Steroid Refractory Acute GvHD Market Size in the 7MM is Projected to Enhance at a Significant CAGR by 2036, Estimates DelveInsight

The market dynamics for Steroid Refractory Acute Graft-Versus-Host Disease (SR-aGvHD) is witnessing significant growth driven by the rising number of allogeneic hematopoietic stem cell transplants, increasing incidence of acute GvHD cases, and higher rates of steroid-refractory disease following first-line corticosteroid treatment. Growing demand for rapid-acting targeted therapies, improved disease recognition, and expanding use of advanced cell-based and immunomodulatory treatments are further supporting market expansion. Additionally, the launch of emerging therapies such as CSL964 (CSL Behring), MaaT013 (MaaT Pharma), Pegtarazimod (ReAlta Life Sciences), and others will further fuel the market.

DelveInsight's "Steroid Refractory Acute Graft-Versus-Host Disease (SR-aGvHD) Market Insights, Epidemiology and Market Forecast - 2036" report delivers an in-depth understanding of Steroid Refractory Acute GvHD, historical and forecasted epidemiology as well as the Steroid Refractory Acute GvHD market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Discover which therapies are expected to grab the Steroid Refractory Acute GvHD Market Share @ https://www.delveinsight.com/sample-request/steroid-refactory-acute-graft-versus-host-disease-gvhd-market

Key Takeaways from the Steroid Refractory Acute GvHD Market Report
• The market size for Steroid Refractory Acute GvHD in the leading markets is expected to grow significantly by 2036.
• The United States accounted for the highest Steroid Refractory Acute GvHD treatment market size in 7MM in 2025, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.
• According to the findings, the 7MM accounted for nearly 54,000 total allogeneic transplant cases and approximately 52,000 total GvHD cases in 2025, with cases expected to rise during the forecast period.
• In 2025, the US accounted for the highest number of GvHD cases with approximately 22,500 cases, followed by EU4 and the UK.
• The leading Steroid Refractory Acute GvHD Companies such as Incyte, Novartis, Mesoblast, CSL Behring, MaaT Pharma, and ReAlta Life Sciences.
• Promising Steroid Refractory Acute GvHD Pipeline Therapies such as ZEMAIRA, MaaT013, Pegtarazimod and others.
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What is Steroid Refractory Acute GvHD?
Steroid-refractory acute graft-versus-host disease (SR-aGvHD) is a severe and difficult-to-treat form of acute graft-versus-host disease that occurs after an allogeneic hematopoietic stem cell or bone marrow transplant, where donor immune cells attack the recipient's tissues. In standard cases, first-line treatment involves high-dose corticosteroids to suppress this immune response. However, when patients do not show adequate improvement or continue to worsen despite steroid therapy, the condition is classified as steroid-refractory. This form of graft-versus-host disease is associated with a higher risk of organ damage, infections, and mortality, and typically requires second-line or novel immunosuppressive therapies to control disease progression and improve outcomes.

Steroid Refractory Acute GvHD Epidemiology Segmentation in the 7MM
• Total Allogeneic Transplant Cases
• Total Cases of GvHD
• Acute GvHD Cases
• Acute GvHD Cases on Steroid Therapy
• Total Steroid Refractory Acute GvHD Cases
• Acute GvHD Cases by Organ Involvement
• Acute GvHD Cases by Grading
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Steroid Refractory Acute GvHD Marketed Drugs
JAKAFI (ruxolitinib): Incyte
In May 2019, the FDA approved JAKAFI for SR-aGvHD in adult and pediatric patients aged 12 years and older. It is a JAK1/JAK2 inhibitor that has significantly improved treatment options in refractory patients.
RYONCIL: Mesoblast
In December 2024, the FDA approved RYONCIL as the first and only approved therapy for pediatric SR-aGvHD patients aged two months and older.

