PUBLISHER: DelveInsight | PRODUCT CODE: 1605434
PUBLISHER: DelveInsight | PRODUCT CODE: 1605434
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.
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).
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
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
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.
Key Updates
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:
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.
CHF Market Insights
CHF Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies