1 Executive Summary: Contract Pharma 2008-2023
1.1 Aims of Contract Pharma 2008-2023 Report
1.2 Scope of Contract Pharma 2008-2023 Report
2 Contract Pharma Prospects in World Regions
2.1 World Market Prospects for Contract Pharma
2.2 Clinical Trial Business Outsourcing will Expand
2.3 Contract Pharma Situation in the US
2.3.1 Drug Approval Rates Have Slowed Down
2.3.2 Outsourcing for Biologics Grow
2.3.3 Overcapacity Situation in CMOs
2.4 Pharmaceutical Industry Still has Reservations
2.5 European CMO Market
2.5.1 Value-added Services Essential to Combat Rising Competition from Indian and Chinese CMOs
2.6 Emerging Opportunities in Contract Manufacturing and Research in India
2.7 Global Companies Build Trust and Reputation
2.8 Japan's Rising Contract Research and Manufacturing Business
2.8.1 Contract manufacturing is a Real Beginning for Japan
2.8.2 Contract Research is Slow to Grow in Japan
3 The Regulatory Aspects of Outsourcing
3.1 Legal Liabilities and Regulatory Considerations in Manufacture Outsourcing
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 Regulations Affecting the Organisation of Clinical Trials
3.12.1 The EU Clinical Trials Directive
3.12.2 Establishing Standards for Good Clinical Practice
3.12.3 FDA's New Rules for Incorporating Foreign Clinical Studies
3.13 Heightened Safety Attention Opens the Door to Contract Pharmacovigilance
3.14 A Brief Account of Regulatory Developments for Clinical Trial
4 Market Analysis for Contract Manufacturing Business
4.1 Revenue Projection for Contract Manufacturing Business
4.2 Summary of the Chapter
5 Contract Manufacturing Businesses to Drive Productivity and Efficiency
5.1 Reasons for Outsourcing
5.2 Drivers for Outsourcing
5.3 Restraints for Outsourcing
5.4 API Manufacturers Closely Linked with Innovative Pharmaceutical Developers
5.5 Various Outsourcing Partners
5.6 Selecting an Appropriate CMO
5.7 Efficient Management of Supply Chain for Low-Cost Contract Manufacturing Industry
5.8 Mergers and Acquisitions for Pharmaceutical Manufacturing
5.8.1 CMO Alliances Shows Continued Growth in the US
5.8.2 Actavis Acquires CMO in China
5.8.3 Merger and Acquisition (M&A) for Indian Contract Manufacturing Companies
5.9 Interview with Manish Badonia, Cadila
5.9.1 Contract Manufacturing Outsourcing to Asia
5.9.2 Alliance Formation for Moving up the Value Chain
5.9.3 Quality Control for Contract Research
5.10 Contract Pharma for Biotech Products
5.10.1 Failure of Early Efforts in Contract Biologic Manufacturing
5.10.2 Cost Benefits of Outsource Manufacturing in Biotech
5.10.3 The Future of Biotech Outsourcing
5.10.4 Custom Peptides are an Opportunity for APIs to Move up the Value Chain
5.10.5 One More Step in the Direction of Outsourcing Contract Manufacturing to Asia
5.11 Western Companies
5.12 Contract Pharma for Improved Process Tools
5.13 Chinese API Export Growing Rapidly
5.14 Outsourcing to Low-Cost Geographic Areas
5.15 Low-Cost Services in India and China Drive Prices Down
5.16 Main Tendencies in Current Asian IP Law
5.17 Patent Protection Status in Indian Pharmaceutical Industry
5.18 Improvement of China's Intellectual Property Rights Situation
5.19 Interview with Dr Zhang Zhicheng, National Intellectual Property (IP) Strategy Formulation Office, SIPO, China
5.19.1 International Framework of the IP Protection for Contract Manufacturing
5.19.2 IP Holders
5.19.3 IP Situation in the Developing Countries
5.19.4 Innovation-Oriented Industry Development in China
