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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
A recent market analysis offers a promising outlook for contract fill-finish and lyophilization services.
The market for biopharmaceutical contract fill-and-finish services reached $1.2 billion in 2012, an increase of 33% over the past two years, according to an analysis by the market research firm High-Tech Business Decisions. This growth results from the underlying growth in the biopharmaceutical market, expansion of services offered by fill-and-finish contract manufacturing organizations and the greater use of contract manufacturing organizations by pharmaceutical and biotechnology companies (1). Contract manufacturing organizations with traditional aseptic, small-molecule filling capacity have expanded their capabilities to meet the filling challenges of temperature sensitive and fragile protein drugs. The biotechnology industry continues to use fill-and-finish contract manufacturers to provide expertise, filling capacity and lyophilization as they focus on drug development and API manufacturing.
The analysis notes that long-term prospects for biopharmaceutical fill-and-finish contractors remain strong with growth opportunities in new presentations that offer improved convenience for both patients and healthcare providers. Other growth opportunities include new services associated with special handling of niche products and smaller dosage volumes. As a result of these growth opportunities, this study projects the worldwide market for biopharmaceutical fill-and-finish contract manufacturing will continue to expand through 2017, reaching $1.6 billion.
"Biopharmaceutical products are becoming increasingly complex requiring special technologies and handling. Capacity utilization rates at contract manufacturing organizations have improved somewhat from two years ago," said William Downey, president of HighTech Business Decisions, in a High-Tech Business Decision release (1). "The investment in new fill capacity by contract manufacturing organizations will be modest over the coming years, thereby keeping industry utilization rates stable. New opportunities exist as the industry evolves to be more flexible with broader offerings and increased capabilities."
1. High-Tech Business Decisions, "Biopharmaceutical Fill-and-Finish Contract Manufacturing Study Shows Market Growth and New Opportunities," Press Release, Jan. 17, 2013.