Meerut Reporter

(Albany, New York) – November 03, 2026: DelveInsight’s “Graft-Versus-Host Disease Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Graft-Versus-Host Disease, historical and forecasted epidemiology as well as the Graft-Versus-Host Disease market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

To Know in detail about the Graft-Versus-Host Disease market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Graft-Versus-Host Disease Market Forecast

Some of the key facts of the Graft-Versus-Host Disease Market Report:

• The Graft-Versus-Host Disease market size was valued approximately USD 1,301 million in 2023 and is anticipated to grow with a significant CAGR of 8.2% during the study period (2020-2034).

• In October 2026, Phase III confirmatory trial of belumosudil initiated, Sanofi initiated a Phase III clinical trial (NCT-linked protocol EFC22965; EU CTIS 2026-525913-30-00) to evaluate belumosudil against best available therapy in patients aged 12 years and older with chronic GVHD.

• In October 2026, Phase II study evaluates topical ruxolitinib for chronic cutaneous GVHD, A randomized, double-blind, placebo-controlled, intra-patient-controlled Phase II study investigated topical ruxolitinib in patients with chronic cutaneous GVHD.

• In September 2026, Clinical trial evaluates mesenchymal stromal cells with ruxolitinib, MD Anderson Cancer Center updated its Phase I clinical study (NCT04744116) investigating cord blood tissue-derived mesenchymal stromal cells (cb-MSCs) in combination with ruxolitinib for steroid-refractory acute GVHD.

• In June 2026, The U.S. FDA approved Tregzi (Orca-T), an allogeneic regulatory T-cell therapy developed by Orca Bio, for use in adults with hematologic malignancies undergoing allogeneic stem cell transplantation. Clinical trial results showed a marked improvement in one-year survival without moderate-to-severe chronic graft-versus-host disease (GvHD) compared with conventional transplant approaches. The therapy is designed to minimize transplant-related complications while promoting immune system recovery.

• In April 2026, Orca Bio’s Orca-T continued to undergo U.S. FDA regulatory review, with the anticipated approval decision recognized as a key upcoming milestone in the development of biologic therapies for hematologic malignancies and the prevention of graft-versus-host disease (GvHD).

• In January 2026, REZUROCK (belumosudil) received a positive re-examination opinion from the European Medicines Agency (EMA), recommending conditional marketing authorization for the treatment of chronic graft-versus-host disease (GvHD) following the resolution of earlier concerns related to its marketing application.

• In November 2025, Mesoblast Limited (Nasdaq: MESO; ASX: MSB), a global leader in allogeneic cellular therapies for inflammatory diseases, announced that due to the high rate of treatment non-response and elevated mortality in adults with severe acute graft-versus-host disease (aGvHD) who fail corticosteroids, it will collaborate with the NIH-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on a pivotal trial. The study will evaluate Ryoncil® (remestemcel-L-rknd) as part of a first-line regimen for adults with corticosteroid-refractory severe aGvHD (SR-aGvHD). The BMT CTN represents U.S. centers conducting roughly 80% of all allogeneic bone marrow transplants in the country.

• In June 2025, According to results from the Phase 3 BM12 CAST trial (ACTRN12618000505202) presented at the 2025 European Hematology Association Congress, cyclophosphamide combined with cyclosporin, a calcineurin inhibitor, significantly improved graft-versus-host disease (GVHD)–free relapse-free survival (RFS) compared to standard prophylaxis in patients with aggressive blood cancers undergoing stem cell transplants from matched related donors with either reduced-intensity or myeloablative conditioning.

• In April 2025, The California Institute for Regenerative Medicine (CIRM) granted $8 million to biotech firm Tr1X to advance its Phase I/IIa clinical trial of TRX103. This therapy aims to prevent graft-versus-host disease (GvHD) in blood cancer patients receiving mismatched stem cell transplants. TRX103 is an allogeneic, engineered type 1 regulatory (Tr1) Treg cell therapy designed to reduce transplant-related complications and improve patient outcomes.

• In 2023, the Graft Versus Host Disease treatment market in the US was valued at around USD 920 million and is expected to grow further with the introduction of new and emerging therapies.

• In 2023, the combined Graft Versus Host Disease market size for the EU4 and the UK was estimated at about USD 252 million, representing nearly 19% of the total market revenue across the 7MM.

