The market for graft versus host disease (GvHD) prophylaxis and treatment in the five growth markets (5GM*) in the Asia-Pacific (APAC) region will undergo steady growth at a compound annual growth rate (CAGR) of 8.2 per cent from 2018 to 2028, according to GlobalData.

GlobalData’s latest report, ‘Graft Versus Host Disease (GvHD): Forecast in Asia-Pacific Markets to 2028’, reveals that the current standard of care (SoC) for the treatment of GvHD is corticosteroids, but more than half of patients do not respond to this line of treatment. After failure of SoC, the treatment options in 5GM remain solely experimental, leading to poor outcome for patients.

Shreya Brahmbhatt, Pharma Analyst at GlobalData, says, “Although the off-label treatments that are currently used in the management of GvHD are established and have a good reputation in their respective indications, they have not yet been demonstrated to provide durable remission following GvHD treatment. Moreover, there are no guidelines in most growth markets for the management of GvHD; instead, there are only recommendations for several off-label therapies.

“Over the past few years, the late-stage development for GvHD treatments has intensified and the approval of six pipeline candidates is expected across the 5GM during the next 10 years. These approved therapies can achieve reimbursement at a significantly higher price than previously used off-label therapies, as generics are available in most cases. Overall, the impact of approved therapies replacing generic off-label treatments will be the main driver of growth in the 5GM GvHD market, over the next decade.”

GlobalData’s report also found that Novartis’ JAK-inhibitor Jakavi is expected to garner a significant share of the GvHD market. With Imbruvica (ibrutinib) and itacitinib also forecast to receive approval during this period, kinase inhibitors are expected to account for 41 per cent of the 5GM GvHD market in 2028.

Brahmbhatt explains, “Novartis’s JAK inhibitor Jakavi is expected to become the first approved treatment for steroid-refractory acute GvHD in the 5GM. Primary research conducted by GlobalData indicated that Jakavi will receive significant uptake after its approval in 2021. As Jakavi is also being developed for chronic GvHD, it is expected Jakavi could experience robust uptake in both acute and chronic GvHD patient populations.”

Takeda’s Entyvio (vedolizumab) is expected to be the most important GvHD prophylaxis candidate approved during the forecast period. This is despite Entyvio only being developed for the prevention of gastrointestinal (GI) tract acute GvHD, and this specificity could limit its uptake in some markets.

Brahmbhatt adds, “The expected increase in the number of patients undergoing allogeneic haematopoietic stem cell transplants (HSCTs) and subsequent increase in the GvHD diagnosed prevalent population, approval of novel treatments and a greater range of prophylaxis options, will lead to significant growth in the GvHD markets over the next decade.”

However, the launch of vedolizumab and abatacept biosimilars for GvHD prophylaxis, coupled with higher preference for currently available biosimilar therapies are likely to provide a barrier to growth.

Brahmbhatt concludes, “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 some of the significant unmet need that exists in GvHD.”

*5GM = India, China, Australia, South Korea and Japan.