Biotech API Manufacturing Services 2014

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For more information on this report please contact ediz.ibrahim@visiongain.com (+44 (0) 2075499976) or refer to our website http://www.visiongain.com/Report/1169/Biotech-API-Manufacturing-Services-World-Industry-and-Market-2014-2024

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Biotech API Manufacturing Services 2014

  1. 1. Biotech API Manufacturing Services: World Industry and Market 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  2. 2. Contents 1. Executive Summary 1.1 Contract Biotech API Manufacturing: World Market Review 2013 1.2 Report Contents 1.2.1 Benefits of this Report 1.3 Methods of the Study 1.3.1 Who is this Report for? 1.3.2 Defining the Contract Biotech API Manufacturing Market 1.4 An Introduction to Biotech API Manufacturing 1.4.1 Producing Biological Drugs: An Introduction to the Manufacturing Process 1.4.1.1 Cell Line Development and Proliferation 1.4.2 There are Challenges in Manufacturing Biotech APIs 1.4.3 Outsourcing Biotech API Manufacturing 1.4.4 Future Trends in Biotech API Manufacturing 2. Contract Biotech API Manufacturing: World Market Outlook and Forecast 2014-2024 2.1 Demand for Outsourced Biotech API Manufacturing 2012-2013 2.1.1 What Services are in Greatest Demand from Biopharma CMOs? 2.2 The Outsourced Biotech API Manufacturing Market 2014-2024 2.2.1 Strong Growth for the Biological Drugs Market 2014-2024 2.2.2 Outsourced Biotech API Manufacturing Market Forecast 2014-2024 2.2.3 What Will Drive Market Growth to 2024? 2.2.4 In-House Expertise and Manufacturing Will Restrain Growth 2.2.5 Contract Biotech API Manufacturing: Submarket Shares 2014-2024 2.3 The Mammalian Cell Culture Submarket 2014-2024 2.3.1 Mammalian Cell Culture: Submarket Forecast 2014-2024 2.3.2 Antibody Drug Development Will Drive Submarket Growth to 2024 www.visiongain.com
  3. 3. Contents 2.4 The Microbial Fermentation Submarket 2014-2024 2.4.1 Microbial Fermentation: Submarket Forecast 2014-2024 2.4.2 Submarket Drivers and Restraints 2014-2024 2.5 Chapter Summary: Strong Market Growth Forecast 2012-2024 3. Leading National Markets for Contract Biotech API Manufacturing 2014-2024 3.1 The US and Europe Dominate Contract Biopharmaceutical Manufacturing 2012-2013 3.1.1 Growth for Leading National Submarkets 2014-2024 3.1.2 How Will National Submarket Shares Change to 2024? 3.2 Contract Biotech API Manufacturing in Europe 2014-2024 3.2.1 Biotech Research Is Growing Strongly in Europe 3.2.2 The European Submarket: Revenue Forecast 2014-2024 3.2.3 Leading EU National Submarkets 2014-2024 3.2.4 Germany Is Europe’s Biopharmaceutical Production Leader 3.2.5 The UK Contract Biotech API Manufacturing Submarket 2014-2024 3.2.5.1 High Demand Expected in the UK 2014-2024 3.2.6 France: Contract Biotech API Submarket Forecast 2014-2024 3.2.7 Switzerland Is a Leading Biotech R&D Destination 3.2.8 Spain: Submarket Forecast 2014-2024 3.2.9 Italy: Traditional Strength in Small Molecule APIs 3.3 The US: The Largest National Submarket for Biotech API Manufacturing 3.3.1 Expanding Clinical Capacity to Drive US Submarket Growth 2014-2024 3.4 Japan: A Relatively New Contract Biotech Manufacturing Submarket 3.4.1 Japanese Contract Biotech API Manufacturing Submarket Forecast 2014-2024 3.5 Contract Biotech API Manufacturing in Emerging Markets 2014-2024 3.5.1 Biologics Markets Are Small in Emerging Nations in 2013 3.5.2 Increased Biosimilar and Biological Drug Development 2014-2024 3.5.3 CMOs Are Investing in China www.visiongain.com
