Bioeconomy Initiative Malaysia 2011 (1)
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Transcript of Bioeconomy Initiative Malaysia 2011 (1)
BIOECONOMY INITIATIVE MALAYSIA
Page | 2
INTRODUCTION
The biotechnology industry is an increasingly significant economic
contributor to leading Asian countries such as Japan, China, India, South
Korea and Taiwan. Developing countries such as Singapore, Philippines and
Thailand have also incorporated biotechnology into their long-term growth
strategies and national development roadmap. Malaysia, through its
National Biotechnology Policy (NBP) is among the leading Asian countries
coordinating and intensifying a national effort in maximising the potential
economic benefits of the entire biotechnology ecosystem and related value
chains.
WHAT IS THE BIOECONOMY?
The Bioeconomy refers to all economic activity derived from scientific and
research activity focused on understanding mechanisms and processes at
the genetic and molecular levels and its application to industrial process.
Bioeconomy activities involve application to agriculture, health, chemical,
energy industries and many others. It covers all industries and economic
sectors based on the values implicit in biomaterials that can be translated
into new income and social well being and at its core is its focus on
sustainability.
Food and energy security
Design treatment for human diseases
Minimising climate change
Biotechnology offers technological solutions to future global challenges
Page | 3
BACKGROUND
The basis of the Bioeconomy is advanced knowledge in the life sciences and
biotechnology supported by ICT, nanotechnology, chemistry, physics,
engineering, information technology and market research. The Bioeconomy
to 2030: Designing a Policy Agenda report published by Organization for
Economic Co-operation and Development (OECD) estimates that
bioeconomy will contribute a global average of 2.7% to Gross National
Income (GDP) and the discoveries of 10-14 new drugs per year over the
next 5 years and will be responsible for 10% of chemical production by
2030.
The first phase of NBP recorded industry investment exceeding USD 1.3
billion (RM 4.5 billion) in which more than 40% contributed by the private
sector. Contribution to GDP is estimated to reach 2.2% by the end of 2011.
More than 50,000 workers in this field and in related fields were recorded
in 2010. The figures suggest an industry with a promising potential for
having a high impact on GDP and GNI growth.
RATIONALE
Malaysia has an appropriate basis to become a global bioeconomy hub
based on a number of factors listed in the annual report of the Malaysian
Biotechnology Country Report 2009/2010 and Malaysian Biotechnology
Statistical Indicator Report 2010. Some of these factors is the support by
the government on the biotechnology sector, the implementation of positive
policies, good infrastructure, natural resources, biodiversity and strategic
location.
Bioeconomy will be a “sustainable economy” for Malaysia as it encompasses
all industries and economic sectors that produce, manage and utilise
biological resources such as agriculture, forestry, fisheries, food, wellness,
chemicals and renewable energy. Although based on knowledge and
innovation in biosciences, bioeconomy converges with other economic
sectors/technologies i.e. engineering, computer science, chemistry and
nanotechnology, and cross-cuts into public and private sectors.
Page | 4
Endorsed by the Biotechnology Implementation Council, chaired by the
Honourable Prime Minister in May 2011, the Bioeconomy Initiative
Malaysia will consolidate and converge to maximise participation of local
private industry in the high-impact opportunities in bioeconomy and
ensuring continuity and implementation of all related national policies.
The rationales for Bioeconomy Initiative Malaysia (BIM) are:
Recognising biotechnology as a key cross-cutting technology driver in
transforming Malaysia into high income economy;
The need for consolidation and convergence of many bioeconomy
initiatives in multiple sectors to maximize local participation from both
public and private domains;
To tap into the unrealised application of locally developed technologies
and discoveries;
Reconciling the urgent need to focus on technology that utilises
renewable resource; and
A comprehensive bioeconomy initiative anchored by the National
Biotechnology Policy and linked with other related policies.
