Global bio/pharma companies received 34 approvals in 2017 (28% of all NDAs), 6% below their 2012-2016 average.
Small commercial companies were responsible for 29 approvals (24% of the total), some 5% above their five-year average.
In 2017, outsourcing of solid-dose NMEs was 8% greater than
the long-term average. However, this was offset by a modest decline in the
incidence of parenteral NME outsourcing from 45% to 42%.
Four leading CMOs (Baxter, Catalent, Patheon [acquired by Thermo Fisher], and Vetter) displayed somewhat different levels of reliance on sponsors for their NME approvals.
Although outsourcing of NME API manufacture is highly dependent on the nature of the drug, the number of both large and small molecule drugs that were outsourced declined in the past year. In 2017, just a single biologic was outsourced, compared to an average of four between 2012–2016. -