Fitch to pharma: don’t expect 2012 to be a bumper year
pharmafile | July 31, 2012 | News story | Sales and Marketing | 2012, FDA approvals, Fitch, IMS Health, NMEs, ratings
The Fitch ratings agency has published pessimistic projections for pharma, saying that it should not expect as many US drug approvals in 2012 as it did last year.
The agency says that the total of 30 new primary care and speciality medicines cleared in the US during 2011 will “be difficult to beat this year”.
Currently the FDA has approved just 14 new molecular entities in the first half of 2012, compared to the 18 this time last year, and this has rate has been slowing since the first quarter.
These trends come as the pharma industry faces several risks over the course of 2012, including an historic peak in the dollar amount of drug patent expirations.
Four of the industry’s once top-ten best-selling medications will have lost market exclusivity by the end of the third quarter, making this potentially the most difficult year in a period used to its fair share of patent expiries.
Fitch says it anticipates little relief from the patent cliff in 2012, as key drug patents continue to lapse and the industry contends with losses from last year.
This is all coupled with pressure from European austerity measures and the ongoing recession in Western markets.
It will get better, says IMS
Industry analysts IMS Health agree that 2012 will be a tough year for the industry, but believe that pharma will weather the crosswinds.
Recent figures from IMS show that approvals of NMEs will rebound during the next five years, and it forecasts that between 32-37 NMEs are expected to be launched per year through 2016.
It says many of these drugs will also be highly innovative, and include new treatments for Alzheimer’s, autoimmune diseases, diabetes, and a number of cancer and orphan diseases.
Treatments for global priority diseases, such as malaria, tuberculosis and neglected diseases, are also expected to improve, although gaps will remain, it adds.
Overall, between 160-185 NMEs are expected to launch between 2011 and 2016, IMS predicts, compared with the 142 approvals between 2007-11.
The message seems to be that 2012 is – as was also expected to be – a tough year, but there is light at the end of the tunnel for pharma.
The true unknown remains the Euro crisis and whether the economic downturn in the West can be turned around in the near future. So long as these pressures remain, austerity packages will continue to hit pharma, and put it on a collision course with Western governments.
Ben Adams
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