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November 17, 2021updated 11 Mar 2022 7:56am

Small-molecule API CMOs more focused on containment capabilities than scale

Research has found large contract manufacturing organisations are focusing on specialist small-molecule API capabilities.

By GlobalData Healthcare

Specialist small-molecule active pharmaceutical ingredient (API) capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities, a GlobalData analysis shows. From 2018 to last year, all small-molecule API contract sites bought in China, Switzerland, Italy and France had containment capabilities, with 58% of small molecule API sites purchased worldwide offering containment.

Controlled substance manufacture and containment capabilities are features strongly associated with larger CMOs, which can afford to develop or acquire these specialist capabilities. High containment facilities manufacture products for which inadvertent or sustained exposure is very dangerous. These high-potency APIs (HPAPIs) are toxic even at small doses, pose a risk to human health, or risk cross-contamination with other drugs in a manufacturing environment. High containment facilities protect operators against exposure and protect against cross-contamination of standard products with highly potent products; because they require separation between the operator and material, premium specialist equipment is required. Dedicated CMOs are investing heavily in these specialist capabilities, no doubt powered by client demand as CMOs’ usual clients—small-cap companies—tend not to be able to afford this type of facility.

Figure 1 is taken from the upcoming GlobalData publication, Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition. All of the top small molecule API CMOs increased the number of containment facilities they owned between 2019 and this year, whereas at the same time, many of these companies decreased their non-containment small molecule API manufacturing facilities, which suggests a move towards high-value specialised manufacture and away from large-volume low-value simple API production.

All the evidence indicates that containment facilities are in high demand and will be increasingly so in future as the oncology pipeline and the use of cytotoxic drugs continues to grow. Oncology accounts for the majority of marketed contained drugs. CMOs with containment capabilities are likely to be at an advantage compared to those without, as the number of marketed HPAPIs tends to increase over time as more of the HPAPIs in development gain approval.

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