GVHD is a potentially life-threatening complication of allogenic HCST. GVHD is a systemic inflammatory reaction triggered by donor T cells’ recognition of host cell antigens in nontarget tissue as foreign. For decades, steroids have been the first-line therapy for the prevention and treatment of GVHD, but interviewed experts call for better treatments for steroid-refractory patients, as well as better first-line and prophylactic treatments for GVHD. Although development in the space has historically been slow, the pipeline for GVHD therapies is now robust with a number of late-phase agents, including Mesoblast’s Prochymal (remestemcel-L), Incyte’s itacitinib, Kadmon’s KD025, Elsalys’s Leukotac (inolimomab), and Takeda’s Entyvio (vedolizumab). Here, we examine the clinical and commercial opportunity for these emerging therapies and how they may affect the commercial performance of current therapies, such as Janssen’s Imbruvica and Incyte / Novartis’s Jakafi / Jakavi (ruxolitinib).

QUESTIONS ANSWERED

  • How large is the GVHD population, and how will it change through 2028? What percentage of the GVHD population receives drug treatment?
  • How is GVHD currently managed in the United States and EU5? How well does the GVHD pipeline align with unmet needs in the space?
  • Which emerging therapies do experts consider most promising? If approved, how would emerging therapies affect the management of GVHD? Which emerging drugs hold the most commercial potential?
  • What are some of the key GVHD market drivers and constraints? How will continuing advances in patient and host HLA matching affect the market?

CONTENT HIGHLIGHTS

  • Geographies: United States and EU5
  • Primary Research: Six country-specific interviews with thought-leading GVHD specialists Supported by survey data collected for this study
  • Epidemiology: Diagnosed incident cases of acute and chronic GVHD, diagnosed incident cases of acute GVHD by grade, drug-treated cases of GVHD by country
  • Forecast: Drug-level sales and patient share of key GVHD therapies in 2028
  • Emerging Therapies: Phase III/PR: 6 drugs; Phase II: >10 drugs; coverage of select preclinical and Phase I products

