The publisher's "Congestive Heart Failure (CHF) - Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the CHF, historical and forecasted epidemiology as well as the CHF market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The CHF market report provides current treatment practices, emerging drugs, CHF market share of the individual therapies, current and forecasted CHF market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current CHF treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
Study Period: 2019-2032
Patients with heart failure can present with a challenging array of comorbid medical conditions. GPs have an important role in recognizing and managing these, to ensure that heart failure therapies are not compromised and that only necessary medications are prescribed.
The signs and symptoms of HF are subtle at the initial stage, and these are generally misguided for common signs of aging. The common symptoms of HF are because of the extra fluid or congestion which leads to blocking of the vessels. The starting of the congestion in the lungs is carry forwarded to the different parts of the body.
Currently, the treatment regimen of heart failure involves the use of ACE inhibitors, Angiotensin II receptor blockers (ARBs), Mineralocorticoid receptor antagonists (MRAs), If-Channel Inhibitor, Beta-blockers, ARNIs, diuretics, digitalis, dinitrate and many others, which are prescribed as either monotherapy or in most cases as combination with each other. Apart from Amgen’s Corlanor and Novartis’s Blockbuster therapy Enteresto, which has now became a part of current standard of care in CHF patients, there are few other extremely potential and recently approved therapies such as Jardiance, Verquvo, and Farxiga that are expected to bring a rise in the Heart Failure market.
CHF market is expected to witness a significant growth rate owing to rising prevalence of heart failure cases due to rapidly aging population and growing awareness among people, market penetration in CHF due to label expansion, and entry of new emerging therapies.
The CHF epidemiology division provides insights about historical and current CHF patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
The disease epidemiology covered in the report provides historical as well as forecasted CHF epidemiology [segmented as total prevalent cases of CHF, total diagnosed prevalent cases of CHF, age-specific prevalence of CHF, gender-specific cases of CHF, NYHA class-specific diagnosed prevalent cases of CHF, diagnosed prevalent cases of Heart Failure with Ejection Fraction cases of CHF and diagnosed prevalent cases of Heart Failure associated with comorbidities cases of CHF in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.
Estimates show that the highest cases of CHF in the 7MM were in the United States, followed by Japan, Germany, the United Kingdom, Italy, France, and Spain in the year 2021.
Drug chapter segment of the CHF report encloses the detailed analysis of CHF marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to 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.
Note: Detailed Current therapies assessment will be provided in the full report of CHF
Drug chapter segment of the CHF report encloses the detailed analysis of CHF marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to 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.
Other products in development include AZD4831 by AstraZeneca, Lenrispodun (ITI - 214) by Intra-Cellular Therapies, Sotagliflozin by Lexicon Pharmaceuticalsand and others.
Note: Detailed emerging therapies assessment will be provided in the final report.
HF is generally defined as a complex clinical syndrome categorized by distinct symptoms and signs which is caused by structural and functional cardiac aberrations. However, at present, the common term for describing heart failure is based on left ventricular ejection fraction. Also, HF with normal LVEF (≥ 50%) is known as HFpEF, and HF with decreased LVEF (< 40%) as HFrEF. HF with a 40 - 49% middle range is known as heart failure with mid-range ejection fraction (HFmrEF). But as of recent guidelines, HFmrEF is considered as a separate unit, but the epidemiology, treatment, pathophysiology, and prognosis of HFmrEF are quite unclear.
The total market size of CHF in the United States is expected to increase with a CAGR of 10.27% in the study period (2019 - 2032).
The total market size of CHF in the Japan is expected to increase with a CAGR of 9.75% in the study period (2019 - 2032).
Analyst Commentary
Otsuka Pharmaceutical is currently developing for OPC-61815 which is a novel compound that is an orally available antagonist of the vasopressin V2-receptor. The company has also submitted a New Drug Application (NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to seek manufacturing and marketing approval of OPC-61815 for the treatment of cardiac edema. If this drug candidate is approved for use as an intravenous diuretic, it will provide a new treatment option for patients with cardiac edema who cannot take tolvaptan orally. The company has completed two Phase III trials of the drug in CHF patients in Japan. The drug is anticipated to enter the US market in 2023 and the EU and Japanese market in 2023 and 2022, respectively, having a peak share of 3%.
Note: Detailed emerging therapies assessment will be provided in the final report.
