MaaT-013 Market Summary

Key Factors Driving MaaT-013 Growth

1. Positive Phase III efficacy positions MaaT-013 as a potential first microbiome therapy for SR-aGvHD

MaaT-013 achieved its primary endpoint in the pivotal Phase III ARES trial, demonstrating a 62% gastrointestinal overall response rate (GI-ORR) at Day 28, substantially exceeding the predefined efficacy threshold of 38%. The study also reported a 54% estimated one-year overall survival, representing a meaningful improvement for patients with third-line gastrointestinal SR-aGvHD, a population with historically poor outcomes and limited therapeutic options. These results significantly strengthen the product's regulatory and commercial prospects.

2. Regulatory progress toward European commercialization

Following the successful Phase III results, MaaT Pharma submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in June 2025 for MaaT-013 (Xervyteg®). The company expects EMA feedback during 2026, making this a pivotal regulatory period. Approval would position MaaT-013 as one of the first approved microbiome ecosystem therapies for hematology patients and could establish a new therapeutic class in graft-versus-host disease.

3. Early Access Program demonstrates increasing physician demand before approval

Commercial demand is already evident through MaaT Pharma's Early Access Program. The company reported €4.4 million in EAP revenue during 2025, representing a 38% increase versus 2024 and the highest annual EAP revenue to date. Earlier, first-half 2025 revenues increased 41% year over year to €2.4 million, reflecting increasing physician adoption and demand across Europe even before formal marketing approval. These trends provide encouraging evidence of future commercial uptake.

4. Strategic commercialization partnership with Clinigen reduces launch risk

MaaT Pharma has entered into an exclusive European licensing and commercialization agreement with Clinigen for Xervyteg®. Under the agreement, MaaT Pharma received a €10.5 million upfront payment, is eligible for up to €18 million in regulatory and sales milestone payments, and will receive mid-thirties percentage royalties on commercial net sales together with manufacturing revenues. This partnership provides commercial infrastructure across Europe while reducing launch and reimbursement risks for MaaT Pharma.

5. Differentiated microbiome ecosystem therapy addresses a major unmet need

MaaT-013 is a standardized pooled-donor microbiota ecosystem therapy designed to restore gut microbial diversity and immune homeostasis rather than directly suppress the immune system. Restoration of the intestinal microbiome has been associated with improved immune regulation, reduced gastrointestinal inflammation, and enhanced survival following allogeneic hematopoietic stem cell transplantation. This novel mechanism differentiates MaaT-013 from conventional immunosuppressive therapies and may support broader applications in other transplant-related complications over time. Clinical and translational studies have consistently demonstrated the importance of microbiome restoration in improving outcomes after HSCT.

MaaT-013 Recent Developments

In May 2026, MaaT Pharma, a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, that it has been informed by the CHMP of the EMA of a “negative trend” opinion on its conditional Marketing Authorization Application (MAA) for MaaT013 (Xervyteg®) for the treatment of acute Graft-versus-Host Disease (aGvHD), following its recent CHMP oral explanation.

The CHMP formal vote is expected at the upcoming June Meeting, and subject to the formal vote, the Company intends to request a re-examination of the application, a standard procedure enabling a new independent scientific assessment by a different set of reviewers. The EMA’s procedure provides that the CHMP shall re-examine its opinion within 60 calendar days following receipt of the Company’s official request for re-examination.

“MaaT-013 Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of MaaT-013 for potential indication like Graft-versus-host disease, Malignant melanoma, Acute myeloid leukaemia, and Myelodysplastic syndromes in the 7MM. A detailed picture of MaaT-013’s existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the MaaT-013 for potential indications. The MaaT-013 market report provides insights about MaaT-013’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current MaaT-013 performance, future market assessments inclusive of the MaaT-013 market forecast analysis for potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of MaaT-013 sales forecasts, along with factors driving its market.

