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
- Key Findings
- 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
- Key Findings
- 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
- Introduction
- 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
- Key Findings
- 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
- Key Findings
- Access & Reimbursement Overview
- Region-Specific Reimbursement Practices
- General Reimbursement Environment: United States
- General Reimbursement Environment: EU5
- Region-Specific Reimbursement Practices
- 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
- COVID-19
Andrew Russell, Ph.D., is a business insights analyst on the Infectious, Niche, and Rare Diseases team at Clarivate. In this role, he authors reports that distill the findings of his research into pharmaceutical markets related to autoimmune disease and bacterial infection. He worked previously in neurodegenerative disease research at Brigham and Women’s Hospital in Boston. He holds a Ph.D. in cellular and molecular biology from Brandeis University.
