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25th February 2009
                Hong, Choong Wan
          Biotech and Nanotech Division
          Ministry of Knowledge Economy
Contents




           1. Why Bioindustry?

              2. Bioindustry Overview and Policies

               3. Korea’s Bioindustry – Opportunities

              4. Vision and Policy Direction

           5. Policy Tasks




                                                     2
1. Why Bioindustry?

    Future Trends

    New Technology Paradigm




                              3
Future Trends


   글로벌화




          Potential to Meet                               Low-Carbon,
           Human Needs                                    Green Growth
   Supports health and longevity by                   Overcome environmental
  utilizing cutting-edge technologies.             challenges by utilizing biomass,
                                                    commercializing biotech, etc.




       The bioindustry is a knowledge-based industry that creates value-
       added and has great potential to meet the needs of a future society.




                                                                                      4
New Technology Paradigm




 * Richard Oliver, author of The Coming Biotech Age, called biotechnology the Fourth Wave,
                                 the Third Wave being IT.

                                                                                       5
2. Bioindustry Overview and Policies


     Bioindustry Trends

     Bioindustries in major countries




                                        6
Bioindustry Trends
             Significant Growth
             Significant Growth                   New Technologies via Convergence
                                                  New Technologies via Convergence
 Annual Average Growth            $1.3 trillion
                                                                                    IT
                                                    New technologies
                 $600 billion                     arising from the
                                                                      Electronics          NT
  $540 billion                                    convergence of         0
    (USD)                                         cutting-edge
                                                  technologies such
                                                  as IT, NT              Machinery Chemicals
      2004          2006             2020



   High Risk, High Value-added
   High Risk, High Value-added                          Low-Carbon, Green Growth
                                                        Low-Carbon, Green Growth
                                                  Sustainable growth technologies (e.g. biorefining)


  Development of new medicines
  is a lengthy, costly process.

  Annual value-added of one new medicine
 = export of 3 million cars



                                                                                                7
Bioindustries in Major Economies
  By concentrating investment in biotechnology, countries are seeking solutions
         to concerns about energy, environment and aging populations.


          Measures Taken
          Policies established at the federal and state levels to foster the bioindustry on the basis of
          world-leading technological competitiveness.
          In 2005, the U.S. accounted for 75.7% of global imports, 78.3% of global R&D in the bioindustry.
           •   State governments continue to increase investment in biotechnology.
           •   Federal government recently increased support for stem cell research and alleviated regulations.

          Has established an EU-wide development strategy emphasizing simultaneous pursuit of
          cooperation and competition.
          Implementing the seventh Framework Program (2007 to 2013, 9.52 billion euros in investment)
           •   Focusing on bioenergy in a new strategy to reduce dependence on oil.

          Has expedited collaboration among industry, academia and research centers through a biotech
          commercialization strategy.
           •   Stressed the need to develop and commercialize new medicine in its New industry Creation Strategy (May
               2004) and Science and Technology Basic Plan for Phase III (2006-2010).
           •   Adopting a pragmatic approach to R&D, fostering translational research and clinical research alongside cutting-
               edge research.

          Government to foster nine core areas in an effort to become a biotech stronghold.
           •   Announced Biotechnology Development Master Plan in September 2005: Nine core areas have been identified
               including agriculture, drugs, food and energy.
           •   Plan to set up biotech clusters in Beijing, Tianjin, Changjiang Delta, Pearl River Delta, etc.



                                                                                                                        8
3. Korea’s Bioindustry

    Status of Korea’s Bioindustry

    Assessment of Issues

    Opportunity: SWOT Analysis




                                    9
Status of Korea’s Bioindustry
     Market Size
     Market Size
   Production in 2008 was about $3.9 billion (Global market size : $124 billion)
   - Annual growth rate from 2006 to 2008 stood around 19.7%




     Investment and Industrial Structure
      Investment and Industrial Structure
  Government investment(‘08) was 920 billion won
   - 8.5% of the total government R&D budget (10.8 trillion won)
    cf.) US(22.5%), Japan(18%)
  Businesses are small and the market has no leading companies or significant
  investment.

