Biopharmaceutical Contracting
Emerging Trends in Outsourcing Protein & Peptide Manufacturing
By: Cindy H. Dubin, Contributor
Patricia Haller, PhD
Director, GMP Production and
Process Development
Firuz Shakoori, MSc
Director of Sales, American
Peptide Company, Inc.
Rodney Lax, PhD
Senior Director of Business
Development, North America
PolyPeptide Laboratories Group
.
MMAYAR2C0H092007 Vol 9 NoV5ol 7 No 3
SPECIALTY PHARMA
6x6x
The market for contract manufacturing of prescription drugs exceeded $30 billion last year, a 10%
increase that is being fuelled by specialist production of biologics and sterile products, according to market
research company Kalorama, which estimates that 2008 saw $30.5 billion in contract manufacturing of
pharma products, with around $2.7 billion of that in the biopharmaceutical sector. That includes both
outright manufacturing of product and secondary manufacturing, creating a finished product out of the
APIs provided in bulk. The latter of which is driving current growth.
The growing number of biotechnology-driven protein and peptide drugs, antibiotics, chemotherapeutic
agents, and other compounds administered as sterile injectables, with its concomitant technological
requirements, has brought about an increase in the demand for contract sterile manufacturing services,
according to the report.
Some observers have suggested that one possible consequence of the investment in biologics capacity in
recent years could be overcapacity. While there is no evidence yet of overcapacity, insiders say it could
happen. What is not expected to happen is the recession affecting contract manufacturing. The March 2,
2009, edition of Pharmafocus reports that, according to Kalorama, “While it's too early in the cycle of this
economic downturn to call anything a recession-proof market, the outsourcing of drug manufacturing is an
area that could see growth in a downturn.”
Specialty Pharma recently posed some tough questions about the protein and peptide manufacturing
market to some experts, including Patricia Haller, PhD, Director, GMP Manufacturing, American Peptide
Company, Inc.; Firuz Shakoori, MSc, Director of Sales, American Peptide Company, Inc.; and Rodney Lax,
PhD, Senior Director of Business Development, North America, PolyPeptide Laboratories Group.
