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울혈성 심부전(CHF) : 시장 인사이트, 역학 및 시장 예측(2036년)

Congestive Heart Failure - Market Insights, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 324 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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울혈성 심부전(CHF)에 대한 인사이트와 동향

  • 심부전은 65세 이상 고령자의 주요 입원 원인 중 하나이며, 임상적·경제적으로 큰 부담이 되고 있습니다. 현재 심부전 관리에는 안지오텐신 전환 효소(ACE) 억제제, 안지오텐신 II 수용체 길항제(ARB), 미네랄코르티코이드 수용체 길항제(MRA), I_f 채널 억제제, β-차단제, 디곡신, 질산염 및 기타 지지 요법을 포함한 다약제 병용 요법에 기반을 두고 있으며, 이들은 단일 요법으로 또는 보다 일반적으로 병용 요법으로 환자의 예후를 개선하기 위해 사용되고 있습니다.
  • 유럽에서는 심부전 유병률이 남성보다 여성에서 더 높은 경향을 보이지만, 미국에서는 그 경향이 정반대입니다.
  • 2025년, 일본에서 심부전 진단을 받은 환자 수는 536만 6,000명이었으나, 2036년까지 증가할 것으로 예측됩니다. 2022년부터 2036년까지의 예측 기간 동안, 일본 내 심부전 확진 환자 총수는 연평균 성장률(CAGR)이 플러스를 기록하며 증가할 것으로 예측됩니다.
  • 미국 및 세계 각국의 주요 심혈관 학회는 INPEFA와 같은 SGLT 억제제를 모든 박출률 유형에 걸친 심부전의 핵심 치료법으로 권장하고 있습니다.
  • INPEFA(소타글리플로진, Lexicon Pharmaceuticals), JARDIANCE(엠파글리플로진, 베링거 인겔하임/일라이 릴리), FARXIGA(다파글리플로진, 아스트라제네카) 등, 미래가 기대되는 여러 치료제가 최근 출시됨에 따라 전 세계 심부전 시장에 긍정적인 영향을 미칠 것으로 전망됩니다.
  • 심부전 치료 파이프라인에는 심근 조직의 재생과 심기능 개선을 목표로 하는 중기부터 후기 단계의 세포 치료법이 점점 더 많이 포함되고 있습니다. 주요 후보로는 BioCardia사의 CardiAMP 세포 치료법(자가 골수 유래 세포) 및 CardiALLO 세포 치료법(동종 중간엽 줄기세포), Secretome Therapeutics사의 STM-01(신생아 심장 전구세포), Salubris Biotherapeutics사의 JK-07(ERBB4 수용체 작용제) 등이 있습니다. 이러한 치료법은 자가 유래에서 동종 유래에 이르기까지, 또한 중간엽계에서 다능성 줄기세포 계통에 이르기까지 다양한 기술적 접근 방식을 대표하며, 심부전 환자의 심장 구조적·기능적 회복이라는 미충족 의료 수요를 해결하는 것을 목표로 하고 있습니다.
  • 그 밖에도 유망한 임상시험 후보로는 오메카무티브·메카르빌(Cytokinetics사), CRD-740 및 CRD-750(Cardurion Pharmaceuticals사), AZD5462(아스트라제네카사 및 타나베 미쓰비시 제약) 등이 있습니다.
  • FDA는 2025년 7월, 심부전이며 좌심실 박출률(LVEF)이 40% 이상인 성인 환자(HFmrEF 및 HFpEF)의 치료제로 KERENDIA(피네레논)를 승인했습니다. 이는 박출률이 유지되고 있는 심부전 및 중등도의 박출률을 보이는 심부전의 치료에 있어 큰 진전을 이루었습니다.

