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시장보고서
상품코드
2082835
악성 흉수 : 시장 인사이트, 역학 및 예측(2036년)Malignant Pleural Effusion - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
악성 흉수 시장 규모 및 전망
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.
북미 : 미국
유럽 : 독일, 프랑스, 이탈리아, 스페인, 영국
아시아태평양 : 일본
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.
MPE의 역학 분석 및 예측에 관한 주요 조사 결과
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.
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.
약제 분류별/MPE 분야의 주요 신흥 치료법에 대한 인사이트(2022-2036년 전망)
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.
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.
Malignant Pleural Effusion (MPE) Market size and forecast
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.
North America: The United States
Europe: Germany, France, Italy, Spain and the United Kingdom
Asia-Pacific: Japan
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.
Key Findings from MPE Epidemiological Analysis and Forecast
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.
Malignant Pleural Effusion (MPE) Key Players, Market Leaders and Emerging Companies
Malignant Pleural Effusion (MPE) Drug Updates
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.
Drug Class/Insights into Leading Emerging Therapies in MPE (2022-2036 Forecast)
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.
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.
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.
Market Insights