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PUBLISHER: DelveInsight | PRODUCT CODE: 1605434

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PUBLISHER: DelveInsight | PRODUCT CODE: 1605434

Chronic Heart Failure - Market Insight, Epidemiology And Market Forecast - 2034

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Key Highlights:

  • In 2023, the total market size of CHF was around USD 8,000 million in the 7MM-the increasing prevalence of the disease is expected to fuel the market during 2020-2034. The prevalence of heart failure continues to rise over time with the aging of the population, improved treatment of and survival with ischemic heart disease, and the availability of effective evidence-based therapies prolonging life in patients with heart failure.
  • Off-label therapies and generics occupy the major share of the current CHF market as they are cheaper and more easily accessible to patients. Generics of olmesartan, eplerenone, furosemide, and Indapamide are easily available in the market. The presence of generics and off-label therapies is a major barrier to newly developed drugs and hinders market growth.
  • The increasing trend of existing key players such as AstraZeneca (FORXIGA), Novartis (ENTRESTO), Eli Lilly Boehringer Ingelheim (JARDIANCE), and others, targeting the label expansion and gaining approval regardless of the patient's left ventricular ejection fraction status to cater to the wider range of population is likely to propel the CHF drugs market.
  • In May 2024, Cardurion Pharmaceuticals presented the results of Phase II CARDINAL HF of CRD740 for heart failure at the annual congress of the Heart Failure Association of the European Society of Cardiology, 2024.
  • In March 2024, Mesoblast announced that the FDA supported an accelerated approval pathway for REVASCOR, in patients with end-stage ischemic HFrEF and Left Ventricular Assist Device (LVAD).
  • In 2023, the FDA approved INJECTAFER (ferric carboxymaltose injection)/FERINJECT (by American Regent, Vifor, and Daiichi Sankyo) and INPEFA ([sotagliflozin], developed by Lexicon Pharmaceuticals and Viatris).
  • Currently, the robust pipeline holds some potential drugs like vicadrostat + empagliflozin (Boehringer Ingelheim), semaglutide and ziltivekimab (Novo Nordisk), omecamtiv mecarbil (Cytokinetics), REVASCOR ([rexlemestrocel-L] Mesoblast), balcinrenone + dapagliflozin and mitiperstat (AstraZeneca), tirzepatide ([LY3298176] Eli Lilly and Company), and others.

DelveInsight's "Congestive Heart Failure (CHF) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of CHF, historical, and forecasted epidemiology as well as the CHF market trends in the US, EU4 (Germany, France, Italy, Spain), and the UK, and Japan.

The CHF market report provides current treatment practices, emerging drugs, CHF market share of individual therapies, and current and forecasted CHF market size from 2020 to 2034, segmented by 7MM. The report also covers current CHF treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered:

  • The US
  • EU4 (Germany, France, Italy, Spain) and the United Kingdom
  • Japan

CHF Understanding and Treatment Algorithm

DelveInsight's CHF market report gives a thorough understanding of CHF by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment.

CHF Overview

CHF commonly referred to as heart failure is a chronic progressive condition in which the heart cannot generate a cardiac output sufficient to meet the body's demands without increasing diastolic pressure resulting from any cardiac disease compromising ventricular systolic or diastolic function. The common term for describing heart failure is based on left ventricular ejection fraction. Also, heart failure with normal LVEF (=50%) is known as heart failure with preserved ejection fraction and heart failure with decreased LVEF (<40%) as heart failure with reduced ejection fraction. Heart failure with a 40-49% middle range is known as heart failure with mid-range ejection fraction (HFmrEF). The signs and symptoms of CHF are subtle at the initial stage, and these are generally misguided for common signs of aging. The common symptoms of CHF are because of extra fluid or congestion, which leads to vessel blocking. The starting of the congestion in the lungs is forwarded to the different body parts.

CHF Diagnosis

The assessment for CHF is achieved using numerous parameters, like physical testing of the patient to know the occurrence of clinical symptoms of heart failure, various blood tests, urine analysis, fasting glucose, and lipid profile, metabolic profiling for serum electrolytes, and thyroid hormone estimation. Apart from these routine tests, different imaging techniques like chest X-ray, ECG, MRI, and others are used for diagnosing CHF.

