Chronic Heart Failure market size in 7MM was nearly USD 5.6 billion in 2023, analyses DelveInsight

Key Chronic Heart Failure Market Players include Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, Mesoblast, among others.

DelveInsight's latest publication, "Congestive Heart Failure Market Insights, Epidemiology, and Market Forecast - 2034," delivers an extensive evaluation of congestive heart failure (CHF), covering both historical data and future projections for disease epidemiology and market performance across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The report assesses current standards of care, emerging treatment options, therapy-specific market share, and CHF market valuation spanning 2020-2034 across the seven major markets. Additionally, it highlights established treatment pathways, major growth drivers, market restraints, and unmet clinical needs to uncover opportunities and assess the long-term growth potential of the congestive heart failure market.

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Key Highlights from the Chronic Heart Failure Market Report
• The overall Chronic Heart Failure market size across the 7MM was estimated at nearly USD 5.6 billion in 2023 and is expected to expand steadily throughout the forecast period (2020-2034).
• In October 2025, the US FDA approved Lasix® ONYU, an innovative furosemide-based drug-device combination developed by SQ Innovation and Ligand Pharmaceuticals, for the treatment of edema in adults with chronic heart failure. The therapy incorporates a high-strength formulation using Ligand's Captisol® technology along with a reusable infusor, enabling at-home subcutaneous administration without medical supervision.
• In April 2025, Mesoblast (ASX: MSB; Nasdaq: MESO) announced its intention to engage with the FDA regarding the accelerated approval pathway for Revascor® (rexlemestrocel-L) in patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammatory pathology.
• Also in April 2025, AskBio Inc. initiated a Phase II clinical study to assess the safety and effectiveness of a single dose of AB-1002, delivered via antegrade intracoronary infusion, in adult patients (>18 years) with non-ischemic cardiomyopathy and NYHA Class III heart failure symptoms.
• In December 2024, AstraZeneca launched a Phase IIb, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial evaluating AZD5462 in stable chronic heart failure patients. The study aims to measure the drug's impact on cardiac function, safety, and pharmacokinetics across two distinct patient cohorts in addition to standard-of-care therapy.
• During December 2024, Regeneron Pharmaceuticals commenced a Phase II, randomized, double-blind, placebo-controlled study investigating REGN5381, an NPR1 monoclonal antibody agonist, in patients with heart failure with reduced ejection fraction (HFrEF), focusing on safety, pharmacokinetics, and pharmacodynamic outcomes.
• The prevalence and distribution of CHF cases have risen consistently across the 7MM, with the United States accounting for the largest share of the patient population.
• According to DelveInsight estimates, the total diagnosed prevalent CHF population in the 7MM reached approximately 20.36 million in 2023.
• In the US, males represented 55% of diagnosed heart failure cases in 2023, while females accounted for 45%.
• In the UK, NYHA Class II heart failure constituted nearly 45% of all diagnosed prevalent cases in 2023.
• Among the EU4 countries, Germany reported the highest number of diagnosed CHF cases in 2023, followed by France and Spain, whereas Italy recorded the lowest prevalence.
• In Japan, age-specific diagnosed prevalent cases in 2023 were estimated at ~4.44 million among individuals aged over 60, 634,900 in the 40-59 age group, and 211,600 in those below 39 years.
• Leading companies active in the chronic heart failure space include Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, Mesoblast, and others.
• Promising therapies under development include Ertugliflozin, Metolazone, AZD5462, Vericiguat (Verquvo/BAY1021189), mRNA-0184, rhNRG-1, among others.

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Chronic Heart Failure Epidemiology
The burden of chronic heart failure has increased steadily across the seven major markets, with the US emerging as the largest contributor to total patient numbers. DelveInsight estimates that approximately 20.36 million diagnosed CHF cases were reported across the 7MM in 2023. In the US, males comprised 55% of the diagnosed population, while females represented 45%. In the UK, NYHA Class II patients formed the largest segment, accounting for about 45% of diagnosed cases. Across the EU4, Germany led in prevalence, followed by France and Spain, with Italy recording the fewest cases. In Japan, CHF prevalence demonstrated strong age dependency, with the majority of cases occurring in individuals aged over 60.