Page | 5
FRAMEWORK OF BIOECONOMY INITIATIVE MALAYSIA (BIM)
"Green" Chemistry
Biocatalysts
Bio-generic Manufacturing
Advanced Bioprocessing
Technologies for Fine & Specialty
Chemical and Biomaterials
Vaccines Biogenerics
Biobanking Molecular
Diagnostics
Development of Agricultural
Biotechnology Centres of Excellence
Adding Value to Crops & Foods
Marine Biotechnology
Initiative
Natural products discovery and
commercialisation
Industrial Biotechnology
Healthcare Biotechnology
Agriculture Biotechnology
AREAS UNDER NATIONAL
BIOTECHNOLOGY POLICY
Other
related
policies
Other
related
policies
Other
related
policies
Other
related
policies
Page | 6
Bioeconomy Initiative: Related EPPs
Proposed projects with direct bioeconomy impact
Existing EPP with direct bioeconomy impact
Existing EPP with indirect bioeconomy impact
Herbal products
Aquaculture
Crop
Breeding services
FDI in agriculture
Livestock
Biofeed
Extracts
BioControl
Biofertilizer
Pharmaceutical generics
Clinical trials
Genomics
Biosimilars
Food- and health-based downstream
Green technology
Oleo derivatives
Industrial biotechnology
Medical devices
AGRICULTURE
HEALTHCARE INDUSTRIAL
Legend :
Page | 7
Linkages to Industry
Key Activities/Deliverables and Timeline
A. Extracts
B. BioFeed
C. BioControl
D. BioFertiliser
E. BioSimilar
F. Genomics
G. Industrial
Biotech
Page | 8
BIOECONOMY OPPORTUNITIES
Page | 9
1) Bioextraction: Increase Capabilities of Extraction Facilities
a) Justification
The Asia-Pacific Active Bio Compound market revenues will grow
at a CAGR of 9.6% from 2010 to 2016.
The high potency Active Bio Compound segment is showing
attractive growth opportunities for the pharmaceutical players. A
number of companies are expanding their facilities for the
production of Active Bio Compound.
A number of contract manufacturers are coming up with high
potency manufacturing capabilities. There is an increasing trend of
contract manufacturing being used in the high potency segment.
b) Targeted result in 2020
Products • High Value Active Pharmaceutical Botanical Drugs -Polypeptide K from Momordica charantia sp
• High Value Active Bio cosmetic ingredient –Xanthones from Garcinia mangostana
• High Value Active Health Supplementary ingredients– Marine Collagen peptide from Tilapia spp
Targeted Output Year Output
2012 2013 2014 2015 2016 2017 2018 2019 2020
Active Compound
1 - - 1 - - 1 - -
Application 2 3 1 2 2 1 2 2 -
Generic Products
10 10 15 10 10 15 10 10 10
Outcome • New domestic high value standardized active compound for pharmaceutical, food and cosmetic industry (100 products)
• Value add the locally sources standardized active compound (reduce import dependency on the active ingredients)
• Increase life expectancy and healthy community (refer to future health trend analysis)
GNI Estimated USD 240 mil (RM 720 mil) until 2020
Jobs Created 10,500 jobs in manufacturing, lab analysis, marketing, plantation
Page | 10
c) Key Activities/Deliverables and Timeline
2) Bioextraction: Strengthening Mushroom Seed Production and Introducing
New Varieties
a) Justification
Globally, mushroom industry is worth RM 135 billion (2005).
Mushroom with its natural ascendency in term of dietary
supremacy can be the primary functional food.
Fungi from the Basidiomycota received great interest because it
contains large number of biologically active compounds such as
polysaccharides, glycoproteins, triterpenes and antibiotics.
Potential to lower cholesterolemia, modulate the immune system
and inhibit substances are able tumoral growth, protect liver, anti-
fibrotic, anti-inflammatory, anti-diabetic, anti-viral and
antimicrobial activities.
However, nutritionals and functional properties of indigenous
mushroom in Malaysia is scanty and poorly known.
This shortfall is due to limited effort in exploiting the economic
potential of indigenous mushroom and establishing a
bioextraction facility.
Page | 11
b) Key Activities/Deliverables and Timeline
3) Bioingredients: Uncovering Natural Bioresources to Develop Bioingredient
a) Justification
Malaysia is one of the 12 megadiverse countries in the world and
is rich with unexplored natural resources.
Malaysia is a strategic country to accommodate global food
ingredients market which has an estimated of RM 72 bilion (USD
24 billion) in 2010 and grows at approximately of 3-5% annually.
Current trend in increasing health awareness and food safety are
influencing the reformulation, detection advances, and more
stringent regulatory safeguards in food ingredient industry.
The turning point in stevia’s fortunes came in 2008, when steviol
glycosides (the sweetening components of the leaf) were deemed
to be safe, and Rebaudioside A, one particular steviol glycoside, was
granted GRAS (Generally Recognised as Safe) status in the US.
Stevia herb in its natural form is approximately 20-30 times
sweeter than common table sugar.
Extracts of Stevia can range anywhere from 100 to 300 times
sweeter than table sugar.
Stevia also being used as medicine, cosmetic ingredient, and
dentifrice.
Page | 12
It is estimated global market for Stevia will reach 11,000 metric
tonnes by 2014, equivalent to USD 825 mil.
