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PCSK9 and CETP Inhibitors Set to Transform Dyslipidemia Market, Analysts Find

Current market constrained by patent expirations of leading treatments

Decision Resources Group, a health care research firm based in Burlington, Mass., finds that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and cholesteryl ester transfer protein (CETP) inhibitors will stimulate significant growth in the dyslipidemia market during the latter half of the 2013–2023 forecast period.

These 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 lowering of low-density lipoprotein cholesterol (LDL-C), according to the report. However, in a market that is increasingly dominated by generic products, these new branded agents are expected to generate high sales, particularly on the back of positive data from cardiovascular outcomes trials and physician confidence in the LDL-C–lowering hypothesis.

“The 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,” said analyst Tim Blackstock, MB, ChB, MPhil.

Other key findings include the following:

  • The late-stage PCSK9 inhibitors –– alirocumab (Sanofi/Regeneron), evolocumab (Amgen), and bococizumab (Pfizer) –– are all expected to achieve blockbuster status.
  • Despite concerns about the CETP inhibitors after earlier discontinuation of candidates in the class, the solid LDL-C and high-density lipoprotein (HDL) improvements offered by anacetrapib (Merck) and evacetrapib (Eli Lilly) will see these novel agents overcome physicians’ caution.
  • 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.
  • The results of cardiovascular outcomes trials will have a greater influence on the market as physicians and regulators look to a new agent’s effect on hard cardiovascular endpoints to guide prescribing and approval decisions.

“The continued generic erosion of former sales leader atorvastatin [Lipitor, Pfizer/Astellas Pharma] 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,” Blackstock concluded.

Source: Decisions Resources Group; December 3, 2014.

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