Contract Manufacturing Strategies: Market Developments, Technology Transfer, And Key Success Factors

DUBLIN, Ireland --(Business Wire)-- Aug. 6, 2008 Research and Markets (http://www.researchandmarkets.com/research/935993/contract_manufactu) has announced the addition of the "Contract Manufacturing Strategies: Market Developments, Technology Transfer and Key Success Factors" report to their offering.

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.
• Off shoring 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 bio manufacturing?
• Which are the current market drivers and constraints of the contract bio manufacturing 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?

Key Topics Covered:

• 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

For more information visit http://www.researchandmarkets.com/research/935993/contract_manufactu.

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