Korean Initiatives on Biotechnology:
Challenges and Opportunities
Korean Initiatives on Biotechnology:
Challenges and OpportunitiesExpert Group Meeting, BINASIA
29-30 April, 2004
Bangkok, Thailand
Sang Ki Rhee, Ph.D. Project Coordinator, BINASIA
Korea Research Institute of Bioscience and Biotechnology
Biotechnology in Korea 2
Biotechnology Calendar Biotechnology Calendar
• In the 1980s : Implementing stageIn the 1980s : Implementing stage• 1982 Korea Biotechnology Research Association was founded.• 1983 Biotechnology Promotion Law was enacted. • 1985 KRIBB was founded.
• In the 1990s : Take-off stageIn the 1990s : Take-off stage• 1991 Bioindustry Association of Korea was founded.• 1992 HAN Project was launched.• 1994 Biotech 2000 Program (Phase I) was initiated. • 1994 “The Year of Biotechnology” was declared.• 1998 Biotech 2000 Program (Phase II) was launched
• In the 2000s : Leaping-up stageIn the 2000s : Leaping-up stage• 2000 Frontier Research Program was launched.• 2001 “The Year of Biotechnology” was
designated• 2002 Biotech 2000 Program (Phase III) was launched.
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National Initiatives (I)National Initiatives (I)
• Korea recognized in early 1980s that biotechnology would emerge as a key discipline for the nation’s economic growth in the 21st century.
• Its policy makers support biotechnology with the highest priority for R&D investment in order to level up the nation’s competitiveness.
• The Korean government recently unveiled a major initiative to boost scientific R&D focusing on biotechnology.
• National technology road map (NTRM) for biotechnology was set up in 2002
• BackgroundBackground
Biotechnology in Korea 4
National Initiatives (II)National Initiatives (II)
• Implementation
• The government’s investment on biotechnology has increased dramatically since 2000. (growth rate: 19.8% in 2003)
• The ratio between biotechnology and total R&D expenditure by the government has been increasing.
- Biotechnology: 3.5% (’94) → 8% (‘01) → 10% (’03) - Average growth rate (’98-’01): biotechnology 46%, total R&D 19.4%
• The implementing policy: “Selection and focus”
• The policy has changed from unit projects in small scale for application and development to long term large scale projects for platform and research since 2000.
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Biotech 2000 : Overview Biotech 2000 : Overview • Set up by the Korean government
• Objective: to place Korea’s biotechnological capability at the world’s top level.
• Duration: 1994 2007 (14 years)∼
• Investment: Total US$14.3 bil.(Public US$5.5bil./Private US$8.8bil.) - Phase I (’94-’97): US$1.5 bil.(Public US$ 482mil./Private US$ 1.0bil.)
- Phase II (‘98-’01): US$2.3 bil.(Public US$ 720mil./Private US$ 1.6bil) - Phase III (‘02-’07): US$10.5 bil.(Public US$ 4.3bil/Private US$ 6.2bil)• Participating Agencies (7 Ministries, coordinated by MOST) - Ministry of Science and Technology (MOST) - Ministry of Commerce, Industry and Energy (MOCIE) - Ministry of Education and HRD (MOEHRD) - Ministry of Environment (MOE) - Ministry of Agriculture and Forestry (MOAF) - Ministry of Health and Welfare (MOHW) - Ministry of Marine Affairs and Fisheries (MOMAF)
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National Committee for Biotechnology & Bioindustry
Biotech 2000 : Operating Structure (I)
Biotech 2000 : Operating Structure (I)
Industrial Applications
MOAF MOHW MOE MOMAF
Agro-Biotech
MedicalBiotech
Environ.Biotech
MarineBiotech
MOEHRD
• HRD• Creative Basic Research
R&D SupportR&D Support
MOST
• National Programs• Infrastructure• TRM
MOCIE
• Industrial Platform Technol.• Commercialization
IndustrializationSupport
IndustrializationSupport
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Biotech 2000 : Operating Structure (II)
Biotech 2000 : Operating Structure (II)
National Committee for BiotecNational Committee for Biotechnology & Bioindustryhnology & Bioindustry
National Committee for BiotecNational Committee for Biotechnology & Bioindustryhnology & Bioindustry
Korea Biotechnology Research Association
Bioindustry Association of Korea
Korea Bioventure Association
Private Companies
Korea Biotechnology Research Association
