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

1. Biotech API Manufacturing Services:
World Industry and Market
2014-2024
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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
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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
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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
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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
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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
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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
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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
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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
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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 ($bn), 2012-2024
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11. Contents
Table 5.1 Contract Biotech API Manufacturing Market: Strengths and Weaknesses, 2012-2013
Table 5.2 Contract Biotech API Manufacturing Market: Opportunities and Threats, 2014-2024
Table 5.3 Contract Biotech API Manufacturing Market: STEP Analysis, 2014-2024
Table 5.4 EU-Approved Biosimilars: Marketers and Manufacturers, 2013
Table 5.5 Approved Next-Generation Antibody Therapies, 2013
Table 5.6 Selected Single-Use Bioreactors Available Commercially, 2013
Table 6.1 Leading Biotech API CMOs: Mammalian Cell Culture and Microbial Fermentation
Manufacturing Scale, 2013
Table 6.2 Selected Other Biotech API CMOs: Mammalian Cell Culture and Microbial
Fermentation Manufacturing Scale, 2013
Table 6.3 Boehringer Ingelheim BioXcellence: Manufacturing Capacity, 2013
Table 6.4 Boehringer Ingelheim BioXcellence: Revenue ($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 ($bn) and Market
Shares (%) by Region, 2012, 2015, 2018, 2021 and 2024
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12. Contents
List of Figures
Figure 1.1 Key Steps in the Biological Drug Manufacturing Process
Figure 1.2 Contract Biotech API Manufacturing: Major Market Trends, 2014-2024
Figure 2.1 Contract API Manufacturing: Market Shares by Sector (%), 2012
Figure 2.2 Contract Biotech API Manufacturing Market: Revenues by Sector ($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
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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 ($m), 2011-2012
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14. Contents
Figure 8.1 Contract Biotech API Manufacturing Market: Revenue Forecast ($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
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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
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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)
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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)
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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)
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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
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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
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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
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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
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