     Technological Competitiveness
     Technological Competitiveness
  Korea’s level of technology is only about 60 to 70% of that seen in advanced
  countries.
  Nevertheless, the industry has made many achievements in a short time and
  shows great potential.

                                                                                   10
Issues


                    Low Investment
                    Low Investment
    Total investment size of Korea government in
    bioindustry is smaller than that of one representative
    global company.
     * R&D investment(‘08) : Korea government - $900 million,
                             Pfizer - $8000 million

         Weak Global Network
         Weak Global Network
    Korean companies lack a strong global network
    comparing with world’s global company.
    - only 6 applications to the U.S. FDA for clinical trials of their products.


                                                                                   11
Issues


     Weak Industrial Basis
     Weak Industrial Basis
   Industrial ecosystem has not formed in place to facilitate
   bioventure companies.

   Despite the growth of the market, most growth was in food
   biotechnology.
   -Production share (2006): food biotechnology 43%, biopharmaceuticals 39%,
   biochemical technology 6%


   Insufficient infrastructures to commercialize research results
   through professional services such as CROs and CMOs.




                                                                               12
Opportunity: SWOT Analysis


 • Advanced technology in the synthesis and
                                                   • Weak globalization of bioindustry
   manufacture of biopharmaceuticals
 • Abundance of researchers with skills in
                                                   • Lack of advanced infrastructure
   basic biotechnology                             • Insufficient number of specialists
 • Over 20 years of experience in drug             • No joint research system in place
   development
 • Export of numerous technologies regarding
                                                     among academia, research and
   bio-candidate substances                          industry



 •   Potential to expand market in consideration   •   Competition from China and India, which
     of aging population and other factors             have an edge in price competitiveness
 •   Increasing expiration of patents has opened   •   Insufficient M&As and partnerships
     up the biosimilar market                          among Korean companies
 •   Well-established base for convergence with    •   Dependency on overseas partners to
     IT, chemical and other related industries         conduct clinical trials
 •   Potential to enter global market in           •   Strong presence of multinationals in
     collaboration with multinationals                 Korean market




                                                                                        13
5. Vision and Policy Direction




                                 14
Vision and Strategy
              To achieve bioeconomy society with healthy lifestyle
                 7th leading country in bioengineering by 2015


                                                    Goals
                                                             2008
                                                             2008                         2015
                                                                                          2015
  Competitiveness in patented tech.                      14th in 2005                      7th

  Nurture core researchers                           10,000 researchers                  17,000

  Create industrialized market(production)              3.9 billion won               60 billion won


Pursue core R&D to produce              Establish infrastructure
                                        Establish infrastructure
Pursue core R&D to produce
        world-class                            & nurture
                                                & nurture
        world-class
         products                          human resources
                                           human resources
         products
                                                                                            Global Bio
                        Revise regulations and
                        Revise regulations and
                            Red Bio                                White Bio
                                                                    Promote            Strengthen regional and
                                                                                       Strengthen regional and
                                                                     Promote
                      lay a solid foundation for
                       lay a solid foundation for              biochemical industry
                                                               biochemical industry       global cooperation
                                                                                           global cooperation
                               business
                                business


 * Based on the 2nd basic plan to promote bio-engineering
                                                                                                         15
6. Policy Tasks
 Pursuit of Essential R&D Projects

 Development of Regional Bioindustry

  Development of Biochemical Industry to Replace Petrochemical
Industry

 Vitalization of Biotech Businesses

 Development of Human Resources




                                                                 16
Pursuit of Essential R&D projects

            Facilitate development of core and source technologies
            Facilitate development of core and source technologies
     and commercialization of technologies in pre-clinical and clinical stages
     and commercialization of technologies in pre-clinical and clinical stages
   Strategic technology development (in 2008, 34.6 billion won),
   Biostar project (in 2008, 12.8 billion won)



           Pursue essential R&D projects to foster new growth engines
            Pursue essential R&D projects to foster new growth engines
     in connection with MKE’s Technology Development Support Road Map
      in connection with MKE’s Technology Development Support Road Map
    Diagnosis   : Develop a small, affordable mass spectrometer and a system
                  to detect diseases at an early stage

