INSTITUTE OF BIOPRODUCT DEVELOPMENT

PO
DEVELOPING HERBAL BASED COSMECEUTICALS IN MALAYSIA
: POTENTIAL AND CHALLENGES TO BE A GLOBAL MARKET
PLAYER
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
ESTIMATED GLOBAL MARKET
FOR WELLNESS PRODUCTS
Total market value
>USD1.9 trillion
Value in USD billions
ADAPTED From Dr.John W,Travis’s
Wellness Illness Continuum
Ref: Spas and the Wellness Market: Synergies and
Opportunities May 2010 , SRI International
2
HERBAL INDUSTRY
GROWTH DRIVERS
Health concerns
• Major markets are looking for new ingredients
• Increasing appreciation towards maintaining health with natural products versus curing disease with
chemical drugs
Side effects of drug
• Increasing awareness about side effects of synthetic drugs, e.g. anti-biotic, pain killers
• Increasing cost of drugs and hospitalisation
Higher confidence
• Upward trend of time tested traditional healing
• Scientific validation and quality products of traditional medicines
Competitive pricing
• Herbal extracts and powders are comparatively cheaper than synthetic drugs and formulations
• Act as an alternate for those who cannot afford the synthetic drugs
Demographics
• Growing middle income class
• Increasing aging population and related demands for health solutions: anti-aging, weight control,
joint and bone health, cognition
Source: Burrill & Co 2007; Malaysian Herbal Industry Outlook 2004
BIODIVERSITYOFMALAYSIA
One of the World’s
OLDEST rainforest
One of the 17
Megadiversity
countries
Home to about
12% of all the
plant species on
earth, which has
not been fully
exploited and
cultivated
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
MALAYSIAFORESTHERITAGE
th
10
BIODIVERSITY
In the World
1200
700sp
spesies
with
165sp
medicinal
birds
values
amphibian
350sp
reptiles
15,000
flowering
plants
MICRO
organism
th
4
In Asia
300sp 300sp
fish mammals
MILLIONS
invertebrate
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
Malaysian Traditional Cosmetics
Pinang (Areca Catechu)
– soften facial skin
Jambu Batu (Psidium guajava Linn)
- anti
acne
Copyright
of IBD
Belimbing (Averrhoa Bilimbi)
– Body cleanser with mild antiseptic
properties
Pegaga (Centella asiatica)
-anti acne
Sireh (Piper beetle)
-Water extract of sireh : anti acne
Limau purut (Citrus hystrix)
- reduce appearance of scaly skin
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
Ficus Deltoidea
Cashew
Andrographis
Paniculata
Copyright of IBD
Mangosteen
Labisia pumila
LOCAL MARKET VALUE
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
( 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.
"The NKEAs will have dedicated focus from the Prime Minister and will have fast-track
mechanisms to resolve disputes or bottlenecks”
EPP1:
High value
herbal
products
ENTRY POINT PROJECTS (EPPs) FOR AGRICULTURAL
GNI – GROSS NATIONAL INCOME
This is due to concentrated efforts in the primary processing, cultivation and extraction,
but not in other high-value add activities
Level of
activities
in
Malaysia
Value
Current Malaysia‘s
scenario
Ideal curve
+
Discovery &
Identification of
Herbal Targets
and IP
Increase in value
Devt of Pre &
Post Clinical
Testing
Primary
Processing of
Herbs
+
Increase in value
Cultivation
Extract & Product
Special
Development
Formulation &
GMP
Manufacturing
Internationall
Marketing
&
Distribution
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
1 month
consumption
Products registered with NPCB, MOH
Percent
100% =
5,019
Imported
55
Local
45
GMP
manufacturers
20,071
40
60
Nutraceuticals
1998
2009
88
175
Malaysian natural products industry, 2007
Percent
100% = USD 2.5 billion
Pharmaceutical
s/
Nutraceuticals
Cosmeceuticals
Dietary supplements
E.g. pegaga capsule,
garlic, ginseng
19%
Functional foods
*
E.g. pegaga tea, noni
juice, energy drink
46%
35%
Flavor and
fragrances
Status of the
current
Malaysian
herbal industry
Botanical Drugs
Herbal
remedies
* Nutraceutical products not based on Malaysian herbs
Cosmetics and personal care
E.g. pegaga soap, shampoo
RM150 /
bottle
RM120 /
bottle
RM120 /
bottle
RM80 /
bottle
RM30 /
box
RM10 /
box
•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
Malaysia is well positioned to
promote the growth and
competitiveness of the herbal
industry
Strengths
Weaknesses
• Rich bio-diversity and associated traditional
knowledge of herbs
• Poor industrial infrastructure (extraction,
monograph, toxicology labs)
• Unique and yet to be explored
• Low sustainability of production
• Strong research and scientific expertise; good
botanists, biochemists, biologists
• Low innovation capacities due to scattered funds
and lack of facilities for clinical validation
• GMP capabilities
• Consumer cynicism; lack of information on the
benefits of Malaysian herbs
• Strong government to drive growth
• 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
• Tainted products (heavy metals & spiked with
illegal ingredients)
• Undiscovered herbs potentials
• Commoditisation of the functional food,
cosmetics and personal care markets
• Alliances/networks with international partners
for better control of supply chain
• Increased regulations in target markets
• Create a unique Malaysia positioning through
geographic indication protection
• Lack of validation tests are threatening
sustainability of production
• Major player of tropical natural product
• 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
VALUE CHAIN OF
HERBAL BUSINESS
QUALITY CONTROL
GAP GCP
SALM HALAL
GMP GLP
HALAL
Raw material
production
• Consistent quality,
quantity and reliability
• Advanced market
information and outlet
• Increase of
production
technologies
• Selection of herbs
for highest content of
bioactive compounds
•Etc…….
Processing/
Formulation
• Standardised materials
•Know ledge in
processing technologies
•Production with high
quality
•Low cost of investment
ISO GMP
HALAL
Manufacturing
• New development in
product formulation
•Awareness on new
types of packaging &
labelling technique
•Knowledge on
standardized extracts
•Comprehensive
pharmacopoeia
ISO
Distribution/
Marketing/
Retailing
• Market survey
•Packaging production
design
•Attractive
advertisement
•Product certification
•Franchise modern
retailers
•Partnership
Consumers
• Education
•Awareness on local
and international
products
CONTINUOUS R&D & HUMAN CAPITAL DEVELOPMENT
5 research clusters setup by
HERBAL DEVELOPMENT
OFFICE (HDO)
HDO provides research grant under NKEA Research Grant Scheme
Discovery
Crop Production &
Agronomy
Toxicology / Preclinical Studies
• Discovery and
identification of new
bioactive compounds as
a result of process of
manipulation in
technique used
• New production and
extraction technology
c/w mechanization and
computerization
• New technique /
process in toxicity
testing or herbal extract
• New technique for
discovery of biomarker
• New Pest and Disease
prevention technique,
• IP on molecules,
indications and genetic
source
• New elite planting
materials, protocols, etc.
• Efficient storage and
post harvest handling
• New technique to
evaluate toxicity or
therapeutic potential of
bioresource;
• Optimize and diversify
related bioassay
protocols
Standardization
• New techniques in
screening and
separation system for
biological entity
Processing
• Process scaling up and
optimisation
• Identification of active
molecular structure
• New technique for
efficient/ optimized
extraction and chemical
analysis of essential oils
• New purification
technique, etc.
• Proprietary extracts and
formulation
• Novel product
formulation
• Establish new standards
of toxicity
IPRs at all level of research and development activities
11 HERBS in FOCUS
Kacip Fatimah
Tongkat Ali
Misai Kucing
Dukung Anak
Hempedu Bumi
In red : have strong effect to the skin (based on scientific research)
Pegaga
Ginger
Mengkudu
Roselle
new inclusion: Belalai Gajah or Sabah Snake Grass
Mas Cotek
Key Enabler
Establishment of Herbal Development Board /
Office
▪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
THE CONCEPT: FROM SEED TO SHELF
FARMING
PROCESSING
1
PRODUCT MARKETING
4
2
PRODUCT FORMULATION
3
PRODUCT DEVELOPMENT
RAW
MATERIAL
SOURCING
PRODUCT
MARKETING
SAFETY
QUALITY
STANDARD
EFFICACY
PLANTATION
THE
CHALLENGES
MANUFACTURING
PRODUCT
FORMULATION
HARVESTING
AND
PROCESSING
1
www.ibd.utm.my
ISSUE : RESEARCH AND DEVELOPMENT, ANALYSIS AND
TESTING RELIABILITY
• Continuous and focus, upstream and downstream or
from planting to applications
NKEA RESEARCH GRANT
SCHEME (NRGS)
• To discover novel compounds, to make exact
standardized extracts and to develop pure analytical
standards
• Identified research gaps
• By researchers of high scientific standings
• 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
2
RAW MATERIAL SOURCING
AND PLANTATION
www.ibd.utm.my
RAW MATERIALS SOURCING
8,000,000 handpicked flower for 1kg
of oil
30kg of roots = 1 kg extract
60,000 of flowers = 1 ounce of oil
5,000 kg of petals = 1 kg of essential oil
15 kg of dried leaves = 1 kg extract
www.ibd.utm.my
RAW MATERIALS SOURCING
Issue: Raw Materials : Quantity, Quality, Reliability
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
2.Locality
identification:
suitability of soil and
climate conditions
1.Plant
identification:
species, variety or
hybrid
4. Pests and weeds
control and other
contaminants
5. Harvesting
technique
7. Drying Method; sun
or oven dry
Source: Prof Zhari Bin Ismail
