The dyslipidemia market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) is forecast to increase at a compound annual growth rate (CAGR) of 10.8% from $5.56 billion in 2022 to $15.53 billion in 2032, driven by the launch of therapies with promising efficacies and new mechanism of actions, as well as the growth of the dyslipidemia population, according to GlobalData, a leading data and analytics company.

GlobalData’s latest report, “Dyslipidemia: Seven-Market Drug Forecast and Market Analysis,” reveals that eight late-stage pipeline therapies are expected to enter the market during the forecast period. According to GlobalData, the most significant driver of growth will be the launch of the new mechanism of action NewAmsterdam Pharma’s, cholesteryl ester transfer protein (CETP) inhibitor obicetrapib across the 7MM, coupled with the anticipated launch of Merck’s first oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor and Akcea Therapeutics apoC-III antisense RNAi oligonucleotide, olezarsen.

Dr Shireen Mohammad, Cardiovascular & Metabolic Disorders Analyst at GlobalData, comments: “The particular areas of unmet need are the mixed dyslipidemia space and the statin-intolerant patient pool. These patients do not necessarily correspond to the high-risk atherosclerotic cardiovascular disease (ASCVD) population, but they consist of large patient groups who most likely will not receive biologic-based therapies.

“These patients are currently treated with statins, ezetimibe, and/or fibrates. However, the latter drug class is falling out of favor with physicians, and ezetimibe is not the most efficacious lipid-lowering therapy, particularly when used as a monotherapy in statin-intolerant patients. Hence, the need for better dyslipidemia treatments.”

At present, there are no specific therapies that target Lp(a) directly on the market. There are several pipeline drugs that are Lp(a)-targeted therapies, such as Akcea Therapeutics’s pelacarsen sodium and Eli Lilly’s muvalaplin. There is also an unmet need for better therapies to specially target high triglyceride levels. Pipeline drugs include the CETP inhibitor obicetrapib being developed by NewAmsterdam Pharma. CETP inhibitors increase high-density lipoprotein (HDL) cholesterol and decrease triglyceride (TG) levels by inhibiting the transfer of cholesteryl esters from HDL to apolipoprotein B-containing lipoproteins.

Other pipeline drugs include antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), which are RNA-based therapies that target specific genes involved in lipid metabolism, such as Angiopoietin-like protein 3 (ANGPTL3) and apolipoprotein C3 (APOC3). ANGPTL3 is a protein that regulates lipid metabolism, and inhibiting this protein has shown to reduce TG levels. Arrowhead Pharmaceuticals is developing ANGPTL3 inhibitors that have shown promising results in clinical trials.

Mohammad concludes: “Overall, the dyslipidemia space is set to undergo a massive shake-up during the forecast period, not just in terms of market leaders, but also in how the disease is treated. Although the rise of novel, efficacious biologics has potential to improve prognosis and quality of life for dyslipidemia patients, these drugs will put a huge financial strain on healthcare systems across the 7MM. Drug developers will need to carefully consider how they price their medications and which patients they will initially target to successfully penetrate the market.”