New York, USA, Sept. 22, 2024 (GLOBE NEWSWIRE) — Graft versus Host Disease Market to Increase at a CAGR of 9.9% During the Study Period (2020–2034) | DelveInsight
The graft versus host disease market is experiencing significant growth, driven by the ongoing adoption of branded therapies such as JAKAFI, IMBRUVICA, ORENCIA, and REZUROCK compared to off-label drugs, a strong pipeline with the anticipated launch of over 10 new drugs during the forecast period, and increased awareness of GvHD management. Innovative treatments and ongoing research are expected to further expand market opportunities, addressing unmet needs in this complex condition.
DelveInsight’s Graft versus Host Disease Market Insights report includes a comprehensive understanding of current treatment practices, graft versus host disease emerging drugs, market share of individual therapies, and current and forecasted graft versus host disease market size from 2020 to 2034, segmented into 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential.
Key Takeaways from the Graft versus Host Disease Market Report
- According to DelveInsight’s analysis, the market size of GvHD in the 7MM was USD 1.3 billion in 2023 which is expected to grow further, driven by the launch of emerging therapies such as Axatilimab, CSL964 (Alpha 1 Antitrypsin), among others and the continued uptake of branded therapies such as Jakavi/Jakafi and REZUROCK.
- Among the 7MM, the US accounted for the highest market share, followed by Japan and Germany, respectively. According to DelveInsight’s analysis, the market size of GvHD in the US reached about USD 1 billion in 2023 and it is projected to grow at a CAGR of 7.4% during the forecast period (2024-2034).
- According to DelveInsight’s estimates, in the 7MM, the total incident cases of aGvHD for Grade B, Grade C, and Grade D were around 6,000, 3,000, and 2000, respectively, in 2023, which are expected to increase by 2034.
- Prominent companies working in the domain of GvHD, including Equillium, Biocon, Takeda, CSL Behring, Regimmune Corporation, Syndax Pharmaceutical, Mesoblast, JCR Pharmaceuticals, Incyte Corporation, Pfizer, Bristol-Myers Squibb, Roche-Genentech, Genentech, Inc., VectivBio AG, Seres Therapeutics, Inc., and others, are actively working on GvHD medication. These novel GvHD therapies are anticipated to enter the GvHD market in the forecast period and are expected to change the market.
- Some of the key therapies for GvHD treatment include EQ001 (itolizumab; Bmab600), ENTYVIO (vedolizumab), ZEMAIRA (CSL 964, alpha-1 antitrypsin), RGI-2001 (KRN-7000; RGI-7000), SNDX-6352 (axatilimab), RYONCIL/TEMCELL HS (remestemcel-L), Itacitinib, Glasdegib, Abatacept, Obinutuzumab, GDC-8264, Apraglutide, SER-155, and others.
- In February 2024, Incyte announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of cGVHD after failure of at least two prior lines of systemic therapy.
- In February 2024, REGiMMUNE announced the positive results of their Phase IIb clinical trial for the prevention of aGVHD after allogeneic hematopoietic cell transplantation (alloHCT) at the 2024 Tandem Meeting of ASTCT and CIBMTR.
Discover which therapies are expected to grab GvHD market share @ Graft versus Host Disease Treatment Market Report
Graft versus Host Disease Overview
Graft versus host disease (GvHD) is an immune system disorder that arises from a complex interaction between the donor’s and recipient’s immune systems. It mainly presents in two forms: acute (aGvHD) and chronic (cGvHD). These forms are further categorized based on their clinical features into acute classic GvHD, persistent, recurrent, or late-onset acute GvHD, Classic chronic GvHD, and overlap syndrome. Acute GvHD usually appears within the first 100 days after a transplant, whereas chronic GvHD can develop at any time following an allogenic transplant, commonly within two years. GVHD Diagnosis typically involves a range of tests, including abdominal X-rays, CT scans of the abdomen and chest, liver function tests, PET scans, MRIs, capsule endoscopy, and liver biopsy. Skin and mucous membrane biopsies may also be used to confirm the diagnosis.
