1. Executive Summary
1.1 Contract Pharma Manufacturing 2010-2025
1.2 Aims, Scope and Format of the Report
1.3 Research & Analysis Methods
2. Introduction to Pharma Outsourcing of Manufacturing
2.1 Contract Pharma Described
2.1.1 Evolving Nature of Contract Research Organisations (CROs) and Contract Manufacturing Organisations (CMOs)
2.2 Contract Development and Manufacturing Organisations (CDMO)
2.3 Why Are Pharma Companies Interested in Contract Pharma?
2.3.1 Small/Mid-sized Pharma and Biotech Have a Flexible Attitude to Outsourcing
2.3.2 Lack of Capacity is Still a Major Reason to Outsource
2.3.3 Tactical vs. Strategic Use of Outsourcing
2.4 The Changing Nature of the Pharmaceutical Market is Affecting the CRM Market
2.4.1 The Rise of Generics
2.4.2 Pipelines are Becoming Expensive
2.4.3 The Decline of the Traditional Blockbuster
2.5 Biopharmaceutical Drug Discovery and Development by Contract Pharma Companies will Continue to Increase
2.6 Disadvantages of Outsourcing in the Pharmaceutical Industry Can be Overcome
3. Regulatory Aspects of Pharma Outsourcing for Manufacturing
3.1 Legal Liabilities and Regulatory Considerations in Outsourced Manufacturing
3.2 Summary of GMP Requirements
3.3 Compliance with FDA Provisions is Vital
3.4 EU Regulations and the Qualified Person Role
3.5 Q7A Guidance for Active Pharmaceutical Ingredient (API) and Excipient Production
3.6 Harmonisation of GMP Standards
3.7 EU API Makers for Good Manufacturing Practices Inspections
3.8 Enforcing cGMP Compliance for APIs in EU
3.9 EU Requirements for Outsourcing Services
3.10 Good Manufacturing Practice (GMP) Compliance
3.11 API Requirements Challenge Outsourcing Services from China
3.12 Summary: Globalisation Benefits Pharma Harmonisation
4. The Outsourcing Decision
4.1 Reasons to Outsource
4.1.1 Outsourcing as a Tactical Decision
4.1.2 Outsourcing as a Strategic Decision
4.2 Cost-Benefit Analysis of Outsourcing
4.3 Risks Associated with Outsourcing Incur Hidden Costs
4.3.1 Errors and Delays Can Cost Millions
4.3.2 Regulatory Compliance Must be Assured
4.3.3 IP and Other Sensitive Data May be at Risk
4.3.4 Management of Outsourcing Requires Continued Monitoring
4.4 Technology Transfer Considerations
4.5 The Virtual Company
4.5.1 'Virtuality' Helps Control Rising Costs
4.5.2 Strong Project and Operations Management is Vital
4.5.3 The Challenges of Virtual Companies are Relevant Across the Industry
4.6 Key Requirements for Successful Outsourcing
4.6.1 Trust and Accountability
4.7 Summary: Planning the Guiding Principle for Outsourcing
5. Pharma Contract Manufacturing Industry and Market 2010-2025
5.1 The World Contract Manufacturing Market in 2010
5.2 Growing Market for Contract Manufacturing Services
5.2.1 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2010-2016
5.2.2 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2017-2025
5.3 Breakdown of the Pharma Contract Manufacturing Market
5.3.1 Revenue Forecast for API Market, 2010-2016
5.3.2 Revenue Forecast for API Market, 2017-2025
5.3.3 Revenue Forecast for Dosage Forms Market, 2010-2016
5.3.4 Revenue Forecast for Dosage Forms Market, 2017-2025
5.4 Leading National Markets for Pharma Contract Manufacturing, 2010-2025
5.4.1 The US Pharma Contract Manufacturing Market, 2010-2025
5.4.2 The Japanese Pharma Contract Manufacturing Market, 2010-2025
5.4.3 The Leading European Pharma Contract Manufacturing Markets, 2010-2025
5.4.4 Emerging Pharma Contract Manufacturing Markets
5.4.5 The Indian Pharma Contract Manufacturing Market, 2010-2025
5.4.6 The Chinese Pharma Contract Manufacturing Market, 2010-2025
5.5 Summary of the Chapter
6. Contract Manufacturing Sector to Provide Marked Benefits to Clients
6.1 Reasons for Outsourcing
6.2 Commercial Drivers of Outsourcing