The aim is to strengthen the production, product quality and
marketing efforts to penetrate global export markets for functional
ingredients: Reb-A from Stevia rebaudiana Bertoni.
b) Targeted result in 2020
Products Plantation of Stevia (PC1 strain), Stevia crude extract Targeted Outputs
500 ha of stevia plantation & 500 MT of stevia crude extract
GNI RM 43 million Jobs created 800 jobs
c) Key Activities/Deliverables and Timeline
4) Biofeed: Production of Quality Feed with High Density for The Local
Aquaculture Industry
a) Justification
Globally, aquaculture contributed 48 per cent of aquatic food in
2010.
Page | 13
Live feed plays a crucial role for the success of any aquaculture
activity - is essential for the early developmental stages of the life
cycle of aquatic organisms.
Local seed industry is facing a setback of continuous and
consistent supply of quality live feed to sustain the aquaculture
seed industry.
This shortfall is due to limited effort in exploiting the economic
potential of local live feed and establishing the production of live
feed in commercial scale.
Annual import value of artemia cysts is reported at RM 4.5 million
and is expected to increase 6-10 folds within 5 years.
Realising the economic importance of live feed and capitalising on
Malaysia’s biodiversity advantage, hence live feed production
should be pursued as a new industry through bioeconomy.
b) Key Activities/Deliverables and Timeline
Page | 14
5) Biocontrol: Development of Biopesticides for Major Agricultural and
Industrial Crops in Malaysia
a) Justification
Biopesticides are defined by the US Environmental Protection
Agency (EPA) as pesticides derived from natural materials, such as
animals, plants, bacteria and certain minerals.
The EPA defines three kinds of biopesticides: microbial, consisting
of microorganisms; biochemical, which are naturally occurring
substances such as extracts and pheromones; and plant-
incorporated protectants, which are substances that plants
produce from genetic material added to the plant.
Biopesticides market is growing rapidly, increasing from USD 672
million in 2005 to over USD 1 billion in 2010, at an AAGR of 9.9%.
In Asia, the biopesticide market was USD 120 million in 2010, an
AAGR of 12% between 2005 and 2010.
The biopesticide market generally (including botanicals, semi-
chemicals and macro- or micro-organisms) was worth
approximately USD 1 billion in 2007/8; approximately 2.5% of the
USD 40.5 billion pesticide market (agrochemical sales estimate for
2008). *CPL Business Consultants.
Advantages of Biopesticides:
Safer and more effective compare to conventional chemically
synthesized pesticides.
Minimum resistance towards biopesticides.
Page | 15
b) Key Activities/Deliverables and Timeline
6) Biofertiliser: Converting (low-value) Agrowaste into (high-value)
Biofertilizer
a) Justification
Most of the Malaysian soils are highly leached infertile acid
tropical soil and the application of fertilizer with high organic
matter is essential to support crop cultivation.
With large tracts of land cultivated with perennial crops such as
palm oil and rubber, substantial quantities of fertilizers are
required annually to sustain maximum growth and yield.
Continuous and excessive application of chemical/mineral
(fertilizer and pesticide) causes extensive soil deterioration and
elimination of soil macro and micro fauna.
Under the 3rd National Agricultural Policy, organic agriculture is
being identified as a niche market opportunity for vegetables and
fruits. Due to the promotion by the government for more
sustainable use and better management of the available natural
resources, the use of organic- and bio- fertilizers has gained
popularity.
Organic fertilizer are naturally occurring fertilizer which include
manure, slurry, worm casting, peat and seaweed; whereas,
Page | 16
processed organic fertilizer include compost, humid acid and
amino acid.
Generally, an organic fertilizer provides organic matter which is
essential for the establishment of soil microorganism and is one of
the building blocks for humus rich fertile soils. Naturally occurring
soil microbes will convert the organic matter into its mineral form
(nutrients) ready for plants.
Biofertilizer, as the name suggest, contains biologically active
living organisms that, both synthesize the atmospheric elements
into soil minerals as plant nutrient, and decompose organic
matters into its minerals. Biofertilizers may be in solid or liquid
medium, enriched with high microbial density (i.e. > 10000000/g).
Although the exact worldwide data for biofertilizer market is not
available, but from available sales volume, it is estimated to be
well over USD 3 billion.
In Malaysia, the sale recorded by major Biofertilizer producer is
estimated to be approximately RM 350 million (as of 2008).
Incorporation of biofertilizer with organic fertilizer is crucial to:
Improve soil fertility (with improved humid acid and amino
acid content).
