The market for graft versus host disease (GvHD) prophylaxis and treatment in the seven major markets (7MM*) will undergo rapid growth, at a compound annual growth rate (CAGR) of 8.3% from 2018 to 2028. Growth is expected to be driven by the launch of approved therapies over the next ten years, which will garner significantly higher prices than currently used off-label therapies, says GlobalData, a leading data and analytics company.

The company’s latest report, ‘Graft Versus Host Disease: Opportunity Analysis and Forecasts to 2028’, states that the current standard of care for the treatment of GvHD is corticosteroids, but approximately half of patients do not respond to this line of treatment.

James Mather, Pharma Analyst at GlobalData, says: “Treatment options for the steroid-refractory patient population currently include a number of immunosuppressents and anti-inflammatory products which are used off-label. Over the past few years the late-stage development for GvHD treatments has intensified and has led to the US approval of Janssen/AbbVie’s Imbruvica (ibrutinib) and Novartis/Incyte’s Jakafi (ruxolitinib) for chronic and acute GvHD, respectively.”

These approved therapies can achieve reimbursement at a significantly higher price than previously used off-label therapies, since many off-label therapies have generics available. Imbruvica’s uptake could in fact be limited by its high cost, with the annual cost of treatment (ACOT) estimated to be $150,000 in the US for chronic GvHD. Overall, the impact from approved therapies launching and replacing generic off-label current-treatment options will be the major driver of growth in the 7MM GvHD market.

GlobalData’s report also found that JAK-inhibitor Jakafi is expected to garner a significant share of the GvHD market, and with JAK1-inhibitor itacitinib also forecast to launch in this timeframe, JAK-inhibitors will account for 19% of the 7MM GvHD market in 2028.

Mather explains: “Novartis/Incyte’s JAK inhibitor Jakafi became the first FDA-approved treatment for steroid-refractory acute GvHD in Q2 2019. Primary research conducted by GlobalData indicated that Jakafi will receive significant uptake over the next five years. As Jakafi is also being developed for chronic GvHD, it is expected Jakafi could experience robust uptake in both acute and chronic GvHD patient populations.”

Incyte’s other JAK-inhibitor in development for GvHD, itacitinib, is being developed as a GvHD prophylaxis, for patients undergoing allogenic hematopoietic stem cell transplants (HSCTs), as well as for aGvHD and cGvHD treatment. Although the development of itacitinib suffered a setback in January aGvHD, failing to achieve its primary endpoint in Phase III, its broad development for other GvHD patient populations could still lead to significant uptake.

Mather adds: “The launch of approved JAK-inhibitors for GvHD prophylaxis and treatment, along with the launch of biologic therapies and further uptake in cell-based therapies, will lead to significant growth in the GvHD market over the next decade.

“The increasing treatment options for GvHD patients, particularly those suffering with steroid-refractory GvHD, which have robust clinical evidence for their use will hopefully help to address the significant unmet need that remains in GvHD.”

*7MM = United States, France, Germany, Italy, Spain, United Kingdom, Japan