  4. 4. Contents 3.5.3.1 Chinese Contract Biotech API Manufacturing Submarket Forecast 2014-2024 3.5.4 Contract Biotech API Manufacturing in India 2014-2024 3.5.5 There Are Two Large Biotech CMOs in South Korea 2013 3.5.5.1 South Korea: Submarket Forecast 2014-2024 3.5.6 Increased Investment in Singapore 2014-2024 3.5.7 Governments in Brazil and Russia Are Promoting Domestic Biotech Development 3.5.7.1 Russia: Submarket Forecast 2014-2024 3.5.7.2 Brazil: Submarket Forecast 2014-2024 3.6 Chapter Summary: Outlook for Leading National Submarkets 2014-2024 4. Biotech API Manufacturing: Outlook for Leading Biological Drug Sectors 2014-2024 4.1 Antibody Therapies: The Largest Biological Drug Sector 2014-2024 4.1.1 Monoclonal Antibody Manufacturing 2013 4.1.1.1 CHO Cell Lines Dominate in 2013 4.1.1.2 Future Developments in Antibody Expression Systems 4.1.2 Outsourced Manufacturing for Antibody APIs 4.1.2.1 There Are Many Clinical Manufacturing Opportunities 4.1.3 Next-Generation Antibody Therapies Offer New Challenges for CMOs 4.2 The Outlook for Insulin Therapies 2014-2024 4.2.1 Manufacturing Trends for Insulin Analogues 2014-2024 4.2.2 Leading Insulin Analogues Are Produced In-House 4.2.3 Development Trends in the Insulin Market to 2024 4.3 Growth Hormone API Manufacturing 2014-2024 4.3.1 Outlook for the Growth Hormone Market to 2024 4.3.2 Long-Acting Therapies in Development May Provide Outsourcing Opportunities 4.4 The Interferon Therapy Market 2014-2024 4.4.1 Multiple Expression Systems Used for Leading Interferons 4.4.2 Contract Manufacturing for Commercial and Clinical Interferon Therapies www.visiongain.com
  5. 5. Contents 4.4.3 Is There Demand for Long-Acting Interferon Beta Therapies? 4.5 Vaccine Manufacturing: An Alternative Market Opportunity for CMOs 4.5.1 The Vaccines Market: Outlook and Forecast 2014-2024 4.5.2 Contract Manufacturing for Vaccines 2014-2024 4.5.3 Challenges in Manufacturing Vaccines 4.6 Chapter Summary: Outsourcing for Key Biological Products 2014-2024 5. Biotech API Manufacturing: Industry Trends 2014-2024 5.1 Contract Biotech API Manufacturing: Strengths and Weaknesses 2012-2013 5.1.1 Manufacturing Biological Drugs is Complex 5.2 Contract Biotech API Manufacturing: Opportunities and Threats 2014-2024 5.3 Contract Biotech API Manufacturing Market: STEP Analysis 2014-2024 5.3.1 Social Factors: Rising Demand for Biological Medicines 5.3.2 Technological Developments Will Drive More-Efficient Manufacturing 5.3.2.1 Improving Yields and Efficiency in Biopharmaceutical Manufacturing 5.3.2.2 The Impact of Higher Yields on Downstream Processing 5.3.3 Economic Pressures: Strains on Healthcare Budgets 5.3.4 Political Issues: Regulatory Developments to Affect Drug Manufacturing 5.4 Trends in Biological Drug Development 2014-2024 5.4.1 Biosimilars as an Opportunity for CMOs 5.4.2 Next-Generation Antibody Development 5.4.3 Orphan Drugs and Personalised Medicine: Smaller Batches and Greater Flexibility Will be Required 5.4.4 Manufacturing APIs for Clinical Trials and Scale-Up 5.5 Outlook for Single-Use Technologies in Biotech API Manufacturing 2014-2024 5.5.1 The Benefits of Single-Use for Biotech API Manufacturing 5.5.2 What Limitations Exist for Single-Use Technologies in 2013? 5.5.3 Single-Use in Downstream Processing 5.5.4 CMOs Are Rapidly Adopting Single-Use Systems www.visiongain.com
