 | 5th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, March 2008 This comprehensive look at the state of worldwide biopharmaceutical manufacturing provides the only on-going assessment of manufacturing capacity and production in this $80 billion global industry. You will find current, quantitative information from 434 worldwide biopharmaceutical developers and contract manufacturers, and over 120 suppliers to the industry. Covers year 2007.Coverage includes:In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic productionComparison of production by biotherapeutic developers and contract manufacturing organizationsCurrent and future potential industry bottlenecksTrend analysis in this 5th in a series of annual biopharmaceutical manufacturing industry evaluationsProjected capacity bottlenecks, and how they might be resolvedThis edition includes the joint industry expertise from BioPlan Associates, and many industry consultants and expertsThere are an estimated 10,000 large molecule biotechnology medicines in preclinical discovery or clinical trials around the world today. Over 2,000 of these are in clinical development . These biotherapeutic drugs target nearly 150 disease states and promise to bring better treatments to patients. However, if new biotherapeutics are to be made more accessible and affordable, most industry participants agree that improvements in performance and optimization of processes will be necessary. As the demand for production of biotherapeutics continues to grow, the question of whether current manufacturing capacity and production performance are sufficient to deal with the challenge becomes an important strategic issue.Building new capacity and improving existing systems to meet the demand for new therapeutics, whether through in-house manufacturing or out-sourced contract manufacturing, has long-term cost implications. Designing new production facilities, bringing new capacity on line, and establishing new support services in these areas require accurate market knowledge, lead-time, large capital expenditures, and careful planning.Both biopharmaceutical producers and contract manufacturers maintain a keen interest in the current and future status of industry capacity and trends. This report summarizes information obtained from worldwide biopharmaceutical manufacturers in late 2007. Its intent is to provide a quantitative assessment of industry capacity, production trends, and benchmarks. MethodologyThis report is the fifth in our annual evaluations of the state of the biopharmaceutical manufacturing industry. The strength of the methodology remains in its breadth of coverage, which yields a composite view from the respondents closest to the industry. This year, BioPlan Associates, Inc. surveyed 434 responsible individualsat biopharmaceutical manufacturers and contract manufacturing organizations in 39 countries around the world. The survey methodology also, separately, provided data from an additional 126 direct suppliers of materials, services and equipment to this industry segment. Using a web-based survey tool, we obtained and evaluatedinformation regarding respondents current capacity, production, novel technology adoption, human resources, and outsourcing issues. We assessed respondents projected reasons for bottlenecks, and their perception of how these bottlenecks might be resolved.This year, we brought in experts from the industry to provide in-depth analysis of the events shaping the past year, and the trends that will shape biopharmaceutical manufacturing in 2008-2013. Our subject matter experts include: Eileen Bartholomew, Senior Consultant, PharmaBioSource, Inc.Geoff Hodge, Vice President, Technology, XcellerexBeth H. Junker, PhD, Senior Director, Bioprocess Research and Development,Merck Research LaboratoriesVladimir Kostyukovsky, Senior Director, Manufacturing, Artisan Pharma Inc.Sean P. McKee, Senior Consultant, PharmaBioSource, Inc.Mark J. Stramaglia, Senior Product Manager, Invitrogen CorporationScott Wheelwright, President and Founder, Strategic Manufacturing WorldwideWilliam B. Wiederseim, President & CEO, PharmaBioSource, Inc.The detailed benchmarking information and industry analysis contained here wasprepared based on these data, and information from earlier studies. Published by BioPlan Associates, Inc. April 2008ISBN 978-1-934106-09-9 Table of Contents Price: $795.00 / €531.38
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