The dyslipidemia market is set to rise from $11.2 billion in 2015 to $29.2 billion by 2025, representing a compound annual growth rate of 10.1%, according to research and consulting firm GlobalData.
The company’s latest report states that such strong growth, which will cover the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will primarily be driven by the launches of three proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors – Amgen’s Repatha, Sanofi and Regeneron’s Praluent, and Eli Lilly’s LY3015014.
Other factors include the launch of several add-on therapies, including Esperion Therapeutics’ ETC-1002 and Merck and Amgen’s cholesteryl ester transfer protein (CETP) inhibitors, and the increase in global prevalence of dyslipidemia.
Elizabeth Hamson, Ph.D., GlobalData’s analyst covering cardiovascular and metabolic disorders, explains, “Despite the availability of efficacious and cost-effective lipid-lowering therapies, such as statins, a large proportion of patients with clinical atherosclerotic cardiovascular disease cannot reach guideline recommended levels of low-density lipoprotein cholesterol (LDL-C).
“However, the revolutionary PCSK9 inhibitors Repatha (evolocumab) and Praluent (alirocumab) were launched in 2015, and both truly demonstrated their efficacy in lowering LDL-C in their pivotal phase III trials. Although uptake has been slow so far, results of cardiovascular outcomes trials from Repatha and Praluent are due throughout 2017. So far, the major barrier for adoption is the price of these therapies; however, once positive trial data are available, uptake is likely to be significantly accelerated for use in high-risk dyslipidemia patients.”
Another exciting drug in the dyslipidemia pipeline is The Medicine Company’s novel PCSK9-targeting small interfering RNA (siRNA), ALN-PCSsc, which offers the potential of a triannual or even biannual dosing regimen. Based on the sheer number of patients eligible for treatment with these biologics and gene-based drugs, coupled with the biologics-level prices they can demand, even modest patient shares will correspond to blockbuster sales.
Hamson concludes, “The growth of the PCSK9 class, among others in the dyslipidemia pipeline, highlights the current expansion of biologics into the market. However, due to their high prices, there is a significant disconnect between patients who are eligible for treatment based on regulatory approval and those who actually receive treatment. In response to this, there is ample opportunity for more cost-effective therapies targeting the more general dyslipidemia market. Particular areas of unmet need are the mixed dyslipidemia space and the statin intolerant patient pool.”