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악성 흉수 : 시장 인사이트, 역학 및 예측(2036년)

Malignant Pleural Effusion - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 123 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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악성 흉수(MPE)에 대한 인사이트 및 동향

  • DelveInsight의 분석에 따르면, 2025년 시점에서 주요 시장(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본)의 악성 흉수 시장 규모는 2억 달러를 넘어섰습니다.
  • 주요 7개국(주요 7개 시장) 중 2025년 악성 흉수 시장에서 10억 달러를 넘어서는 최대 시장 점유율을 차지한 곳은 미국이며, 앞으로도 견조한 성장세를 유지할 것으로 전망됩니다.
  • 2025년, 주요 7개국 중 미국은 MPE 신규 환자 수가 가장 많았으며, 약 18만 건이었습니다. 미국 내 MPE 환자 수 증가는 암 발병률과 생존율의 상승, 그리고 의료 서비스 접근성 개선에 기인한 것으로, 그 결과 이 질환에 대한 인식이 높아지면서 환자 수가 증가하고 있습니다.
  • 현재 시장은 승인된 치료법이 존재하지 않는다는 점과 이 질환의 중증도가 높다는 점 때문에 주로 배액 시술에 의존하고 있습니다. 이 질환은 종종 통증을 동반하는 시술이 필요하기 때문입니다. 전신 암 치료, 흉강 천자, 흉강 배액, 경화제를 이용한 흉막 유착술, 흉막 카테터 삽입, 흉막-복막 션트, 흉막 절제술 등 다양한 완화 치료법을 이용할 수 있습니다. 이 모든 것은 증상 관리와 환자의 편안함 증진을 목적으로 합니다.
  • 탈크를 이용한 흉막 유착술, 특히 대구경 드레인을 병용한 흉강경 하 파우더법은 높은 성공률과 증상 완화 효과로 인해 MPE의 1차 치료법으로 권장되고 있습니다. 삽입형 흉막 카테터(IPC)는 유사한 증상 완화 효과를 얻을 수 있고 입원 기간 단축도 기대할 수 있으므로 대체 요법으로 고려할 수 있지만, 이상반응 발생률은 높아집니다. 통증 관리에는 흉막 유착술의 성공률에 영향을 미치지 않는 비스테로이드성 진통제를 사용해야 합니다.
  • MPE에 대한 새로운 치료법에서는 이 질환의 다면적인 측면을 해결하기 위해 다양한 작용기전이 검토되고 있습니다. 그중에서도 Gongwing Biopharma사가 개발 중인 저분자 후보 화합물인 PTS500은 현재 2상 임상시험을 통해 평가가 진행되고 있습니다.
  • MPE에 관한 역학 연구가 부족하여 그 발생률과 위험 요인에 대한 이해가 제한되고 있으며, 이로 인해 조기 진단 및 근거에 기반한 치료 전략 수립이 저해되고 있습니다. 이러한 격차는 치료 관리의 불일치, 임상시험 개발의 정체, 부적절한 자원 배분, 미흡한 보건의료 계획으로 이어지며, 궁극적으로는 환자의 예후에 영향을 미치고 MPE 치료의 진전을 저해하게 됩니다.

악성 흉수 시장 규모 및 전망

  • 주요 7개국 악성 흉수 시장 규모(2025년) : 약 20억 달러
  • MPE 성장률(2022-2036년) : 연평균 성장률(CAGR) 4.9%

본 악성 흉수 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. MPE 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 주요 7개 국가 및 지역 전체에 걸친 상세한 시장 규모 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시합니다. 본 보고서에서는 MPE 분야의 주요 미충족 수요를 부각시키고, 경쟁 구도 및 임상 환경을 분석하여 고부가가치의 성장 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

대상 지역 :

북미 : 미국

유럽 : 독일, 프랑스, 이탈리아, 스페인, 영국

아시아태평양 : 일본

악성 흉수(MPE)에 대한 이해와 치료 알고리즘

악성 흉수(MPE)의 개요 및 진단

MPE는 악성 세포의 존재가 특징인 흉수입니다. 흉벽과 폐 사이에 체액과 암세포가 축적됩니다. 이는 흔한 질환이지만, 삶의 질 저하, 발병률, 사망률과 관련된 심각한 상태입니다. MPE는 전이성 질환 환자에게서 흔히 나타나는 증상입니다. 가장 흔한 것은 폐암이며, 그 다음으로 유방암, 림프종, 부인과암, 악성 중피종 순입니다.

