Malignant Ascites - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights

• Malignant ascites (MA) is a pathological condition due to a variety of primary abdominal and extra-abdominal neoplasms. It is a primary cause of morbidity and presents many difficulties and treatment challenges. Malignant ascite is a sign of peritoneal carcinomatosis, the presence of malignant cells in the peritoneal cavity.
• Malignant ascites, characterized by the abnormal accumulation of fluid in the abdominal cavity due to cancer, present with several distinct symptoms. One primary indicator is noticeable abdominal swelling or distension, often leading to an increase in girth.
• The pathophysiology of Malignant ascites is multifactorial. Increased permeability of tumor vessels, with forced production and release of peritoneal fluid, is the main factor in Malignant ascites development.
• The causes of intra-abdominal fluid production are many, including cirrhosis, congestive heart failure, nephrosis, pancreatitis, peritonitis, primary malignancy, or hepatic metastases. It is not possible to distinguish benign ascites from malignant ascites by physical exam or radiographic techniques alone. Invasive testing is necessary to differentiate the two types.
• (Baretti et al., 2019) conducted a study in Japan and reported the prevalence of ascites in patients with gastrointestinal cancers is 21% typically from malignancies such as pancreatic, gastric, colorectal, and gallbladder cancers.
• In 2020, the total incident cases of Malignant Ascites associated cancers were ~ 1.6 million in the 7MM.
• Many treatments are palliative, focusing on symptom relief and improving the quality of life rather than providing a cure for malignant ascites. With only two approved therapies, i.e., OK-432 and KM-CART in Japan, most patients are limited to the best palliative care, which is often inadequate to address these unmet needs.
• In 2020, in the 7MM the total market size of Malignant ascites was ~ USD 1.99 billion.

This report delivers an in-depth understanding of Malignant ascites, historical and forecasted epidemiology as well as the Malignant ascites market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Malignant ascites market report provides current treatment practices, emerging drugs, Malignant ascites market share of the individual therapies, and current and forecasted Malignant ascites market size from 2020 to 2034, segmented by seven major markets. The report also covers current Malignant ascites treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Malignant ascites Disease Understanding and Treatment Algorithm

Malignant ascites Overview

Malignant ascites (MA) is a pathological condition due to a variety of primary abdominal and extra-abdominal neoplasms. It is a primary cause of morbidity and presents many difficulties and treatment challenges. Malignant ascite is a sign of peritoneal carcinomatosis, the presence of malignant cells in the peritoneal cavity. Tumors causing carcinomatosis are more commonly secondary peritoneal surface malignancies, which include ovarian, colorectal, pancreatic, and uterine; extra-abdominal tumors originating from lymphoma, lung, and breast; and a small number of unknown primary tumors.

Malignant ascites Diagnosis

The causes of intra-abdominal fluid production are many, including cirrhosis, congestive heart failure, nephrosis, pancreatitis, peritonitis, primary malignancy, or hepatic metastases. It is not possible to distinguish benign ascites from malignant ascites by physical exam or radiographic techniques alone. Invasive testing is necessary to differentiate the two types. Abdominal paracentesis with ascitic fluid analyses can diagnose malignant causes of ascite production in most cases, but laparoscopic tissue sampling may be necessary. Recently, several molecular profiling studies aimed at examining the different contents of MA, such as soluble molecules (proteins, DNA, and RNA), extracellular vesicles (EVs), and cells, have provided new insights into the outcome of PDAC (pancreatic ductal adenocarcinoma) patients with MA.

Malignant ascites Treatment

With only two approved therapies, i.e., OK-432 and KM-CART in Japan, most patients are limited to the best palliative care, which is often inadequate to address these unmet needs. Several treatment modalities can alleviate the symptoms associated with malignant ascites. Because the natural history of ascite formation is poorly understood, these measures and quality of life data are limited, and the efficacy of existing treatments is difficult to assess. Traditional modalities for managing malignant ascites include sodium-restricted diets, diuretic therapy, serial paracentesis, and peritoneovenous shunting.

Malignant ascites Epidemiology

The Malignant ascites epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by the total incident cases of Malignant ascites associated cancers, total patient pool of malignant ascites in the 7MM market covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the United States accounted for the highest incident cases of Malignant ascites in 2020, with around 350,000 cases; these cases are expected to increase during the forecast period.
• Among all the associated cancers, the highest incident cases were reported in Breast Cancer. In 2020 the total incident cases of Breast Cancer were 640,000.
• In 2020, the total patient pool of Malignant Ascites were 390,000 in the EU4 and the UK.

Malignant ascites Drug Chapters

The drug chapter segment of the Malignant ascites report encloses a detailed analysis of the early-stage (Phase I/II and Phase I), mid-stage (Phase II and Phase II/III), and late-stage (Phase III) pipeline drug. The current key players for emerging drugs and their respective drug candidates include Lindis Biotech (Catumaxomab), Wuhan YZY Biopharma (M701). The drug chapter also helps understand the Malignant ascites clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, and the latest news and press releases.

Emerging Drugs

Catumaxomab: Lindis Biotech

Catumaxomab is a bispecific trifunctional antibody that binds directly to the tumor cell with one of its binding sites. It activates two essential components of the immune system with the other binding sites: T cells and macrophages (scavenger cells). The antibody recognizes and binds to all EpCAM-positive tumor cells, including critical cancer stem cells and all CD3-positive T cells. The EpCAM marker is present on almost all carcinomas and is, therefore, a promising approach for targeted cancer treatment. As per company pipeline, catumaxomab is in the preregistration stage of development for the treatment of Malignant ascites.

