Novel emerging treatments are set to reinvigorate the market for dyslipidemia therapies, which is currently constrained by patent expirations on leading products, according to new research.

The novel proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and cholesteryl ester transfer protein (CETP) inhibitors will stimulate significant growth in the dyslipidemia market over the latter half of the 2013-23 period, says the research, from Decision Resources. 

These novel emerging branded therapies are likely to be used in later lines of therapy in a limited number of patients who have the highest residual cardiovascular risk and a need for additional low-density lipoprotein cholesterol (LDL-C) lowering, it forecasts. However, in an initially contracting market that is increasingly dominated by generic products, these new branded agents will generate high sales, particularly on the back of positive cardiovascular outcomes trial data and physician confidence in the LDL-C lowering hypothesis.

The late-stage PCSK9 inhibitors – Sanofi/Regeneron’s alirocumab, Amgen’s evolocumab and Pfizer’s bococizumab – are all expected to achieve blockbuster status, according to the report. It also goes on to note that, despite concerns over the CETP inhibitors following earlier discontinuation of candidates in the class. The solid LDL-C and dramatic HDL improvements offered by anacetrapib from Merck (known as MSD outside the US and Canada) and Eli Lilly’s evacetrapib will see these novel agents overcome physician caution, it says.

However, statins will continue to be the most commonly-prescribed antidyslipidemia agents, particularly after generics are available for all current therapies in all markets by 2017, it forecasts.

“The continued generic erosion of former sales leader atorvastatin and forthcoming generic competition to key brands will limit growth of the dyslipidemia market during the first half of the forecast period, but this will be offset by the launch and uptake of several novel agents, such as PCSK9 and CETP inhibitors,” says Decision Resources group analyst Tim Blackstock.

The report also finds that the results of cardiovascular outcomes trial data will have a greater influence on the market, as physicians and regulators are looking to a new agent’s impact on hard cardiovascular end points to guide prescribing and approval decisions.

“Results of several major cardiovascular outcomes trials should result in greater consensus regarding the choice of second- and third-line therapies among physicians and are likely to trigger changes in international guidelines for dyslipidemia management in the near term,” Mr Blackstock advises.