The Graft Versus Host Disease market report also offers comprehensive insights into the Graft Versus Host Disease market size, share, Graft Versus Host Disease epidemiology, emerging therapies, market drivers and barriers, ongoing clinical trials, key collaboration in the space, market uptake by key therapies and companies actively pushing Graft Versus Host Disease market size growth forward.
Some of the key highlights from the Graft Versus Host Disease Market Insights Report:
In December 2024, the FDA approved Mesoblast’s cell therapy, Ryoncil, for the treatment of Graft Versus Host Disease (GVHD) in patients who have undergone stem cell or bone marrow transplants. Ryoncil is the first mesenchymal stromal cell therapy authorized for pediatric patients aged two months and older whose GVHD symptoms have not responded to standard steroid therapy.
On August 14, 2024, the FDA granted approval to AstraZeneca’s IMFINZI (durvalumab) for treating adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) who do not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. The approved treatment regimen includes IMFINZI in combination with neoadjuvant chemotherapy before surgery, followed by IMFINZI as adjuvant monotherapy after surgery.
The graft versus host disease companies are Biocon, medac GmbH, MaaT Pharma, ElsaLys Biotech, Glia, Syndax Pharmaceuticals, ASC Therapeutics, SCM Lifescience, REGiMMUNE, Roche, VectivBio, Chia Tai Tianqing Pharmaceutical Group, Amgen, Pfizer, Plexxikon, Medsenic, Xenothera, and others.
The graft versus host disease therapies are JAKAFI MOA/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), ZEMAIRA (CSL 964, alpha-1 antitrypsin), EQ001 (itolizumab; Bmab600), and others.
The Graft Versus Host Disease (GVHD) Treatment Market is expected to experience steady growth, with a strong compound annual growth rate (CAGR) projected from 2025 to 2034. This expansion across the seven major markets (7MM) will be driven by the introduction of novel therapies, including ZEMAIRA, EQ001, MaaT013, and RGI-2001, among others.
According to DelveInsight’s analysis, the GVHD market in the 7MM was valued at approximately USD 1,301.8 million in 2023. Over the forecast period (2025–2034), the market is anticipated to grow at a CAGR of 8.2%.
Currently, available GVHD treatments include steroids, NIKTIMVO, JAKAVI/JAKAFI MOA, IMBRUVICA, RYONCIL/TEMCELL HS, and ORENCIA, among others. Meanwhile, pharmaceutical companies such as CSL Behring, Equillium, MaaT Pharma, and REGiMMUNE are actively advancing their pipeline therapies through various clinical trial phases, fostering innovation and creating substantial growth opportunities.
In 2023, approximately 52,000 cases of GVHD were reported across the 7MM. Of these, the United States accounted for 45%, the EU4 and the UK made up nearly 39%, and Japan represented 16% of the cases.
A significant development occurred in November 2024, when Equillium expedited the Phase III EQUATOR study timeline for EQ001, targeting GVHD, with completion now expected in Q1 2025.
As per DelveInsight analysis, the Graft Versus Host Disease market is anticipated to witness growth at a considerable CAGR
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Graft Versus Host Disease Overview
Graft Versus Host Disease (GVHD) is an immune-related complication that arises following transplant procedures, occurring when donor-derived immune cells (T cells) attack the recipient’s healthy tissues. This condition is a common side effect of allogeneic bone marrow transplants and, in some cases, can be life-threatening. Before undergoing an allogeneic stem cell transplant, patients typically receive high-dose chemotherapy or radiation to eliminate diseased cells and prepare the body for donor cell engraftment.
There are two main types of GVHD: acute and chronic. Recipients of allogeneic transplants may develop either form, both, or none at all. On average, 30–50% of patients undergoing allogeneic hematopoietic cell transplantation experience GVHD.
Diagnosis of GVHD is based on clinical evaluation, organ biopsies (skin, liver, gastrointestinal tract), and ruling out conditions with similar presentations, such as infections or drug reactions. While laboratory tests and imaging can assist in assessment, a major challenge remains the lack of predictive biomarkers to identify at-risk patients before symptoms arise. Diagnosis requires at least one characteristic clinical manifestation (e.g., lichenoid lesions or scleroderma) after excluding alternative causes. Emerging blood-based biomarker panels hold promise for improving risk stratification and guiding personalized immunosuppressive therapy, addressing current limitations in GVHD diagnosis.
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Graft Versus Host Disease Epidemiology Insights
According to DelveInsight’s epidemiology model, approximately 57,000 allogeneic transplant cases and nearly 52,000 cases of Graft Versus Host Disease (GVHD) were recorded across the seven major markets (7MM) in 2023, with numbers projected to increase by 2034.
The United States had the highest prevalence of GVHD among the 7MM, reporting around 24,000 cases in 2023, a figure anticipated to grow further by 2034.
