NDA Outsourcing Up, Despite NME Decline


In 2016, outsourced dose form manufacturing of NDA approvals reached 60%, some 10% higher than the five-year average. This and other insights into CMO performance were revealed in PharmSource’s recently published CMO Scorecard.

In what proved to be a mediocre year for drug approvals, the increase in outsourcing levels was restricted to the manufacture of non-new molecular entities (NMEs), which stood at 64%, the report disclosed (see graphic below). In contrast, just under half of all NMEs were outsourced, a figure consistent with the five-year average.

2016 also witnessed a significant increase in external manufacturing of solid dose products, from 48% to 67%, although this was balanced by a decline in outsourced parenteral manufacturing. Global bio/pharma companies reduced their use of external vendors, outsourcing just 11% of their NMEs. However, they were much more willing to use CMOs to manufacture non-NMEs than in previous years.

This article is reprinted from the March issue of Bio/Pharmaceutical Outsourcing Report. The full article addresses the pre-eminent position of the US within the CMO landscape. 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