The patient's journey begins with the onset of symptoms like breathlessness at night, congestion of the lungs, difficulty in walking, and edema in the legs. Following an initial visit with a general practitioner, during which the patient underwent a complete physical examination, and the results revealed a few alarming findings related to CHF, the patient was referred to a cardiologist. Further, the cardiologist will immediately recommend a blood examination, assessment of brain natriuretic peptide (BNP) or N-terminal pro-b-type BNP (NT-proBNP), and ECG is prescribed to diagnose heart failure. If the test result shows an increased BNP level and an abnormal ECG-the possibility of heart failure is confirmed. Once heart failure is confirmed an echocardiogram is done to measure the ejection fraction, which helps in identifying causes and stages of heart failure, and also helps in undertaking proper treatment decisions.

CHF Treatment

Currently, CHF treatment depends on angiotensin-converting enzyme inhibitors, angiotensin receptor II blockers, beta-blockers, and diuretics. Additionally, other therapies, such as aldosterone antagonists, amiodarone, antiaggregants, anticoagulants, calcium antagonists, diuretics, and nitrates, among others, are used for the treatment of patients affected by heart failure. In addition to this, the treatment of heart failure should be viewed uninterruptedly. In general, early treatment focuses on lifestyle changes (quitting smoking, avoiding alcohol, caffeine, and stress, reducing fluid intake, and reducing the amount of salt in the diet) and optimization of necessary medical therapies. The next step in treatment might include more intense medical therapies or the installation of a device, such as a pacemaker or Implantable Cardioverter Defibrillator (ICD).

CHF Epidemiology

As the market is derived using the patient-based model, the CHF epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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, and age-specific cases of heart failure in the 7MM covering the US, EU4 (Germany, France, Italy, Spain) and the UK, and Japan from 2020 to 2034.

Key findings

  • Driven by multiple factors, the number and distribution of reported cases of CHF have increased over time in the 7MM, among which the US contributed the major patient share.
  • As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20,360,000 in 2023.
  • In 2023, the percentage of diagnosed prevalence of males with heart failure in the US was 55%, and that for females was 45%.
  • In the UK, among all the four NYHA Classes of heart failure, Class II accounted for around 45% of the total diagnosed prevalent heart failure cases in 2023.
  • Among the EU4, the highest number of diagnosed prevalent cases of CHF were found in Germany, followed by France, and Spain, and the lowest number of diagnosed prevalent cases in Italy in 2023.
  • In Japan, the age-specific dignosed prevalent cases of heart failure in 2023 accounted for approximately 4,444,000 (for age group more than 60 years), 634,900 (for age group 40-59 years), and 211,600 (for age group below 39 years).

CHF Drug Chapters

The drug chapter segment of the CHF report encloses a detailed analysis of CHF-marketed drugs and late-stage (Phase III and Phase II) CHF pipeline drugs. It also helps understand the CHF clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Congestive Heart Failure (CHF) drugs

INJECTAFER (ferric carboxymaltose injection)/FERINJECT: American Regent, Vifor, and Daiichi Sankyo

INJECTAFER (ferric carboxymaltose injection) is indicated for the treatment of iron deficiency in adult patients with heart failure; Iron Deficiency Anemia (IDA) in adult and pediatric patients 1-year of age and older who have either intolerance to oral iron or unsatisfactory response to oral iron; and adult patients with IDA who have non-dialysis dependent chronic kidney disease. Its dosing for iron deficiency in adult patients with heart failure and NYHA class II/III is based on patient weight and hemoglobin level starting at a single 500mg dose up to two 1000mg doses separated by six weeks. A maintenance dose of 500mg may be administered at 12, 24, and 36 weeks for certain patients based on their serum ferritin levels and transferrin saturation value. INJECTAFER is manufactured and marketed under the name of FERINJECT (Ferric Carboxymaltose) by CSL Vifor outside of North America. CSL Vifor specializes in strategic global partnering, in-licensing and developing, manufacturing, and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. In June 2023, Daiichi Sankyo and American Regent announced that the US FDA approved INJECTAFER for the treatment of iron deficiency in adult patients with heart failure categorized as NYHA class II/III to improve exercise capacity. The approval was supported by INJECTAFER data from a randomized controlled study CONFIRM-HF.

