Congestive Heart Failure Market Poised for Substantial Growth by 2034, Driven by Emerging Cell Therapies and Recent FDA Approvals | DelveInsight

The congestive heart failure therapeutics market is projected to witness substantial growth driven by rising prevalence, technological advancements, and innovative treatment options. Key pharmaceutical companies, including Novartis, Alnylam, Otsuka, AstraZeneca, Bayer, Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Lexicon, Mesoblast, BioCardia, Cytokinetics, and others, are actively developing novel therapies to address significant unmet needs in this rapidly evolving landscape.
DelveInsight's "Congestive Heart Failure Market Insights, Epidemiology, and Market Forecast- 2034 [https://www.delveinsight.com/report-store/congestive-heart-failure-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr]" report delivers comprehensive insights into congestive heart failure, historical and forecasted epidemiology, and market trends across the seven major heart failure major markets, which include the US, EU4 countries (Germany, France, Italy, and Spain), the UK, and Japan. According to the analysis, the total chronic heart failure market size in the 7MM was approximately USD 7 billion in 2023 and is projected to grow significantly during the forecast period (2024-2034).

The US accounts for the largest market share of the total congestive heart failure market size and will continue to experience substantial growth throughout the forecast period. Among the EU4 and the UK, Germany contributes the highest revenue share, while the UK has the smallest market share. This regional disparity is attributed to varying prevalence rates, healthcare infrastructure differences, and reimbursement policies across markets.

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From the epidemiological perspective, the total congestive heart failure patient pool in the 7MM was approximately 21 million in 2023, with males representing a higher share compared to females. Furthermore, the majority of heart failure cases occur in individuals aged 60 years and above. In 2023, this age group accounted for approximately 7 million heart failure cases in the US.

DelveInsight's analysis segments this patient population by various parameters, including total diagnosed prevalent cases, gender-specific cases, age-specific cases, NYHA class-specific cases, ejection fraction-specific cases, and type-specific cases (acute and chronic). Heart failure with preserved ejection fraction (HFpEF) contributes to the majority of cases, while NYHA class II and class III represent the highest proportion among class-specific diagnosed prevalence.

The DelveInsight report also analyses the congestive heart failure drugs market and treatment landscape. The current congestive heart failure treatment landscape relies heavily on established drug classes like ACE inhibitors, ARBs, beta-blockers, and diuretics. Among the approved therapies, ENTRESTO (sacubitril/valsartan) from Novartis (SWX: NOVN) leads the market and is expected to maintain its dominant position during the forecast period, followed by beta blockers. However, with Novartis expecting to lose exclusivity in the United States in 2025, the introduction of generics poses a significant threat to this billion-dollar medication.

SGLT2 inhibitors such as JARDIANCE (empagliflozin) from Boehringer Ingelheim and Eli Lilly (NYSE: LLY), and FARXIGA (dapagliflozin) from AstraZeneca (LON: AZN) have gained substantial traction in the congestive heart failure therapeutic landscape. In June 2021, the European Commission granted marketing authorization for JARDIANCE as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction, followed by FDA approval in August 2021.

In March 2025, the FDA approved AMVUTTRA, an RNA interference therapy manufactured by Alnylam Pharmaceuticals (NASDAQ: ALNY), for transthyretin amyloid cardiomyopathy (ATTR-CM), a rare but serious cause of heart failure, marking the first RNAi drug to reduce cardiovascular death, hospitalizations, and urgent heart failure visits in this population.

Furthermore, in December 2024, the FDA granted tentative approval to SQ Innovation's Lasix ONYU, a combination of a high-concentration furosemide formulation and an on-body drug delivery device developed by Gerresheimer, for home treatment of fluid overload in congestive heart failure. Full approval is expected after a competing product's exclusivity ends in October 2025, with market launch anticipated by the end of 2025.

The congestive heart failure pipeline is robust, with several promising candidates in various stages of clinical development. In December 2024, AstraZeneca initiated a Phase IIb randomized, placebo-controlled study evaluating AZD5462 in stable patients with chronic heart failure. Similarly, Regeneron Pharmaceuticals began investigating REGN5381, an NPR1 monoclonal antibody agonist, in patients with chronic heart failure with reduced ejection fraction. Other notable pipeline drugs include KERENDIA (Bayer), MOUNJARO (Eli Lilly), Semaglutide (Novo Nordisk), CardiAMP Cell Therapy (BioCardia), and Mesoblast.

The use of stem cells to stimulate myocardial healing represents a promising new approach to treating heart failure. The late-stage cell therapy CardiAMP Cell Therapy by BioCardia (NASDAQ: BCDA) is expected to secure a significant market position, highlighting the growing interest in regenerative medicine approaches for cardiovascular conditions.

Several notable developments have occurred recently in the treatment landscape for congestive heart failure. In late April 2025, new clinical trial data presented at Heart Rhythm 2025 highlighted that left bundle branch area pacing (LBBAP) offers better outcomes than traditional biventricular pacing for patients needing cardiac resynchronization, reducing death and heart failure hospitalizations. Additionally, in March 2025, the FDA granted priority review to KERENDIA for heart failure with preserved ejection fraction, with a decision expected in the third quarter of 2025.

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Despite these advancements, significant challenges remain in the congestive heart failure market. The high price of recently developed therapies, general reluctance of cardiologists to adopt new treatment options, and widespread use of generic heart failure drugs make it difficult for premium-priced branded therapies to penetrate the market effectively. Additionally, the chronic heart failure market faces challenges from underdiagnosis and delayed recognition due to overlapping symptoms with other conditions.

Looking forward, the chronic heart failure market is poised for substantial growth, driven by the anticipated expanded indication for therapies like Bayer's KERENDIA, the launch of several oral and injectable agents, and the increasing global prevalence of chronic heart failure, potentially reshaping the treatment landscape in the coming years.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Congestive Heart Failure

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Congestive Heart Failure (CHF) Market Overview At A Glance

7. Disease Background and Overview

8. Congestive Heart Failure Treatment

9. Heart Failure with Preserved Ejection Fraction: Diagnosis And Management

10. Congestive Heart Failure Guidelines

11. Congestive Heart Failure Epidemiology and Patient Population

12. Congestive Heart Failure Patient Journey

13. Congestive Heart Failure Marketed Drugs

14. Congestive Heart Failure Emerging Drugs

15. Congestive Heart Failure (CHF): 7MM Analysis

16. Congestive Heart Failure Unmet Needs

17. Swot Analysis

18. Kol Views

19. Market Access and Reimbursement

20. Appendix

21. Delveinsight Capabilities

22. Disclaimer

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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