DUBLIN, Ireland–(EMWNews)–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.

Source: Business Insights

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