주요 7개국에서의 울혈성 심부전(CHF) 시장 규모 및 전망

  • 2025년 CHF 시장 규모 : 약 90억 달러
  • 2036년 CHF 시장 규모 전망: 약 190억 달러
  • CHF의 성장률(2026년-2036년) : 연평균 성장률(CAGR) 8%

본 CHF 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. CHF 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 CHF 분야의 주요 미충족 요구 사항에 초점을 맞추어, 경쟁 구도와 임상 현황을 분석함으로써 고부가가치의 성장 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

CHF 시장을 주도하는 주요 요인

  • 전 세계 질병 부담 증가

울혈성 심부전은 심기능 저하, 높은 발병률, 그리고 삶의 질 저하를 특징으로 하는 만성적이고 진행성인 질환으로, 전 세계적으로 심각하고 점점 더 커지고 있는 의료 부담이 되고 있습니다. 고령화, 심혈관 질환의 위험 요인(고혈압, 당뇨병 등) 증가, 그리고 급성 심장 질환의 생존율 향상으로 인한 유병률 상승은 의료 서비스 이용 증가와 장기적인 질환 관리 수요 증가에 기여하고 있습니다.

  • 울혈성 심부전 치료 기회의 확대

CHF의 치료 환경은 진단 및 모니터링 도구의 개선은 물론, 새로운 약물 요법(예: ARNI, SGLT2 억제제), 의료기기를 활용한 중재, 그리고 맞춤형 관리 접근법의 개발을 통해 발전하고 있습니다. 인식 제고, 임상 지침의 발전, 연구 투자 증가는 혁신을 가속화하여 질환 관리 개선과 환자 예후 향상을 위한 기회를 확대되고 있습니다.

울혈성 심부전(CHF)의 이해와 치료 알고리즘

CHF 개요 및 진단

만성 심부전은 일반적으로 심실의 수축 기능 또는 이완 기능 장애로 인해, 충만압을 상승시키지 않으면 신체 수요를 충족시키기에 충분한 혈액을 펌프질할 수 없는 진행성 질환이며, 좌심실 박출률(LVEF)에 따라 저하형(<40%), 보존형(>=50%), 중간형(40-49%)으로 분류됩니다. 초기 증상은 종종 경미하여 노화의 탓으로 오해되기 쉬우나, 일반적으로 호흡 곤란, 피로감, 그리고 폐울혈이나 말초 부종을 유발하는 체액 저류 등이 포함됩니다. 진단에는 임상 평가 외에도 검사(BNP/NT-proBNP 포함), 심전도(ECG), 그리고 흉부 X선 및 심초음파 검사 등의 영상 검사가 실시됩니다. 이를 통해 심부전이 확인되고, 박출률이 측정되며, 병기 분류 및 치료 방침 결정에 활용됩니다.

CHF의 치료

현재 CHF의 치료는 안지오텐신 전환 효소 억제제, 안지오텐신 II 수용체 길항제, 베타 차단제, 이뇨제에 의존하고 있습니다. 또한, 알도스테론 길항제, 아미오다론, 항혈소판제, 항응고제, 칼슘 채널 차단제, 이뇨제, 질산염 등 그 밖의 치료법들도 심부전 환자의 치료에 사용되고 있습니다. 또한, 심부전 치료는 지속적인 과정으로 인식해야 합니다. 일반적으로 초기 치료에서는 생활 습관 개선(금연, 알코올·카페인·스트레스 피하기, 수분 섭취량 제한, 식사 시 염분 섭취량 줄이기) 및 필요한 약물 요법의 최적화에 중점을 둡니다. 치료의 다음 단계에서는 더 강력한 약물 요법, 심박조율기 및 이식형 제세동기(ICD)와 같은 의료기기의 삽입이 포함될 수 있습니다.

CHF의 역학

CHF에 대한 역학적 분석 및 예측을 통해 도출된 주요 결과

  • Mauro 등(2023)에 따르면, 급성 심부전 환자 중 상당수(35-40%에 가까운 비율)는 좌심실 박출률(LVEF)의 저하가 나타나지 않습니다. LVEF가 유지되고 있는 환자는 대개 고령(평균 연령 75세)이며, 여성 비율이 높은(환자의 60% 가까이) 경향이 있습니다.
  • CHF는 65세 이상 인구의 주요 입원 원인이며, 임상적·경제적 부담을 크게 초래하고 있습니다. 심부전의 분류는 좌심실 박출률(LVEF)에 따라 이루어지며, HFrEF(40% 이하), HFmrEF(41-49%), HFpEF(50% 이상)로 분류됩니다. 환자의 거의 절반이 HFmrEF 또는 HFpEF로 진단받고 있지만, 이러한 유형에 대한 효과적인 치료법은 여전히 제한적입니다.
  • 2025년 기준으로, 미국에서는 HFpEF 환자가 약 459만 7,000명, HFrEF 환자가 약 212만 8,000명, 경증 박출률 저하형 심부전(HFmrEF) 환자가 약 75만 8,000명이었습니다.
  • 유럽에서는 심부전 유병률이 남성보다 여성에서 더 높은 경향을 보이지만, 미국에서는 그 경향이 정반대입니다. EU4 국가 중 2025년 만성 심부전(CHF)으로 진단받은 환자 수가 가장 많았던 나라는 독일이었으며, 그 다음으로 프랑스와 스페인이 뒤를 이었고, 가장 적었던 나라는 이탈리아였습니다.

