Adverse Events?
CMOs with a lot of oncology drugs in their portfolios, especially injectables manufacturers, could be in for a big downside surprise.
A new study released by the Tufts Center for the Study of Drug Development puts the success rate of clinical-stage oncology candidates at 8 percent, compared with an overall success rate of 20 percent. The study used data for candidates that began human testing between 1993 and 1997 and that have known fates (thereby excluding all drugs that got stuck in a phase and were never terminated). The study also noted that it took oncology candidates an average of 7 years to complete clinical development vs. an average of 6 years for all candidates.
If success rates for oncology compounds continue to be this low going forward, it could have a serious impact on contract manufacturers, many of whom are counting on some of these compounds for future projects. Tufts CSDD points out that the number of oncology candidates entering clinical development more than doubled from the early '90's to the mid-2000's, meaning that now, more than ever, CMOs are heavily reliant on the success or failure of oncology candidates.
The large number of recent contract signings has raised hopes and expectations for CMOs. But this could be an unsupported euphoria. CMOs anxious to sell capacity often don't do rigorous due diligence on new client candidates and are susceptible to downside surprises. Those CMOs that are counting on oncology candidates to be successful could face the daunting task of trying to fill capacity on short notice in a few years time.
A new study released by the Tufts Center for the Study of Drug Development puts the success rate of clinical-stage oncology candidates at 8 percent, compared with an overall success rate of 20 percent. The study used data for candidates that began human testing between 1993 and 1997 and that have known fates (thereby excluding all drugs that got stuck in a phase and were never terminated). The study also noted that it took oncology candidates an average of 7 years to complete clinical development vs. an average of 6 years for all candidates.
If success rates for oncology compounds continue to be this low going forward, it could have a serious impact on contract manufacturers, many of whom are counting on some of these compounds for future projects. Tufts CSDD points out that the number of oncology candidates entering clinical development more than doubled from the early '90's to the mid-2000's, meaning that now, more than ever, CMOs are heavily reliant on the success or failure of oncology candidates.
The large number of recent contract signings has raised hopes and expectations for CMOs. But this could be an unsupported euphoria. CMOs anxious to sell capacity often don't do rigorous due diligence on new client candidates and are susceptible to downside surprises. Those CMOs that are counting on oncology candidates to be successful could face the daunting task of trying to fill capacity on short notice in a few years time.
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