Graft Versus Host Disease (GvHD) Market Forecast 2034: Clinical Trials, Prevalence, Medication, FDA, EMA, PDMA Approvals, Statistics, Revenue and Companies by DelveInsight

(Albany, USA) DelveInsight's "Graft Versus Host Disease (GvHD) Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Graft Versus Host Disease (GvHD), historical and forecasted epidemiology as well as the Graft Versus Host Disease (GvHD) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Graft Versus Host Disease (GvHD) market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Graft Versus Host Disease (GvHD) market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Graft Versus Host Disease (GvHD) treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Graft Versus Host Disease (GvHD) market.

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Some facts of the Graft Versus Host Disease (GvHD) Market Report are:
• According to DelveInsight, Graft Versus Host Disease (GvHD) market size is expected to grow at a decent CAGR by 2034.
• The Graft versus Host Disease Market Size in the US was around USD 1100 million in 2023.
• Leading Graft Versus Host Disease (GvHD) companies working in the market are Medac, MaaT Pharma, ElsaLys Biotech (Mediolanum Farmaceutici Spa), Syndax Pharmaceutical, Kadmon Corporation, AstraZeneca, Biogen, Amgen, Pfizer, AltruBio, CSL Behring, Incyte Corporation, Takeda, OncoImmune, Merck (MSD), Regimmune Corporation, Jazz Pharmaceuticals, Millennium Pharmaceuticals, Takeda Oncology, Roche, Genentech, Bristol-Myers Squibb, Xenikos, Synthetic Biologics, Equillium/Biocon, CTI BioPharma, Novartis, GlaxoSmithKline and others.
• Key Graft Versus Host Disease (GvHD) Therapies expected to launch in the market are ZEMAIRA (CSL 964, alpha-1 antitrypsin), EQ001 (itolizumab; Bmab600), Jakafi (Ruxolitinib), Temcell (Ryoncil; Remestemcel-L; Prochymal), Obnitix (MC0518), MaaT013, Leukotac (Inolimomab), KD025 (Belumosudil), Itacitinib, and many others.
• In April 2025, The California Institute for Regenerative Medicine (CIRM) has 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 March 2025, Orca Bio's investigational T-cell immunotherapy for blood cancers significantly improved outcomes, more than doubling the rate of patients who remained free from moderate-to-severe chronic graft-versus-host disease (GvHD). According to results from the Phase III Precision-T trial (NCT05316701), 78% of patients treated with Orca-T (TRGFT-201), the company's lead allogeneic T-cell therapy, were GvHD-free after one year, compared to only 38% in the group receiving standard allogeneic stem cell transplants.
• In January 2025, MaaT Pharma (EURONEXT: MAAT), a clinical-stage biotech company specializing in Microbiome Ecosystem Therapies Trademark (MET) aimed at improving survival outcomes in cancer patients through immune system modulation, has announced positive topline results from its pivotal Phase 3 ARES trial. This single-arm, open-label, multicenter study conducted across Europe assessed the safety and efficacy of MaaT013 in patients with acute Graft-versus-Host Disease involving the gastrointestinal tract (GI-aGvHD) who are in third-line treatment - meaning they are resistant to steroids and either refractory or intolerant to ruxolitinib. The trial successfully achieved its primary endpoint, with a 28-day gastrointestinal overall response rate (GI-ORR) of 62%, significantly surpassing the expected rate of 38%. These outcomes, evaluated by an Independent Review Committee (IRC), exceeded the predefined efficacy threshold and underscore the strong clinical potential of MaaT013 in treating third-line GI-aGvHD.
• In December 2024, The FDA has granted approval to Mesoblast's allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, remestemcel-L, for treating steroid-refractory acute graft versus host disease (GvHD) in pediatric patients aged two months and older. Significantly, this marks the first FDA-approved MSC-based therapy. The treatment will be commercially available under the brand name Ryoncil.
• In June 2024, Chia Tai Tianqing Pharmaceutical Group Co., Ltd announced results of a Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).
• In June 2024, Incyte Corporation announced results of a Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease After at Least 2 Lines of Systemic Therapy
• In June 2024, Sanofi announced results of a Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)
• In January 2024, BioSenic reached an agreement on a binding term sheet with Phebra PTY Ltd. with respect to the development of the first oral formulation of arsenic troxide for cGvHD treatment. In particular, the binding term sheet for the indication chronic Graft versus Host Disease (cGvHD) license now provides for a royalty payment of 2% on worldwide sales, which simplifies the conditions for offering sublicenses to new external partners. In addition, under the license agreement, Phebra PTY Ltd. agrees that Medsenic SAS will have exclusive worldwide territorial rights for the use of OATO in GvHD
• In April 2023, REGiMMUNE Limited (REGiMMUNE), a biotech company focused on creating innovative immunotherapies for immune disorders and cancer, and San Fu Biotech (SFB), a subsidiary of San Fu Chemical Co., Ltd. (4755.TW) had entered into a licensing agreement to develop and commercialize RGI2001 for the prophylaxis of acute Graft-versus host disease (aGvHD) in major Asian countries

