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
D/&/amp;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.
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.
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.
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.
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/&/amp;MD’s “Biodisposables:
Utility and Technological Advances” report: www.drugandmarket.com/9215.