PCSK9 and CETP Inhibitors Are Set to Transform the Dyslipidemia Market

BURLINGTON, Mass., Dec. 3, 2014 /PRNewswire/ -- Decision Resources Group finds that 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 2013-2023 forecast period. 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. 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.

Other key findings from the Pharmacor Advisory Service report entitled Dyslipidemia:

• Emerging blockbusters: The late-stage PCSK9 inhibitors, Sanofi/Regeneron's alirocumab, Amgen's evolocumab, and Pfizer's bococizumab are all expected to achieve blockbuster status.
• Re-emergence of CETP inhibitors: Despite concerns over the CETP inhibitors following earlier discontinuation of candidates in the class, the solid LDL-C and dramatic HDL improvements offered by Merck's anacetrapib and Eli Lilly's evacetrapib will see these novel agents overcome physician caution.
• Continued dominance of statins: 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.
• Impact of cardiovascular outcomes trial data: The results of cardiovascular outcomes trials 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.

Comments from Decision Resources Group Analyst Tim Blackstock, MB. ChB., M. Phil.:

• "The continued generic erosion of former sales leader atorvastatin (Pfizer/Astellas Pharma's Lipitor/Tahor/Sortis/Cardyl, generics) 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."
• "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."

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