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시장보고서
상품코드
2082940
울혈성 심부전(CHF) : 시장 인사이트, 역학 및 시장 예측(2036년)Congestive Heart Failure - Market Insights, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
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.
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.
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.
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.
CHF에 대한 역학적 분석 및 예측을 통해 도출된 주요 결과
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.
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
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.
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.
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.
Key Findings from CHF Epidemiological Analysis and Forecast
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.
CHF Key Players, Market Leaders and Emerging Companies
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.
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.
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.
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.
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.
Market Insights