Graft Versus Host Disease Treatment Market - Growth, Trends, and Forecasts (2023 - 2028)

The Graft Versus Host disease treatment market is projected to register a CAGR of 8.4% during the forecast period (2022-2027).

The COVID-19 pandemic has had a significant impact on the market's growth rate. Graft-versus-Host disease (GvHD) is a condition that occurs in people who have received allogeneic transplantation. The donor immune cells attack the recipient's body organs and cause a "cytokine storm". A cytokine storm refers to the overproduction of inflammatory cytokines, which may result in local organ damage. As per a review titled "Systemic and organ-specific immune-related manifestations of COVID-19" published in Nature in 2021, a similar condition occurs during the incidence of COVID-19, where the immune system of the infected individual produces increased levels of inflammatory cytokines, resulting in organ failure. Thus, the severity of the GvHD increases when the patient is affected by COVID-19. The increase in complications posed a serious challenge to the healthcare system globally during the COVID-19 pandemic phase. Thus, there was a surge in demand for Graft-versus-Host disease treatment products to combat the further complications that developed due to COVID-19.

The increasing rate of bone marrow or hematopoietic stem cell treatment, the growing incidence of acute GvHD, and the increasing number of pipeline drugs are likely to propel the market growth throughout the analysis period. For instance, as per a report titled "Graft Versus Host Disease" published by StatPearls Publishing in October 2021, it was found that the incidence of acute GvHD was found to be about 50% for patients receiving HCT from Human Leukocyte Antigen (HLA) matched siblings, and the range was even higher in unmatched donors. The incidence of chronic GvHD was found to be in the range of 6-80%. Additionally, according to an article titled "Epidemiology and Treatment of Chronic Graft-versus-Host Disease Post-Allogeneic Hematopoietic Cell Transplantation: A US Claims Analysis" published by Elsevier in June 2021, in the United States, 42% of the patients had developed cGvHD within three years of allogenic HCT; 66% of those affected by cGvHD were found to have acute GvHD prior. The refractory nature of cGvHD is expected to propel the growth of the GvHD treatment market.

Furthermore, more research is focused on drugs for GvHD treatment that will have a positive impact on the market's growth. For instance, a review article titled "New Approaches for the Treatment of Chronic Graft-Versus-Host Disease: Current Status and Future Directions" featured in Frontiers in Immunology in October 2020 revealed that a second-line treatment is required for about 50% - 60% of chronic GvHD (cGvHD) patients. Several new strategies are being studied to combat cGvHD by targeting B cells or T cells for immune regulation, thereby reducing inflammation and diminishing the severity of the disease. Additionally, a recent news article by the National Cancer Institute in May 2020 investigated the use of ruxolitinib for treating GvHD patients who do not respond to other treatments based on a randomized clinical trial.

High investments in R&D capabilities by industry players and governments are anticipated to create lucrative opportunities in the market. For instance, in June 2021, Equillium, Inc. reported the completion of an End-of-Phase 1 meeting with the United States Food and Drug Administration (FDA) for itolizumab in the first-line treatment of patients with acute graft-versus-host disease (aGvHD). Thus, the positive outcome of such clinical trials will likely lead to new treatments, which will be expected to boost the market's growth over the forecast period.

Thus, owing to the abovementioned factors, the market is anticipated to project growth over the forecast period. However, the high cost of GvHD treatment is expected to limit the growth of the market.

Graft Versus Host Disease Treatment Market Trends

The Corticosteroids Segment is Expected to Hold a Major Market Share in the Graft-versus-Host disease treatment Market.

The corticosteroids segment is expected to grow owing to the growing burden of target disease and increasing research studies. The corticosteroids segment is expected to hold the major share in the forecast period due to increasing research and development in corticosteroid and corticosteroid combination therapy to treat HCT patients with Graft-versus-Host disease. Furthermore, according to the article titled "Steroid-refractory chronic graft-versus-host disease: treatment options and patient management" published in July 2021, the absence of second-line treatment for patients suffering from steroid-refractory chronic graft-versus-host disease is concerning. It also demonstrates the huge scope of research that helps benefit the expansion of the Graft-versus-Host disease treatment market.

Additionally, according to the Organ Procurement and Transplantation Network of the United States Department of Human Health Services, around 41,355 transplants were performed in the United States in 2021. Since graft versus host disease is most commonly associated with and might occur after transplants, the demand for corticosteroids as an introductory therapy is likely to increase among the patient population, ultimately driving the segment growth.

Furthermore, research studies carried out to improve the efficiency of the corticosteroids in the treatment are also boosting the growth of the market segment. For instance, as of June 2022, a clinical trial titled "Ruxolitinib-corticosteroid as first-line therapy for newly diagnosed high-risk acute graft versus host disease: study protocol for a multicenter, randomized, phase II-controlled trial" is ongoing. It is an open-label, multicenter, two-arm randomized trial that will evaluate whether the addition of ruxolitinib combined with corticosteroids is superior to corticosteroids alone in newly diagnosed high-risk aGvHD. It was reported that there is about a 50% response rate to first-line therapy with corticosteroids for acute graft versus host disease (aGvHD). The positive outcome of such clinical trials can improve efficiency and thus may lead to segmental growth in the future.

Thus, owing to the abovementioned factors, the market segment is expected to project growth over the forecast period.

North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period

The North American region is expected to hold a significant share in the studied market owing to well-developed healthcare infrastructure, increasing research and development coupled with a growing number of transplants. For instance, according to the data published by the Organ Procurement and Transplantation Network, operated under the United States Department of Health and Human Services, updated in July 2022, the total number of transplants performed in the United States between January 2022 to June 2022 is 20,663. Such an increase in the number of transplant procedures may in turn boost the demand for graft versus host disease treatment owing to the immune-mediated response between donor and recipient adaptive immunity, thus propelling the market's growth.

Furthermore, the approval from the regulatory authority is also contributing to the growth in the region. For instance, in September 2021, the United States Food and Drug Administration (FDA) approved the use of Ruxolitinib for the treatment of chronic Graft-versus-Host disease after the failure of any two conventional treatments in patients aged 12 years or older. Ruxolitinib is a promising candidate drug since the drug helps to overcome steroid resistance associated with Graft-versus-Host disease.

Additionally, in July 2021, the United States Food and Drug Administration (FDA) approved Belumosudil for the treatment of chronic Graft-versus-Host disease. The drug is permissible for patients older than 12 years and older and those who have already attempted two other treatments. Such approvals are bolstering the growth of the market in the region.

Thus, owing to the abovementioned factors, the North American region is expected to show significant growth over the forecast period.

Graft Versus Host Disease Treatment Market Competitor Analysis

The Graft Versus Host disease treatment market is competitive and consists of several major players. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Pfizer Inc., Abbvie Inc., Sanofi (Kadmon Pharmaceuticals), Sanofi (Genzyme), Incyte Corporation, Bristol Myers Squibb Company, Genentech Inc., Astellas Pharma US Inc., and others.

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