Graft versus Host Disease Epidemiology Segmentation
The GvHD epidemiology section provides insights into the historical and current GvHD patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The GvHD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Hematopoietic Stem-cell Transplant Cases
- Total Allogeneic Transplant Cases
- Total GvHD Cases by Types
- Total Incident Cases of aGvHD by Grading and Organ Involvement
- Total Five-Year Prevalent Cases of cGvHD by Severity and Organ Involvement
- Total Treated Patients of GvHD
- Mortality Adjusted GvHD Treated Patients
Download the report to understand which factors are driving GvHD epidemiology trends @ Graft versus Host Disease Epidemiological Insights
Graft versus Host Disease Treatment Market
Treatment for GvHD is determined by the severity of symptoms and the specific organs affected. Typically, treatment options aim to suppress the donor T cells’ immune response, and this must be carefully managed to alleviate GvHD symptoms without compromising the beneficial graft-versus-tumor (GVT) effect. Corticosteroids are still the most frequently used treatment.
Patients undergoing hematopoietic cell transplantation (HCT) should receive preventative treatment for graft-versus-host disease (GvHD). While specific protocols vary between institutions, the typical approach involves a combination of cyclosporine and methotrexate, which is continued for several months after the transplant. Additionally, antibacterial, antiviral, and antifungal prophylaxis are generally used post-HCT to reduce the risk of infections.
Management of GvHD commonly includes medications such as steroids (prednisolone, methylprednisolone), calcineurin inhibitors (cyclosporine, tacrolimus), cyclophosphamide (Cytoxan), antithymocyte globulins (Thymoglobuline, ATG-Grafalon), monoclonal antibodies (alemtuzumab, infliximab, rituximab, basiliximab), mechanistic target of rapamycin (mTOR) inhibitors (sirolimus, everolimus), tyrosine kinase inhibitors (imatinib), tumor necrosis factor inhibitors (etanercept), thalidomide, inosine monophosphate dehydrogenase (IMDH) inhibitors (mycophenolate mofetil), chemotherapy drugs (pentostatin, methotrexate), Janus kinase (JAK) inhibitors (ruxolitinib, itacitinib), Rho-associated coiled-coil kinase 2 (ROCK-2) inhibitors (belumosudil), and Bruton’s tyrosine kinase (BTK) inhibitors (ibrutinib).
Learn more about the FDA-approved drugs for GvHD @ Drugs for Graft versus Host Disease Treatment
Graft versus Host Disease Emerging Drugs and Companies
The GvHD pipeline is quite robust, with many late-stage assets like EQ001, CSL964, Axatilamab, and ENTYVIO anticipated to hit the market soon, providing physicians with additional alternatives.
CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is designed to treat steroid-refractory acute graft-versus-host disease (aGvHD) and to prevent aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently under investigation in:
- A Phase III clinical trial as a first-line treatment for high-risk acute GvHD.
- A Phase II/III trial for preventing GvHD in patients undergoing hematopoietic cell transplantation.
MaaT013 is a standardized microbiome ecosystem therapy, derived from donors and rich in diversity, which includes BUTYCORE—a collection of bacterial species that generate anti-inflammatory short-chain fatty acids. The drug is currently undergoing Phase III clinical trials and has been granted Orphan Drug Designation by both the FDA and EMA.
The other GvHD therapies in the pipeline include
- EQ001 (itolizumab; Bmab600): Equillium/Biocon
- ENTYVIO (vedolizumab): Takeda
- ZEMAIRA (CSL 964, alpha-1 antitrypsin): CSL Behring
- RGI-2001 (KRN-7000; RGI-7000): Regimmune Corporation
- SNDX-6352 (axatilimab): Syndax Pharmaceutical
- RYONCIL/TEMCELL HS (remestemcel-L): Mesoblast/JCR Pharmaceuticals
- Itacitinib: Incyte Corporation
- Glasdegib: Pfizer
- Abatacept: Bristol-Myers Squibb
- Obinutuzumab: Roche-Genentech
- GDC-8264: Genentech, Inc.
- Apraglutide: VectivBio AG
- SER-155: Seres Therapeutics, Inc.
