1. Executive Summary
1.1 Pharmaceutical Contract Manufacturing: World Market Review
1.2 Report Contents
1.3 Research and Analysis Methods
2. Pharmaceutical Contract Manufacturing: An Introduction
2.1 Outsourcing in the Pharmaceutical Industry
2.1.1 Reasons to Outsource
2.1.2 Benefits to Outsourcing
2.1.3 Challenges in Outsourcing
2.1.4 Strategic Outsourcing vs. Tactical Outsourcing
2.1.5 Virtual Companies
2.2 Contract Manufacturing Organisations (CMOs)
2.2.1 Manufacturing Services Offered
2.2.2 Biopharmaceutical Manufacturing
3. The Pharmaceutical Contract Manufacturing Market 2012-2022
3.1 The Pharmaceutical Contract Manufacturing Market in 2011
3.1.1 The Roles of Biologics and Small Molecule Drugs in the Market 2011
3.2 The Pharmaceutical Contract Manufacturing Market: Overall Revenue Forecast 2012-2022
3.2.1 Market Drivers 2012-2022
3.2.2 Market Restraints 2012-2022
3.3 The API Contract Manufacturing Submarket 2012-2022
3.3.1 The API Contract Manufacturing Submarket: Revenue Forecast 2012-2022
3.3.2 The Generic API Contract Manufacturing Submarket: Revenue Forecast 2012-2022
3.3.3 The HPAPI Contract Manufacturing Submarket: Revenue Forecast 2012-2022
3.3.3.1 Focus on Oncology
3.4 The Finished Dosage Form Submarket 2012-2022
3.4.1 The Finished Dosage Form Contract Manufacturing Submarket: Revenue Forecast 2012-2022
3.4.2 The Solid Dosage Form Contract Manufacturing Submarket: Revenue Forecast 2012-2022
3.4.3 The Injectable Dosage Form Contract Manufacturing Submarket: Revenue Forecast 2012-2022
4. Leading National Markets for Pharmaceutical Contract Manufacturing 2012-2022
4.1 Supply and Demand for Contract Manufacturing Services
4.2 The Pharmaceutical Contract Manufacturing Market: Regional Breakdown 2011
4.3 The Pharmaceutical Contract Manufacturing Market: Regional Forecast 2012-2022
4.4 The US
4.4.1 The US: CMO Revenues 2012-2022
4.5 The EU
4.5.1 The EU: CMO Revenues 2012-2022
4.5.2 Germany: CMO Revenues 20120-2022
4.5.3 France: CMO Revenues 2012-2022
4.5.4 Italy: CMO Revenues 2012-2022
4.5.5 Spain: CMO Revenues 2012-2022
4.5.6 The UK: CMO Revenues 2012-2022
4.6 Japan
4.6.1 Japan: CMO Revenues 2012-2022
4.7 Pharmaceutical Contract Manufacturing in Emerging Markets
4.7.1 Outsourcing to Emerging Markets
4.7.1.1 Outsourcing to India and China
4.7.2 Brazil: CMO Revenues 2012-2022
4.7.3 Russia: CMO Revenues 2012-2022
4.7.4 India: CMO Revenues 2012-2022
4.7.5 China: CMO Revenues 2012-2022
4.8 South Korea
4.8.1 South Korea: CMO Revenues 2012-2022
5. Leading Pharmaceutical Contract Manufacturers 2012
5.1 The Pharmaceutical Contract Manufacturing Market by Company in 2011
5.1.1 Significant Deals in 2011 and 2012
5.2 Catalent
5.2.1 Recent Financial Performance
5.2.2 Strong Growth for Oral Delivery Technologies
5.2.3 Catalent Adjusts its Services
5.2.4 Outlook
5.3 Lonza
5.3.1 Recent Financial Performance
5.3.2 Lonza and Biologics
5.3.3 Lonza and Regenerative Medicine
5.3.4 Lonza Expands in Asia and Africa
5.3.5 Outlook
5.4 Boehringer Ingelheim
5.4.1 Recent Financial Performance
5.4.2 Ben Venue Laboratories
5.4.3 Manufacturing Deals 2011-2012
5.4.4 Outlook
5.5 Royal DSM
5.5.1 Recent Financial Performance
5.5.2 DSM Reorganises its Anti-Infectives Division
5.5.3 New Service Offerings
5.5.4 Outlook
5.6 Patheon
5.6.1 Recent Financial Performance
5.6.2 Developed Market Reorganisation