Increase nutrient availability from the soil to the plants (i.e.
breaking down of organic maters into its minerals, ready for
plant uptake).
b) Key Activities/Deliverables and Timeline
Page | 17
7) Biosimilar: Develop and commercialise biosimilar
a) Justification
A biosimilar is a copy version of an already authorized biological
medicinal product developed after its patent expired and with
demonstrated similarity in physicochemical characteristics,
efficacy and safety, based on a comprehensive comparability
exercise.
Not similar to generic drug (small molecule) because of its
complexity, larger size and difficult to produce exact copy.
Biosimilar is relatively a new area, started in 2006 with first
approval of Omnitrope, a version of somatropin in EU.
Currently 14 biosimilars already approved in EU.
Guidelines already in place: EU, Malaysia (2008), India etc.
Lower cost, shorter timeline, less risky than novel or innovator
biologics.
Biosimilars would provide an affordable alternative source
(estimated discount as much as 85%*) of biologics drugs.
Supply chain available in Malaysia (R&D, CMO, fill and finish
facility, distribution).
Fast growth (The global biosimilars market will grow from
USD243 million in 2010 to USD3.7 billion in 2015 (source:
Datamonitor).
More than 30 branded biologics with sales of USD 51 billion set to
lose patent exclusivity between 2011 and 2015. There is high
potential for growth of biosimilar industry.
Page | 18
b) Proposed biosimilar products
Product EPO Herceptin (trastuzumab) Rituxan (rituximab) Remicade (infliximab)
Description Glycoprotein hormone produced in kidney
A humanised monoclonal antibody
A novel immunotherapeutic agent.
Chimeric monoclonal antibody
Indication Used clinically for conditions such as -anaemia in patients with chronic renal failure, -chemotherapy induced anaemia in cancer patients.
Targets a receptor that is overexpressed in tumor cells. Used as adjuvant therapy in patients with HER2 –positive breast cancer.
Non-Hodgkin’s Lymphoma, Chronic lymphocytic Leukemia (CLL), Rheumatoid arthritis.
Rheumatoid arthritis, Ulcerative colitis, psoriatic arthritis, Crohn's disease.
Off-patent Epoetin beta (2004). 2015 2015 2012 (US / EU)
Originator Amgen/ Kirin
Genentech Roche/ Biogen Idec Johnson & Johnson/ Schering Plough
World market *USD11 Billion USD4.1 Billion (datamonitor, 2007 sales)
USD4.6 Billion (datamonitor, sales 2007)
USD5.1 Billion (datamonitor, 2007 sales)
CAGR 10% 23% 15% 5 to 10%
Page | 19
c) Key Activities/Deliverables and Timeline
8) Biosimilar: Securing strategic investment for the biopharmaceutical and
biologic projects
a) Justification
Lack of expertise and technology in this field.
No commercial manufacturing plant for biopharmaceuticals has
been setup in Malaysia yet.
b) Targeted result in 2020
Locally manufacture biopharmaceutical and biologic products.
Technology transfer and developing local expertise in the relevant
fields.
Creating job opportunities (approximately 450 employees per
company).
GNI contribution (approximately RM 218.1 million in 2020 which
is equivalent to USD 72.7 million).
Page | 20
c) Key Activities/Deliverables and Timeline
9) Genomics: Bioinformatics And Healthcare genomics and proteomics
a) Justification
In 2010, the total global market for biomarkers was an estimated
USD 13.5 billion.
Global omics-based (proteomics, genomics) diagnostics
technology market in 2009 was USD 19.3 billion.
To pool the genome data together and easy accessible by the local
and private sectors.
High value project can attract FDI from companies involved in
diagnostics, personalized medicine, precision medicine, etc.
b) Targeted result in 2020
Estimated GNI contribution of RM 1 billion.
Jobs creation of 3,000 k-workers.
Page | 21
c) Key Activities/Deliverables and Timeline
10) Industrial Biotechnology (IB): Alternative Energy Crop Production
a) Justification
Objective: To gradually reduce Malaysia’s dependence on natural
gas – a major input for Industrial Biotechnology and Malaysia’s
manufacturing sector as a whole.
The Malaysian Government has announced this year its
commitment to reduce subsidies on natural gas to manage the
country’s budget deficit. As a result, alternative sources of energy
must be explored.
Production and harvesting of energy crops is one of the most
viable alternative energy options for Malaysia. These energy crops
have not been fully explored in Malaysia.
Prime example of an energy crop for Malaysia is Acacia.
Low cost, low maintenance local plant with a 5-year planting cycle.
Woodchips can be used to generate steam.
Page | 22
Currently on small scale and scattered across the country.
Other possible crop: Jathropa.
b) Targeted result in 2020
Plantation area of 7,000 hectares.
Steam supply to 3 strategic Industrial Biotechnology plants, valued
at USD 77.1 million in 2020.
