Graft versus Host Disease Assessment, By Disease Type [Acute Graft versus Host Disease, Chronic Graft versus Host Disease], By Drug Class [Monoclonal Antibodies, Immunosuppressive Drugs, Steroids, TNF Inhibitors, Others], By Route of Administration [Oral,

Graft versus Host Disease Assessment, By Disease Type [Acute Graft versus Host Disease, Chronic Graft versus Host Disease], By Drug Class [Monoclonal Antibodies, Immunosuppressive Drugs, Steroids, TNF Inhibitors, Others], By Route of Administration [Oral, Intravenous, Others], By End-user [Hospital Pharmacies, Retail Pharmacies, Online Pharmacies, Others], By Region, Opportunities and Forecast, 2017-2031F

Global graft versus host disease market is projected to witness a CAGR of 9.51% during the forecast period 2024-2031, growing from USD 2.99 billion in 2023 to USD 6.19 billion in 2031. The graft versus host disease (GvHD) market is experiencing growth due to factors such as rising demand for transplants, such as organ transplants or stem cell transplants, advancements in technology, government initiatives, and the integration of AI. Increasing demand for transplantations has boosted the prevalence of GvHD, which, in turn, has accelerated the demand for treatment options. Patients are looking for a more reliable, hassle-free, and best possible approach to deal with the symptoms that come after the transplantations. Furthermore, the government is also spending significant amounts on research and development to bring out the best possible techniques in the market. Many new advancements are helping faster and better recovery of patients after undergoing transplantation procedures.

Results from a phase 2 study (NCT02867384) presented during the 2023 ASH Annual Meeting showed that using obinutuzumab (Gazyva) to enhance B-cell depletion significantly reduced the need for corticosteroids and increased relapse-free survival in patients with steroid-requiring chronic GvHD undergoing well-matched hematopoietic stem cell transplant.

Rising Prevalence of GvHD

The market for GvHD is expanding significantly due to the rising use of stem cell transplants. A potent new technique for treating several immunological and hematological problems is stem cell transplantation. However, the prevalence of GvHD has increased in tandem with the growth in transplant procedures. Stem cell transplants have become a common therapy option for a variety of illnesses. They can be performed autologously, using the patient's stem cells, or allogeneically, using donor stem cells. Treatments for non-malignant conditions, including aplastic anemia and severe combined immunodeficiency (SCID), as well as hematological malignancies like leukemia, lymphoma, and myeloma, are both benefiting from this rising use. There is a growing risk of developing GvHD as more individuals receive stem cell transplantation. Beyond the conventional applications, physicians and researchers are investigating solid organ transplant support, autoimmune disease transplantation, and regenerative medicine applications. The demand for efficient GvHD treatments is being further driven by the expansion of the patient pool at risk of developing GvHD due to the diversity of transplant procedures.

In the United States, 42% of patients had developed chronic (cGvHD) within three years following allogenic HCT; 66% of those impacted by cGvHD had acute GvHD prior, per an Elsevier paper from June 2021.

Government Initiatives

Ongoing support by regulatory bodies toward the production and approval of GvHD medicines is acting as one of the main market drivers of flourishing growth. Research, clinical studies, and the commercialization of promising medicines related to GvHD are receiving significant funding from the government and private sectors. The government is taking initiatives to collaborate with research centers, healthcare professionals, and institutes that deal with this sector. According to the Australian government's Department of Health and Aged Care, new medications are now available for treating esophageal cancer, chronic rhinosinusitis, and GvHD. The new and upgraded medications, which will be covered under the Pharmaceutical Benefits Scheme (PBS), include Opdivo (nivolumab), Jakavi (ruxolitinib), and Nucala (mepolizumab).

Technological Advancements

The treatment techniques for GvHD are expanding at an impressive rate, mostly due to the ongoing progress in medical technology. The ability to diagnose GvHD has greatly improved due to developments in healthcare technologies. Using genome sequencing, biomarker identification, and high-resolution imaging, medical professionals can detect GvHD with high accuracy. Early detection is essential because it enables timely action, which may stop the illness from getting worse. Targeted therapies that are specifically designed to meet the needs of patients with GvHD are now possible due to advancements in medical technology. Promising therapies for GvHD include immunomodulatory medications, biologics, and monoclonal antibodies. These precisely tailored immunological profile-based medicines provide a less harmful and more successful means of controlling the illness.

