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2082992

복수 : 시장 인사이트, 역학 및 예측(2036년)

Ascites - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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복수에 대한 인사이트 및 동향

  • 복수 시장은 주요 시장 전체에서 꾸준한 성장이 예상되며, 조사 기간 동안 미국이 시장 규모에서 1위를 차지하고, 그 뒤를 EU4(독일, 프랑스, 이탈리아, 스페인), 영국, 일본 순으로 이어질 것으로 전망됩니다.
  • 복수로 인한 부담의 상당 부분은 성인에게 집중되어 있으며, 특히 남성이나 진행성 만성 간질환을 앓고 있는 환자에서 많이 나타납니다. 이를 통해 간 기능 장애의 조기 발견, 문맥 고혈압 및 체액 저류의 적시 진단, 효과적인 질환 관리에 대한 접근성 개선, 그리고 합병증, 입원 및 사망률을 줄이기 위한 표적화된 개입의 필요성이 부각되고 있습니다.
  • 복수 치료에는 주로 나트륨 섭취 제한, 스피로노락톤이나 플로세미드 등의 이뇨제, 알부민 보충을 동반한 대량 복수 천자, 그리고 체액 저류를 조절하고 합병증을 예방하기 위한 기초가 되는 간 질환 관리가 중심이 됩니다. 한편, 경경정맥 간내 문맥 체순환 우회술(TIPS)이나 간 이식은 시술에 수반되는 위험, 비용, 기증자 확보, 환자의 적격성 등의 제약이 있음에도 불구하고, 난치성 복수를 보이는 환자에게 여전히 중요한 선택지로 남아 있습니다.
  • 현재 복수에 특화된 승인된 질환 수정 요법은 존재하지 않으며, 치료는 주로 이뇨제, 나트륨 제한, 천자 배액 및 기저 간 질환의 관리에 의존하고 있습니다.
  • 개발 파이프라인은 여전히 제한적이며, 텔리프레신(BIV-201), 도칼파민(CIQUAAX), PHIN-214 등 개발 중인 신약 치료법이 몇 가지 있습니다. 이러한 임상시험용 의약품은 순환 기능 장애, 신장 관류 및 체액 균형 개선 가능성에 대해 평가되고 있으며, 난치성 또는 진행성 복수 환자의 중요한 미충족 의료 수요를 충족시키는 것입니다.

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.

복수 시장을 주도하는 주요 요인

  • 복수 유병률 증가

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.

  • 복수 시장의 새로운 경쟁 구도

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 이해와 치료 알고리즘

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.

복수의 역학

복수에 관한 역학적 분석 및 예측의 주요 결과

  • G7 국가 전체에서 간경변에 기인한 복수의 총 유병 수는 만성 간질환의 부담 증가, 알코올 관련 간 질환, MASLD, 바이러스성 간염의 발생률 상승, 그리고 진행성 간경변 환자의 생존율 향상을 배경으로, 조사 기간(2022-2036년)에 걸쳐 증가할 것으로 예측됩니다.
  • 주요 7개국 중 2025년 간경변으로 인한 복수 환자 수가 가장 많은 나라는 미국입니다.
  • EU4 및 영국 내에서 독일이 가장 높은 복수 유병률을 보고하고 있으며, 그 다음으로 영국, 프랑스 순입니다. 2025년 시점에서 유럽 국가들 중 스페인의 유병자 수가 가장 적은 것으로 밝혀졌습니다.
  • 2025년의 악성 복수증 환자 수는 난소암, 위암, 유방암 및 대장암을 기준으로 산출되었습니다. 미국에서는 이러한 암으로 인한 복수 환자 수에서 유방암이 가장 높은 비율을 차지했습니다.
  • 복수가 남성에게서 더 많이 나타나고 발병 연령도 이른 경향은 기저 간 질환의 조기 발견 및 관리, 표적화된 위험 감소 전략, 그리고 질환의 진행 및 관련 합병증을 예방하기 위한 조기 개입의 중요성을 여실히 보여주고 있습니다.

복수 시장 전망

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.

  • 추산에 따르면, 조사 기간 동안 주요 시장 중 미국이 복수 시장에서 가장 큰 점유율을 차지했습니다.
  • 복수 치료 시장은 이뇨제나 천자를 통한 대증 요법에서 표적 치료로 점차 전환되고 있습니다. BIV-201, CIQUAAX, PHIN-214 등의 신흥 후보 약물은 체액 관리를 개선하고, 난치성 복수 분야에서 중요한 미충족 의료 수요를 해결할 가능성이 있어 주목을 받고 있습니다.
  • 미국에서는 활발한 연구 활동과 진행성 간 질환의 부담 증가로 인해 복수 치료제 시장이 성장할 것으로 예측됩니다. 한편, 유럽과 일본에서는 확립된 의료 제도와 혁신적인 치료 옵션에 대한 수요가 증가함에 따라, 임상적 및 상업적 관심이 계속해서 이어지고 있습니다.
  • 이뇨제 및 표준 치료 : 현재의 치료는 주로 스피로노락톤이나 플로세미드와 같은 이뇨제에 의존하고 있습니다. 이들은 나트륨과 수분의 배설을 촉진하여 체액 과다를 완화하는 것으로, 난치성 환자의 경우 종종 복수 천자를 병행합니다.
  • 바소프레신 수용체 작용제 : 테릴프레신 아세테이트(BIV-201)와 같은 새로운 치료법은 바소프레신 수용체에 작용하여 내장 혈관 수축을 촉진하고, 유효 혈액량을 증가시켜, 보상 불능 간경변증에서 복수 형성의 병태생리학적 요인을 완화합니다.
  • 알도스테론 경로 조절제 및 신약 : CIQUAAX 및 PHIN-214와 같은 임상시험 후보 약물은 체액 저류에 관여하는 알도스테론 및 바소프레신 매개 경로를 조절하도록 설계되었으며, 복수 관리를 개선하고 침습적 시술에 대한 의존도를 낮추는 것을 목적으로 합니다.

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.

자주 묻는 질문

  • 복수 시장의 주요 성장 요인은 무엇인가요?
  • 복수 치료 시장의 현재 상황은 어떤가요?
  • 복수 치료에 대한 개발 파이프라인은 어떤 상태인가요?
  • 2025년 복수 환자 수는 어떻게 예측되나요?
  • 복수 치료 시장의 향후 전망은 어떤가요?
  • 복수 치료에 대한 주요 기업은 어디인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 역학 및 예측 조사 방법

제6장 복수 : 시장 개요

제7장 복수 : 질환 배경 및 개요

제8장 복수 : 역학 및 환자 인구

제9장 복수 : 환자 경과

제10장 신흥 치료제

제11장 복수 : 주요 7개국 분석

제12장 복수 : 미충족 수요

제13장 복수 : SWOT 분석

제14장 복수 : KOL(Key Opinion Leader)의 견해

제15장 복수 : 시장 참여 및 상환

제16장 부록

제17장 DelveInsight의 서비스 내용

제18장 면책사항

제19장 DelveInsight에 대해

KTH 26.07.24

Ascites Insights and Trends

  • The Ascites market is expected to witness steady growth across the major markets, with the United States leading in market size, followed by the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan during the study period.
  • A significant proportion of the Ascites burden is concentrated among adults, particularly males and individuals with advanced chronic liver disease, underscoring the need for earlier detection of liver dysfunction, timely diagnosis of portal hypertension and fluid accumulation, improved access to effective disease management, and targeted interventions to reduce complications, hospitalizations, and mortality.
  • The treatment of Ascites primarily involves sodium restriction, diuretics such as spironolactone and furosemide, large-volume paracentesis with albumin replacement, and management of the underlying liver disease to control fluid accumulation and prevent complications, while transjugular intrahepatic portosystemic shunt (TIPS) and liver transplantation remain important options for patients with refractory ascites despite limitations related to procedural risks, cost, donor availability, and patient eligibility.
  • Currently, there are no approved disease-modifying therapies specifically for Ascites, and treatment primarily relies on diuretics, sodium restriction, paracentesis, and management of underlying liver disease.
  • The pipeline remains limited, with a few emerging therapies under development, including Terlipressin (BIV-201), Docarpamine (CIQUAAX), and PHIN-214, among others. These investigational agents are being evaluated for their potential to improve circulatory dysfunction, renal perfusion, and fluid balance, addressing significant unmet needs in patients with refractory or advanced ascites.

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

  • Rising Ascites Prevalence

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.

  • Emerging Ascites Competitive Landscape

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 Understanding and Treatment Algorithm

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.