Bioindustry Association of Korea
Korea Bioventure Association
Private Companies
Korea Research Institute of Bioscience and Biotechnology
Other governmental or public research institutions
Korea Research Institute of Bioscience and Biotechnology
Other governmental or public research institutions
Universities
Research Centers (SRC, ERC, RRC, MRC)
National Research Laboratories
Universities
Research Centers (SRC, ERC, RRC, MRC)
National Research Laboratories
MOST, MOCIE, MOEHRD, MOHW, MOE, MOAF, MOMAF
IndustryIndustry IndustryIndustry AcademiaAcademiaAcademiaAcademiaResearch Institutions Research Institutions Research Institutions Research Institutions
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Biotech 2000 : Strategic Objectives
Biotech 2000 : Strategic Objectives
To increase the commercializing capability and expand the nation’s world market share of domestic bioproducts to 5 %
To develop platform technology and improve industrial R&D capability
To establish a scientific foundation for the development of novel biotechnology
III(2002~2007)
II(1998~2001)
I(1994~1997)
ObjectivePhase
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• The government spent U$ 482 million for R&D during the Phase I, and U$ 720 million during the Phase II.
Biotech 2000 : InvestmentBiotech 2000 : Investment
(Unit : U$ mil.)
(Unit : U$ mil.) Agency Phase I(‘94-’97)
Phase II(‘98-’01)
TotalPhase III (2002-2007)
2002 2003 2004 2005 2006 2007 SubTotal
MOST 269 317 172 207 269 340 408 496 1,892 2,478MOEHRD 25 32 35 43 57 71 86 104 396 453
MOAF 90 135 48 60 79 99 119 145 550 775MOCIE 21 141 53 71 93 117 141 171 646 808
MOHW 56 5147 69 89 112 135 164 620 723MOE 11 36 10 12 16 20 24 30 112 159
MOMAF 10 8 9 12 12 16 19 23 87 109Total 482 720 377 471 615 775 932 1,133 4,303 5,505
• In the Phase III, the total investment is expected to increase substantially to U$ 4,303 million.
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Ministry of Science and Technology (I)
Ministry of Science and Technology (I)
Role Supports for R&D activities from basic science to application Supports for R&D activities from basic science to application
Major Programs
G-7 Project (HAN Project) 21C Frontier Science Program
G-7 Project (HAN Project) 21C Frontier Science Program
• G-7 Project Duration: 1992-2001, Total Budget: U$ 193 million Main Area: Screening of lead compounds and commercialization
• G-7 Project Duration: 1992-2001, Total Budget: U$ 193 million Main Area: Screening of lead compounds and commercialization
• 21C Frontier Science Program Supports core science and emerging technologies for 21st century Duration: 2000-2010, Total Budget: U$ 3.6 billion Main Areas: - Functional analysis of human, microbial and crop genomes - Biodiversity of indigenous plants - Stem cell biology and therapeutic applications - Proteomics research - High throughput screening of novel compounds for bioregulators using structural biology and pharmacogenomics
• 21C Frontier Science Program Supports core science and emerging technologies for 21st century Duration: 2000-2010, Total Budget: U$ 3.6 billion Main Areas: - Functional analysis of human, microbial and crop genomes - Biodiversity of indigenous plants - Stem cell biology and therapeutic applications - Proteomics research - High throughput screening of novel compounds for bioregulators using structural biology and pharmacogenomics
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Ministry of Science and Technology (II)
Ministry of Science and Technology (II)
Role Supports for R&D activities ranging basic science to application Supports for R&D activities ranging basic science to application
Major Programs
National R&D Program Basic Life Science Promotion Program
National R&D Program Basic Life Science Promotion Program
• National R&D Programs Duration: 2003-2012, Total Budget: U$ 600 million Main Areas: - BioDiscovery Program (Screening and development of new drugs ) - BioChallenge Program (Preclinical studies and commercialization of biodrug
s) - BioFusion Program (Integrated technology with IT and NT) - BioInfra Program (National Genome Information Center)
