Dyslipidemia is a key modifiable risk factor for cardiovascular disease (CVD). Current lipid-modifying therapies, including statins, ezetimibe, bempedoic acid, fibrates, omega-3 fatty acid compounds, and PCSK9 inhibitors, focus on improving lipid levels with the 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 Pfizer's vupanorsen, will further expand the array of dyslipidemia drug treatments, although the highly genericized market will see these novel agents used in later lines of therapy.

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 therapy market?
  • How are the PCSK9 inhibitors Repatha and Praluent positioned in the dyslipidemia market? How will inclisiran impact the market penetration of Repatha and Praluent after it launches?
  • How will the launch of Esperion Therapeutics’ orally administered bempedoic acid and its FDC affect the use of the injectable PCSK9 inhibitors? Which product will experience the most use and why?
  • What impact will the launch of Pfizer's vupanorsen and the label expansion and genericization of Vascepa have on the management of hypertriglyceridemia?

PRODUCT DESCRIPTION

DRG’s 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.

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 2029, segmented by brands/generics and CVD prevention setting.

Table of contents

  • Dyslipidemia - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • November 2020
      • Q3 2020
        • July 2020
      • Q2 2020
        • May 2020
      • Q1 2020
        • March 2020
    • Key Findings
      • Dyslipidemia - Key Findings - January 2021
        • March 2020
    • Market Outlook
      • Key Findings
        • Market Share of Dyslipidemia Drug Classes: 2019
        • Market Share of Dyslipidemia Drug Classes: 2029
        • 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: 2019-2029
          • Annual Sales of Dyslipidemia Drug Classes in the United States: 2019-2029
          • Patient Share of Dyslipidemia Drug Classes in Europe: 2019-2029
          • Annual Sales of Dyslipidemia Drug Classes in Europe: 2019-2029
          • Patient Share of Dyslipidemia Drug Classes in Japan: 2019-2029
          • Annual Sales of Dyslipidemia Drug Classes in Japan: 2019-2029
        • Drug-Class-Specific Trends
          • Patient Share of Statins in Dyslipidemia in the United States: 2019-2029
          • Patient Share of Statins in Dyslipidemia in Europe: 2019-2029
          • Patient Share of Statins in Dyslipidemia in Japan: 2019-2029
          • Annual Sales of Statins for Dyslipidemia in the Major Markets: 2019-2029
          • Patient Share of Cholesterol Absorption Inhibitors in Dyslipidemia in the United States: 2019-2029
          • Patient Share of Cholesterol Absorption Inhibitors in Dyslipidemia in Europe: 2019-2029
          • Patient Share of Cholesterol Absorption Inhibitors in Dyslipidemia in Japan: 2019-2029
          • Annual Sales of Cholesterol Absorption Inhibitors in Dyslipidemia in the Major Markets: 2019-2029
          • Patient Share of Bempedoic Acid and Its FDC in Dyslipidemia in the United States: 2019-2029
          • Patient Share of Bempedoic Acid and Its FDC in Dyslipidemia in Europe 2019-2029
          • Patient Share of Bempedoic Acid and Its FDC in Dyslipidemia in Japan 2019-2029
          • Annual Sales of Bempedoic Acid and Its FDC in Dyslipidemia in the Major Markets: 2019-2029
          • Patient Share of PCSK9-Targeting Agents in Dyslipidemia in the United States: 2019-2029
          • Patient Share of PCSK9-Targeting Agents in Dyslipidemia in Europe: 2019-2029
          • Patient Share of PCSK9-Targeting Agents in Dyslipidemia in Japan: 2019-2029
          • Annual Sales of PCSK9-Targeting Agents in Dyslipidemia in the Major Markets: 2019-2029
          • Patient Share of Omega-3 Fatty Acid Compounds in Dyslipidemia in the United States: 2019-2029
          • Patient Share of Omega-3 Fatty Acid Compounds in Dyslipidemia in Europe: 2019-2029
          • Patient Share of Omega-3 Fatty Acid Compounds in Dyslipidemia in Japan: 2019-2029
          • Annual Sales of Omega-3 Fatty Acid Compounds in Dyslipidemia in the Major Markets: 2019-2029
          • Patient Share of Angiopoietin-Like Protein 3 Inhibitors in Dyslipidemia in the Major Markets: 2019-2029
          • Annual Sales of Angiopoietin-Like Protein 3 Inhibitors in Dyslipidemia in the Major Markets: 2019-2029
          • Patient Share of PPAR Modulators in Dyslipidemia in the United States: 2019-2029
          • Patient Share of PPAR Modulators in Dyslipidemia in Europe: 2019-2029
          • Patient Share of PPAR Modulators in Dyslipidemia in Japan: 2019-2029
          • Annual Sales of PPAR Modulators in Dyslipidemia in the Major Markets: 2019-2029
      • 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
        • 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): 2019-2029
              • Total Prevalent Cases of Secondary Prevention Eligible Dyslipidemia (Thousands): 2019-2029
              • Diagnosed Prevalent Cases of Primary Prevention Dyslipidemia (Thousands): 2019-2029
              • Diagnosed Prevalent Cases of Secondary Prevention Dyslipidemia (Thousands): 2019-2029
              • Drug-Treated Prevalent Cases of Primary Prevention Dyslipidemia (Thousands): 2019-2029
              • Drug-Treated Prevalent Cases of Secondary Prevention Dyslipidemia (Thousands): 2019-2029