Chronic Heart Failure Epidemiology Segmentation (7MM)
• Total diagnosed prevalent cases
• Gender-specific prevalence
• Ejection fraction-based segmentation
• NYHA class-wise distribution
• Type-specific classification
• Age-specific prevalence

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Congestive Heart Failure Competitive Landscape
Marketed Therapies

INJECTAFER® / FERINJECT® (ferric carboxymaltose injection) - American Regent, Vifor, Daiichi Sankyo
INJECTAFER is approved for treating iron deficiency in adult heart failure patients, iron deficiency anemia in adults and pediatric patients aged one year and above with intolerance or poor response to oral iron, and adults with IDA and non-dialysis-dependent chronic kidney disease. For heart failure patients with NYHA Class II/III, dosing is determined by body weight and hemoglobin levels, ranging from a single 500 mg dose to two 1,000 mg doses administered six weeks apart.

INPEFA® (sotagliflozin) - Lexicon Pharmaceuticals, Viatris
INPEFA is an oral dual SGLT1/SGLT2 inhibitor that regulates glucose absorption in both the kidneys and gastrointestinal tract. In May 2023, the FDA approved INPEFA to reduce the risk of cardiovascular death and heart failure hospitalizations in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. The approval spans patients across the full spectrum of left ventricular ejection fraction, including HFpEF and HFrEF, irrespective of diabetes status, marking a major milestone for Lexicon Pharmaceuticals.

Emerging Therapies
Omecamtiv Mecarbil - Cytokinetics
Omecamtiv mecarbil is a selective cardiac myosin activator designed to directly enhance myocardial contractility by improving the heart's pumping efficiency. Preclinical studies indicate improved cardiac performance without increasing intracellular calcium or myocardial oxygen demand. The therapy has completed Phase III trials in CHF, with Phase III HFrEF data expected in Q4 2024.

KERENDIA® (finerenone) - Bayer
Finerenone is a nonsteroidal, selective mineralocorticoid receptor antagonist that counteracts MR overactivation, a key contributor to cardiovascular injury and chronic kidney disease progression. Marketed globally as KERENDIA or FIRIALTA, it is approved in more than 90 countries for adults with type 2 diabetes. The drug has completed Phase III trials in patients with LVEF ≤40%, with the first regulatory submission anticipated by mid-2025.

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Chronic Heart Failure Companies
Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, Mesoblast, and others.

Chronic Heart Failure Market Outlook
The CHF therapeutic landscape has undergone significant evolution following years of limited innovation. Recent FDA approvals including VERQUVO (vericiguat), ENTRESTO (sacubitril/valsartan), and CORLANOR (ivabradine) have enhanced guideline-directed therapy via diverse mechanisms such as soluble guanylate cyclase activation, ARNI modulation, and sinoatrial node regulation.

More recent approvals, including INJECTAFER/FERINJECT and INPEFA, have expanded treatment options by addressing iron deficiency and reducing cardiovascular mortality and hospitalizations among high-risk patient groups. SGLT2 inhibitors like FARXIGA and JARDIANCE are now widely recommended regardless of diabetes status, and multiple therapies have received label expansions to support broader adult and pediatric use.

Ongoing investment across innovative therapeutic classes including cardiac myosin activators, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and myeloperoxidase inhibitors-is expected to redefine future market dynamics. A strong late-stage pipeline featuring programs from Bayer, Cytokinetics, BioCardia, Mesoblast, Novo Nordisk, AstraZeneca, Eli Lilly, Cardurion Pharmaceuticals, and others is poised to drive sustained market growth.

In 2023, the CHF market across the 7MM was valued at approximately USD 5.6 billion, with continued expansion anticipated through 2034. The United States dominated market share, supported by higher disease prevalence, rapid uptake of innovative therapies, and favorable reimbursement. Within Europe, Germany generated the highest revenue, while the UK contributed the smallest share.

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Scope of the Chronic Heart Failure Market Report
• Geographic Coverage: 7MM
• Study Period: 2020-2034
• Key Companies: Novartis, Boehringer Ingelheim, Eli Lilly and Company, Bayer, Cytokinetics, BioCardia, Novo Nordisk, Mesoblast, and others
• Key Therapies: Ertugliflozin, Metolazone, AZD5462, Vericiguat (Verquvo/BAY1021189), mRNA-0184, rhNRG-1, and others
• Market Dynamics: Drivers, barriers, and challenges
• Additional Insights: Unmet needs, KOL opinions, analyst perspectives, market access, and reimbursement

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.