The CHF market report provides current treatment practices, emerging drugs, CHF market share of the individual therapies, current and forecasted CHF market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current CHF treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Study Period: 2019-2032
CHF Disease Understanding and Treatment Algorithm
Heart Failure (HF) often referred to as Congestive heart failure (CHF), is a serious condition, and usually there’s no cure. But many people with heart failure lead a full, enjoyable life when the condition is managed with heart failure medications and healthy lifestyle changes.Patients with heart failure can present with a challenging array of comorbid medical conditions. GPs have an important role in recognizing and managing these, to ensure that heart failure therapies are not compromised and that only necessary medications are prescribed.
The signs and symptoms of HF are subtle at the initial stage, and these are generally misguided for common signs of aging. The common symptoms of HF are because of the extra fluid or congestion which leads to blocking of the vessels. The starting of the congestion in the lungs is carry forwarded to the different parts of the body.
Currently, the treatment regimen of heart failure involves the use of ACE inhibitors, Angiotensin II receptor blockers (ARBs), Mineralocorticoid receptor antagonists (MRAs), If-Channel Inhibitor, Beta-blockers, ARNIs, diuretics, digitalis, dinitrate and many others, which are prescribed as either monotherapy or in most cases as combination with each other. Apart from Amgen’s Corlanor and Novartis’s Blockbuster therapy Enteresto, which has now became a part of current standard of care in CHF patients, there are few other extremely potential and recently approved therapies such as Jardiance, Verquvo, and Farxiga that are expected to bring a rise in the Heart Failure market.
CHF market is expected to witness a significant growth rate owing to rising prevalence of heart failure cases due to rapidly aging population and growing awareness among people, market penetration in CHF due to label expansion, and entry of new emerging therapies.
CHF Epidemiology
The CHF epidemiology division provides insights about historical and current CHF patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings
The disease epidemiology covered in the report provides historical as well as forecasted CHF epidemiology [segmented as total prevalent cases of CHF, total diagnosed prevalent cases of CHF, age-specific prevalence of CHF, gender-specific cases of CHF, NYHA class-specific diagnosed prevalent cases of CHF, diagnosed prevalent cases of Heart Failure with Ejection Fraction cases of CHF and diagnosed prevalent cases of Heart Failure associated with comorbidities cases of CHF in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.
Country Wise CHF Epidemiology
Estimates show that the highest cases of CHF in the 7MM were in the United States, followed by Japan, Germany, the United Kingdom, Italy, France, and Spain in the year 2021.
- The total prevalent cases of Heart Failure in 2021 in the 7MM were estimated to be 16,630,560, out of which the highest prevalent cases of this disease were seen in the United States i.e. 6,543,570.
- As per the the publisher analysis, the total diagnosed prevalent cases of HF in Japan were found to be 894,093 cases in 2021 which are expected to increase during the study period.
- According to the analysis, in 2021, the estimated cases of HF were 2,512,731 in males and 2,722,125 in females in the US
- In 2021, the United States accounted for 157,569, 261,743, 729,215, 1,204,017, 1,630,259 and 1,252,053 for the age group < 44 years, 45-54 years, 55-64 years, 65-74 years, 75-84 years and ≥85 years.
- In 2021, the estimated cases of Heart failure with preserved and medium ejection fraction (HFpEF and HFmEF) and Heart failure with reduced ejection fraction (HFrEF) were 3,140,914 and 2,093,942 respectively in the US.
- There were 2,669,777, 1,533,813, 523,486, and 523,486 cases respectively, of NHYA-class I, class II, class III and class IV, in the US in 2021.
- As per the estimates in 2021, 3,891,069, 2,268,263, 1,005,092, 1,648,980, 1,609,718, 3,140,914 and 2,093,942 cases were observed in Hypertension, Diabetes Mellitus, Chronic Kidney Disease, Atrial Fibrillation, COPD, Ischemic heart disease and dilated cardiomyopathy.
- The total diagnosed prevalent cases of HF in EU5 were found to be 6,671,149 cases in 2021. Among the EU5 countries, the highest diagnosed prevalent cases of Heart Failure was found to be in Germany with 2,258,512 cases, followed by Spain with 1,305,726 cases in 2021. On the other hand, the UK had the least diagnosed prevalent cases of Heart Failure, with 741,205 cases in 2021. These numbers are expected to increase during the study period (2019-2032).
