Chronic Heart Failure Market Set to Expand as Novel Drug Classes, Label Expansions, and a Robust Pipeline Reshape the Treatment Landscape Through 2034

Key Chronic Heart Failure companies such as Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, Mesoblast, and others.
(Albany, US) September 30, 2026 - DelveInsight's "Chronic Heart Failure Treatment Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Chronic Heart Failure, historical and forecasted epidemiology, and market trends across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Curious to know what's driving the Chronic Heart Failure market through 2034?

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Key Takeaways from the Chronic Heart Failure Market Report

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In October 2025, the FDA approved Lasix ONYU, a novel furosemide injection drug-device combination from SQ Innovation and Ligand Pharmaceuticals for edema in adults with chronic heart failure, enabling subcutaneous at-home administration without healthcare professional supervision.

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In April 2025, Mesoblast announced plans to meet with the FDA to discuss the accelerated approval pathway for Revascor in ischemic chronic HFrEF with inflammation.

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The Chronic Heart Failure Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034 across the 7MM, along with epidemiology trends, treatment algorithms, and unmet medical needs.

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As per DelveInsight's estimate, total diagnosed prevalent cases of Chronic Heart Failure in the 7MM were approximately 20,360,000 in 2023, with the US contributing the major patient share.

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Off-label therapies and generics, such as olmesartan, eplerenone, furosemide, and indapamide, occupy the major share of the current market because they are cheaper and more accessible, creating a barrier for newly developed drugs.

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ENTRESTO currently leads the market among approved therapies, though SGLT2 inhibitors (FARXIGA and JARDIANCE), VERQUVO, and other new medicines pose a threat, alongside the risk of generic entry following Novartis' expected loss of US exclusivity in 2025.

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The pipeline includes vicadrostat + empagliflozin (Boehringer Ingelheim), semaglutide and ziltivekimab (Novo Nordisk), omecamtiv mecarbil (Cytokinetics), REVASCOR (Mesoblast), balcinrenone + dapagliflozin and mitiperstat (AstraZeneca), and tirzepatide (Eli Lilly and Company).

Chronic Heart Failure Market Overview

Chronic Heart Failure is a chronic progressive condition in which the heart cannot generate a cardiac output sufficient to meet the body's demands without increasing diastolic pressure, resulting from any cardiac disease compromising ventricular systolic or diastolic function. Based on left ventricular ejection fraction, it is classified as heart failure with preserved ejection fraction (HFpEF, LVEF of 50% or above), heart failure with reduced ejection fraction (HFrEF, LVEF below 40%), and heart failure with mid-range ejection fraction (HFmrEF, LVEF of 40-49%).

The signs and symptoms are subtle in the initial stage and are generally mistaken for common signs of aging. Common symptoms arise from extra fluid or congestion, which begins in the lungs and spreads to different parts of the body.

Gain a competitive edge in the Chronic Heart Failure Market by exploring our in-depth analysis @ Chronic Heart Failure Market [https://www.delveinsight.com/sample-request/chronic-heart-failure-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=akpr]Chronic Heart Failure Market Key Growth Drivers

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Aging Population and Rising Prevalence: CHF risk increases with age, and growing elderly populations in developed and many emerging markets expand the patient pool. DelveInsight's assessment in 2024 estimated approximately 20 million diagnosed prevalent cases in the 7MM.

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Dominance of FORXIGA: AstraZeneca's FORXIGA is the leading prescribed SGLT2 inhibitor globally by volume and has emerged as an important therapy in chronic heart failure, showing benefits beyond glucose control.

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Emergence of Novel Drug Classes: Major companies are investing in SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more.

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Ongoing Clinical Trials in HFpEF: Many trials are underway, providing possible medical evidence for future HFpEF treatment.

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Increasing Clinical Trial Activity: The pipeline holds mid- and late-stage candidates including cardiAMP and cardiALLO cell therapies (BioCardia), HS-001 (Heartseed and Novo Nordisk), STM-01 (Secretome Therapeutics), OZTx-556 (Orizuru Therapeutics), CK-586 (Cytokinetics), CRD-740 and CRD-750 (Cardurion Pharmaceuticals), and AZD5462 (AstraZeneca and Mitsubishi Tanabe Pharma).

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Label Expansion Efforts: Companies such as AstraZeneca (FORXIGA), Novartis (ENTRESTO), and Eli Lilly and Boehringer Ingelheim (JARDIANCE) are targeting label expansion regardless of a patient's left ventricular ejection fraction status to cater to a wider population.

Chronic Heart Failure Epidemiology

The epidemiology chapter provides historical and forecasted data from 2020 to 2034 across the 7MM, segmented by:

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Total Diagnosed Prevalent Cases of Heart Failure

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Gender-specific Cases of Heart Failure

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Ejection Fraction-specific Cases of Heart Failure

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NYHA Class-specific Cases of Heart Failure

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Type-specific Cases of Heart Failure

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Age-specific Cases of Heart Failure

Key epidemiology findings:

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In 2023, the diagnosed prevalence of heart failure in the US was 55% among males and 45% among females.

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In the UK, NYHA Class II accounted for around 45% of total diagnosed prevalent heart failure cases in 2023.

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Among the EU4, Germany had the highest number of diagnosed prevalent cases, followed by France and Spain, with Italy the lowest in 2023.