CHF 시장 전망

10년 이상 지속된 혁신의 정체기를 거친 후, 울혈성 심부전(CHF)에 대한 몇 가지 새로운 치료법이 승인되었습니다. 여기에는 베리시구아트(VERQUVO), 사큐비트릴/발살탄(ENTRESTO, ARNI), 이바브라진(CORLANOR)이 포함되며, 이들 모두 종합적인 치료의 일환으로 사용되고 있습니다. 또한 최근에는 철결핍증 치료제인 페리카르복시말토스(INJECTAFER/FERINJECT)와 심혈관 위험을 감소시키는 소타글리플로진(INPEFA) 등이 추가되었습니다. 다파글리플로진(FARXIGA)이나 엠파글리플로진(JARDIANCE)과 같은 SGLT2 억제제는 입원 위험과 사망 위험을 낮춤으로써 치료 성과를 더욱 향상시키고 있습니다. 전반적으로, 현재 심부전(CHF)의 치료 환경에는 다양하고 내약성이 좋은 치료법이 포함되어 있으며, 최근 적응증 확대로 인해 더 폭넓은 환자 집단에 적용할 수 있게 되었습니다.

많은 대기업들이 CHF 치료를 위한 다양한 작용기전에 대한 연구 개발에 투자하고 있으며, SGLT2 억제제, 심근 미오신 활성화제, 미엘로퍼옥시다제 억제제, 미네랄코르티코이드 수용체 길항제, GLP-1 수용체 작용제, 세포 치료법 등이 있습니다. 이러한 요인들은 앞으로 CHF 시장을 더욱 확대시킬 것입니다. 결론적으로, CHF 환자 치료를 위한 새로운 파이프라인에는 CHF 치료 분야에 도입될 경우 상당한 시장 점유율을 확보할 잠재력을 지닌 유망한 의약품 및 세포 치료법이 다수 포함되어 있습니다. 앞으로 큰 변화를 가져올 가능성이 있는 유망한 의약품 및 세포 치료제로는 비카드로스타트+엠파글리플로진(베링거 인겔하임), 세마글루티드 및 질티베키맙(노보 노르디스크), 오메캄티브 메칼빌(사이토키네틱스), REVASCOR((렉스레메스트로셀-L) 메소블라스트), 바르신레논+다파글리플로진 및 미티펠스타트(아스트라제네카), 틸제파티드((LY3298176) 일라이 릴리 앤드 컴퍼니), CardiAMP 세포 치료제(바이오카르디아), KERENDIA((피네레논), 바이엘), CRD-740(칼듀리온 파마슈티컬스) 등이 각각 임상 개발의 서로 다른 단계에서 주력 후보 약물의 평가를 진행하고 있습니다. 바이엘(KERENDIA(피네레논)) 등의 주요 기업, 바이오카디아(CardiAMP 세포 치료제), 메소블라스트(REVASCOR(렉스레메스트로셀-L)), sc 파마슈티컬스(FUROSCIX Infusor), 사이토키네틱스(오메카무티브·메카르빌), 렉시콘 파마슈티컬스(소타글리플로진) 등의 주요 기업들은 각각 임상 개발의 서로 다른 단계에서 주력 후보 약물의 평가를 진행하고 있습니다.