- as per the publisher's estimates, Japan accounted for 1,192,124 prevalent cases of CHF in 2021.
CHF Drug Chapters
Drug chapter segment of the CHF report encloses the detailed analysis of CHF marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to 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 Drugs
Entresto (Novartis)
Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes. Sacubitril is a neprilysin inhibitor. Valsartan, on the other hand, is an angiotensin II receptor blocker, also known as ARB. The drug keeps blood vessels from contracting and helps in decreasing the blood pressure, and progresses blood flow. The company is planning for the regulatory submission for CHF in pediatric patients in 2022 in the EU region and for post-AMI in 2021. In February 2021, Novartis announced that the US FDA had approved the following expanded indication for Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with CHF.Jardiance (Boehringer Ingelheim and Eli Lilly)
Jardiance is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. Sodium-glucose cotransporter 2 (SGLT2) is the predominant transporter responsible for the reabsorption of glucose from the glomerular filtrate back into circulation. Eli Lilly and Company in its annual report announced that the company applied for regulatory submission in Japan in 2020 for Heart failure with reduced ejection fraction. In August 2021, the company announced that the US FDA had approved Jardiance (empagliflozin) 10 mg to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with HFrEF.Verquvo (Bayer and Merck)
Verquvo is a soluble guanylate cyclase (sGC) stimulator, indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic HF and ejection fraction less than 45%. In January 2021, Bayer announced that the US FDA approved soluble guanylate cyclase (sGC) stimulator vericiguat under the brand name Verquvo to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic CHF and ejection fraction less than 45%.Farxiga (AstraZeneca)
Farxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated in adults to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. In May 2020, AstraZeneca’s Farxiga (dapagliflozin) was approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).Corlanor (Amgen)
Ivabradine comes under the brand name Corlanor, a new heart rate lowering medicine used as the symptomatic treatment in the case of stable angina pectoralis and chronic heart failure. The drug helps lower heart rate by selectively inhibiting if channels in the heart through a concentration-dependent method but does not affect any other cardiac ionic channels. The drug is also approved under the brand name Procoralan in Europe for patients with heart failure. In May 2019, the US FDA approved the use of Corlanor to treat stable symptomatic HF due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.Note: Detailed Current therapies assessment will be provided in the full report of CHF
CHF Emerging Drugs
Drug chapter segment of the CHF report encloses the detailed analysis of CHF marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to 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.
OPC-61815 (Otsuka Pharmaceutical)
OPC-61815 is a prodrug of oral tolvaptan (tolvaptan sodium phosphate), with improved water solubility, and is considered suitable for intravenous administration. Tolvaptan, discovered by Otsuka, is a novel compound that is an orally available antagonist of the vasopressin V2-receptor. It inhibits water reabsorption at the renal collecting duct, thereby enhancing water diuresis (aquaresis) without depletion of electrolytes. The company has also submitted a New Drug Application (NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to seek manufacturing and marketing approval of OPC-61815 for the treatment of cardiac edema.Omecamtiv Mecarbil (Cytokinetics)
Omecamtiv mecarbil (AMG 423, CK-1827452) is a small molecule drug that is administered orally. It is currently in Phase III trial and was under development by Amgen in collaboration with Cytokinetics and Servier for the treatment of CHF. The drug works by increasing cardiac contractility by specifically activating the enzymatic domain of the cardiac myosin heavy chain. It also helps in generating the force of the motor protein in the cardiac sarcomere. In May 2020, the US FDA granted Fast Track designation for omecamtiv mecarbil, which is being developed for the potential treatment of HFrEF. The drug is currently in a second Phase III (METEORIC-HF) study to evaluate its potential to increase exercise performance in HFrEF, for which results are expected in 2H 2022. Furthermore, the company announced FDA acceptance of NDA for Omecamtiv Mecarbil for the treatment of heart failure with reduced ejection fraction with a PDUFA target action date set for November 2022Rexlemestrocel-L (Mesoblast)
