herbal industry
TRANSCRIPT
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Ramlan Aziz, Harisun Yaakob, Rohaizan Khairul Anuar, Jeffrey Samsulbahrin, Mariani bt Abdul Hamid
Institute of Bioproduct Development Universiti Teknologi Malaysia
www.ibd.utm.my
HERBAL INDUSTRY POTENTIAL IN MALAYSIA : ISSUES AND CHALLENGES TO BE A MARKET PLAYER
BIOTECHCORP BNP LABS
RAMLAN AZIZ : Director of IBD and Member of Malaysia Herbal Development Board
• 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
Source: WHO
Date Approved
Drug Name
Use
Risks
Date Withdrawn
2004 2001
Tysabri Bextra
Multiple Sclerosis Pain reliever
Rare, frequently fatal demyleinating disease of CNS
Heart attack/stroke; fatal skin reactions 2005 2005
1999 Vioxx Pain reliever Heart attack/stroke 2004
1997 Baycol Cholesterol Severe damage to muscle, that is sometimes fatal
2001
1999 Raplon Anesthesia An inability to breathe normally 2001
1993 Propulsid Heartburn Fatal heart rhythm abnormalities 2000
1997 Rezulin Type 2 diabetes Severe liver toxicity 2000
1988 Hismanal Antihistamine Fatal heart rhythm abnormalities 1999
1997 Raxar Antibiotic Fatal heart rhythm abnormalities 1999
1997 Posicor High blood pressure Dangerous interactions with other drugs 1998
1997 Duract Pain reliever Severe liver damage 1998
1985 Seldane Antihistamine Fatal heart rhythm abnormalities 1998
1973 Pondimin Obesity Heart valve abnormalities 1997
1996 Redux Obesity Heart valve abnormalities 1997
Pulled from the Market
UNHEALTHY DIET
Year Government Spent Usage 1995 RM 300 million to procure drugs in public hospitals (Lek, 2005)
2004 RM 800 million to subsidize 97% of healthcare cost (NST, 2004)
2010 RM 1200 million to pay for effective drugs ( Hill S, 2010)
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
MALAYSIAFORESTHERITAGE BI
OD
IVER
SITY
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
11
1ADAPTED From Dr.John W,Travis’sWellness Illness Continuum
Value in USD billions
ESTIMATED GLOBAL MARKET FOR WELLNESS PRODUCTS
Total market value >USD1.9 trillion
Ref: Spas and the Wellness Market: Synergies and Opportunities May 2010 , SRI International
USD 60b
USD 160b
USD 200b
USD 5 trillion
Source: World Bank
Global Market Value of Herbal Industry
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 )
+ 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
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
45 60
55 40Imported
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
Pharmaceuticals/ 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
bottlenecks.
EEPP1: 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”
•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
Tongkat Ali
Mas Cotek
Hempedu Bumi Misai Kucing Dukung Anak Kacip Fatimah
Roselle Mengkudu Ginger Pegaga
Plus 5 Additional Herbal Plants
5 Herbal Plants of Focus
Latest addition - BELALAI GAJAH or SABAH SNAKE GRASS
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
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
Raw material production
Processing/ Formulation
Manufacturing gDistribution/Marketing/
Retailing
/Consumers
QQUALITY CONTROL
CONTINUOUS R&D & HUMAN CAPITAL DEVELOPMENT
GLP HALAL
GMP ISO GMP HALAL
GCP GAP SALM HALAL
VALUE CHAIN OF HERBAL BUSINESS
• Consistent quality, quantity and reliability • Advanced market information and outlet • Increase of production technologies • Selection of herbs for highest content of bioactive compounds•Etc…….
• Standardised materials •Know ledge in processing technologies •Production with high quality •Low cost of investment
• New development in product formulation •Awareness on new types of packaging & labelling technique •Knowledge on standardized extracts •Comprehensive pharmacopoeia
• Market survey •Packaging production design •Attractive advertisement •Product certification •Franchise modern retailers •Partnership
• Education •Awareness on local and international products
ISO
▪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 Council / Office
THE CONCEPT: FROM SEED TO SHELF
FARMING PROCESSING
PRODUCT FORMULATION PRODUCT MARKETING
1
4 3
2
PRODUCT DEVELOPMENT
THE CHALLENGES
PLANTATION
RAW MATERIAL SOURCING
SAFETY QUALITY
STANDARD EFFICACY
PRODUCT FORMULATION
PRODUCT MARKETING
HARVESTING AND
PROCESSING
MANUFACTURING
www.ibd.utm.my
• Continuous and focus, upstream and downstream or from planting to applications
• To discover novel compounds, to make exact standardized extracts and to develop pure analytical standards
• By researchers of high scientific standings
ISSUE : RESEARCH AND DEVELOPMENT, ANALYSIS AND TESTING RELIABILITY
NKEA RESEARCH GRANT SCHEME (NRGS) • Identified research gaps • A more coordinated R&D
work amongst IPTAs/RIs in partnership with INDUSTRY or must be MARKET DRIVEN
• Enriched the scientific contents and literature especially for local herbs
• Grants are available for researchers with specific focus on the scope of research
1
Discovery Crop Production & Agronomy
Toxicology / Pre-clinical Studies
Standardization Processing
• Discovery and identification of new bioactive compounds as a result of process of manipulation in technique used
• New technique for discovery of biomarker
• IP on molecules, indications and genetic source
• New production and extraction technology c/w mechanization and computerization
• Efficient storage and post harvest handling
• New Pest and Disease prevention technique,
• New elite planting materials, protocols, etc.
