DEVELOPING HERBAL BASED COSMECEUTICALS IN … · Nutraceutical products not based on Malaysian...
Transcript of DEVELOPING HERBAL BASED COSMECEUTICALS IN … · Nutraceutical products not based on Malaysian...
PO
Ramlan Aziz*, M.R. Sarmidi, Rohaizan Khairul Anuar,
Jeffrey Samsulbahrin, Mariani Abdul Hamid, Harisun Yaakub
Institute of Bioproduct Development
Universiti Teknologi Malaysia www.ibd.utm.my
BIOTECHCORP BNP LABS
*Director of IBD and Member of Malaysia Herbal Development Board
DEVELOPING HERBAL BASED COSMECEUTICALS IN MALAYSIA
: POTENTIAL AND CHALLENGES TO BE A GLOBAL MARKET
PLAYER
2
ADAPTED From Dr.John W,Travis’s Wellness 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
• 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
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 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
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
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Malaysian Traditional Cosmetics
Pinang (Areca Catechu) – soften facial skin
Belimbing (Averrhoa Bilimbi)
– Body cleanser with mild antiseptic properties
Sireh (Piper beetle)
-Water extract of sireh : anti acne
Jambu Batu (Psidium guajava Linn)
- anti acne
Pegaga (Centella asiatica)
-anti acne
Limau purut (Citrus hystrix)
- reduce appearance of scaly skin
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Universiti Teknologi Malaysia
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Andrographis Paniculata
Cashew Ficus Deltoidea
Labisia pumila
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 )
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. - Malaysia’s Prime Minister in 2010
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”
+
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
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
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
•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
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 Distribution/Marketing/
Retailing Consumers
QUALITY 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
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
11 HERBS in FOCUS
Tongkat Ali
Mas Cotek
Hempedu Bumi Misai Kucing Dukung Anak Kacip Fatimah
Roselle Mengkudu Ginger Pegaga
new inclusion: Belalai Gajah or Sabah Snake Grass
In red : have strong effect to the skin (based on scientific research)
▪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 Board /
Office
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
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
PLANTLETS DERIVED FROM TISSUE CULTURE
USING GENETIC ENGINEERING TO PRODUCE FAST GROWING PLANTS THAT CONTAIN HIGH AMOUNT OF BENEFICIAL PHYTOCHEMICALS ETC.
GOOD AGRICULTURAL, COLLECTION & STORAGE 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
Stress on socioeconomic impact and inclusivity to all interested farmers in the rural areas
CONTRACT FARMING
DISTRIBUTION CENTRE
COLLECTION CENTRE COLLECTION CENTRE COLLECTION CENTRE
FARMER FARMER FARMER FARMER FARMER FARMER
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
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
CHEMICAL PROFILE FOR STANDARDISATION
High Perfomance Liquid
Chromatography (HPLC) HPLC Profile
Tongkat Ali Pegaga
Challenges : Chemical markers of some herbs have not been determined or some pure markers are very expensive as they have to be imported
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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
Other Issues
&
Challenges
Lack of Large Manufacturers
Lack of Marketing Strategy
Lack of Initial Funding
Lack of Qualified
Human Capital
Validation and Certification Mechanism
Few Local Companies on Global Stage
GOVERNMENT INVESTMENT IN
PRECLINICAL AND CLINICAL TRIALS BY
ANCHOR COMPANIES (2011)
Ref : ETP ANNUAL REPORT 2011
HIGH VALUE
HERBAL PRODUCTS
NKEA AGRICULTURE HERBS 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
New herbal based serums based on Kacip Fatimah and Mas Cotek extracts are currently undergoing preclinical
trials in India and will be undergoing clinical trials
in Mauritius
NKEA Grant from Malaysian Government (Whitening serum
from Ficus deltoidea & Antiaging serum from Labisia
pumila)
Phytobiznet Sdn. Bhd.
Pre-clinical Study (India) (January-June ‘13)
Clinical Study Phase II and III (Mauritius)
(July-October ‘13)
Dongguk University, Seoul,
South Korea
Institute of Bioproduct
Development (IBD)
GLOBAL
MARKET
INSTITUTE OF BIOPRODUCT DEVELOPMENT
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• INTERNATIONAL COLLABORATIVE RESEARCH between IBD UTM (Malaysia) and DGU (Korea) has succesfully carried out: - Screening Cosmeceuticals from
Malaysia Tropical Plants - Outcomes from The Collaboration: The following 3 plant extracts Labisia pumila Ficus deltoidea Mangosteen have the following properties:
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Antiaging Novel Cosmetic Actives - Labisia pumila water extract
- Ficus deltoidea water extract
Whitening Novel Cosmetic Actives - Ficus deltoidea water extract
-α-mangostin
Melanogenic Cosmetic Actives - Mangosteen leaf water extract
Institute of Bioproduct Development
Universiti Teknologi Malaysia (formerly known as CEPP)
www.cepp.utm.my
CONCLUSION
The HERBAL INDUSTRY is set to be the next multibillion
dollar business for Malaysia by 2020 in which Natural Cosmetics/Cosmeceutical Industry will be one of the major contributors. Her greatest asset lies on the abundance of vast plant materials in one of the most bio diverse environment in the world. The success however will depend highly on her plans to fill the gaps that still exist in the business chain of the industry. This plan can only be successfully implemented through smart partnership between Public – Private Sectors with international flavours. This industry will promote wellness products utilising our beautiful and rich flora and fauna ensuring our future generations will have the same if not better opportunities to live in a peaceful, healthy and sustainable environment.
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
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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]
T h a n k Y o u
N22
N23a
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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IBD’s Technological Platform
BIO
PR
OC
ESSI
NG
HER
BA
L &
PH
YTO
CH
EMIC
AL
BIO
VA
LID
ATI
ON
Fermentation, microbiology, downstream
processing, cell culture
Extraction, purification, steam distillation
Metabolites profiling and safety & efficacy
assessment
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Universiti Teknologi Malaysia
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Equipments & Facilities
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
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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]
T h a n k Y o u
N22
N23a