October 1, 2006 (Vol. 26, No. 17)

Guidance for Determining the Utility of Biodisposables in Biomanufacturing

The value of the primary and secondary U.S. biomanufacturing market in 2006 is estimated to be approximately $50 billion with a healthy growth rate almost approaching double digits due to the escalating number of biotech drugs in the pipeline and skyrocketing sales of approved high-value, life-saving biopharmaceuticals.

D&MD’s “Biodisposables: Utility and Technological Advances” market analysis report details and reviews the implementation, cost-effectiveness, utility, and applications, including advances in specific apparatus, for disposable biotechnology equipment, such as filters, mixers, dispensers, connectors, storage bags, and bioreactors.

The current economic and regulatory reality, highlighted by the imminent establishment of drug pricing controls and tightening regulatory and quality standards, indicates the added pressures that are emerging for pharmaceutical companies to re-strategize their overall approach. There is a trend toward fewer blockbuster drugs, as patient populations become smaller and the associated histories and genetic makeup become stratified as personalized medicine begins to come into its own.

Biodisposable manufacturers have responded to these trends by developing fully integrated, turnkey manufacturing–production lines that combine single-use components with modular software, disposable bioreactors and equipment, and a disposable stir-tank and mixing system.

Market research necessary to design and implement a disposable biotech facility is summarized in this report, including the latest disposable technologies and applications from leading industry users. In addition, detailed examples for analyzing cost of goods and savings are provided to assist professionals attempting to determine the utility of disposables in their own facility.

The biopharmaceutical industry in the U.S. grew by an average of 11% annually from 1993 to 2003. Cartridges used for filtering liquids represent a $10.8 billion dollar market now, but by 2009, sales will reach an annual level of $14.2 billion. The market for membrane technology used in biopharmaceutical discovery, development, and commercial production, estimated at $740 million in 2004, is expected to rise at an average annual growth rate of 10.7% to more than $900 million in 2008 and to $1.23 billion in 2009. The average time required to construct a biotech facility is about five years, putting tremendous pressure on drug manufacturers to expend capital when the risk of drug failure is still high. Existing manufacturing plant costs linger between $10–50 million, depending upon required output and therapeutic bioproduct. At the two extreme price ranges, a 100-L, $10,000 Mab plant scales up to a 10,000-L plant costing $120 million.

Within the next five years, it is expected that 25% of all drugs will be biological products. As discovery and production of these products relies heavily on membranes, hundreds of membrane products (many single-use) and processes will continue to be developed to meet the emerging market.

Jeffery Terryberry has over a dozen peer-reviewed publications in clinical chemistry research focusing on orthobiologic drug development. Gautam Thor is the author of scientific and medical publications through NeuroConsultants. For sample content from D&MD’s “Biodisposables: Utility and Technological Advances” report: www.drugandmarket.com/9215. E-mail: [email protected].

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