TECHNOLOGY AND INNOVATION
Injectable opportunities for CMOs despite internal capacity of big pharma sponsors
An increasing number of companies are turning to outsourcing to meet market demand for huge numbers of injectables, according to a review by GlobalData Healthcare.
E
ven giant pharma companies with large internal production capabilities are leaning on outsourcing to meet market
demand for huge numbers of injectables, including high-value biologics and COVID-19 vaccines, according to a GlobalData analysis. Large (market cap $10bn – $100bn) and
mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).
The number of US Food and Drug Administration (FDA) injectable drug approvals for large and mega-cap pharma sponsors tends to be greater than that for small-cap (market cap <$2bn) and mid-cap (market cap $2bn – $10bn) companies. This trend was borne out in last year’s approvals, although new drug application (NDA) approvals were relatively high in 2021 for small-cap and mega- cap drug sponsors compared with historic standards. Injectables are more complex than oral solid dose drugs and so require more costly manufacturing capabilities, which only larger companies tend to be able to afford. A lack of small and mid-cap companies among marketing authorisation holders is not normally good news for contractors, but even large and mega-cap sponsors require outsourcing partners in certain conditions.
24 | Clinical Trial Supply Handbook
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