Congestive Heart Failure (CHF) - Market Insights, Epidemiology, And Forecast - 2036 7MM Market To Reach $19 Billion As Novel Therapies Drive 8% CAGR
Dublin, Oct. 01, 2026 (GLOBE NEWSWIRE) -- "Congestive Heart Failure - Market Insights, Epidemiology, and Market Forecast - 2036" has been added to ResearchAndMarkets.com's offering.
The global congestive heart failure (CHF) market is entering a period of sustained expansion, driven by an aging population, rising cardiovascular risk factors, broader use of guideline-directed therapies, and continued investment in novel drugs, devices, and cell-based treatments. According to the Congestive Heart Failure (CHF) - Market Insights, Epidemiology and Market Forecast - 2036 report, the CHF market across the seven major markets (7MM) was valued at approximately USD 9,000 million in 2025 and is projected to reach approximately USD 19,000 million by 2036, reflecting an estimated CAGR of 8% during 2026-2036.
The report examines CHF epidemiology, treatment practices, market access, drug uptake, pricing, competitive dynamics, and commercial opportunities across the United States, EU4 countries comprising Germany, France, Italy, and Spain, the United Kingdom, and Japan. The United States represented the largest CHF market in 2025, with an estimated value of USD 6.50 billion, and is expected to retain its leading position through 2036 due to its substantial patient population, higher treatment costs, and adoption of emerging therapies.
CHF Epidemiology and Patient Burden
Heart failure remains a leading cause of hospitalization among individuals aged 65 years and older, creating substantial clinical and economic pressure on healthcare systems. Increasing rates of hypertension, diabetes, obesity, chronic kidney disease, and other cardiovascular conditions are contributing to the expanding patient burden. Improved survival following acute cardiovascular events is also increasing the number of patients requiring long-term heart failure management.
- Japan recorded approximately 5,366,000 diagnosed prevalent heart failure cases in 2025, with the total expected to increase through 2036. In the United States, approximately 4,597,000 patients had HFpEF, 2,128,000 had HFrEF, and 758,000 had HFmrEF in 2025. Nearly 35-40% of patients with acute heart failure do not have reduced left ventricular ejection fraction (LVEF). Patients with preserved LVEF are generally older, with a mean age of approximately 75 years, and nearly 60% are female. Heart failure prevalence is higher among females in Europe, while males account for a greater proportion of patients in the United States. Among the EU4, Germany had the highest diagnosed CHF prevalence in 2025, followed by France and Spain, while Italy recorded the lowest total.
Heart failure is categorized by LVEF as HFrEF (?40%), HFmrEF (41-49%), and HFpEF (?50%). The high proportion of patients with HFmrEF and HFpEF continues to reinforce the need for therapies that address the clinical complexity of preserved and mildly reduced ejection fraction disease.
CHF Treatment Landscape and Recent Approvals
Current CHF management relies on multidrug strategies involving ACE inhibitors, ARBs, beta-blockers, mineralocorticoid receptor antagonists, SGLT inhibitors, If-channel inhibitors, diuretics, nitrates, digoxin, anticoagulants, and other supportive treatments. Device-based interventions, including pacemakers and Implantable Cardioverter Defibrillators (ICDs), remain important for eligible patients.
The treatment landscape has expanded through the introduction and broader use of ENTRESTO (sacubitril/valsartan), VERQUVO (vericiguat), CORLANOR (ivabradine), INPEFA (sotagliflozin), FARXIGA (dapagliflozin), JARDIANCE (empagliflozin), and INJECTAFER/FERINJECT (ferric carboxymaltose). Leading cardiology societies recommend SGLT inhibitors as foundational therapy across multiple ejection fraction categories, supporting further market adoption.
In July 2025, the FDA approved KERENDIA (finerenone) for adults with heart failure and LVEF?40%, representing an important therapeutic advancement for patients with HFmrEF and HFpEF. INPEFA is approved to reduce the risk of cardiovascular death, heart failure hospitalization, and urgent heart failure visits in eligible adults across the LVEF spectrum. INJECTAFER received FDA approval in June 2023 for iron deficiency in adults with NYHA class II/III heart failure to improve exercise capacity.
CHF Pipeline and Emerging Therapies
The congestive heart failure pipeline includes targeted small molecules, combination regimens, biologics, and regenerative cell therapies. These programs address cardiac contractility, neurohormonal activation, inflammation, fluid overload, remodeling, and myocardial repair.
