Heart failure (HF) is classified as acute or chronic, and both settings are the focus of this report. Although much progress has been made in the pharmacological management of HF, it mainly relates to chronic HF (CHF), particularly HF with reduced ejection fraction (HFrEF); significant unmet need remains in the treatment of HF with preserved ejection fraction (HFpEF). Additionally, the treatment of acute HF (AHF) is dominated by old, generic products. This report provides insights into the current and future CHF and AHF therapy markets, the performance of current market leader, Entresto, and the expected dynamics of the HFrEF and HFpEF therapy markets following the entries of several new therapies (Boehringer Ingelheim / Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Bayer / Merck Sharp & Dohme’s vericiguat, Cytokinetics’ omecamtiv mecarbil, and Bayer’s finerenone). This report also assesses how the AHF market will evolve given the lack of new drug launches in this patient population.

QUESTIONS ANSWERED

  • How large are the treatable AHF, HFrEF, and HFpEF populations, and how will diagnosis rates change over time?
  • What is the state of treatment for heart failure? What are the most important drugs and why? What clinical needs remain unfulfilled?
  • How will the use of Entresto evolve over the forecast period?
  • How will the treatment of HFpEF change following the launches of the first evidence-based drugs for this population?
  • For which emerging therapies do thought leaders express the most enthusiasm, and what level of market penetration can they expect?

GEOGRAPHIES

United States, EU5, Japan.

PRIMARY RESEARCH

20 country-specific interviews with thought-leading cardiologists; supported by survey data collected for this and other DRG research.

EPIDEMIOLOGY

Diagnosed events of AHF by country and diagnosed prevalence of CHF by country, segmented by ejection fraction.

FORECAST

10-year, annualized, drug-level sales and patient shares of key HF therapies through 2029, segmented by brands / generics and ejection fraction (HFrEF and HFpEF).

EMERGING THERAPIES

Phase III/PR: 7 drugs; Phase II: 10 drugs.