흉부 초음파 검사, 컴퓨터 단층촬영(CT), 양전자 방출 단층촬영·컴퓨터 단층촬영(PET-CT), 그리고 흉막 생검은 MPE를 진단하기 위한 주요 방법입니다. 초음파 검사는 흉수의 특성을 평가하고 시술 시 안내 역할을 하는 데 효과적입니다. 한편, CT는 감도는 낮지만 흉막의 이상을 확인하는 데 도움이 됩니다. PET-CT는 흉막 질환의 병기 분류에서 높은 특이도를 보이지만, 일반적으로 사용되는 세포진 검사의 민감도는 제한적입니다. 흉막 생검은 특히 영상 유도 하에 시행될 경우, 높은 민감도와 특이도를 지닌 골드 스탠다드이며, 의료용 흉강경 검사는 진단과 치료 양면에서 유용합니다.

악성 흉수(MPE)의 현재 치료 현황

현재 MPE의 치료는 주로 증상 관리를 목적으로 하는 흉강천자, 흉막유착술, 삽입형 흉막카테터 등의 배액 처치를 통해 이루어지고 있습니다. 악성 흉수 시장은 근치적 치료법의 부재와 흉강천자, 흉막유착술, 삽입형 흉막카테터와 같은 대증요법에 대한 의존으로 인해 큰 과제에 직면해 있습니다. 이러한 방법들은 단기적인 증상 완화를 가져오지만, 재발률과 합병증 발생률이 높다는 점은 의약품 분야의 혁신 필요성을 여실히 보여주고 있습니다. 시장의 성장은 새로운 치료법으로부터 가장 큰 혜택을 볼 것으로 예상되는 환자 집단을 파악하는 역학 연구에 달려 있을 것으로 전망됩니다. 발생률과 생존률을 파악하는 것은 의약품 개발에 있어 매우 중요합니다. 새로운 치료법이 이러한 과제를 해결할 가능성은 있지만, 그 성공 여부는 확실한 임상 결과와 규제 당국의 적시 승인에 달려 있습니다.

미국 MPE 치료 시장의 주도권을 확보하기 위해 일부 주요 제약사들은 Gongwing Biopharma사의 PTS500, RS Oncology사의 RSO-021, Wuhan YZY Biopharma사의 M701 등 개발 중인 후보 약물에 적극적으로 나서고 있으며, 이러한 약물들이 예측 기간 동안 MPE 치료에 혁명을 가져올 것으로 기대되고 있습니다.

악성 흉수(MPE)의 역학

MPE의 역학 분석 및 예측에 관한 주요 조사 결과

  • 2025년 주요 7개국에서 MPE 신규 환자 수는 총 약 48만 명에 달했습니다.
  • DelveInsight의 추산에 따르면, 2025년 미국의 MPE 신규 환자 수는 여성이 약 10만 명, 남성이 약 7만 명을 차지할 것으로 예측됩니다. 미국에서는 유전적 소인이나 환경적 요인으로 인해 폐암 환자가 MPE에 걸릴 위험이 높기 때문에 폐암 환자 중 MPE 신규 환자 수가 증가할 것으로 예측됩니다.
  • 2025년, EU4 국가 및 영국에서는 유방암으로 인한 MPE 신규 사례가 약 5만 건, 림프종으로 인한 사례가 2만 5,000건 이상 발생했습니다. DelveInsight의 분석에 따르면, 예측 기간 동안 이 두 유형의 신규 환자 수는 전반적으로 증가할 것으로 예측됩니다.
  • 일본에서는 2025년에 증상이 동반된 MPE 사례가 5만 건 가까이, 무증상 사례가 약 1만 2,000건 기록되었습니다. 예측에 따르면, MPE 증상을 동반한 사례 수는 증가할 것으로 보입니다.

