Graft-Versus-Host Disease | Niche & Rare Disease Landscape & Forecast | US/EU5 | 2019

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).


  • 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?


  • 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
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