    Treatment :    Develop embryonic and placental stem cell drugs and gene drugs


    Materials :   Develop body-friendly, next-generation implant technology




                                                                                    17
Development of Regional Bioindustry

     Specialized Bioindustry Cluster
     Specialized Bioindustry Cluster
    Foster specialized regional biotech centers
    while promoting biopharmaceutical businesses in Chungcheong provinces.
    - High-tech (Daejeon, Chuncheon), health supplement industry (Yeongdong, Naju), Korean medicine (Jecheon, Daegu)

    Through 20 regional centers, provide necessary education to start up
    businesses and create jobs.
                                                                               Regional Bioindustry Clusters
                                                                               Regional Bioindustry Clusters


Enhanced Network Among Different Clusters
Enhanced Network Among Different Clusters

   Enhance regional and global networks.
   - Through Korea Bio-Hub center




                                                                                                                 18
Development of Biochemical Industry to Replace Petrochemical
Industry

 Development of Environmentally Friendly Products Utilizing Biomass and Biotechnology
 Development of Environmentally Friendly Products Utilizing Biomass and Biotechnology

   R&D investment in biorefinery tech. (08-12, 12.5 billion won) and bioplastics
   & 2 additional projects will be supported in 2009.

   Establish biorefinery pilot plants,
   with joint efforts by industry, universities and research centers.
   - Cooperation with local governments to utilize existing petrochemical complexes.




                                                                                       19
Vitalization of Biotech Businesses

      Support for Investment
      Support for Investment
    Offer support to promising biotech companies by utilizing the Biofund*
    * To be established in 2009, 100 billon won


       Support for infrastructure
       Support for infrastructure
     Build Medical multi-complex
     - Global R&D hub in medical industry, support research for new medicine
     - Invest 5600 billion won by 2027
     - select 1~2 regions in 2009

     Support for Exports
     Support for Exports
     Support the commercialization and export of biotechnology
     - cGMP-based drug production facilities (Songdo Techno Park)
     - a Medical Industry Overseas Marketing Support Center (KOTRA.)
     - Exhibition & Confernece (Biokorea, Global Biotech Forum)


                                                                               20
Development of Human Resources

   Researchers
   Researchers
   Nurture top researchers by opening specialized graduate schools
    * 2 schools, 800 million won in 2009
   - Establish master’s and Ph.D. courses in collaboration with industries (medicine,
     biotech), academia and research centers to converge IT, nanotech and biotech




    Specialists
    Specialists
   Foster specialists in areas where demand is rising rapidly, such as
   cGMP, quality management, biomaterial manufacturing, etc.
    * 1.48 billion won in 2009