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

  • Heart Failure - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q2 2021
        • April 2021
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • March 2021
        • February 2021
        • January 2021
      • Q3 2020
        • September 2020
      • Q2 2020
        • June 2020
      • Q1 2020
        • February 2020
    • Key Findings
      • Heart Failure Key Findings: September 2020
        • February 2020
    • Market Outlook
      • Key Findings
        • Market Share of Drug Classes for Acute Heart Failure: 2019
        • Market Share of Drug Classes for Acute Heart Failure: 2029
        • Market Share of Drug Classes for Chronic Heart Failure: 2019
        • Market Share of Drug Classes for Chronic Heart Failure: 2029
        • Heart Failure SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Heart Failure?
          • What Factors Are Constraining the Market for Heart Failure?
          • Patient Share of AHF Drug Classes by Market in 2019
          • Patient Share of AHF Drug Classes by Market in 2029
          • Patient Share of HFrEF Drug Classes by Market in 2019
          • Patient Share of HFrEF Drug Classes by Market in 2029
          • Patient Share of HFpEF Drug Classes by Market in 2019
          • Patient Share of HFpEF Drug Classes by Market in 2029
        • Drug-Class-Specific Trends
          • Major-Market Patient Share of RAAS-Blocking Agents in CHF: 2019-2029
          • Patient Share of Branded Sacubitril/Valsartan in CHF by Market: 2019-2029
          • Sales of Branded Sacubitril/Valsartan by Region: 2019-2029
          • Total Major-Market Patient Share of SGLT-2 Inhibitors in HFrEF and HFpEF: 2019-2029
          • Major-Market Sales of Branded SGLT-2 Inhibitors in CHF: 2019-2029
          • Patient Share of Vericiguat in HFrEF by Market: 2019-2029
          • Sales of Vericiguat by Region: 2019-2029
          • Patient Share of Omecamtiv Mecarbil by Market: 2019-2029
          • Sales of Omecamtiv Mecarbil by Region: 2019-2029
      • Forecast
        • Market Forecast Assumptions - AHF (2019-2029) - September 2020
        • Market Forecast Assumptions - CHF (2019-2029) - September 2020
        • Market Forecast Dashboard - AHF (2019-2029) - September 2020
        • Market Forecast Dashboard - CHF (2019-2029) - September 2020
      • Etiology and Pathophysiology
        • Disease Overview
          • Etiology
            • Most Common Causes of Heart Failure
          • Pathophysiology
            • Pathological Ventricular Remodeling in HFpEF and HFrEF
            • Compensatory Mechanisms in the Heart
          • Heart Failure Development
            • Heart Failure Stages
              • ACC/AHA Prognostic Classification System and the NYHA System
            • Key Pathways and Drug Targets
              • Drug Targets in Heart Failure
          • Epidemiology
            • Key Findings
              • Epidemiology Populations
                • Methods
                • Sources Used for Diagnosed Events of Acute Heart Failure
                • Diagnosed Events of Acute Heart Failure in the Mature Markets (Thousands): 2019-2029
                • Disease Definition
                • Methods
                • Sources Used for Diagnosed Prevalent Cases of Chronic Heart Failure
                • Diagnosed Prevalent Cases of Chronic Heart Failure in the Mature Markets (Thousands): 2019-2029
                • Disease Definition
                • Methods
                • Sources Used for Diagnosed Prevalent Cases of Chronic Heart Failure by NYHA Functional Classification Scheme
                • Number of Diagnosed Prevalent Cases of Chronic Heart Failure in the Major Pharmaceutical Markets by NYHA Functional Class (Thousands): 2019-2029
                • Disease Definition
                • Methods
                • Sources Used for Chronic Heart Failure Cases Classified by Ejection Fraction
                • Number of Diagnosed Prevalent Cases of Chronic Heart Failure in the Major Pharmaceutical Markets Classified by Ejection Fraction (Thousands): 2019-2029
                • Sources Used for Drug-Treated Prevalent Cases of CHF and Events of AHF
                • Drug-Treated Prevalent Cases of CHF
                • Drug-Treated Events of AHF
            • Current Treatment
              • Key Findings
                • Treatment Goals
                  • Key Endpoints Used in Clinical Trials for Acute Heart Failure
                  • Key Endpoints Used in Clinical Trials for Chronic Heart Failure
                • Key Current Therapies
                  • Overview
                  • Mechanism of Action of Key Current Drug Classes Used for Acute and Chronic Heart Failure
                  • Current Treatments Used for Acute Heart Failure
                  • Current Treatments Used for Chronic Heart Failure
                  • Advantages and Disadvantages of Loop Diuretics
                  • Expert Insight: Loop Diuretics
                  • Advantages and Disadvantages of Nitrate Vasodilators
                  • Expert Insight: Nitrate Vasodilators
                  • Advantages and Disadvantages of Inotropic Sympathomimetics
                  • Expert Insight: Inotropic Sympathomimetics
                  • Advantages and Disadvantages of Phosphodiesterase 3 Inhibitors
                  • Expert Insight: Phosphodiesterase 3 Inhibitors
                  • Advantages and Disadvantages of Natriuretic Peptide Receptor Agonists
                  • Expert Insight: Natriuretic Peptide Receptor Agonists
                  • Advantages and Disadvantages of Calcium Sensitizers
                  • Expert Insight: Calcium Sensitizers
                  • Advantages and Disadvantages of ACE Inhibitors
                  • Expert Insight: ACE Inhibitors
                  • Advantages and Disadvantages of AIIRA/ARBs
                  • Expert Insight: AIIRA/ARBs
                  • Advantages and Disadvantages of Sacubitril/Valsartan
                  • Expert Insight: Sacubitril/Valsartan
                  • Advantages and Disadvantages of Beta Blockers
                  • Expert Insight: Beta Blockers
                  • Advantages and Disadvantages of Mineralocorticoid Receptor Antagonists
                  • Expert Insight: Mineralocorticoid Receptor Antagonists
                  • Advantages and Disadvantages of Digitalis Glycosides
                  • Expert Insight: Digitalis Glycosides
                  • Advantages and Disadvantages of Ivabradine
