Novel lipid altering therapies will steer acute coronary syndrome market beyond $12 billion by 2022

Growth attributed to launches of the first proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors), Repatha and Praluent by 2016, the launch of ETC-1002 by 2021, and increases in the global prevalence of ACS.

The company’s latest report states that this growth, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, can be attributed to launches of the first proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors), Repatha (evolocumab) and Praluent (alirocumab) by 2016, the launch of ETC-1002 by 2021, and increases in the global prevalence of ACS.

Michela J. McMullan, GlobalData’s Analyst covering Cardiovascular and Metabolic Disorders, explains: “At present, a large proportion of patients with clinical atherosclerotic cardiovascular disease cannot reach guideline recommended levels of LDL-C with the standard of care therapies, which leads to recurrent ACS events.

“However, the revolutionary PCSK9 inhibitors Repatha and Praluent have both truly demonstrated their efficacy in lowering LDL-C in their pivotal Phase III trials, as 57% and 58% reductions in LDL-C from baseline compared to placebo were observed for evolocumab and alirocumab, respectively.”

Esperion’s ETC-1002, a novel lipid-lowering drug, is another therapy set to drive the ACS market. It has shown impressive efficacy in its Phase IIb study and is initiating a sweep of Phase III trials in 2016. As the drug is an oral, once-daily treatment, GlobalData believes that Esperion may be a viable competitor in the latter half of the forecast period by capturing the majority of patient share from the statin-intolerant patient population.

McMullan continues: “Generally speaking, the ACS market is a highly lucrative area for pharmaceutical companies to invest in drug development. Historically, Merck & Co. was the leading innovator in this space, boasting a multitude of therapies to combat atherosclerosis, such as the first-in-class statin Mevacor (lovastatin), as well as Zocor (simvastatin) and the cholesterol absorption inhibitor Zetia (ezetimibe).

“However, all of these drugs will lose patent exclusivity within the first half of the forecast period, so it is unlikely that Merck will maintain a competitive position during the forecast period. Amgen and Sanofi/Regeneron, developers of the newly launched PCSK9 inhibitors Repatha (evolocumab) and Praluent (alirocumab), respectively, are now seen as the leading innovators in the lipid–lowering arena.”