3. Propagation
technique
6. Cleaning
(Wash)
technique
8. Pack and
storage
CONTRACT FARMING
FARMER
FARMER
COLLECTION CENTRE
FARMER
FARMER
COLLECTION CENTRE
FARMER
FARMER
COLLECTION CENTRE
DISTRIBUTION CENTRE
Stress on socioeconomic impact and inclusivity to all interested farmers in the rural areas
GOVERNMENT INITIATIVES
HIGH VALUE HERBAL PLANTATIONS
3
HERBAL AND PHYTOCHEMICAL
PROCESSING
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
Utilising Relevant Extraction Technology
Example:
Supercritical Fluid
Technology, etc.
technology used must be able to produce…
MAXIMUM QUANTITY OF PRODUCTS OF
HIGHEST QUALITY (eg. ACTIVITY) AT THE
LOWEST POSSIBLE COST
4
PRODUCT FORMULATION
AND
MANUFACTURING
QUALITY, STANDARDISATION(EFFICACY), SAFETY AND TRACEABILITY ARE
THE KEY PLATFORMS FOR GLOBAL MARKET ACCEPTANCE
HERBAL PRODUCT
FORMULATION
CHALLENGES
QUALITY
SAFETY
EFFICACY (STANDARDISATION)
TRACEABILITY
CHEMICAL PROFILE FOR STANDARDISATION
Tongkat Ali
High Perfomance Liquid
Chromatography (HPLC)
Pegaga
HPLC Profile
Challenges : Chemical markers of some herbs have not been
determined or some pure markers are very expensive
as they have to be imported
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
5
PRODUCT MARKETING
ISSUES AND CHALLENGES
IN NATURAL PRODUCTS
MARKETING
Target Market
Regulatory Compliance
Lack of Initial
Funding
Lack of
Qualified
Human Capital
Lack of
Marketing
Strategy
Lack of Large
Manufacturers
Validation and
Certification
Mechanism
Other Issues
&
Challenges
Few Local
Companies on
Global Stage
CASE STUDY
IBD’S SPINOFF COMPANY : PHYTO BIZNET SDN. BHD.
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
PROPOSAL
CLINICAL TRIALS FOR
ANTI-AGING SERUM
from KACIPFATIMAH
has approved a grant
of RM9.8 million.
PHYTO BIZNET
SDN BHD
(651345-K)
MASCOTEK
WHITENINGSERUM
CURRENT KACIP FATIMAH EXTRACT BASED PRODUCT
NATURAL
NON-TOXIC
FEATURES
HALAL
Water-based Formulation
Liposome Delivery System
UVB / UVA Protected
BENEFITS
 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
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)
Dongguk
University, Seoul,
South Korea
Phytobiznet Sdn. Bhd.
Institute of
Bioproduct
Development
(IBD)
Pre-clinical Study (India)
(January-June ‘13)
Clinical Study Phase II and III
(Mauritius)
(July-October ‘13)
GLOBAL
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
•
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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INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
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
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www.cepp.utm.my
Institute of Bioproduct Development
Universiti Teknologi Malaysia
(formerly known as CEPP)
CONCLUSION
HERBAL INDUSTRY
The
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
Thank You
N23a
N22
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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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
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
Fermentation, microbiology,
downstream
processing, cell culture
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Extraction, purification,
steam distillation
BIOVALIDATION
BIOPROCESSING
HERBAL & PHYTOCHEMICAL
IBD’s Technological Platform
Metabolites profiling and
safety & efficacy
assessment
INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
Equipments & Facilities
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INSTITUTE OF BIOPRODUCT DEVELOPMENT
Universiti Teknologi Malaysia
Thank You
N23a
N22
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]
Copyright of IBD
THANK YOU , TERIMA KASIH
57