Graft Versus Host Disease – Landscape & Forecast – Disease Landscape & Forecast

Graft versus host disease (GVHD) is a potentially life-threatening complication of allogeneic hematopoietic stem-cell transplantation (HSCT). 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 this space has historically been slow, the pipeline for GVHD therapies is now robust with a number of late-phase agents, including Mesoblast’s Ryoncil (remestemcel-L), Incyte’s itacitinib, Kadmon’s belumosudil, Elsalys / Mediolanum's Leukotac (inolimomab), and Xenikos's T-Guard. Here, we examine the clinical and commercial opportunity of these emerging therapies and how they may affect the commercial performance of current therapies, such as AbbVie / Janssen’s Imbruvica and Incyte / Novartis’s Jakafi / Jakavi.

QUESTIONS ANSWERED

  • How large is the GVHD population, and how will it change through 2029? 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 human leukocyte antigen (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 2029.
  • Emerging therapies: Late phase / preregistered: 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
      • Key Findings
        • Graft Versus Host Disease Key Findings - November 2020
      • Commercial Outlook
        • Key Findings
          • Regional Sales of Key Therapies to Treat Graft Versus Host Disease: 2029
          • Graft Versus Host Disease SWOT Analysis
        • COVID-19: Areas of Potential Forecast Impact
          • Drivers and Constraints
            • What Factors Are Driving Sales for Graft Versus Host Disease?
            • What Factors Are Constraining Sales for Graft Versus Host Disease?
          • Drug Class-Specific Trends
            • Bruton's Tyrosine Kinase Inhibitors
            • JAK Inhibitors
            • ROCK2 Inhibitors
            • Stem Cell Therapy
          • Alternative Market Scenarios
            • Alternative Scenarios for the Graft Versus Host Disease Market Through 2029
        • Forecast
          • Forecast Sales of Key Therapies for Graft Versus Host Disease
        • Etiology and Pathophysiology
          • Key Findings
            • 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 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
          • 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: 2019-2029
                • 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: 2019-2029
                • 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: 2019-2029
                • 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: 2019-2029
                • Sources Used for Drug-Treated Prevalence or Incidence Estimates of Graft Versus Host Disease
                • Drug-Treated Diagnosed Events of Allogeneic HSCT: 2019-2029
                • Drug-Treated Diagnosed Incident Cases of Acute Graft Versus Host Disease: 2019-2029
                • Drug-Treated Diagnosed Incident Cases of Chronic Graft Versus Host Disease: 2019-2029
                • Drug-Treated Diagnosed Prevalent Cases of Chronic Graft Versus Host Disease: 2019-2029
            • 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 of Methotrexate-Containing Prophylactic Regimens
                • Key Results of 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 Regimens for Graft Versus Host Disease Prophylaxis
                • Expert Insights: Methotrexate-Containing Prophylactic Regimens
                • Clinical Trial Outcomes for Antithymocyte Globulin
                • Key Results of 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
                • Clinical Trial Outcomes for Systemic Corticosteroids
                • Key Results of 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 Diseaseu2014Current 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 Therapies in Development for Graft Versus Host Disease
                • Estimated Launch Dates of Key Emerging Therapies for 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 for 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
                • Ryoncil Profile
                • Analysis of Clinical Development Program for Ryoncil
                • Expert Insights: Ryoncil
                • Expectations for Launch and Sales Opportunity of Ryoncil in Graft Versus Host Disease
                • UVADEX Profile
                • Analysis of Clinical Development Program for UVADEX
                • Expert Insight: ECP
                • 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
                • Belumosudil Profile
                • Analysis of Clinical Development Program for Belumosudil
                • Expert Insights: Belumosudil
                • Expectations for Launch and Sales Opportunity of Belumosudil in Graft Versus Host Disease
                • Inolimomab
                • Inolimomab Profile
                • Analysis of Clinical Development Program for Inolimomab
                • Key Clinical Trials of Inolimomab in the Treatment of Graft Versus Host Disease
                • Expert Insights: Inolimomab
                • Expectations for Launch and Sales Opportunity of Inolimomab in Graft Versus Host Disease
                • T-Guard Profile
                • Analysis of Clinical Development Program for T-Guard
                • Expert Insights: T-Guard
                • Expectations for Launch and Sales Opportunity of T-Guard in Graft Versus Host Disease
                • Vedolizumab
                • CD24Fc
                • Expert Insights
              • Early-Phase Pipeline Analysis
                • Select Compounds in Phase II 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
              • 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