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Biotech API Manufacturing Services: World Industry and Market

2014-2024

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Contents

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

2.1 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

1. Executive Summary

2. Contract Biotech API Manufacturing: World Market Outlook and Forecast 2014-2024

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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

3.1 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

3. Leading National Markets for Contract Biotech API Manufacturing 2014-2024

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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

4.1 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

4. Biotech API Manufacturing: Outlook for Leading Biological Drug Sectors 2014-2024

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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

5.1 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

5. Biotech API Manufacturing: Industry Trends 2014-2024

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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

6.1 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

6. Leading CMOs Manufacturing Biotech APIs 2013

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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

7.1 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

7. Research Interviews

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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

8.1 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

8. Conclusions to Our Study

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Contents

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 (%), 2012-

2024

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

List of Tables

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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), 2012-

2024

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), 2012-

2024

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

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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Contents

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

List of Figures

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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), 2012-

2024

Figure 3.19 Singaporean Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-

2024

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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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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Contents

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

Companies and Other Organisations Mentioned

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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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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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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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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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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

Page 58

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Biotech API Manufacturing Services: World Industry and Market 2014-2024

3.2.5 The UK Contract Biotech API Manufacturing Submarket 2014-2024 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).

2012 2013 2014 2015 2016 2017 2018

Submarket Size ($bn) 0.22 0.23 0.25 0.27 0.29 0.32 0.36

Annual Growth (%) 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

Table 3.7 UK Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024

Page 59

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Biotech API Manufacturing Services: World Industry and Market 2014-2024

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 cost-

efficient manufacturing option.

0.20

0.25

0.30

0.35

0.40

0.45

0.50

0.55

0.60

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

Subm

arke

t Si

ze ($

bn)

Year

Figure 3.7 UK Contract Biotech API Manufacturing Submarket Forecast ($bn), 2012-2024

Source: visiongain 2013