  6. 6. Contents 5.5.5 Future Directions in Single-Use Technologies for Biotech API Manufacturing 5.6 Outsourcing Trends for Biotech API Manufacturing 2014-2024 5.6.1 Biopharma Companies Continue to Invest in In-House Facilities 5.6.2 Offshoring Biotech API Manufacturing to Emerging Markets: Not a Trend for this Decade? 5.6.3 Is There a Risk of Overcapacity for the Biotech CMO Industry? 5.7 New Production Platforms for Biotech API Manufacturing to 2024 5.7.1 Plant Made Pharmaceuticals (PMPs) 5.7.2 Transgenic Systems 5.8 Chapter Summary: Industry Trends for Contract Biotech API Manufacturing to 2024 6. Leading CMOs Manufacturing Biotech APIs 2013 6.1 Four Companies Lead the Market 2013 6.1.1 Many CMOs Offer Small-Scale Biopharmaceutical Manufacturing 6.1.2 Barriers to Market Entry 2014-2024 6.1.2.1 Biologics Manufacturing Facilities Are Costly to Set Up 6.2 Boehringer Ingelheim BioXcellence 6.2.1 Investing in New Services 2012-2013 6.2.2 Expanding Manufacturing into Asia 6.3 Celltrion: Market-Leading Capacity in Asia 6.3.1 Celltrion Aims to Become a Leading Biopharmaceutical Developer 6.4 DSM Biologics 6.4.1 DSM Invests in Single-Use Technologies 6.5 Lonza 6.5.1 Lonza is a Leader in Cell Culture Scale 6.5.2 Steady Increase in Demand, 2011-2013 6.5.3 Investing in Next-Generation Biologics Production 6.6 Other Leading and Fast-Growing Market Players 2013 6.6.1 Samsung BioLogics www.visiongain.com
  7. 7. Contents 6.6.2 Cytovance Biologics 6.6.3 Fujifilm Diosynth Biotechnologies 6.6.3.1 Facility and Service Expansion 2012-2013 6.6.4 Gallus Biopharmaceuticals 6.6.4.1 Gallus Acquires Laureate Biopharma, Doubling Capacity in the US 6.7 Leading Biopharmaceutical Companies Operate CMO Divisions 6.7.1 AbbVie Contract Manufacturing 6.7.2 GSK Biopharmaceuticals 6.7.3 Sandoz 6.8 Chapter Summary: Leading Companies 2014-2024 7. Research Interviews 7.1 Dr Stephen Taylor, SVP and Commercial Director Fujifilm Diosynth Biotechnologies 7.1.1 Biotech API Manufacturing as an Opportunity for CMOs 7.1.2 Single-Use Technologies and Biopharmaceutical Manufacturing 7.1.3 Major Technology Trends for Biologics 7.1.4 Emerging Markets in the Biotech API Manufacturing Market 7.2 Company Insight: Boehringer Ingelheim BioXcellence 7.2.1 Recent Demand for Contract Biomanufacturing 7.2.1.1 Future Demand for Services 7.2.2 Drug Development Trends Affecting Biopharmaceutical CMOs 7.2.3 Commercial Drivers and Restraints 7.3 Dr Abhinav Shukla, Vice President, Process Development and Manufacturing, KBI Biopharma 7.3.1 KBI Biopharma 7.3.2 Single-Use Technologies in Biopharma Manufacturing 7.3.3 Demands for Biopharma Manufacturing Services 7.3.4 Outlook for the US Contract Manufacturing Market 7.4 Dr Stefan Beyer, CEO, Vibalogics 7.4.1 Vibalogics: Company Overview www.visiongain.com
  8. 8. Contents 7.4.2 Outsourcing Vaccine Manufacturing 7.4.3 Challenges in Vaccine Manufacturing 7.4.4 Developments in Technology and Vaccine R&D to Affect CMOs 8. Conclusions to Our Study 8.1 The Contract Biotech API Manufacturing Market 2012-2013 8.1.1 Mammalian Cell Culture Dominates Outsourced Biotech API Manufacturing in 2013 8.1.2 The US and Europe Supplied 80% of the World’s Outsourced Biotech APIs in 2012 8.2 Outlook for the Biotech API Manufacturing Market 2014-2024 8.2.1 New Technology Will Stimulate Market Expansion 8.2.2 Growth in the Market 2014-2024 8.2.3 The Future of Biotech API Supply in Emerging National Markets www.visiongain.com