  • 주요 7개국의 심부전(CHF) 시장 규모는 2025년에 약 90억 달러로 추정되며, 예측 기간(2026년-2036년) 동안 긍정적인 연평균 성장률(CAGR)을 기록하며 2036년까지 견조한 성장이 예상됩니다.
  • 추산에 따르면, 환자 수가 많고 치료비가 비교적 높은 점을 고려할 때, 2036년까지 미국이 CHF 시장에서 가장 큰 비중을 차지할 것으로 보이며, 그 뒤를 독일과 프랑스가 이을 것으로 예측됩니다.
  • G7 국가 중 미국은 CHF 시장에서 가장 큰 시장 규모를 차지하고 있었습니다. 2025년 총 시장 규모는 65억 달러였습니다. 새로운 치료법의 등장으로 인해, CHF 시장 규모는 2022년부터 2036년에 걸쳐 확대될 것으로 전망됩니다.
  • 저분자 화합물: CHF의 치료법에는 신경호르몬 활성화, 체액 과다, 심기능 장애 등 주요 병태생리학적 경로를 표적으로 하는 몇 가지 저분자 화합물이 포함됩니다. ACE 억제제, ARB, β-차단제, 미네랄코르티코이드 수용체 길항제, SGLT2 억제제 등의 이러한 약물은 심박출량을 개선하고, 울혈을 완화하며, 유해한 심장 리모델링을 억제하고, 전반적인 심혈관 기능을 향상시킴으로써 작용하여, 이를 통해 심부전 환자의 증상을 완화하고 입원 및 사망 위험을 감소시킵니다.

자주 묻는 질문

  • 울혈성 심부전(CHF) 시장 규모는 어떻게 예측되나요?
  • 울혈성 심부전(CHF) 치료에 사용되는 주요 약물은 무엇인가요?
  • 울혈성 심부전(CHF)의 주요 유병률은 어떻게 되나요?
  • 울혈성 심부전(CHF) 환자의 치료 환경은 어떻게 변화하고 있나요?
  • 울혈성 심부전(CHF) 치료에 대한 최근 FDA 승인 사항은 무엇인가요?
  • 울혈성 심부전(CHF) 치료를 위한 유망한 임상시험 후보는 무엇인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 울혈성 심부전 : 주요 요약

제4장 주요 이벤트

제5장 울혈성 심부전 : 시장 개요

제6장 역학 및 시장 예측 조사 방법

제7장 질환 배경과 개요

제8장 심부전 치료

제9장 심부전(CHF) 역학 및 환자 인구

제10장 심부전(CHF) 환자 경과

제11장 심부전(CHF) 시판 치료법

제12장 심부전 새로운 치료법

제13장 울혈성 심부전 : 주요 7개국 분석

제14장 울혈성 심부전 : 미충족 요구

제15장 울혈성 심부전 : SWOT 분석

제16장 KOL(Key Opinion Leader)의 견해

제17장 시장 참여 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight에 대해

LSH 26.07.27

Congestive Heart Failure (CHF) Insights and Trends

  • Heart failure is a leading cause of hospitalization among individuals aged >=65 years and represents a major clinical and economic burden. Current heart failure management is based on a multidrug therapeutic strategy that includes angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs), If-channel inhibitors, B-blockers, digoxin, nitrates, and other supportive therapies, which are used either as monotherapy or, more commonly, in combination to improve patient outcomes.
  • Females are more prevalent in Europe for heart failure than male but in the US, the trend is opposite.
  • In 2025, the number of diagnosed prevalent cases of heart failure in Japan was 5,366,000, which is likely to increase by 2036. The total diagnosed prevalent cases of heart failure in Japan is expected to increase at a positive CAGR during the forecast period, 2022-2036.
  • Leading cardiology societies in the US and globally recommend SGLT inhibitors, like INPEFA, as a core treatment for heart failure across all ejection fraction types.
  • Recent launches of several high-potential therapies such as INPEFA (sotagliflozin, Lexicon Pharmaceuticals), JARDIANCE (empagliflozin, Boehringer Ingelheim/Eli Lilly), FARXIGA (dapagliflozin, AstraZeneca), are expected to positively impact the global heart failure market.
  • The heart failure pipeline features a growing roster of mid- to late-stage cell therapies aiming to regenerate myocardial tissue and improve cardiac function. Key candidates include CardiAMP Cell Therapy (autologous bone marrow-derived cells) and CardiALLO Cell Therapy (allogeneic mesenchymal stem cells) from BioCardia, STM-01 (neonatal cardiac progenitor cells) from Secretome Therapeutics, and JK-07 (ERBB 4 receptor agonists) from Salubris Biotherapeutics, among others. These therapies represent diverse technological approaches ranging from autologous to allogeneic sources, and from mesenchymal to pluripotent stem cell lineages which are targeting the unmet need for structural and functional cardiac repair in heart failure.
  • Additional promising investigational candidates include omecamtiv mecarbil (Cytokinetics), CRD-740 and CRD-750 (Cardurion Pharmaceuticals), AZD5462 (AstraZeneca and Mitsubishi Tanabe Pharma), and others.
  • The FDA approved KERENDIA (finerenone) in July 2025, for the treatment of adult patients with heart failure and left ventricular ejection fraction (LVEF) >= 40% (HFmrEF and HFpEF), marking a significant advancement in therapy for preserved and mid-range ejection fraction heart failure.