INPEFA (sotagliflozin): Lexicon Pharmaceuticals and Viatris

INPEFA (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as SGLT2 and SGLT1. SGLT2 is responsible for glucose reabsorption by the kidney, and SGLT1 is responsible for glucose absorption in the gastrointestinal tract. In May 2023, Lexicon Pharmaceuticals announced that the US FDA had approved INPEFA (sotagliflozin) to reduce the risk of cardiovascular death, hHF, and uHF visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The broad label encompasses heart failure patients across the full range of LVEF, including HFpEF and HFrEF, and for patients with or without diabetes. The approval of INPEFA in heart failure indication, along with the breadth of the label, is a major milestone in Lexicon's path to fulfilling its mission of pioneering medicines that transform patients' lives.

Emerging CHF drugs

Omecamtiv mecarbil: Cytokinetics

Omecamtiv mecarbil is a selective small-molecule cardiac myosin activator. It is designed to directly target the contractile mechanism or pumping function of the heart. By stimulating cardiac myosin, a protein responsible for converting chemical energy into the mechanical force that helps the heart contract, omecamtiv mecarbil may improve cardiac muscle performance. Preclinical research has shown that cardiac myosin activators increase cardiac contractility without affecting intracellular myocyte calcium concentrations or myocardial oxygen consumption. It has completed its Phase III for CHF and its Phase III for HFrEF is anticipated in the fourth quarter of 2024.

KERENDIA (finerenone): Bayer

Finerenone is a nonsteroidal, selective Mineralocorticoid Receptor (MR) antagonist that has been shown to block the harmful effects of MR overactivation. MR overactivation contributes to Chronic Kidney Disease (CKD) progression and cardiovascular damage, which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors. Finerenone is marketed as KERENDIA or, in some countries, as FIRIALTA, and approved for the treatment of adult patients associated with Type II Diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the US. It has completed its Phase III trial for heart and left ventricular ejection fraction =40% and the company is anticipating the first submission of the drug by mid-2025.

Drug Class Insights

  • Currently, heart failure treatment depends on angiotensin-converting enzyme inhibitors, angiotensin receptor II blockers, beta-blockers, and diuretics. Other therapies, such as aldosterone antagonists, amiodarone, antiaggregants, anticoagulants, calcium antagonists, diuretics, and nitrates, are used to treat 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 years. At present, ENTRESTO leads the CHF 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.
  • For many years, ENTRESTO had unparalleled access to the CHF market; nevertheless, the introduction of SGLT2 inhibitors (FARXIGA, and JARDIANCE), VERQUVO, and other new medicines will pose a threat to this billion-dollar medication. In addition to this, Novartis expects to lose exclusivity in the United States in 2025. There is a threat of generics. Several patent lawsuits are being pursued by Novartis.
  • SGLT2 inhibitors have also made inroads into the CHF market. Even though JARDIANCE and FARXIGA are old candidates, they are new to the CHF market. The future of SGLT-2 drugs in heart failure appears to be promising. Even though both medications appear to be promising, AstraZeneca and Lilly/Boehringer will not have much time to convince heart specialists because FARXIGA's US patent expires in 2025 and JARDIANCE's expires in 2028. Sotagliflozin is a newly approved SGLT2 inhibitor, and gaining market share from older medications such as FARXIGA and JARDIANCE could be difficult.

CHF Market Outlook

After a scarcity of sustainable new therapies for more than a decade, new classes of agents for the treatment of patients with CHF were approved by the US FDA - VERQUVO (vericiguat), 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 INJECTAFER (ferric carboxymaltose injection)/FERINJECT by American Regent, Vifor, and Daiichi Sankyo and INPEFA (sotagliflozin) by Lexicon Pharmaceuticals and Viatris, in 2023 are the newest additions for treating heart failure. These drugs are indicated for the treatment of iron deficiency in adult patients with heart failure and to reduce the risk of cardiovascular death, hHF, and uHF visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors, respectively. VERQUVO is a stimulator of soluble guanylate cyclase. Other than these, other candidates like FARXIGA (dapagliflozin) or JARDIANCE (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. Therefore, the current treatment landscape for this patient pool includes a range of drugs with a variable mechanism of action, offering safe and tolerable treatment options. Recently, some approved drugs also got the label expansion for treating CHF in pediatric and adult patients.