• National R&D Programs Duration: 2003-2012, Total Budget: U$ 600 million Main Areas: - BioDiscovery Program (Screening and development of new drugs ) - BioChallenge Program (Preclinical studies and commercialization of biodrug
s) - BioFusion Program (Integrated technology with IT and NT) - BioInfra Program (National Genome Information Center)
• Basic Life Science Promotion Program Supports for basic life science programs Duration: 1978- Main Area: SRC, ERC, RRC, MRC
• Basic Life Science Promotion Program Supports for basic life science programs Duration: 1978- Main Area: SRC, ERC, RRC, MRC
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Ministry of Commerce, Industry and Energy
Ministry of Commerce, Industry and Energy
Role Builds infrastructure for industrialization and commercialization Builds infrastructure for industrialization and commercialization
Major Programs
Industrial Platform Technology Development Industrial Platform Technology Development
• Industrial Platform Technology Development
Develops common platform technology, mid-term core technology and technology for next generation
Duration: 1992~ , Total Budget: U$ 808 million Main Areas:
- Development of processes for bioenergy production- Development of biosensors, BIOMEMS, Biomimics-Development of DNA microarrays and protein chips (Lab-on-a-chip)-Cell culture technology for therapeutic proteins- Infrastructure (GMP, Bioclusters)
• Industrial Platform Technology Development
Develops common platform technology, mid-term core technology and technology for next generation
Duration: 1992~ , Total Budget: U$ 808 million Main Areas:
- Development of processes for bioenergy production- Development of biosensors, BIOMEMS, Biomimics-Development of DNA microarrays and protein chips (Lab-on-a-chip)-Cell culture technology for therapeutic proteins- Infrastructure (GMP, Bioclusters)
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Ministry of Education and Human Resources Development
Ministry of Education and Human Resources Development
Role Supports for the development of HR in biotechnology Supports for the development of HR in biotechnology
Major Programs Brain Korea 21 Program Brain Korea 21 Program
• Brain Korea 21 Program
Duration: 1999-2005, Total Budget: U$ 150 million
Major Areas:
- Human resources development in higher learning and industrial skills
- Reform of higher education programs
- Upgrade of graduate research infrastructure in biotechnology
• Brain Korea 21 Program
Duration: 1999-2005, Total Budget: U$ 150 million
Major Areas:
- Human resources development in higher learning and industrial skills
- Reform of higher education programs
- Upgrade of graduate research infrastructure in biotechnology
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Ministry of Health and Welfare
Ministry of Health and Welfare
Role Supports for the development of biotechnology in public health and medical sectors
Supports for the development of biotechnology in public health and medical sectors
Major Programs
Medical Biotechnology and Biopharmaceuticals Medical Biotechnology and Biopharmaceuticals
• Medical Biotechnology and Biopharmaceuticals
Duration: 1997-2010, Total Budget: U$ 900 million Major Areas: - Prevention, diagnosis, and treatments of diseases to improve public health - Development of new drugs - Development of vaccines, anti-aging and anti-cancer new drugs - Analysis of Korean genome types - Neurobiology and brain research (Braintech 21) - Gene therapy
• Medical Biotechnology and Biopharmaceuticals
Duration: 1997-2010, Total Budget: U$ 900 million Major Areas: - Prevention, diagnosis, and treatments of diseases to improve public health - Development of new drugs - Development of vaccines, anti-aging and anti-cancer new drugs - Analysis of Korean genome types - Neurobiology and brain research (Braintech 21) - Gene therapy
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Ministry of Agriculture and Forestry
Ministry of Agriculture and Forestry
Role Supports for R&D in agrobiotechnology and horticulture Supports for R&D in agrobiotechnology and horticulture
Major Programs BioGreen 21 Program BioGreen 21 Program
• BioGreen 21 Program
Duration: 1994-2011, Total Budget: U$ 1 billion Major Areas:
- Collection, assessment, preservation of genetic resources of biodiversity
- Development of breeding technology for transgenic animals and plants
- Research on animal and plant genomics
- Biosafety issues on GMOs
- Biodiversity and Bioprospecting
• BioGreen 21 Program
Duration: 1994-2011, Total Budget: U$ 1 billion Major Areas:
- Collection, assessment, preservation of genetic resources of biodiversity
- Development of breeding technology for transgenic animals and plants
- Research on animal and plant genomics
- Biosafety issues on GMOs
- Biodiversity and Bioprospecting
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Ministry of EnvironmentMinistry of Environment
Role Supports for R&D in environmental biotechnology Supports for R&D in environmental biotechnology
Major Programs Environmental Biotechnology Promotion ProgramEnvironmental Biotechnology Promotion Program
• Environmental Biotechnology Promotion Program
Duration: 2001-2010, Total Budget: U$ 116 million
Major Areas:
- Screening and isolation of environmental microbes
- Bioremediation
- Development of biosensors for monitoring of environmental pollutants
- Conservation of natural environment and sustainable development
• Environmental Biotechnology Promotion Program
Duration: 2001-2010, Total Budget: U$ 116 million
Major Areas:
- Screening and isolation of environmental microbes
- Bioremediation
- Development of biosensors for monitoring of environmental pollutants
- Conservation of natural environment and sustainable development
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Ministry of Marine Affairs and Fisheries
Ministry of Marine Affairs and Fisheries
Role Supports for R&D in marine biotechnology and aquacultureSupports for R&D in marine biotechnology and aquaculture
Major Programs
Marine Biotechnology and Aquaculture Technology Promotion ProgramsMarine Biotechnology and Aquaculture Technology Promotion Programs
• Marine Biotechnology and Aquaculture Technology Promotion Programs
Duration: 1999-2010, Total Budget: U$ 100 million Major Areas: - Bioprospecting from marine bioresources - Search and utilization of polar biodiversity - Development of transgenic fishes - Development of new aquaculture technology - Screening of marine GMOs
• Marine Biotechnology and Aquaculture Technology Promotion Programs
Duration: 1999-2010, Total Budget: U$ 100 million Major Areas: - Bioprospecting from marine bioresources - Search and utilization of polar biodiversity - Development of transgenic fishes - Development of new aquaculture technology - Screening of marine GMOs
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BioindustryBioindustry• Domestic biotechnology market
• Types of business
Description 1995 1997 1999 2001
Total 200 330 530 1,000
TypePharma-
ceuticalsFood Chemicals Agriculture
Process
EngineeringEnvironment
% 58 12 9 8 7 6
Description Korea USA Japan EU
Market Size (U$ mil.)
900 22,300 7,200 6,000
Growth Rate (%)
30 22 20 20
• Korea vs. World (as of 2000)
(Unit: US mil.)
Biotechnology in Korea 19
Investment in BioindustryInvestment in Bioindustry
• Total R&D spending in bioindustry (Unit : U$
mil.)
• Investment plans
Description 2000 2001 2002 2003 2004
Total 447 478 525 584 676
- CJ: U$ 1.4 bil. for R&D for 5 years (2001-2005)
- Samsung Fine Chemicals: U$ 300 mil. for R&D for 3 years (2001-2003)
- LGCI: U$ 50 mil. invested to bioventures in 2000 - SK Global: U$ 35 mil. invested to bioventures in 2000 - Hanwha Chemical Co.: U$ 50 mil. for R&D in 2000 - Hansol: U$ 150 mil. for R&D from 2000 to 2006 - Isu Chemical : U$ 150 mil. for R&D in the period of 2000 -2005
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BioventuresBioventures
• Government’s initiative to boost bioventure businessGovernment’s initiative to boost bioventure business
• Current status and prospects of bioventures in KoreaCurrent status and prospects of bioventures in Korea
Description 2001 2004 2007
No. of start-ups 500 700 1,000
No. of employees 6,500 15,000 45,000
Market Size (U$ bil.) 1.0 2.1 5.8
- MOCIE pushes a 5-year program to encourage the bioventure business. It earmarked a U$ 30 mil. fund in FY 2000's budget to develop the infrastructure needed by bioventure start-ups.
