본 보고서에서는 스테로이드 불응성 급성 이식편대 숙주병(SR-aGvHD) 를 상세하게 조사하여 동종이식의 총 건수, 급성 GvHD의 유병 사례 총계, 중증도별 급성 GvHD 발생 사례, 장기별 급성 GvHD 발생 사례, SR-aGVHD의 총발생 사례, SR-aGVHD의 치료 사례 등의 과거 및 향후 역학 데이터를 제시하고 있습니다. 또한 진단 프로세스, 처방 패턴, 의사의 견해, 시장 접근, 치료 옵션, 시장 전망 동향을 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본의 주요 7개국 시장에 걸쳐 2020-2034년 기간으로 분석했습니다. 또한 기존의 치료실태와 미충족 수요를 종합적으로 평가하여 시장의 잠재력과 새로운 사업 기회를 명확히 하고 있습니다.
DelveInsight's comprehensive report titled "Steroid Refractory Acute Graft-Versus-Host Disease - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of SR-aGvHD. The report presents historical and projected epidemiological data covering Total Allogenic Transplant Cases, Total Acute GvHD Cases, Acute GvHD cases by grading, Acute GvHD cases by organ involvement, Total Cases of SR-aGvHD, and Total Treated Cases of SR-aGvHD. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.
The report analyzes the existing treatment practices and unmet medical requirements in SR-aGvHD. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.
Steroid Refractory Acute Graft-Versus-Host Disease Overview
Acute graft-versus-host disease (aGVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (alloHCT) and is a major cause of morbidity and mortality. Systemic steroid therapy is the first-line treatment for aGVHD, although about half of patients will become refractory to treatment. As the number of patients undergoing alloHCT increases, developing safe and effective treatments for aGVHD will become increasingly important, especially for those whose disease becomes refractory to systemic steroid therapy
Steroid Refractory Acute Graft-Versus-Host Disease Diagnosis and Treatment Algorithm
aGVHD is diagnosed clinically after laboratory analysis, imaging, and/or endoscopic examination to exclude potential differential diagnoses. Biopsy may help confirm the diagnosis but lacks sensitivity and specificity. Following diagnosis, aGVHD severity is graded from mild (grade I) to very severe (grade IV). The recommended first-line treatment for aGVHD is systemic steroid therapy; however, many patients become refractory to steroid therapy. SR-aGVHD can be defined as a clear progression after 3-5 days of treatment or no response after 5-7 days of treatment. SR-aGVHD is associated with a high mortality risk.
Ruxolitinib, an oral Janus kinase (JAK) 1/2 inhibitor, has become a cornerstone treatment for SR-AGVHD. It modulates immune cell development, proliferation, and activation to inhibit cytokine signaling and promote T regulatory cells. The FDA approved ruxolitinib for SR-AGVHD in 2019 based on results of the REACH-1 trial, followed by the EMA in 2022, significantly altering the treatment paradigm and establishing its role as the standard second-line treatment. Mesenchymal stem cells (MSCs) are stem cells with a capacity for pluripotent differentiation. They can be obtained from bone marrow, adipose tissue, or umbilical cord and infused intravenously, usually without adverse event. Supportive care remains essential throughout treatment, including antimicrobial prophylaxis, nutritional support, skin care, and management of fluid and electrolyte imbalances. Regular reassessment at Days 7, 14, and 28 is recommended to monitor therapeutic response and guide escalation.
The epidemiology section of the SR-aGVHD market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.
This section also presents the data with relevant tables and graphs, offering a clear and concise view of the epidem of SR-aGVHD. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.
The SR-aGVHD therapeutics market is further expected to increase by the major drivers, such as the rising population, technological advancements, and upcoming therapies in the forecast period (2025-2034).
With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the SR-aGVHD in the 7MM is expected to change significantly during the forecast period 2025-2034.
Marketed Steroid Refractory Acute Graft-Versus-Host Disease Drugs
JAKAFI (ruxolitinib): Incyte
JAKAFI is a first-in-class JAK1/JAK2 inhibitor approved by the US FDA for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. In May 2024, Incyte Corporation announced that the US Food and Drug Administration approved JAKAFI for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. The approval was based on data from REACH1, an open-label, single-arm, multicenter study of JAKAFI in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. It was the first therapy to be approved for this indication.
RYONCIL (remestemcel-L-rknd): Mesoblast
RYONCIL is the first and only FDA-approved, allogeneic, off-the-shelf, bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of pediatric patients aged 2 months and older, including adolescents and teenagers, with SR-aGvHD. It got FDA approval for SR-aGvHD in December 2024.
Emerging Steroid Refractory Acute Graft-Versus-Host Disease Drugs
The SR-aGVHD market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players such as RLS-0071, ALTB-168, and others, showing commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.
RLS-0071 (pegtarazimod): ReAlta Life Sciences
RLS-0071 is an investigational peptide therapy developed by ReAlta Life Sciences that leverages a novel dual mechanism of action to rebalance complement activation and neutrophil-driven inflammation specifically through inhibiting myeloperoxidase, neutrophil extracellular traps (NETs), and complement components. The US FDA has granted it both Orphan Drug and Fast Track designations for SR-aGVHD. The Company is currently conducting a Phase II, open label clinical trial of RLS-0071 in hospitalized patients with SR-aGvHD.