Many major companies are investing in different mechanisms of action for the treatment of CHF, SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and others, which will boost the CHF market in the future. Conclusively, the emerging pipeline for treating patients with CHF is filled with potential drugs and cell therapies that can significantly capture a major market share, once launched into the CHF treatment space. The potential drugs and cell therapy that can mark a significant change in the upcoming period include vicadrostat + empagliflozin (Boehringer Ingelheim), Semaglutide and Ziltivekimab (Novo Nordisk), Omecamtiv Mecarbil (Cytokinetics), REVASCOR ([rexlemestrocel-L] Mesoblast), Balcinrenone + dapagliflozin and Mitiperstat (AstraZeneca), Tirzepatide ([LY3298176] Eli Lilly and Company), CardiAMP Cell Therapy (BioCardia), KERENDIA ([finerenone], Bayer), CRD-740 (Cardurion Pharmaceuticals), and others are evaluating their lead candidates in different stages of clinical development, respectively Key players like Bayer (KERENDIA [finerenone]), BioCardia (CardiAMP Cell Therapy), Mesoblast (REVASCOR [rexlemestrocel-L]), scPharmaceuticals (FUROSCIX Infusor), Cytokinetics (omecamtiv mecarbil), Lexicon Pharmaceuticals (sotagliflozin) and others are evaluating their lead candidates in different stages of clinical development.

  • The total market size of CHF in the 7MM was approximately USD 5,600 million in 2023 and is projected to grow during the forecast period (2020-2034).
  • 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.
  • In 2023, among the EU4 countries and the UK, Germany had the maximum revenue share, while the UK had the smallest market share.

Key Updates

  • 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.

CHF drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034. The landscape of CHF treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

CHF Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Gastric cancer therapies.

KOL Views

To keep up with current epidemiology and market trends, we take KOLs and SMEs' opinions working in the CHF domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on CHF's evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, drug uptake along with challenges related to accessibility, include Medical/scientific writers, Cardiologists, and Professors: MD, Cardiologist at Mayo Clinic, Cardiologist and HOD of Mount Sinai Hospital, and Others.

Delveinsight's analyst connected with 50+ KOLs (cardiologists, physicians, researchers, principal investigators, etc.) across the 7MM. Centers such as Mount Sinai Hospital, Mayo Clinic, Southern Illinois University; University of Verona, Verona, Italy; University of Valencia and INCLIVA Biomedical Research Institute, Valencia, Spain; and others were contacted. Their opinion helps to understand and validate current and emerging therapies, treatment patterns, and CHF market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure, based on a time-to-event analysis, played an important role as a part of the efficacy parameter. Moreover, the adverse events during the analysis are majorly observed as safety parameters. The ranking of drugs and cell therapies was done accordingly.

Market Access and Reimbursement

The burden of heart failure is multifaceted, including impacts on quality of life, medical comorbidities, and financial costs to patients and the health care system. Medications constitute the majority of direct costs for patients with heart failure. Many nonprofit organizations, companies, government hospitals, and private healthcare insurance companies provide low-cost copay programs to reduce the financial burden of medication on the patient. By receiving financial assistance, patients can focus on improving their health and overall quality of life.

According to the NICE UK, ENTRESTO is recommended as an option for treating symptomatic CHF with reduced ejection fraction only in people:

  • NYHA Class II-IV symptoms
  • With a left ventricular ejection fraction of 35% or less
  • Who are already taking a stable dose of Angiotensin-converting Enzyme (ACE) inhibitors or Angiotensin II Receptor blockers (ARBs)

This guidance is not intended to affect the position of patients whose treatment with sacubitril valsartan was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, and a descriptive overview of CHF, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
  • Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
  • A detailed review of the CHF market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM CHF market.