• New technique / process in toxicity testing or herbal extract
• New technique to evaluate toxicity or therapeutic potential of bioresource;
• Optimize and diversify related bioassay protocols
• Establish new standards of toxicity
• New techniques in screening and separation system for biological entity
• Identification of active molecular structure
• New purification technique, etc.
• Novel product formulation
• Process scaling up and optimisation
• New technique for efficient/ optimized extraction and chemical analysis of essential oils
• Proprietary extracts and formulation
IPRs at all level of research and development activities
5 research clusters setup by HERBAL DEVELOPMENT OFFICE (HDO)
HDO provides research grant under NKEA Research Grant Scheme
RAW MATERIAL SOURCING AND PLANTATION 2
www.ibd.utm.my
8,000,000 handpicked flower for 1kg of oil
60,000 of flowers = 1 ounce of oil 5,000 kg of petals = 1 kg of essential oil
30kg of roots = 1 kg extract 15 kg of dried leaves = 1 kg extract
RAW MATERIALS SOURCING
www.ibd.utm.my
Issue: Raw Materials : Quantity, Quality, Reliability
RAW MATERIALS SOURCING
PLANTLETS DERIVED FROM TISSUE CULTURE
USING GENETIC ENGINEERING TO PRODUCE FAST GROWING PLANTS THAT CONTAIN HIGH AMOUNT OF BENEFICIAL PHYTOCHEMICALS ETC.
GOOD AGRICULTURAL AND COLLECTION PRACTICE
FLOW OF ACTIVITY
1.Plant identification:
species, variety or hybrid
2.Locality identification:
suitability of soil and climate conditions
3. Propagation technique
4. Pests and weeds control and other
contaminants
5. Harvesting technique
6. Cleaning (Wash)
technique
7. Drying Method; sun or oven dry
8. Pack and storage
Source: Prof Zhari Bin Ismail
Organic Farming
• Horticultural research in the growing of herbal plants will emphasize organic farming in view of consumer demand.
• Quality control, safety and efficacy issues are vital to the long-term success of the herbal products industry.
• In the current industry trend towards natural ingredients, organic farming is gaining its prestige.
(FLAVOURS, March-May 2001)
GOVERNMENT INITIATIVES
HIGH VALUE HERBAL PLANTATIONS
CONTRACT FARMING
DISTRIBUTION CENTRE
COLLECTION CENTRE COLLECTION CENTRE COLLECTION CENTRE
FARMER FARMER FARMER FARMER FARMER FARMER
HERBAL AND PHYTOCHEMICAL PROCESSING 3
ISSUE : PROCESSING : EXTRACTION AND PURIFICATION
• Utilizing latest and custom design extraction procedures (no two botanicals are exactly the same)
• Spray, freeze, fluid bed or vacuum dryer
• Extract must match the botanical profile of the original plants, so that final products are truly as nature intended
Extraction plant (Perfume Oil)
(2x100ltr)
MAXIMUM QUANTITY OF PRODUCTS OF
HIGHEST QUALITY (eg. ACTIVITY) AT THE
LOWEST POSSIBLE COST
technology used must be able to produce…
PRODUCT FORMULATION AND
MANUFACTURING 4
QUALITY, STANDARDISATION(EFFICACY), SAFETY AND TRACEABILITY ARE THE KEY PLATFORMS FOR GLOBAL MARKET ACCEPTANCE
STANDARDIZATION
PROCESS OF PRODUCING HERBAL EXTRACTS OR PHYTOCHEMICALS IN WHICH PRODUCT POTENCY IS GUARANTEED THROUGH CONSISTENCY IN ACTIVE COMPOUND CONTENT LEVEL
CHEMICAL PROFILE FOR STANDARDISATION
High Perfomance Liquid Chromatography (HPLC)
HPLC Profile
Tongkat Ali Pegaga
www.ibd.utm.my
ISSUE : PRODUCT FORMULATIONS FOR DOWNSTREAM APPLICATIONS
• Extracts (solid, fluid or powdered) can be used as ingredients for vitamin, pharmaceutical, cosmetic, food and beverages companies locally and worldwide
• Promoting consumer products formulated from these extracts ; higher added value
GOOD MANUFACTURING PRACTICE (GMP)
Good Manufacturing Practice ( GMP ) guidelines is to ensure that products are consistently manufactured and controlled to the specified quality. It is concerned with all aspects of production and quality control.
