Congestive Heart Failure Market Size (7MM) was ~USD 6,900 Million in 2023 and It is expected to grow by 2034, estimates DelveInsight

DelveInsight’s “Congestive Heart Failure Market Insight, Epidemiology and Market Forecast – 2034” 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, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Congestive Heart Failure Market Report

• In September 2025, Corstasis Therapeutics Inc. announced that the FDA approved ENBUMYST (bumetanide nasal spray) for the treatment of edema associated with congestive heart failure (CHF), as well as hepatic and renal diseases, including nephrotic syndrome in adults. ENBUMYST offers an enhanced outpatient therapeutic option for patients with cardiovascular and renal conditions.
• In September 2025, Aptar Pharma announced that its Unidose Liquid System has been selected as the delivery platform for Enbumyst™ (Bumetanide Nasal Spray) 0.5mg, recently approved by the U.S. FDA. Developed by Corstasis Therapeutics, Enbumyst™ is the first intranasal loop diuretic approved for the treatment of edema associated with congestive heart failure, liver and kidney diseases, including nephrotic syndrome, in adults.
• The analysis of Congestive Heart Failure in the 7MM draws a clear scenario which showed that the patients with HFpEF have a larger proportion (i.e., ~50%) because the heart is not severely affected but keeps on working through medication or symptomatic treatment, whereas, in the case of HFrEF, the patient’s heart is majorly affected. With growing age, the pumping rate of the heart declines.
• In 2023, among all the four New York Heart Association (NYHA) Classes of heart failure, Class II accounted for around 45% of the total diagnosed heart failure cases in the 7MM.
• Maximum cases of heart failure fall in the age group of ≥ 60 years. In 2023, approximately 6.8 million cases of heart failure in the US belonged to this age group.
• In 2023, among EU4 and the UK, the largest number of heart failure cases were observed in Germany, followed by France and Spain, whereas the United Kingdom accounted for the smallest number of cases in the 7MM.
• The leading Congestive Heart Failure Companies such as Novartis, Boehringer Ingelheim, Elli Lilly, Otsuka pharmaceuticals, Cytokinetics, AstraZeneca, Applied Therapeutics, Mesoblast, Bayer, Novo Nordisk, Lexicon Pharmaceuticals, scPharmaceuticals, Merck Sharp & Dohme LLC, Corthera, Inc., AstraZeneca, GlaxoSmithKline, Otsuka Pharma, Scios, Inc., Janssen Pharma, Pharmacosmos A/S, Pfizer, GE Healthcare, and others.
• Promising Congestive Heart Failure Therapies such as ENTRESTO, JARDIANCE, MOUNJARO (tirzepatide), OPC-61815, Omecamtivmecarbil, AZD4831, AT-001, Rexlemestrocel-L (Revascor), Finerenone (Kerendia), Sotagliflozin, Furoscix(furosemide injection), KW-3902IV, Relaxin, Dapagliflozin, GSK716155, tolvaptan, Nesiritide, Iron oligosaccharide, Rosuvastatin, atorvastatin, 123I-mIBG, and others.

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Congestive Heart Failure Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalent Cases of Heart Failure
• Gender-specific Cases of Heart Failure
• Ejection Fraction-specific Cases of Heart Failure
• NYHA Class-specific Cases of Heart Failure
• Type-specific Cases of Heart Failure (Acute and Chronic)
• Age-specific Cases of Heart Failure

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Marketed Congestive Heart Failure Drugs

• ENTRESTO: Novartis

ENTRESTO combines a neprilysin inhibitor and an angiotensin II receptor blocker. In July 2015, the US FDA approved sacubitril with valsartan to reduce the risk of cardiovascular (CV) death and hospitalization in patients with Congestive Heart Failure (NYHA Class II-IV) associated with reduced ejection fraction and got expanded approval in October 2019 and February 2021 for pediatric patients aged ≥1 with symptomatic heart failure with systemic left ventricular systolic dysfunction and adult patients with Congestive Heart Failure respectively. ENTRESTO captured the major share of the Congestive Heart Failure market in 2022.

• JARDIANCE: Boehringer Ingelheim and Eli Lilly

JARDIANCE is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. The candidate is also being investigated in pivotal trials for heart failure post myocardial infarction and chronic kidney disease. In June 2021, Boehringer Ingelheim and Eli Lilly and Company announced that the European Commission had granted marketing authorization for JARDIANCE (empagliflozin) as a treatment for adults with symptomatic chronic HFrEF. Later in August 2021, it was approved by the US FDA. US FDA had granted Breakthrough Therapy designation based on results from the Phase III EMPEROR-Preserved trial. In the last year, JARDIANCE grabbed regulatory approval from all the major regulatory bodies (FDA, EMA, and PMDA) for the treatment of chronic heart failure in patients with HFpEF, thereby extending its targeted niche.

Emerging Congestive Heart Failure Drugs

• KERENDIA (finerenone): Bayer

Finerenone (BAY 94-8862) is an investigational novel, nonsteroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block many harmful effects of mineralocorticoid receptor (MR) overactivation, which is a major driver of kidney and heart damage. The drug has received regulatory approval in the US, Canada, and the EU to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes. The drug is currently in a Phase III FINEARTS-HF trial in patients with heart failure and left ventricular ejection fraction greater or equal to 40%. FINEARTS-HF is currently the largest outcome trial investigating an MRA in HFpEF.