CHF Report Insights

  • Patient Population
  • Therapeutic Approaches
  • CHF Pipeline Analysis
  • CHF Market Size and Trends
  • Existing and Future Market Opportunity

CHF Report Key Strengths

  • 11 years forecast
  • The 7MM Coverage
  • CHF epidemiology segmentation
  • Key Cross Competition
  • Conjoint Analysis
  • Drugs Uptake and Key Market Forecast Assumptions

CHF Report Assessment

  • Current treatment practices
  • Unmet needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions:

CHF Market Insights

  • What was the CHF market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
  • What are the key findings of the market across the 7MM, and which class will account for the largest market share during the forecast period (2020-2034)?
  • How will the launch of FUROSCIX affect the treatment paradigm in the management of CHF?
  • Will the label expansion of ENTRESTO bring a significant impact on its market growth during the forecast period?
  • What would the impact of SGLT2 inhibitors be on the treatment paradigm in the management of CHF?
  • What is the impact of off-label usage of conventional therapies on the current CHF market and what are the prospects? What are the various strategies adopted by the pharma giants to tackle this threat?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

CHF Epidemiology Insights

  • What are the disease risks, burdens, and unmet needs of CHF? What will be the growth opportunities across the 7MM concerning the patient population of CHF?
  • What is the historical and forecasted CHF patient pool in the 7MM, and where can one observe the highest patient population and growth opportunities?
  • What are the key factors driving the epidemiology trends for seven major markets covering the United States, EU4 (Germany, Spain, France, Italy), the UK, and Japan?
  • Which age group accounts for the major share of the diagnosed CHF population?
  • Which Class of CHF is the largest contributor to the total CHF patient pool among all the four NYHA Classes?
  • What factors are contributing to the rise in the prevalence rate of Heart failure?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

  • What are the current options for the treatment of CHF? What are the current guidelines for treating CHF in the US and Europe?
  • How many companies are developing therapies for the treatment of CHF?
  • How many emerging therapies are in the mid-stage and late stage of development for treating CHF?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • What are the key designations that have been granted for emerging therapies for CHF?
  • What is the cost burden of approved therapies on the patient?
  • What are the key designations that have been granted for emerging therapies for CHF?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
  • What is the 7MM historical and forecasted market of CHF?

Reasons to Buy:

  • The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the CHF market.
  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the Conjoint analysis section to provide visibility around leading classes.
  • Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
Product Code: DIMI0055

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 by Countries (%) Distribution of CHF in 2020 in the 7MM
  • 4.2. Market Share by Countries (%) Distribution of CHF in 2034 in the 7MM

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
  • 13.5. 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