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In Japan, diagnosed prevalent cases in 2023 were approximately 4,444,000 (above 60 years), 634,900 (40-59 years), and 211,600 (below 39 years).

Explore further details on the Chronic Heart Failure Market @ Chronic Heart Failure Market [https://www.delveinsight.com/sample-request/chronic-heart-failure-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=akpr]Chronic Heart Failure Diagnosis and Treatment

Assessment involves physical examination, blood tests, urine analysis, fasting glucose, lipid profile, serum electrolytes, and thyroid hormone estimation, along with imaging such as chest X-ray, ECG, and MRI. After an initial visit with a general practitioner, patients are referred to a cardiologist, who recommends BNP or NT-proBNP testing and ECG. If BNP is elevated and the ECG is abnormal, heart failure is likely confirmed, and an echocardiogram is then performed to measure ejection fraction, helping identify causes and stages and guide treatment decisions.

Current treatment depends on angiotensin-converting enzyme inhibitors, angiotensin receptor II blockers, beta-blockers, and diuretics. Other therapies include aldosterone antagonists, amiodarone, antiaggregants, anticoagulants, calcium antagonists, and nitrates. Early treatment focuses on lifestyle changes such as quitting smoking, avoiding alcohol, caffeine, and stress, reducing fluid intake, and lowering dietary salt, alongside optimization of medical therapies. The next step may include more intense medical therapy or a device such as a pacemaker or Implantable Cardioverter Defibrillator (ICD).

Chronic Heart Failure Marketed Drugs

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

INJECTAFER is indicated for iron deficiency in adult patients with heart failure, as well as iron deficiency anemia (IDA) in adult and pediatric patients aged 1 year and older with intolerance or unsatisfactory response to oral iron, and in adults with IDA who have non-dialysis dependent chronic kidney disease. It is marketed as FERINJECT by CSL Vifor outside North America. In June 2023, the US FDA approved INJECTAFER for 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.

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INPEFA (sotagliflozin): Lexicon Pharmaceuticals and Viatris

INPEFA is an oral inhibitor of SGLT2 and SGLT1. In May 2023, the US FDA approved it to reduce the risk of cardiovascular death, heart failure hospitalization, and urgent heart failure visits in adults with heart failure or Type 2 Diabetes Mellitus, Chronic Kidney Disease, and other cardiovascular risk factors. The broad label covers patients across the full range of LVEF, including HFpEF and HFrEF, with or without diabetes.

Chronic Heart Failure Emerging Drugs

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Omecamtiv mecarbil: Cytokinetics

A selective small-molecule cardiac myosin activator designed to directly target the heart's contractile mechanism. By stimulating cardiac myosin, it may improve cardiac muscle performance, and preclinical research shows cardiac myosin activators increase contractility without affecting intracellular myocyte calcium concentrations or myocardial oxygen consumption.

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KERENDIA (finerenone): Bayer

A nonsteroidal, selective mineralocorticoid receptor (MR) antagonist that blocks the harmful effects of MR overactivation, which contributes to CKD progression and cardiovascular damage. It has completed its Phase III trial in heart failure with LVEF of 40% or above, and the company anticipated its first submission by mid-2025.

Chronic Heart Failure Market Outlook

After a scarcity of sustainable new therapies for more than a decade, new classes of agents, including VERQUVO, ENTRESTO, and CORLANOR (ivabradine), have been approved by the US FDA. The newest additions in 2023, INJECTAFER/FERINJECT and INPEFA, address iron deficiency in heart failure and cardiovascular risk reduction, respectively.

The emerging pipeline, spanning SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, and cell therapies, is expected to capture significant market share once launched. However, generics and off-label therapies remain a barrier, with FARXIGA's US patent expiring in 2025 and JARDIANCE's in 2028.

The US contributed the largest market share in 2023 and is expected to continue rising steeply through the forecast period. Among the EU4 and the UK, Germany held the maximum revenue share and the UK the smallest.

Gain a competitive edge in the Chronic Heart Failure Market by exploring our in-depth analysis @ Chronic Heart Failure Market [https://www.delveinsight.com/report-store/chronic-heart-failure-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=akpr]Scope of the Chronic Heart Failure Market Report

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Study Period: 2020-2034

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Forecast Period: 2024-2034

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Geographies Covered: US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan

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Key Companies: Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, Mesoblast, and others

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Key Therapies: INPEFA (sotagliflozin), INJECTAFER/FERINJECT, JARDIANCE (empagliflozin), omecamtiv mecarbil, KERENDIA (finerenone), VERQUVO (vericiguat), REVASCOR (rexlemestrocel-L), TNX-103 (levosimendan), and others

Table of Content

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Key Insights

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Report Introduction

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Executive Summary of CHF

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CHF Market Overview at a Glance

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Key Events

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Epidemiology and Market Forecast Methodology

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Disease Background and Overview

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Treatment

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Epidemiology and Patient Population

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Patient Journey

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Marketed Drugs

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Emerging Drugs

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CHF: 7MM Analysis

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Unmet Needs

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SWOT Analysis

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KOL Views

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Market Access and Reimbursement

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Appendix

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DelveInsight Capabilities

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Disclaimer

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About DelveInsight

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