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.