Graft Versus Host Disease Epidemiology Segmentation
DelveInsight’s Graft Versus Host Disease market report is prepared on the basis of epidemiology model. It offers comprehensive insights to the Graft Versus Host Disease historical patient pools and forecasted Graft Versus Host Disease patients. The report provides in-depth data of various subtypes and for the same epidemiology is segmented further. The Graft Versus Host Disease Market report proffers epidemiological analysis for the study period 2020-34 in the 7MM segmented into:
Graft Versus Host Disease Prevalence
Age-Specific Graft Versus Host Disease Prevalence
Gender-Specific Graft Versus Host Disease Prevalence
Diagnosed and Treatable Cases of Graft Versus Host Disease
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Graft Versus Host Disease Treatment Market
Graft Versus Host Disease (GVHD) is a significant complication of allogeneic stem cell transplantation, where stem cells are derived from bone marrow, peripheral blood, or umbilical cord blood. The primary first-line treatment involves corticosteroids such as prednisone and methylprednisolone, often used in combination with other immunosuppressive agents.
Mild GVHD is typically managed with topical steroids, while systemic cases necessitate stronger immunosuppressive therapies. Treatment is tailored to the severity of the disease, with localized symptoms addressed using topical treatments, whereas more severe cases require systemic corticosteroids like prednisone to control the immune response.
Graft Versus Host Disease Market Outlook
Graft Versus Host Disease (GVHD) is a significant complication of allogeneic stem cell transplants. The primary first-line treatment involves corticosteroids such as prednisone, often used in combination with immunosuppressants like cyclosporine.
Mild GVHD can typically be managed with topical steroids, while more severe cases require systemic corticosteroids. Prednisone is the preferred treatment for widespread symptoms, whereas localized therapies—such as steroid creams or eye drops—are used for mild, organ-specific cases.
Several pharmaceutical companies are actively developing treatments for Graft Versus Host Disease (GVHD). Notable companies include CSL, with ZEMAIRA (CSL964, Alpha-1 antitrypsin), Equillium Bio, developing EQ001 (Itolizumab), MaaT Pharma, working on MaaT013, and Medac, advancing MC0518, among others.
In addition, multiple GVHD therapies are currently in the early stages of development, including:
RLS-0071 by ReAlta Life Sciences
Vimseltinib by Deciphera Pharmaceuticals
ASC-930 by ASC Therapeutics
RGI-2001 by REGiMMUNE
CYP-001 by Cynata Therapeutics
Arsenic trioxide (As₂O₃) by BioSenic (Medsenic)
TRX103 (Tregs) by Tr1X
TCD601 (Siplizumab) by ITB-MED
F-652 by Evive Biotech
RHPRG4 by Lubris BioPharma
XBI302 by Xbiome
RG6287 by Genentech
ALTB-168 by AltruBio
SER-155 by Seres Therapeutics
These emerging treatments represent ongoing efforts to improve GVHD management and expand therapeutic options.
Graft Versus Host Disease Marketed Therapies
JAKAFI MOA/JAKAVI (ruxolitinib): Incyte
IMBRUVICA (ibrutinib): Pharmacyclics (acquired by AbbVie)/ Janssen
Graft Versus Host Disease Emerging Therapies
ZEMAIRA (CSL 964, alpha-1 antitrypsin): CSL Behring
EQ001 (itolizumab; Bmab600): Equillium/Biocon
Graft Versus Host Disease Key Companies
Biocon, medac GmbH, MaaT Pharma, ElsaLys Biotech, Glia, Syndax Pharmaceuticals, ASC Therapeutics, SCM Lifescience, REGiMMUNE, Roche, VectivBio, Chia Tai Tianqing Pharmaceutical Group, Amgen, Pfizer, Plexxikon, Medsenic, Xenothera, and others
For more information, visit Graft Versus Host Disease Market Analysis, Patient Pool, and Emerging Therapies
Scope of the Graft Versus Host Disease Market Report:
11 Years Forecast
7MM Coverage
Descriptive overview of Graft Versus Host Disease, causes, signs and symptoms, diagnosis, treatment
Comprehensive insight into Graft Versus Host Disease epidemiology in the 7MM
Graft Versus Host Disease marketed and emerging therapies
Graft Versus Host Disease companies
Graft Versus Host Disease market drivers and barriers
Table of Contents:
1 Graft Versus Host Disease Market Key Comprehensive Insights
2 Graft Versus Host Disease Market Report Introduction
3 Competitive Intelligence Analysis for Graft Versus Host Disease
4 Graft Versus Host Disease Market Analysis Overview at a Glance
5 Executive Summary of Graft Versus Host Disease
6 Graft Versus Host Disease Epidemiology and Market Methodology
7 Graft Versus Host Disease Epidemiology and Patient Population
8 Graft Versus Host Disease Patient Journey
9 Graft Versus Host Disease Treatment Algorithm, Graft Versus Host Disease Current Treatment, and Medical Practices
10 Key Endpoints in Graft Versus Host Disease Clinical Trials
11 Graft Versus Host Disease Marketed Therapies
12 Graft Versus Host Disease Emerging Therapies
13 Graft Versus Host Disease: 7 Major Market Analysis
14 Attribute analysis
15 Access and Reimbursement Overview of Graft Versus Host Disease
16 Graft Versus Host Disease Market Key Opinion Leaders Reviews
18 Graft Versus Host Disease Market Drivers
19 Graft Versus Host Disease Market Barriers
20 SWOT Analysis
21 Disclaimer
22 DelveInsight Capabilities
23 About DelveInsight
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