发布时间：2008.5

摘要

Countries covered: Global

Contract Manufacturing Strategies

Drug manufacturing now typically accounts for 25% of company costs and achieving agility in the production process has become essential for pharma companies hoping to align their supply chains with constant shifts in global product demand. In addition to offering efficiencies in cost, capacity and time-to-market, contract manufacturing organizations (CMOs) can provide innovative, state-of-the-art process and production technologies to support the rapid technical transfer of products from R&D to commercial manufacturing. However, the effective management of the CMO/sponsor relationship is critical not only in satisfying regulatory requirements amid growing concerns over quality control, but also in meeting the overall commercial aim of the project.

‘Contract Manufacturing Strategies: Market developments, technology transfer and key success factors’ is a new report published by Business Insights that explores the future of the contract manufacturing market with a detailed analysis of emerging drivers and restraints, business models and production strategies. The potential benefits and risks of contract manufacturing are assessed and the key strategies for effective CMO selection and successful relationship management are identified. This report also reviews the latest FDA contract legislation to determine the most effective measures in ensuring regulatory compliance and assesses the rapidly expanding markets of India and China to discover their growth potential and regulatory outlook.

Understand how the CMO market will develop over 2008-2013, identify emerging manufacturing strategies/regulatory issues and assess the outsourcing growth potential of India and China with this report...

Some key findings from this report...

• The global CMO market will be worth $20.5bn by the end of 2008, having expanded from $12.8bn in 2002. Steady growth in this sector is set to continue, with a projected CAGR of 10%.
• Contract Research and Manufacturing Organization (CRAMs) have emerged as key future business models, engaging in both contract research and manufacturing. These hybrids can offer molecule synthesis from the milligram to the multi-hundred-tonne scale.
• 29% of all manufacturing output is expected to be produced via third parties by 2010, as large companies continue to scale back on production and focus on core competencies. Major players including AstraZeneca, Roche, Pfizer and Schering are currently undertaking manufacturing strategy reviews to enhance profitability.
• Asia-based CMOs increased their contract service revenues by 44% over the 2006-2007 period. Low-cost competition from Asia will be a key influence on the CMO industry over the next 5-10 years.
• Biologicals manufacturing has become a focus area for CMOs. The number of new biotechnology-based drugs progressing through development far exceeds the number of conventional drugs

Top five reasons to order your copy today

• Assess future outsourcing trends and manufacturing strategies with this report’s analysis of the changing CMO industry structure, emerging business model capabilities and five year market growth forecasts.
• Discover the outsourcing potential of India and China and measure the impact of low cost manufacturing by using this report’s assessment of future growth potential, regulatory frameworks, recent patent and safety issues and a case study of Heparin producers in China.
• Identify the latest FDA contract manufacturing legislation and understand the how to ensure regulatory compliance by examining current regulatory requirements for both sponsors and contract manufacturers.
• Understand the key success factors for establishing successful CMO partnerships with this report’s detailed analysis of the multi-step sourcing process for CMOs and determine the essential criteria for CMO selection and effective relationship management.
• Evaluate the major risks and challenges of contract manufacturing projects by gaining insights into potential downsides and costs.

Key issues examined in this report...

• Importance of tech-transfer/scale-up. Effective technology transfer is a key component in the success of a contract-manufacturing project, but it is engulfed in uncertainty. Timelines and costs both vary dramatically, and together with scale-up capabilities, this constitutes a deciding factor in determining the fit between a client and a CMO.
• Ensuring regulatory compliance. The client company is deemed to be responsible for the manufacturing process, whether it be external or internal. All facilities involved in the manufacturing/testing of a drug product must adhere to the cGMPs that apply to their operations.
• Effective risk management. Although the risk of drug failure is assumed by the client company, the CMO business model is not designed to absorb high levels of risk. It is therefore critical for the client company to implement a wide array of risk-mitigation tactics.
• Offshoring to India/China. Asia continues to expand it’s outsourcing capabilities to offer high cost-savings and revenue-growth opportunities, however many CMOs in the region are still failing to demonstrate the levels of regulatory compliance expected by clients.

Your questions answered...

• How will the CMO market develop over the period 2008-11?
• What are the key factors influencing ‘buy vs. make’ decisions in biomanufacturing?
• Which are the current market drivers and constraints of the contract biomanufacturing market?
• What is the forecast global manufacturing capacity and growth rates for microbial fermentation and mammalian cell culture expression systems over 2006-2011?
• What kind of risks and challenges are inherent in an outsourced manufacturing project?
• What are the key selection criteria and success factors for contract manufacturing organizations?
• What are the critical issues affecting technology transfer & scale-up?
• How will India and China influence the global CMO market?
• What is the long-term future of in-house manufacturing?

目录及图表

Contract Manufacturing Strategies

Executive Summary

The contract manufacturing market

CMO industry analysis

Manufacturing strategies in the biopharmaceutical industry

Managing contract manufacturing

India and China - emerging outsourcing markets

Chapter 1 The contract manufacturing market

Summary

Introduction

Overview of the global contract manufacturing market

Current market drivers

The expansion of the biopharmaceutical contract manufacturing market

The reorganization of pharmaceutical production

Case Study - Pharma manufacturing site close-down

Growth in Offshoring - Asian CMOs becoming a global force

Current market restraints

Fewer new drug approvals

The threat of overcapacity

Increased competiton - low barriers to entry

Conclusions

Chapter 2 CMO industry analysis

Summary

Introduction to biopharmaceutical manufacturing

The stages of pharmaceutical development

Primary manufacturing

Secondary manufacturing

Structure of the CMO industry

Size of contract manufacturing organizations

Does size really matter?