Congestive Heart Failure (CHF) Market size and forecast in the 7MM

  • 2025 CHF Market Size: USD ~9,000 million
  • 2036 Projected CHF Market Size: USD ~19,000 million
  • CHF Growth Rate (2026-2036): 8% CAGR

DelveInsight's 'Congestive Heart Failure (CHF) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the CHF, historical and forecasted epidemiology, as well as the CHF market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The CHF market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, CHF patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in CHF and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the CHF Market

  • Rising Global Disease Burden

Congestive heart failure represents a substantial and increasing global healthcare burden as a chronic, progressive condition characterized by impaired cardiac function, high morbidity, and reduced quality of life. Rising prevalence driven by aging populations, increasing incidence of cardiovascular risk factors (e.g., hypertension, diabetes), and improved survival from acute cardiac events contributes to greater healthcare utilization and long-term disease management needs.

  • Rising Opportunities in Congestive Heart Failure

CHF treatment landscape is advancing with the development of novel pharmacologic therapies (e.g., ARNIs, SGLT2 inhibitors), device-based interventions, and personalized management approaches, alongside improved diagnostic and monitoring tools. Growing awareness, evolving clinical guidelines, and increased research investments are accelerating innovation and expanding opportunities for better disease control and patient outcomes.

Congestive Heart Failure (CHF) Understanding and Treatment Algorithm

CHF Overview and Diagnosis

Chronic heart failure is a progressive condition in which the heart cannot pump sufficient blood to meet the body's needs without increased filling pressures, usually due to impaired ventricular systolic or diastolic function, and is classified by left ventricular ejection fraction (LVEF) into reduced (<40%), preserved (>=50%), and mid-range (40-49%) categories. Early symptoms are often subtle and mistaken for aging, but commonly include breathlessness, fatigue, and fluid retention causing pulmonary congestion and peripheral edema. Diagnosis involves clinical assessment along with laboratory tests (including BNP/NT-proBNP), ECG, and imaging such as chest X-ray and echocardiography, which confirms heart failure, measures ejection fraction, and guides staging and 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 Unmet Needs

The section "unmet needs of CHF" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Need for tailored and effective treatment options

2. Need for timely diagnosis

3. Urgent need for prevention of heart failure in individuals at risk and others.....

CHF Epidemiology

Key Findings from CHF Epidemiological Analysis and Forecast

  • As per Mauro et al. (2023), a significant number of acute heart failure patients (nearly 35-40%) do not have reduced left ventricle ejection fraction (LVEF). Patients with preserved LVEF are usually older (mean age of 75 years) and more frequently female (nearly 60% of patients).
  • CHF is the leading hospitalization cause for those over 65, creating substantial clinical and economic burdens. Types of heart failure are based on left ventricular ejection fraction (LVEF): HFrEF (<=40%), HFmrEF (41-49%), and HFpEF (>=50%). With nearly half of patients diagnosed with HFmrEF or HFpEF, effective treatments for these types remain scarce
  • In 2025, there were ~4,597,000 patients affected with HFpEF, ~2,128,000 patient with HFrEF, and ~758,000 with Heart Failure with mildly reduced Ejection Fraction (HFmrEF) in the US.
  • Females are more prevalent in Europe for heart failure than male but in the US, the trend is opposite. 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 2025.

