Discussing the evolving third-party manufacturing landscape at the CPhI Worldwide preconnect conference last week, Peter Stevenson – VP and general manager for contract manufacturing at pharma giant Pfizer – said the speed to market is crucial for drug developers.
“Even if you have the best in class product if you’re number three in launching your product then you’ve just lost 50% of the potential value of that product,” he told the audience.
“There’s a lot at stake, there’s a lot of money here,” he continued, adding that the risk-adjusted revenues projected for the top 500 molecules in development by 2022 are approximately $180bn (€164bn). “You don’t want to be number three, you want to be number one or two.”
Drugmakers are therefore increasingly selecting their contract manufacturers on this criterion, but Stevenson said to achieve this CMOs need to offer a wider breadth of services than simply supplying an API or a finished dose.
“Are you fast enough to beat out your competition?” he asked. “To do that you need these capabilities: the regulatory expertise, tech transfer capabilities, developmental services, management of supply chain risk through quality, and a resilience that gives you the ability to take a punch.”
Whereas CMOs used to be all about economies of scale, “increasingly it’s now economies of capability,” he added.
As such, some CMOs have been moving towards an end-to-end, or ‘one-stop-shop,’ services model, whereby the third-party handles a client’s entire needs from API to dosage form, and from early development to commercialisation.
According to Gil Roth, president and founder of CMO advocacy group PBOA, such a concept “sort of had a crash and burn in the early part of this century,” for example through problems with over-capacity, but the idea is now returning.
“We see a few companies trying to drive it. Definitely companies like Patheon and AMRI have tried [through M&A] to really accelerate a one-stop ‘smart-sourcing’ idea, as they put it,” he also told delegates in Barcelona last week.
“Some of the lessons to how it failed previously are going to be corrected for this new incarnation,” he continued, and “similarly I think the clients have a better idea of what their demands are and what they can really get from single-source/one-stop-shop versus broader CMO providers.”