Steroid Refractory Acute GvHD Drugs and Companies
• CSL Behring: ZEMAIRA
• MaaT Pharma: MaaT013
• ReAlta Life Sciences: Pegtarazimod
To learn more about Steroid Refractory Acute GvHD treatment guidelines, visit @ https://www.delveinsight.com/sample-request/steroid-refactory-acute-graft-versus-host-disease-gvhd-market

Key Factors Driving Steroid Refractory Acute GvHD Market
• Rising number of allogeneic stem cell transplants (HSCT): The primary driver of the SR-aGVHD market is the increasing use of allogeneic hematopoietic stem cell transplantation for hematologic malignancies such as leukemia, lymphoma, and myeloma.
• High incidence of steroid-refractory disease: A substantial proportion of patients (approximately 35-50%) do not respond adequately to first-line corticosteroids and develop steroid-refractory or steroid-dependent GVHD.
• Poor prognosis and high unmet medical need: SR-aGVHD is associated with severe morbidity and very high mortality, historically exceeding 50-70% in many real-world cohorts, especially in severe cases.
• Advancements in targeted and immunomodulatory therapies: The emergence of novel therapeutic classes such as JAK inhibitors (e.g., ruxolitinib), mesenchymal stromal cell therapies, and cytokine-targeting biologics is expanding treatment options.
• Active clinical pipeline and regulatory support: Strong R&D pipelines and regulatory incentives for orphan and rare disease therapies are encouraging pharmaceutical companies to invest in SR-aGVHD drug development, increasing market competitiveness and innovation.

Recent Developments in the Steroid Refractory Acute GvHD Market
• During ASH2025, ReAlta Life Sciences announced Phase 2 data showing that RLS-0071 (pegtarazimod) demonstrated rapid clinical responses, target engagement, and favorable safety in steroid-refractory acute GvHD. Notably, Pegtarazimod received EMA orphan drug designation for GVHD, supported by phase 2 AURORA trial data, highlighting its potential in addressing unmet needs in acute GVHD treatment.
• In Nov, 2025, Mesoblast announced that, in collaboration with the NIH-funded BMT CTN, it is initiating a pivotal Phase III trial of its MSC therapy Ryoncil (remestemcel-L) in adults with severe steroid-refractory acute GvHD to expand its use beyond pediatric patients and address a high-mortality population with limited treatment options.

Scope of the Steroid Refractory Acute GvHD Market Report
• Coverage- 7MM
• Study Period- 2022-2036
• Steroid Refractory Acute GvHD Companies: Incyte, Novartis, Mesoblast, CSL Behring, MaaT
• Pharma, ReAlta Life Sciences and others.
• Steroid Refractory Acute GvHD Pipeline Therapies: JAKAFI/JAKAVI, RYONCIL, ZEMAIRA, MaaT013,
• Pegtarazimod and others.
• Steroid Refractory Acute GvHD Market Dynamics: Steroid Refractory Acute GvHD Market Drivers and Barriers
• Steroid Refractory Acute GvHD Market Access and Reimbursement, Unmet Needs and Future Perspectives
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Table of Contents
1. Steroid Refractory Acute GvHD Market Report Introduction
2. Executive Summary for Steroid Refractory Acute GvHD
3. SWOT Analysis of Steroid Refractory Acute GvHD
4. Steroid Refractory Acute GvHD Patient Share (%) Overview at a Glance
5. Steroid Refractory Acute GvHD Market Overview at a Glance
6. Steroid Refractory Acute GvHD Background and Overview
7. Steroid Refractory Acute GvHD Epidemiology and Patient Population
8. Country-Specific Patient Population of Steroid Refractory Acute GvHD
9. Steroid Refractory Acute GvHD Current Treatment and Medical Practices
10. Steroid Refractory Acute GvHD Unmet Needs
11. Steroid Refractory Acute GvHD Emerging Therapies
12. Steroid Refractory Acute GvHD Market Outlook
13. Country-Wise Steroid Refractory Acute GvHD Market Analysis (2022-2036)
14. Steroid Refractory Acute GvHD Market Access and Reimbursement of Therapies
15. Steroid Refractory Acute GvHD Market Drivers
16. Steroid Refractory Acute GvHD Market Barriers
17. Steroid Refractory Acute GvHD Appendix
18. Steroid Refractory Acute GvHD Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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