Graft Versus Host Disease (GvHD) Overview
Graft-versus-host disease (GvHD) is a serious condition that can occur after an allogeneic stem cell or bone marrow transplant, where the donated cells (the graft) attack the recipient's (host's) tissues. GvHD arises because the donor immune cells recognize the host's body as foreign. It is a significant complication affecting the success and outcome of the transplant.
GvHD is categorized into acute and chronic forms. Acute GvHD typically develops within the first 100 days post-transplant and primarily affects the skin, liver, and gastrointestinal tract. Symptoms include rash, jaundice, liver dysfunction, nausea, vomiting, and diarrhea. Chronic GvHD can occur at any time post-transplant, presenting more widespread and persistent symptoms that may affect multiple organs, including the skin, liver, eyes, mouth, lungs, and digestive system.
The severity of GvHD can range from mild to life-threatening. Treatment involves immunosuppressive drugs like corticosteroids to control the donor immune response and mitigate tissue damage. Prophylactic measures, including the use of immunosuppressants and careful matching of donor and recipient tissues, are critical in reducing the incidence and severity of GvHD.
Ongoing research focuses on improving prevention strategies, understanding the underlying mechanisms, and developing targeted therapies to enhance patient outcomes and quality of life post-transplant.

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Graft Versus Host Disease (GvHD) Market
The Graft Versus Host Disease (GvHD) market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Graft Versus Host Disease (GvHD) market trends by analyzing the impact of current Graft Versus Host Disease (GvHD) therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.
This segment gives a thorough detail of the Graft Versus Host Disease (GvHD) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Graft Versus Host Disease (GvHD) market data are presented with relevant tables and graphs to give a clear view of the market at first sight.
According to DelveInsight, the Graft Versus Host Disease (GvHD) market in 7MM is expected to witness a major change in the study period 2020-2034.

Graft Versus Host Disease (GvHD) Epidemiology
The Graft Versus Host Disease (GvHD) epidemiology section provides insights into the historical and current Graft Versus Host Disease (GvHD) patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Graft Versus Host Disease (GvHD) market report also provides the diagnosed patient pool, trends, and assumptions.

