Statin revenues could drop by as much as $7 billion by 2018 as generics permeate the market, according to an analysis by GBI Research.
In 2011, Pfizer’s patent for the blockbuster atorvastatin (Lipitor) expired, placing the company in the ranks of pharmaceutical giants such as Merck, whose statin market declined after the patent expires. Lipitor revenues dropped by 11 percent in fiscal year 2011 compared with the previous year, according to Pfizer. “We expect that the losses of exclusivity for Lipitor in the U.S. and various international markets … will have a significant adverse impact on our revenues in 2012 and subsequent years,” the company stated in its 2011 financial report.
In “Statins Market to 2018,” GBI Research forecasted that the valuation of the worldwide market for statins will tumble from $19.7 billion in 2012 to $12.2 billion in 2018 while generics’ market share will increase from 11 percent in 2011 to 34 percent in 2018.
The introduction of generic statins is contributing to the lion’s share of the decline, according to GBI, but analysts also pointed to other factors. “GBI Research estimates that the market, valued at $20.5 billion in 2011, is set to experience a significant decline due to the increasing availability of generics, the implementation of cost-containment policies, rising generic usage, weak product pipelines and a shift of focus towards the use of combination therapies and non-statins,” the authors wrote.
The global statin market had already been on a downward slide, dropping from $23.7 billion in 2004 to $20.5 billion in 2011, thanks in part to patent expiries for Merck’s simvastatin (Zocor) and Bristol Myers Squibb’s pravastatin (Pravachol). The compound annual growth rate (CAGR) is expected to further decline 7.2 percent by 2018.
The U.S. statin market is forecast to slip from $10.7 billion in 2011 to $5.8 billion in 2018, for an 8.4 percent decline in CAGR. But those losses may be a gain for the U.S. healthcare system. In an unrelated analysis, researchers projected that the switch from Lipitor to generic atorvastatin could save $4.5 billion by 2014.
It is unlikely that many new products will enter the marketplace, according to the GBI report, given the highly competitive statin market, efforts to contain costs and few options in the drug development pipeline.
The report covered treatment usage patterns for dyslipidemia in the U.S., the U.K., France, Germany, Spain, Italy and Japan.