Deloitte Recap recently analyzed the 29 mAb approvals that have thus far passed the FDA. These drugs generated an aggregate $24 B in revenues in 2009. In looking at the length of time the mAbs were in development, Deloitte found that their mean time to market was 7.6 years - but this time frame is getting longer. For the period, 1994-2003, the mean time was 6.7 years and that has increased to 8.3 years for the time span 2004-2011. This could possibly be due to the increased complexity of diseases that developers are now trying to attack - most of this time is from additional time in the clinic.
Surprisingly, and unfortunately, Deloitte also discovered that the regulatory programs geared at speeding up a drug's time through the approval process - like fast track, accelerated approval, priority review or orphan status - did not seem to help mAbs arrive any faster. In fact, fast track status was associated with a longer mean time in development.
In looking at the data for mAbs, particularly as compare to small molecules, Deloitte also concluded that mAbs approval rates are higher (23 percent), and given some are blockbusters to boot, we're likely to see heavy investment in mAbs for the foreseeable future. At present, 27 key companies followed by Deloitte have 130 mAbs in their pipelines aimed at 211 indications.
Posted by Bruce Lehr April 5th 2011.