Product Code: DIMI0055

List of Tables

  • Table 1: Summary of CHF Market and Epidemiology (2020-2034)
  • Table 2: Heart Failure Classification based on the New York Heart Association
  • Table 3: Heart Failure Classification based on the New York Heart Association
  • Table 4: Heart Failure Classification based on the American College of Cardiology
  • Table 5: Shift along the Frank-Starling Curve and Its Causes
  • Table 6: Characteristics of Other Biomarkers for HF
  • Table 7: Different test for the estimation of the HF
  • Table 8: Recommendation for Non-pharmacological intervention and lifestyle modification
  • Table 9: Recommendations for Clinical Assessment: History and Physical Examination
  • Table 10: Key Recommendations for Use of Biomarkers for Prevention, Initial Diagnosis, and Risk Stratification
  • Table 11: Key Recommendations for Genetic Evaluation and Testing
  • Table 12: Key Recommendations for Evaluation with Cardiac Imaging
  • Table 13: Key Recommendations for Invasive Evaluation
  • Table 14: Key Recommendations for Patients at Risk for Heart Failure (Stage A: Primary Prevention)
  • Table 15: Key Recommendations for Management of Stage B: Preventing the Syndrome of Clinical Heart Failure In Patients With Pre-heart Failure
  • Table 16: Key Recommendations for Nonpharmacological Interventions
  • Table 17: Key Recommendations for Pharmacological Treatment for HFrEF
  • Table 18: Key Recommendations for Heart Failure with Mildly Reduced Ejection Fraction
  • Table 19: Key Recommendations for Heart Failure with Improved Ejection Fraction
  • Table 20: Key Recommendations for HFpEF
  • Table 21: Classes of Recommendations
  • Table 22: Recommendation for the Treatment of Patients with Symptomatic Heart Failure with Mildly Reduced Ejection Fraction
  • Table 23: Recommendation for the Treatment of Patients with Symptomatic HFpEF
  • Table 24: Recommendation for Pre-discharge and Early Post-discharge Follow-up of Patients Hospitalized for Acute Heart Failure
  • Table 25: Recommendations for the Prevention of Heart Failure in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease
  • Table 26: Recommendations for the Management of Iron Deficiency in Patients with Heart Failure
  • Table 27: Recommendations for Measuring Biomarkers in HF
  • Table 28: Recommendations for Managing Blood Pressure in HF
  • Table 29: Recommendations for Renin-Angiotensin System Inhibition With ACE Inhibitor or ARB or ARNI
  • Table 30: Recommendation for Ivabradine
  • Table 31: Total Diagnosed Prevalent Cases of Heart Failure in the 7MM (2020-2034)
  • Table 32: Total Diagnosed Prevalent Cases of Heart Failure in the US (2020-2034)
  • Table 33: Gender-specific Cases of Heart Failure in the US (2020-2034)
  • Table 34: Ejection Fraction-specific Cases of Heart Failure in the US (2020-2034)
  • Table 35: NYHA Class-specific Cases of Heart Failure in the US (2020-2034)
  • Table 36: Type-specific Cases of Heart Failure in the US (2020-2034)
  • Table 37: Age-specific Cases of Heart Failure in the US (2020-2034)
  • Table 38: Total Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK (2020-2034)
  • Table 39: Gender-specific Cases of Heart Failure in the US (2020-2034)
  • Table 40: Ejection Fraction-specific Cases of Heart Failure in EU4 and the UK in '000s (2020-2034)
  • Table 41: NYHA Class-specific Cases of Heart Failure in EU4 and the UK in '000s (2020-2034)
  • Table 42: Type-specific Cases of Heart Failure in EU4 and the UK in '000s (2020-2034)
  • Table 43: Age-specific Cases of Heart Failure in EU4 and the UK in '000s (2020-2034)
  • Table 44: Total Diagnosed Prevalent Cases of Heart Failure in Japan (2020-2034)
  • Table 45: Gender-specific Cases of Heart Failure in Japan (2020-2034)
  • Table 46: Ejection Fraction-specific Cases of Heart Failure in Japan (2020-2034)
  • Table 47: NYHA Class-specific Cases of Heart Failure in Japan (2020-2034)
  • Table 48: Type-specific Cases of Heart Failure in Japan (2020-2034)
  • Table 49: Age-specific Cases of Heart Failure in Japan (2020-2034)
  • Table 50: Key Competitor
  • Table 51: VERQUVO (vericiguat), Clinical Trial Description, 2024
  • Table 52: Comparison of Emerging Drugs Under Development
  • Table 53: Omecamtiv Mecarbil, Clinical Trial Description, 2024
  • Table 54: KERENDIA (finerenone), Clinical Trial Description, 2024
  • Table 55: Tirzepatide (LY3298176), Clinical Trial Description, 2024
  • Table 56: CardiAMP Cell Therapy, Clinical Trial Description, 2024
  • Table 57: Ziltivekimab (NN6018), Clinical Trial Description, 2024
  • Table 58: REVASCOR (rexlemestrocel-L), Clinical Trial Description, 2024
  • Table 59: Levosimendan (TNX-103), Clinical Trial Description, 2024
  • Table 60: Semaglutide, Clinical Trial Description, 2024
  • Table 61: Balcinrenone (AZD9977) + dapagliflozin, Clinical Trial Description, 2024
  • Table 62: Mitiperstat (AZD4831), Clinical Trial Description, 2024
  • Table 63: Vicadrostat (BI 690517) + Empagliflozin, Clinical Trial Description, 2024
  • Table 64: Cimlanod (CXL-1427/BMS-986231), Clinical Trial Description, 2024
  • Table 65: Lenrispodun (ITI - 214), Clinical Trial Description, 2024
  • Table 66: CRD-740, Clinical Trial Description, 2024
  • Table 67: HU6, Clinical Trial Description, 2024
  • Table 68: Key Market Forecast Assumption of CHF in the United States
  • Table 69: Key Market Forecast Assumption of CHF in EU4 and the UK
  • Table 70: Key Market Forecast Assumption of CHF in Japan
  • Table 71: Total Market Size of CHF in the 7MM, in USD million (2020-2034)
  • Table 72: Total Market Size of CHF in the United States, in USD million (2020-2034)
  • Table 73: Market Size of CHF by Therapies in the United States, in USD million (2020-2034)
  • Table 74: Total Market Size of CHF in EU4 and the UK, in USD million (2020-2034)
  • Table 75: Market Size of CHF by Therapies in EU4 and the UK, in USD million (2020-2034)
  • Table 76: Total Market Size of CHF in Japan, in USD million (2020-2034)
  • Table 77: Market Size of CHF by Therapies in Japan, in USD million (2020-2034)
  • Table 78: Reimbursement in the EU4
  • Table 79: Medical service rendered (SMR) - The Spanish Agency of Medicines and Medical Devices (AEMPS)
  • Table 80: Medical Service Rendered (SMR) - The Spanish Agency of Medicines and Medical Devices (AEMPS)
  • Table 81: Improvement of Medical Service Rendered (ASMR)- The Spanish Agency of Medicines and Medical Devices (AEMPS)

