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시장보고서
상품코드
2082992
복수 : 시장 인사이트, 역학 및 예측(2036년)Ascites - Market Insight, Epidemiology, and Market Forecast - 2036 |
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본 '복수' 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, 복수 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입률 분석을 평가하는 한편, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서는 복수 분야에서 주요 미충족 수요 사항을 부각시키고, 경쟁 구도 및 임상 현황을 분석함으로써 고부가가치의 성장 기회를 도출하며, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
복수의 유병률 증가는 시장 성장의 주요 촉진요인이며, 알코올 관련 간 질환, 바이러스성 간염, 대사 기능 장애 관련 지방간 질환(MASLD)을 포함한 만성 간 질환의 부담 확대가 이를 뒷받침하고 있습니다. 특히 남성 환자나 고령층에서 간기능 부전 발생률이 증가함에 따라, 효과적인 복수 관리 및 치료법에 대한 수요가 높아질 것으로 예측됩니다.
텔리프레신(BIV-201), 도칼파민(CIQUAAX), PHIN-214 및 기타 임상시험용 의약품과 같은 새로운 치료법의 등장은 복수 시장의 주요 성장 동력이 될 것으로 예측됩니다. 현재 복수에 대해 FDA 승인을 받은 질환 수정 요법은 존재하지 않으므로, 개발 기업에게는 미충족 의료 수요가 높은 이 분야에서 최초의 표적 치료법을 확립할 수 있는 큰 기회가 있습니다. 임상적 유효성을 입증하고 규제 당국의 승인을 획득한 기업은 조기 시장 침투, 의료진의 적극적인 채택, 프리미엄 가격 책정 가능성, 그리고 거의 개척되지 않은 치료 분야에서의 리더십 등, 상당한 선점 우위를 확보할 가능성이 있습니다. 그 결과, 임상 개발 활동의 활성화로 인해 예측 기간 동안 경쟁이 심화되고 시장 성장이 촉진될 것으로 예측됩니다.
복수의 개요와 진단
복수란 복강 내에 체액이 비정상적으로 축적되는 것을 특징으로 하는 임상적 상태이며, 가장 흔한 원인으로는 간경변, 문맥압 상승증, 악성 종양, 심부전, 감염증 등의 기저 질환이 있습니다. 이러한 상태는 정수압과 온코틱 압력의 불균형, 그리고 나트륨 및 수분의 저류로 인해 발생하며, 복강 내 체액의 점진적인 축적으로 이어집니다. 복수는 진행된 만성 간 질환과 가장 빈번하게 연관되어 있지만, 광범위한 기저 질환(전신성 및 복강 내 질환)에서 발생할 가능성이 있습니다. 주로 만성 간질환, 알코올성 간손상, 바이러스성 간염 또는 악성 종양이 있는 환자에게 영향을 미치며, 그 중증도는 기저 질환의 진행 정도와 관련된 합병증에 따라 달라집니다.
복수는 영상 검사 및 복수 검사를 보완하는 임상 검사를 통해 진단됩니다. 주요 검사에는 복부 초음파 검사 및 복수 검사(SAAG, 단백질, 세포 수, 배양)를 동반한 진단적 천자 외에도, 근본적인 원인을 규명하고 치료 방침을 결정하기 위한 간 기능 및 신장 기능 검사가 포함됩니다.
복수 치료
복수 치료의 주요 목표는 체액 저류를 줄이고, 증상을 완화하며, 합병증을 예방하고, 삶의 질을 향상시키며, 문맥고혈압증 및 간 질환의 근본 원인을 관리하는 것입니다. 치료에는 일반적으로 식이 요법을 통한 나트륨 제한, 수분 관리, 그리고 스피로노락톤이나 플로세미드와 같은 이뇨제를 이용한 치료가 포함됩니다. 장성 복수나 난치성 복수의 경우, 알부민 수액 요법을 병행한 대량 천자가 일반적으로 시행됩니다. 또한, 자발성 세균성 복막염의 경우 항생제를 투여하는 경우가 있습니다. 난치성 증례의 경우, TIPS(경정맥적 문맥압 저하술)를 통해 문맥압을 낮추고 복수 재발을 억제할 수 있습니다. 대사 기능 부전을 동반한 간경변증 환자나 재발성 또는 치료 저항성 복수를 보이는 환자에게 있어, 간 이식은 여전히 유일한 근치적 치료법입니다.
복수에 관한 역학적 분석 및 예측의 주요 결과
복수 치료 시장은 점차 변화하고 있으며, 나트륨 제한, 이뇨제, 대량 천자, 간 이식 등 기존의 증상 관리 접근법에서 진행성 간 질환에서 체액 저류의 근본 원인이 되는 혈역학적 및 병태생리학적 기전을 해결하는 것을 목표로 하는 표적 치료로 전환되고 있습니다. 지속 주입형 바소프레신 유사체나 문맥 고혈압, 신기능 장애, 순환 이상을 표적으로 하는 기타 치료법을 포함한 신약 개발은 장기적인 질환 관리 개선, 재발 감소, 그리고 질환 진행 지연에 대한 관심이 높아지고 있음을 반영하고 있습니다. 이러한 발전으로 인해 혁신적인 복수 치료법에 대한 임상계와 규제 당국의 관심이 높아지고 있으며, 이는 향후 경쟁 구도를 재편하고 있습니다.
BIV-201, CIQUAAX, PHIN-214 등 개발 중인 후보 약물과 그 밖의 새로운 치료법의 지속적인 발전에 따라, 복수 치료 분야는 질환 특이적이고 기전에 기반한 중재 방식으로 진화하고 있습니다.
전반적으로, 복수에 대해 특별히 적응증이 승인된 FDA 승인 치료법의 부족, 만성 간 질환 유병률 증가, 간경변과 관련된 합병증에 대한 인식 제고, 그리고 혁신적인 의약품 개발에 대한 지속적인 투자가 예측 기간 동안 시장 성장을 견인할 것으로 예상되며, 신흥 치료법과 향후 승인될 치료법 모두에게 큰 상업적 기회가 창출될 것으로 전망됩니다.
전반적으로 볼 때, 현재의 복수 관리에는 여전히 지지 요법이 주를 이루고 있지만, 순환 기능 장애나 신경호르몬 경로를 표적으로 하는 새로운 치료법이 등장하고 있으며, 이러한 치료법들은 증상 관리의 개선, 재발 감소, 그리고 난치성 복수의 근본적인 기전에 대한 대응을 목표로 하는 미래의 혁신을 주도하고 있습니다.
DelveInsight's 'Ascites- Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Ascites, historical and forecasted epidemiology, as well as the Ascites market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Ascites market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, Ascites 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 Ascites 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 Ascites Market
The increasing prevalence of ascites is a key driver of market growth, fueled by the expanding burden of chronic liver diseases, including alcohol-associated liver disease, viral hepatitis, and metabolic dysfunction-associated steatotic liver disease (MASLD). The growing incidence of hepatic decompensation, particularly among male patients and the aging population, is expected to increase the demand for effective ascites management and treatment options.
The emergence of novel therapies such as terlipressin (BIV-201), docarpamine (CIQUAAX), PHIN-214, and other investigational agents is expected to be a key driver of the Ascites market. With no FDA-approved disease-modifying therapies currently available for ascites, developers have a significant opportunity to establish the first targeted treatment in this high-unmet-need space. Companies that successfully demonstrate clinical benefit and secure regulatory approval could gain substantial first-mover advantages, including early market penetration, strong physician adoption, premium pricing potential, and leadership in a largely untapped therapeutic landscape. As a result, increasing clinical development activity is expected to intensify competition and stimulate market growth over the forecast period.
Ascites Overview and Diagnosis
Ascites is a clinical condition characterized by the abnormal accumulation of fluid within the peritoneal cavity, most commonly resulting from underlying liver disease such as cirrhosis, portal hypertension, malignancies, heart failure, or infections. The condition develops due to imbalances in hydrostatic and oncotic pressures, along with sodium and water retention, leading to progressive fluid buildup in the abdomen. Ascites is most frequently associated with advanced chronic liver disease but can occur across a wide range of underlying systemic and intra-abdominal disorders. It primarily affects individuals with chronic hepatic conditions, alcohol-related liver injury, viral hepatitis, or malignancy, with severity influenced by the progression of the underlying disease and associated complications.
Ascites is diagnosed through clinical examination supported by imaging and Ascitic fluid analysis. Key investigations include abdominal ultrasound and diagnostic paracentesis with fluid studies (SAAG, protein, cell count, and culture), along with liver and renal function tests to identify the underlying cause and guide management.
Ascites Treatment
The primary goals of ascites treatment are to reduce fluid accumulation, relieve symptoms, prevent complications, improve quality of life, and manage the underlying cause of portal hypertension or liver disease. Management typically includes dietary sodium restriction, fluid management, and diuretic therapy with agents such as spironolactone and furosemide. Large-volume paracentesis with albumin infusion is commonly used for tense or refractory ascites, while antibiotics may be administered for spontaneous bacterial peritonitis. In patients with refractory disease, TIPS can help reduce portal pressure and control fluid recurrence. Liver transplantation remains the only definitive treatment for patients with decompensated cirrhosis and recurrent or treatment-resistant ascites.
Ascites Unmet Needs
The section "unmet needs of Ascites" 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 Ascites Epidemiological Analysis and Forecast
Ascites Drug Chapters & Competitive Analysis
The Ascites drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the Ascites treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the Ascites therapeutics market.
