Peptide API Market Growth Expected to Continue

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CMOs with existing expertise in and capacity for development and manufacture of peptide drugs may find themselves uniquely positioned to take advantage of a surge in interest in such products. As the ability to synthesize these products grows and more dosage forms become available, more companies are adding peptide products—including potential biosimilars as some of the earliest patents expire—to their pipelines.

Since it takes time and money to develop sufficient expertise and add the necessary equipment to make these products, companies that don’t already have in-house capacity will likely turn to established CDMOs to help get new peptide products through clinical trials and into commercial production.

Peptide drugs are enjoying increased attention from the bio/pharmaceutical industry, with an estimated market of around $16 billion and forecast growth in the range of at least 3% per year and possibly up to 9% per year through 2020, according to IMS Health and other industry observers.

Approximately 72 products identified as peptide drugs currently are approved by the US FDA, with many more in the pipeline. The market continues to be dominated by synthesized peptides, rather than recombinant products, with a great deal of technological development focused on refining the ability to synthesize products comprising longer chains of amino acids. The Strategic Advantage products database identifies 31 peptide drugs with contract-manufactured APIs.

This article is reprinted from the September issue of Bio/pharmaceutical Outsourcing Report. The full article addresses the peptide pipeline and CMO investments seen. To learn more, click here.

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Jim Miller is the founder and president of PharmSource Information Services, Inc. A preeminent expert in bio/pharmaceutical outsourcing, Jim established and presides over the industry’s principal resource for serious consumers of information on contract drug development and manufacturing, PharmSource STRATEGIC ADVANTAGE. He is editor and publisher of Bio/Pharmaceutical Outsourcing Report and Emerging Markets Outsourcing Report.

More posts by Jim Miller