  9. 9. Contents List of Tables Table 1.1 Currency Exchange Rates Table 2.1 Contract API Manufacturing: Revenues ($bn) and Market Share (%) by Sector, 2012 Table 2.2 Top Ten Bestselling Biologics: Market Sectors and Revenues ($bn), 2012 Table 2.3 Contract Biotech API Manufacturing Market: Revenues ($bn) by Sector, 2012-2013 Table 2.4 Contract Biotech API Manufacturing Market: Overall Market and Revenue Forecasts ($bn) by Sector, 2012-2024 Table 2.5 Contract Biotech API Manufacturing Market: Submarket Shares (%), 2012-2024 Table 2.6 Mammalian Cell Culture Submarket: Revenue Forecast ($bn), 2012-2024 Table 2.7 Microbial Fermentation Submarket: Revenue Forecast ($bn), 2012-2024 Table 3.1 Contract Biotech API Manufacturing Market: Revenues ($bn) and Market Shares (%) by Region, 2012 Table 3.2 Contract Biotech API Manufacturing Market: Leading Regional and National Submarket Revenue Forecasts ($bn), 2012-2024 Table 3.3 Contract Biotech API Manufacturing Market: National Submarket Shares (%), 20122024 Table 3.4 Leading European Contract Biotech API Manufacturing Submarket: Leading National Submarket Revenue Forecasts ($bn), 2012-2024 Table 3.5 European Contract Biotech API Manufacturing Submarket: Revenues ($bn) and Submarket Shares (%) by Leading Country, 2012 Table 3.6 German Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.7 UK Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.8 French Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.9 Swiss Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.10 Spanish Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.11 Italian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.12 US Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.13 Japanese Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 www.visiongain.com
  10. 10. Contents Table 3.14 Contract Biotech API Manufacturing Market: Emerging National Submarket Revenue Forecasts ($bn), 2012-2024 Table 3.15 Biologics Market: Emerging Submarket Revenues ($bn) and Market Shares (%), 2012 Table 3.16 Chinese Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.17 Indian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.18 South Korean Contract Biotech API Manufacturing Submarket Forecast ($bn), 20122024 Table 3.19 Selected Biotechs and Pharmaceutical Companies with Manufacturing Facilities in Tuas, 2013 Table 3.20 Singaporean Contract Biotech API Manufacturing Submarket Forecast ($bn), 20122024 Table 3.21 Russian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 3.22 Brazilian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Table 4.1 Lonza: New Biological Drug Sector Manufacturing Agreements, 2012-2013 Table 4.2 US Biologics Clinical Pipeline by Sector, 2013 Table 4.3 Monoclonal Antibody Market: Revenue Forecast ($bn), 2012-2024 Table 4.4 Monoclonal Antibody Types and Sources Table 4.5 Blockbuster Antibody Therapies: Antibody Types and Sources Table 4.6 Contract Manufacturers for Leading Antibody Therapies, 2013 Table 4.7 Clinical Contract Manufacturing Agreements for Antibody Therapies, 2013 Table 4.8 Next-Generation Antibody Therapy Pipeline by Drug Type, 2013 Table 4.9 Insulin Therapies Market: Revenue Forecast ($bn), 2012-2024 Table 4.10 Expression Systems for Leading Insulin Analogues Table 4.11 Growth Hormone Market by Drug: Revenues ($bn) and Market Share (%), 2012 Table 4.12 Growth Hormones Market: Revenue Forecast ($bn), 2012-2024 Table 4.13 Selected Long-Acting Growth Hormones in Development, 2013 Table 4.14 Interferon Therapies Market: Revenue Forecast ($bn), 2012-2024 Table 4.15 Interferon API Manufacturers in the EU, 2013 Table 4.16 Vaccines Market: Revenue Forecast ($bn), 2012-2024 Table 4.17 Vaccine Contract Manufacturing Market: Revenue Forecast ($bn), 2012-2024 www.visiongain.com