• MOUNJARO (tirzepatide): Eli Lilly and Company

Tirzepatide (LY3298176) is a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. In May 2022, tirzepatide was approved by the US FDA as a treatment for adults with type 2 diabetes. Currently, the drug is in the Phase III stage of the clinical development program evaluating its safety and efficacy in participants with HFpEF and obesity. This drug has true potential and is expected to garner the maximum revenue by 2034.

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Congestive Heart Failure Drugs Market Insights

The primeval drug classes like ACE inhibitors, ARBs, beta-blockers, and diuretics are still at the forefront of the heart failure treatment space. Furthermore, off-label usage of other therapies such as aldosterone antagonists, amiodarone, antiaggregants, anticoagulants, calcium antagonists, and nitrates, are also high in patients affected by heart failure. The majority of therapies are prescribed in combination, and beta-blockers are one of the most prescribed classes. Among the approved therapies, ENTRESTO is Novartis’ one of the most important drugs, and its revenue is expected to rise in the next few years. At present, ENTRESTO leads the Congestive Heart Failure market among the approved therapies. After a slow beginning, ENTRESTO has emerged as one of Novartis’ most important growth drivers. With the current approval in preserved ejection fraction, ENTRESTO is getting bigger and better.

Congestive Heart Failure Companies

Novartis, Boehringer Ingelheim, Elli Lilly, Otsuka pharmaceuticals, Cytokinetics, AstraZeneca, Applied Therapeutics, Mesoblast, Bayer, Novo Nordisk, Lexicon Pharmaceuticals, scPharmaceuticals, Merck Sharp & Dohme LLC, Corthera, Inc., AstraZeneca, GlaxoSmithKline, Otsuka Pharma, Scios, Inc., Janssen Pharma, Pharmacosmos A/S, Pfizer, GE Healthcare, and others.

Congestive Heart Failure Market Outlook

After a scarcity of sustainable new therapies for more than a decade, new classes of agents for the treatment of patients with Congestive Heart Failure were approved by the US FDA – ENTRESTO (sacubitril/valsartan), a combined angiotensin receptor-neprilysin inhibitor (ARNI) and CORLANOR (ivabradine), a sinoatrial node modulator. Both drugs are recommended for use as part of a comprehensive medical therapy regimen. Recently approved VERQUVO (vericiguat), from Merck Pharma, in January 2021 is the newest addition for treating heart failure. The drug is indicated to reduce the risk of cardiovascular death, heart failure hospitalizations, or the need for outpatient intravenous diuretics. It is recommended in adults with symptomatic chronic heart failure and less than 45% ejection fraction. VERQUVO is a stimulator of soluble guanylate cyclase. In a recent update from the Heart Failure Association on SGLT2 inhibitors in heart failure, dapagliflozin or empagliflozin are recommended to reduce the risk of heart failure hospitalization and cardiovascular death in HFrEF patients already receiving guideline-directed medical therapy, regardless of the presence of type 2 diabetes mellitus.

Congestive Heart Failure Treatment Market

The Congestive Heart Failure Treatment Market Landscape for this patient pool includes a range of drugs with a variable Congestive Heart Failure mechanism of action, offering safe and tolerable treatment options. Recently, some approved drugs also got the label expansion for treating Congestive Heart Failure in pediatric and adult patients. Many major companies are investing in different mechanisms of action for the treatment of Congestive Heart Failure, SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and others, which will boost the Congestive Heart Failure market in the future.

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Scope of the Congestive Heart Failure Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Congestive Heart Failure Companies- Novartis, Boehringer Ingelheim, Elli Lilly, Otsuka pharmaceuticals, Cytokinetics, AstraZeneca, Applied Therapeutics, Mesoblast, Bayer, Novo Nordisk, Lexicon Pharmaceuticals, scPharmaceuticals, Merck Sharp & Dohme LLC, Corthera, Inc., AstraZeneca, GlaxoSmithKline, Otsuka Pharma, Scios, Inc., Janssen Pharma, Pharmacosmos A/S, Pfizer, GE Healthcare, and others.
• Congestive Heart Failure Therapies-ENTRESTO, JARDIANCE, MOUNJARO (tirzepatide), OPC-61815, Omecamtivmecarbil, AZD4831, AT-001, Rexlemestrocel-L (Revascor), Finerenone (Kerendia), Sotagliflozin, Furoscix(furosemide injection), KW-3902IV, Relaxin, Dapagliflozin, GSK716155, tolvaptan, Nesiritide, Iron oligosaccharide, Rosuvastatin, atorvastatin, 123I-mIBG, and others.
• Congestive Heart Failure Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Congestive Heart Failure Unmet Needs, KOL’s views, Analyst’s views, Congestive Heart Failure Market Access and Reimbursement

Table of Contents

1. Key Insights
2. Congestive Heart Failure Market Report Introduction
3. Country-wise Congestive Heart Failure Market Overview at a Glance
4. Congestive Heart Failure Market Overview by Therapeutic Class
5. Methodology of Congestive Heart Failure Epidemiology and Market
6. Congestive Heart Failure Executive Summary
7. Key Events
8. Congestive Heart Failure Disease Background and Overview
9. Congestive Heart Failure Epidemiology and Patient Population
10. Congestive Heart Failure Patient Journey
11. Congestive Heart Failure Marketed Drugs
12. Congestive Heart Failure Emerging Drugs
13. Congestive Heart Failure: Market Analysis
14. Key Opinion Leaders’ Views
15. Congestive Heart Failure SWOT Analysis
16. Congestive Heart Failure Unmet Needs
17. Congestive Heart Failure Market Access and Reimbursement
18. Appendix
19. Congestive Heart Failure Report Methodology
20. DelveInsight Capabilities
21. Disclaimer

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