                                                                                        21
22

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Bioindustry in Korea

  • 1. 25th February 2009 Hong, Choong Wan Biotech and Nanotech Division Ministry of Knowledge Economy
  • 2. Contents 1. Why Bioindustry? 2. Bioindustry Overview and Policies 3. Korea’s Bioindustry – Opportunities 4. Vision and Policy Direction 5. Policy Tasks 2
  • 3. 1. Why Bioindustry? Future Trends New Technology Paradigm 3
  • 4. Future Trends 글로벌화 Potential to Meet Low-Carbon, Human Needs Green Growth Supports health and longevity by Overcome environmental utilizing cutting-edge technologies. challenges by utilizing biomass, commercializing biotech, etc. The bioindustry is a knowledge-based industry that creates value- added and has great potential to meet the needs of a future society. 4
  • 5. New Technology Paradigm * Richard Oliver, author of The Coming Biotech Age, called biotechnology the Fourth Wave, the Third Wave being IT. 5
  • 6. 2. Bioindustry Overview and Policies Bioindustry Trends Bioindustries in major countries 6
  • 7. Bioindustry Trends Significant Growth Significant Growth New Technologies via Convergence New Technologies via Convergence Annual Average Growth $1.3 trillion IT New technologies $600 billion arising from the Electronics NT $540 billion convergence of 0 (USD) cutting-edge technologies such as IT, NT Machinery Chemicals 2004 2006 2020 High Risk, High Value-added High Risk, High Value-added Low-Carbon, Green Growth Low-Carbon, Green Growth Sustainable growth technologies (e.g. biorefining) Development of new medicines is a lengthy, costly process. Annual value-added of one new medicine = export of 3 million cars 7
  • 8. Bioindustries in Major Economies By concentrating investment in biotechnology, countries are seeking solutions to concerns about energy, environment and aging populations. Measures Taken Policies established at the federal and state levels to foster the bioindustry on the basis of world-leading technological competitiveness. In 2005, the U.S. accounted for 75.7% of global imports, 78.3% of global R&D in the bioindustry. • State governments continue to increase investment in biotechnology. • Federal government recently increased support for stem cell research and alleviated regulations. Has established an EU-wide development strategy emphasizing simultaneous pursuit of cooperation and competition. Implementing the seventh Framework Program (2007 to 2013, 9.52 billion euros in investment) • Focusing on bioenergy in a new strategy to reduce dependence on oil. Has expedited collaboration among industry, academia and research centers through a biotech commercialization strategy. • Stressed the need to develop and commercialize new medicine in its New industry Creation Strategy (May 2004) and Science and Technology Basic Plan for Phase III (2006-2010). • Adopting a pragmatic approach to R&D, fostering translational research and clinical research alongside cutting- edge research. Government to foster nine core areas in an effort to become a biotech stronghold. • Announced Biotechnology Development Master Plan in September 2005: Nine core areas have been identified including agriculture, drugs, food and energy. • Plan to set up biotech clusters in Beijing, Tianjin, Changjiang Delta, Pearl River Delta, etc. 8
  • 9. 3. Korea’s Bioindustry Status of Korea’s Bioindustry Assessment of Issues Opportunity: SWOT Analysis 9
  • 10. Status of Korea’s Bioindustry Market Size Market Size Production in 2008 was about $3.9 billion (Global market size : $124 billion) - Annual growth rate from 2006 to 2008 stood around 19.7% Investment and Industrial Structure Investment and Industrial Structure Government investment(‘08) was 920 billion won - 8.5% of the total government R&D budget (10.8 trillion won) cf.) US(22.5%), Japan(18%) Businesses are small and the market has no leading companies or significant investment. Technological Competitiveness Technological Competitiveness Korea’s level of technology is only about 60 to 70% of that seen in advanced countries. Nevertheless, the industry has made many achievements in a short time and shows great potential. 10
  • 11. Issues Low Investment Low Investment Total investment size of Korea government in bioindustry is smaller than that of one representative global company. * R&D investment(‘08) : Korea government - $900 million, Pfizer - $8000 million Weak Global Network Weak Global Network Korean companies lack a strong global network comparing with world’s global company. - only 6 applications to the U.S. FDA for clinical trials of their products. 11
  • 12. Issues Weak Industrial Basis Weak Industrial Basis Industrial ecosystem has not formed in place to facilitate bioventure companies. Despite the growth of the market, most growth was in food biotechnology. -Production share (2006): food biotechnology 43%, biopharmaceuticals 39%, biochemical technology 6% Insufficient infrastructures to commercialize research results through professional services such as CROs and CMOs. 12