Table of contents

  • Graft Versus Host Disease - Landscape & Forecast - Disease Landscape & Forecast
    • COVID-19
      • Commercial Outlook
        • Key Findings
          • Regional Sales of Key Therapies to Treat Graft Versus Host Disease: 2028
          • Graft Versus Host Disease SWOT Analysis
          • Expert Insight
        • Drivers and Constraints
          • What Factors Are Driving Sales in Graft Versus Host Disease?
          • What Factors Are Constraining Sales in Graft Versus Host Disease?
        • Drug Class-Specific Trends
          • Bruton's Tyrosine Kinase Inhibitors
          • JAK Inhibitors
          • Photosensitizing Agents
          • Stem cell therapy
        • Alternative Market Scenarios
          • Alternative Scenarios for the Graft Versus Host Disease Market Through 2028
      • Forecast
        • Forecast Sales of Key Therapies in Graft Versus Host Disease
      • Etiology and Pathophysiology
        • Key Findings
          • Expert Insight
          • Disease Overview
          • Common Signs and Symptoms of Graft Versus Host Disease
          • National Institutes of Health Classification of Graft Versus Host Disease
        • Etiology
          • Stem Cell Transplantation
          • Select Risk Factors for Graft Versus Host Disease
          • Examples of Select Indications for Allogeneic HSCT
        • Pathophysiology
          • The Role of Select Donor Immune Cells
          • Three-Phase Model of Acute Graft Versus Host Disease Pathophysiology
          • Select Cytokines That Mediate Graft Versus Host Disease
          • Expert Insight
        • Clinical Staging
          • Severity Staging Systems for Acute Graft Versus Host Disease
          • National Institutes of Health Staging System for Chronic Graft Versus Host Disease
        • Infection and Relapse
          • Key Pathways and Drug Targets
          • Epidemiology
            • Introduction
              • Key Findings
            • Epidemiology Populations
              • Disease Definition
              • Methods
              • Sources Used for Event Estimates of Allogeneic HSCTs
              • Diagnosed Events of Allogeneic HSCTs: 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Incidence of Acute Graft Versus Host Disease by Severity
              • Diagnosed Incident Cases of Acute Graft Versus Host Disease by Severity: 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Incidence of Chronic Graft Versus Host Disease by Severity
              • Diagnosed Incident Cases of Chronic Graft Versus Host Disease by Severity: 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalence of Chronic Graft Versus Host Disease by Severity
              • Diagnosed Prevalent Cases of Chronic Graft Versus Host Disease: 2018-2028
              • Sources Used for Drug-Treated Prevalence or Incidence Estimates of Graft Versus Host Disease
              • Drug-Treated Diagnosed Events of Allogeneic HSCT: 2018-2028
              • Drug-Treated Diagnosed Incident Cases of Acute Graft Versus Host Disease: 2018-2028
              • Drug-Treated Diagnosed Incident Cases of Chronic Graft Versus Host Disease: 2018-2028
              • Drug-Treated Diagnosed Prevalent Cases of Chronic Graft Versus Host Disease: 2018-2028
          • Current Treatment
            • Key Findings
              • Expert Insight
            • Diagnosis
              • 2014 Updates to NIH Criteria for Diagnosis and Severity Scoring in Chronic Graft Versus Host Disease
              • Treatment Providers and Referral Patterns
              • Expert Insight on Diagnosis of Graft Versus Host Disease
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for Graft Versus Host Disease
              • Physician Insight on Clinical Trial Endpoints
              • Expert Insight on Clinical Trial Endpoints for Graft Versus Host Disease
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drug Classes Used for Graft Versus Host Disease
              • Current Treatments Used for Graft Versus Host Disease
              • Clinical Trial Outcomes for Methotrexate-Containing Prophylactic Regimens
              • Key Results from Select Clinical Trials Investigating Methotrexate-Containing Prophylactic Regimens for Graft Versus Host Disease Prophylaxis
              • Advantages and Disadvantages of Methotrexate-Containing Prophylactic Regimens
              • Key Ongoing Clinical Trials of Methotrexate-Containing Prophylactic Regimen for Graft Versus Host Disease Prophylaxis
              • Expert Insights: Methotrexate-Containing Prophylactic Regimen
              • Clinical Trial Outcomes for Antithymocyte Globulin
              • Key Results from Select Clinical Trials Investigating Antithymocyte Globulin for Graft Versus Host Disease Prophylaxis
              • Advantages and Disadvantages of Antithymocyte Globulin
              • Key Ongoing Clinical Trials of Antithymocyte Globulin for Graft Versus Host Disease Prophylaxis
              • Expert Insights: Antithymocyte Globulin
              • Clinical Trial Outcomes for Post-Transplant Cyclophosphamide
              • Advantages and Disadvantages of Post-Transplant Cyclophosphamide
              • Key Ongoing Clinical Trials of Post-Transplant Cyclophosphamide for Graft Versus Host Disease Prophylaxis
              • Expert Insights: Post-Transplant Cyclophosphamide
              • Key Results from Select Clinical Trials Investigating Systemic Corticosteroids for the Treatment of Graft Versus Host Disease
              • Advantages and Disadvantages of Systemic Corticosteroids
              • Expert Insights: Systemic Corticosteroids
              • Clinical Trial Outcomes for Imbruvica
              • Key Results from Select Clinical Trials Investigating Imbruvica for Graft Versus Host Disease Treatment
              • Advantages and Disadvantages of Imbruvica
              • Key Ongoing Clinical Trials of Imbruvica for Graft Versus Host Disease
              • Expert Insights: Imbruvica
              • Clinical Trial Outcomes for Extracorporeal Photopheresis
              • Key Results from Select Clinical Trials Investigating Extracorporeal Photopheresis for Graft Versus Host Disease Prophylaxis