                  • Expert Insight: Ivabradine
                  • Advantages and Disadvantages of Vasodilator Combination Therapies
                  • Expert Insight: Vasodilator Combination Therapies
                  • Advantages and Disadvantages of Vasopressin Receptor Antagonists
                  • Expert Insight: Vasopressin Receptor Antagonists
                • Medical Practice
                  • Overview
                  • Country-Specific Heart Failure Treatment Guidelines
                  • Factors Influencing Drug Selection in Heart Failure
                  • Treatment Decision Tree for Acute Heart Failure: United States
                  • Treatment Decision Tree for Chronic Heart Failure: United States
                  • Treatment Decision Tree for Acute Heart Failure: Europe
                  • Treatment Decision Tree for Chronic Heart Failure: Europe
                  • Treatment Decision Tree for Acute Heart Failure: Japan
                  • Treatment Decision Tree for Chronic Heart Failure: Japan
              • Unmet Need Overview
                • Current and Future Attainment of Unmet Needs in Heart Failure
                • Top Unmet Needs in Heart Failure: Current and Future Attainment
              • Emerging Therapies
                • Key Findings
                  • Pipeline Trends in Heart Failure
                • Key Emerging Therapies
                  • Notable Developments Among Key Emerging Therapies for Heart Failure
                  • Key Therapies in Development for Heart Failure
                  • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Heart Failure
                  • Istaroxime Profile
                  • Analysis of Clinical Development Program for Istaroxime
                  • Expectations for Launch and Sales Opportunity of Istaroxime in Heart Failure
                  • Vericiguat Profile
                  • Analysis of Clinical Development Program for Vericiguat
                  • Key Development Milestones for Vericiguat in the Treatment of Heart Failure
                  • Expert Insight: Vericiguat
                  • Expectations for Launch and Sales Opportunity of Vericiguat in Heart Failure
                  • Dapagliflozin Profile
                  • Analysis of Clinical Development Program for Dapagliflozin
                  • Key Development Milestones for Dapagliflozin in the Treatment of Heart Failure
                  • Expert Insight: Dapagliflozin
                  • Expectations for Launch and Sales Opportunity of Dapagliflozin in Heart Failure
                  • Empagliflozin Profile
                  • Analysis of Clinical Development Program for Empagliflozin
                  • Key Development Milestones for Empagliflozin in the Treatment of Heart Failure
                  • Expert Insight: Empagliflozin
                  • Expectations for Launch and Sales Opportunity of Empagliflozin in Heart Failure
                  • Omecamtiv Mecarbil Profile
                  • Analysis of Clinical Development Program for Omecamtiv Mecarbil
                  • Key Development Milestones for Omecamtiv Mecarbil in the Treatment of Heart Failure
                  • Expert Insight: Omecamtiv Mecarbil
                  • Expectations for Launch and Sales Opportunity of Omecamtiv Mecarbil in Heart Failure
                  • Finerenone Profile
                  • Analysis of the Clinical Development Program for Finerenone
                  • Key Development Milestones for Finerenone in the Treatment of Heart Failure
                  • Expert Insight: Finerenone
                  • Expectations for Launch and Sales Opportunity of Finerenone in Heart Failure
                  • Analysis of Clinical Development Program for Stem Cell Therapies
                  • Expert Insight: Stem Cell Therapies
                  • Expectations for Launch and Sales Opportunity of Stem Cell Therapies in Heart Failure
                • Early-Phase Pipeline Analysis
                  • Select Compounds in Early-Phase Development for Heart Failure
                • Key Discontinuations and Failures in Heart Failure
                • Access & Reimbursement Overview
                  • Region-Specific Reimbursement Practices
                    • Key Market Access Considerations in Heart Failure: United States
                    • General Reimbursement Environment: United States
                    • Key Market Access Considerations in Heart Failure: EU5
                    • General Reimbursement Environment: EU5
                    • Key Market Access Considerations in Heart Failure: Japan
                    • General Reimbursement Environment: Japan
                  • Looking for More?
                • Appendix
                  • Key Abbreviations Related to Heart Failure
                  • Brands, Marketers, and Generic Availability of Key Therapies for Acute Heart Failure by Market
                  • Brands, Marketers, and Generic Availability of Key Therapies for Chronic Heart Failure by Market
                  • Heart Failure Bibliography

              Author(s): Dominika Rudnicka-Noulin, Ph.D., M.Sc.; Sunali D. Goonesekera, S.M.

              Dominika Rudnicka-Noulin, Ph.D., M.Sc., is a senior business insights analyst on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at DRG, part of Clarivate. She has authored reports on heart failure, acute coronary syndrome, and NASH. Prior to joining DRG, Dr. Rudnicka-Noulin was an associate editor at Nature Communications, working in a variety of therapy areas. She also worked for three years as a postdoctoral research associate on a joint project between Imperial College London and MedImmune aimed at developing more-potent antibody-based drugs. She earned her Ph.D. at the Institut Pasteur in Paris, France, where her work was funded by the European Commission's Marie Skłodowska-Curie Actions.

              Sunali Goonesekera, S.M., is a senior epidemiologist at DRG, part of Clarivate. Prior to joining DRG, Ms. Goonesekera conducted epidemiological research on racial/ethnic disparities in metabolic diseases at the New England Research Institute and lead-authored two manuscripts. She has contributed to multiple publications in peer-reviewed journals in epidemiology and the biological sciences. She holds a master’s degree in epidemiology from the Harvard School of Public Health and a B.A. in biology (Honors) from Dartmouth College.


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