Rexlemestrocel-L (Revascor) is a Phase III product candidate being developed to treat advanced and end-stage chronic heart failure. Revascor consists of 150 million mesenchymal precursor cells (MPCs) administered by direct injection into the heart muscle in patients suffering from CHF and progressive loss of heart function. MPCs release a range of factors when triggered by specific receptor-ligand interactions within the damaged tissue. Based on preclinical data, it is believed that these factors induce functional cardiac recovery by simultaneous activation of multiple pathways, including induction of endogenous vascular network formation, reduction in harmful inflammation, reduction in cardiac scarring and fibrosis, and regeneration of heart muscle through activation of tissue precursors. In June 2019, the US FDA granted rexlemestrocel-L an Orphan Drug Designation to prevent post-implantation mucosal bleeding in end-stage chronic heart failure patients who require a left ventricular assist device (LVAD). Mesoblast has completed a Phase III trial. Based on the observed reduction in mortality and morbidity in this Phase III trial, it intends to meet with the FDA to discuss a potential approval pathway.Finerenone (Bayer)
Finerenone (Kerendia/BAY 94-8862) is an investigational novel, nonsteroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to block many of the harmful effects of mineralocorticoid receptor (MR) overactivation, which is a major driver of kidney and heart damage. The drug is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes (FDA, 2021). The anticipated patent expiration of Finerenone (Kerendia) is 2029. The drug is currently in a Phase III trial in patients with heart failure and left ventricular ejection fraction greater or equal to 40%.Semaglutide (Novo Nordisk)
Semaglutide 2.4 mg injection is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). In June 2021, the US FDA approved the once-weekly semaglutide (Wegovy) injection in the US for chronic weight management. It is the first and only once-weekly GLP-1 receptor agonist therapy approved for weight management for people living with obesity. The drug is currently in a phase III trial in patients living with heart failure and obesity (STEP HFpEF) and in another phase III trial in patients living with heart failure, obesity and type 2 diabetes (STEP HFpEF DM).Other products in development include AZD4831 by AstraZeneca, Lenrispodun (ITI - 214) by Intra-Cellular Therapies, Sotagliflozin by Lexicon Pharmaceuticalsand and others.
Note: Detailed emerging therapies assessment will be provided in the final report.
CHF Market Outlook
HF is generally defined as a complex clinical syndrome categorized by distinct symptoms and signs which is caused by structural and functional cardiac aberrations. However, at present, the common term for describing heart failure is based on left ventricular ejection fraction. Also, HF with normal LVEF (≥ 50%) is known as HFpEF, and HF with decreased LVEF (< 40%) as HFrEF. HF with a 40 - 49% middle range is known as heart failure with mid-range ejection fraction (HFmrEF). But as of recent guidelines, HFmrEF is considered as a separate unit, but the epidemiology, treatment, pathophysiology, and prognosis of HFmrEF are quite unclear.
- Currently, the treatment of heart failure is dependent 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, nitrates, among others, are used for the treatment of patients affected by heart failure.
- Diuretics are commonly prescribed as symptomatic relief for the treatment of patients affected by heart failure. The drugs get free of the excess fluids, which cause swollen legs, shortness of breath, weight gain, and coughing. Some examples of diuretics are chlorthalidone, ethacrynic acid (Edecrin), and furosemide (Lasix), among others.
- Entresto (sacubitril/valsartan) developed by Novartis is a first-in-class angiotensin receptor/neprilysin inhibitor approved and marketed for the treatment of chronic heart failure with reduced ejection fraction (HFrEF). Recently, in February 2021, Novartis announced that the US FDA had approved the following expanded indication for Entresto (sacubitril/valsartan) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with CHF.
- Jardiance by Boehringer Ingelheim and Eli Lilly is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults genital or perineal area, along with fever or malaise, to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease and to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduce ejection fraction. It is approved in US and EU for heart failure.
- Verquvo by Bayer and Merck is a soluble guanylate cyclase (sGC) stimulator, indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic HF and ejection fraction less than 45%. It is approved in US, EU, and Japan for heart failure.
- Farxiga by AstraZeneca is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated in adults as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors, to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHA class II - IV) and to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. It is approved in the US, EU, and Japan for heart failure.
- Corlanor (Ivabradine) developed by Amgen helps lower heart rate by selectively inhibiting If channels in the heart through a concentration-dependent method but does not affect any other cardiac ionic channels. This drug got approval in March 2012 by EMA for the treatment of heart failure and in April 2015 by the US FDA to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with a left ventricular ejection fraction.
Key Findings
- The market size of CHF in the seven major markets is expected to rise from USD 7,412 million in 2021 during the study period (2019 - 2032).
