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      Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

      DelveInsight_Logo

      News provided by

      DelveInsight Business Research, LLP

      Jan 22, 2025, 17:46 ET

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      Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape.

      LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. 

      Key Takeaways from the Chronic Heart Failure Market Report

      • According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023.
      • Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period.
      • As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately  20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases.
      • Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum.
      • Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient.
      • Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors,  Farxiga is the leading prescribed SGLT2 inhibitor globally by volume
      • Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others.
      • In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU.
      • In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024.
      • In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines.
      • AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025.

      Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report

      Chronic Heart Failure Overview

      Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development.

      The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities.

      Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications.

      Chronic Heart Failure Epidemiology Segmentation

      The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

      The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

      • Total Diagnosed Prevalent Cases of Heart Failure
      • Gender-specific Cases of Heart Failure
      • Ejection Fraction-specific Cases of Heart Failure
      • New York Heart Association (NYHA) Class-specific Cases of Heart Failure
      • Type-specific Cases of Heart Failure
      • Age-specific Cases of Heart Failure   

      Chronic Heart Failure Treatment Market 

      Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition.

      Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly.

      However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position.

      SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments.

      To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management 

      Chronic Heart Failure Pipeline Therapies and Key Companies

      • Omecamtiv Mecarbil: Cytokinetics
      • KERENDIA (finerenone): Bayer
      • Tirzepatide (LY3298176): Eli Lilly and Company
      • CardiAMP Cell Therapy: BioCardia
      • Ziltivekimab (NN6018): Novo Nordisk
      • REVASCOR (rexlemestrocel-L): Mesoblast
      • Levosimendan (TNX-103): Tenax Therapeutics
      • Semaglutide: Novo Nordisk
      • Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca
      • Mitiperstat (AZD4831): AstraZeneca
      • Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim
      • Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb
      • Lenrispodun (ITI - 214): Intra-Cellular Therapies
      • CRD-740: Cardurion Pharmaceuticals
      • HU6: Rivus Pharmaceuticals

      Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials 

      Chronic Heart Failure Market Dynamics

      The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. 

      Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory.

      Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM.

      However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. 

      Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure.

      Chronic Heart Failure Market Report Metrics

      Details

      Study Period

      2020–2034

      Coverage

      7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

      Chronic Heart Failure Market CAGR


      Chronic Heart Failure Market Size in 2023

      USD 8.1 Billion (7MM)

      Key Chronic Heart Failure Companies

      Novartis, Otsuka, AstraZeneca, Merck, Amgen/Servier, scPharmaceuticals, LexiconPharmaceuticals/Viatris.Cytokinetics, Bayer, Eli Lilly and Company, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others

      Key Pipeline Chronic Heart Failure Therapies

      Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others

      Scope of the Chronic Heart Failure Market Report

      • Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies
      • Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook
      • Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
      • Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement

      Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends

      Table of Contents

      1

      Key Insights

      2

      Report Introduction

      3

      Executive Summary of CHF

      4

      CHF Market Overview at a Glance

      4.1

      Market Share Distribution (%) of CHF in 2020: By Therapies

      4.2

      Market Share Distribution (%) of CHF in 2034: By Therapies

      5

      Key Events

      6

      Epidemiology and Market Forecast Methodology

      7

      Disease Background and Overview

      7.1

      Introduction

      7.2

      Causes of CHF

      7.3

      Signs and Symptoms

      7.4

      Stages of Heart Failure

      7.5

      Classification of Heart Failure

      7.6

      Common Pathophysiologic Mechanisms in Heart Failure

      7.7

      Biomarkers for the Heart Failure

      7.8

      Diagnosis

      7.8.1

      Differential Diagnosis

      8

      Treatment

      8.1

      Guidelines

      8.1.1

      Guideline for the Management of Heart Failure: American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines (2022)

      8.1.2

      European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and CHF (Updated, 2023)

      8.1.3

      American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA) (2021)

      8.1.4

      CHF in Adults: Diagnosis and Management (National Institute for Health and Care Excellence [NICE] Guidelines 2018)

      8.1.5

      NICE Acute Heart Failure: Diagnosis and Management (Updated; 2021)