악성 흉수(MPE) 파이프라인 분석

M701 : 우한 YZY 바이오파마

M701은 YZY Biopharma가 독자적으로 개발한 신규 카테고리 I 생물학적 제제로, 종양으로 인한 MPE 및 악성 복수의 치료제로 개발이 진행되고 있습니다. M701은 EpCAM(종양 세포 표면의 표적)과 CD3(면역 T세포의 활성화 표적)을 모두 표적으로 삼을 수 있으며, 이러한 표적과 결합함으로써 종양 세포와 면역 T세포를 연결하는 가교 역할을 하여 T세포를 활성화시켜 종양 세포를 사멸시킵니다. 따라서, M701을 복강 내 또는 흉강 내에 주입함으로써 면역 세포를 활성화시켜, 복강 내 및 흉강 내의 종양 세포를 선택적으로 제거·억제할 수 있습니다. 현재 이 약제는 비소세포폐암(NSCLC)으로 인한 MPE를 대상으로 한 제2상 임상시험이 진행 중입니다.

  • 2026년 2월, Wuhan YZY Biopharma는 진행성 폐암 및 유방암 환자를 대상으로 MPE를 표적으로 하는 이중 특이성 항체 'M701'에 대한 IND 신청에 대해 FDA의 승인을 획득했습니다.

악성 흉수 시장 전망

현재 악성 흉수 시장에는 FDA 승인을 받은 근치적 치료법이 존재하지 않으며, 대신 흉강 천자, 흉막 유착술, 삽입형 흉막 카테터 등의 대증 요법에 의존하고 있습니다. 이러한 치료법은 체액 저류를 줄이고 호흡 곤란을 완화함으로써 증상 관리에 도움이 되지만, 그 효과는 일시적이며 재발이 빈번하게 발생합니다. 또한, 일부 시술은 침습적일 뿐만 아니라 감염이나 통증 등의 합병증을 유발할 가능성이 있어, 장기적인 질환 관리에 새로운 과제를 안겨주며, 보다 진보된 치료법의 필요성을 부각시키고 있습니다.

  • 주요 7개국 중 EU 4개국과 영국은 악성 흉수 시장에서 두 번째로 큰 시장 규모를 차지하고 있으며, 2025년에는 약 7억 5,000만 달러에 달했습니다. 이는 신흥 치료법의 출시가 예상에 따라 더욱 확대될 것으로 전망됩니다.
  • EU4 및 영국의 악성 흉수 시장에서도 EMA(유럽의약품청) 승인을 받은 치료법이 부족하여, 흉강천자, 흉막유착술, 삽입형 흉막카테터 등의 대증요법에 의존하고 있습니다. 이러한 치료법은 일시적인 증상 완화를 가져오지만, 재발률이 높고 합병증을 동반하며 장기적인 효과에도 한계가 있기 때문에 해당 지역에서는 보다 효과적이고 승인된 치료법의 필요성이 부각되고 있습니다.
  • 일본에서는 2025년 악성 흉수 시장 규모가 2억 달러에 육박했습니다. 일본의 악성 흉수 시장은 약물 치료뿐만 아니라, 질환 관리에서 중요한 역할을 하는 배액 시술의 영향도 받고 있습니다.

약제 분류별/MPE 분야의 주요 신흥 치료법에 대한 인사이트(2022-2036년 전망)

  • 항혈관신생제

최근 MPE 치료 분야에서 구강 내 생물학적 요법이 주목받는 연구 분야로 떠오르고 있습니다. 조사에 따르면, 재조합 인간 혈관내피성장인자(VEGF) 억제제를 관강 내 화학요법과 병용함으로써 악성 흉수를 약 60%의 제어율로 억제할 수 있는 것으로 나타났습니다. 이는 악성 흉수 및 복수의 치료에 있어 항혈관신생제의 유망한 적용 가능성을 시사하는 것입니다. 시스플라틴 등 다른 흉부용 약물과의 병용 요법도 단일제 요법에 비해 유효성이 향상된 것으로 나타났습니다. VEGF에 결합하는 재조합 인간화 단일클론 항체인 베바시주맙은 신생혈관 형성을 억제하며, 화학요법과 병용 투여 시 양호한 결과를 보이고 있습니다.

  • 생물학적 제제를 이용한 치료

임상 현장에서 MPE 치료에 일반적으로 사용되는 생물학적 제제는 주로 인터루킨-2(IL-2)와 종양괴사인자(TNF)입니다. IL-2는 인터페론 및 다양한 사이토카인의 분비를 자극하는 흉선 의존성 림프구 증식 인자입니다. IL-2는 장기 생존을 촉진하고 T세포의 살상 활성을 높일 뿐만 아니라, 자연살해세포, 림포카인 활성화 살해세포 및 종양 침윤 림프구의 증식과 활성화를 촉진합니다. IL-2는 종양의 보조 치료나 암성 흉수 치료에 사용됩니다. 연구에 따르면, IL-2는 단독으로 사용하든 다른 항암 요법과 병용하든 진행성 암 환자의 생존율을 개선할 수 있는 것으로 나타났습니다.

자주 묻는 질문

  • 2025년 악성 흉수 시장 규모는 어떻게 예상되나요?
  • 악성 흉수 시장의 연평균 성장률(CAGR)은 어떻게 되나요?
  • 2025년 미국의 악성 흉수 신규 환자 수는 얼마나 될 것으로 예상되나요?
  • 악성 흉수 치료에 사용되는 주요 방법은 무엇인가요?
  • MPE에 대한 새로운 치료법 개발 현황은 어떤가요?
  • 2025년 일본의 악성 흉수 시장 규모는 어떻게 될 것으로 예상되나요?
  • MPE의 주요 원인으로 어떤 암이 가장 흔한가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 악성 흉수 : 시장 개요

제4장 주요 요약

제5장 주요 이벤트

제6장 질환 배경 및 개요

제7장 역학 및 예측 조사 방법

제8장 역학 및 환자 인구

제9장 환자 경과

제10장 신흥 의약품 개요

제11장 악성 흉수 : 시장 분석

제12장 KOL(Key Opinion Leader)의 견해

제13장 미충족 수요

제14장 SWOT 분석

제15장 시장 참여 및 상환

제16장 부록

제17장 DelveInsight의 서비스 내용

제18장 면책사항

제19장 DelveInsight에 대해

KTH

Malignant Pleural Effusion (MPE) Insights and Trends

  • According to DelveInsight analysis, Malignant Pleural Effusion (MPE) market size was found to be more than USD 2 billion in the leading markets (the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan) in 2025.
  • Among the 7MM, the largest market share of more than USD 1 billion in the MPE market was captured by the US in 2025 and it is projected to continue with a positive growth trajectory.
  • In 2025, the US had the highest incident cases of MPE among the 7MM which was approximately 180,000 cases. The rise in MPE cases in the US is attributed to increased cancer incidence and survival rates and improved healthcare access, resulting in increased and heightened awareness of the condition.
  • The current market predominantly depends on drainage procedures due to the absence of approved therapies and the severe nature of the disease, which necessitates often painful interventions. A range of palliative treatment options is available, including systemic cancer therapy, thoracentesis, tube thoracostomy, pleurodesis with sclerosants, pleural catheter placement, pleuroperitoneal shunts, and pleurectomy. They are all aimed at managing symptoms and improving patient comfort.
  • It is recommended that talc pleurodesis, particularly via thoracoscopic poudrage with large-bore drains, be used as the preferred treatment for MPE due to its high success rates and effectiveness in symptom relief. Indwelling pleural catheters (IPC) can be considered as an alternative, as they provide similar symptom relief and shorter hospital stays, though they are associated with higher adverse event rates. Nonsteroidal analgesics should be used for pain management, as they do not impact pleurodesis success.
  • Emerging therapies for MPE are investigating diverse mechanisms to address multiple facets of the disease. Among them, PTS500, a small-molecule candidate from Gongwing Biopharma, is currently being evaluated in Phase II clinical trials.
  • The lack of epidemiological studies on MPE limits understanding of its incidence and risk factors, hindering early diagnosis and evidence-based treatment strategies. This gap results in inconsistent management, reduced clinical trial development, inadequate resource allocation, and poor healthcare planning, ultimately affecting patient outcomes and limiting advancements in MPE therapy.

