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Current Status of Biotech Industry in Korea : Strengths and Challenges December 2005 Jin-Ho Seo, Ph.D. Director, Bio-MAX Institute, Seoul National University Bioindustry Association of Korea(BAK) EU-Korea Biotech Seminar

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Page 1: Current Status of Bioindustry in Korea

Current Status of Biotech Industry

in Korea : Strengths and Challenges

December 2005

Jin-Ho Seo, Ph.D.Director, Bio-MAX Institute, Seoul National University

Bioindustry Association of Korea(BAK)

EU-Korea Biotech Seminar

Page 2: Current Status of Bioindustry in Korea

Ⅰ. Fundamental Structure of Bioindustry in Korea 1. History of Korean Bioindustry 2. Bioindustry Fields 3. Government Role and R&D Investment 4. Journal & Patent 5. Driving System

Ⅱ. New Breakthroughs of Bioindustry in Korea 1. Vision for BioSociety and Goal of Bioindustry 2. Basic Direction of Bioindustry Policy 3. Strengthening Strategy of Competitiveness on Bioindustry 4. What We Focus On

Ⅲ. Current Status of Bioindustry in Korea 1. Category of Companies 2. Manpower of Companies 3. Market Size 4. Example of Bio-Products 5. Trend of Technology Development 6. Investment by Major Corporates 7. Industrialization by Major Corporates 8. Launching Trend of New Bio-products 9. SWOT of the Korean Bioindustry 10. Strengths and Challenges

Ⅳ. Future of Korean Bioindustry 1. Prospect for the Future 2. Strategy for the Future

CONTENTS

Page 3: Current Status of Bioindustry in Korea

1. History of Korean Bioindustry

1980~1989 : Technology Development Stage Introduction & Development of New Biotechnology

Enactment of Biotechnology Promotion Law, 1983

Establishment of Biotechnology Departments & Research Institutes in Universities, 1984

Establishment of the Korea Research Institute of Bioscience & Biotechnology(KRIBB), 1985

1990~1999 : Product Manufacturing Stage Establishment of Bioindustry Association of Korea(BAK), 1991

Formalizing of Biotech 2000 Program(MOST), 1994

Proclaim of Bioindustry Vision 2000(MOCIE), 1994

Development of Bioprocess Technology & Launching of Bio-products

2000~Current : Bioindustry Introduction Stage Establishment of Korean Bioindustry Development Strategy, 2000 Key National Strategic Industry Inauguration of National Bioindustry Action Plan

Productivity Improvement of Generic Products, Development of New & Modified Bio-products

Investment Increase in Public & Private Sector

1I. Fundamental Structure of Bioindustry in Korea

Page 4: Current Status of Bioindustry in Korea

Areas Contents

BiochemicalsBiopolymer, Industrial enzymes, Organic acids, Amino acids, Reagents & Kits, Bioagrochemicals, etc.

BioenvironmentsWaste water & Wastes treatment, Bioremediation, Polution monitoring, Microbial agents, etc.

BiopharmaceuticalsImmunomodulator, Growth factor, Blood protein, Antibiotics, Vaccines, Diagnostics, Tissue & Cell engineering, Gene therapy, etc.

Bioenergy & Resources

Biomass & Biogas, Artificial seed & tree, Transgenic animal & plant, Marine bioresources, etc.

BiofoodsAmino acid, Functional peptide & protein, Functional lipid & carbohydrate, Food additives & enzymes, etc.

BioelectronicsDNA chip, Protein chip, Lab on a Chip, Biosensors, Bio MEMS, Bio devices, etc.

Bioprocess & Bioequipment

Fermentation, Cell culture, Bioconversion, Separation & Purification, Formulation, Bioengineering, etc.

Bioevaluation & Bioinformatics

Safety evaluation, Efficacy evaluation, Biostandardization, Bioinformatics, etc.