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Graft Versus Host Disease (GvHD) Drugs Uptake
This section focuses on the uptake rate of the potential Graft Versus Host Disease (GvHD) drugs recently launched in the Graft Versus Host Disease (GvHD) market or expected to be launched in 2020-2034. The analysis covers the Graft Versus Host Disease (GvHD) market uptake by drugs, patient uptake by therapies, and sales of each drug.
Graft Versus Host Disease (GvHD) Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Graft Versus Host Disease (GvHD) market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Graft Versus Host Disease (GvHD) Pipeline Development Activities
The Graft Versus Host Disease (GvHD) report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Graft Versus Host Disease (GvHD) key players involved in developing targeted therapeutics. Emerging Graft vs Host Disease Drugs Under Different Phases of Clinical Development Include:
• 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

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Graft Versus Host Disease (GvHD) Therapeutics Assessment
Major key companies are working proactively in the Graft Versus Host Disease (GvHD) Therapeutics market to develop novel therapies which will drive the Graft Versus Host Disease (GvHD) treatment markets in the upcoming years are AstraZeneca (LSE: AZN), Biogen (NASDAQ: BIIB), Amgen (NASDAQ: AMGN), Pfizer (NYSE: PFE), CSL Behring (ASX: CSL), Incyte Corporation (NASDAQ: INCY), Takeda (TYO: 4502), Merck & Co., Inc. (NYSE: MRK), Jazz Pharmaceuticals (NASDAQ: JAZZ), Roche (SWX: ROG), Bristol-Myers Squibb (NYSE: BMY), CTI BioPharma (NASDAQ: CTIC), Novartis (SWX: NOVN), GlaxoSmithKline (LSE: GSK), Equillium (NASDAQ: EQ), Biocon (NSE: BIOCON), Syndax Pharmaceuticals (NASDAQ: SNDX), Kadmon Corporation (formerly NASDAQ: KDMN), Medac (Private), MaaT Pharma (EPA: MAAT), ElsaLys Biotech (Private, subsidiary of Mediolanum Farmaceutici Spa), AltruBio (Private), OncoImmune (Acquired by Merck & Co., Inc.), Regimmune Corporation (Private), Millennium Pharmaceuticals (Acquired by Takeda), Takeda Oncology (Division of Takeda), Genentech (Subsidiary of Roche), Xenikos (Private), Synthetic Biologics (NYSE American: SYN), and others.

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Graft Versus Host Disease (GvHD) Report Key Insights
1. Graft Versus Host Disease (GvHD) Patient Population
2. Graft Versus Host Disease (GvHD) Market Size and Trends
3. Key Cross Competition in the Graft Versus Host Disease (GvHD) Market
4. Graft Versus Host Disease (GvHD) Market Dynamics (Key Drivers and Barriers)
5. Graft Versus Host Disease (GvHD) Market Opportunities
6. Graft Versus Host Disease (GvHD) Therapeutic Approaches
7. Graft Versus Host Disease (GvHD) Pipeline Analysis
8. Graft Versus Host Disease (GvHD) Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Graft Versus Host Disease (GvHD) Market

Table of Contents
1. Key Insights
2. Executive Summary
3. Graft Versus Host Disease (GvHD) Competitive Intelligence Analysis
4. Graft Versus Host Disease (GvHD) Market Overview at a Glance
5. Graft Versus Host Disease (GvHD) Disease Background and Overview
6. Graft Versus Host Disease (GvHD) Patient Journey
7. Graft Versus Host Disease (GvHD) Epidemiology and Patient Population
8. Graft Versus Host Disease (GvHD) Treatment Algorithm, Current Treatment, and Medical Practices
9. Graft Versus Host Disease (GvHD) Unmet Needs
10. Key Endpoints of Graft Versus Host Disease (GvHD) Treatment
11. Graft Versus Host Disease (GvHD) Marketed Products
12. Graft Versus Host Disease (GvHD) Emerging Therapies
13. Graft Versus Host Disease (GvHD) Seven Major Market Analysis
14. Attribute Analysis
15. Graft Versus Host Disease (GvHD) Market Outlook (7 major markets)
16. Graft Versus Host Disease (GvHD) Access and Reimbursement Overview
17. KOL Views on the Graft Versus Host Disease (GvHD) Market
18. Graft Versus Host Disease (GvHD) Market Drivers
19. Graft Versus Host Disease (GvHD) Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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