CMO business models - evolving over time

The advent of biopharmaceutical contract manufacturing

CMOs focusing on early drug development stages

The emerging full-service CMO business model

Examples of CMO service offerings

Lonza Group Ltd.

Patheon Inc.

Siegfried Group

CMO Industry Outlook

Chapter 3 Manufacturing strategies in the biopharmaceutical industry

Summary

Introduction

Strategic options for manufacturing

Vertical integration - The business model of the past

Drivers of vertical integration

Benefits of vertical integration

The deconstruction into a fragmented industry structure

The shift towards outsourcing

The make vs. buy decision

Factors influencing the make vs. buy decision

Mixed sourcing models

The sale and leaseback model

Examples of recent sale and leaseback deals

The potential downsides of outsourcing

Transaction costs of outsourcing

Drivers of hidden costs in outsourcing

Efficiency, effectiveness and flexibility, all in one outsourcing project?

Outsourcing manufacturing is like buying commodities

The need for a comprehensive contract

Contracts do not matter

CMOs are insurance companies

The project is not the client’s problem anymore

The first failure should be the last attempt

Conclusions

Chapter 4 Managing contract manufacturing

Summary

Introduction

Key factors in selecting and managing a CMO

Sourcing CMO partners

Defining the goals of outsourcing

Writing a Request for Proposal

The site visit - a critical step

The Selection

Managing the CMO relationship

Technology transfer and scale-up

The Design of Experiments (DOE) used for the scale-up process

Challenges of the technology transfer process

The importance of engineering runs

Ensuring regulatory compliance

The definition of responsibilities

The importance of change control in contract manufacturing

The Annual Product Review and other ways to ensure compliance

Due Diligence - common pitfalls and how to mitigate the risks

Avoiding faulty contracts and contractors

Case Study - Pharmaceutical companies caught out by Inyx collapse

Due diligence from a CMO perspective

Risk management in the outsourced relationship

The business risk

The technical risk

The CMO Relationship - A lifecycle model

Stage 1 - Aligning relationship strategy with long-term business needs

Stage 2 - Employing a structured evaluation and selection process

Stage 3 - Building working relationships

Stage 4 - Technology transfer and scale-up

Stage 5 - Ongoing operations

Stage 6 - Changes over time

Awarding preferred provider status

Chapter 5 India and China - Emerging outsourcing markets

Summary

Introduction

Contract Manufacturing in India

Size of the Indian CMO market

Patent situation and implications for foreign direct investment

Challenges in current patent law

India as a preferred offshoring destination

The new, integrated business model of Indian CMOs

Challenges facing the CRAMS business model

Expansion strategies of India’s major contract manufacturing organizations

Conclusions

Contract manufacturing in China

Drivers of the Chinese contract manufacturing market

Challenges of the Chinese contract manufacturing market

China’s regulatory framework

Intellectual property protection

Counterfeit drugs

Case Study - China’s Heparin producers

China’s major contract manufacturing organizations

CMOs offering finished drugs services

Biopharmaceutical contract manufacturing in China

Conclusions

Chapter 6 Appendix

Bibliography

Index

List of Figures

Figure 1.1: Size of the global contract manufacturing market, 2002-2011e

Figure 1.2: Structure of the pharmaceutical API market, 2007

Figure 1.3: Structure of the pharmaceutical API market, 2006

Figure 1.4: Size of the contract biomanufacturing market, 2000-2008e

Figure 1.5: Contract manufacturing providers across the service chain, India

Figure 1.6: FDA approvals for NDAs and NBEs, 2000-2007

Figure 1.7: Captial expenditures of top 15 pharma companies, 2004-2007

Figure 2.8: Drug development and relevant milestones during the pharmaceutical manufacturing process

Figure 2.9: Lonza’s life science platform

Figure 2.10: Siegfried’s pipeline in 2006

Figure 3.11: Change in pharmaceutical industry structure over time

Figure 3.12: Categorization of varying degrees of integration

Figure 3.13: Percentage of manufacturing output produced through CMOs, 2007 and 2010e

Figure 3.14: Business objectives for moving to contract manufacturing

Figure 3.15: Considerations influencing the make vs. buy decision

Figure 4.16: Critical success factors for the manufacture of an early phase product

Figure 4.17: Stages 1 - 6 of the CMO lifecycle

Figure 4.18: Percentage of outsourcing dollars spent on preferred providers*(2007)

Figure 4.19: How many preferred providers do you utilize?*(2007)

Figure 5.20: Assessment of API manufacturing costs by region, 2005

Figure 5.21: Size of India’s contract manufacturing market 2005-2010e

Figure 5.22: Global outsourcing expenditure and segmentation of contracted services, 2005 and 2010e

Figure 5.23: Size of China’s API Industry, 2005 and 2010e

List of Tables

Table 1.1: Big pharma ongoing or recently completed manufacturing projects

Table 1.2: New entrants in the pharmaceutical CMO market

Table 2.3: Key characteristics of biotechnological and chemical API manufacturing (figures indicative only)

Table 2.4: Summary of services offered by contract manufacturing organizations

Table 2.5: Structure of the CMO industry

Table 2.6: Mammalian cell culture capacity in the biopharmaceutical industry

Table 2.7: Comparison of in-house production vs. outsourcing

Table 2.8: Pros and cons of the ‘one-stop shop’ concept

Table 3.9: Challenges for the pharmaceutical industry

Table 3.10: The benefits of outsourcing

Table 3.11: Examples of transaction costs

Table 3.12: Drivers of hidden costs in outsourcing

Table 4.13: Typical steps of an outsourced project

Table 4.14: Definition of responsibilities for main quality areas

Table 4.15: Risk-mitigation tactics for pharmaceutical companies

Table 5.16: Selected contract manufacturing/ research deals in India as of July 2007

Table 5.17: Strategic options for Indian pharmaceutical companies