5.6.3 New Services and Focus
5.6.4 Outlook
5.7 Dr. Reddy's Laboratories
5.7.1 Recent Financial Performance
5.7.2 Continued Investment in the UK
5.7.3 Outlook
5.8 Abbott Laboratories
5.8.1 Abbott Laboratories to Split
5.8.2 Outlook
5.9 Jubilant Life Sciences
5.9.1 Recent Financial Performance
5.9.2 Manufacturing Partnerships 2011-2012
5.9.3 Outlook
5.10 Haupt Pharma
5.10.1 Focus on the EU, the US and Japan
5.10.2 Outlook
5.11 Recipharm
5.11.1 Recent Financial Performance
5.11.2 Strategic Acquisitions 2010-2012
5.11.3 Outlook
5.12 Pfizer
5.12.1 Meeting Market Demands
5.13 Piramal Healthcare
5.13.1 Recent Financial Performance
5.13.2 US and EU Expansion
5.13.3 Outlook
5.14 Evonik Degussa
5.14.1 Growing Through Acquisitions
5.14.2 Specialising in HPAPIs
5.15 Aenova
5.15.1 Specialising in Solid Dosage Forms
5.16 Nipro
5.16.1 Recent Financial Performance
5.16.2 Outlook
5.17 Divis Laboratories
5.17.1 Recent Financial Performance
5.17.2 Outlook
5.18 Hospira One 2 One
5.19 Famar
5.19.1 Expansion in Spain
5.20 Fareva
5.20.1 Company and Facility Acquisitions 2011
5.21 Kemwell Biopharma
5.21.1 Biologics and Biosimilars
5.21.2 Facility Growth
6. Pharmaceutical Contract Manufacturing Industry Trends 2012-2022: CMO Perspective
6.1 Pharmaceutical Contract Manufacturing Market: Strengths and Weaknesses for CMOs 2011-2012
6.2 Pharmaceutical Contract Manufacturing Market: Opportunities and Threats for CMOs 2012-2022
6.3 Pharmaceutical Contract Manufacturing Market: STEP Analysis for CMOs 2012-2022
6.4 Trends in Drug Development
6.4.1 Orphan Drug Development
6.4.2 Biologics and Biosimilars
6.4.2.1 Antibody-Drug Conjugates (ADCs)
6.4.2.2 Challenges in Manufacturing Biologics
6.4.2.3 Lyophilisation as a Service
6.4.2.4 The Rise of Biosimilars
6.5 CMO Expansion
6.5.1 An Increasingly Competitive Market
6.5.2 Regional Expansion
6.5.3 Buying Underused Facilities
6.5.3.1 The Risk of Overcapacity
6.5.4 CMOs as a One-Stop-Shop
6.5.5 CMO Consolidation
6.5.6 Manufacturing Clinical Trial Materials
6.5.7 Pharmaceutical Companies as Competitors
6.6 Improving Manufacturing Processes
6.6.1 Quality by Design (QbD)
6.6.2 Batch vs. Continuous Manufacturing
7. Pharmaceutical Contract Manufacturing Industry Trends 2012-2022: Client Perspective
7.1 Pharmaceutical Contract Manufacturing Market: Strengths and Weaknesses for Drug Developers 2011-2012
7.2 Pharmaceutical Contract Manufacturing Market: Opportunities and Threats for Drug Developers 2012-2022
7.3 The Outsourcing Decision
7.3.1 Reasons and Benefits to Outsourcing
7.3.2 Risks in Outsourcing Manufacturing
7.3.3 Selecting a CMO
7.3.4 Globalisation vs. Localisation
7.3.5 Using Emerging Market CMOs
7.3.6 Strategic Partnering
7.4 Outsourcing Strategy Depends on Company Size
7.4.1 Virtual Pharmaceutical Companies
7.5 Good Communication is Vital
7.5.1 Technology Transfer
7.6 Regulatory Compliance
7.6.1 The Responsibility of the Pharmaceutical Client
7.6.1.1 Drug Recalls
8. Regulatory Aspects of Pharmaceutical Manufacturing 2012-2022
8.1 Good Manufacturing Practice (GMP)
8.2 Global Harmonisation of Manufacturing Regulations: The ICH
8.2.1 ICH Q11
8.3 Collaboration Between Regulatory Bodies
8.4 Pharmaceutical Manufacturing Regulation in the US
8.4.1 Response to Industry Trends
8.4.2 The FDA and Foreign Manufacturing Sites
8.4.3 Generic Drug User Fee Act 2012
