TECHNOLOGY AND INNOVATION
The number of approved products sponsored
by small, large and mega-cap companies increased between 2020 and 2021. The trend of small-cap approvals increasing is potentially advantageous to contract manufacturing organisations (CMOs), given that smaller companies are unable to invest in their own facilities or enhance their own capabilities and so historically rely more heavily on outsourcing. For small-cap company sponsors, the number of NDAs last year is the second highest recorded, with the highest occurring in 2018. As with non-injectable approvals, mid-cap companies tend to account for the fewest approvals as a group, a consistent theme over the past 10 years.
Why do large and mega-cap sponsors outsource? Certain innovative products like cell and gene therapies have a limited pool of staff and expertise that can engage with their production; large CMOs have been acquiring these capabilities in recent years and, again, large and mega-cap sponsors will require these services, according to an upcoming GlobalData report, Contract Pharmaceutical Dose Manufacturing Industry: Composition, Size, Market Share and Outlook (2022 Edition). Larger sponsor companies can also choose to dual-source their manufacture (using both
“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”
in-house and outsourced production) and can use contractors as an additional site in a multi-site supply strategy that increases supply chain security and offers backup capacity. This is especially the case in an age of supply chain disruption caused by the pandemic and the Russian-Ukraine war. Outsourcing may also be pursued if it is more favourable in terms of time and/or cost. Contract packaging of cell and gene therapies also requires specialist capabilities, and contractors manufacturing dose often also provides the packaging as part of an integrated approach.
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