Countries Types of certification & its recognized bodies
Australia -GMP (for anti-perspirant and sunscreen only) by TGA ( Therapeutic Goods Administration) - License to Manufacture by TGA
Austria Self issued CFS endorsed by F.C.I.O- Fachverband der Chemischen Industrie Osterreich
Belgium -GMP by Belgium Ministry of Public Health - self-issued GMP endorsed by Ministere Des Affaires Sociales De la Sante Et De D’Environnement and Inspection des Denrees Alinmentaires
Malaysia -Ministry of Health -National Pharmaceutical Control Bureau
PRODUCT MARKETING 5
HERBAL PRODUCTS IN MALAYSIAN MARKET
MODERN HERBAL OUTLET
HIMALAYA, KLCC
GOVERNMENT INVESTMENTS IN PRECLINICAL AND CLINICAL TRIALS BY ANCHOR COMPANIES (2011)
Ref : ETP ANNUAL REPORT 2011
HIGH VALUE HERBAL PRODUCTS NKEA AGRICULTURE NKEA AGRICRICULTURRECURIC REHERBS SUB-SECTOR has approved a grant
of RM9.8 million.
PHYTO BIZNET SDN BHD
(651345-K)
PROPOSAL
WHITENING MASCOTEK
SERUM
ANTI-AGING KACIPFATIMAH from
SERUM
CLINICAL TRIALS FOR
CURRENT KACIP FATIMAH EXTRACT BASED PRODUCT
70% more effective in preventing skin aging compared to vitamin C 7% increase in elasticity in 7 days 17% increase in elasticity in 28 days
BENEFITS
HALAL NON-TOXIC NATURAL
Water-based Formulation Liposome Delivery System UVB / UVA Protected
FEATURES
YEAR 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
GNI/USD
- 0.297 0.424 0.625 0.837 2.384 4.296 5.854 7.142 8.870 10.89
GNI CONTRIBUTION 2010 - 2020
GNI CONTRIBUTION USD 10.9 millions
by the year 2020
INVESTMENT REQUIRED : (Private & Public)
EXPECTED JOBS CREATED : 412
Total GNI 2010 – 2020 = USD 41.619
INSTITUTE OF BIOPRODUCT DEVELOPMENT Universiti Teknologi Malaysia
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• Based on this in-vitro data, if we want to produce 1 kg of L. pumila serum/cream or any cosmeceutical skin care product, the amount of L. pumila standardize extract needed is only about 0.01 g. • For F. deltoidea, the highest concentration (dosage) that can be used for the production of 1 kg of any cosmeceutical formulation is about 1 g standardize extract. • To produce the same amount of cosmeceutical formulation, only 0.005 g pure extract alpha mangostin from mangosteen pericarp needed.
ACTUAL DOSAGE NEEDED
INSTITUTE OF BIOPRODUCT DEVELOPMENT Universiti Teknologi Malaysia
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Summary
Antiaging Novel Cosmetic Actives - Labisia pumila water extract - Ficus deltoidea water extract Whitening Novel Cosmetic Actives - Ficus deltoidea water extract -α-mangostin
Melanogenic Cosmetic Active - Mangosteen leaf water extract
CONTINUOUS ACTIONS
•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
BY THE GOVERNMENT
CONTINUOUS ACTIONS
•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
BY THE INDUSTRY
CONTINUOUS ACTIONS
•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 ‘FAST SYNDROME’: ANYTHING FAST, FAST TO THE GRAVE •BUY LOCAL PRODUCTS IF YOU CAN IN ORDER TO SUPPORT THEIR GROWTH AND HOPE TO BECOME A GLOBAL PLAYER
BY THE CONSUMERS
Institute of Bioproduct Development Universiti Teknologi Malaysia (formerly known as CEPP)
www.cepp.utm.my
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
INSTITUTE OF BIOPRODUCT DEVELOPMENT Universiti Teknologi Malaysia
Our Vision
To be an innovative leader in bioproduct research and development.
Our Mission
To develop innovative market driven bioproduct to promote and enhance
wellness and healthy living deriving from natural resources through
sustainable processes and creating wealth for the nation.
Research Theme
Biotechnology for Wellness Industry
www.ibd.utm.my BIOTECHCORP ISO/IEC 17025
INSPIRING CREATIVE & INNOVATIVE MINDS
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Metabolites profiling and safety & efficacy
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To explore your research and commercial opportunities please contact :
INSTITUTE OF BIOPRODUCT DEVELOPMENT Universiti Teknologi Malaysia
81310 UTM Skudai Johor Darul Takzim.
Tel : 07-5532499 Fax : 07-5569706 E-mail : [email protected] /[email protected]
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