Bioindustry Fields

Source : Korea Institute for Industrial Economics & Trade(KIET), 2004

2. Bioindustry Fields

2I. Fundamental Structure of Bioindustry in Korea

Page 5: Current Status of Bioindustry in Korea

Department Main Role

Ministry of Commerce, Industry and Energy

(MOCIE)

Applied Biotechnologies and Industrialization

Development of Substitute Energy

Ministry of Science and Technology

(MOST)

Basic and Leading-edge Technologies

Promotion of Biotechnology-supporting Systems

Ministry of Education & Human Resources

Development(MOE)

Education

Assistance of Basic Researches on Life Science

Ministry of Health and Welfare

(MOHW)

Development of New Biopharmaceuticals

Clinical Trials & Regulations

Ministry of Agriculture & Forestry

(MAF)

Breeding Animals, Plants

New Food Additives

Ministry of Environment

(ME)

Preservation and Use of Biodiversity

Development of Wastes Treatment Technology

Ministry of Maritime & Fisheries

(MOMAF)

Conservation of Marine Resources

Gene Analysis of the Marine Species

Government Role in Bioindustry

Government Role

I. Fundamental Structure of Bioindustry in Korea 3

3. Government Role and R&D Investment

Source : Biotechnology Promotion Law

Page 6: Current Status of Bioindustry in Korea

Research InstitutesResearch Institutes

Governmental AgenciesGovernmental Agencies

US$ 450 million R&D Investment by 7 Ministries in 2003

US$ 525 million R&D Investment by 8 Ministries in 2004

Governmental AgenciesGovernmental Agencies

US$ 450 million R&D Investment by 7 Ministries in 2003

US$ 525 million R&D Investment by 8 Ministries in 2004

Industries Industries

Bioindustry Association of Korea

Korea Biotechnology Research Association

Korea Bio Venture Association

Biotech Institutes in Private Companies

Bioindustry Association of Korea

Korea Biotechnology Research Association

Korea Bio Venture Association

Biotech Institutes in Private Companies

AcademiaAcademia

Biotechnology-related Departments in Universities

University-associated Research Institutes

Science & Engineering Research Centers

Biotechnology-related Societies

Biotechnology-related Departments in Universities

University-associated Research Institutes

Science & Engineering Research Centers

Biotechnology-related Societies

Korea Research Institute of Bioscience and Biotechnology

POSTECH Biotech Center

Biocluster : Bio Venture Center & New Region Promotion Business

Other Governmental or Public Research Institutes

Korea Research Institute of Bioscience and Biotechnology

POSTECH Biotech Center

Biocluster : Bio Venture Center & New Region Promotion Business

Other Governmental or Public Research Institutes

Government R&D Investment

I. Fundamental Structure of Bioindustry in Korea 4

3. Government Role and R&D Investment

Page 7: Current Status of Bioindustry in Korea

Case published in the Journals listed by SCI

I. Fundamental Structure of Bioindustry in Korea 5

4. Journal & Patent

43 55 69120

246300 308

394445

498

050

100150200250300350400450500

SC

I(C

ase

)

1991 1992 1993 1994 1995 1996 1997 1998 1999 2000

Year

Source : Ministry of Science and Technology(MOST), Biotechnology in Korea

Page 8: Current Status of Bioindustry in Korea

Patent registration to the US PTO

I. Fundamental Structure of Bioindustry in Korea 6

4. Journal & Patent

3

710

6

15

23

13

26

0

5

10

15

20

25

30

Pa

ten

t

1994 1995 1996 1997 1998 1999 2000 2001

Year

Source : Ministry of Science and Technology(MOST), Biotechnology in Korea

Page 9: Current Status of Bioindustry in Korea

5. Driving System Government

7I. Fundamental Structure of Bioindustry in Korea

Korean Intellectual Property Office(KIPO)

Genetic Engineering Examination Division

Korea Food & Drug Administration(KFDA)

Safety Evaluation Office

Ministry of Commerce, Industry and Energy(MOCIE)

Biotechnology & Chemicals Industries Division

Ministry of Science and Technology(MOST)

Biotech and Environmental Technology Division

Ministry of Education & Human Resources Development(MOE)

Ministry of Agriculture & Forestry(MAF)

Ministry of Health and Welfare(MOHW)

Ministry of Environment(ME)

Ministry of Maritime Affairs & Fisheries(MOMAF)

Page 10: Current Status of Bioindustry in Korea

Academia

I. Fundamental Structure of Bioindustry in Korea

5. Driving System

Biotechnology-related Departments were set up in around 40 Universities

College of Science 60%, College of Agriculture 25%, College of Engineering 15%

30 University-associated Research Institutes on the Genetic Engineering were established

Institute of Molecular Biology and Genetics, Seoul National University, etc.