          • 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
                • Expert Insight: Bile Acid Sequestrants
                • Advantages and Disadvantages of Niacin Derivatives
                • Expert Insight: Niacin Derivatives
                • Advantages and Disadvantages of Waylivra
                • Key Results from Select Clinical Trials Investigating Waylivra for the Treatment of Dyslipidemia
                • Key Ongoing Clinical Trials of Waylivra
                • Expert Insight: Waylivra
                • Advantages and Disadvantages of Juxtapid
                • Advantages and Disadvantages of Kynamro
              • Medical Practice
                • Overview
                • Country-Specific Dyslipidemia Treatment Guidelines
                • Factors Influencing Drug Selection in Dyslipidemia
                • Treatment Decision Tree for Dyslipidemia: United States
                • Treatment Decision Tree for Dyslipidemia: France
                • Treatment Decision Tree for Dyslipidemia: Germany
                • Treatment Decision Tree for Dyslipidemia: Italy
                • Treatment Decision Tree for Dyslipidemia: Spain
                • Treatment Decision Tree for Dyslipidemia: United Kingdom
                • 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
                • Pipeline Trends for Dyslipidemia
              • 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
                • Clinical Development Milestones for Inclisiran in the Treatment of Dyslipidemia
                • Expert Insight: Inclisiran
                • Expectations for Launch and Sales Opportunity of Inclisiran in Dyslipidemia
                • Key Results from Select Clinical Trials Investigating Lypdiso (MAT9001) for the Treatment of Dyslipidemia
                • Key Ongoing Clinical Trials of Lypdiso (MAT9001) in the Treatment of Dyslipidemia
                • Analysis of the Clinical Development Program for Lypdiso (MAT9001)
                • Clinical Development Milestones for Lypdiso (MAT9001) in the Treatment of Dyslipidemia
                • Expectations for Launch and Sales Opportunity of Lypdiso (MAT9001) in Dyslipidemia
                • Key Results from Select Clinical Trials Investigating Vupanorsen for the Treatment of Dyslipidemia
                • Key Ongoing Clinical Trials of Vupanorsen in the Treatment of Dyslipidemia
                • Analysis of the Clinical Development Program for Vupanorsen
                • Clinical Development Milestones for Vupanorsen in the Treatment of Dyslipidemia
                • Expectations for Launch and Sales Opportunity of Vupanorsen in Dyslipidemia
                • Key Results from Select Clinical Trials Investigating Evinacumab for the Treatment of Dyslipidemia
                • Key Ongoing Clinical Trials of Evinacumab in the Treatment of Dyslipidemia
                • Analysis of the Clinical Development Program for Evinacumab
                • Expert Insight: Evinacumab
                • Expectations for Launch and Sales Opportunity of Evinacumab in Dyslipidemia
                • Key Results from Select Clinical Trials Investigating LIB003 for the Treatment of Dyslipidemia
                • Key Ongoing Clinical Trials of LIB003 in the Treatment of Dyslipidemia
                • Analysis of the Clinical Development Program for LIB003
                • Expectations for Launch and Sales Opportunity of LIB003 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
                • 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
                • Clinical Development Milestones for Ezetimibe / Pitavastatin FDC in the Treatment of Dyslipidemia
                • Expectations for Launch and Sales Opportunity of Ezetimibe / Pitavastatin FDC in Dyslipidemia
                • Apabetalone Profile
                • Key Ongoing Clinical Trials of Apabetalone in the Treatment of Dyslipidemia
                • Analysis of the Clinical Development Program for Apabetalone
                • Expert Insight: Apabetalone
                • Expectations for Launch and Sales Opportunity of Apabetalone in Dyslipidemia
                • Dalcetrapib Profile
                • Key Ongoing Clinical Trials of Dalcetrapib in the Treatment of Dyslipidemia
                • Analysis of the Clinical Development Program for Dalcetrapib
                • Expert Insight: Dalcetrapib
                • Expectations for Launch and Sales Opportunity of Dalcetrapib 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
              • Key Abbreviations Related to Dyslipidemia
              • Brands, Marketers, and Generic Availability of Current Therapies Used for Dyslipidemia by Market
              • Dyslipidemia Bibliography

          Author(s): Rohit Bansal, M.S. (Pharm.); Sandeep Mahapatra, B.D.S., M.P.H.

          Rohit Bansal, M.S. (Pharm.), is an analyst on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at DRG, part of Clarivate. He has authored several reports on metabolic indications, chiefly dyslipidemia and nonalcoholic steatohepatitis (NASH). Prior to joining DRG, he worked in a consultancy assisting various pharmaceutical companies. He earned his master’s degree in pharmacoinformatics from the National Institute of Pharmaceutical Education and Research (NIPER) in India.

          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.


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