- Focusing on commercialization of biotechnology, the Korean government announced a package that envisages to create 600 bioventures by 2003 and to expand the number to 1,000 by 2007.
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• Amino acids : 20 % share of world market in 2000 (U$ 75 million)
Facts and Status : the Success Story
Facts and Status : the Success Story
• Ryfamycin : 10% share of world market in 2000 (U$ 7.5 million)
• Hepatitis B Vaccine : Developed in 1987 by Korea Green Cross Corp. World market share was rapidly increased (40% in 1999)
• Recombinant human growth hormone : Developed by LG Chemical Ltd. Technology transferred to SmithKline Beecham of U.K. in 1990.
• First domestic new drug, Sunpla, for anticancer: Developed in 1997 by SK Chemicals and approved by KFDA. Technology transferred to Johnson & Johnson Co.
• First global new drug, Factive, for anti-infectious diseases : Developed by LGCI and approved by FDA in 2003.
• About 300 new drugs are under development. Among them, 23 new drugs are in progress or in completion of clinical trials for FDA approval.
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Manpower in BiotechnologyManpower in Biotechnology
• By degreesDescription 1994 1996 1998 2000
Total Number 7,595 8,230 8,485 9,392
Ph. D. (%) 43.7 44.7 46.3 47.1
M. S. (%) 35.4 38.0 37.4 36.5
B. S. (%) 20.9 17.3 16.3 16.4
Description 1994 1996 1998 2000
Total Number 7,595 8,230 8,485 9,392
Universities (%) 50.4 52.3 54.0 55.4
Private Companies (%) 28.7 27.8 27.1 25.0
Government Research Institutions (%) 20.9 19.9 18.9 19.6
• By distribution
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Patents & PublicationsPatents & Publications• Publications in SCI journals ( in genomics and proteomicPublications in SCI journals ( in genomics and proteomic
s)s) Description 1994 1998 1999 2000
Korea 21 135 157 185
USA 2,871 4,004 4,318 4,500
Japan 643 1,147 1,238 1,236
Korea/USA (%) 0.7 3.4 3.6 4.1
Korea/Japan (%) 3.3 11.8 12.7 15.0
• US patents registeredUS patents registeredDescription 1991-1995 1996-2001
Korea 20 83
USA 2,993 10,480
Japan 741 1,153
Korea/USA (%) 0.7 0.8
Korea/Japan (%) 2.7 7.2
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• BackgroundBiosafety IssuesBiosafety Issues
• Governmental agencies in chargeGovernmental agencies in chargeAgency Role / ActivitiesMOFAT Focal point
MOSTPreparation of regulatory guidelines to oversee recombinant DNA plants
MOHW Providing guidelines for recombinant DNA experimental research
MOEProposed to the National Assembly to enact a law regulating research with an environmental impact and industrial applications
MOCIEPreparing a draft law to supervise the National Assembly with biosafety management and the import and export of LMOs for enactment
- In 2000, more than 130 countries including Korea reached an agreement to adopt the Biosafety Protocol which applies to the transboundary movement, transit, handling and use of all LMOs.
- The Korean government set up an interministrial committee to assess the safety of LMO products in 2000.
- The Act for trans-boundary movement of LMOs was enacted in 2001.
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International CooperationInternational Cooperation
Description
All Areas Biotech. Areas
No. of Projects
Spending (A) (U$ mil.)