Science Research Center(SRC) & Engineering Research Center(ERC)

Over 20 Centers in Biotechnology Area in the Universities

Seoul National University, Korea University, KAIST, etc.

Biotechnology-related Societies are Working on

Korean Society for Biotechnology and Bioengineering(KSBB)

Korean Institute of Chemical Engineering / Division of Biochemical Engineering, etc.

8

Page 11: Current Status of Bioindustry in Korea

Research Institutes Biotechnology-dedicated Research Institutes

Korea Research Institute of Bioscience and Biotechnology(KRIBB) is the only government research

institute dedicated to biotechnology research across a broad span of expertise, from basic studies

for the fundamental understanding of life phenomena to applied studies, established in 1985

Korea Research Institute of Bioscience and Biotechnology(KRIBB)

MOGAM Biotechnology Institute is one of the best private research institutes established in 1984

on the promotions of the research and development in the field of Biopharmaceuticals

MOGAM Biotechnology Institute

I. Fundamental Structure of Bioindustry in Korea

5. Driving System

9

SNU Bio-MAX Institute is a research organization established in 2003 with a support from MOCIE

to carry out innovative projects in a multidisciplinary environment

Bio-MAX Institute, Seoul National University

Page 12: Current Status of Bioindustry in Korea

Biocluster

Biotechnology Innovation Center, Chuncheon Bio Venture Center, Daejeon Center for Biotechnology and Bioventure,

Jeonbuk Bio21 Center, Kyungnam Biotechnology Industrialization Center,

Dongshin University Biotechnology Innovation Center,

Youngdong University Technology Innovation Center,

Sangju National University Bioindustry Development Center, Jeju Marine Biotechnology Center for Functional

Material Industry, Busan

Bio Venture Town, Daejeon Bio Venture Plaza, Chuncheon Institute for Marine Bioindustry, Gangneung Biotechnology Center for Bioindustry, Jeonnam Biotechnology Research Center, Jeonnam Biohealth Industry Support Center, Kyungbuk Bioscience Park, Jeju Traditional Pharmaceutical R&D Center, Chungbuk

Animal Resources Support Center, Chungnam Healthcare Industry Center, Chungbuk Marinebio Enviromental Industry Center, Kyungbuk

Biomaterial Industrialization Center, Daegu Herb Medicine Support Center, Daegu Bio Venture Plaza, Kyungnam Bio-Industry Support Center, Busan

New Region Promotion Business(15)Bio Venture Center(9)

Research Institutes

I. Fundamental Structure of Bioindustry in Korea

5. Driving System

10

Page 13: Current Status of Bioindustry in Korea

Biotechnology-related Research Institutes

Korea Institute of Science and Technology(KIST) Korea Tomorrow & Good Research Institute(KTGRI) Korea Food Research Institute(KFRI) Korea Institute of Toxicology(KIT) Korea Biotechnology Commercialization Center(KBCC) Korea Institute of Energy Research(KIER) Korea Ocean Research & Development Institute(KORDI)

Korean Agency for Technology and Standards(ATS) National Institute of Health(NIH) National Institute of Environmental Research(NIER) National Institute of Agricultural Science and Technology(NIAST) Korea Forest Research Institute(KFRI) National Veterinary Research and Quarantine Service(NVRQS) National Fisheries Research and Development Institute(NFRDI) National Institute of Scientific Investigation(NISI)

Government-donated Research Institutes

National and Public Research Institutes

Research Institutes

I. Fundamental Structure of Bioindustry in Korea

5. Driving System

11

Page 14: Current Status of Bioindustry in Korea

Korean Collection for Type Cultures(KCTC)

Korean Culture Center of Microorganisms(KCCM)

Korean Cell Line Research Foundation

Microorganism Depository Organizations

Asan Institute for Life Science

Samsumg Bioscience Research Institute

Private Research Institutes

Korea Institute of Science and Technology Information(KISTI)

