Dyslipidemia – Landscape & Forecast – Disease Landscape & Forecast
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.
Table of contents
- Dyslipidemia - Landscape & Forecast - Disease Landscape & Forecast
- Key Updates
- Q4 2021
- December 2021
- November 2021
- Q3 2021
- September 2021
- August 2021
- July 2021
- Q2 2021
- June 2021
- May 2021
- April 2021
- Q1 2021
- March 2021
- February 2021
- January 2021
- Q4 2020
- November 2020
- Q4 2021
- Key Findings
- Dyslipidemia - Key Findings - November 2021
- November 2020
- Dyslipidemia - Key Findings - November 2021
- Market Outlook
- Key Findings
- Market Share of Dyslipidemia Drug Classes: 2020
- Market Share of Dyslipidemia Drug Classes: 2030
- Dyslipidemia SWOT Analysis
- COVID-19: Areas of Potential Forecast Impact
- Market Drivers and Constraints
- What Factors Are Driving the Market for Dyslipidemia?
- What Factors Are Constraining the Market for Dyslipidemia?
- Patient Share of Dyslipidemia Drug Classes in the United States: 2020-2030
- Annual Sales of Dyslipidemia Drug Classes in the United States: 2020-2030
- Patient Share of Dyslipidemia Drug Classes in Europe: 2020-2030
- Annual Sales of Dyslipidemia Drug Classes in Europe: 2020-2030
- Patient Share of Dyslipidemia Drug Classes in Japan: 2020-2030
- Annual Sales of Dyslipidemia Drug Classes in Japan: 2020-2030
- Drug-Class-Specific Trends
- Patient Share of Statins in Dyslipidemia in the United States: 2020-2030
- Patient Share of Statins in Dyslipidemia in Europe: 2020-2030
- Patient Share of Statins in Dyslipidemia in Japan: 2020-2030
- Annual Sales of Statins for Dyslipidemia in the Major Markets: 2020-2030
- Patient Share of Cholesterol Absorption Inhibitors in Dyslipidemia in the United States: 2020-2030
- Patient Share of Cholesterol Absorption Inhibitors in Dyslipidemia in Europe: 2020-2030
- Patient Share of Cholesterol Absorption Inhibitors in Dyslipidemia in Japan: 2020-2030
- Annual Sales of Cholesterol Absorption Inhibitors in Dyslipidemia in the Major Markets: 2020-2030
- Patient Share of Bempedoic Acid and Its FDC in Dyslipidemia in the United States: 2020-2030
- Patient Share of Bempedoic Acid and Its FDC in Dyslipidemia in Europe 2020-2030
- Patient Share of Bempedoic Acid and Its FDC in Dyslipidemia in Japan 2020-2030
- Annual Sales of Bempedoic Acid and Its FDC in Dyslipidemia in the Major Markets: 2020-2030
- Patient Share of PCSK9-Targeting Agents in Dyslipidemia in the United States: 2020-2030
- Patient Share of PCSK9-Targeting Agents in Dyslipidemia in Europe: 2020-2030
- Patient Share of PCSK9-Targeting Agents in Dyslipidemia in Japan: 2020-2030
- Annual Sales of PCSK9-Targeting Agents in Dyslipidemia in the Major Markets: 2020-2030
- Patient Share of Omega-3 Fatty Acid Compounds in Dyslipidemia in the United States: 2020-2030
- Patient Share of Omega-3 Fatty Acid Compounds in Dyslipidemia in Europe: 2020-2030
- Patient Share of Omega-3 Fatty Acid Compounds in Dyslipidemia in Japan: 2020-2030
- Annual Sales of Omega-3 Fatty Acid Compounds in Dyslipidemia in the Major Markets: 2020-2030
- Patient Share of Angiopoietin-Like Protein 3 Inhibitors in Dyslipidemia in the Major Markets: 2020-2030
- Annual Sales of Angiopoietin-Like Protein 3 Inhibitors in Dyslipidemia in the Major Markets: 2020-2030
- Patient Share of PPAR Modulators in Dyslipidemia in the United States: 2020-2030
- Patient Share of PPAR Modulators in Dyslipidemia in Europe: 2020-2030
