Pharma Trends Rising Opportunities in API Manufacturing as Innovative Biologic Approvals Increase

In 2020, the Food and Drug Administration (FDA) approved more biologic new molecular entities as compared to the previous years. In this background, the leading data and analytics company Global Data also found that the sponsors increased the outsourcing of these biologics’ active pharmaceutical ingredient (API) manufacturing.

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London/UK – The 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’ API manufacturing. Mega cap and large cap companies sponsored 52 % of FDA approvals of biologic NMEs in 2020, says Global Data, a leading data and analytics company.

Adam Bradbury, Pharmsource Analyst at Global Data, comments: “As pipeline and marketed biologics increase in both complexity and number, most contract manufacturing organizations (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 the 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.

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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.”

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