Top 7 Companies in the Steroid Refractory Acute Graft versus Host Disease Market in 2025

The steroid refractory acute graft versus host disease market growth is driven by the increasing allogeneic stem cell transplantations and rising adoption of cell therapies across the 8 major markets.

Acute graft versus host disease that does not respond to steroids is a serious complication that occurs after stem cell transplantation. In this condition, the donor's immune cells attack the recipient's tissues, leading to organ injury. Several factors like the severity of the immune reaction from the transplant and the overall health of the patient play a role in the resistance observed, leading to the need to investigate different treatment options. Diagnosis requires assessing symptoms, conducting laboratory tests, and obtaining tissue samples. Options for treatment comprise immunosuppressants, kinase inhibitors, monoclonal antibodies, and biological therapies tailored to individual reactions and the seriousness of symptoms.

The rising prevalence of allogeneic stem cell transplants is fueling the demand for steroid-resistant acute graft versus host disease market. The increased use of hematopoietic stem cell transplants in the United States, especially for blood cancers and genetic disorders, has resulted in a higher number of steroid-resistant cases of graft-versus-host disease. Advancements in medical technology and patient care are driving the need for better graft-versus-host disease treatments. Innovations in immunotherapy, like CAR T-cell therapy and checkpoint inhibitors, are offering new ways to treat steroid-resistant graft-versus-host disease, which is expected to aid market expansion.

In February  2024, a study published on the use of Ruxolitinib for treating graft-versus-host disease in children found it effective in steroid-refractory cases. Ruxolitinib, a JAK 1–2 inhibitor, showed positive results in adult trials and is now considered the preferred treatment when corticosteroids are ineffective. The drug also had favorable outcomes in children under 12 years of age, including those with high-risk GvHD categories. The rising availability of such advanced immunotherapies is anticipated to elevate the market value in the coming years.

Let’s explore the profile of top companies leading the steroid refractory acute graft versus host disease market in 2025.

1. Bristol Myers Squibb

Bristol Myers Squibb, a leading pharmaceutical company based in the United States, plays a major role in the growth of the market for steroid refractory acute graft versus host disease. In 2021 , the company’s abatacept was approved by the FDA for the prophylaxis of acute graft versus host disease in hematopoietic stem cell transplantation (HSCT) patients, which can prevent severe cases that may become steroid refractory. This authorization marks a change towards utilizing real-life data to improve comprehension and efficacy of treatments in medical environments.

2. Novartis AG

Novartis AG, a Switzerland-based multinational pharmaceutical company headquartered in Basel, is dedicated to developing groundbreaking drugs. It focuses on exploring, creating, producing, and promoting both prescription and generic medications and offers therapies for cancer, heart conditions, and various other illnesses. In September  2024, a research project funded by Novartis Pharmaceuticals and recorded on clinicalTrials .gov is being conducted to assess the efficiency and safety of ruxolitinib therapy in Chinese adults and teenagers with Grade II-IV steroid-resistant acute graft versus host disease.

3. Mesoblast Ltd.

Mesoblast Limited is an Australian company that was founded in 2004. The company's focus is on regenerative medicine for different illnesses. Their goal is to bring cutting-edge cellular treatments for sought-after severe illnesses. The biologics license application for remestemcel-L was approved by the FDA in July  2024 for the treatment of steroid-refractory acute graft versus host disease in children.

4. Equillium Bio

Equillium is a biotechnology company that utilizes immunobiology knowledge to develop treatments for autoimmune and inflammatory conditions. Their Phase  3 trial is investigating itolizumab's efficacy in severe acute GVHD patients, targeting harmful T cell function. This aligns with the growing demand for alternative treatments due to low survival rates in non-steroid-responsive patients.

5. Cynata Therapeutics

Cynata Therapeutics, an Australian biotechnology firm, is working on regenerative medicine treatments, such as CYP-001 for aGvHD. Their clinical trials are focused on filling the current lack of treatment options, with positive safety and effectiveness outcomes prompting a Phase 2 investigation in 2023 . This development marks significant progress in aGvHD therapy.

6. MaaT Pharma

MaaT Pharma is dedicated to enhancing cancer survival outcomes by restoring patient-microbiome symbiosis. In April  2024, the company revealed additional results from a European study on 140 patients with steroid-resistant or steroid-dependent acute graft-versus-host disease in the gastrointestinal tract who were treated with MaaT013. They pointed out a notably high response rate, showcasing the company's commitment to enhancing patient results.

7. Xenikos B.V.

Xenikos is a biotech company working on a new treatment to reboot the immune system in individuals with severe immune disorders and organ transplant rejection. In June  2022, Xenikos began the first patient enrollment in a Phase 3 trial that compares T-Guard® with ruxolitinib to treat Grade III or IV steroid-refractory acute GVHD after a transplant. The research, endorsed by the FDA, EMA, and MHRA, intends to recruit additional participants to evaluate the effectiveness of T-Guard in addressing severe graft-versus-host disease.