Outsourced clinical manufacturing may be one of the most competitive areas of contract manufacturing. There are several different types of providers with varying capabilities vying for the work. In addition to global CDMO giants with one-stop-shop capabilities, midsize, full-service CDMOs, and using a combination of small, specialized drug substance and drug product CDMOs, there are also integrated clinical trial supply service providers (some of which are big CROs) and clinical trial sourcing service providers all positioned to help drug innovators meet their clinical material needs.
A recent ISR study on outsourced clinical manufacturing revealed that respondents use a combination of different types of service providers to meet their clinical manufacturing needs, in part because the nature of the therapy in development determines which types of providers are potential options. This is further supported by the contingent of respondents with preferred provider lists who confirmed there are providers from multiple categories among the roughly five preferred providers (on average) on their lists.