Leading investigational candidates include:
- Omecamtiv mecarbil from Cytokinetics CardiAMP Cell Therapy and CardiALLO Cell Therapy from BioCardia STM-01 from Secretome Therapeutics JK-07 from Salubris Biotherapeutics CRD-740 and CRD-750 from Cardurion Pharmaceuticals AZD5462 from AstraZeneca and Mitsubishi Tanabe Pharma Vicadrostat plus empagliflozin from Boehringer Ingelheim Semaglutide and ziltivekimab from Novo Nordisk REVASCOR (rexlemestrocel-L) from Mesoblast Balcinrenone plus dapagliflozin and mitiperstat from AstraZeneca Tirzepatide from Eli Lilly and Company
Cell therapy represents an increasingly important area of CHF research, with mid- to late-stage programs evaluating autologous bone marrow-derived cells, allogeneic mesenchymal stem cells, and neonatal cardiac progenitor cells. CardiAMP Cell Therapy is being studied in the Phase IIIB CardiAMP HF II trial for ischemic HFrEF and has received FDA Breakthrough Therapy Designation. BioCardia reported additional trial site enrollment during October and November 2025, while the CardiALLO-HF study continued following a favorable Data Safety Monitoring Board review in April 2025.
CHF Market Growth Drivers and Unmet Needs
Market growth is expected to be supported by rising diagnosis rates, greater physician awareness, evolving clinical guidelines, improved monitoring technologies, and increasing use of combination therapy. Commercial opportunities are also expanding as manufacturers pursue indications across the complete LVEF spectrum and develop treatments for patients with multiple cardiovascular, renal, and metabolic comorbidities.
Significant unmet needs remain, including:
- Earlier and more accurate diagnosis More effective treatment options tailored to heart failure phenotype and comorbidity profiles Prevention strategies for high-risk populations Improved access, affordability, and long-term adherence Additional therapies for HFpEF and HFmrEF Interventions capable of structural and functional cardiac repair
Pricing and reimbursement will remain central to CHF market access. In 2023, the wholesale acquisition cost of INPEFA was USD 598 per month, or USD 7,176 annually, compared with a monthly list price of USD 570.48 and an annual cost of USD 6,846 for JARDIANCE. Payers are increasingly assessing cost-effectiveness, clinical differentiation, hospitalization reduction, and long-term cardiovascular benefits when making reimbursement decisions.
Competitive Landscape and Report Coverage
Major companies active in the CHF market include Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, AstraZeneca, Novo Nordisk, Cytokinetics, BioCardia, Mesoblast, Lexicon Pharmaceuticals, Cardurion Pharmaceuticals, and scPharmaceuticals. Competition is expected to intensify as pipeline assets advance and approved therapies secure broader labels.
The report provides an 11-year CHF market forecast supported by epidemiology-based bottom-up modeling and Artificial Intelligence (AI)-enabled analysis. It assesses patient populations, historical and projected market size, therapy-level market share, drug adoption, peak patient share, pricing trends, reimbursement, treatment practices, clinical development, and market attractiveness. SWOT and conjoint analyses evaluate emerging therapies using efficacy, safety, administration frequency, route of administration, entry timing, probability of success, and addressable patient population.
These insights are designed to support pharmaceutical companies, investors, healthcare providers, and other stakeholders in identifying CHF market opportunities, prioritizing pipeline assets, evaluating competitive risks, and developing evidence-based market access and commercialization strategies through 2036.
Key Topics Covered:
1. Key Insights
2. Report Introduction
3. Executive Summary of Heart Failure
4. Key Events
4.1. Upcoming Key Catalysts
4.2. Key Collaborations and Transactions
4.3. News Flow (Key Designations, Discontinuation, etc.)
4.4. Key Conference Insights
5. Heart Failure Market Overview at a Glance
5.1. Clinical Landscape Analysis (By Phase, RoA, and Molecule Type)
5.2. Market Share (%) Distribution of Heart Failure by Therapies in 2025
5.3. Market Share (%) Distribution of Heart Failure by Therapies in 2036
6. Epidemiology and Market Forecast Methodology
7. Disease Background and Overview
7.1. Introduction
7.2. Causes of Heart Failure
7.3. Signs and Symptoms
7.4. Stages of Heart Failure
7.5. Classification of Heart Failure
7.6. Biomarkers for the Heart Failure
7.7. Diagnosis, Diagnostic Algorithm, and Differential Diagnosis
7.8. Diagnostic Guidelines
8. Treatment of CHF
8.1. Treatment Algorithm
8.2. Guidelines
8.2.1. European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Heart Failure
8.2.2. American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA)
8.2.3. Japanese Circulation Society (JCS)/JHFS 2025 Guideline on Diagnosis and Treatment of Heart Failure
9. Epidemiology and Patient Population of CHF
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Total Diagnosed Prevalent Cases of Heart Failure in the 7MM
9.4. The United States