List of Figures

  • Figure 1: Different Conditions in Heart Failure
  • Figure 2: Stages of Heart Failure
  • Figure 3: Symptoms of Heart Failure
  • Figure 4: Different Classes of Drug
  • Figure 5: Total Diagnosed Prevalent Cases of Heart Failure in the 7MM (2020-2034)
  • Figure 6: Total Diagnosed Prevalent Cases of Heart Failure in the US (2020-2034)
  • Figure 7: Gender-specific Cases of Heart Failure in the US (2020-2034)
  • Figure 8: Ejection Fraction-specific Cases of Heart Failure in the US (2020-2034)
  • Figure 9: NYHA Class-specific Cases of Heart Failure in the US (2020-2034)
  • Figure 10: Type-specific Cases of Heart Failure in the US (2020-2034)
  • Figure 11: Age-specific Cases of Heart Failure in the US (2020-2034)
  • Figure 12: Total Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK (2020-2034)
  • Figure 13: Gender-specific Cases of Heart Failure in EU4 and the UK (2020-2034)
  • Figure 14: Ejection Fraction-specific Cases of Heart Failure in EU4 and the UK (2020-2034)
  • Figure 15: NYHA Class-specific Cases of Heart Failure in EU4 and the UK (2020-2034)
  • Figure 16: Type-specific Cases of Heart Failure in EU4 and the UK (2020-2034)
  • Figure 17: Age-specific Cases of Heart Failure in EU4 and the UK (2020-2034)
  • Figure 18: Total Diagnosed Prevalent Cases of Heart Failure in Japan (2020-2034)
  • Figure 19: Gender-specific Cases of Heart Failure in Japan (2020-2034)
  • Figure 20: Ejection Fraction-specific Cases of Heart Failure in Japan (2020-2034)
  • Figure 21: NYHA Class-specific Cases of Heart Failure in Japan (2020-2034)
  • Figure 22: Type-specific Cases of Heart Failure in Japan (2020-2034)
  • Figure 23: Age-specific Cases of Heart Failure in Japan (2020-2034)
  • Figure 24: Total Market Size of CHF in the 7MM (2020-2034)
  • Figure 25: Total Market Size of CHF in the United States (2020-2034)
  • Figure 26: Market Size of CHF by Therapies in the United States (2020-2034)
  • Figure 27: Total Market Size of CHF in EU4 and the UK (2020-2034)
  • Figure 28: Market Size of CHF by Therapies in EU4 and the UK (2020-2034)
  • Figure 29: Total Market Size of CHF in Japan (2020-2034)
  • Figure 30: Market Size of CHF by Therapies in Japan (2020-2034)
  • Figure 31: Unmet Needs
  • Figure 32: Health Technology Assessment
  • Figure 33: Reimbursement Process in Germany
  • Figure 34: Reimbursement Process in France
  • Figure 35: Reimbursement Process in Italy
  • Figure 36: Reimbursement Process in Spain
  • Figure 37: Reimbursement Process in the United Kingdom
  • Figure 38: Reimbursement Process in Japan
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