Malignant Pleural Effusion (MPE) Market size and forecast

  • 2025 MPE Market Size in the 7MM: ~USD 2 billion
  • MPE Growth Rate (2022-2036): 4.9% CAGR (Compound Annual Growth Rate)

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

The MPE market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, MPE 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 the 7MM regions. The report highlights key unmet medical needs in MPE and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Geography Covered:

North America: The United States

Europe: Germany, France, Italy, Spain and the United Kingdom

Asia-Pacific: Japan

Malignant Pleural Effusion (MPE) Understanding and Treatment Algorithm

Malignant Pleural Effusion (MPE) Overview and Diagnosis

MPE is an effusion characterized by the presence of malignant cells. The fluid and cancer cells build up between the chest wall and the lung. It is a common but serious condition related to poor quality of life, morbidity, and mortality. MPE is a common manifestation in patients with metastatic disease. It is most common in lung cancer, followed by breast cancer, lymphoma, gynecological cancers, and malignant mesothelioma.

Chest ultrasonography, Computed tomography (CT), Positron emission tomography-computed tomography (PET-CT), and pleural biopsy are key tools for diagnosing MPE. Ultrasound is effective in assessing pleural effusion characteristics and guiding procedures, while CT can identify pleural abnormalities, although it has lower sensitivity. PET-CT offers high specificity for staging pleural disease, and cytology, while commonly used, has limited sensitivity. Pleural biopsy, particularly when guided by imaging, is the gold standard with high sensitivity and specificity, and medical thoracoscopy provides both diagnostic and therapeutic benefits.

Current Malignant Pleural Effusion (MPE) Treatment Landscape

Currently, MPE treatment is primarily driven by drainage procedures such as thoracentesis, pleurodesis, and indwelling pleural catheters, which are used for symptom management. The MPE market faces substantial challenges due to the lack of curative treatments and dependence on symptomatic procedures like thoracentesis, pleurodesis, and indwelling pleural catheters. While these methods offer short-term relief, high recurrence rates and complications underscore the need for pharmaceutical innovations. Market growth is anticipated to rely on epidemiological studies identifying patient populations most likely to benefit from new therapies. Understanding incidence and survival rates is key for drug development. While emerging treatments may address these gaps, their success will depend on robust clinical results and timely regulatory approvals.

To proclaim MPE treatment market rule in the US, some major pharma players are proactive with their emerging candidates, including PTS500 by Gongwing Biopharma, RSO-021 by RS Oncology, M701 by Wuhan YZY Biopharma, and others are expected to revolutionize the MPE treatment in the forecast period.

Malignant Pleural Effusion (MPE) Unmet Needs

The section "unmet needs of MPE" 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. Improved early detection and diagnosis

2. Lack of epidemiological studies

3. Prognostic and therapeutic markers

4. Lack of targeted therapies and others.....

Malignant Pleural Effusion (MPE) Epidemiology

Key Findings from MPE Epidemiological Analysis and Forecast

  • The total number of incident cases of MPE in the 7MM is approximately 480,000 in 2025.
  • According to DelveInsight's estimates, in the US, females accounted for approximately 100,000 incident cases and males for nearly 70,000 incident cases of MPE in 2025. Incident MPE cases in the US are expected to rise in lung cancer patients due to genetic predispositions and environmental factors, which make individuals with lung cancer more susceptible to developing MPE.
  • In 2025, there were approximately 50,000 incident cases of MPE due to breast cancer and more than 25,000 cases due to lymphoma across EU4 and the UK. According to DelveInsight's analysis, the overall incident in both types is projected to rise during the forecast period.
  • Japan recorded nearly 50,000 symptomatic cases of MPE in 2025 and around 12,000 cases were asymptomatic. Projections indicate a rise in symptom-specific incidence in MPE.

Malignant Pleural Effusion (MPE) Analysis & Competitive Landscape

The MPE drug chapter provides a detailed, market-focused review of 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 MPE treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the MPE therapeutics market.