M 701: Wuhan YZY Biopharma

M701 is a new biological Class I drug that targets both EpCAM and CD3 being developed by YBODY Biotech through its independently patented asymmetric bispecific antibody YBODY® platform. The drug is mainly used for the treatment of malignant ascites (MA) and malignant pleural effusion (MPE) derived from EpCAM-positive cancer.M701 dual-antibody targets the EpCAM antigen on one end. At the same time, the CD3 antibody on the other end can bridge T cells and activate T cells to kill EpCAM-positive tumor cells. Currently, M701 is in the Phase II stage of development for the treatment of malignant ascites.

Drug Class Insight

Antibody-dependent cell cytotoxicity

Antibody-Dependent Cellular Cytotoxicity (ADCC) is a crucial mechanism of the immune system involving the targeting and destruction of pathogenic cells by effector cells, particularly natural killer (NK) cells. ADCC is a process where specific antibodies bind to pathogens, marking them for destruction by NK cells through the injection of cytotoxic factors, leading to cell lysis. Antibodies recognize and bind to target cells, which are then attacked and destroyed by effector cells like NK cells. This process plays a vital role in immune responses against pathogens and cancer cells.

Malignant ascites Market Outlook

With only two approved therapies, i.e., OK-432 and KM-CART in Japan, most patients are limited to the best palliative care, which is often inadequate to address these unmet needs.. Only few key players are active in the pipeline such as Lindis Biotech and Wuhan YZY Biopharma for the treatment of Malignant ascites.

OK-432 (Picibanil) is a freeze-dried biological product that is prepared from the Su strain of Streptococcus pyogenes (group A) by treatment with benzylpenicillin and heat. OK-432 has been reported to induce various cytokines, activate immunological cells, and thus augment anticancer immunity.

KM-CART is a novel cell-free and concentrated ascites reinfusion therapy. It is modified from a conventional CART approved by the Ministry of Health, Labor and Welfare in Japan. KM-CART is easier to use and can be applied for massive malignant ascites.

Key Findings

• The total market size of Malignant Ascites in the 7MM was approximately USD 1.99 billion in 2020, which is anticipated to rise to USD 2.34 billion by 2034.
• The total market size of Malignant Ascites in the United States was approximately USD 800 million in 2020, which is anticipated to rise to USD 1.14 billion by 2034.
• By 2034, among all the therapies, the highest revenue is expected to be generated by chemotherapy i.e., USD 650 million, while the lowest revenue is expected to be generated by Concomitant diuretic therapy, i.e., USD 240 million in the US.
• The total market size of Malignant Ascites in the EU4 and the UK was approximately USD 490 million in 2020, which is anticipated to rise to USD 540 million by 2034.
• The total market size of Malignant Ascites in Japan was USD 690 million in 2020, which is anticipated to decline to USD 650 million by 2034.

Malignant ascites Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034. The landscape of Malignant ascites treatment has experienced a transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncologists and the entire healthcare community in their tireless pursuit of advancing care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.

Malignant ascites Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II and Phase I. It also analyzes key players involved in developing targeted therapeutics. Companies like Lindis Biotech and Wuhan YZY Biopharma actively engage in late stage research and development efforts for Malignant ascites. The pipeline of Malignant ascites possesses few potential drugs. However, there is a positive outlook for the therapeutics market, with expectations of growth during the forecast period (2024-2034).

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Malignant ascites emerging therapy.

Market Access and Reimbursement

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), third-party organizations that provide services and educational programs to aid patients are also present.

A zero-dollar copay program is a healthcare initiative designed to eliminate out-of-pocket costs for patients when obtaining specific medical services or prescription medications. Under this program, individuals enrolled in health insurance plans or prescription drug benefit programs can access certain services or medications without having to make any direct financial contributions in the form of copayments. The program is often implemented to improve medication adherence and access to essential healthcare services, particularly for chronic conditions. Pharmaceutical manufacturers or healthcare providers may offer zero-dollar copay programs as a strategy to make necessary treatments more affordable and accessible for patients, ultimately enhancing overall health outcomes and patient satisfaction.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Malignant ascites, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of mid-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Malignant 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 shape and drive Malignant ascites.

Malignant ascites Report Insights

• Patient Population
• Therapeutic Approaches
• Malignant ascites Pipeline Analysis
• Malignant ascites Market Size and Trends
• Existing and Future Market Opportunity

Malignant ascites Report Key Strengths

• Eleven Years Forecast
• The 7MM Coverage
• Malignant ascites Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Malignant ascites Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Analyst Views)

FAQs

• What was the Malignant ascites market size, the market size by therapies, market share (%) distribution in 2023, and what would it look like by 2034? What are the contributing factors for this growth?
• What can be the future treatment paradigm for Malignant ascites?
• What are the disease risks, burdens, and unmet needs of Malignant ascites? What will be the growth opportunities across the 7MM concerning the patient population with Malignant ascites?
• What are the current options for the treatment of Malignant ascites? What are the current guidelines for treating Malignant ascites in the 7MM?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What is the patient share in Malignant ascites?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving Malignant ascites.
• 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 ranking of class-wise potential current and emerging therapies under the analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around 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.