1. Late and under-diagnosis of early-stage ascites

2. Lack of reliable non-invasive diagnostic biomarkers

3. Poor long-term control of recurrent or refractory ascites

4. Limited options for diuretic-resistant patients, and others.....

Ascites Epidemiology

Key Findings from Ascites Epidemiological Analysis and Forecast

  • The total prevalent cases of Ascites due to cirrhosis across the 7MM is expected to increase throughout the study period (2022-2036), driven by the growing burden of chronic liver diseases, increasing rates of alcohol-related liver injury, MASLD, viral hepatitis, and improved survival of patients with advanced cirrhosis.
  • Among the 7MM, the United States has the highest prevalent cases of Ascites in 2025 due to cirrhosis.
  • Among the EU4 & UK, Germany reported the highest prevalent cases of Ascites, followed by UK and France. Spain was found to have the least cases in 2025 among all European countries.
  • In 2025, Malignant Ascites cases are calculated from ovarian cancer, stomach cancer, breast cancer, and colorectal cancer. Breast cancer accounted for the highest number of prevalent cases of Ascites from these cancers in the United States.
  • The observed male predominance and earlier onset of Ascites highlight the importance of timely identification and management of underlying liver disease, targeted risk-reduction strategies, and early intervention to prevent disease progression and associated complications.

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

  • BioVie
  • Martin Pharmaceuticals
  • PharmaIN, and others

Ascites Drug Updates

  • In December 2024, Martin Pharmaceuticals entered into a licensing agreement with Mitsubishi Tanabe Pharma Corporation (MTPC), securing exclusive rights outside Japan and China to access docarpamine-related toxicology, preclinical, clinical safety, and pharmacokinetic data for gastrointestinal indications, including ascites. Under the agreement, MTPC is eligible to receive an upfront payment, as well as future milestone payments and royalties.
  • In November 2024, Martin Pharmaceuticals announced that results from its DREAM study of CIQUAAX (oral docarpamine) would be presented at the 75th Annual Liver Meeting (AASLD 2024). The company also reported the allowance of a key US patent covering the use of CIQUAAX for the treatment of ascites, strengthening its intellectual property position and supporting the drug's development for advanced liver disease complications.

Drug Class Insights

Ascites Market Outlook

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.

  • According to the estimates, the United States accounted for the largest share of the Ascites market among the major markets during the study period.
  • The ascites market is shifting from symptomatic management with diuretics and paracentesis toward targeted therapies. Emerging candidates such as BIV-201, CIQUAAX, and PHIN-214 are attracting attention for their potential to improve fluid control and address significant unmet needs in refractory ascites.
  • The United States is expected to lead the ascites market due to strong research activity and a growing burden of advanced liver disease, while Europe and Japan continue to demonstrate clinical and commercial interest supported by established healthcare systems and increasing demand for innovative treatment options.

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.

  • Diuretics and Standard Therapies: Current management primarily relies on diuretics such as spironolactone and furosemide, which promote sodium and water excretion to reduce fluid overload, often supplemented by paracentesis in patients with refractory disease.
  • Vasopressin Receptor Agonists: Emerging therapies such as terlipressin acetate (BIV-201) act on vasopressin receptors to improve splanchnic vasoconstriction, enhance effective arterial blood volume, and reduce the pathophysiological drivers of ascites formation in decompensated cirrhosis.
  • Aldosterone Pathway Modulators and Novel Agents: Investigational candidates such as CIQUAAX and PHIN-214 are designed to modulate aldosterone- and vasopressin-mediated pathways involved in fluid retention, with the goal of improving ascites control and reducing dependence on invasive procedures.

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of Ascites, explaining its 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 Ascites 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 Ascites market.

Report Insights

  • Ascites Patient Population Forecast
  • Ascites Therapeutics Market Size
  • Ascites Pipeline Analysis
  • Ascites Market Size and Trends
  • Ascites 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
  • Ascites Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Ascites Treatment Addressable Market (TAM)
  • Ascites Competitive Landscape
  • Ascites Major Companies Insights
  • Ascites Price Trends and Analogue Assessment
  • Ascites Therapies Drug Adoption/Uptake
  • Ascites Therapies Peak Patient Share analysis

Report Assessment

  • Ascites Current Treatment Practices
  • Ascites Unmet Needs
  • Ascites Clinical Development Analysis
  • Ascites Emerging Drugs Product Profiles
  • Ascites Market Attractiveness
  • Ascites Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Ascites 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 Ascites?
  • What are the disease risks, burdens, and unmet needs of Ascites? What will be the growth opportunities across the 7MM concerning the patient population with Ascites?
  • 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 Ascites? What are the current guidelines for treating Ascites 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 Ascites 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 within 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

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Forecast Methodology

6. Ascites Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of Ascites By Therapies in the 7MM, in 2026
  • 6.3. Market Share (%) Distribution of Ascites By Therapies in the 7MM, in 2036

