Innovative drug approvals increased in the US between 2019 and 2020. This increase happened despite the FDA’s stretched resources, as it had to reassign staff to cope with COVID-19-related activities. The agency approved 121 novel drugs in 2020, compared with 119 in in 2019, says GlobalData, a leading data and analytics company.

Adam Bradbury, PharmSource Analyst at GlobalData comments: “There was a large increase in approvals of new molecular entities (NMEs), the most innovative drug type with 21% more NME approvals than in 2019. There were also more small cap pharma–sponsored drug approvals and overall approvals compared with 2019. This is a positive sign for contract manufacturing organizations (CMOs), as small cap pharma companies tend to heavily outsource manufacturing.”

This increased approval count does not include Emergency Use Authorizations (EUAs) for COVID-19, such as Pfizer and BioNTech’s COVID-19 vaccine. Emergency approvals for COVID-19 were even more highly outsourced due to the scale of production and compressed development timelines.

Bradbury continues: “Even large pharma companies outsourced complex manufacturing in 2020, such as Gilead Sciences with its Trodelvy, a monoclonal antibody conjugated requiring containment. Trodelvy has both its API and dose production outsourced to CMOs.”

For 2020 approvals, the propensity to outsource the dose manufacture of NMEs and non-NME NDAs increased by 4%. For NMEs, approvals remained strong, although lower than in 2017 and 2018.

Bradbury concludes: “NMEs are the most innovative and challenging drugs to develop and manufacture, and many small pharma company drug sponsors lack the capabilities to manufacture them and must outsource their production.”