8.5 European Manufacturing Regulations
8.5.1 API Regulation in the EU
8.5.1.1 Falsified Medicine Directive
8.5.2 Other Recent Regulation Revisions
8.6 Pharmaceutical Manufacturing in Japan
8.7 Emerging Markets and Manufacturing Regulations
8.7.1 Brazil
8.7.2 Russia
8.7.3 India
8.7.4 China
8.7.4.1 Consequences of Stricter Regulations
8.8 South Korea
9. Opinions from Our Survey: Research Interviews
9.1 Dr Franck Latrille, CEO, NextPharma Technologies
9.1.1 NextPharma Technologies
9.1.2 Change in Demand for Contract Manufacturing Services
9.1.3 Opportunities for Growth and Market Restraints
9.1.4 Growth for NextPharma
9.1.5 The Advantages of a Full Service CMO
9.2 Mr Kevin Cook, Managing Director, API Business Unit, Aesica Pharmaceuticals
9.2.1 Aesica Pharmaceuticals
9.2.1.1 Recent Acquisitions
9.2.2 Patent Expiries and the European API Manufacturing Market
9.2.3 Opportunities for European API Manufacturers
9.2.4 The Impact of the Falsified Medicines Directive
9.2.5 Outlook for Aesica Pharmaceuticals
10. Conclusions
10.1 State of the Pharmaceutical Contract Manufacturing Market in 2011
10.2 Growth in the Pharmaceutical Contract Manufacturing Market 2012-2022
10.2.1 The API Manufacturing Market 2012-2022
10.2.2 The Finished Dosage Form Manufacturing Market 2012-2022
10.3 Regional Breakdown of the Pharmaceutical Contract Manufacturing Market 2012-2022
10.3.1 Regional Developments in Supply of Services
10.3.2 Regional Developments in Demand for Services
10.4 Many Opportunities Exist
List of Tables
Table 1.1 Currency Exchange Rates, 2011
Table 3.1 Pharmaceutical Contract Manufacturing Market by Sector, 2011
Table 3.2 Recent Financial Performance for the Five Leading CMOs, Combined, 2009- 2011
Table 3.3 World Biologics Market by Company, 2011
Table 3.4 Pharmaceutical Contract Manufacturing Market: Overall Market and Revenue Forecasts by Sector, 2011-2022
Table 3.5 Pharmaceutical Contract Manufacturing Submarket Shares, 2011-2022
Table 3.6 Pharmaceutical Contract Manufacturing Market: Drivers and Restraints, 2012-2022
Table 3.7 API Contract Manufacturing Submarket by Sector, 2011
Table 3.8 API Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Table 3.9 API Contract Manufacturing Market: Drivers and Restraints, 2012-2022
Table 3.10 Generic API Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Table 3.11 HPAPI Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Table 3.12 Finished Dosage Form Contract Manufacturing Submarket by Sector, 2011
Table 3.13 Finished Dosage Form Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Table 3.14 Finished Dosage Form Contract Manufacturing Market: Drivers and Restraints, 2012-2022
Table 3.15 Solid Dosage Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Table 3.16 Injectable Dosage Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Table 4.1 Pharmaceutical Contract Manufacturing Market by Country, 2011
Table 4.2 Pharmaceutical Contract Manufacturing Market: Revenue Forecasts by Country, 2011-2022
Table 4.3 Pharmaceutical Contract Manufacturing: Market Shares by Country, 2011-2022
Table 4.4 US Submarket: Revenue Forecast, 2011-2022
Table 4.5 Pharmaceutical Contract Manufacturing: EU Market by Country, 2011
Table 4.6 EU Pharmaceutical Contract Manufacturing Market: Revenue Forecasts by Leading Country 2011-2022
Table 4.7 German Submarket: Revenue Forecast, 2011-2022