The development of cellular and gene treatments is one of the biggest developments in the treatment of GvHD. GvHD may be treated with chimeric antigen receptor T-cell (CAR-T) therapy, which targets the immune cells that cause the illness. CRISPR-Cas9 and other gene editing methods show promise for precisely modifying immune cells to prevent or treat GvHD. Innovative medical technology makes these state-of-the-art treatments possible. Treatment has been transformed by the combination of telemedicine and remote monitoring technology, especially when it comes to GvHD. Improved GvHD management and patient outcomes are a result of this accessibility, which also improves patient compliance and overall quality of care. Big data analytics and artificial intelligence (Al) are being utilized to help with GvHD early detection and prevention. Large-scale datasets can be analyzed by machine learning algorithms, which can then spot patterns and risk factors that human clinicians could miss. With the use of this technology, medical professionals can anticipate future GvHD consequences, personalize treatment regimens, and make better decisions.

Research studies from Michigan Medicine, the Children's Hospital of Philadelphia, and Penn Medicine are paving the road for novel gene therapy treatments for blood disorders like sickle cell anemia. A patient still needs chemotherapy and the transplantation of their own corrected cells even after gene therapy corrects the mutation in their cells. However, it is possible to genetically modify blood stem cells in the bone marrow during a single therapy.

Corticosteroids are Dominating the Global Market

Tyrosine kinase inhibitors, corticosteroids, monoclonal antibodies, and other pharmaceuticals make up the product segment of this market. Due to the increasing number of research studies and the rising prevalence of the target disease, the corticosteroid segment retained the biggest share in 2023. Furthermore, the corticosteroid segment is anticipated to grow over the forecast period due to increased research and development efforts focused on corticosteroids and their combinations for the treatment of GvHD in patients undergoing hematopoietic cell transplantation (HCT). Corticosteroids help in managing the immune system and can also limit the activity of donated T-cells in the host’s body. It even helps to reduce inflammation caused after the transplant, which regulates the blood pressure well. As of June 2022, an open-label, multicenter, two-arm randomized trial was conducted to evaluate the efficacy of corticosteroids alone or in combination with Ruxolitinib for newly identified high-risk acute gene therapy-related heart failure or dysfunction. It has been observed that roughly 50% of instances of acute graft-versus-host disease (aGvHD) respond to corticosteroid first-line therapy.

North America to Dominate GvHD Market

The North American region is expected to hold a significant market size due to its well-established healthcare infrastructure, ongoing research and development activities, and a growing number of transplant procedures. An increasing number of transplants performed in North America is accelerating market opportunities in the region. Between January 2022 and June 2022, 20,663 transplant procedures were performed in the United States, according to statistics provided by the Organ Procurement and Transplantation Network, which is supervised by the US Department of Health and Human Services and updated in July 2022. Due to the immunological-mediated reactions that take place between the recipients' and donors' adaptive immune systems, the rise in transplant cases may raise demand for therapies for GvHD, which would ultimately spur market demand.

Future Market Scenario (2024 – 2031F)

The growing need to address a variety of symptoms that occur post transplantation processes can fuel the market of GvHD. Increasing number of organ transplantations and the use of new types of inhibitors are also driving market expansion.

The advent of new and improved technologies, well researched drugs, gene editing techniques, and the integration of AI have enabled high accuracy and precision, which, in turn, is anticipated to increase market share in the upcoming years.

Personalised treatment strategies that target genetic alterations and pathways are becoming more and more popular as precision medicine gains traction. AI has also enhanced early detection for any possible indications that further helps the treatment as well as ensure market expansion.

Global regulatory bodies are building frameworks to speed up the development of specialized transplantation departments, which is also driving the expansion of the GvHD market worldwide.

Key Players Landscape and Outlook

There are several significant players in the competitive graft versus host disease market. Currently, the market is dominated by a few dominant players, such as Merck & Co., Inc, Novartis AG, Astellas Pharma Inc., Astra Zeneca PLC, Bayer AG, Boehringer Ingelheim International Gmbh, Abott Inc., Bristol Myers Squibb, Pfizer Inc., F. Hoffmann-La Roche Ltd, Novartis AG, Elli Lilly and Company, etc. These companies are governing the market share because of their consistent efforts toward R&D, technological advancements, and reliable quality.

Jakavi (ruxolitinib), approved by the European Commission (EC) in May 2022, is intended to treat individuals with acute or chronic GvHD who are 12 years of age or older and do not respond well to corticosteroids or other systemic therapy.

The EQUATOR project, a major Phase III clinical trial of itolizumab in patients with aGvHD, was started by Equillium Inc. in March 2022. When used in conjunction with corticosteroids, itolizumab versus placebo will be evaluated for both safety and efficacy as first-line therapy for aGvHD in this randomized, double-blind study.