IMS, the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries released the annual "U.S. Pharmaceutical Market Performance Review" which found that pharmaceutical market growth slowed from 8% in 2006 to 3.8% in 2007. According to the release, this was the slowest growth seen since 1961.
The company attributes the slowdown to:
- loss of exclusivity of branded medicines;
- fewer new product approvals
- the leveling of year-over year growth from the Medicare Part D program
- the impact of safety issues.
The categories leading in sales were anti-depressants, lipid control agents, pain medications and blood pressure medications such as ace inhibitors and beta blockers.
Also of note, with respect to the second reason listed for the slowdown – fewer product approvals – one can truly see one of the many impacts of the fact that the agency has issued more approvable letters in 2007, to a degree shutting down the pipeline, impacting the market, patients and stockholders. This of course, leads to the question whether or not this is a product of (i) a risk averse environment, or (ii) products have suddenly gotten bad, or (iii) the FDA has purposely slowed things down so that it can catch up.
And, perhaps most importantly, why is the pipeline so slow and enforcement expressed through warning letters so lax when the FDA is getting more budget and increased PDUFA fees?