Graft Versus Host Disease Market is expected to Reach USD 3,304 million by 2034

The Graft Versus Host Disease (GvHD) market across the seven major markets (7MM) is projected to grow significantly, increasing from USD 1,626 million in 2025 to approximately USD 3,304 million by 2034, reflecting a CAGR of 8.2%. This growth will be primarily driven by the launch of innovative therapies such as ZEMAIRA, EQ001, MaaT013, and RGI-2001, alongside the expanding use of existing treatments like steroids, NIKTIMVO, JAKAVI/JAKAFI, IMBRUVICA, RYONCIL/TEMCELL HS, and ORENCIA.

According to DelveInsight’s estimates, the GvHD market was valued at around USD 1.3 billion in 2023, with approximately 52,000 diagnosed cases across the 7MM. Of these, the United States accounted for the largest share (45%), followed by EU4 and the UK (39%), and Japan (16%). Key pharmaceutical players, including CSL Behring, Equillium, MaaT Pharma, and REGiMMUNE, are advancing multiple drug candidates through late-stage clinical trials, such as Equillium’s EQ001, which is expected to complete its Phase III EQUATOR study by early 2025.

Overall, the United States remains the largest GvHD market, supported by strong clinical activity, innovative drug development, and growing patient awareness, all contributing to the robust market expansion expected through 2034.

DelveInsight’s “Graft Versus Host Disease (GvHD) Market Insights, Epidemiology, and Market Forecast – 2034” report offers a comprehensive overview of the GvHD landscape across the United States, EU5 (Germany, Spain, Italy, France, and the UK), and Japan. It provides detailed insights into historical and forecasted epidemiology, current treatment practices, emerging therapies, and market trends from 2020 to 2034. The report also examines the market size, therapy-wise market share, and the treatment algorithms currently in use. Additionally, it highlights key market drivers, barriers, and unmet needs, identifying growth opportunities and assessing the future potential of the 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 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.

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Graft Versus Host Disease (GvHD) Market Outlook

The total GvHD treatment market size across the 7MM was approximately USD 1,302 million in 2023 and is expected to rise steadily throughout 2025–2034. The United States accounted for the majority share, valued at around USD 920 million in 2023, driven by the anticipated launch of new therapies.

In the EU4 and the UK, the market was valued at approximately USD 252 million, representing nearly 19% of the total 7MM market. Within this region, Germany led with USD 98 million, followed by France (USD 41 million) and the UK (USD 40 million). Meanwhile, Japan’s GvHD treatment market reached about USD 130 million in 2023 and is also projected to expand over the forecast period. Among the emerging therapies, REZUROCK is expected to generate roughly USD 173 million by 2034 in the 7MM.

Several key pharmaceutical companies are advancing drug development for Graft Versus Host Disease (GvHD), including CSL with ZEMAIRA (CSL964, Alpha-1 antitrypsin), Equillium Bio with EQ001 (Itolizumab), MaaT Pharma with MaaT013, and Medac with MC0518, among others.

Additionally, a range of early-stage therapies are under development, such as RLS-0071 (ReAlta Life Sciences), Vimseltinib (Deciphera Pharmaceuticals), ASC-930 (ASC Therapeutics), RGI-2001 (REGiMMUNE), CYP-001 (Cynata Therapeutics), arsenic trioxide (As₂O₃) (BioSenic/Medsenic), TRX103 (Tregs) (Tr1X), TCD601 (Siplizumab) (ITB-MED), F-652 (Evive Biotech), RHPRG4 (Lubris BioPharma), XBI302 (Xbiome), RG6287 (Genentech), ALTB-168 (AltruBio), and SER-155 (Seres Therapeutics).

Graft Versus Host Disease (GvHD) Epidemiology 

According to DelveInsight’s epidemiology model, in 2023, there were around 57,000 allogenic transplant cases and approximately 52,000 Graft Versus Host Disease (GVHD) cases across the 7MM, with both numbers expected to rise by 2034. The United States accounted for the largest share, reporting about 24,000 GVHD cases in 2023, followed by Germany, which recorded the highest number among the EU4 and the UK at roughly 8,000 cases. Italy and France each had around 3,000 cases, while Spain reported the lowest, at about 2,700 cases.

Japan had approximately 8,000 GVHD cases in 2023, also projected to increase by 2034. Within the U.S., there were around 5,000 incident cases and about 18,000 prevalent GVHD cases over a five-year span.

In the EU4 and the UK, the 2023 GVHD distribution by grading included around 2,000 Grade B (II), 1,000 Grade C (III), and 800 Grade D (IV) cases. In Germany, approximately 900 GVHD cases affected the skin, 400 the liver, and 800 the gastrointestinal tract. The UK reported around 600 mild, 1,000 moderate, and 800 severe GVHD cases. In Japan, the 2023 GVHD burden included about 1,000 skin cases, 3,000 oral mucosa cases, 2,000 ocular cases, 300 hepatic cases, 800 gastrointestinal cases, 2,000 pulmonary cases, 300 genital cases, and 400 cases affecting the joints and fascia.

Graft Versus Host Disease Epidemiology Segmentation

• Total allogenic transplant cases
• Total Graft Versus Host Disease prevalence cases
• Type-specific cases of Graft Versus Host Disease
• Graft Versus Host Disease cases by grading
• Graft Versus Host Disease cases by organ involvement
• Graft Versus Host Disease cases by grading
• Graft Versus Host Disease cases by organ involvement
• Total treated cases of Graft Versus Host Disease
• Mortality-adjusted treated cases of Graft Versus Host Disease

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Graft Versus Host Disease (GvHD) Drugs Uptake

• ZEMAIRA (CSL 964, alpha-1 antitrypsin): CSL Behring
• EQ001 (itolizumab; Bmab600): Equillium/Biocon
• MaaT013: MaaT Pharma
• RGI-2001 (KRN-7000; RGI-7000): REGiMMUNE
• MC0518: medac
• RLS-0071 (pegtarazimod): ReAlta Life Sciences
• Vimseltinib: Ono Pharmaceutical (Deciphera Pharmaceuticals)
• ARSCIMED (ATO; arsenic trioxide): Medsenic/BioSenic
• ASC-930: ASC Therapeutics
• CYP-001: Cynata Therapeutics
• F-652: Evive Biotech (Yifan Pharmaceutical)
• Apraglutide: Ironwood

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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About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.