      9

      Epidemiology and Patient Population

      9.1

      Key Findings

      9.2

      Assumptions and Rationale

      9.3

      Total Diagnosed Prevalent Cases of Heart Failure in the 7MM

      9.4

      United States

      9.4.1

      Total Diagnosed Prevalent Cases of Heart Failure in the United States

      9.4.2

      Gender-specific Cases of Heart Failure in the United States

      9.4.3

      Ejection Fraction-specific Cases of Heart Failure in the United States

      9.4.4

      NYHA Class-specific Cases of Heart Failure in the United States

      9.4.5

      Type-specific Cases of Heart Failure in the United States

      9.4.6

      Age-specific Cases of Heart Failure in the United States

      9.5

      EU4 and the UK

      9.5.1

      Total Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK

      9.5.2

      Gender-specific Cases of Heart Failure in EU4 and the UK

      9.5.3

      Ejection Fraction-specific Cases of Heart Failure in EU4 and the UK

      9.5.4

      NYHA Class-specific Cases of Heart Failure in EU4 and the UK

      9.5.5

      Type-specific Cases of Heart Failure in EU4 and the UK

      9.5.6

      Age-specific Cases of Heart Failure in EU4 and the UK

      9.6

      Japan

      9.6.1

      Total Diagnosed Prevalent Cases of Heart Failure in Japan

      9.6.2

      Gender-specific Cases of Heart Failure in Japan

      9.6.3

      Ejection Fraction-specific Cases of Heart Failure in Japan

      9.6.4

      NYHA Class-specific Cases of Heart Failure in Japan

      9.6.5

      Type-specific Cases of Heart Failure in Japan

      9.6.6

      Age-specific Cases of Heart Failure in Japan

      10

      Patient Journey

      11

      Marketed Drugs

      11.1

      Key Competitor

      11.2

      ENTRESTO (sacubitril and valsartan): Novartis and Otsuka Pharmaceutical

      11.2.1

      Product Description

      11.2.2

      Regulatory Milestones

      11.2.3

      Other Developmental Activities

      11.2.4

      Safety and Efficacy

      11.3

      JARDIANCE (empagliflozin): Boehringer Ingelheim/Eli Lilly

      11.3.1

      Product Description

      11.3.2

      Regulatory Milestones

      11.3.3

      Other Development Activities

      11.3.4

      Safety and Efficacy

      11.4

      VERQUVO (vericiguat): Bayer and Merck

      11.4.1

      Product Description

      11.4.2

      Regulatory Milestones

      11.4.3

      Other Development Activities

      11.4.4

      Clinical Development

      11.4.4.1

      Clinical Trial Information

      11.4.5

      Safety and Efficacy

      11.5

      FARXIGA/FORXIGA (dapagliflozin): AstraZeneca

      11.5.1

      Product Description

      11.5.2

      Regulatory Milestones

      11.5.3

      Other Development Activities

      11.5.4

      Safety and Efficacy

      11.6

      CORLANOR/CORALAN/PROCORALAN (Ivabradine): Amgen and Servier

      11.6.1

      Product Description

      11.6.2

      Regulatory Milestones

      11.6.3

      Other Development Activities

      11.6.4

      Safety and Efficacy

      11.7

      SAMTASU/SAMSCA (Tolvaptan Sodium Phosphate): Otsuka Pharmaceutical

      11.7.1

      Product Description

      11.7.2

      Regulatory Milestone

      11.7.3

      Safety and Efficacy

      11.8

      FUROSCIX (furosemide Injection): scPharmaceuticals

      11.8.1

      Product Description

      11.8.2

      Regulatory Milestone

      11.8.3

      Other Development Activity

      11.8.4

      Safety and Efficacy

      11.9

      INJECTAFER (ferric carboxymaltose): American Regent, Vifor Pharma, and Daiichi Sankyo