Malignant Pleural Effusion (MPE) Pipeline Analysis

M701: Wuhan YZY Biopharma

M701 is a new category I biological drug independently developed by YZY Biopharma, which is intended to be developed for the treatment of MPE and malignant ascites caused by tumors. M701 can target both EpCAM (as the target on tumor cells) and CD3 (as the immune T cell activation target), which bridges both tumor cells and immune T cells by binding these targets, thereby activating T cells to kill the tumor cells. Accordingly, intraperitoneal/intrapleural infusion of M701 can activate immune cells to selectively eliminate and suppress tumor cells in the abdominal/chest cavity. The drug is currently in Phase II trials for MPE caused by NSCLC.

  • In February 2026, Wuhan YZY Biopharma received FDA approval for its IND application for M701, a bispecific antibody targeting MPE in patients with advanced lung and breast cancers.

Malignant Pleural Effusion (MPE) Key Players, Market Leaders and Emerging Companies

  • Gongwing Biopharm
  • Wuhan YZY Biopharma
  • RS Oncology
  • Genelux Corporation

Malignant Pleural Effusion (MPE) Drug Updates

  • In March 2024, RS Oncology reported two abstracts with comprehensive preclinical and translational data in support of RSO-021, accepted for poster presentations at the Annual Meeting of the American Association for Cancer Research.
  • In June 2024, RS Oncology reported positive data from the Phase I trial of RSO-021.

Malignant Pleural Effusion (MPE) Market Outlook

The current market for MPE lacks FDA approved curative treatments, relying instead on palliative interventions such as thoracentesis, pleurodesis, and indwelling pleural catheters. While these approaches help manage symptoms by reducing fluid buildup and alleviating dyspnea, their effectiveness is temporary, with frequent recurrence. Additionally, some procedures can be invasive or cause complications such as infection and pain, further challenging long-term disease management and emphasizing the need for more advanced therapeutic options.

  • Among the 7MM, EU4 and the UK accounted for the second largest market size of MPE i.e., approximately USD 750 million in 2025 which is expected to rise with the anticipated launch of the emerging therapies.
  • EU4 and the UK market for MPE also lacks EMA-approved treatments, relying on palliative interventions such as thoracentesis, pleurodesis, and indwelling pleural catheters. While these treatments provide temporary relief, they are associated with high recurrence rates, complications, and limited long-term effectiveness, highlighting the need for more effective, approved therapies in these regions.
  • In Japan, the total market size of MPE was nearly USD 200 million in 2025. The MPE market in Japan is influenced not only by pharmacological treatments but also by drainage procedures, which play a significant role in disease management.

Drug Class/Insights into Leading Emerging Therapies in MPE (2022-2036 Forecast)

  • Anti-angiogenic agents

In recent years, intracavitary biotherapy has become a prominent area of research in the treatment of MPE. Studies have shown that recombinant human vascular endothelial growth factor inhibitors, when combined with intracavitary chemotherapy, can control malignant pleural effusion with a control rate of approximately 60%. This suggests a promising application of anti-angiogenic drugs in treating malignant thoracic and abdominal effusions. Combinations with other thoracic drugs, such as cisplatin, have also demonstrated improved efficiency compared to single-agent treatments. Bevacizumab, a recombinant humanized monoclonal antibody that binds to VEGF, prevents neovascularization and has shown positive results when used in combination with chemotherapy.

  • Biological agent treatment

The commonly used biological agents in the clinic for treating MPE are primarily interleukin 2 (IL-2) and tumor necrosis factor (TNF). IL-2 is a thymus-dependent lymphocyte growth factor that stimulates the secretion of interferon and various cytokines. It promotes long-term survival and enhances the killing activity of T cells, as well as the proliferation and activation of natural killer cells, lymphokine-activated killer cells, and tumor-infiltrating lymphocytes. IL-2 is used as an adjuvant therapy for tumors and the treatment of cancerous pleural effusion. Studies have shown that IL-2, whether used alone or in combination with other anti-cancer therapies, can improve survival outcomes for patients with advanced cancer.

Malignant Pleural Effusion (MPE) 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 MPE 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.

According to DelveInsight estimates, the pipeline for MPE treatments appears moderate, with some therapies expected to launch during the forecast period. These include Gongwing Biopharma's PTS500, Wuhan YZY Biopharma's M701, and RS Oncology's Thiostrepton (RSO-021).