5.20 Interview with Manish Badonia, Cadila
5.20.1 IP Regime and Protection
6 Contract Manufacturing Businesses in India
6.1 Contract Manufacturing in India
6.2 Drivers for Contract Manufacturing for Outsourcing to India
6.3 Contract Manufacturing and Role of Indian Companies
6.3.1 Outsourcing for Generics
6.3.2 Sourcing Generics from Non-Competitors
6.3.3 Divi's Laboratories' Business Model
6.3.4 Granules India for Production of Generic Prescription Medicines and OTC Products
6.3.5 Matrix Contract Manufacturer for CNS Products
6.3.6 Neuland Focused on Anti-Bacterials
6.3.7 Natco Chose Chronic Diseases
6.4 Enforcing cGMP Compliance for APIs in EU
6.5 Growth in Biotechnology Sector of India
6.6 Interview with Dr Jagdish N Sheth, Business School of Emory University
6.6.1 India's Key Strength
6.6.2 India's Edge Over China in Pharmaceutical Business
6.6.3 Need for Routine Inspection of Outsourcing Sites
6.6.4 Need for Creation of Economic Zone for Pharmaceutical Industry
6.6.5 India as an Emerging Market
6.6.6 Vertical Integration
6.6.7 India's Emergence as a Major Pharmaceutical Market
7 Market for Clinical Trial Business
7.1 Outsourcing for Clinical Trial Business
7.2 Phase IIIb and IV Studies
7.3 Safety Concerns and Development Pressures
7.4 Demand for Phase II and Phase I Studies
8 SWOT Analysis for Outsourcing Clinical Research to CROs
8.1 Outsourcing Clinical Trial Business to CROs
8.2 SWOT Analysis for Outsourcing Clinical Trials
8.3 Growth of CRO Industry
9 SWOT Analysis for Outsourcing Clinical Trials to Lower-Cost Regions
9.1 SWOT Analysis for Outsourcing Clinical Trials to Developing Countries
9.2 China
9.3 India
9.4 Clinical Trial Outsourcing
10 Firsthand Interviews for Clinical Trial Business
10.1 Interview with Dr Arun Bhatt, Clininvent
10.1.1 Biotech Companies
10.2 Interview with Dr Ernst Johannes, Quintiles
10.2.1 Reasons for Outsourcing Clinical Research from CROs
10.3 Interview with Dr Louis Christian Clauss, Baxter
10.3.1 How CRO Industry will Develop
10.4 Interview with Dr. Venkat Jasti, Suven Life Sciences
10.4.1 Advantages of Using Services from CROs
10.5 Interview with Patricia Moenaert, Progenitor International Research
10.5.1 Outsourcing Bioequivalence Studies for Phase I Clinical Studies in India and China
10.5.2 Central Laboratory Facilities in Asia
11 Contract Pharma for Specialised Areas
11.1 Value-Added Services and Contract Pharma
11.2 One-Stop Shop (CRO and CMO)
11.3 Interview with Manish Badonia, Cadila
11.3.1 One-Stop Shop (CRO and CMO)
11.3.2 Value-Added Services in Global Settings
11.4 Presentation at Dissolution Testing, Bioequivalence and Bioavailability Strategies 2008 conference by Kevin Deane
11.4.1 Off Shoring for Automation
11.5 Interview with Wesley Wheeler, Patheon
11.5.1 Outsourcing for Analytical Testing Services
11.6 Suitable Trial Supply Chain Management
11.7 Presentation at Clinical Trial Congress 2008 by Carmen Salazar, Cellerix
11.7.1 Management Skills for Ensuring Good Supply Chain
11.7.2 Essentials of Trial Supply Chain Management
11.8 CMOs Venture into New Areas
11.9 The Use of CROs as Major Pharma Changes
11.9.1 Contract Research for Drug Discovery at Suven Life Sciences
11.10 Interview with Dr Debra Sponholtz, Chembiotek
11.10.1 CROs Offer a Full Range of Services
11.11 Interview with Dr Arun Bhatt, Clininvent
11.11.1 India's Own Innovative Products
11.12 Outsourcing Electronic Data Management
11.13 Outsourcing Clinical Data Management
11.13.1 GlaxoSmithKline to Outsource Data Management
11.13.2 Clininvent is a CRO with Standardised Data Management Skills
11.13.3 Wyeth to Outsource Majority of its Data Management to India
11.14 Forward Planning is Required for Regulatory Affairs Outsourcing
11.15 Outsourcing Bioequivalence Studies for Generic Drugs
11.16 Requesting a Waiver from a Bioequivalence Trial
11.17 Bioequivalence Studies for New Drug Application
11.18 Interview with Helmut Schutz, BEBAC
11.18.1 When in Vivo Bioequivalent Studies are Waived
11.18.2 Success of Outsourcing Dissolution Testing/Bioequivalence Studies
11.18.3 Off-Shoring in Vivo Bioequivalence Studies to India
11.19 Interview with Dr Daniel Abran, Sandoz
11.19.1 Waivers of in vivo BE Studies (Biowaivers) for Abbreviated New Drug Application (ANDA)
11.19.2 Comparative Clinical Trial Requirement for ANDA
11.20 Interview with Manish Badonia, Cadila
11.20.1 Prospects for Outsourcing Bioequivalence Studies
11.21 Outsourced Bio-storage Becomes a Strategic Consideration
11.22 Contract Pharma for Lyophilisation
11.23 Outsourcing Sales and Marketing Brings Flexibility
11.24 Contract Packaging Services
11.24.1 Contract Packaging is Not Just Boxes
11.24.2 Advantages Offered by Contract Packaging Organisations
12 Conclusions
12.1 Growth Rates will Vary According to Sector
12.2 Contract Pharma Expanded to Include Biotechnology
12.3 Contract Research has an Increasing Role in Lifecycle Management
12.4 Outsourcing Data Management
12.5 Global Companies Required for Global Trials
12.6 Outsourcing for Value-Added Services
List of Tables
Table 1.1 World Contract Manufacturing Revenue Forecasts, 2007-2015
Table 3.1 Key Stages in the History of Clinical Trials
Table 4.1 World Contract Manufacturing Revenue Forecasts, 2007-2015
Table 4.2 World Contract Manufacturing Revenue ($bn) Forecasts, 2016-2023
Table 4.3 Forecasts for Contract Manufacturing Revenue from India, 2007-2015
Table 4.4 Forecasts for Contract Manufacturing Revenue from India, 2016-2023
Table 4.5 Forecasts for Contract Manufacturing Revenue from China, 2007-2015
Table 4.6 Forecasts for Contract Manufacturing Revenue from China, 2016-2023
Table 5.1 Alliances for APIs in India, 2007
Table 5.2 Relationship Build-Up for Contract Manufacturing in India, 2007
Table 5.3 SWOT Analysis for Contract Manufacturing Services from Low-Cost Geographic Areas
Table 7.1 World Clinical Trial Revenue ($bn) Forecasts for Phase II, 2006-2014
Table 7.2 World Clinical Trial Revenue Forecasts for Phase II, 2015-2023
Table 7.3 World Clinical Trial Revenue Forecasts for Phase I, 2006-2014
Table 7.4 World Clinical Trial Revenue ($bn) Forecasts for Phase I, 2015-2023
List of Figures
Figure 1.1 World Contract Manufacturing Revenue Forecasts, 2007-2015
Figure 4.1 World Contract Manufacturing Revenue Forecasts, 2007-2015
Figure 4.2 World Contract Manufacturing Revenue Forecasts, 2016-2023
Figure 4.3 Forecasts for Contract Manufacturing Revenue from India, 2007-2015
Figure 4.4 Forecasts for Contract Manufacturing Revenue from India, 2016-2023
Figure 4.5 Forecasts for Contract Manufacturing Revenue from China, 2007-2015
Figure 4.6 Forecasts for Contract Manufacturing Revenue from China, 2016-2023
Figure 6.1 Path up the Value Chain for Indian Companies
Figure 7.1 World Clinical Trial Revenue Forecasts for Phase II, 2006-2014
Figure 7.2 World Clinical Trial Revenue Forecasts for Phase II, 2015-2023
Figure 7.3 World Clinical Trial Revenue Forecasts for Phase I, 2006-2014
Figure 7.4 World Clinical Trial Revenue Forecasts for Phase I, 2015-2023