Agriculture and Life Science Research Center, Seoul National University

Biological Research Information Center(BRIC), Pohang University of Science and Technology

Research Institutes on Bioinformatics

I. Fundamental Structure of Bioindustry in Korea

5. Driving System

12

Others

Research Institutes

Page 15: Current Status of Bioindustry in Korea

I. Fundamental Structure of Bioindustry in Korea

5. Driving Systems

13

Industry Organizations

Industrial Organization established as an affiliated Organization of Ministry of Commerce, Industry and Energy(MOCIE) in 1991 for the Purpose of the Development and Growth of Bioindustry in Korea

Main Activities

- Formation of Bioindustry Platform

- International Cooperation in Bioindustry

Members : General(Company : 60), Associate(Organization : 19, Individual : 110)

Research Association established as an affiliated Organization of Ministry of Science and Technology(MOST) in 1982 for the Purpose of the Support on the Development of Biotechnology

Bioventure Organization established as an affiliated one of Ministry of Commerce, Industry and Energy(MOCIE) in 2000

Bioindustry Association of Korea(BAK)

The Korea Biotechnology Research Association(KBRA)

Korea Bio Venture Association(KOBIOVEN)

Page 16: Current Status of Bioindustry in Korea

Transformation to BioSociety where the Bio-Products and Services are

just on Your Hands

The Coming BioSociety after the Bio-Revolution of 21C through the Fusion of

Biotechnology(BT) and Information Technology(IT)

1. Vision for BioSociety and Goal of Bioindustry

14

Vision for BioSociety

The Core Contributor in Korea Economy in 21C

The paradigm shift in economy from mass assembly industry to knowledge based industry

Impact of Bioindustry

II. New Breakthrough of Bioindustry in Korea

Remaking the World Transforming Ourselves From Alchemy to Algeny

Page 17: Current Status of Bioindustry in Korea

II. New Breakthrough of Bioindustry in Korea

1. Vision for BioSociety and Goal of Bioindustry

15

Settlement as Growth Engine Industry for Next generation

- Industrialization as the main force in Post-IT era

Commercialization of Export-driven Bio-Product

- Marketing of New Bio-Product in advanced countries

- Globalization of Korean traditional Bio-Products

Vision for Bioindustry

Export : US$ 0.7 billion(2002) US$ 10 billion(2012)

Targeting 10% of share in Global Market

Page 18: Current Status of Bioindustry in Korea

Bioindustry Development Strategy 2005

Intensive Promotion of Bioindustry as a National Strategic Industry Active Lead toward Development of Bioindustry

2. Basic Direction of Bioindustry Policy

16

Creation of BioSociety for the 21st Century

Healthy BioSociety

Wealthy BioSociety

Clean BioSociety

II. New Breakthrough of Bioindustry in Korea

Growth of Bioindustry

3 Goals : R&D, Infra, Business Environment

12 Programmes : Bio-Star Project, Biocluster, etc.

Page 19: Current Status of Bioindustry in Korea

3. Strengthening Strategy of Competitiveness on Bioindustry

17II. New Breakthrough of Bioindustry in Korea

Development of Core Technology - Technology for Mid-term & Next generation

Growth Engine Industry for Next generation - New Bio-Drug / Artificial Organ, Bio-Chip

Bio-Star Project - Innovative Biotechnology & Bio-Product

Establishment of Bio-product Manufacturing - International authorization of GLP System - Establishment of GCP system for Functional Active Compound - Expansion of cGMP and Improvement of Management

Implementation of LMOs - Biosafety Information Center - Foundation of Bio-hazard Evaluation Center

Expansion of Industrialization

Infrastructure

Development of Core Technology

& Bio-Product

Page 20: Current Status of Bioindustry in Korea

3. Strengthening Strategy of Competitiveness on Bioindustry

18II. New Breakthrough of Bioindustry in Korea

Activation of Biocluster - Construction of Korea Bio-Hub - Strengthening of existing Biocluster - Promotion of using Micro-biochip production platform - Establishment of platform for supporting Industrialization of BIT technology