• In 2023, Germany led the Graft Versus Host Disease Treatment Market within the EU4 and the UK, generating approximately USD 98 million. France was next with about USD 41 million, and the UK reported nearly USD 40 million.

• In 2023, Japan’s Graft Versus Host Disease Treatment Market Size was estimated at around USD 130 million and is expected to grow throughout the forecast period (2025-2034).

• It is estimated that REZUROCK will generate around USD 173 million by 2034 across the 7MM.

• DelveInsight estimates that in 2023, there were around 52,000 cases of Graft Versus Host Disease (GVHD) across the 7MM. The United States contributed to about 45% of these cases, while the EU4 countries and the UK collectively made up nearly 39%. Japan accounted for the remaining 16%.

• According to DelveInsight’s epidemiological model, around 57,000 allogeneic transplants and nearly 52,000 Graft Versus Host Disease (GVHD) cases were reported across the 7MM in 2023. These numbers are projected to rise by 2034.

• In 2023, the United States recorded the highest number of Graft Versus Host Disease cases among the 7MM, with around 24,000 cases, and this count is anticipated to increase by 2034.

• In 2023, Germany had the highest number of Graft Versus Host Disease cases among the EU4 and the UK, with an estimated 8,000 cases. Italy and France followed closely, each reporting around 3,000 cases, while Spain recorded the fewest, with approximately 2,700 cases.

• In 2023, the United States recorded nearly 5,000 new cases of Graft Versus Host Disease, along with an estimated 18,000 prevalent cases accumulated over a five-year period.

• In 2023, Germany documented roughly 900 Graft Versus Host Disease cases affecting the skin, around 400 involving the liver, and nearly 800 cases impacting the gastrointestinal tract.

• Key Graft-Versus-Host Disease Companies: Abbisko Therapeutics, Theriva Biologics, Seres Therapeutics, Cellestia Biotech, Pfizer, Chia Tai Tianqing Pharmaceutical, Regimmune Corporation, Syndax Pharmaceuticals, MaaT Pharma, Medac, Equillium, Xenikos, and others

• Key Graft-Versus-Host Disease Therapies: ABSK021, SYN-004, SER-155, CB103, Glasdegib, TQ 05105, RGI-2001, Axatilimab, MaaT013, MC 0518, Itolizumab, T-Guard, and others

• In the United States in 2022, roughly 4,780 cases of acute Graft-versus-host disease (aGvHD) and approximately 17,210 cases of chronic Graft-versus-host disease (cGvHD) received first-line treatment. Projections suggest an anticipated increase in these cases by the year 2034.

• The Graft-Versus-Host Disease market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Graft-Versus-Host Disease pipeline products will significantly revolutionize the Graft-Versus-Host Disease market dynamics.

Graft-Versus-Host Disease Overview

Graft-Versus-Host Disease (GVHD) is a condition that occurs after a bone marrow or stem cell transplant in which the donated (graft) immune cells attack the recipient’s (host) body tissues. This reaction happens because the donor’s immune cells recognize the recipient’s cells as foreign and initiate an immune response against them.

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Graft-Versus-Host Disease Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Graft-Versus-Host Disease Epidemiology Segmentation:

The Graft-Versus-Host Disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of Graft-Versus-Host Disease

• Prevalent Cases of Graft-Versus-Host Disease by severity

• Gender-specific Prevalence of Graft-Versus-Host Disease

• Diagnosed Cases of Episodic and Chronic Graft-Versus-Host Disease

Download the report to understand which factors are driving Graft-Versus-Host Disease epidemiology trends @ Graft-Versus-Host Disease Epidemiology Forecast

Graft-Versus-Host Disease Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Graft-Versus-Host Disease market or expected to get launched during the study period. The analysis covers Graft-Versus-Host Disease market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Graft-Versus-Host Disease Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Graft-Versus-Host Disease Therapies and Key Companies

• ABSK021: Abbisko Therapeutics

• SYN-004: Theriva Biologics

• SER-155: Seres Therapeutics

• CB103: Cellestia Biotech

• Glasdegib: Pfizer

• TQ 05105: Chia Tai Tianqing Pharmaceutical

• RGI-2001: Regimmune Corporation

• Axatilimab: Syndax Pharmaceuticals

• MaaT013: MaaT Pharma

• MC 0518: Medac

• Itolizumab: Equillium

• Elranatamab: Pfizer

• Felzartamab: Janssen Pharmaceutical

• T-Guard: Xenikos

• MaaT013: MaaT Pharma

• Axatilimab: Syndax Pharmaceuticals

• TQ 05105: Chia Tai Tianqing Pharmaceutical Group

Discover more about therapies set to grab major Graft-Versus-Host Disease market share @ Graft-Versus-Host Disease Treatment Landscape

Graft-Versus-Host Disease Market Drivers

• Increasing Hematopoietic Stem Cell Transplantation Procedures: The growing number of allogeneic hematopoietic stem cell and bone marrow transplants is expanding the patient population at risk of developing GVHD.