9.4.1. Total Diagnosed Prevalent Cases of Heart Failure in the United States
9.4.2. Gender-specific Diagnosed Prevalent Cases of Heart Failure in the United States
9.4.3. Ejection Fraction-specific Diagnosed Prevalent Cases of Heart Failure in the United States
9.4.4. NYHA Class-specific Diagnosed Prevalent Cases of Heart Failure in the United States
9.4.5. Type-specific Diagnosed Prevalent Cases of Heart Failure in the United States
9.4.6. Age-specific Diagnosed Prevalent Cases of Heart Failure in the United States
9.5. EU4 and the UK
9.5.1. Total Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
9.5.2. Gender-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
9.5.3. Ejection Fraction-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
9.5.4. NYHA Class-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
9.5.5. Type-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
9.5.6. Age-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
9.6. Japan
9.6.1. Total Diagnosed Prevalent Cases of Heart Failure in Japan
9.6.2. Gender-specific Diagnosed Prevalent Cases of Heart Failure in Japan
9.6.3. Ejection Fraction-specific Diagnosed Prevalent Cases of Heart Failure in Japan
9.6.4. NYHA Class-specific Diagnosed Prevalent Cases of Heart Failure in Japan
9.6.5. Type-specific Diagnosed Prevalent Cases of Heart Failure in Japan
9.6.6. Age-specific Diagnosed Prevalent Cases of Heart Failure in Japan
10. Patient Journey of CHF
11. Marketed Therapies of CHF
11.1. Competitive Landscape Summary
11.2. ENTRESTO (sacubitril and valsartan): Novartis and Otsuka Pharmaceutical
11.2.1. Product Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activities
11.2.4. Summary of Pivotal Trial
11.2.5. Safety and Efficacy
11.2.6. Analyst Views
11.3. JARDIANCE (empagliflozin): Boehringer Ingelheim/Eli Lilly
11.3.1. Product Description
11.3.2. Regulatory Milestones
11.3.3. Other Development Activities
11.3.4. Summary of Pivotal Trial
11.3.5. Safety and Efficacy
11.3.6. Analyst Views
11.4. VERQUVO (vericiguat): Bayer and Merck
11.4.1. Product Description
11.4.2. Regulatory Milestones
11.4.3. Other Development Activities
11.4.4. Clinical Development
11.4.4.1. Clinical Trial Information
11.4.5. Summary of Pivotal Trial
11.4.6. Safety and Efficacy
11.4.7. Analyst Views
11.5. FARXIGA/FORXIGA (dapagliflozin): AstraZeneca
11.5.1. Product Description
11.5.2. Regulatory Milestones
11.5.3. Other Development Activities
11.5.4. Summary of Pivotal Trial
11.5.5. Safety and Efficacy
11.5.6. Analyst Views
12. Emerging Therapies of CHF
12.1. Competitive Landscape Summary
12.2. Omecamtiv Mecarbil: Cytokinetics
12.2.1. Product Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.3.1. Clinical Trial Information in Heart Failure
12.2.4. Safety and Efficacy
12.2.5. Analyst Views
12.3. Ziltivekimab (NN6018): Novo Nordisk
12.3.1. Product Description
12.3.2. Other Developmental Activities
12.3.3. Clinical Development
12.3.3.1. Clinical Trial Information in Heart Failure
12.3.4. Safety and Efficacy
12.3.5. Analyst Views
12.4. CardiALLO Cell Therapy: BioCardia
12.4.1. Product Description
12.4.2. Other Developmental Activities
12.4.3. Clinical Development
12.4.3.1. Clinical Trial Information in Heart Failure
12.4.4. Safety and Efficacy
12.4.5. Analyst Views
12.5. CardiAMP Cell Therapy: BioCardia
12.5.1. Product Description
12.5.2. Other Developmental Activities
12.5.3. Clinical Development
12.5.3.1. Clinical Trial Information in Heart Failure
12.5.4. Safety and Efficacy
12.5.5. Analyst Views
13. Heart Failure: Seven Major Market Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. Conjoint Analysis
13.4. Key Market Forecast Assumptions
13.4.1. Cost Assumptions and Rebates
13.4.2. Pricing Trends
13.4.3. Analogue Assessment
13.4.4. Launch Year and Therapy Uptakes
13.5. Total Market Size of Heart Failure in the 7MM
13.6. The United States Market Size
13.6.1. Total Market Size of Heart Failure in the United States
13.6.2. Market Size of Heart Failure by Therapies in United States
13.7. EU4 and the UK Market Size
13.7.1. Total Market Size of Heart Failure in EU4 and the UK
13.7.2. Market Size of Heart Failure by Therapies in EU4 and the UK
13.8. Japan Market Size
13.8.1. Total Market Size of Heart Failure in Japan
13.8.2. Market Size of Heart Failure by Therapies in Japan
14. Unmet needs of Heart Failure
15. SWOT Analysis of Heart Failure
16. KOL Views
17. Market Access and Reimbursement
17.1. The United States
17.1.1. Centre for Medicare and Medicaid services (CMS)
17.2. EU4 and the UK
17.2.1. Germany
17.2.2. France
17.2.3. Italy
17.2.4. Spain
17.2.5. The United Kingdom
17.3. Japan
17.3.1. MHLW
17.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
17.5. Heart Failure Market Access and Reimbursement
18. Appendix
18.1. Bibliography
18.2. Report Methodology
19. Analyst's Capabilities
20. Disclaimer
21. About the Publisher
List of Tables [81]
List of Figures [38]
A selection of companies mentioned in this report includes, but is not limited to:
- Novartis Boehringer Ingelheim Eli Lilly and Company Bayer Cytokinetics BioCardia Novo Nordisk
For more information about this report visit
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