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.
- 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?
- 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.