Approved Therapies for Ascites
Ascites remains a significant unmet medical need due to the absence of FDA-approved therapies specifically indicated for its treatment and the limitations of current management approaches, creating substantial opportunities for innovative therapeutic development and future clinical advancements.
Ascites Pipeline Analysis
Terlipressin (BIV-201): BioVie
Terlipressin (BIV-201), developed by BioVie, is an investigational continuous-infusion formulation of terlipressin being evaluated for ascites, hepatorenal syndrome (HRS), and other complications of advanced liver cirrhosis. Designed to provide sustained vasoconstrictive activity, BIV-201 aims to improve efficacy and tolerability compared with conventional dosing approaches. It is initially being developed for ascites, a major complication of decompensated cirrhosis with no FDA-approved drug therapy currently available. The therapy has received FDA Fast Track designation, Orphan Drug designations for ascites and HRS, and US patent protection, underscoring its potential to address significant unmet needs in advanced liver disease.
Docarpamine (CIQUAAX): Martin Pharmaceuticals/Mitsubishi Tanabe Pharma Corporation (MTPC)
Docarpamine (CIQUAAX), developed by Martin Pharmaceuticals, is an investigational oral therapy for the treatment of refractory ascites and other complications associated with advanced chronic liver disease. The therapy is being evaluated for its ability to reduce ascites accumulation and decrease the need for repeated large-volume paracentesis procedures by modulating neurohumoral pathways involved in fluid regulation. CIQUAAX aims to provide a non-invasive treatment option that improves symptom control, enhances quality of life, and addresses a significant unmet need in patients with decompensated liver disease.
Ascites Key Players, Market Leaders and Emerging Companies
Ascites Drug Updates
Drug Class Insights
The Ascites market is undergoing a gradual transformation, moving beyond conventional symptom-management approaches such as sodium restriction, diuretics, large-volume paracentesis, and liver transplantation toward targeted therapies aimed at addressing the underlying hemodynamic and pathophysiological mechanisms of fluid accumulation in advanced liver disease. The development of novel agents, including continuous-infusion vasopressin analogs and other therapies targeting portal hypertension, renal dysfunction, and circulatory abnormalities, reflects a growing focus on improving long-term disease control, reducing recurrence, and delaying disease progression. These advancements are increasing clinical and regulatory interest in innovative ascites treatments and reshaping the future competitive landscape.
With the continued advancement of pipeline candidates such as BIV-201, CIQUAAX, PHIN-214, and other emerging therapies, the ascites treatment landscape is evolving toward more disease-specific and mechanism-driven interventions.
Overall, the lack of FDA-approved therapies specifically indicated for ascites, increasing prevalence of chronic liver diseases, growing awareness of cirrhosis-related complications, and continued investment in innovative drug development are expected to drive market growth during the forecast period, creating significant commercial opportunities for both emerging therapies and future approved treatments.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Ascites (2022-2036 Forecast)
The ascites treatment landscape comprises diuretics, vasopressin receptor agonists, aldosterone synthase inhibitors, and other hemodynamic-modulating therapies, each targeting key mechanisms involved in sodium retention, fluid accumulation, and circulatory dysfunction associated with advanced liver disease.
Overall, current ascites management remains largely supportive, while emerging therapies targeting circulatory dysfunction and neurohormonal pathways are driving future innovation aimed at improving symptom control, reducing recurrence, and addressing the underlying mechanisms of refractory ascites.
Ascites 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 Ascites market's uptake by drugs, patient uptake by therapy, and sales of each drug.
Market Access and Reimbursement of Ascites
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.
Ascites Therapies Price Scenario & Trends
Pricing and analogue assessment of Ascites therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.
Industry Experts and Physician Views for Ascites
To keep up with Ascites 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 Ascites 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 Ascites, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of Mississippi Medical Center, University of Bologna, and Teikyo University School of Medicine, etc. were contacted. Their opinion helps understand and validate current and emerging Ascites therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in Ascites.
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 Ascites, 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
7.3.. Causes of Ascites
7.8.. Treatment and Management
7.8.1.. Basic Management of Ascites
7.8.2.. Treatment of the underlying disorder
7.8.3.. Dietary sodium restriction
7.8.4.. Fluid restriction
7.8.5.. Diuretics
7.8.6.. The daily limit for weight loss
7.8.7.. Management of refractory Ascites
7.8.8.. Grades of Ascites and Management Strategy
7.9.. Treatment Algorithm for Ascites and Malignant Ascites
7.9.1.. Treatment Algorithm for Ascites
7.9.2.. Treatment Algorithm for Malignant Ascites
7.9.3.. British Society of Gastroenterology and the British Association for the Study of the Liver Guidelines
7.9.4.. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis
7.9.5.. American Association for the Study of Liver Diseases (AASLD) Management of Adult Patients with Ascites Due to Cirrhosis: Update 2012