Establishment of Investment / Consulting Company - Participation from public company, private & foreign companies - Support of long-term investment

Construction of Complex - Advanced Biopharmaceutical production complex - Bulk Vaccine production complex

Joint R&D with Foreign Countries Training International Standard Specialist

Networking among Domestic & Foreign association, companies and government

Strengthening & Promoting of Biocluster

Promoting Global Network

Page 21: Current Status of Bioindustry in Korea

4. What We Focus On

19II. New Breakthrough of Bioindustry in Korea

Development of Therapeutic Protein by Animal Cell Culture

Development of Biomaterial by Intelligence-type Bioinformatics

Development of Gene Therapy for Incurable Diseases

Mass Production of Protein-DNA chip System

Development of High Value Added Protein

Immunomodulator

Drug Delivery System

Gene Therapy

Cell Therapy

cGMP Technology

Growth Engine Project : New Bio-Drug / Artificial Organ & Bio-Chip

Mid-term & Next Generation Project

Page 22: Current Status of Bioindustry in Korea

Types of Companies No. of Companies in 2003 : 605 No. of Companies on both R&D and Sales of Bio-Products : 432 No. of Companies focusing on R&D : 173

Types of Companies No. of Companies

Companies focusing on R&D 173

Companies working on R&D and Sales of Bio-Products

- Domestic Products

- Imported Products

432

(387)

(45)

Types of Bioindustry Companies in 2003

2004 No. of Companies in Bioindustry : About 600

1. Category of Companies

III. Current Status of Bioindustry in Korea 20

Source : Korean Agency for Technology & Standards, Korea Institute for Industrial Economics & Trade, Bioindustry Association of Korea, 2004

Page 23: Current Status of Bioindustry in Korea

Company Group

Large

Size

Group

Large

Size

Group

Above 30 Companies

LGLS, CJ, Daesang, TS Corporation, etc.

Operating the fully Integrated System on R&D, Production, Marketing

Above 30 Companies

LGLS, CJ, Daesang, TS Corporation, etc.

Operating the fully Integrated System on R&D, Production, Marketing

Middle

Size

Group

Middle

Size

Group

Above 70 Companies

Dong-A Pharm., Chong Kun Dang, Green Cross, Daewoong, etc.

Focused on the Competitive Core Products

Above 70 Companies

Dong-A Pharm., Chong Kun Dang, Green Cross, Daewoong, etc.

Focused on the Competitive Core Products

SmallSize &

Venture Group

SmallSize &

Venture Group

Above 500 Companies

Dong Kook Pharm., Bioneer, Macrogen, KoBioTech, etc.

Individually concentrated on the Niche Fields of R&D, Production and Marketing

Above 500 Companies

Dong Kook Pharm., Bioneer, Macrogen, KoBioTech, etc.

Individually concentrated on the Niche Fields of R&D, Production and Marketing

III. Current Status of Bioindustry in Korea

1. Category of Companies

21

Page 24: Current Status of Bioindustry in Korea

III. Current Status of Bioindustry in Korea 22

2. Manpower of Companies 2003 Total : 11,013

R&D Area : 5,808(53%)

Manufacturing Area : 5,205(47%)

2004 : About 13,000

Manpower of Bioindustry in 2003

Ph.D. M.S. B.S. Technician Total

R&D 1,001 2,654 1,593 560 5,808

Manufacturing 35 363 1,405 3,402 5,205

Total 1,036 3,017 2,998 3,962 11,013

Source : Korean Agency for Technology & Standards, Korea Institute for Industrial Economics & Trade, Bioindustry Association of Korea, 2004

Page 25: Current Status of Bioindustry in Korea

3. Market Size 2003 : US$ 1,332 million Biopharmaceuticals 61%, Non-biopharmaceuticals 39%

Domestic Products 68%, Imported Products 32%

2004 : About US$ 1,701 million

Area Domestic Products Imported Products

Biopharmaceuticals

Biofoods

Biochemicals

Bioenvironments

Bioenergy & Resources

Bioprocess & Bioequipment

Bioelectronics & Bioinformatics

545

148

65

76

11

26

33

267

1

35

-

2

122

1

Total 904 428

1,332

Bioindustry Market Size in 2003(Unit : US$ million)

III. Current Status of Bioindustry in Korea 23

Source : Korean Agency for Technology & Standards, Korea Institute for Industrial Economics & Trade, Bioindustry Association of Korea, 2004

Page 26: Current Status of Bioindustry in Korea

Human Growth Hormone

Vaccines : Hepatitis B Vaccine, etc.