The anticipated launch of these emerging therapies are poised to transform the GvHD market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about GvHD clinical trials and recent advancements, visit @ Graft versus Host Disease Drugs Market
Graft versus Host Disease Market Dynamics
GVHD Treatment Options
The GVHD treatment market includes treatments for both acute and chronic forms of the disease. Current therapies include corticosteroids, immunosuppressive agents (such as calcineurin inhibitors and antithymocyte globulin), and newer targeted therapies like JAK inhibitors and biological agents. The development of novel therapies and advancements in existing treatments are key market drivers.
Emerging Graft versus Host Disease Therapies
Research into new therapies, such as T-cell therapies and small molecules that target specific pathways involved in GVHD, is ongoing. Many potential therapies are being investigated for the treatment of GvHD, and it is safe to predict that the treatment space will significantly impact the GvHD therapeutics market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the GvHD market in the 7MM.
Graft versus Host Disease Market Demand
The incidence of GVHD is rising due to an increasing number of hematopoietic stem cell transplants and a growing awareness of the disease. The demand for effective GVHD treatments drives market growth, pushing pharmaceutical companies to invest in research and development.
Regulatory Landscape
Regulatory approval processes for new GVHD treatments can impact market dynamics. The speed at which new therapies are approved and brought to market can influence the competitive landscape and market share of existing products.
Geographic Variations
Market dynamics can vary by region. In developed countries with advanced healthcare systems, the focus may be on new and innovative treatments, while in developing regions, there might be a greater need for access to existing therapies.
Patient Population
The increasing GVHD prevalence of conditions requiring transplants, such as leukemia and lymphoma, contributes to the market for GVHD treatments. Demographic changes, such as an aging population, also influence market demand.
Competitive Landscape
The Graft versus Host Disease therapeutics market is competitive, with several pharmaceutical and biotechnology companies involved. The presence of key players and the introduction of novel therapies can impact market shares and influence competitive strategies.
| Graft versus Host Disease Report Metrics | Details |
| Study Period | 2020–2034 |
| Graft versus Host Disease Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Graft versus Host Disease Market Size in the US in 2023 | USD 1 Billion |
| Key Graft versus Host Disease Companies | Equillium, Biocon, Takeda, CSL Behring, Regimmune Corporation, Syndax Pharmaceutical, Mesoblast, JCR Pharmaceuticals, Incyte Corporation, Pfizer, Bristol-Myers Squibb, Roche-Genentech, Genentech, Inc., VectivBio AG, Seres Therapeutics, Inc., and others |
| Key Graft versus Host Disease Therapies | EQ001 (itolizumab; Bmab600), ENTYVIO (vedolizumab), ZEMAIRA (CSL 964, alpha-1 antitrypsin), RGI-2001 (KRN-7000; RGI-7000), SNDX-6352 (axatilimab), RYONCIL/TEMCELL HS (remestemcel-L), Itacitinib, Glasdegib, Abatacept, Obinutuzumab, GDC-8264, Apraglutide, SER-155, and others |
Scope of the Graft versus Host Disease Market Report
- Graft versus Host Disease Therapeutic Assessment: Graft versus Host Disease current marketed and emerging therapies
- Graft versus Host Disease Market Dynamics: Conjoint Analysis of Emerging Graft versus Host Disease Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, Graft versus Host Disease Market Access and Reimbursement
Discover more about GvHD drugs in development @ Graft versus Host Disease Clinical Trials
Table of Contents
| 1. | Graft versus Host Disease Market Key Insights |
| 2. | Graft versus Host Disease Market Report Introduction |
| 3. | Graft versus Host Disease Market Overview at a Glance |
| 4. | Graft versus Host Disease Market Executive Summary |
| 5. | Disease Background and Overview |
| 6. | Graft versus Host Disease Treatment and Management |
| 7. | Graft versus Host Disease Epidemiology and Patient Population |
| 8. | Patient Journey |
| 9. | Graft versus Host Disease Marketed Drugs |
| 10. | Graft versus Host Disease Emerging Drugs |
| 11. | Seven Major Graft versus Host Disease Market Analysis |
| 12. | Graft versus Host Disease Market Outlook |
| 13. | Potential of Current and Emerging Therapies |
| 14. | KOL Views |
| 15. | Unmet Needs |
| 16. | SWOT Analysis |
| 17. | Appendix |
| 18. | DelveInsight Capabilities |
| 19. | Disclaimer |
| 20. | About DelveInsight |
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