Growing opportunities in API manufacturing as innovative biologic approvals increase: GlobalData

The US Food and Drug Administration (FDA) approved more biologic new molecular entities (NMEs) in 2020 than in any other year in the previous decade, while at the same time, sponsors increased the outsourcing of these biologics’ active pharmaceutical ingredient (API) manufacturing. Mega cap and large cap companies sponsored 52 per cent of FDA approvals of biologic NMEs in 2020, says GlobalData.

Adam Bradbury, PharmSource Analyst at GlobalData, comments, “As pipeline and marketed biologics increase in both complexity and number, most contract manufacturing organisations (CMOs) remain unable to manufacture biologic APIs to meet sponsor companies’ needs. CMOs can benefit from investing in capabilities and expertise to produce and handle sensitive biologics, as the marketed drugs landscape will become increasingly flooded with these in coming years.”

The outsourcing of manufacturing of biologic (protein and peptide) NMEs has been increasing since 2017, while the outsourcing propensity for biologic APIs was higher than dose manufacturing during 2019–2020.

Bradbury continues, “API for biologics—protein and peptide, as well as advanced therapy medicinal products (ATMPs)—have become increasingly complex, and larger companies are leaning on the expertise of CMOs for API production.”

Among the biologics that received COVID-19 Emergency Use Approvals, API outsourcing was at an even higher level than for those biologics receiving full market approval, and COVID-19 vaccines in particular have been heavily outsourced due to scale or technical expertise difficulties.

Bradbury adds, “Unfortunately for CMOs, larger companies tend to invest in developing their own internal manufacturing capabilities to manufacture drugs rather than outsource production. However, they do frequently dual source to mitigate risk and for other strategic reasons.”