α-Interferon, γ-Interferon

Antibiotics : 7-ACA, etc.

Diagnostic Kits

Amino Acids : Lysine, etc.

Oligosaccharides

Microbial Agents

Insulin

Human Growth Hormone

α-Interferon, β-Interferon

Vaccines : Influenza, etc.

Erythropoietin

Diagnostic Kits

Equipments : Bioprocess, etc.

Industrial Enzymes

Examples of Domestic Products Examples of Imported Products

III. Current Status of Bioindustry in Korea

4. Example of Bio-products

24

Page 27: Current Status of Bioindustry in Korea

Upstream Technology : Well Developed

Recombinant DNA Technology, Cell Fusion Technology, etc.

Downstream Technology

Fermentation : Well Developed

Animal & Plant Cell Culture, Separation & Purification, etc. : Improving

Emerging Technology : Early Stage

Genomics, Proteomics, Bioinformatics, etc.

Use of Established Biotechnology

Improvement of level on Bioprocess Technology

Development of Post genomics-related New Technology

Industrialization of Improved and New Bio-products

Improved Bio-product

New Bio-product

Technology

Level

Trend of Technology Development

5. Trend of Technology Development

III. Current Status of Bioindustry in Korea 25

Page 28: Current Status of Bioindustry in Korea

Investment to Biotech Investment to Biotech CompanyCompany

SamsungSamsung

SKSK

LGLSLGLS

DaesangDaesang

Green CrossGreen Cross

ISU ChemicalISU Chemical

DooSan DooSan

CJCJ

US$ 155 million by 2004US$ 155 million by 2004

US$ 230 million by 2003US$ 230 million by 2003

US$ 100 million by 2005US$ 100 million by 2005

US$ 115 million by 2006US$ 115 million by 2006

US$ 77 million by 2004US$ 77 million by 2004

US$ 32 million in 2001, domestic and oversea investment US$ 32 million in 2001, domestic and oversea investment

US$ 85 million to Biotech, 30 million to Biotech VenturesUS$ 85 million to Biotech, 30 million to Biotech Ventures

US$ 230 million by 2004US$ 230 million by 2004

6. Investment by Major Corporates Investment by Major Corporates

III. Current Status of Bioindustry in Korea 26

Page 29: Current Status of Bioindustry in Korea

7. Industrialization by Major Corporates Industrialization by Major Corporates

III. Current Status of Bioindustry in Korea

Bio-Products of LG Life Science Ltd.

No.No. ProductProduct ApplicationApplication Approval Approval DateDate

1Intermax gamma

InjectionChronic myelogeneous leukemia(CML), Rheumatoid arthritis(RA) 1989

2Euvax B Injectio

nImmunization against infection caused by all known subtypes of hepatitis B virus 1992

3Intermax alpha I

njectionMultiple myeloma , Renal cell carcinoma, Malignant melanoma, Kaposi's sarcoma in patients with AIDS, Hairy cell leukemia, Improvement of viremia in chronic hepatitis B, etc.

1992

4Eutropin Injectio

nShort stature due to GHD, Short stature due to Turner's syndrome 1993

5 BoostinSustained-release(SR) formulation of recombinant Bovine Somatotropin(rBST) for increasing milk production in lactating dairy cows.

1994

6Leucogen Injecti

onNeutropenia due to chemotheraphy in patients with solid tumor, Neutropenia after bone marrow transplantation(BMT)

1995

7 HCD ELISA kit for the detection of Ab against hepatitis C virus 1995

8Hyal 2000 Injecti

onHyal 2000 Inj. is used during surgical procedures on the eyes, for example, cataract (intraocular lens implantation), keratotransplantation, glaucoma, etc.