              • Advantages and Disadvantages of Extracorporeal Photopheresis
            • Medical Practice
              • Overview
              • Regional Graft Versus Host Disease Treatment Guidelines
              • Generalized Treatment Decision Tree for Acute Graft Versus Host Disease
              • Generalized Treatment Decision Tree for Chronic Graft Versus Host Disease
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in Graft Versus Host Disease
            • Top Unmet Needs in Graft Versus Host Disease—Current and Future Attainment
            • Expert Insight on Unmet Needs in Graft Versus Host Disease
          • Emerging Therapies
            • Key Findings
              • Pipeline Trends for Graft Versus Host Disease
            • Key Emerging Therapies
              • Key Emerging Therapies in Development for Graft Versus Host Disease
              • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Graft Versus Host Disease
              • Jakafi / Jakavi Profile
              • Analysis of Clinical Development Program for Jakafi / Jakavi
              • Key Ongoing Clinical Trials of Jakafi / Jakavi in the Treatment of Graft Versus Host Disease
              • Expert Insight: Jakafi / Jakavi
              • Expectations for Launch and Sales Opportunity of Jakafi / Jakavi in Graft Versus Host Disease
              • Itacitinib Profile
              • Analysis of Clinical Development Program for Itacitinib
              • Key Ongoing Clinical Trials of Itacitinib in the Treatment of Graft Versus Host Disease
              • Expert Insights: Itacitinib
              • Expectations for Launch and Sales Opportunity of Itacitinib in Graft Versus Host Disease
              • Prochymal Profile
              • Analysis of Clinical Development Program for Prochymal
              • Expert Insights: Prochymal
              • Expectations for Launch and Sales Opportunity of Prochymal in Graft Versus Host Disease
              • Uvadex Profile
              • Analysis of Clinical Development Program for Uvadex
              • Key Ongoing Clinical Trials of Uvadex in the Treatment of Graft Versus Host Disease
              • Expert Insight: Uvadex
              • Expectations for Launch and Sales Opportunity of Uvadex in Graft Versus Host Disease
              • Alpha-1 Antitrypsin Profile
              • Analysis of Clinical Development Program for Alpha-1 Antitrypsin
              • Key Ongoing Clinical Trials of Alpha-1 Antitrypsin in the Treatment of Graft Versus Host Disease
              • Expert Insights: Alpha-1 Antitrypsin
              • Expectations for Launch and Sales Opportunity of Alpha-1 Antitrypsin in Graft Versus Host Disease
              • KD025 Profile
              • Analysis of Clinical Development Program for KD025
              • Key Ongoing Clinical Trials of KD025 in the Treatment of Graft Versus Host Disease
              • Expert Insights: KD025
              • Expectations for Launch and Sales Opportunity of KD025 in Graft Versus Host Disease
              • ATIR101 Profile
              • Analysis of Clinical Development Program for ATIR101
              • Key Clinical Trials of ATIR101 in the Treatment of Graft Versus Host Disease
              • Expert Insights: ATIR101
              • Expectations for Launch and Sales Opportunity of ATIR101 in Graft Versus Host Disease
              • Imolimomab
              • Vedolizumab
              • Expert Insights
            • Early-Phase Pipeline Analysis
              • Select Phase II Compounds in Development for Graft Versus Host Disease
              • Select Compounds in Early-Phase Development for Graft Versus Host Disease
            • Patient Registries
              • Patient Registries and Resources for Donor Bone Marrow
              • Prominent Graft Versus Host Disease Patient Organizations
            • Orphan Drug Designation
            • Access & Reimbursement Overview
              • Region-Specific Reimbursement Practices
                • General Reimbursement Environment: United States
                • General Reimbursement Environment: EU5
              • Looking for More?
            • Methodology
              • Bottom-Up Forecasting Overview
                • Patient Populations
                • Drug-Specific Assumptions
              • Bottom-Up Forecast Assumptions
                • General Sources of Data
                • Drug-Treatment Rate Assumptions in Graft Versus Host Disease
                • Patient-Share Assumptions in Graft Versus Host Disease
                • General Statements About Pricing
                • Sources for Drug Prices
                • 2018 Exchange Rates
                • Price per Treated Day: 2028
                • Dosing, Days of Therapy, and Compliance
                • Out-Year Forecasting
                • Emerging Therapy Prices
              • Primary Market Research
                • Experts Interviewed
            • Appendix
              • Key Abbreviations Related to Graft Versus Host Disease
              • Brands, Marketers, and Generic Availability of Key Therapies for Graft Versus Host Disease, by Market
              • Graft Versus Host Disease Bibliography

          Author(s): Rachit Singhal, M.Pharm; Devashri Mukherjee, MPH

          Rachit Singhal is an analyst in the Infectious, Niche, & Rare Diseases (INRD) team at Decision Resources. In this role he works on GVHD and hematologic malignancy reports. He has an experience of more than 4 years in multi facets of healthcare analytics such as digital analytics as well as IQVIA’s proprietary MIDAS data-based analytics. He also has experience in stakeholder management, client liaising and product management.

          Research enthusiast with a flair for academic writing, member of the DRG family since April 2015 and working from the India office.

          Started off career with a bachelor’s in Dental Surgery followed by a master’s in Public health; having primarily worked in the hospital setting as a Research Consultant prior to DRG and with 10 international publications to my credit.