Graft vs Host Disease Market Size to Reach US$ 6.2 Billion by 2034, Impelled by Advancements in Early Detection

Graft vs Host Disease Market Outlook 2024-2034:

The graft vs host disease market size reached a value of US$ 1.4 Billion in 2023. Looking forward, the market is expected to reach US$ 6.2 Billion by 2034, exhibiting a growth rate (CAGR) of 14.6% during 2024-2034. The market is driven by the continuous development of novel treatment techniques focused on targeting T-cell responses or signaling pathways. Besides this, the introduction of innovative drug candidates that aid in overcoming the steroid resistance associated with the ailment is also propelling the market growth.

Advances in Early Detection and Diagnostic Technologies: Driving the Graft vs Host Disease Market 

Advancements in early detection and diagnostic technologies are profoundly impacting the Graft-versus-Host Disease (GVHD) market, leading to improved patient outcomes and driving market growth. Emerging biomarker research has identified critical markers like IL-2Rα and TNFR1, which allow for early detection of GVHD and prediction of outcomes. These biomarkers provide a non-invasive way to monitor patients during the vulnerable post-transplant period, helping clinicians make timely decisions about intervention and treatment. Additionally, imaging technologies such as Positron Emission Tomography (PET) and Contrast-Enhanced Ultrasound (CEUS) offer powerful tools for non-invasive diagnosis, particularly for gastrointestinal GVHD. Molecular imaging with PET can visualize specific cellular processes linked to GVHD, enabling early-stage detection before clinical symptoms fully manifest. Meanwhile, CEUS has become valuable for gastrointestinal GVHD diagnosis by allowing real-time assessment of intestinal blood flow and tissue health. These imaging advancements are essential in providing clinicians with actionable data that can prevent progression to severe GVHD. Molecular diagnostics also play a vital role, with techniques like PCR-ELISA and Fluorescence In Situ Hybridization (FISH) helping detect GVHD markers at microscopic levels. This molecular-level analysis fosters personalized treatment, reducing the need for broad, generalized immunosuppressive therapies and minimizing patient exposure to unnecessary side effects. Coupled with enhanced endoscopic and biopsy techniques, these diagnostics improve diagnostic accuracy and ensure that GVHD is quickly and correctly identified.

Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion

The development of novel therapies and pharmacological treatments is significantly driving growth in the graft-versus-host disease market. New therapeutic approaches are focusing on targeted treatments and immunomodulation, which provide greater specificity in managing GVHD with fewer side effects than traditional broad-spectrum immunosuppressive drugs. Recent developments in biologics, for instance, such as monoclonal antibodies and cytokine inhibitors, target specific immune pathways, reducing the overactive immune response without entirely suppressing the patient's immune system. This targeted approach not only enhances treatment efficacy but also minimizes the risk of infections and other complications. Cell-based therapies, particularly mesenchymal stem cell (MSC) therapy, have shown promise in treating GVHD by promoting immune tolerance and tissue repair. MSCs have immunomodulatory properties, reducing inflammation and promoting healing in damaged tissues, making them particularly useful for patients with steroid refractory GVHD who have limited options. The success of these cell therapies in early trials has spurred investment in further research and development, aiming to bring more MSC-based treatments to the market. In addition, small-molecule inhibitors that interfere with signaling pathways involved in immune activation are expanding the pharmacological options for GVHD treatment. These inhibitors can modulate specific inflammatory pathways, reducing GVHD severity while preserving immune functionality. This precision in targeting GVHD’s underlying mechanisms has increased the demand for novel pharmacological agents, particularly for patients with chronic or refractory disease.

Marketed Therapies in Graft vs Host Disease Market

Imbruvica (ibrutinib): Janssen/Pharmacyclics 

Imbruvica (ibrutinib) is a once-daily oral drug co-developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. Imbruvica inhibits Bruton’s tyrosine kinase protein, which is required for normal and aberrant B cells, including certain cancer cells, to grow and spread. By suppressing Bruton’s tyrosine kinase, Imbruvica may help transfer aberrant B cells out of their nourishing surroundings and reduce their multiplication.

Jakafi (Ruxolitinib): Incyte Corporation/Novartis

Jakafi is designed for the treatment of steroid-refractory acute graft-versus-host disease in adults and children aged 12 and up. Jakafi is also approved for the treatment of chronic graft-versus-host disease in adult and pediatric patients aged 12 and above who have failed one or two lines of systemic therapy. Jakafi is a Janus kinase (JAK) inhibitor that selectively targets JAK1 and JAK2. JAK1 and JAK2 gather signal transducers and activators of transcription (STATs) to cytokine receptors, which modulate gene expression.

Orencia (Abatacept): Bristol-Myers Squibb

Orencia (Abatacept) is a disease-modifying antirheumatic drug used for the prophylaxis of acute graft-versus-host disease. Abatacept is a selective costimulation modulator; like CTLA-4, the drug has been found to decrease T-cell (T lymphocyte) activation by binding to CD80 and CD86, preventing interaction with CD28. It has been demonstrated that inhibiting this connection prevents the delivery of the second co-stimulatory signal essential for effective T-cell activation. This inhibits autoimmune T-cell activation, which has been implicated in the etiology of the ailment.

Rezurock (Belumosudil): Kadmon Pharmaceuticals 

Rezurock (belumosudil) is used to treat chronic graft-versus-host disease in adults and children aged 12 and above who have failed at least two previous lines of systemic therapy. Ruxolitinib, a selective inhibitor of JAK1 and JAK2, lowers graft-versus-host disease by suppressing the production of proinflammatory cytokines like as IL-1, IL-6, IL-12, IL-17, TNF-α, and IFN-γ. This inhibits T-cell proliferation while keeping the favorable graft-versus-leukemia effect.

