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The term dyslipidemia refers to abnormalities in the composition, concentration, or size of lipoproteins in the circulation. Dyslipidemia is a key modifiable risk factor for cardiovascular (CV) disease, but has historically been underdiagnosed in patients because of its asymptomatic nature and the lack of screening programs across markets. Treatment of dyslipidemia and therapeutic research have chiefly centered on reducing the levels of atherogenic lipids; agents that target low-density lipoprotein (LDL) cholesterol have enjoyed particular commercial success owing to their demonstrated ability to reduce CV risk. However, the focus of R&D is shifting away from simply improving the concentration of circulating lipids and more toward improving the composition and functionality of lipoproteins and their components. Importantly, physicians and regulatory authorities are no longer satisfied with just improvement in lipid profile and are seeking evidence of CV outcomes benefits. During the 2015-2025 forecast period, the dyslipidemia market is expected to have two distinct phases. Over the first half of the study period, the continuing genericization of the dominant statin class and reduced use of many older nonstatin therapies will eventually see a contraction of the market. However, the second half will see marked growth in the market owing to the emergence of keenly awaited novel therapies. including the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.
Several leading antidyslipidemic products, including AstraZeneca/Shionogi’s Crestor and Merck’s Zetia/Ezetrol, will face generic competition early on in the 2015-2025 forecast period. How will the generic availability of these products affect medical practice in the major markets? What will be the impact on drug sales?
Many nonstatin therapies have been associated with poor trial results in recent years. What do thought leaders say about these therapies in light of these results? How will the treatment paradigm change?
The results of various CV outcomes trials (CVOTs) for several current and emerging therapies are expected across the forecast period. Now that there is much more emphasis on such data, how will these results impact medical practice? How will the market share and sales of antidyslipidemic drugs with and without CVOT data be affected?
The highly efficacious proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors entered the market early in the forecast period. For what patient populations are these novel agents likely to be approved? How will this keenly awaited class affect physician prescribing? What will be the impact on the potential for other novel treatments for hypercholesterolemia?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 23 country-specific interviews with thought leaders.
Epidemiology: Primary and secondary prevention patients; high low-density lipoprotein cholesterol (LDL-C), low high-density lipoprotein cholesterol (HDL-C), high triglycerides (TGs), mixed dyslipidemia.
Population segments in market forecast: Primary and secondary prevention patients.
Emerging therapies: Phase II: 16 drugs; Phase III: 3 drugs; preregistration: 1 drug; registered: 1 drug. Coverage of 13 select preclinical and Phase I products.
Key companies: Amarin Corporation, Amgen, AstraZeneca, Esperion Therapeutics, Ionis Pharamaceuticals, Kowa Pharmaceuticals, Merck & Co., Regeneron Pharmaceuticals, Sanofi
Key drugs: anacetrapib, Crestor, Epanova, bempedoic acid (ETC-1002), Livalo, pemafibrate (K-877), Praluent, Repatha, Vascepa, Volanesorsen, Vytorin, Zetia