• Rising Prevalence of Hematological Malignancies: Increasing cases of leukemia, lymphoma, and other blood cancers requiring stem cell transplantation are contributing to greater demand for GVHD prevention and treatment.

• Advancements in Targeted Therapies: The development and approval of JAK inhibitors, ROCK2 inhibitors, monoclonal antibodies, and cell-based therapies are expanding treatment options.

• Growing Research and Development Activities: Increasing clinical research into microbiome-based therapies, immune modulation, and novel biologics is creating opportunities for market growth.

• Improved Disease Awareness and Diagnosis: Advancements in diagnostic techniques, patient monitoring, and risk assessment are supporting earlier identification and improved management of GVHD.

Graft-Versus-Host Disease Market Barriers

• High Treatment Costs: The high cost of advanced biologics, cell therapies, and long-term treatment regimens can limit patient access, particularly in developing regions.

• Risk of Infections: Immunosuppressive treatments increase susceptibility to bacterial, viral, and fungal infections, complicating disease management.

• Treatment Resistance and Relapse: Some patients experience inadequate responses or relapse following corticosteroid and other systemic treatments, creating a need for more effective therapies.

• Limited Understanding of Disease Mechanisms: The complex pathophysiology of acute and chronic GVHD makes it challenging to develop treatments that provide durable responses with fewer adverse effects.

• Manufacturing and Reimbursement Challenges: Complex production requirements for cell-based therapies, limited manufacturing capacity, and reimbursement restrictions may hinder wider treatment adoption

Scope of the Graft-Versus-Host Disease Market Report

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Graft-Versus-Host Disease Companies: Abbisko Therapeutics, Theriva Biologics, Seres Therapeutics, Cellestia Biotech, Pfizer, Chia Tai Tianqing Pharmaceutical, Regimmune Corporation, Syndax Pharmaceuticals, MaaT Pharma, Medac, Equillium, Xenikos, and others

• Key Graft-Versus-Host Disease Therapies: ABSK021, SYN-004, SER-155, CB103, Glasdegib, TQ 05105, RGI-2001, Axatilimab, MaaT013, MC 0518, Itolizumab, T-Guard, and others

• Graft-Versus-Host Disease Therapeutic Assessment: Graft-Versus-Host Disease current marketed and Graft-Versus-Host Disease emerging therapies

• Graft-Versus-Host Disease Market Dynamics: Graft-Versus-Host Disease market drivers and Graft-Versus-Host Disease market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Graft-Versus-Host Disease Unmet Needs, KOL’s views, Analyst’s views, Graft-Versus-Host Disease Market Access and Reimbursement

To know more about Graft-Versus-Host Disease companies working in the treatment market, visit @ Graft-Versus-Host Disease Clinical Trials and Therapeutic Assessment

Table of Contents

1. Graft-Versus-Host Disease Market Report Introduction

2. Executive Summary for Graft-Versus-Host Disease

3. SWOT analysis of Graft-Versus-Host Disease

4. Graft-Versus-Host Disease Patient Share (%) Overview at a Glance

5. Graft-Versus-Host Disease Market Overview at a Glance

6. Graft-Versus-Host Disease Disease Background and Overview

7. Graft-Versus-Host Disease Epidemiology and Patient Population

8. Country-Specific Patient Population of Graft-Versus-Host Disease

9. Graft-Versus-Host Disease Current Treatment and Medical Practices

10. Graft-Versus-Host Disease Unmet Needs

11. Graft-Versus-Host Disease Emerging Therapies

12. Graft-Versus-Host Disease Market Outlook

13. Country-Wise Graft-Versus-Host Disease Market Analysis (2020–2034)

14. Graft-Versus-Host Disease Market Access and Reimbursement of Therapies

15. Graft-Versus-Host Disease Market Drivers

16. Graft-Versus-Host Disease Market Barriers

17. Graft-Versus-Host Disease Appendix

18. Graft-Versus-Host Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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