7. Disease Background and Overview of Ascites

  • 7.1. Introduction
  • 7.2. Types of ascites and underlying primary diseases

7.3.. Causes of Ascites

  • 7.4. Symptoms of Ascites
  • 7.5. Pathogenesis of Ascites
  • 7.6. Diagnosis of Ascites
  • 7.7. Diagnostic Guidelines of Ascites
    • 7.7.1. British Society of Gastroenterology and the British Association for the Study of the Liver Guidelines
    • 7.7.2. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis
    • 7.7.3. American Association for the Study of Liver Diseases (AASLD) Management of Adult Patients with Ascites Due to Cirrhosis

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

      • 7.10.1.1. Option if intolerant to spironolactone
      • 7.10.1.2. Medical treatment
      • 7.10.1.3. Serial large volume therapeutic paracenteses
      • 7.10.1.4. Transjugular intrahepatic portosystemic shunt (TIPS)
      • 7.10.1.5. Absolute Contraindications
      • 7.10.1.6. Relative Contraindications
      • 7.10.1.7. Liver Transplantation

8. Epidemiology and Patient Population of Ascites

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale
  • 8.3. Total Diagnosed Prevalent Cases of Ascites in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Prevalent Cases of Ascites due to Cirrhosis in United States
    • 8.4.2. Total Prevalent Cases of Ascites Cases by Malignancies in United States
    • 8.4.3. Severity-specific Prevalent Cases of Ascites due to Cirrhosis in United States
    • 8.4.4. Total Treated Cases of Ascites in United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Prevalent Cases of Ascites due to Cirrhosis in EU4 and the UK
    • 8.5.2. Total Prevalent Cases of Ascites Cases by Malignancies in EU4 and the UK
    • 8.5.3. Severity-specific Prevalent Cases of Ascites due to Cirrhosis in EU4 and the UK
    • 8.5.4. Total Treated Cases of Ascites in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Prevalent Cases of Ascites due to Cirrhosis in Japan
    • 8.6.2. Total Prevalent Cases of Ascites Cases by Malignancies in Japan
    • 8.6.3. Severity-specific Prevalent Cases of Ascites due to Cirrhosis in Japan
    • 8.6.4. Total Treated Cases of Ascites in Japan

9. Patient Journey of Ascites

10. Emerging Drugs

  • 10.1. Competitive landscape of emerging therapies
  • 10.2. Terlipressin (BIV-201): BioVie
    • 10.2.1. Drug Description
    • 10.2.2. Other Developmental Activities
    • 10.2.3. Clinical Development
      • 10.2.3.1. Clinical Trials Information
    • 10.2.4. Analyst's Views
  • 10.3. Docarpamine (CIQUAAX): Martin Pharmaceuticals/Mitsubishi Tanabe Pharma Corporation (MTPC)
    • 10.3.1. Drug Description
    • 10.3.2. Other Developmental Activities
    • 10.3.3. Clinical Development
      • 10.3.3.1. Clinical Trials Information
    • 10.3.4. Analyst's Views

11. Ascites: 7MM Analysis

  • 11.1. Key Findings
  • 11.2. Market Outlook
  • 11.3. Conjoint Analysis
  • 11.4. Key Market Forecast Assumptions
    • 11.4.1. Cost Assumptions
    • 11.4.2. Pricing Trends
    • 11.4.3. Analogue Assessment
    • 11.4.4. Launch Year and Therapy Uptakes
  • 11.5. Total Market Size of Ascites in the 7MM
  • 11.6. Total Market Size of Ascites by Therapies in the 7MM
  • 11.7. The United States
    • 11.7.1. Total Market Size of Ascites in the United States
    • 11.7.2. Total Market Size of Ascites by Therapies in the United States
  • 11.8. EU4 and the UK
    • 11.8.1. Total Market Size of Ascites in EU4 and the UK
  • 11.2. Total Market Size of Ascites by Therapies in EU4 and the UK
  • 11.9. Japan
    • 11.9.1. Total Market Size of Ascites in Japan
    • 11.9.2. Total Market Size of Ascites by Therapies in Japan

12. Unmet Needs of Ascites

13. SWOT Analysis of Ascites

14. KOL Views of Ascites

15. Market Access and Reimbursement of Ascites

  • 15.1. The United States
  • 15.2. EU4 and the UK
    • 15.2.1. Germany
    • 15.2.2. France
    • 15.2.3. Italy
    • 15.2.4. Spain
    • 15.2.5. United Kingdom
  • 15.3. Japan
  • 15.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 15.5. Market Access and Reimbursement of Ascites Therapies

16. Appendix

  • 16.1. Bibliography
  • 16.2. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight

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