CHF Drug Analysis & Competitive Landscape

The CHF drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the CHF treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the CHF market.

Approved Therapies for CHF

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

INJECTAFER is an intravenous iron replacement therapy used to treat iron deficiency anemia (IDA), including in patients with congestive heart failure and chronic kidney disease. It works by replenishing iron stores, enabling effective hemoglobin production and improving oxygen transport (mechanism of action). Administered via intravenous infusion (route of administration), it is typically given in weight- and hemoglobin-based doses.

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.

CHF Pipeline Analysis

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.

CardiAMP Cell Therapy: BioCardia

CardiAMP cell therapy is designed to be a comprehensive biotherapeutic heart failure solution, incorporating a proprietary molecular diagnostic to characterize the potency of a patient's bone marrow cells and determine if they are an optimal candidate for therapy, a point-of-care processing platform to prepare cells at the patient's bedside. The Phase IIIB CardiAMP HF II Trial (NCT06258447) is actively enrolling in the US. The US FDA granted BTD for the CardiAMP cell therapy system to treat heart failure.

  • In November 2025, BioCardia announced that the first patient had been enrolled at Henry Ford Health in its ongoing Phase III CardiAMP HF II clinical trial for patients with ischemic HFrEF.
  • In October, 2025, BioCardia announced that the first patient had been enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase III CardiAMP HF II clinical trial.

CHF Key Players, Market Leaders and Emerging Companies

  • Novartis
  • Boehringer Ingelheim
  • Eli Lilly and Company
  • Bayer
  • Cytokinetics
  • BioCardia
  • Novo Nordisk and others.

CHF Drug Updates

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2022-2036. The landscape of rheumatoid arthritis 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, professionals, and the entire healthcare community in their tireless pursuit of advancing disease care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

  • In November 2025, BioCardia announced that the first patient had been enrolled at Henry Ford Health in its ongoing Phase III CardiAMP HF II clinical trial for patients with ischemic HFrEF.
  • In October, 2025, BioCardia announced that the first patient had been enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase III CardiAMP HF II clinical trial.
  • In April 2025, BioCardia announced that the study's independent Data Safety Monitoring Board (DSMB), which conducted a planned review of the 30-day safety data from the roll-in 20 million cell dosing cohort in the CardiALLO-HF trial, recommended that the study continue as designed.

CHF Market Outlook

After over a decade of limited innovation, several new therapies for congestive heart failure (CHF) have been approved, including vericiguat (VERQUVO), sacubitril/valsartan (ENTRESTO, an ARNI), and ivabradine (CORLANOR), all used as part of comprehensive treatment. More recent additions include ferric carboxymaltose (INJECTAFER/FERINJECT) for iron deficiency and sotagliflozin (INPEFA) to reduce cardiovascular risk. SGLT2 inhibitors like dapagliflozin (FARXIGA) and empagliflozin (JARDIANCE) further improve outcomes by lowering hospitalization and mortality risk. Overall, the CHF treatment landscape now includes diverse, well-tolerated therapies, with recent label expansions extending use to broader patient populations.

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 in the 7MM for CHF was estimated to be USD ~9,000 million in 2025, which is expected to show a positive growth by 2036 at a positive CAGR during the forecast period (2026-2036)
  • According to the estimates, the United States will account for the largest market size of CHF by 2036, owing to higher cases and comparatively higher treatment costs, followed by Germany and France.
  • Among the 7MM, the United States accounted for the largest market size for CHF. The total market size in 2025 was USD 6,500 million. Due to the emergence of novel therapies, the overall market size of CHF will experience an increase by 2036 from 2022 to 2036.

Drug Class/Insights into Leading Emerging and Marketed Therapies in CHF (2022-2036 Forecast)

The CHF market comprises targeted small molecules, and others alongside conventional and off-label therapies, each addressing distinct immunologic pathways and mechanisms underlying CHF.

