FDA new drug approvals down 16% in 2019

In 2019 the US Food and Drug Administration (FDA) accepted 119 New Drug Approvals (NDAs) and Biologics License Applications (BLAs) including New Molecular Entities (NMEs) and new formulations of older drugs. This figure represents a 3% increase over the 2014–2018 period average of 115 approvals, but is a 16% decrease on 2018’s 137 approvals, according to GlobalData, a leading data and analytics company.

The 10th edition of GlobalData’s pharmaceutical contract manufacturing organization (CMO) industry report, ‘PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2020 Edition’, reveals that small cap companies have traditionally had a higher chance of outsourcing their manufacture than other market cap groups. The report findings correspond to that trend, although outsourcing propensity fluctuates yearly depending on product count; over the last ten years, 79% of NMEs and 67% of non-NME NDAs sponsored by small caps were outsourced.

Adam Bradbury, Associate Healthcare Analyst at GlobalData, explains: “It is a concern for CMOs that the number of small cap and mid cap sponsored product approvals has also declined markedly since 2018 while the number of mega cap sponsored product approvals has risen sharply, which will partly account for lower levels of outsourcing observed for 2019 approvals compared with 2018 approvals. The size of the sponsor is historically inversely proportional with its need for contract manufacturing.”

In 2019, 44 FDA NDAs were outsourced to contract manufacturers, a figure that is much lower than the 2014–2018 average (55.6).

Bradbury continues: “Apart from a large proportion of approvals being sponsored by mega cap companies, the number of FDA novel approvals had also declined since 2018, with the US Government shutdown in January 2019 causing a reduction in FDA approvals in 2019, where the FDA suspended reviews of existing Investigational New Drug (IND) and BLA applications. These factors combined account for the low number of outsourced products.”

Historical findings suggest that the large proportion of mega cap approvals will not be a persistent and sustained trend and that the proportion of this group’s NDA approvals will fluctuate from year to year.

Bradbury adds: “It is difficult to predict in these unprecedented times how the COVID-19 crisis could impact drug approvals, pharma CMOs and global supply chain networks, but 2020’s FDA approval numbers may be substantially affected depending on how well the crisis is handled.”

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