  11. 11. Contents Table 5.1 Contract Biotech API Manufacturing Market: Strengths and Weaknesses, 2012-2013 Table 5.2 Contract Biotech API Manufacturing Market: Opportunities and Threats, 2014-2024 Table 5.3 Contract Biotech API Manufacturing Market: STEP Analysis, 2014-2024 Table 5.4 EU-Approved Biosimilars: Marketers and Manufacturers, 2013 Table 5.5 Approved Next-Generation Antibody Therapies, 2013 Table 5.6 Selected Single-Use Bioreactors Available Commercially, 2013 Table 6.1 Leading Biotech API CMOs: Mammalian Cell Culture and Microbial Fermentation Manufacturing Scale, 2013 Table 6.2 Selected Other Biotech API CMOs: Mammalian Cell Culture and Microbial Fermentation Manufacturing Scale, 2013 Table 6.3 Boehringer Ingelheim BioXcellence: Manufacturing Capacity, 2013 Table 6.4 Boehringer Ingelheim BioXcellence: Revenue ($bn), 2011-2012 Table 6.5 Celltrion: Revenue ($bn), 2007-2012 Table 6.6 Celltrion: Recent Biosimilar Licensing Agreements Table 6.7 DSM Biologics: Manufacturing Capacity, 2013 Table 6.8 DSM: Pharmaceutical Contract Manufacturing: Revenue ($bn), H1 2012-2013 Table 6.9 Lonza: Biotech API Manufacturing Capacity, 2013 Table 6.10 Lonza: Revenue ($bn), 2008-2012 Table 6.11 Cytovance Biologics: Revenue ($m) and Employees, 2008 and 2013 Table 6.12 Fujifilm Diosynth Biotechnologies: Commercial Manufacturing Agreements, 2013 Table 6.13 Sandoz: Biosimilars Revenue ($m), 2011-2012 Table 8.1 Contract Biotech API Manufacturing Market: Revenue Forecasts ($bn) and Market Shares (%) by Sector, 2012, 2015, 2018, 2021 and 2024 Table 8.2 Contract Biotech API Manufacturing Market: Revenue Forecasts ($bn) and Market Shares (%) by Region, 2012, 2015, 2018, 2021 and 2024 www.visiongain.com
  12. 12. Contents List of Figures Figure 1.1 Key Steps in the Biological Drug Manufacturing Process Figure 1.2 Contract Biotech API Manufacturing: Major Market Trends, 2014-2024 Figure 2.1 Contract API Manufacturing: Market Shares by Sector (%), 2012 Figure 2.2 Contract Biotech API Manufacturing Market: Revenues by Sector ($bn), 2012-2013 Figure 2.3 World Biologics Market: Revenue Forecast ($bn), 2012-2024 Figure 2.4 Contract Biotech API Manufacturing Market: Revenue Forecast ($bn), 2012-2024 Figure 2.5 Contract Biotech API Manufacturing: Market Drivers, 2014-2024 Figure 2.6 Contract Biotech API Manufacturing: Market Restraints, 2014-2024 Figure 2.7 Contract Biotech API Manufacturing: Market Shares (%) by Sector, 2018 Figure 2.8 Contract Biotech API Manufacturing: Market Shares (%) by Sector, 2024 Figure 2.9 Mammalian Cell Culture Submarket: Revenue Forecast ($bn), 2012-2024 Figure 2.10 Mammalian Cell Culture Submarket: Drivers and Restraints, 2014-2024 Figure 2.11 Microbial Fermentation Submarket: Revenue Forecast ($bn), 2012-2024 Figure 2.12 Microbial Fermentation Submarket: Drivers and Restraints, 2014-2024 Figure 3.1 Contract Biotech API Manufacturing: Market Shares by Region (%), 2012 Figure 3.2 Contract Biotech API Manufacturing: Market Shares by Region (%), 2018 Figure 3.3 Contract Biotech API Manufacturing: Market Shares by Region (%), 2024 Figure 3.4 European Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.5 European Contract Biotech API Manufacturing Submarket: National Submarket Shares (%), 2012 Figure 3.6 German Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.7 UK Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.8 French Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.9 Swiss Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.10 Spanish Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.11 Italian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.12 US Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 www.visiongain.com
  13. 13. Contents Figure 3.13 Japanese Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.14 Contract Biotech API Manufacturing Market: Emerging National Submarket Revenue Forecasts ($bn), 2012 and 2024 Figure 3.15 Biologics Market: Emerging Submarket Shares (%), 2012 Figure 3.16 Chinese Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.17 Indian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.18 South Korean Contract Biotech API Manufacturing Submarket Forecast ($bn), 20122024 Figure 3.19 Singaporean Contract Biotech API Manufacturing Submarket Forecast ($bn), 20122024 Figure 3.20 Russian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 3.21 Brazilian Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024 Figure 4.1 US Biologics Clinical R&D Pipeline by Sector, 2013 Figure 4.2 Monoclonal Antibody Market: Revenue Forecast ($bn), 2012-2024 Figure 4.3 Insulin Therapies Market: Revenue Forecast ($bn), 2012-2024 Figure 4.4 Growth Hormones Market: Revenue Forecast ($bn), 2012-2024 Figure 4.5 Interferon Therapies Market: Revenue Forecast ($bn), 2012-2024 Figure 4.6 Vaccines Market: Revenue Forecast ($bn), 2012-2024 Figure 4.7 Vaccine Contract Manufacturing Market: Revenue Forecast ($bn), 2012-2024 Figure 5.1 Biosimilars Market: Revenue Forecast ($bn), 2012, 2018 and 2024 Figure 5.2 Cost-Savings for Single-Use Bioreactors Figure 6.1 Leading Biotech API CMOs: Mammalian Cell Culture Manufacturing Scale, 2013 Figure 6.2 Leading Biotech API CMOs: Microbial Fermentation Manufacturing Scale, 2013 Figure 6.3 Boehringer Ingelheim BioXcellence: Revenue ($bn), 2011-2012 Figure 6.4 Celltrion: Revenue ($bn), 2007-2012 Figure 6.5 DSM: Pharmaceutical Contract Manufacturing: Revenue ($bn), H1 2012-2013 Figure 6.6 Lonza: Revenue ($bn), 2008-2012 Figure 6.7 Cytovance Biologics: Revenue ($m), 2008 and 2013 Figure 6.8 Sandoz: Biosimilars Revenue ($m), 2011-2012 www.visiongain.com
  14. 14. Contents Figure 8.1 Contract Biotech API Manufacturing Market: Revenue Forecast ($bn) by Sector, 2012, 2015, 2018, 2021 and 2024 Figure 8.2 Contract Biotech API Manufacturing Market: Revenue Forecast ($bn) by Region, 2012, 2015, 2018, 2021 and 2024 www.visiongain.com
  15. 15. Contents Companies and Other Organisations Mentioned 3P Biopharmaceuticals A5 Laboratories AbbVie AbbVie Contract Manufacturing (part of AbbVie) A-Bio Pharma Actavis Adocia Alexion Pharmaceuticals Althea Technologies Altus Pharmaceuticals American Diabetes Association Amgen Apexigen Association of the British Pharmaceutical Industry (ABPI) AstraZeneca Athera Biotechnologies AutekBio Avalanche Biotechnologies Bachem BaroFold Baxter International Bayer Biocad Bioceuticals Arzneimittel (part of Stada) Biocon Biogen Idec Bionomics www.visiongain.com