Emerging Therapies in Graft vs Host Disease Market

Alzumab (Itolizumab): Biocon/Equillium 

Alzumab (Itolizumab) is a clinical-stage monoclonal antibody that mainly targets the CD6-ALCAM pathway. This pathway is critical for altering the activity and trafficking of T cells, which drives a variety of immuno-inflammatory disorders. Itolizumab is currently being investigated in several clinical trials in individuals with severe illnesses, including acute graft-versus-host disease. Equillium obtained rights to itolizumab through an exclusive partnership with Biocon Limited.

Axatilimab: Syndax Pharmaceuticals  

Axatilimab is a first-in-class anti-colony stimulating factor-1 receptor (CSF-1R) antibody used to treat chronic graft-versus-host disease in adults and children weighing at least 40kg who have failed at least two previous lines of systemic therapy. By blocking CSF-1R, axatilimab reduces the number of circulating proinflammatory and profibrotic monocytes, as well as monocyte-derived macrophages. It inhibits the function of dangerous macrophages within tissues.

ASC930: ASC Therapeutics

ASC930 is a treatment being developed by ASC Therapeutics for graft-versus-host disease. The therapy is given intravenously to hospitalized patients on a weekly basis. It is a cell replacement drug that involves intravenous infusions of allogeneic decidua stromal cells. This medication works by suppressing the immune system so that it does not attack the recipient's tissues.

Itacitinib: Incyte Corporation

Itacitinib is a new and specific JAK1 inhibitor that is currently being studied for the first-line treatment of acute and chronic graft-versus-host disease. This therapeutic candidate regulates the formation, proliferation, and activation of immune cells that are critical for graft-versus-host disease development. In addition, itacitinib modulates the amounts of helper T-cell 1 and helper T-cell 2 cytokines, which are crucial in the pathophysiology of this illness.

MC 0518: Medac

MC 0518 refers to a mesenchymal stromal cell therapy used to treat acute graft-versus-host disease in both adults and adolescents. MC 0518 interacts with the immune system through signaling with monocytes and macrophages to boost anti-inflammatory pathways and repair damaged tissue. The therapy can also secrete proteins, peptides, and hormones to create an immunosuppressive environment.

Detailed list of emerging therapies in Graft vs Host Disease is provided in the final report.

Leading Companies in the Graft vs Host Disease Market:

The market research report by IMARC encompasses a comprehensive analysis of the competitive landscape in the market. Across the global graft vs host disease market, several leading companies are at the forefront of developing integrated platforms to enhance the management of graft vs host disease. Some of the major players include Janssen/Pharmacyclics, Bristol-Myers Squibb, and Novartis. These companies are driving innovation in the graft vs host disease market through continuous research, diagnostic tools, and expanding their product offerings to meet the growing demand for the illness.

​In February 2024, Johnson & Johnson, in collaboration with its alliance partner, Pharmacyclics LLC, an AbbVie Company, announced that the U.S. FDA had approved a label expansion for IMBRUVICA (ibrutinib) with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma; Waldenström's macroglobulinemia; and chronic graft versus host disease after failure of one or more lines of systemic.

In May 2022, Novartis stated that the European Commission (EC) had approved Jakavi (ruxolitinib) for the treatment of patients aged 12 and above with acute or chronic graft versus host disease who have not responded well to corticosteroids or other systemic treatments.

In December 2021, Bristol Myers Squibb announced that Orencia (abatacept) was approved by the U.S. FDA for the prophylaxis, or prevention, of acute graft versus host disease, in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.

Key Players in Graft vs Host Disease Market:

The key players in the Graft vs Host Disease market who are in different phases of developing different therapies are Janssen, Pharmacyclics, Incyte Corporation, Novartis, Bristol-Myers Squibb, Kadmon Pharmaceuticals, Biocon, Equillium, Syndax Pharmaceuticals, ASC Therapeutics, Medac, and Others.

Regional Analysis:

The major markets for graft vs host disease include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for graft vs host disease while also representing the biggest market for its treatment. This can be attributed to the rising prevalence of allogeneic stem cell transplants due to advancements in cancer treatment, particularly for hematologic cancers like leukemia and lymphoma, which heightens the incidence of GVHD.

Moreover, substantial investments in R&D are accelerating the introduction of innovative therapies, such as targeted biologics, cellular therapies, and small-molecule inhibitors, which offer enhanced efficacy and safety compared to traditional immunosuppressants.

Besides this, the increasing application of personalized care and tailored therapeutics corresponds to the need for accuracy in GVHD therapy, especially in chronic and steroid-refractory patients. Additionally, the growing use of diagnostic technologies such as biomarker-based testing and molecular imaging enables earlier diagnosis and more effective intervention, further boosting the market in the U.S.

Recent Developments in Graft vs Host Disease Market:

• In August 2024, Incyte and Syndax Pharmaceuticals announced that the FDA had approved Niktimvo (axatilimab-csfr), an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease in adult and pediatric patients weighing at least 40 kg (88.2 lbs.).
• In August 2024, Equillium, Inc. reported a positive recommendation from the Independent Data Monitoring Committee (IDMC) after reviewing the interim data of the Phase 3 EQUATOR study testing itolizumab in participants with acute graft-versus-host disease. The IDMC reviewed unblinded data on over 100 patients from Day 29 of therapy in the study, with predetermined futility and efficacy stopping borders, and recommended that the study continue enrollment without modification.
   

Key information covered in the report.

• Base Year: 2023
• Historical Period: 2018-2023
• Market Forecast: 2024-2034
   

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

 Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the graft vs host disease market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the graft vs host disease market
• Reimbursement scenario in the market
• In-market and pipeline drugs
   

Competitive Landscape:

This report offers a comprehensive analysis of current graft vs host disease marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

 Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

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