6.3 Commercial Restraints for Outsourcing
6.4 API Manufacturers Closely Linked with Innovative Pharmaceutical Developers
6.5 Various Outsourcing Partners
6.6 Selecting an Appropriate CMO
6.7 Management of the Supply Chain for Cost-Efficient Contract Manufacturing
6.8 Mergers and Acquisitions for Pharmaceutical Manufacturing
6.8.1 Alliances with CMOs – a Growing Trend in the US
6.8.2 Patheon Forms Alliance with India's Kemwell
6.9 Interview with Manish Badonia, Cadila
6.9.1 Contract Manufacturing Outsourcing to Asia will Grow due to Cost Competitiveness
6.9.2 Alliance Formation for Moving up the Value Chain
6.9.3 Quality Control for Contract Pharma to Improve Further
6.10 Contract Pharma for Biotech Products
6.10.1 Failure in Early Efforts in Contract Biologic Manufacturing
6.10.2 Cost Benefits of Outsourced Manufacturing in Biotech Sector
6.10.3 The Future of Pharma Biotech Outsourcing
6.10.4 Custom Peptides are an Opportunity for APIs to Move up the Value Chain
6.10.5 One More Step for Outsourcing Contract Pharma Manufacturing to Asia
6.11 Western Companies Can Compete by Moving into Speciality API Manufacturing
6.12 Contract Pharma for Improved Process Tools
6.13 Chinese API Export Growing Rapidly
6.14 Outsourcing to Low-Cost Geographic Areas
6.15 Low Cost Services in India and China Drive Prices Down
6.16 Main Tendencies in Current Asian IP Law
6.17 Patent Protection Status in Indian Pharmaceutical Industry
6.18 Recommendation for Improvement of China's Intellectual Property Rights
6.19 Interview with Dr Zhang Zhicheng, National Intellectual Property (IP) Strategy Formulation Office, SIPO, China
6.19.1 International Framework: IP Protection for Contract Manufacturing
6.19.2 IP Holders Get the Profits
6.19.3 Changing IP Situation in the Developing Countries
6.19.4 Innovation-Oriented Industry Development in China
7. The Pharma Contract Manufacturing Sector in India
7.1 Contract Manufacturing in India
7.2 Drivers for Contract Manufacturing Outsourcing to India
7.3 Contract Manufacturing and Role of Indian Companies
7.3.1 Outsourcing for Generics
7.3.2 Sourcing Generics from Non-Competitors
7.3.3 Divis Laboratories’ Business Model
7.3.4 Granules India in Production of Generic Prescription Medicines and OTCs
7.3.5 Matrix Acquired by PharmaLinkFHI/Novella, a Global CRO
7.3.6 Neuland Focused on Anti-Bacterials
7.3.7 Natco Chose Chronic Diseases
7.4 Enforcing cGMP Compliance for APIs in EU
7.5 Expansion of Indian Biotechnology Sector
7.6 Interview with Dr Jagdish N Sheth, Business School, Emory University
7.6.1 India's Key Strength
7.6.2 India's Edge over China in Pharmaceutical Business
7.6.3 Need for Routine Inspection of Outsourcing Sites
7.6.4 Need for Creation of Economic Zone for Pharmaceutical Industry
7.6.5 India as an Emerging Market
7.6.6 Vertical Integration Recommended for India's Companies
7.6.7 India's Emergence as a Major Pharmaceutical Market
8. Contract Pharma for Specialised Areas
8.1 Value-Added Services and Contract Pharma
8.2 One-Stop Shop (CRO and CMO)?
8.3 Interview with Manish Badonia, Cadila
8.3.1 One-Stop Shop: CROs and CMOs
8.3.2 Value-Added Services in Global Settings
8.4 Interview with Wesley Wheeler, Patheon
8.4.1 Outsourcing for Analytical Testing Services
8.5 CMOs Venture into Development and Product Extensions
8.6 The Use of CROs in Drug Discovery and Development is Increasing in Pharma Industry
8.6.1 Contract Research for Drug Discovery at Suven Life Sciences
8.7 Interview with Dr Debra Sponholtz, Chembiotek
8.7.1 CROs Offer a Full Range of Services
8.8 Outsourcing Electronic Data Management
8.9 Outsourcing of Data Management in India
8.9.1 GlaxoSmithKline to Outsource Data Management
8.9.2 Wyeth (Pfizer): Outsourced Data Management
8.10 Planning Required for Regulatory Affairs Outsourcing
