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
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].
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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 Novartis, Otsuka, AstraZeneca, Merck, Amgen/Servier, scPharmaceuticals, LexiconPharmaceuticals/Viatris.Cytokinetics,
Companies 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 Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018),
Failure Therapies 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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