“Currently, an average of roughly one-third of biologic API manufacturing projects are outsourced in a tactical manner, meaning the CMO is engaged on a one-off or project-by-project basis,” Kate Hammeke, market research director, Industry Standard Research, told Outsourcing-Pharma.com.
“At present, respondents engage CMOs through tactical outsourcing and by outsourcing to preferred providers at similar rates.”
While this may be the current state, respondents anticipate a change within three years as more biologic manufacturing projects will be outsourced to preferred providers and fewer projects will be outsourced on a tactical basis.
Sponsor's needs
As the outsourcing paradigm shifts, a sponsor’s needs and outsourcing methods will still vary based on the type of project outsourced: small molecule, biologic, or fill finish.
For example, according to the report, among respondents who use CMOs for small molecule services, the majority use CMOs for all of their small molecule manufacturing needs. However, respondents who use CMOs for biologic manufacturing services are looking to augment their internally manufactured supply.
Respondents who outsource fill finish services fell evenly into both these groups: those who use CMOs for all secondary manufacturing and those who use CMOs to support internal drug product manufacturing.
Opportunity
Today, according survey respondents, distribution for biologic API is outsourced with the greatest frequency.
“General awareness levels for contract manufacturers with biologic manufacturing capabilities is fairly strong, however there is a lot of opportunity to improve the familiarity levels with individual contract manufacturers’ large molecule service offerings,” added Hammeke.
“When respondents were asked to name leaders in the biologic/large molecule API manufacturing industry, they gave names of both traditional CMOs and pharma companies that have CMO offerings.”