No. of Projects
Spending(B)
(U$ mil.)Percentage
(B/A)
MOST 133 6.9 34 1.5 21.5
KOSEF 187 2.4 52 0.7 27.8
MOCIE 52 5.2 3 0.4 5.8
RDA 21 0.4 9 0.2 50. 0
• International joint research projects in 2000International joint research projects in 2000
* RDA: Rural Development Administration
• Overseas Cooperation Programs & joint research centers Overseas Cooperation Programs & joint research centers - Joint Research Center at the Fred Hutchinson Cancer Research Center, USA - Korea-UK Bioindustry Collaboration Program (HGMPRC, Bio-Nano IRC) - Korea-France S&T Focal Points Program (focal point in biotech area) - Korea-China Bioscience and Biotechnology Cooperation Center (Shanghai Institutes
for Biological Sciences, CAS) - Korea-Israel Biotechnology Collaboration Program (Weizmann Ins. of Science) - Bioventure Incubating Centers (Germany, USA)
Biotechnology in Korea 26
• Strengths
Challenges and Opportunities : SWOT Analysis (I)
Challenges and Opportunities : SWOT Analysis (I)
• Weaknesses
- Strong drive policy by the government - Good R&D infrastructure in industry, universities and research institu
tes - Booming bioventure business - Skilled manpower - Strong knowledge and industry bases
- Shortage of innovative R&Ds for platform technology - Comparatively insufficient R&D expenditure - Weak link between industry and academia - Small domestic market and limited marketing power for global sales - Poor biodiversity and bioresources
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• Opportunities
Challenges and Opportunities : SWOT Analysis (II)
Challenges and Opportunities : SWOT Analysis (II)
• Threats
- Paradigm shift in biotechnology for post genomic era
- Top priority in national R&D projects
- Increase of public awareness in health and welfare
- Emerging new technology innovation
- Growing competition worldwide
- Depression of local investment atmosphere
- Regulatory issues: biosafety and bioethics
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CompetitivenessCompetitiveness
Description Technology Competitiveness(% of Top Level)
Basic Technology
• Genetic Engineering/Genomics• Protein Engineering/Proteomics• Cell Engineering/Immunology• Transgenic Animals/Plants
80/50
70/50
80/60
85/70
New Drug Development
• Screening• Structure Analysis• Efficacy/Valuation• Biosafety Evaluation
70
50
30
30
Process Development
• Fermentation/Process• Cell Culture Technology• Bioreactor Design• Separation/Purification
90/80
75
40
65
Overall (%) 60-70
(as of 2002)
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Vision 2010Vision 2010
–현재–현재
종 합 13th in the world
2000
Competitiveness –선진–선진 –7–7–개국–개국
2010
G-7 level
5% of total governmental
R&D spending종 합R&D Spending
종 합R&D Capability (% of top level)
-Basic: 70%-NDD: 50%-Process: 70%
종 합MarketSize: - World: U$ 54 bil. - Korea: U$ 0.9 bil.
Share: 1.7 % of world market
20% of total governmental R&D spending
-Basic: 90%-NDD: 90%-Process: 90%
Size: - World: U$150 bil. - Korea: U$ 10 bil.
Share: 6.6% of world market
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SummarySummary
• Biotechnology is a key platform to accelerate the national economic growth in Korea.
• Korea has set up a solid strategy to achieve international competitiveness by leveraging existing capabilities and creating new strengths.
- “selection and focus” on the areas with high international
competitiveness
- implementation of inter-ministerial coordination for biotechnology
development
- promotion of international cooperation and strategic alliances
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Thank you !Thank you !
Biotechnology in Korea 32
What should be put in BINASIA?
What should be put in BINASIA?
• Science and Technology Related Data National Science and Technology Policies
National Policies on Biotechnology
Biotechnology R&D Activities
Status of Biological Diversity
Biosafety Protocol
Manpower Training Centers / Programs
International Cooperation in Biotech Area
Bilateral Cooperation with Member Countries and beyond
Biotechnology Infrastructure
National Budget for the Promotion of Biotechnology
Biotechnology in Korea 33
• Key Factors
- Part A: Basic Data – Land Area, Population, GNP
- Part B: R&D – National R&D Expenditures in Total, National R&D Expenditures in Biotech
- Part C: Human Resources – Number of Scientists in Biotech Area in Total, Number of Scientists in Biotech Area by Sector
- Part D: Biotechnology Development and Diffusion – Bioindustry Market (in Total and by Sector), International Trade in Bioproducts, Number of Biotechnology Companies (Venture, Established), Number of Patents(in Total, by Field), Number of Publications (Domestic and Overseas), etc.
- Part E: International Cooperation – Number of Bilateral & Multinational Agreements (MOU), Number of International Cooperation Centers, Number of International Joint Research Projects