(Albany, US), October 29, 2026 – DelveInsight’s ‘Congestive Heart Failure Market Insights, Epidemiology and Market Forecast – 2036’ report delivers an in-depth understanding of Congestive Heart Failure, historical and forecasted epidemiology, as well as the Congestive Heart Failure market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Congestive Heart Failure Market Report

• In April 2026, HemoCept Inc. announced result of Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart.

• The Congestive Heart Failure market is witnessing significant growth, driven by the rising prevalence of heart failure, a growing geriatric population, advancements in diagnostic technologies, and the development of innovative therapies.

• The 2025 Congestive Heart Failure market size was approximately USD 9,000 million and is projected to reach approximately USD 19,000 million by 2036, growing at a CAGR of 8% during 2026–2036.

• In 2025, the number of diagnosed prevalent cases of heart failure in Japan was 5,366,000, and it is likely to increase by 2036 at a positive CAGR during the forecast period.

• In the US in 2025, there were approximately 4,597,000 patients with HFpEF, approximately 2,128,000 with HFrEF, and approximately 758,000 with HFmrEF.

• Heart failure is a leading cause of hospitalization among individuals aged ≥65 years and represents a major clinical and economic burden.

• Leading cardiology societies in the US and globally recommend SGLT inhibitors, like INPEFA, as a core treatment for heart failure across all ejection fraction types.

• The FDA approved KERENDIA (finerenone) in July 2025 for adult patients with heart failure and LVEF ≥ 40% (HFmrEF and HFpEF).

• The leading Congestive Heart Failure companies include Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, and others.

• Promising Congestive Heart Failure therapies include INPEFA (sotagliflozin), INJECTAFER (ferric carboxymaltose injection)/FERINJECT, JARDIANCE (empagliflozin), omecamtiv mecarbil, KERENDIA (finerenone), VERQUVO (vericiguat), REVASCOR (rexlemestrocel-L), TNX-103 (levosimendan), and others.

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Congestive Heart Failure Overview

Chronic heart failure is a progressive condition in which the heart cannot pump sufficient blood to meet the body’s needs without increased filling pressures, usually due to impaired ventricular systolic or diastolic function. It is classified by left ventricular ejection fraction (LVEF) into reduced (<40%), preserved (≥50%), and mid-range (40–49%) categories. Early symptoms are often subtle and mistaken for aging, but commonly include breathlessness, fatigue, and fluid retention causing pulmonary congestion and peripheral edema. Diagnosis involves clinical assessment along with laboratory tests (including BNP/NT-proBNP), ECG, and imaging such as chest X-ray and echocardiography, which confirms heart failure, measures ejection fraction, and guides staging and treatment decisions.

Congestive Heart Failure Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalent Cases of Heart Failure

• Gender-specific Diagnosed Prevalent Cases of Heart Failure

• Ejection Fraction-specific Diagnosed Prevalent Cases of Heart Failure

• New York Heart Association (NYHA) Class-specific Diagnosed Prevalent Cases of Heart Failure

• Type-specific Diagnosed Prevalent Cases of Heart Failure

• Age-specific Diagnosed Prevalent Cases of Heart Failure

Download the report to understand which factors are driving Congestive Heart Failure Epidemiology trends @ Heart Failure Drugs Market

Congestive Heart Failure Epidemiology Key Findings

• Females are more prevalent in Europe for heart failure than males, but in the US the trend is opposite.

• Among the EU4, Germany had the highest number of diagnosed prevalent cases of Congestive Heart Failure, followed by France and Spain, while Italy had the lowest number in 2025.

• As per Mauro et al. (2023), nearly 35–40% of acute heart failure patients do not have reduced LVEF. Patients with preserved LVEF are usually older (mean age of 75 years) and more frequently female (nearly 60% of patients).

• With nearly half of patients diagnosed with HFmrEF or HFpEF, effective treatments for these types remain scarce.

Approved Therapies for Congestive Heart Failure

• INJECTAFER (ferric carboxymaltose injection)/FERINJECT: American Regent, Vifor, and Daiichi Sankyo

INJECTAFER is an intravenous iron replacement therapy used to treat iron deficiency anemia, including in patients with congestive heart failure and chronic kidney disease. In June 2023, Daiichi Sankyo and American Regent announced that the US FDA approved INJECTAFER for the treatment of iron deficiency in adult patients with heart failure categorized as NYHA class II/III to improve exercise capacity, supported by data from the randomized controlled study CONFIRM-HF.

• INPEFA (sotagliflozin): Lexicon Pharmaceuticals and Viatris

INPEFA is an oral inhibitor of SGLT2 and SGLT1. In May 2023, the US FDA approved INPEFA to reduce the risk of cardiovascular death, hHF, and uHF visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The broad label covers heart failure patients across the full range of LVEF, including HFpEF and HFrEF, with or without diabetes.