Table 4.8 French Submarket: Revenue Forecast, 2011-2022
Table 4.9 Italian Submarket: Revenue Forecast, 2011-2022
Table 4.10 Spanish Submarket: Revenue Forecast, 2011-2022
Table 4.11 UK Submarket: Revenue Forecast, 2011-2022
Table 4.12 Japanese Submarket: Revenue Forecast, 2011-2022
Table 4.13 Brazilian Submarket: Revenue Forecast, 2011-2022
Table 4.14 Russian Submarket: Revenue Forecast, 2011-2022
Table 4.15 Indian Submarket: Revenue Forecast, 2011-2022
Table 4.16 Chinese Submarket: Revenue Forecast, 2011-2022
Table 4.17 South Korean Submarket: Revenue Forecast, 2011-2022
Table 5.1 Pharmaceutical Contract Manufacturing Market by Company, 2011
Table 5.2 Selected Manufacturing Deals for Leading CMOs, 2011-2012
Table 5.3 Capacity Expansion for Leading CMOs, 2011-2012
Table 5.4 Catalent: Revenue by Division, 2009-2011
Table 5.5 Lonza: Custom Manufacturing Revenue, 2009-2011
Table 5.6 Boehringer Ingelheim: Contract Manufacturing Revenue by Division, 2009-2011
Table 5.7 DSM: Contract Manufacturing Revenue, 2009-2011
Table 5.8 DSM: Contract Manufacturing Revenue by Division, 2010-2011
Table 5.9 Patheon: Contract Manufacturing Revenue by Division, 2009-2011
Table 5.10 Global DMFs Submitted by Dr. Reddy's Laboratories to 2012
Table 5.11 Dr. Reddy's Laboratories: Contract Manufacturing Revenue, 2010-2012
Table 5.12 Jubilant Life Sciences: Contract Manufacturing Revenue by Division, 2009-2011
Table 5.13 Haupt Pharma: Revenue, 2005-2011
Table 5.14 Recipharm: Revenue by Customer Type, 2011
Table 5.15 Recipharm: Revenue by Region, 2009-2011
Table 5.16 Pfizer: Contract Manufacturing Revenue by Region, 2009-2011
Table 5.17 Piramal Pharma Solutions: Contract Manufacturing Revenue by Region, 2011-2012
Table 5.18 Nipro: Pharmaceutical Business Revenue, 2010-2012
Table 5.19 Divis Laboratories: Contract Manufacturing Revenue by Region, 2011-2012
Table 6.1 Pharmaceutical Contract Manufacturing Market Strengths and Weaknesses: CMO Perspective, 2012
Table 6.2 Pharmaceutical Contract Manufacturing Market Opportunities and Threats: CMO Perspective, 2012-2022
Table 6.3 Pharmaceutical Contract Manufacturing Market: STEP Analysis, 2012-2022
Table 6.4 Selected Pharmaceutical Industry Facility Buyouts, 2011-2012
Table 7.1 Pharmaceutical Contract Manufacturing Market Strengths and Weaknesses: Client Perspective, 2012
Table 7.2 Pharmaceutical Contract Manufacturing Market Opportunities and Threats: Client Perspective, 2012-2022
Table 7.3 Comparison of Selected European and Indian API Manufacturers
Table 8.1 ICH Guidelines: Key Facts and Adoption, 2000-2012
Table 9.1 NextPharma Technologies: Global Locations and Capabilities, 2012
Table 10.1 Pharmaceutical Contract Manufacturing Market: Revenues by Sector, 2011, 2016 and 2022
Table 10.2 Pharmaceutical Contract Manufacturing Market: Revenues by Region, 2011, 2016 and 2022
List of Figures
Figure 2.1 Selected Tasks Outsourced in the Pharmaceutical Industry, 2012
Figure 2.2 The Rise of Contract Development and Manufacturing Organisations
Figure 3.1 Pharmaceutical Contract Manufacturing Market by Sector, 2011
Figure 3.2 Recent Financial Performance for the Five Leading CMOs, Combined, 2009-2011
Figure 3.3 World Biologics Market by Company, 2011
Figure 3.4 Pharmaceutical Contract Manufacturing Market: Overall Market Forecast, 2011-2022