1997

9Hyruan™ Injecti

onDeformative osteoarthritis of the knees, Shoulder periarthritis 1998

10Espogen Injectio

nAnemia in patients with chronic renal failure 1999

11LG Malaria

anti-P.V.ELISA kit for the detection of Ab against Plasmodium vivax 2000

27

Page 30: Current Status of Bioindustry in Korea

7. Industrialization by Major Corporates Industrialization by Major Corporates

III. Current Status of Bioindustry in Korea

Sales of LG Life Science Ltd. from Main Bio-Products in 2003

28

Euvax BInjection

Immunization against infection diseases caused by subtypes of hepatitis B virus

$ 29 mil.

Eutropin Injection

Short stature due to GHD or due to Tuner’s syndrome

BoostinSustained-release(SR) formulation of recombinant Bovine Somatotropin(rBST) for inducing increased milk production in dairy cows.

Hyruan™ Injection

Deformative osteoarthritis of the knees or shoulder periarthritis

Espogen Injection

Anemia in patients with chronic renal failure

$ 19 mil.

$ 8 mil.

$ 6 mil.

$ 8 mil.

Sales

Page 31: Current Status of Bioindustry in Korea

7. Industrialization by Major Corporates Industrialization by Major Corporates

III. Current Status of Bioindustry in Korea

Bio-Products of CJ Corp.

No. Product Application

1 7-ACA Intermediate for cephalosporins

2 Hepaccine-B Hepatitis B vaccine

3 VancomycinTreatment for the infection due to staphylococci and skin structure infections, etc.

4 Epokine Treatment of anemia associated with chronic renal failure

5 AlphaferonTreatment of multiple myeloma, malignant melanoma, Kaposi's sarcoma, hairy cell leukemia, and chronic hepatitis B viremia

6 Serratiopeptidase A proteolytic enzyme derived from Serratia spp

7 G-CSF Therapeutics of Neutropenia

8 Lysine Feed Additives

9 Nucleic Acid Food Additives

29

Page 32: Current Status of Bioindustry in Korea

7. Industrialization by Major Corporates Industrialization by Major Corporates

III. Current Status of Bioindustry in Korea 30

Sales of CJ Corporation from Main Bio-Products in 2003

                                                                                                                        

Lysine Feed additives $ 256 mil.

Nucleic Acid Food additives

7-ACA Intermediate for cephalosporins.

VancomycinTreatment for the infection due to staphylococci and skin structure infections, etc.

EpokineTreatment of anemia associated with chronic renal failure

$ 128 mil.

$ 22 mil.

$ 8 mil.

$ 27 mil.

Sales

Page 33: Current Status of Bioindustry in Korea

7. Industrialization by Major Corporates Industrialization by Major Corporates

III. Current Status of Bioindustry in Korea

Bio-Products of Dong-A Pharmaceutical Co., Ltd.

No. Product ApplicationApproval

Date

1 ADM Anti-cancer 1988

2 Vaxigrip Influenza vaccine 1989

3 Dong-A Prostin Injection Chronic Arterial Scleosis 1993

4 Leucostim Injection Human granulocyte-colony stimulating factor 1995

5Dong-A Interferon alpha-2

InjectionMultiple myeloma, Malignant melanoma, Kaposi's sarcoma, Hairy cell leukemia, etc.

1996

6 Growtropin Human growth hormone 1999

7 Eporon Injection Treatment of Anemia 1999

8Dong-A Syphilis, HCV, HBsA

g ELISA, AIDSDIAAnti-Treponema pallidum Diagnostic Kit, Diagnosis of Hepatitis C, B,

Diagnosis of HIV

31

Page 34: Current Status of Bioindustry in Korea

7. Industrialization by Major Corporates Industrialization by Major Corporates

III. Current Status of Bioindustry in Korea

Sales of Dong-A Pharmaceutical Co., Ltd. from Main Bio-Products in 2003

32

                                                                                                                        Eporon Injection

Treatment of anemia $ 5 mil.

Vaxigrip Influenza vaccine

Leucostim Injection

Human granulocyte-colony stimulating factor

Beszyme Tab Treatment of Indigestion and dyspepsia

Growtropin Human growth hormone

$ 7 mil.

$ 9 mil.

