DelveInsight’s “Graft Versus Host Disease Market Insight, Epidemiology And Market Forecast – 2034” report offers a comprehensive understanding of GvHD epidemiology alongside evolving treatment market trends across the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. The US dominates the graft versus host disease treatment market with approximately 70% share, benefiting from favorable reimbursement structures and quicker adoption of premium-priced therapeutic innovations. Meanwhile, the EU4 and UK collectively represent about 19% of the graft versus host disease treatment landscape.
According to DelveInsight’s analysis, the graft versus host disease market is projected to grow at a CAGR of 8.2% through 2034 from its USD 1.3 billion valuation in 2023, with significant contributions from innovative treatments like ZEMAIRA, EQ001, MaaT013, and RGI-2001.
Explore the driving factors behind the graft versus host disease treatment market @ Graft Versus Host Disease Market Trends.
The report segments epidemiological data by total allogenic transplant cases, GvHD prevalence, type-specific cases, grading distribution, organ involvement patterns, treated cases, and mortality-adjusted treatment figures. DelveInsight estimates approximately 52K graft versus host disease cases across the 7MM. In 2023, the EU4 and UK reported the highest incidence of Grade D Graft Versus Host Disease, corresponding with patterns observed in hematologic malignancy transplants.
For graft versus host disease patient pool forecasts and trends, visit @ Graft Versus Host Disease Epidemiology Analysis.
The graft versus host disease treatment market is evolving from broad immunosuppression strategies toward targeted and cell-based therapeutic approaches. Current treatment protocols include steroids, NIKTIMVO, JAKAFI, IMBRUVICA, RYONCIL/TEMCELL HS, and ORENCIA. JAKAFI, functioning as a JAK1/JAK2 inhibitor, remains a cornerstone therapy in the GVHD treatment market, generating substantial revenue through its demonstrated efficacy in steroid-refractory cases.
DelveInsight’s analysis reveals robust activity in the graft versus host disease clinical trials landscape, with numerous investigational therapies advancing through development pipelines. Notable candidates in the graft versus host disease pipeline include ZEMAIRA (CSL Behring), EQ001 (Equillium/Biocon), MaaT013 (MaaT Pharma), RGI-2001 (REGiMMUNE), MC0518 (Medac), RLS-0071 (ReAlta Life Sciences), VIMSELTINIB (Deciphera Pharmaceuticals), ARSCIMED (Medsenic/BioSenic), ASC-930 (ASC Therapeutics), CYP-001 (Cynata Therapeutics), F-652 (Yifan Pharmaceutical), and APRAGLUTIDE (Ironwood).
The graft versus host disease treatment market saw a significant milestone in January 2025 with FDA approval of Incyte’s and Syndax’s NIKTIMVO (axatilimab-csfr) in 9 mg and 22 mg vial formulations for treating chronic graft-versus-host disease in both adult and pediatric patients. This approval, based on the AGAVE-201 trial results, demonstrates progressive advancement in the graft versus host disease clinical trials sector.
In March 2025, MaaT Pharma announced positive outcomes from the final Data Safety Monitoring Board (DSMB) meeting for its pivotal Phase III clinical trial evaluating MaaT013 in acute GVHD, marking a significant step towards potential regulatory approval.
Furthermore, in December 2024, the FDA approved RYONCIL, marking it as the first FDA-approved mesenchymal stromal cell therapy for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients aged two months and older. RYONCIL is an allogeneic, bone marrow-derived MSC product developed by Mesoblast, and its approval represents a significant milestone in cell-based therapies for immune-related conditions.
Discover recent advancements in the graft versus host disease treatment landscape @ Graft Versus Host Disease Recent Developments.
Looking ahead, anticipated developments in the graft versus host disease treatment market include potential label expansions for cellular therapies such as mesenchymal stromal cells, which could redefine first-line treatment approaches. However, the graft versus host disease treatment landscape faces ongoing challenges, including standardization of response criteria across clinical trials and addressing financial burdens associated with chronic graft versus host disease management. DelveInsight emphasizes that advancing the graft versus host disease treatment market requires collaborative efforts among pharmaceutical stakeholders and transplant networks to enhance patient stratification and outcome tracking.
Table of Contents
1. Key Insights
2. Report Introduction
3. GvHD Market Overview at a Glance
4. Executive Summary
5. Key Events
6. Graft Versus Host Disease Background and Overview
7. Methodology
8. Graft Versus Host Disease Epidemiology and Patient Population
9. Patient Journey
10. Graft Versus Host Disease Marketed Drugs
11. Graft Versus Host Disease Emerging Drugs
12. GvHD – 7MM Market Analysis
13. KOL Views
14. Graft Versus Host Disease Unmet Needs
15. SWOT Analysis
16. Graft Versus Host Disease Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight
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About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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