ALTB-168 (Neihulizumab): AltruBio
Neihulizumab is an immune checkpoint regulator that targets PSGL-1. It is designed to trigger the depletion of chronically activated T cells. The US FDA has granted it both Orphan Drug and Fast Track designations for SR-aGVHD. Currently, it has completed Phase I trial, and ReAlta is enrolling a Phase II, open-label clinical trial of RLS-0071 in patients with SR-aGVHD
Steroid Refractory Acute Graft-Versus-Host Disease Market Segmentation
DelveInsight's 'Steroid Refractory Acute Graft-Versus-Host Disease - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future SR-aGVHD market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.
Steroid Refractory Acute Graft-Versus-Host Disease Market Size by Countries
The SR-aGVHD market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) SR-aGVHD market. This dominance is projected to persist, especially with the potential early introduction of new products.
Steroid Refractory Acute Graft-Versus-Host Disease Market Size by Therapies
SR-aGVHD Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.
This section focuses on the sales uptake of potential SR-aGVHD drugs that have recently been launched or are anticipated to be launched in the SR-aGVHD market between 2020 and 2034. It estimates the market penetration of SR-aGVHD drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the SR-aGVHD.
The emerging SR-aGVHD therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the SR-aGVHD market.
Steroid Refractory Acute Graft-Versus-Host Disease Market Access and Reimbursement
DelveInsight's 'Steroid Refractory Acute Graft-Versus-Host Disease - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of SR-aGVHD.
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
KOL Views
To keep up with current SR-aGVHD market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the SR-aGVHD domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or SR-aGVHD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the SR-aGvHD unmet needs.
Steroid Refractory Acute Graft-Versus-Host Disease: KOL Insights
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Mercer University, US, University Hospital Tubingen, Germany, University of Barcelona, Barcelona, Spain, ellvitge-Idibell University Hospital, Barcelona, Spain, University of Leeds, Leeds, UK, and University of Occupational and Environmental Health, Japan, among others.
"The norm is basically that you start them on steroids, and if they're progressing within 3 to 4 days, you'd call them refractory. If they don't get better and don't get worse, they're not responding well. Those who progress need to move quickly to something else because they're not going to do well."
"With ruxolitinib, the median time to response is pretty good, so you're hopefully going to see a response within 7 to 14 days. It's not always that early, but the median time is right around there. No matter what, I'm already trying to think about what I am going to be using next to help me try to get this patient's graft-versus-host disease under control."
Competitive Intelligence Analysis
We conduct a Competitive and Market Intelligence analysis of the SR-aGVHD Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.
Steroid Refractory Acute Graft-Versus-Host Disease Pipeline Development Activities
The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for SR-aGVHD. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.
Pipeline Development Activities
The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging SR-aGVHD therapies.
The primary treatment goals for SR-aGVHD are to rapidly control inflammation, prevent further tissue damage, and improve overall survival while minimizing the risk of treatment-related toxicity. Given the high morbidity and mortality associated with SR-aGVHD, particularly in cases involving the gastrointestinal tract, therapies aim to suppress the pathogenic immune response without causing broad immunosuppression that could predispose patients to life-threatening infections. An ideal treatment should selectively modulate or eliminate activated T cells driving the disease, promote tissue repair, and allow tapering of corticosteroids.
Managing SR-aGVHD presents several critical challenges. First, the condition is associated with high mortality especially in patients with severe gastrointestinal involvement yet therapeutic options remain limited and variably effective. The lack of reliable biomarkers to predict steroid resistance or guide treatment decisions early in the disease course complicates timely intervention. Additionally, many second-line therapies, such as JAK inhibitors or experimental agents, can lead to profound immunosuppression, increasing the risk of opportunistic infections, sepsis, and impaired immune reconstitution. Another challenge is the heterogeneity in clinical presentation and organ involvement, which requires tailored treatment strategies rather than a one-size-fits-all approach.
The growth of the SR-aGVHD treatment landscape is driven by the rising number of allogeneic stem cell transplants, high unmet clinical need, and poor outcomes with corticosteroids. Regulatory incentives and the success of targeted therapies like ruxolitinib have spurred investment and innovation. Advances in immunology, biomarker development, and supportive care have further enabled earlier diagnosis and expanded treatment opportunities, accelerating market expansion.
The SR-aGVHD Market and Epidemiology Forecast Report offers clients critical insights to inform strategic decision-making. By providing detailed, region-specific epidemiological data, the report helps clients quantify the patient population, identify high-burden segments, and assess market potential. It also tracks current and emerging therapies, competitive dynamics, and unmet needs-enabling clients to evaluate opportunities for differentiation, investment, or partnership. Furthermore, the report outlines regulatory trends, pricing considerations, and forecasted market growth, supporting evidence-based planning for clinical development, commercialization, and resource allocation.