M701, a bispecific antibody developed by Wuhan YZY Biopharma, is under investigation for MPE treatment. At ESMO 2024, intrapleural infusion of M701 showed promising results, including a trend toward preventing pleural effusion buildup, achieving a 61.5% pleurodesis success rate, and extending puncture-free survival to 237 days. M701 is anticipated to launch in EU4 and the UK market by 2029, with peak sales expected to occur within 7 years of its release.

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

Market Access and Reimbursement of emerging therapies in Malignant Pleural Effusion (MPE)

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.

Malignant Pleural Effusion (MPE) Standard of Care

Once the diagnosis of MPE is made palliation of symptoms and improving the quality of life becomes the priority. The treatment approach varies depending on performance status, type of tumor, and expected survival. In a patient who is asymptomatic and has limited survival, an approach of best supportive care without any intervention is reasonable.

  • Therapeutic thoracentesis: It is typically the first step in management and should be performed in most patients with dyspnea. It allows for the assessment of improvement in clinical symptoms, lung re-expansion, and the rate of recurrence. Thoracentesis is a safe procedure, and complication rates have decreased significantly with the routine use of pre-procedural ultrasound.
  • Pleurodesis: Pleurodesis is the process of fusing the parietal and visceral pleura, leading to the obliteration of the pleural space and preventing the accumulation of pleural effusion. While the exact mechanism remains unclear, it is believed to involve inflammation and fibrosis, potentially mediated by transforming growth factor beta. Various mechanical and chemical agents, such as talc, bleomycin, tetracycline, corynebacterium parvum, and doxycycline, have been used to achieve pleurodesis.
  • Talc slurry versus poudrage: Talc can be administered during thoracoscopy via an atomizer (talc poudrage) or in a suspension form (talc slurry) through a chest tube. A 2004 Cochrane review suggested that talc was the most effective sclerosant and found talc poudrage at thoracoscopy to be more effective than talc slurry in preventing recurrence.
  • Tunneled pleural catheter (TPC): The use of TPC is becoming increasingly common for managing MPE. A TPC is a silicone tube placed into the pleural cavity, tunneled under the skin with a small cuff, and exits the body with a one-way valve, allowing patients or caregivers to drain pleural fluid at home easily. TPCs have been shown to be safe and effective in improving symptoms and quality of life.
  • Indwelling pleural catheter (IPC): The IPC is a silicone catheter placed in the pleural cavity and tunneled under the skin. It has a cuff at the distal end that forms fibrous adhesions in the subcutaneous tissue over time, securing the IPC in place and preventing ascending infections.
  • Anti-angiogenic agents: In recent years, intracavitary biotherapy has become a prominent area of research in the treatment of MPE. Studies have shown that recombinant human VEGF inhibitors, when combined with intracavitary chemotherapy, can control malignant pleural effusion with a control rate of approximately 60%.
  • The thoracoperitoneal shunt: For patients whose lungs cannot be expanded or trapped due to MPE, a thoracoabdominal shunt tube can be placed, which is a subcutaneous tunnel from the chest to the abdomen. The liquid is pumped manually, but due to the limited capacity of the pump chamber, it needs to be pumped frequently.
  • Immunotherapy: Immunotherapy primarily involves immune cell therapy and immune checkpoint inhibitor therapy (such as PD-1/PD-L1 and CTLA-4 inhibitors). Intrathoracic autoimmune cell infusion therapy is an alternative approach to control MPE, with its effectiveness correlating with a higher frequency of peripheral blood effector T cells. Although its efficacy may be limited, it is generally well tolerated, causes fewer adverse effects, and is not restricted by the patient's liver or kidney function or physical status.

NOTE: Further Details are provided in the final report.

Industry Experts and Physician Views for Malignant Pleural Effusion (MPE)

To keep up with MPE 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 MPE 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 MPE, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 8+ KOLs to gather insights at country level. Centers such as the Johns Hopkins Hospital, City of Hope National Medical Center, American Thoracic Society, University Medicine Essen etc. were contacted.

Their opinion helps understand and validate current and emerging MPE therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in MPE.

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 MPE, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provide 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 MPE, 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 the 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 MPE 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 MPE market.