8.11 Outsourcing Bioequivalence Studies for Generic Drugs
8.12 Requesting a Waiver from a Bioequivalence Trial
8.13 Bioequivalence Studies for New Drug Applications
8.14 Interview with Helmut Schutz, BEBAC
8.14.1 When in Vivo Bioequivalent Studies are Waived for ANDA
8.14.2 Success of Outsourcing Dissolution Testing/ Bioequivalence Studies
8.14.3 Success of Off-Shoring in Vivo Bioequivalence Studies to India
8.15 Interview with Dr Daniel Abran, Sandoz
8.15.1 Waivers of in Vivo BE Studies (Biowaivers) for Abbreviated New Drug Applications
8.15.2 Comparative Clinical Trial Requirement for ANDA
8.16 Interview with Manish Badonia, Cadila
8.16.1 Prospects for Outsourcing Bioequivalence Studies
8.17 Outsourced Biostorage Becomes a Strategic Consideration
8.18 Contract Pharma for Lyophilisation
8.19 Contract Packaging Services
8.19.1 Contract Packaging is Not Just Boxes and Packs
8.19.2 Advantages Offered by Contract Packaging Organisations
9. Conclusions from this Study
9.1 Growth Rates will Vary According to Sector
9.2 Contract Pharma Manufacturing Encompasses Requirements in Biotechnology
9.3 Outsourcing for Value-Added Services
9.4 Concluding Remarks
List of Tables
Table 2.1 Top 10 Pharma Biotech Products, 2009
Table 2.2 Top 10 Biotech Companies: Revenues and Market Shares, 2009
Table 5.1 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2010-2016
Table 5.2 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2017-2025 Table 5.3 API Market: World Revenue Forecast, 2010-2016
Table 5.4 API Market: World Revenue Forecast, 2017-2025
Table 5.5 Finished Dosage Forms Market: World Revenue Forecast, 2010-2016
Table 5.6 Finished Dosage Forms Market: World Revenue Forecast, 2017-2025
Table 5.7 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2010-2016
Table 5.8 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2017-2025
Table 5.9 Pharma Contract Manufacturing (CM) National Market Forecasts, 2010-2015, 2020 & 2025
Table 6.1 Alliances for APIs in India, 2010
Table 6.2 Relationship Build-Up for Contract Manufacturing in India, 2010
Table 6.3 SWOT Analysis for Contract Manufacturing Services from Developing Countries, 2010
Table 6.4 Top US DMF Holders in India and China, 2007-2008
Table 7.1 FDA-Approved Manufacturing Sites in India, 2010
Table 9.1 Pharma Contract Manufacturing Market: World Revenue Forecast, 2010, 2012, 2015, 2018, 2020 & 2025
List of Figures
Figure 2.1 Examples of Contract Services During the Pharma Product Lifecycle, 2010
Figure 2.2 The Role of Contract Pharma Organisations in Drug Development, 2010
Figure 2.3 Comparison of R&D Costs and the Number of Approved NMEs, 2010
Figure 5.1 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2010-2016
Figure 5.2 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2017-2025
Figure 5.3 API Market: World Revenue Forecast, 2010-2016
Figure 5.4 API Market: World Revenue Forecast, 2017-2025
Figure 5.5 Finished Dosage Forms Market: World Revenue Forecast, 2010-2016
Figure 5.6 Finished Dosage Forms Market: World Revenue Forecast, 2017-2025
Figure 5.7 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2010-2025
Figure 5.8 US Pharma CM Market: Revenue Forecast, 2010-2025
Figure 5.9 Other Leading Pharma CM National Markets: Revenue Forecasts, 2010-2025
Figure 5.10 Pharma CM Revenue Shares in Leading National Markets, 2010
Figure 5.11 Pharma CM Revenue Shares in Leading National Markets, 2015
Figure 5.12 Pharma CM Revenue Shares in Leading National Markets, 2020
Figure 5.13 Pharma CM Revenue Shares in Leading National Markets, 2025
Figure 6.1 Top Ten Biotech Drugs: World Sales, 2009
Figure 7.1 Path up the Value Chain for Indian Pharma Companies, 2010
Figure 9.1 Pharma Contract Manufacturing Market: Revenue Trends, Overall and by Class, 2009-2025