By Kate Hammeke, VP of Market Research, Industry Standard Research (ISR)
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.
Aside from molecule/therapy traits that may narrow the pool of potential providers, respondents stated they are looking for a vendor with a reputation for quality work, mentioned by 53 percent as a top five service provider selection criteria, along with flexibility (41 percent) and prior positive experience with the provider (40 percent). Having a track record of on-time, in-full delivery narrowly edged out the others as the most important selection factor, despite landing in fourth place (36 percent) as a top five attribute. Having a global, full-service one-stop-shop offering with commercial capacity that enables a sponsor to stay with the same provider for commercial manufacturing ranked fifth with 34 percent of respondents including it in their top five — and indicates an advantage for this service provider category.
REASONS PROVIDERS LOSE BIDS
Looking at clinical manufacturing service provider selection from the opposite vantage point, respondents specified that high cost (25 percent) and being unable to meet the sponsors’ required time lines (22 percent) are the main reasons service providers lose bids.
The majority of respondents (57 percent) use a combination of drug substance and drug product CDMOs to meet their clinical manufacturing needs; this is also 42 percent of respondents’ preferred method of acquiring clinical supply. Half of respondents use global, full-service one-stop-shop CDMOs, while one-third prefer them for outsourced clinical manufacturing. Roughly one-third of respondents use integrated clinical trial supply service providers (33 percent) and clinical trial sourcing service providers (30 percent) to support their clinical manufacturing needs.
Respondents were also asked to allocate their annual clinical manufacturing spend across provider types. Considering many respondents’ preference for using a combination of specialized drug substance and drug product CDMOs, it is not unexpected to see this grouping allocated the largest proportion of clinical manufacturing expenditure. It is spread across a large number of contract manufacturers, however, while the 30 percent allocated to global, full-service one-stop-shop CDMOs is distributed among only a handful of companies.
This expenditure allocation may not hold. Despite the aforementioned preference, respondents predict more clinical manufacturing will be assigned to global, full-service one-stop-shops three years from now. Predictions can be tricky though. They often don’t take enough unknowns into consideration. One thing we do know is that there will be a need for more specialized clinical manufacturing services to support orphan drugs, biologics, and cell and gene therapies in development which may not fit well with the one-stop-shop model.
* Outsourcing clinical manufacturing was a requirement for participating in the research. The data reported is not intended to be representative of the overall clinical manufacturing market size or industry; rather, it is representative of the participants in the study who are active outsourcers.
KATE HAMMEKE is VP of market research at Industry Standard Research.