- The United States accounts for the largest market size of CHF compared to EU5 (Germany, the United Kingdom, Italy, France, and Spain) and Japan.
- In the United States, the market size of CHF is anticipated to rise from USD 4,484 million in 2021 during the forecast period.
- Among the EU5 countries, Germany had the largest market size (USD 887 million) in 2021, while UK had the smallest with USD 273 million.
- In 2021, Japan accounted for a market size of USD 346 million.
The United States Market Outlook
The total market size of CHF in the United States is expected to increase with a CAGR of 10.27% in the study period (2019 - 2032).
EU-5 Countries: Market Outlook
The total market size of CHF in EU5 is expected to increase with a CAGR of 10.31% in the study period (2019 - 2032).Japan Market Outlook
The total market size of CHF in the Japan is expected to increase with a CAGR of 9.75% in the study period (2019 - 2032).
Analyst Commentary
- The approval of three new candidates since 2020 has recently crowded the heart failure market where only two drugs were approved earlier.
- The approval of Entresto to include patients with HFpEF will definitely provide an upper hand to the drug in the current market where Boehringer Ingelheim and Eli Lilly, and AstraZeneca are still struggling to find approval in the same patient population. But, as per the recently published results, Jardiance might overthrow Entresto from the market as the study found a 21% reduction in the risk of cardiovascular death or hospitalization for heart failure, the composite primary outcome, with Jardiance plus standard of care versus standard of care alone as compared to 13% benefit seen with Novartis’s Entresto in its HFpEF study. Based on these results, in September 2021, Boehringer Ingelheim and Eli Lilly and Company announced the US FDA had granted Breakthrough Therapy designation for empagliflozin as an investigational treatment for adults with HFpEF. Based on Phase III EMPEROR-Preserved trial.
- The expanded approval of Jardiance is anticipated to rule over Entresto and Farxiga in the HFpEF segment.
- The current pipeline landscape is robust, the entry of pharmaceutical firms exploring novel medicines for CHF in the future label extension of currently approved medications can contribute to the overall market size.
- To summarize, various possible treatments for the management of CHF will be researched in the near future, and it is safe to expect that the therapeutic space will suffer substantial influence throughout the forecast period, 2022 - 2032.
CHF Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the CHF market or expected to get launched in the market during the study period 2019-2032. The analysis covers CHF market uptake by drugs; patient uptake by therapies; and sales of each drug. For example-Otsuka Pharmaceutical is currently developing for OPC-61815 which is a novel compound that is an orally available antagonist of the vasopressin V2-receptor. The company has also submitted a New Drug Application (NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to seek manufacturing and marketing approval of OPC-61815 for the treatment of cardiac edema. If this drug candidate is approved for use as an intravenous diuretic, it will provide a new treatment option for patients with cardiac edema who cannot take tolvaptan orally. The company has completed two Phase III trials of the drug in CHF patients in Japan. The drug is anticipated to enter the US market in 2023 and the EU and Japanese market in 2023 and 2022, respectively, having a peak share of 3%.
Note: Detailed emerging therapies assessment will be provided in the final report.
CHF Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses CHF key players involved in developing targeted therapeutics.Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for CHF emerging therapies.Reimbursement Scenario in CHF
- The Novartis Patient Assistance Foundation (NPAF) is committed to providing access to Novartis medications for those most in need. If patients are experiencing financial hardship and have limited or no prescription coverage, they may be eligible to receive Novartis medications for free.
- With the Jardiance Savings Card, patients could pay as little as USD 10 per month. For patients with Medicare Part D who also qualify for the Extra Help program, the average cost is between USD 4 and USD 10 a month. Medicare beneficiaries can qualify for Extra Help paying for their monthly premiums, annual deductibles, and co-payments related to Medicare Part D (prescription drug coverage). Patients on Medicaid have co-pay costs that range from USD 0 to USD 10 a month, on average. Patients with Veterans Administration prescription coverage pay a co-pay of USD 11 for a 30-day supply of Jardiance.
- The Merck Patient Assistance Program provides certain medicines and adult vaccines free of charge to eligible individuals who do not have insurance or whose insurance does not cover their prescription Merck products. The Merck Access Program may be able to help answer questions related to insurance coverage and financial assistance options for certain Merck products.
- With the Corlanor Copay Card, patients may lower their out-of-pocket costs and pay as little as USD 20 per month, subject to a maximum dollar limit.
