Outsourcing for Contract Manufacturing Services 2008-2023

Outsourcing for Contract Manufacturing Services 2008-2023

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

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