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Rising innovative biologic approvals spell API manufacturing opportunities

By GlobalData Healthcare 27 Apr 2021 (Last Updated April 27th, 2021 14:22)

The US Food and Drug Administration (FDA) approved more biologic new molecular entities (NMEs) last year than in any other year in the previous decade. At the same time, sponsors increased the outsourcing of these biologics’ active pharmaceutical ingredient (API) manufacturing.

The US Food and Drug Administration (FDA) approved more biologic new molecular entities (NMEs) last year than in any other year in the previous decade. At the same time, sponsors increased the outsourcing of these biologics’ active pharmaceutical ingredient (API) manufacturing. But 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.

Figure 1 shows an increase in biologic (protein and peptide) NME approvals since 2016. In the meantime, the outsourcing of manufacturing for these molecules has been increasing since 2017. Outsourcing propensity for biologic APIs was higher than dose manufacturing during 2019–2020.

APIs 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 even higher levels than for those biologics receiving full market approvals. Covid-19 vaccines in particular have been heavily outsourced.


Mega and large-cap companies sponsored 52% of biologic FDA NME approvals last year. Unfortunately for CMOs, larger companies tend to invest in developing their own drug manufacturing capabilities rather than outsourcing production. But they frequently dual source to mitigate risk and for other strategic reasons. Covid-19 vaccines and ATMP manufacturing are heavily outsourced due to scale or technical expertise difficulties. 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.

Figures 1 and 2 are adapted from more detailed figures in a presentation given by Peter Shapiro, editor-in-chief of GlobalData’s PharmSource, on 21 April at the New Statesman BioProcessing 2021 Series: Enhancing the Value Chain webinar. Figure 1 is also available in more detail in the recently published GlobalData New Drug Approvals and Their Contract Manufacture – 2021 Edition report (April 2021).

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