Contract Pharma 2008-2023

Summary

The revenue for world contract manufacturing business in 2007 was approximately $30bn, with a growth rate of 6% from 2006. The technical expertise and cost savings offered by contract manufacturing organisations (CMOs) make them increasingly essential to you and your organisation. Greater emphasis has been put on European CMOs to leverage low-cost contract manufacturing markets, such as those existing in India and China, to enhance cost efficiency. Many CMOs in Europe have turned to biotech services as a means of avoiding competition with lower-cost API companies based in developing countries. In common with European service providers, North American CMOs are adopting a dynamic approach.

Also, they are providing other services, such as packaging, logistics and marketing support. Are you taking advantage of the opportunities available? This unique report will guide you and inform you on how to benefit from the options you should take the opportunity today.

Recent years have seen the emergence of moderate level competition from Indian and Chinese CMOs. This new visiongain report Contract Pharma 2008-2023 evaluates the prospects for outsourcing manufacturing and other operations from pharmaceutical companies, especially off-shoring to developing nations such as China and India. Furthermore, this report analyses the increasing trend for Japan to outsource services abroad.

In particular, the following factors have been highlighted in this report:

• Synchronization of regulations
• Mutual recognition of GMP documentation
• Improved information exchange.

Why you should buy this report: In Contract Pharma 2008-2023 you will receive the following essential information for understanding the contract pharma market:

• The value of the contract pharma business market and its principal market segments from 2008 to 2023, with detailed forecasts and growth analyses
• Market drivers and restraints, including a comprehensive SWOT analysis
• Comprehensive views of key opinion leaders on contract pharma, including leading companies, with full interview transcripts from our in-depth survey worldwide
• The companies involved in contract pharma business and their business strategy
• The present state of contract pharma business and future trends there
• What contract pharma opportunities exist for market entrants, both established companies and newcomers
• The main concerns for outsourcing clinical trials to CROs
• Changes in contract pharma regulations
• CMOs are increasingly undertaking analytical testing and other value-added services alongside traditional contract manufacturing of APIs. In some major CMOs, these value-added services have taken up significant proportion of their revenue generation. This rate will increase further in the coming decade. The establishment of large, global companies offering a full range of contract services has led to a change in the image of CROs and CMOs. There has been a shift in the business model of CMOs to integrate themselves more fully into the supply chain of pharmaceutical and biopharmaceutical companies by offering a wider range of services.

The report is intended for the following professionals, amongst others:

• Directors, business development managers and researchers of pharmaceutical and biopharmaceutical companies worldwide
• Directors, business development managers and researchers in the healthcare industry
• Policy makers, researchers, analysts and academic researchers

Contents

• 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
• Companies Listed
  • Actavis
  • Advanced Medical Optics
  • Altana
  • Anhui BBCA Biochemical
  • AstraZeneca
  • Avecia
  • Aurobindo
  • Baxter International
  • BEBAC - Consultancy Services
  • Bristol-Myers-Squibb
  • Cadila Healthcare
  • Carbogen and Amcis
  • Cellerix
  • Celltrion
  • Chembiotek
  • Clininvent Research
  • Cognizant Manipal Acunova
  • Damon Biotech
  • Dishman
  • Divi's Labs
  • Dr. Reddy's Laboratories
  • Ranbaxy
  • Eli Lilly
  • GlaxoSmithKline
  • Granules India
  • HCL Systems
  • iGATE Clinical Research International
  • Johnson & Johnson
  • Jubilant Organosys
  • Matrix
  • Matrix Strides
  • Merck
  • Mylan
  • Natco
  • Neuland
  • Neeman Medical International
  • Nicholas Piramal
  • Northeast Gen Pharma Factory
  • Novartis
  • Novo Nordisk
  • Orchid Chemicals and Pharma
  • Patheon
  • Pfizer
  • Progenitor International Research
  • Quintiles
  • Ranbaxy
  • Rhodia
  • Roche
  • Sandoz
  • Sanofi-Aventis (Aventis)
  • Shadong XINHUA Pharm
  • Shasun
  • SIRO Clinpharm
  • Solvay
  • Suven Life Sciences
  • Veeda Clinical Research
  • Wyeth
  • Zhejiang Medicine
  • Zhejiang NHU
  • Zhejiang Chiral
  • Zyday Cadila