- To apply for the coupon of Verquvo, eligible, privately insured patients may pay as little as USD 10 per prescription on each of up to 13 qualifying prescriptions.
KOL - Views
To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are President and Chief Executive Officer, Cytokinetics, Senior Vice President and Head of Research and Early Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals, AstraZeneca and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or CHF market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the CHF Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.Scope of the Report
- The report covers the descriptive overview of CHF, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
- Comprehensive insight has been provided into the CHF epidemiology and treatment in the 7MM
- Additionally, an all-inclusive account of both the current and emerging therapies for CHF are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
- A detailed review of CHF market; historical and forecasted is included in the report, covering drug outreach in the 7MM
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the global CHF market
Report Highlights
- In the coming years, CHF market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
- The companies and academics are working to assess challenges and seek opportunities that could influence CHF R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
- Major players are involved in developing therapies for CHF. Launch of emerging therapies will significantly impact the CHF market
- A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for CHF
- Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities
CHF Report Insights
- Patient Population
- Therapeutic Approaches
- CHF Pipeline Analysis
- CHF Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
CHF Report Key Strengths
- 11 Years Forecast
- 7MM Coverage
- CHF Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
CHF Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
Key Questions
Market Insights:
- What was the CHF drug class share (%) distribution in 2019 and how it would look like in 2032?
- What would be the CHF total market size as well as market size by therapies across the 7MM during the forecast period (2019-2032)?
- What are the key findings pertaining to the market across 7MM and which country will have the largest CHF market size during the forecast period (2019-2032)?
- At what CAGR, the CHF market is expected to grow in 7MM during the forecast period (2019-2032)?
- What would be the CHF market outlook across the 7MM during the forecast period (2019-2032)?
- What would be the CHF market growth till 2032, and what will be the resultant market Size in the year 2032?
- How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
- What is the disease risk, burden and regional/ethnic differences of the CHF?
- What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What is the historical CHF patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- What would be the forecasted patient pool of CHF in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
- Where will be the growth opportunities in the 7MM with respect to the patient population pertaining to CHF?
- Out of all CHF countries, which country would have the highest prevalent population of CHF during the forecast period (2019-2032)?
- At what CAGR the patient population is expected to grow in 7MM during the forecast period (2019-2032)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
- What are the current options for the CHF treatment in addition to the approved therapies?
- What are the current treatment guidelines for the treatment of CHF in the USA, Europe, and Japan?
- What are the CHF marketed drugs and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
- How many companies are developing therapies for the treatment of CHF?
- How many therapies are in-development by each company for CHF treatment?
- How many are emerging therapies in mid-stage, and late stage of development for CHF treatment?
- What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the CHF therapies?
- What
Table of Contents
1. Key Insights2. Report Introduction3. Executive Summary4. Key Events5. SWOT Analysis12. American College of Cardiology (ACC), American Heart Association (AHA), and HF Society of America (HFSA) (2021)17. Organizations contributing towards CHF18. Patient Journey21. Potential of Current Therapies and Emerging Therapies23. Market Drivers24. Market Barriers25. Unmet Needs26. Market Access and Reimbursement28. Capabilities29. Disclaimer30. About the Publisher
6. Congestive Heart Failure (CHF) Market Overview at a Glance
7. Disease Background and Overview
8. Treatment
9. Heart Failure with Preserved Ejection Fraction: Diagnosis and Management (2017)
10. ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure (2021)
11. JCS/JHFS 2021 Guideline Focused Update on Diagnosis and Treatment of Acute and Chronic Heart Failure (Update From 2017)
13. Chronic Heart Failure in Adults: Diagnosis and Management (NICE Guidelines 2018)
14. Acute heart failure: Diagnosis And Management (NICE Guidelines 2014)
15. Epidemiology and Patient Population
16. Country Wise-Epidemiology of HF
19. Marketed Drugs
20. Emerging Drugs
22. Congestive Heart Failure (CHF): Seven Major Market Analysis
27. Appendix
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Novartis
- Boehringer Ingelheim and Eli Lilly
- Bayer and Merck
- AstraZeneca
- Amgen
- Otsuka Pharmaceutical
- Cytokinetics
- Mesoblast
- Novo Nordisk
- Lexicon Pharmaceuticals
- scPharmaceuticals
- Bristol-Myers Squibb
- Intra-Cellular Therapies
- Tenax Therapeutics
- BioCardia