GNI Impact in 2020 estimated at USD 65.8 million.
Employment of 760 workers.
c) Key Activities/Deliverables and Timeline
11) Industrial Biotechnology: Feedstock Production for Industrial
Biotechnology
a) Justification
Objective: To create a supply of feedstock from domestic sources
to attract IB investment.
Feedstock is one of the single largest cost component that
accounts about 40% -60% of the production cost in Industrial
Biotechnology (IB). To make IB a long-term business opportunity,
attention must be given to the critical issue of availability of the
right feedstock and at the right cost.
A mature industrial biotechnology sector requires a stable and
sustainable supply of feedstock. As an emerging global destination
Page | 23
of choice for industrial biotechnology activities such as bioplastics,
biofuels and bio-based fine and specialty chemicals, it is critical for
Malaysia to establish dedicated feedstock sources. Readily
available and accessible feedstock sources would also attract
further foreign interest to invest into the country.
b) Targeted result in 2020
Starch production to be supplied to strategic IB plants, valued at
USD 37.3 million in 2020.
GNI Impact in 2020 estimated at USD 20.7 million
Employment of 590 workers.
c) Key Activities/Deliverables and Timeline
12) Industrial Biotechnology: Translating Wastes to Wealth
a) Justification
Objective: To create value from industrial/agriculture wastes.
Wastes as the result of rapid growth in agriculture, industrial and
manufacturing activities has drastically impacted the
environment.
Bioremediation is one of the key focus areas for development
under the NBP. The success of bioremediation business represents
a key ingredient in the completion of a conducive biotechnology
ecosystem in Malaysia.
Page | 24
A collective of green, biotechnology-based technology providers
and businesses that offer innovative and highly effective waste
management and treatment solutions have begins to emerge –
potential to contribute significantly to the economy.
b) Targeted result in 2020
GNI Impact estimated at USD 11.4 million
Employment of 100 workers.
c) Key Activities/Deliverables and Timeline
13) Industrial Biotechnology: Venturing into pre-commercialisation
a) Justification
Objective: To attract new investment in IB and increase adoption
of new IB technologies in local market.
Bio-based chemicals/polymer producers often establish pre-
commercial pilot plants as precursors to larger, full commercial
production. These pilot plants are designed for early marketing
purposes, demonstrate the viability of the technology in scale-up
scenarios, conduct trials runs and testing to reduce
commercialisation-scale risks, and even initiate early commercial
activities.
Support on these pilot projects will also position Malaysia as a
viable destination for pre-commercialisation industrial
biotechnology activities. These pre-commercialisation projects
often lead to sizeable amount of investment.
Page | 25
20 projects are targeted with average investment of RM10 million
per project.
To further accelerate the establishment of these projects,
BiotechCorp will work closely with the existing economic
corridors and state development agencies (such as ECER, IRDA,
SCORE etc.).
b) Key Activities/Deliverables and Timeline
14) Industrial Biotechnology: Securing strategic investment
a) Justification
Objective: To intensify investment in IB.
Strategic investments, from both foreign and domestic sources,
would substantially accelerate the development of the local
biotechnology industry, while simultaneously establish a strong
basis for a knowledge-based economy for the country and
ensuring that the NBP targets are met.
Increase in strategic investment would substantially encourage
technology transfer, increase employment opportunities, generate
revenue for the country and contribute significantly to the
country’s total GNI.
Collectively, the successful investments into industrial
biotechnology would also position Malaysia as the preferred
destination for industrial biotechnology investment and drive the
economic growth of the country through bio-economy.
Page | 26
b) Targeted result in 2020
Total investment of USD 500 million
15) Other projects (to be proposed)
SUMMARY
Bioeconomy Initiative Malaysia (BIM) is the framework to implement the action plan outlined in the National Biotechnology Policy (NBP) for the development of biotechnology industry in various fields so as the engine to improve the national economy, supporting Malaysia’s intention to achieve the status of high-income nation by 2020. The implementation of bioeconomy projects will add high economic value and provide a significant impact on GDP/GNI growth. The focus of bio-based economy includes focusing on investments in infrastructure, research and development (R&D) and expansion of highly skilled talent pool required by this sector. These focuses lead to rapid success achieved by bio-based sector under Phase 1 of NBP in the past 5 years which has contributed more than 2.2% of GDP and aims to achieve 5% at the end of Phase 3. BIM covers life-sciences and bio-based economy with current priority areas in bioextraction, biofeeds, biocontrol, biofertilisers, biosimilars, genomics and industrial biotechnology. The implementations expected to yield GNI score of USD0.9 billion and total investment of more than USD 2.1 billion in 2020.