Dyslipidemia is a key modifiable risk factor for cardiovascular disease (CVD). Current lipid-modifying therapies, including statins, ezetimibe, fibrates, omega-3 fatty acid compounds, and PCSK9 inhibitors, focus on improving lipid levels with an end goal of reducing the risk of CVD. Statins dominate the market owing to their good risk-benefit profiles and evidence of their ability to reduce CV morbidity and mortality. The positive CV outcomes trial (CVOT) data for some nonstatin therapies such as the PCSK9 inhibitors and Vascepa are expected to open the market to these branded agents. The launches of emerging therapies, including Novartis’s inclisiran and Esperion Therapeutics’ bempedoic acid, during the forecast period will further enhance dyslipidemia treatment; however, the discontinuation of Epanova’s STRENGTH CVOT and the CaPre TRILOGY-1 trial failure add uncertainty to the future of these therapies.

QUESTIONS ANSWERED

  • What is the impact of the genericization of statins and Merck’s Zetia/Ezetrol (ezetimibe) and Vytorin/Inegy (ezetimibe/simvastatin) on the dyslipidemia market?
  • How are the PCSK9 inhibitors positioned in the dyslipidemia market? How have positive CVOT data and price reductions influenced the market penetration of Repatha (evolocumab) and Praluent (alirocumab)?
  • How will the anticipated launch of Esperion Therapeutics’ orally administered bempedoic acid affect the use of the injectable PCSK9 inhibitors? Which products will experience the most use and why?
  • What impact will the discontinuation of AstraZeneca’s Epanova and label expansion of Vascepa have on the management of hypertriglyceridemia?

PRODUCT DESCRIPTION

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 20 country-specific interviews with thought-leading lipidologists. Supported by survey data collected for this and other DRG research.

Epidemiology: Prevalent cases of dyslipidemia by country, CVD prevention setting, and diagnosed/drug-treated populations.

Emerging therapies: Coverage of select emerging therapies from preclinical to preregistration stages.

Market forecast features: Ten-year, annualized, drug-level sales and patient share of key dyslipidemia therapies through 2028, segmented by brands/generics and CVD prevention setting.

Table of contents

  • Dyslipidemia - Landscape & Forecast - Disease Landscape & Forecast

Author(s): Rohit Bansal, MS (Pharm.); Ema Rodrigues, DSc, MPH

Rohit joined Decision Resources Group (DRG)’s Cardiovascular, Metabolic, Renal, and Hematologic Disorders team in April 2019. His current focus includes non-alcoholic steatohepatitis (NASH), glomerulonephritis, and renal anemia. Prior to joining DRG, Rohit worked as analyst helping pharmaceutical clients address their business questions across various therapeutic areas.

Rohit’s postgraduate research centred on molecular dynamics. His work included computer-aided drug design software that involved studying the effect of pharmaceutical excipients on the reabsorption of drug molecules from cancer cells leading to drug resistance.

Ema is an epidemiologist with expertise in forecasting incident and prevalent populations within oncology, as well as some cardiovascular indications such as venous thromboembolism. She has significant experience with statistical methods such as multivariate linear regression, conditional logistic regression, principal components analysis, mixed models, hierarchical modeling, and path analysis to account for the complex relationships among various predictors of health outcomes, particularly correlated variables.

She completed her master’s and doctoral degree (MPH, D.Sc.) in Environmental Health at Boston University School of Public Health, where she worked on projects investigating significant predictors of various health outcomes including central nervous system cancer, cognitive function, and birth outcomes.

             


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