  • Small molecules: CHF therapies include several small-molecule agents that target key pathophysiological pathways such as neurohormonal activation, fluid overload, and cardiac dysfunction. These agents such as ACE inhibitors, ARBs, beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors work by improving cardiac output, reducing congestion, modulating adverse cardiac remodeling, and enhancing overall cardiovascular function, thereby alleviating symptoms and reducing hospitalization and mortality risk in heart failure patients.

CHF Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the CHF drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in CHF

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.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report....

CHF therapies Price Scenario & Trends

Pricing and analogue assessment of CHF therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most approproiate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

  • Pricing of CHF Approved Drugs

The wholesale acquisition cost (WAC) for INPEFA is USD 598 per month in 2023, resulting in an annual cost of USD 7,176. INPEFA's price is comparable to JARDIANCE, which had a current list price of USD 570.48 per month in 2023, amounting to an annual cost of USD 6,846. This similarity in cost between the two drugs reflects comparable pricing strategies within their therapeutic class.

Industry Experts and Physician Views for CHF

To keep up with CHF market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the CHF emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in CHF, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights at country level. Centers such as the University of California, Imperial College London, Hokkaido University, and Cholangiocarcinoma Foundation, etc. were contacted. Their opinion helps understand and validate current and emerging CHF therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in CHF.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of CHF, 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.

Conjoint analysis analyzes 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.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of CHF, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on 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.

Report Insights

  • CHF Patient Population Forecast
  • CHF Therapeutics Market Size
  • CHF Pipeline Analysis
  • CHF Market Size And Trends
  • CHF Market Opportunity (current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) bottom-up forecasting
  • Artificial Intelligence (AI)-enabled market research report
  • 11-year forecast
  • CHF market outlook (North America, Europe, Asia-Pacific)
  • Patient Burden trends (by geography)
  • CHF Treatment addressable Market (TAM)
  • CHF Competitive Landscape
  • CHF major companies Insights
  • CHF price trends and analogue assessment
  • CHF therapies and Drug Adoption/Uptake
  • CHF therapies Peak Patient Share Analysis

Report Assessment

  • CHF Current treatment practices
  • CHF Unmet needs
  • CHF Clinical development Analysis
  • CHF Emerging drugs product profiles
  • CHF Market attractiveness
  • CHF Qualitative analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the CHF market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of CHF?
  • What are the disease risks, burdens, and unmet needs of CHF? What will be the growth opportunities across the 7MM concerning the patient population with CHF?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of CHF? What are the current guidelines for treating CHF in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the CHF market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to 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.
  • To understand KOLs' perspectives on 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.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets withing the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Heart Failure

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Collaborations and Transactions
  • 4.3. News Flow (Key Designations, Discontinuation, etc.)
  • 4.4. Key Conference Insights

5. Heart Failure Market Overview at a Glance

  • 5.1. Clinical Landscape Analysis (By Phase, RoA, and Molecule Type)
  • 5.2. Market Share (%) Distribution of Heart Failure by Therapies in 2025
  • 5.3. Market Share (%) Distribution of Heart Failure by Therapies in 2036

6. Epidemiology and Market Forecast Methodology

7. Disease Background and Overview

  • 7.1. Introduction
  • 7.2. Causes of Heart Failure
  • 7.3. Signs and Symptoms
  • 7.4. Stages of Heart Failure
  • 7.5. Classification of Heart Failure
  • 7.6. Biomarkers for the Heart Failure
  • 7.7. Diagnosis, Diagnostic Algorithm, and Differential Diagnosis
  • 7.8. Diagnostic Guidelines

8. Treatment of CHF

  • 8.1. Treatment Algorithm
  • 8.2. Guidelines
    • 8.2.1. European Society of Cardiology (ESC) Guidelines for the Diagnosis and Treatment of Acute and Heart Failure
    • 8.2.2. American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA)
    • 8.2.3. Japanese Circulation Society (JCS)/JHFS 2025 Guideline on Diagnosis and Treatment of Heart Failure