$ 4 mil.

$ 4 mil.

                                                                                                                                                                                                                                      

Sales

Page 35: Current Status of Bioindustry in Korea

8. Launching Trend of New Bio-Product Launching Trend of New Bio-Product

III. Current Status of Bioindustry in Korea 33

Cell & Tissue Therapy

SureDerm™(approved in 2000)

Acellular human dermis for the repairor replacement of damaged tissue.

Chondron(approved in 2001)

Autologous chondrocyte transplantation(ACT)

Holoderm(approved in 2002)

Cultured epidermal autograft(CEA)

Hans Biomed

Cellontech

Tego Science

Products ApplicationCompanies

Page 36: Current Status of Bioindustry in Korea

8. Launching Trend of New Bio-Product Launching Trend of New Bio-Product

III. Current Status of Bioindustry in Korea 34

Bio-Chip

MyGene Inc. Detection of Human Papillomavirus(HPV)

High sensitivity and specificity for the detection

of cervical disease in early stage

Minimal specimen preparation required

Cost effective and user-friendly test

My HPV Chip(approved in 2004)

HPVDNAChip(approved in 2004)

Biomedlab Co. Detection of Human Papillomavirus(HPV) Accurate risk determination by genotype

information

Assist diagnosis or prognosis of cervical cancers

Useful in vaccine development and evaluation

Page 37: Current Status of Bioindustry in Korea

9. SWOT of the Korean Bioindustry SWOT of the Korean Bioindustry

III. Current Status of Bioindustry in Korea 35

• International Level of IT Technology • Enthusiasm to Education• Strong Driving Policy of Government

• International Level of IT Technology • Enthusiasm to Education• Strong Driving Policy of Government

StrengthStrength

• Narrow gap in the Potential of Korea with Advanced Countries• Innumerable fields to be Investigated• Increase of the interests in Bioindustry among Koreans

• Narrow gap in the Potential of Korea with Advanced Countries• Innumerable fields to be Investigated• Increase of the interests in Bioindustry among Koreans

OpportunityOpportunity

• Inferior in Technology Competitiveness • Far behind level in Industrial Infrastructures• Insufficient Investment

• Inferior in Technology Competitiveness • Far behind level in Industrial Infrastructures• Insufficient Investment

WeaknessWeakness

• Spread of the Anxiety on Bio-Products• Monopoly of the Patents and IPR by a limited no. of Countries• Speedy of Technology Development

• Spread of the Anxiety on Bio-Products• Monopoly of the Patents and IPR by a limited no. of Countries• Speedy of Technology Development

ThreatThreat

Page 38: Current Status of Bioindustry in Korea

10. Strengths and Challenges Strengths and Challenges

III. Current Status of Bioindustry in Korea 36

Stem Cell R&D

Embryo Originated Stem Cell

Cloned cow, dog

Development of mini pig

Challenges

Amino Acid & Food Additives

Amino Acid : Lysine, etc.

Food Additives : Nucleic Acid, etc.

Strengths

BIT

Biochip, etc.

Biopharmaceuticals

Antibiotics : 7-ACA, etc.

Gene Drug : Hepatitis B Vaccine, etc

Page 39: Current Status of Bioindustry in Korea

37

Creation of BioSociety for the 21st Century

Healthy BioSociety

Wealthy BioSociety

Clean BioSociety

Ready for BioSociety Growth of Bioindustry

IV. Future of Korean Bioindustry

Intensive Promotion of Bioindustry as a National

Strategic Industry

Enhancement of International Cooperation

with China, etc.

Active Lead toward Development

& Enlargement of Bioindustry

1. Prospect for the Future Prospect for the Future

Page 40: Current Status of Bioindustry in Korea

38IV. Future of Korean Bioindustry

Strong Support Policy by Government

  Securing the Research Manpower by Education and Training

  Support to Build-up of t Infrastructures for Research and

     Commercialization

Increase of R&D Investment

Encouragement of Industry / Academia Cooperation

  Formulation of Consortium System by Bio-companies

Encouragement of International Cooperation

Support to Venture Capitals + Industries

Support to Bioclusters

2. Strategy for the Future Strategy for the Future