MaaT-013 Drug Summary

MaaT-013 is an investigational, standardized, pooled-donor, high-richness microbiota ecosystem therapy developed by MaaT Pharma for the treatment of acute gastrointestinal graft-versus-host disease (GI-aGvHD), particularly in patients who are refractory to corticosteroids. Administered by rectal enema, MaaT-013 is designed to restore gut microbial diversity and function, thereby re-establishing intestinal homeostasis, strengthening the gut barrier, and modulating immune responses that contribute to gastrointestinal inflammation. Manufactured from rigorously screened healthy donor microbiota using a standardized production process, the therapy aims to overcome the dysbiosis commonly observed after allogeneic hematopoietic stem cell transplantation. Clinical studies, including the Phase III ARES trial and the Early Access Program in Europe, have demonstrated encouraging gastrointestinal response rates, improved overall survival, and a favorable safety profile in patients with steroid-refractory GI-aGvHD, supporting MaaT-013 as a promising microbiome-based therapeutic candidate for a condition with significant unmet medical need. The report provides MaaT-013’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the MaaT-013 Market Report

The report provides insights into:

• A comprehensive product overview including the MaaT-013 MoA, description, dosage and administration, research and development activities in potential indication like Graft-versus-host disease, Malignant melanoma, Acute myeloid leukaemia, and Myelodysplastic syndromes.
• Elaborated details on MaaT-013 regulatory milestones and other development activities have been provided in MaaT-013 market report.
• The report also highlights MaaT-013‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
• The MaaT-013 market report also covers the patents information, generic entry and impact on cost cut.
• The MaaT-013 market report contains current and forecasted MaaT-013 sales for potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The MaaT-013 market report also features the SWOT analysis with analyst views for MaaT-013 in potential indications.

Methodology

The MaaT-013 market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

MaaT-013 Analytical Perspective by DelveInsight

• In-depth MaaT-013 Market Assessment

This MaaT-013 sales market forecast report provides a detailed market assessment of MaaT-013 for potential indication like Graft-versus-host disease, Malignant melanoma, Acute myeloid leukaemia, and Myelodysplastic syndromes in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted MaaT-013 sales data uptil 2034.

• MaaT-013 Clinical Assessment

The MaaT-013 market report provides the clinical trials information of MaaT-013 for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

MaaT-013 Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

MaaT-013 Market Potential & Revenue Forecast

• Projected market size for the MaaT-013 and its key indications
• Estimated MaaT-013 sales potential (MaaT-013 peak sales forecasts)
• MaaT-013 Pricing strategies and reimbursement landscape

MaaT-013 Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• MaaT-013 Market positioning compared to existing treatments
• MaaT-013 Strengths & weaknesses relative to competitors

MaaT-013 Regulatory & Commercial Milestones

• MaaT-013 Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

MaaT-013 Clinical Differentiation

• MaaT-013 Efficacy & safety advantages over existing drugs
• MaaT-013 Unique selling points

MaaT-013 Market Report Highlights

• In the coming years, the MaaT-013 market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The MaaT-013 companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence MaaT-013’s dominance.
• Other emerging products for Graft-versus-host disease, Malignant melanoma, Acute myeloid leukaemia, and Myelodysplastic syndromes are expected to give tough market competition to MaaT-013 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of MaaT-013 in potential indications.
• Analyse MaaT-013 cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted MaaT-013 sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of MaaT-013 in potential indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of MaaT-013? How strong is MaaT-013’s clinical and commercial performance?
• What is MaaT-013’s clinical trial status in each individual indications such as Graft-versus-host disease, Malignant melanoma, Acute myeloid leukaemia, and Myelodysplastic syndromes and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the MaaT-013 Manufacturers?
• What are the key designations that have been granted to MaaT-013 for potential indications? How are they going to impact MaaT-013’s penetration in various geographies?
• What is the current and forecasted MaaT-013 market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of MaaT-013 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to MaaT-013 for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is MaaT-013? What is the duration of therapy and what are the geographical variations in cost per patient?