Report Insights

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

Report Assessment

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

FAQs:

Market Insights

  • What was the MPE 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 MPE?
  • What are the disease risks, burdens, and unmet needs of MPE? What will be the growth opportunities across the 7MM concerning the patient population with MPE?
  • 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 MPE? What are the current guidelines for treating MPE 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 MPE 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. MPE Market Overview at a Glance

  • 3.1. Market Share (%) Distribution of MPE by Therapies in the 7MM in 2025
  • 3.2. Market Share (%) Distribution of MPE by Therapies in the 7MM in 2036

4. Executive Summary

5. Key Events

6. Disease Background and Overview

  • 6.1. Introduction
  • 6.2. Signs and Symptoms
  • 6.3. Etiology and Pathophysiology
  • 6.4. MPE Caused by Different Diseases
  • 6.5. Diagnosis
    • 6.5.1. Diagnostic Recommendations
    • 6.5.2. Diagnostic Algorithm
  • 6.6. Treatment
    • 6.6.1. Treatment Algorithm
    • 6.6.2. Treatment Recommendations
  • 6.7. Diagnostic and Treatment Guidelines
    • 6.7.1. British Thoracic Society (BTS) Guidelines
    • 6.7.2. Management of MPEs: An Official ATS/STS/STR Clinical Practice Guideline, 2018
    • 6.7.3. ERS/EACTS Guidelines on the Diagnosis and Management of MPE, 2018

7. Epidemiology and Market Forecast Methodology

8. Epidemiology and Patient Population

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale: 7MM
    • 8.2.1. Incident Cases of MPE
    • 8.2.2. Tumor Type-specific Incident Cases of MPE
    • 8.2.3. Gender-specific Incident Cases of MPE
    • 8.2.4. Symptom-specific Incident Cases of MPE
  • 8.3. Total Incident Cases of MPE in the 7MM
  • 8.4. The United States
    • 8.4.1. Incident Cases of MPE in the US
    • 8.4.2. Tumor Type-specific Incident Cases of MPE in the US
    • 8.4.3. Gender-specific Incident Cases of MPE in the US
    • 8.4.4. Symptom-specific Incident Cases of MPE in the US
  • 8.5. EU4 and the UK
    • 8.5.1. Incident Cases of MPE in EU4 and the UK
    • 8.5.2. Tumor Type-specific Incident Cases of MPE in EU4 and the UK
    • 8.5.3. Gender-specific Incident Cases of MPE in EU4 and the UK
    • 8.5.4. Symptom-specific Incident Cases of MPE in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Incident Cases of MPE in Japan
    • 8.6.2. Tumor Type-specific Incident Cases of MPE in Japan
    • 8.6.3. Gender-specific Incident Cases of MPE in Japan
    • 8.6.4. Symptom-specific Incident Cases of MPE in Japan

9. Patient Journey

10. Emerging Drug Profiles

  • 10.1. Competitive Landscape: Emerging Drugs
  • 10.2. PTS500: Gongwin Biopharm
    • 10.2.1. Product Description
    • 10.2.2. Other Developmental Activities
    • 10.2.3. Clinical Trials Information
    • 10.2.4. Safety and Efficacy
    • 10.2.5. Analysts' View
  • 10.3. M701: Wuhan YZY Biopharma
    • 10.3.1. Product Description
    • 10.3.2. Safety and Efficacy
    • 10.3.3. Analysts' View
  • 10.4. RSO-021: RS Oncology
    • 10.4.1. Product Description
    • 10.4.2. Other Developmental Activities
    • 10.4.3. Clinical Trials Information
    • 10.4.4. Safety and Efficacy
    • 10.4.5. Analysts' View

11. MPE: Market Analysis

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

12. Key Opinion Leaders' Views

13. Unmet Needs

14. SWOT Analysis

15. Market Access and Reimbursement

  • 15.1. The United States
    • 15.1.1. CMS
  • 15.2. In EU4 and the UK
    • 15.2.1. Germany
    • 15.2.2. France
    • 15.2.3. Italy
    • 15.2.4. Spain
    • 15.2.5. The United Kingdom
  • 15.3. Japan
    • 15.3.1. MHLW

16. Appendix

  • 16.1. Acronyms and Abbreviations
  • 16.2. Bibliography
  • 16.3. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight

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