      11.9.1

      Product Description

      11.9.2

      Regulatory Milestones

      11.9.3

      Other Development Activities

      11.9.4

      Safety and Efficacy

      11.1

      INPEFA (sotagliflozin): Lexicon Pharmaceuticals and Viatris

      11.10.1

      Product Description

      11.10.2

      Regulatory Milestones

      11.10.3

      Other Development Activities

      11.10.4

      Safety and Efficacy

      12

      Emerging Drugs

      12.1

      Key Cross Competition

      12.2

      Omecamtiv Mecarbil: Cytokinetics

      12.2.1

      Product Description

      12.2.2

      Other Developmental Activities

      12.2.3

      Clinical Development

      12.2.3.1

      Clinical Trial Information in CHF

      1.1.3

      Safety and Efficacy

      12.3

      KERENDIA (finerenone): Bayer

      12.3.1

      Product Description

      12.3.2

      Other Developmental Activities

      12.3.3

      Clinical Development

      12.3.3.1

      Clinical Trial Information in CHF

      12.3.4

      Safety and Efficacy

      12.4

      Tirzepatide (LY3298176): Eli Lilly and Company

      12.4.1

      Product Description

      12.4.2

      Other Developmental Activities

      12.4.3

      Clinical Development

      12.4.3.1

      Clinical Trial Information in CHF

      12.4.4

      Safety and Efficacy

      12.5

      CardiAMP Cell Therapy: BioCardia

      12.5.1

      Product Description

      12.5.2

      Other Developmental Activities

      12.5.3

      Clinical Development

      12.5.3.1

      Clinical Trial Information in CHF

      12.5.4

      Safety and Efficacy

      12.6

      Ziltivekimab (NN6018): Novo Nordisk

      12.6.1

      Product Description

      12.6.2

      Other Developmental Activities

      12.6.3

      Clinical Development

      12.6.3.1

      Clinical Trial Information in CHF

      12.7

      REVASCOR (rexlemestrocel-L): Mesoblast

      12.7.1

      Product Description

      12.7.2

      Other Developmental Activities

      12.7.3

      Clinical Development

      12.7.3.1

      Clinical Trial Information in CHF

      12.7.4

      Safety and Efficacy

      12.8

      Levosimendan (TNX-103): Tenax Therapeutics

      12.8.1

      Product Description

      12.8.2

      Other Developmental Activities

      12.8.3

      Clinical Development

      12.8.3.1

      Clinical Trial Information in CHF

      12.8.4

      Safety and Efficacy

      12.9

      Semaglutide: Novo Nordisk

      12.9.1

      Product Description

      12.9.2

      Other Developmental Activities

      12.9.3

      Clinical Development

      12.9.3.1

      Clinical Trial Information in CHF

      12.9.4

      Safety and Efficacy

      12.1

      Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca

      12.10.1

      Product Description

      12.10.2

      Other Developmental Activities

      12.10.3

      Clinical Development

      12.10.3.1

      Clinical Trial Information in CHF

      12.10.4

      Safety and Efficacy

      12.11

      Mitiperstat (AZD4831): AstraZeneca

      12.11.1

      Product Description

      12.11.2

      Clinical Development

      12.11.2.1

      Clinical Trial Information in CHF

      12.11.3

      Safety and Efficacy

      12.12

      Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim

      12.12.1

      Product Description

      12.12.2

      Clinical Development

      12.12.2.1

      Clinical Trial Information in CHF

      12.13

      Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb

      12.13.1

      Product Description

      12.13.2

      Clinical Development

      12.13.2.1

      Clinical Trial Information in CHF

      12.13.3

      Safety and Efficacy

      12.14

      Lenrispodun (ITI - 214): Intra-Cellular Therapies

      12.14.1

      Product Description

      12.14.2

      Clinical Development

      12.14.2.1

      Clinical Trial Information in CHF

      12.14.3

      Safety and Efficacy

      12.15

      CRD-740: Cardurion Pharmaceuticals

      12.15.1

      Product Description

      12.15.2

      Other Developmental Activities

      12.15.3

      Clinical Development

      12.15.3.1

      Clinical Trial Information in CHF

      12.15.4

      Safety and Efficacy

      12.16

      HU6: Rivus Pharmaceuticals

      12.16.1

      Product Description

      12.16.2

      Other Developmental Activities

      12.16.3

      Clinical Development

      12.16.3.1

      Clinical Trial Information in CHF

      12.16.4

      Safety and Efficacy

      13

      CHF: 7MM Analysis

      13.1

      Key Findings

      13.2

      Market Outlook

      13.3

      Conjoint Analysis

      13.4

      Key Market Forecast Assumptions

      13.4.1

      Cost Assumptions and Rebates

      13.4.2

      Pricing Trends

      13.4.3

      Analogue Assessment

      13.4.4

      Launch Year and Therapy Uptakes

      13.5

      Total Market Size of CHF in the 7MM

      13.6

      United States Market Size

      13.6.1

      Total Market Size of CHF in the United States

      13.6.2

      Market Size of CHF by Therapies in United States

      13.7

      EU4 and the UK Market Size

      13.7.1

      Total Market Size of CHF in EU4 and the UK

      13.7.2

      Market Size of CHF by Therapies in EU4 and the UK

      13.8

      Japan Market Size

      13.8.1

      Total Market Size of CHF in Japan

      13.8.2

      Market Size of CHF by Therapies in Japan

      14

      Unmet needs

      15

      SWOT Analysis

      16

      KOL Views

      17

      Market Access and Reimbursement

      17.1

      United States

      17.1.1

      Centre for Medicare and Medicaid Services (CMS)

      17.2

      EU4 and the UK

      17.2.1

      Germany

      17.2.2

      France

      12.6

      Ziltivekimab (NN6018): Novo Nordisk

      12.6.1

      Product Description

      12.6.2

      Other Developmental Activities

      12.6.3

      Safety and Efficacy

      17.2.3

      Italy

      17.2.4

      Spain

      17.2.5

      United Kingdom

      17.3

      Japan

      17.3.1

      MHLW

      17.4

      CHF Market Access and Reimbursement

      18

      Appendix

      18.1

      Bibliography

      18.2

      Report Methodology

      19

      DelveInsight Capabilities

      20

      Disclaimer

      21

      About DelveInsight

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