  16. 16. Contents Bioprocessing Technology Institute (BTI) Biosidus Boehringer Ingelheim Boehringer Ingelheim BioXcellence (part of Boehringer Ingelheim) Bristol-Myers Squibb Catalent Pharma Solutions Celladon Celltrion Centocor Ortho Biotech (now Janssen Biotech, part of J&J) CinnaGen CMC Biologics Cook Pharmica Cornerstone Therapeutics Critical Pharmaceuticals Crucell (part of J&J) CT Arzneimittel (part of Teva) Cytogen (part of EUSA Pharma) Cytovance Biologics Dendreon DSM Biologics (part of Royal DSM) Dyax Eclipse Therapeutics (part of Bionomics) Eden Biodesign (part of Actavis) Egis Pharmaceuticals Eli Lilly Elona Biotechnologies (part of Zimmerman Biotechnologies) EMA Committee for Medicinal Products for Human Use (CHMP) [EU] Emcure Pharmaceuticals European Medicines Agency (EMA) EUSA Pharma (part of Jazz Pharmaceuticals) www.visiongain.com
  17. 17. Contents Food and Drug Administration (FDA) [US] Fountain Biopharma Fresenius Fujifilm Fujifilm Diosynth Biotechnologies Gallus Biopharmaceuticals GE Healthcare Genentech (part of Roche) Genmab Genzyme (part of Sanofi) GlyTech GSK GSK Biopharmaceuticals (part of GSK) GTC Biotherapeutics Hexal Arzneimittel (part of Novartis) Hikma Pharmaceuticals Hospira Hospira One2One (part of Hospira) Human Genome Sciences (part of GSK) Hyclone (part of Thermo Fisher Scientific) iBio IHI Corporation immatics Immune Pharmaceuticals Inno Biologics Intellect Neurosciences J&J KBI Biopharma Kemwell Biopharma kSep Systems (part of KBI Biopharma) www.visiongain.com
  18. 18. Contents Kyowa Hakko Kirin Laureate Biopharma (part of Gallus Biopharmaceuticals0 Lek Pharmaceuticals (Sandoz) LG Life Sciences Lonza Medical Research Council (MRC) [UK] Medice MedImmune (part of AstraZeneca) Merck & Co. Merck Serono Merckle (part of Teva) Ministry of Health [Brazil] Ministry of Health, Labor and Welfare (MHLW) [Japan] Mitsubishi Tanabe Pharma Momenta Pharmaceuticals Mylan National Institutes of Health Center for Regenerative Medicine (NIH CRM) [US] Nippon Kayaku Norbitec Novartis Novo Nordisk Nuron Biotech OncoMed Pharmaceuticals Open Monoclonal Technology (OMT) PanGen Biotech Pfizer Pfizer CentreSource (part of Pfizer) Pharming Pharmstandard Pharmaceutical Research and Manufacturers of America (PhRMA) www.visiongain.com
  19. 19. Contents PHW Group Pierre Guerin Piramal Healthcare PlantForm PolyTherics ProBioGen Prolor Biotech Protalix BioTherapeutics Purdue Pharma Quintiles ratiopharm (part of Teva) Recepta Biopharma Reliance Life Sciences Rentschler Biotechnologie Ridgemont Equity Partners Roche Royal DSM SAFC (part of Sigma-Aldrich) Samsung Samsung Bioepis Samsung BioLogics Sandoz (part of Novartis) Sanofi Sartorius Stedim Biotech Schering-Plough (part of Merck & Co.) Seattle Genetics ShanghaiTech University SICOR Biotech (part of Teva) Stada Arzneimittel SynCo Bio Partners www.visiongain.com
  20. 20. Contents Synpromics Synthon TaiMed Biologics Technology Strategy Board (TSB) [UK] Teva Pharmaceutical Industries Therapure Biopharma Thermo Fisher Scientific ThromboGenics Toyobo Biologics Tufts Center for the Study of Drug Development (CSDD) UCB UMN Pharma Unigen (part of UMN Pharma) University of Arkansas Versartis Vibalogics (part of PHW Group) Vida Pharma Wacker Biotech Wave Biotech (part of GE Healthcare) World Health Organization (WHO) WuXi PharmaTech Xcellerex Zhangjiang Biotech and Pharmaceutical Base Development (ZJ Base) Zimmerman Biotechnologies www.visiongain.com