  • 13. Opportunity: SWOT Analysis • Advanced technology in the synthesis and • Weak globalization of bioindustry manufacture of biopharmaceuticals • Abundance of researchers with skills in • Lack of advanced infrastructure basic biotechnology • Insufficient number of specialists • Over 20 years of experience in drug • No joint research system in place development • Export of numerous technologies regarding among academia, research and bio-candidate substances industry • Potential to expand market in consideration • Competition from China and India, which of aging population and other factors have an edge in price competitiveness • Increasing expiration of patents has opened • Insufficient M&As and partnerships up the biosimilar market among Korean companies • Well-established base for convergence with • Dependency on overseas partners to IT, chemical and other related industries conduct clinical trials • Potential to enter global market in • Strong presence of multinationals in collaboration with multinationals Korean market 13
  • 14. 5. Vision and Policy Direction 14
  • 15. Vision and Strategy To achieve bioeconomy society with healthy lifestyle 7th leading country in bioengineering by 2015 Goals 2008 2008 2015 2015 Competitiveness in patented tech. 14th in 2005 7th Nurture core researchers 10,000 researchers 17,000 Create industrialized market(production) 3.9 billion won 60 billion won Pursue core R&D to produce Establish infrastructure Establish infrastructure Pursue core R&D to produce world-class & nurture & nurture world-class products human resources human resources products Global Bio Revise regulations and Revise regulations and Red Bio White Bio Promote Strengthen regional and Strengthen regional and Promote lay a solid foundation for lay a solid foundation for biochemical industry biochemical industry global cooperation global cooperation business business * Based on the 2nd basic plan to promote bio-engineering 15
  • 16. 6. Policy Tasks Pursuit of Essential R&D Projects Development of Regional Bioindustry Development of Biochemical Industry to Replace Petrochemical Industry Vitalization of Biotech Businesses Development of Human Resources 16
  • 17. Pursuit of Essential R&D projects Facilitate development of core and source technologies Facilitate development of core and source technologies and commercialization of technologies in pre-clinical and clinical stages and commercialization of technologies in pre-clinical and clinical stages Strategic technology development (in 2008, 34.6 billion won), Biostar project (in 2008, 12.8 billion won) Pursue essential R&D projects to foster new growth engines Pursue essential R&D projects to foster new growth engines in connection with MKE’s Technology Development Support Road Map in connection with MKE’s Technology Development Support Road Map Diagnosis : Develop a small, affordable mass spectrometer and a system to detect diseases at an early stage Treatment : Develop embryonic and placental stem cell drugs and gene drugs Materials : Develop body-friendly, next-generation implant technology 17
  • 18. Development of Regional Bioindustry Specialized Bioindustry Cluster Specialized Bioindustry Cluster Foster specialized regional biotech centers while promoting biopharmaceutical businesses in Chungcheong provinces. - High-tech (Daejeon, Chuncheon), health supplement industry (Yeongdong, Naju), Korean medicine (Jecheon, Daegu) Through 20 regional centers, provide necessary education to start up businesses and create jobs. Regional Bioindustry Clusters Regional Bioindustry Clusters Enhanced Network Among Different Clusters Enhanced Network Among Different Clusters Enhance regional and global networks. - Through Korea Bio-Hub center 18
  • 19. Development of Biochemical Industry to Replace Petrochemical Industry Development of Environmentally Friendly Products Utilizing Biomass and Biotechnology Development of Environmentally Friendly Products Utilizing Biomass and Biotechnology R&D investment in biorefinery tech. (08-12, 12.5 billion won) and bioplastics & 2 additional projects will be supported in 2009. Establish biorefinery pilot plants, with joint efforts by industry, universities and research centers. - Cooperation with local governments to utilize existing petrochemical complexes. 19
  • 20. Vitalization of Biotech Businesses Support for Investment Support for Investment Offer support to promising biotech companies by utilizing the Biofund* * To be established in 2009, 100 billon won Support for infrastructure Support for infrastructure Build Medical multi-complex - Global R&D hub in medical industry, support research for new medicine - Invest 5600 billion won by 2027 - select 1~2 regions in 2009 Support for Exports Support for Exports Support the commercialization and export of biotechnology - cGMP-based drug production facilities (Songdo Techno Park) - a Medical Industry Overseas Marketing Support Center (KOTRA.) - Exhibition & Confernece (Biokorea, Global Biotech Forum) 20
  • 21. Development of Human Resources Researchers Researchers Nurture top researchers by opening specialized graduate schools * 2 schools, 800 million won in 2009 - Establish master’s and Ph.D. courses in collaboration with industries (medicine, biotech), academia and research centers to converge IT, nanotech and biotech Specialists Specialists Foster specialists in areas where demand is rising rapidly, such as cGMP, quality management, biomaterial manufacturing, etc. * 1.48 billion won in 2009 21
  • 22. 22