(Albany, US), October 29, 2026 – DelveInsight’s “Malignant Pleural Effusion Market Insights, Epidemiology and Market Forecast – 2036” report delivers an in-depth understanding of Malignant Pleural Effusion (MPE), historical and forecasted epidemiology, as well as the Malignant Pleural Effusion market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.
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Key Takeaways from the Malignant Pleural Effusion Market Report
In September 2026, Base Therapeutics (Shanghai) Co., Ltd. announced result of First-in-Human Phase I Study of TIGIT-Blocked NK510 Cells in Patients With PD-1 Refractory Advanced NSCLC.
According to DelveInsight’s analysis, the Malignant Pleural Effusion market size was found to be more than USD 2 billion in the 7MM in 2025.
Among the 7MM, the United States captured the largest Malignant Pleural Effusion market share of more than USD 1 billion in 2025, and it is projected to continue on a positive growth trajectory.
The Malignant Pleural Effusion market in the 7MM is expected to grow at a CAGR of 4.9% during the forecast period of 2026-2036.
The total incident cases of Malignant Pleural Effusion in the 7MM were approximately 480,000 in 2025.
In 2025, the US had the highest number of Malignant Pleural Effusion incident cases among the 7MM, at approximately 180,000 cases. The rise is attributed to increased cancer incidence and survival rates, improved healthcare access, and heightened awareness of the condition.
The current pleural effusion market depends predominantly on drainage procedures, owing to the absence of approved therapies and the severe nature of the disease.
The lack of epidemiological studies limits understanding of the incidence and risk factors of Malignant Pleural Effusion, hindering early diagnosis and evidence-based treatment strategies.
The leading Malignant Pleural Effusion companies include Gongwing Biopharm, Wuhan YZY Biopharma, RS Oncology, Genelux Corporation, and others.
Promising Malignant Pleural Effusion therapies include PTS500, M701, RSO-021, and others.
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Malignant Pleural Effusion Overview
Malignant Pleural Effusion is an effusion characterized by the presence of malignant cells. Fluid and cancer cells build up between the chest wall and the lung. It is a common but serious condition associated with poor quality of life, morbidity, and mortality, and is a common manifestation in patients with metastatic disease. MPE is most common in lung cancer, followed by breast cancer, lymphoma, gynecological cancers, and malignant mesothelioma. Chest ultrasonography, computed tomography, 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 with lower sensitivity. PET-CT offers high specificity for staging pleural disease, and cytology, while commonly used, has limited sensitivity. Pleural biopsy, particularly when imaging-guided, is the gold standard with high sensitivity and specificity, and medical thoracoscopy provides both diagnostic and therapeutic benefits.
Malignant Pleural Effusion Epidemiology Segmentation in the 7MM
Malignant Pleural Effusion Incident Cases
Malignant Pleural Effusion Tumor Type-specific Incident Cases
Malignant Pleural Effusion Gender-specific Incident Cases
Malignant Pleural Effusion Symptom-specific Incident Cases
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Malignant Pleural Effusion Epidemiology Key Findings
The total number of Malignant Pleural Effusion incident cases in the 7MM was approximately 480,000 in 2025.
In the US, females accounted for approximately 100,000 incident cases and males for nearly 70,000 incident cases of Malignant Pleural Effusion in 2025. Incident cases in the US are expected to rise among 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 Malignant Pleural Effusion due to breast cancer and more than 25,000 cases due to lymphoma across EU4 and the UK. The overall incidence in both types is projected to rise during the forecast period.
Japan recorded nearly 50,000 symptomatic cases of Malignant Pleural Effusion in 2025, and around 12,000 cases were asymptomatic. Symptom-specific incidence is projected to rise.
Approved Therapies for Malignant Pleural Effusion
Currently, the Malignant Pleural Effusion treatment landscape lacks approved curative treatments and relies on palliative interventions. A range of options is available, including systemic cancer therapy, thoracentesis, tube thoracostomy, pleurodesis with sclerosants, pleural catheter placement, pleuroperitoneal shunts, and pleurectomy, all aimed at managing symptoms and improving patient comfort. Talc pleurodesis, particularly via thoracoscopic poudrage with large-bore drains, is recommended as the preferred treatment for MPE owing 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 with higher adverse event rates. Nonsteroidal analgesics are recommended for pain management, as they do not impact pleurodesis success. While these methods offer short-term relief, high recurrence rates and complications underscore the need for pharmaceutical innovations.