  21. 21. Biotech API Manufacturing Services: World Industry and Market 2014-2024 3.2.5 The UK Contract Biotech API Manufacturing Submarket 20142024 According to the Association of the British Pharmaceutical Industry (ABPI), the UK is the second largest market for biopharmaceutical R&D investment, behind only the US. There are more than 250 companies operating in the British biopharmaceutical market, ranging from multinationals to university spin-outs. A significant proportion of the start-up biotechs are based in the South and East of England, while the north of the country has become a hub for manufacturing, with many leading pharmaceutical companies establishing bases there. It is also the site for a number of biotech CMOs, including Fujifilm Diosynth Biotechnologies and Eden Biodesign, which is part of the generics manufacturer Actavis. Lonza also operates a cell culture facility in the UK, adding to outsourced manufacturing capacity in that country. The development of novel biologics by small biotechs will drive demand for UK-based CMOs in this decade, visiongain predicts. With strong government investment in the biotech industry, discussed below, the UK will continue to be a leading market for biopharmaceutical research. Facility expansion for leading CMOs in this decade - such as Fujifilm’s recent capacity addition - will also drive growth in the UK contract biotech API manufacturing submarket, in terms of supply. By 2024, that submarket will be worth $0.56bn, up from $0.22bn in 2012 and $0.36bn in 2018 (Table and Figure 3.7). Table 3.7 UK Contract Biotech API Manufacturing Submarket Forecast ($bn), 20122024 2012 Submarket Size ($bn) Annual Growth (%) 2013 2014 2015 2016 2017 2018 0.22 0.23 0.25 0.27 0.29 0.32 0.36 6 7 8 10 10 11 CAGR (%) 8.5 2019 2020 2021 2022 2023 2024 Submarket Size ($bn) 0.39 0.42 0.46 0.49 0.52 0.56 Annual Growth (%) 10 8 8 7 7 7 CAGR (%) 7.7 Source: visiongain 2013 www.visiongain.com Page 58
  22. 22. Biotech API Manufacturing Services: World Industry and Market 2014-2024 Figure 3.7 UK Contract Biotech API Manufacturing Submarket Forecast ($bn), 20122024 0.60 0.55 Submarket Size ($bn) 0.50 0.45 0.40 0.35 0.30 0.25 0.20 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Year Source: visiongain 2013 3.2.5.1 High Demand Expected in the UK 2014-2024 Future demand for contract biotech manufacturing services in the UK will be driven by the large number of small biopharmaceutical companies developing novel biologics, as well as government incentives to invest in biopharmaceutical R&D. In 2012, for example, the Technology Strategy Board (TSB) and the Medical Research Council (MRC) established the Biomedical Catalyst, which provides funding for innovative healthcare projects, providing support for clinical development. In 2013, the TSB reported that the project had provided $120m in funding for biomedical development in the UK. The UK government has also established the Patent Box scheme, which offers tax incentives for UK-based patents and technological developments. Visiongain believes this scheme will encourage UK-based biopharmaceutical development and manufacturing, although Big Pharma companies will continue to manufacture products in-house - GSK reported that the Patent Box scheme was one of the key drivers for deciding to establish a new manufacturing facility in the UK. For smaller companies looking to keep development in that country, CMOs will provide a costefficient manufacturing option. www.visiongain.com Page 59

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