Figure 3.5 Pharmaceutical Contract Manufacturing: Market Shares by Sector, 2016
Figure 3.6 Pharmaceutical Contract Manufacturing: Market Shares by Sector, 2022
Figure 3.7 API Contract Manufacturing Submarket by Sector, 2011
Figure 3.8 API Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Figure 3.9 Generic API Contract Manufacturing: Submarket Revenue Forecast, 2011-2022
Figure 3.10 HPAPI Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Figure 3.11 Finished Dosage Form Contract Manufacturing Submarket by Sector, 2011
Figure 3.12 Finished Dosage Form Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Figure 3.13 Solid Dosage Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Figure 3.14 Injectable Dosage Contract Manufacturing Submarket: Revenue Forecast, 2011-2022
Figure 4.1 Pharmaceutical Contract Manufacturing: Market Shares by Country, 2011
Figure 4.2 Pharmaceutical Contract Manufacturing: Market Shares by Country, 2016
Figure 4.3 Pharmaceutical Contract Manufacturing: Market Shares by Country, 2022
Figure 4.4 US Submarket: Revenue Forecast, 2011-2022
Figure 4.5 Pharmaceutical Contract Manufacturing: EU Market by Country, 2011
Figure 4.6 EU Submarket: Revenue Forecast, 2011-2022
Figure 4.7 German Submarket: Revenue Forecast, 2011-2022
Figure 4.8 French Submarket: Revenue Forecast, 2011-2022
Figure 4.9 Italian Submarket: Revenue Forecast, 2011-2022
Figure 4.10 Spanish Submarket: Revenue Forecast, 2011-2022
Figure 4.11 UK Submarket: Revenue Forecast, 2011-2022
Figure 4.12 Japanese Submarket: Revenue Forecast, 2011-2022
Figure 4.13 Brazilian Submarket: Revenue Forecast, 2011-2022
Figure 4.14 Russian Submarket: Revenue Forecast, 2011-2022
Figure 4.15 Indian Submarket: Revenue Forecast, 2011-2022
Figure 4.16 Chinese Submarket: Revenue Forecast, 2011-2022
Figure 4.17 South Korean Submarket: Revenue Forecast, 2011-2022
Figure 5.1 Pharmaceutical Contract Manufacturing Market by Company, 2011
Figure 5.2 Catalent: Revenue by Division, 2011
Figure 5.3 Lonza: Custom Manufacturing Revenue, 2009-2011
Figure 5.4 Boehringer Ingelheim: Contract Manufacturing Revenue by Division, 2009-2011
Figure 5.5 DSM: Contract Manufacturing Revenue, 2009-2011
Figure 5.6 Patheon: Contract Manufacturing Revenue by Division, 2009-2011
Figure 5.7 Dr. Reddy's Laboratories: Contract Manufacturing Revenue, 2010-2012
Figure 5.8 Jubilant Life Sciences: Contract Manufacturing Revenue by Division, 2009-2011
Figure 5.9 Haupt Pharma: Revenue, 2005-2011
Figure 5.10 Recipharm: Revenue by Customer Type, 2011
Figure 5.11 Recipharm: Revenue by Region, 2009-2011
Figure 5.12 Pfizer: Contract Manufacturing Revenue by Region, 2009-2011
Figure 5.13 Piramal Pharma Solutions: Contract Manufacturing Revenue by Region, 2011-2012
Figure 5.14 Nipro: Pharmaceutical Business Revenue, 2010-2012
Figure 5.15 Divis Laboratories: Contract Manufacturing Revenue by Region, 2011-2012
Figure 6.1 World Biological Drugs Market Forecast, 2011, 2016 and 2022
Figure 6.2 World Lyophilisation Services and Products: Market Forecasts, 2011, 2016 and 2022
Figure 8.1 Overview of ICH Manufacturing Guidelines, 2012
Figure 9.1 Aesica Pharmaceuticals: Revenue 2010-2011
Figure 10.1 Pharmaceutical Contract Manufacturing Market: Revenues by Sector, 2011, 2016 and 2022
Figure 10.2 Pharmaceutical Contract Manufacturing Market: Revenues by Region, 2011, 2016 and 2022