Dyslipidemia is a key modifiable risk factor for atherosclerotic cardiovascular disease (ASCVD). Current lipid-modifying therapies include statins, ezetimibe, fibrates, omega-3 fatty acid compounds, and proprotein convertase subtilisin / kexin type 9 (PCSK9) inhibitors. These agents are used to improve lipid levels with a goal of CV risk reduction. Statins dominate the treatment paradigm owing to their good risk-benefit profile, evidence of CV benefits, and the availability of low-cost generic products. We expect recent positive cardiovascular outcomes trial (CVOT) data from certain nonstatin therapies, such as PCSK9 inhibitors and Vascepa, to influence the market penetration of these branded agents. Furthermore, the launches of novel therapies, including Novartis’s inclisiran and Esperion Therapeutics’ Nexletol / Nilemdo, will provide greater competition and drive market growth.
QUESTIONS ANSWERED
What is the impact of the genericization of statins and ezetimibe on the dyslipidemia therapy market?
How have CVOT data and price reductions influenced the market penetration of Amgen’s Repatha and Sanofi / Regeneron’s Praluent?
How will the launch of Esperion Therapeutics’ orally administered Nexlizet / Nustendi and the long-acting injectable inclisiran affect the use of the currently available PCSK9 inhibitors?
What impact will the label expansion of Amarin’s Vascepa to CV risk reduction have on uptake? How will generics competition for this product affect the U.S. market?
CONTENT HIGHLIGHTS
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 Clarivate 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 2030, segmented by brands/generics and CVD prevention setting.
PRODUCT DESCRIPTION
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
SOLUTION ENHANCEMENT
Disease Landscape & Forecast will feature continuous updates in 2021 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Key Ongoing Clinical Trials of Parmodia in the Treatment of Dyslipidemia
Expert Insight: Parmodia
Advantages and Disadvantages of Fibrates
Advantages and Disadvantages of Bile Acid Sequestrants
Advantages and Disadvantages of Niacin Derivatives
Expert Insight: Niacin Derivatives
Advantages and Disadvantages of Juxtapid
Advantages and Disadvantages of Kynamro
Advantages and Disadvantages of Waylivra
Key Results From Select Clinical Trials Investigating Waylivra for the Treatment of Dyslipidemia
Expert Insight: Waylivra
Advantages and Disadvantages of Evkeeza
Key Results From Select Clinical Trials Investigating Evkeeza for the Treatment of Dyslipidemia
Key Ongoing Clinical Trials of Evkeeza
Expert Insight: Evkeeza
Medical Practice
Overview
Factors Influencing Drug Selection in Dyslipidemia
Treatment Decision Tree for Dyslipidemia: United States
Treatment Decision Tree for Dyslipidemia: France
Treatment Decision Tree for Dyslipidemia: Japan
Unmet Need Overview
Current and Future Attainment of Unmet Needs in Dyslipidemia
Top Unmet Needs in Dyslipidemia: Current and Future Attainment
Expert Insight: Unmet Need in Dyslipidemia
Emerging Therapies
Key Findings
Key Emerging Therapies
Key Therapies in Development for Dyslipidemia
Estimated Launch Dates of Key Emerging Therapies for the Treatment of Dyslipidemia
Key Results From Select Clinical Trials Investigating Inclisiran for the Treatment of Dyslipidemia
Key Ongoing Clinical Trials of Inclisiran in the Treatment of Dyslipidemia
Analysis of the Clinical Development Program for Inclisiran
Expert Insight: Inclisiran
Expectations for Launch and Sales Opportunity of Inclisiran in Dyslipidemia
Analysis of the Clinical Development Program for Vupanorsen
Key Results From Select Clinical Trials Investigating Vupanorsen for the Treatment of Dyslipidemia
Key Ongoing Clinical Trials of Vupanorsen in the Treatment of Dyslipidemia
Expert Insight: Vupanorsen
Expectations for Launch and Sales Opportunity of Vupanorsen in Dyslipidemia
Key Results From Select Clinical Trials Investigating Lerodalcibep (LIB-003) for the Treatment of Dyslipidemia
Key Ongoing Clinical Trials of Lerodalcibep (LIB-003) in the Treatment of Dyslipidemia
Analysis of the Clinical Development Program for Lerodalcibep (LIB-003)
Expert Insight: LIB-003
Expectations for Launch and Sales Opportunity of Lerodalcibep (LIB-003) in Dyslipidemia
Key Results From Select Clinical Trials Investigating Pelacarsen for the Treatment of Dyslipidemia
Key Ongoing Clinical Trials of Pelacarsen in the Treatment of Dyslipidemia
Analysis of the Clinical Development Program for Pelacarsen
Expert Insight: Pelacarsen
Expectations for Launch and Sales Opportunity of Pelacarsen in Dyslipidemia
Key Ongoing Clinical Trials of Ezetimibe / Pitavastatin FDC in the Treatment of Dyslipidemia
Analysis of the Clinical Development Program for Ezetimibe / Pitavastatin FDC
Expectations for Launch and Sales Opportunity of Ezetimibe / Pitavastatin FDC in Dyslipidemia
Key Results From Select Clinical Trials Investigating Obicetrapib for the Treatment of Dyslipidemia
Analysis of the Clinical Development Program for Obicetrapib
Expert Insight: Obicetrapib
Expectations for Launch and Sales Opportunity of Obicetrapib in Dyslipidemia
Early-Phase Pipeline Analysis
Select Compounds in Phase II and Early-Phase Development for Dyslipidemia
Key Discontinuations and Failures in Dyslipidemia
Key Discontinuations and Failures
Access & Reimbursement Overview
Region-Specific Reimbursement Practices
Key Market Access Considerations in Dyslipidemia: United States
General Reimbursement Environment: United States
Key Market Access Considerations in Dyslipidemia: EU5
General Reimbursement Environment: EU5
Key Market Access Considerations in Dyslipidemia: Japan
General Reimbursement Environment: Japan
Appendix
Dyslipidemia Bibliography
Saptaswa Sen, Ph.D.
Saptaswa Sen, Ph.D., is an analyst on the Cardiovascular, Metabolic, Renal, and Hematologic Disorders team at Clarivate. Prior to joining the company, he held postdoctoral research positions at the University of Kansas, where he worked on the development of novel inhibitors of the hepatitis C virus, and the Royal Institute of Technology in Stockholm, where he investigated the properties of cancer cells through modern imaging techniques. As a research fellow at the Tata Institute of Fundamental Research in Mumbai, Dr. Sen studied the biochemical functions of diverse proteins. He holds a Ph.D. degree in biochemistry-biophysics from Leiden University, where he developed innovative optical techniques for biosensing applications of enzymes and proteins.
Sandeep Mahapatra, B.D.S., M.P.H.
Sandeep Mahapatra, B.D.S., M.P.H., is an epidemiologist at DRG, part of Clarivate. Prior to joining DRG, he worked with the state and central governments of India to plan, design, and conduct large-scale research and implementation projects on noncommunicable diseases, tobacco cessation, and childhood nutrition. He holds a master’s degree in public health with a specialization in epidemiology.