Pace of drug approvals to moderate for global pharma companies, says Fitch Ratings

Global pharmaceutical novel drug approvals will moderate in 2013 due to the exceptional research success in 2012, according to a Fitch Ratings report.

The US Food and Drug Administration approved 12 new molecular entities (NMEs) in the first quarter of 2013. Fitch expects cancer drugs to lead specialty drug authorizations again in 2013, but new diabetes treatments could be a close second. Fitch notes that the FDA has instituted a new program - breakthrough therapy designation - to expedite the drug approval process.

The current period of patent expiration is nearing an end as Fitch-rated pharmaceutical developers may see around $25 billion in sales negatively affected by patent expiration in 2013, compared with $50 billion in 2012. Fitch believes that continuing effects of the diminishing patent cliff will weigh on operating profiles. Fitch expects flat to modestly increasing revenues for the sector in 2013.