9. Epidemiology and Patient Population of CHF

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Total Diagnosed Prevalent Cases of Heart Failure in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Diagnosed Prevalent Cases of Heart Failure in the United States
    • 9.4.2. Gender-specific Diagnosed Prevalent Cases of Heart Failure in the United States
    • 9.4.3. Ejection Fraction-specific Diagnosed Prevalent Cases of Heart Failure in the United States
    • 9.4.4. NYHA Class-specific Diagnosed Prevalent Cases of Heart Failure in the United States
    • 9.4.5. Type-specific Diagnosed Prevalent Cases of Heart Failure in the United States
    • 9.4.6. Age-specific Diagnosed Prevalent 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 Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
    • 9.5.3. Ejection Fraction-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
    • 9.5.4. NYHA Class-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
    • 9.5.5. Type-specific Diagnosed Prevalent Cases of Heart Failure in EU4 and the UK
    • 9.5.6. Age-specific Diagnosed Prevalent 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 Diagnosed Prevalent Cases of Heart Failure in Japan
    • 9.6.3. Ejection Fraction-specific Diagnosed Prevalent Cases of Heart Failure in Japan
    • 9.6.4. NYHA Class-specific Diagnosed Prevalent Cases of Heart Failure in Japan
    • 9.6.5. Type-specific Diagnosed Prevalent Cases of Heart Failure in Japan
    • 9.6.6. Age-specific Diagnosed Prevalent Cases of Heart Failure in Japan

10. Patient Journey of CHF

11. Marketed Therapies of CHF

  • 11.1. Competitive Landscape Summary
  • 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. Summary of Pivotal Trial
    • 11.2.5. Safety and Efficacy
    • 11.2.6. Analyst Views
  • 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. Summary of Pivotal Trial
    • 11.3.5. Safety and Efficacy
    • 11.3.6. Analyst Views
  • 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. Summary of Pivotal Trial
    • 11.4.6. Safety and Efficacy
    • 11.4.7. Analyst Views
  • 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. Summary of Pivotal Trial
    • 11.5.5. Safety and Efficacy
    • 11.5.6. Analyst Views

12. Emerging Therapies of CHF

  • 12.1. Competitive Landscape Summary
  • 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 Heart Failure
    • 12.2.4. Safety and Efficacy
    • 12.2.5. Analyst Views
  • 12.3. Ziltivekimab (NN6018): Novo Nordisk
    • 12.3.1. Product Description
    • 12.3.2. Other Developmental Activities
    • 12.3.3. Clinical Development
      • 12.3.3.1. Clinical Trial Information in Heart Failure
    • 12.3.4. Safety and Efficacy
    • 12.3.5. Analyst Views
  • 12.4. CardiALLO Cell Therapy: BioCardia
    • 12.4.1. Product Description
    • 12.4.2. Other Developmental Activities
    • 12.4.3. Clinical Development
      • 12.4.3.1. Clinical Trial Information in Heart Failure
    • 12.4.4. Safety and Efficacy
    • 12.4.5. Analyst Views
  • 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 Heart Failure
    • 12.5.4. Safety and Efficacy
    • 12.5.5. Analyst Views

13. Heart Failure: Seven Major Market Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook
  • 13.3. Conjoint Analysis
  • 13.4. Key Market Forecast Assumptions
    • 13.4.1. Cost Assumptions and Rebates
    • 13.4.2. Pricing Trends
    • 13.4.3. Analogue Assessment
    • 13.4.4. Launch Year and Therapy Uptakes
  • 13.5. Total Market Size of Heart Failure in the 7MM
  • 13.6. The United States Market Size
    • 13.6.1. Total Market Size of Heart Failure in the United States
    • 13.6.1. Total Market Size of Heart Failure in the United States
    • 13.6.2. Market Size of Heart Failure by Therapies in United States
  • 13.7. EU4 and the UK Market Size
    • 13.7.1. Total Market Size of Heart Failure in EU4 and the UK
    • 13.7.2. Market Size of Heart Failure by Therapies in EU4 and the UK
  • 13.8. Japan Market Size
    • 13.8.1. Total Market Size of Heart Failure in Japan
    • 13.8.2. Market Size of Heart Failure by Therapies in Japan

14. Unmet needs of Heart Failure

15. SWOT Analysis of Heart Failure

16. KOL Views

17. Market Access and Reimbursement

  • 17.1. The 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
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. The United Kingdom
  • 17.3. Japan
    • 17.3.1. MHLW
  • 17.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Heart Failure Market Access and Reimbursement

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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