Outsourcing of NDA Approvals and CMO Performance - 2018 Edition

by Sameer Joshi or 19-Apr-2018

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.
  • The EMA approved 29 New Active Substances, of which 14 were also approved by the FDA.
  • The overall total of 87 therapeutic drugs is 20% higher than the 2012–2016 average and included 15 biosimilars and 19 generics.
  • Overall, 57 products were manufactured by third parties in 2017, the highest since 2012.
  • Outsourcing penetration declined to 46% compared to the five-year average of 54% from 2012–2016.
  • In 2017, 48% of NMEs were outsourced, compared to 45% of non-NME NDA products.

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. -