- Patient Share of PPAR Modulators in Dyslipidemia in Japan: 2020-2030
- Annual Sales of PPAR Modulators in Dyslipidemia in the Major Markets: 2020-2030
- Key Findings
- Forecast
- Market Forecast Assumptions
- Market Forecast Dashboard
- Etiology and Pathophysiology
- Disease Overview
- Etiology
- Composition of Lipoproteins and Key Function
- Hepatic Cholesterol Biosynthesis and Sites of Inhibition
- Pathophysiology
- Endogenous and Exogenous Lipid Pathways
- Atherogenesis and HDL Protective Mechanisms
- Natural History
- Formation of Atherosclerotic Plaque
- Major Clinical Manifestations of Atherosclerotic Disease
- Key Pathways and Drug Targets
- Dyslipidemia Drug Targets and Rationale
- Disease Overview
- Epidemiology
- Key Findings
- Epidemiology Populations
- Disease Definition
- Methods
- Sources Used for Total Prevalence of Dyslipidemia
- Sources Used for Primary- and Secondary-Prevention-Eligible Dyslipidemia
- Total Prevalent Cases of Primary-Prevention-Eligible Dyslipidemia (Thousands): 2020-2030
- Total Prevalent Cases of Secondary-Prevention-Eligible Dyslipidemia (Thousands): 2020-2030
- Diagnosed Prevalent Cases of Primary Prevention Dyslipidemia (Thousands): 2020-2030
- Diagnosed Prevalent Cases of Secondary Prevention Dyslipidemia (Thousands): 2020-2030
- Drug-Treated Prevalent Cases of Primary Prevention Dyslipidemia (Thousands): 2020-2030
- Drug-Treated Prevalent Cases of Secondary Prevention Dyslipidemia (Thousands): 2020-2030
- Key Findings
- Current Treatment
- Key Findings
- Treatment Goals
- Key Endpoints Used in Clinical Trials for Dyslipidemia
- Key Current Therapies
- Overview
- Mechanism of Action of Key Current Drug Classes Used for Dyslipidemia
- Current Treatments Used for Dyslipidemia
- Market Events Impacting the Use of Key Current Therapies for Dyslipidemia
- Advantages and Disadvantages of Statins
- Expert Insight: Statins
- Advantages and Disadvantages of Cholesterol Absorption Inhibitors
- Expert Insight: Cholesterol Absorption Inhibitors
- Advantages and Disadvantages of Nexletol / Nexlizet
- Key Results From Select Clinical Trials Investigating Bempedoic Acid for the Treatment of Dyslipidemia
- Key Ongoing Clinical Trials of Bempedoic Acid in the Treatment of Dyslipidemia
- Expert Insight: Bempedoic Acid
- Advantages and Disadvantages of Repatha
- Key Results From Select Clinical Trials Investigating Repatha for the Treatment of Dyslipidemia
- Ongoing Clinical Development of Repatha
- Key Ongoing Clinical Trials of Repatha in the Treatment of Dyslipidemia
- Expert Insight: Repatha
- Advantages and Disadvantages of Praluent
- Key Results From Select Clinical Trials Investigating Praluent for the Treatment of Dyslipidemia
- Ongoing Clinical Development of Praluent
- Expert Insight: Praluent
- Advantages and Disadvantages of Vascepa
- Key Results From Select Clinical Trials Investigating Vascepa for the Treatment of Dyslipidemia
- Expert Insight: Vascepa
- Advantages and Disadvantages of Lovaza / Omacor / Lotriga
- Expert Insight: Prescription Omega-3 Fatty Acid Compounds
- Advantages and Disadvantages of Parmodia
- 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
- Key Findings
- 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
- Key Findings
- 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
- Region-Specific Reimbursement Practices
- Appendix
- Dyslipidemia Bibliography
- Key Updates
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., 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.