Phase 2

Dose determination

Phase 3

Action on patients

Phase 4

Pharmaco vigilance

AMM

Patent expiry

Page 80: Chapter 1 SKKK4313

TARGETS

3 herbal cultivation parks

to produce herbs on a

commercial scale

5 botanical drugs launched

in 2015

5 nutraceuticals with pre-clinical claim launched

in 2012

Page 82: Chapter 1 SKKK4313

▪Empowered to spearhead initiatives

▪One-stop-centre on matters related to herbal industry

▪Coordinate across all relevant ministries and agencies

▪Promote smart partnerships between government and herbal industry stakeholders

Key Enabler

Establishment of Herbal Development Division in MOA

Page 83: Chapter 1 SKKK4313

Lose the opportunity to capitalize on Malaysia’s

biodiversity – Malaysia’s true possession for competitive

advantage

Biopiracy will continue to benefit other nations

and foreign companies

Lose opportunities to harvest low hanging fruits in the near

future

Lose the chance to develop our own science in the longer

term, from fundamental R&D to industrial application

Industry may regress & some industry players may EXIT !

WHAT IF WE DO NOTHING

Page 84: Chapter 1 SKKK4313

Institute of Bioproduct Development

Universiti Teknologi Malaysia (formerly known as CEPP)

www.cepp.utm.my

Page 85: Chapter 1 SKKK4313

CONTINUOUS REQUIREMENT

•CONTINUOUS R&D PROMOTION AT IHLs and RIs

•DEVELOPING RELEVANT HUMAN CAPITAL

•PROVIDING PROBUSINESS ENVIRONMENT WITH APPROPRIATE

INFRASTRUCTURE SUPPORTS AND INCENTIVES FROM

‘SEED TO SHELF’

•CREATE ONE STOP CENTRE TO DEAL ALL ISSUES PERTAINING

TO THE INDUSTRY

•DYNAMIC REGULATORY BODY TO PROMOTE HIGH STANDARD TO

LOCAL INDUSTRY IN FACING GLOBAL CHALLENGES. AND BETTER

ENFORCEMENT TO WEEDOUT THE BLACK SHEEP

FROM THE GOVERNMENT

Page 86: Chapter 1 SKKK4313

CONTINUOUS REQUIREMENT

•CONTINUOUS R&D EFFORT TO ADD VALUE TO THE PRODUCTS

AND TO COMPLY WITH INTERNATIONAL STANDARDS

•CONTINUOUS HUMAN CAPITAL DEVELOPMENT

•PROMOTE GLOBAL BRANDING AND MARKETING STRATEGY

•HALAL AND EFFECTIVE PRODUCTS FOR

THE VAST MUSLIM MARKET

•PROMOTE IHLS AND RIs – INDUSTRY COLLABORATION

•USE LOCAL RAW MATERIALS AND EXPERTISE

•PROMOTE ETHICAL BUSINESS AND WEEDOUT THE BLACK SHEEP

periodic negative press or concern regarding safety & efficacy

of herbal medicine largely because of fraudulent claims

& unscrupulous manufacturers

FROM THE INDUSTRY

Page 87: Chapter 1 SKKK4313

CONTINUOUS REQUIREMENT

•CONTINUOUS AWARENESS ON PLANT BASED

HEALTH AND BEAUTY PRODUCTS THROUGH EDUCATION

•NOT TO BE TAKEN FOR A RIDE BY SALES GIMMICK

•BE EYES AND EARS FOR THE REGULATORY AUTHORITIES

•USE HALAL AND EFFECTIVE PRODUCTS

•AVOID ‘SEGERA SINDROM’: ANYTHING SEGERA, SEGERA TO THE GRAVE

•BUY LOCAL PRODUCTS IF YOU CAN

FROM THE CONSUMERS

Page 88: Chapter 1 SKKK4313

PHYTOCHEMICAL (HERBAL) INDUSTRY WILL BE THE NEXT

MULTIBILLION INDUSTRY. EVERY EFFORT MUST BE FOCUSSED IN

TURNING INDUSTRY UNIQUE TO THIS BIODIVERSE COUNTRY OF OURS.

THIS INDUSTRY WILL PROMOTE WELLNESS PRODUCTS UTILISING

OUR BEAUTIFUL AND RICH FLORA AND FAUNA, AND ENSURE

OUR FUTURE GENERATIONS WILL HAVE THE SAME OR BETTER

OPPORTUNITIES TO LIVE IN A PEACEFUL, HEALTHY AND SUSTAINABLE

ENVIRONMENT.

CONCLUSION

Page 89: Chapter 1 SKKK4313

89

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