Congestive Heart Failure Pipeline Analysis

• Omecamtiv mecarbil: Cytokinetics

Omecamtiv mecarbil is a selective small-molecule cardiac myosin activator designed to directly target the pumping function of the heart. By stimulating cardiac myosin, it may improve cardiac muscle performance. Preclinical research has shown that cardiac myosin activators increase cardiac contractility without affecting intracellular myocyte calcium concentrations or myocardial oxygen consumption. It has completed its Phase III for Congestive Heart Failure.

• CardiAMP Cell Therapy: BioCardia

CardiAMP cell therapy is designed to be a comprehensive biotherapeutic heart failure solution, incorporating a proprietary molecular diagnostic to characterize the potency of a patient’s bone marrow cells and a point-of-care processing platform to prepare cells at the patient’s bedside. The Phase IIIB CardiAMP HF II Trial (NCT06258447) is actively enrolling in the US, and the US FDA has granted BTD for the CardiAMP cell therapy system to treat heart failure.

Discover more about therapies set to grab Major Share in the Congestive Heart Failure Drugs Market @ Congestive Heart Failure Drugs Market Drivers and Barriers

Congestive Heart Failure Market Outlook

After over a decade of limited innovation, several new therapies for Congestive Heart Failure have been approved, including vericiguat (VERQUVO), sacubitril/valsartan (ENTRESTO), and ivabradine (CORLANOR). More recent additions include ferric carboxymaltose (INJECTAFER/FERINJECT) for iron deficiency and sotagliflozin (INPEFA) to reduce cardiovascular risk. SGLT2 inhibitors like dapagliflozin (FARXIGA) and empagliflozin (JARDIANCE) further improve outcomes by lowering hospitalization and mortality risk.

Major companies are investing in diverse mechanisms of action, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, and cell therapies, which will boost the Congestive Heart Failure market in the future. The Germany heart failure drugs market, UK heart failure drugs market, Italy heart failure drugs market, and France heart failure drugs market are covered alongside the US and Japan in the report, while the India heart failure drugs market is also tracked by DelveInsight for broader regional context.

Congestive Heart Failure Market Drivers

• Rising prevalence of Congestive Heart Failure due to aging populations and the growing burden of cardiovascular disease

• Growing geriatric population

• Advancements in diagnostic technologies, including improved imaging techniques and biomarkers

• Introduction of novel therapies such as ARNIs, SGLT2 inhibitors, and gene-based therapies

• Rising healthcare expenditure

• Strong pipeline of emerging therapies

• Shift toward personalized medicine

• Improved survival rates, leading to longer treatment duration

• Growing adoption of combination therapies

• Lifestyle-related risk factors such as obesity, diabetes, and hypertension

• Expansion of healthcare access in emerging markets

Congestive Heart Failure Market Barriers

• High Treatment Costs

• Complex Disease Management

• Limited Treatment Efficacy

• Diagnostic Challenges

• Regulatory Approval Hurdles

Congestive Heart Failure Treatment Landscape

Congestive Heart Failure treatment currently depends on ACE inhibitors, angiotensin II receptor blockers, beta-blockers, and diuretics, along with aldosterone antagonists, amiodarone, antiaggregants, anticoagulants, calcium antagonists, and nitrates. Early treatment focuses on lifestyle changes and optimization of medical therapies. The next step might include more intense medical therapies or the installation of a device such as a pacemaker or Implantable Cardioverter Defibrillator (ICD), with technological advancements in implantable devices supporting the congestive heart failure treatment device market.

To know more about Congestive Heart Failure Companies working in the treatment market, visit @ Congestive Heart Failure Treatment Device Market

Scope of the Congestive Heart Failure Market Report

• Coverage: 7MM

• Study Period: 2022–2036

• Forecast Period: 2026–2036

• Congestive Heart Failure Companies: Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, and others.

• Congestive Heart Failure Therapies: INPEFA (sotagliflozin), INJECTAFER (ferric carboxymaltose injection)/FERINJECT, JARDIANCE (empagliflozin), omecamtiv mecarbil, KERENDIA (finerenone), VERQUVO (vericiguat), REVASCOR (rexlemestrocel-L), TNX-103 (levosimendan), and others.

• Congestive Heart Failure Market Dynamics: market drivers and market barriers

• Congestive Heart Failure Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis

• Congestive Heart Failure Unmet Needs, KOL Views, Reimbursement, Cost Assumptions and Pricing Analogues

Table of Content

1. Key Insights

2. Report Introduction

3. Executive Summary of Heart Failure

4. Key Events

5. Heart Failure Market Overview at a Glance

6. Epidemiology and Market Forecast Methodology

7. Disease Background and Overview

8. Treatment of CHF

9. Epidemiology and Patient Population of CHF

10. Patient Journey of CHF

11. Marketed Therapies of CHF

12. Emerging Therapies of CHF

13. Heart Failure: Seven Major Market Analysis

14. Unmet Needs of Heart Failure

15. SWOT Analysis of Heart Failure

16. KOL Views

17. Market Access and Reimbursement

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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