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



Copyright of IBD Mangosteen

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”

ENTRY POINT PROJECTS (EPPs) FOR AGRICULTURAL

GNI – GROSS NATIONAL INCOME

+

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

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

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, 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

GOVERNMENT INITIATIVES

HIGH VALUE HERBAL PLANTATIONS

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

Utilising Relevant Extraction Technology

Example:

Supercritical Fluid

Technology, etc.

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

HERBAL PRODUCT FORMULATION

CHALLENGES

QUALITY SAFETY EFFICACY (STANDARDISATION) TRACEABILITY

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

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

PRODUCT MARKETING 5

ISSUES AND CHALLENGES

IN NATURAL PRODUCTS

MARKETING

Target Market Regulatory Compliance

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

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 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



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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:



Copyright of IBD

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.



Copyright of IBD

To explore your research and commercial opportunities please contact :



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


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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Equipments & Facilities



Copyright of IBD

To explore your research and commercial opportunities please contact :



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

57

THANK YOU , TERIMA KASIH

developing herbal based cosmeceuticals in … · nutraceutical products not based on malaysian...

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