Malignant Pleural Effusion Pipeline Analysis
M701 is a new category I biological drug independently developed by YZY Biopharma, intended for the treatment of MPE and malignant ascites caused by tumors. M701 targets both EpCAM (on tumor cells) and CD3 (the immune T cell activation target), bridging tumor cells and immune T cells to activate T cells to kill the tumor cells. Intraperitoneal/intrapleural infusion of M701 can therefore 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.
PTS500 is a small-molecule candidate from Gongwing Biopharma, currently being evaluated in Phase II clinical trials for MPE. It is administered via intratumoral injection, acts as a cell death stimulant, and has an anticipated US launch in 2030.
RSO-021 is a peroxiredoxin III inhibitor being developed by RS Oncology for MPE and is administered via pleural infusion. It is in Phase I/II development. 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.
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Malignant Pleural Effusion Market Outlook
The current pleural diseases market lacks FDA-approved curative treatments for Malignant Pleural Effusion, 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, emphasizing the need for more advanced therapeutic options and shaping the dyspnea treatment market. Malignant Pleural Effusion market growth is anticipated to rely on epidemiological studies identifying the patient populations most likely to benefit from new therapies, as understanding incidence and survival rates is key for drug development. Emerging therapies may address these gaps, but their success will depend on robust clinical results and timely regulatory approvals. Pleurisy market trends and pleurisy market analysis in the forecast period will be shaped by this shift from drainage-dependent care to pharmaceutical innovation. The US pleurisy market holds the largest share, at more than USD 1 billion in 2025, while EU4 and the UK accounted for the second-largest pleural effusions treatment market size, at approximately USD 750 million in 2025, which is expected to rise with the anticipated launch of emerging therapies. The EU4 and UK market also lacks EMA-approved treatments, and in Japan, the pleural effusion treatment market size was nearly USD 200 million in 2025, influenced not only by pharmacological treatments but also by drainage procedures.
Malignant Pleural Effusion Market Drivers
Rising prevalence of cancer-associated conditions such as lung cancer, breast cancer, and lymphoma
Growing geriatric population
Advancements in diagnostic techniques
Increasing demand for minimally invasive treatments
Development of novel therapeutic approaches
Improved supportive care and palliative treatments
Favorable reimbursement and healthcare policies
Increasing healthcare expenditure
Growing awareness and clinical research activities
Malignant Pleural Effusion Market Barriers
Absence of approved curative treatments and dependence on symptomatic procedures
High recurrence rates and complications associated with current procedures
Lack of epidemiological studies on Malignant Pleural Effusion
Inconsistent management, reduced clinical trial development, and inadequate resource allocation
Lack of targeted therapies
Malignant Pleural Effusion Treatment Landscape
Malignant Pleural Effusion treatment is primarily driven by drainage procedures such as thoracentesis, pleurodesis, and indwelling pleural catheters, used for symptom management. Emerging therapies are investigating diverse mechanisms. In recent years, intracavitary biotherapy has become a prominent area of research. 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%, suggesting a promising application of anti-angiogenic drugs. Bevacizumab, a recombinant humanized monoclonal antibody that binds to VEGF, prevents neovascularization and has shown positive results in combination with chemotherapy. Biological agents commonly used in the clinic include Interleukin 2 (IL-2) and Tumor Necrosis Factor (TNF). IL-2, used alone or in combination with other anti-cancer therapies, can improve survival outcomes for patients with advanced cancer. Major pharma players such as Gongwing Biopharma, RS Oncology, and Wuhan YZY Biopharma are proactive with their emerging candidates and are expected to transform Malignant Pleural Effusion treatment in the forecast period.
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Scope of the Malignant Pleural Effusion Market Report
Coverage- 7MM
Study Period- 2022-2036
Forecast Period- 2026-2036
Malignant Pleural Effusion Companies- Gongwing Biopharm, Wuhan YZY Biopharma, RS Oncology, Genelux Corporation, and others.
Malignant Pleural Effusion Therapies- PTS500, M701, RSO-021, and others.
Malignant Pleural Effusion Market Dynamics: Malignant Pleural Effusion market drivers and market barriers
Malignant Pleural Effusion Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis
Malignant Pleural Effusion Unmet Needs, KOL Views, Reimbursement
Table of Contents
Key Insights
Report Introduction
MPE Market Overview at a Glance
Executive Summary
Key Events
Disease Background and Overview
Epidemiology and Market Forecast Methodology
Epidemiology and Patient Population
Patient Journey
Emerging Drug Profiles
MPE: Market Analysis
Key Opinion Leaders’ Views
Unmet Needs
SWOT Analysis
Market Access and Reimbursement
Appendix
DelveInsight Capabilities
Disclaimer
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