Treosulfan API Market

Treosulfan API market is experiencing a CAGR of 7.5% during the forecast period from 2025-2035. The market growth is primarily driven by its increasing use as a conditioning agent before hematopoietic stem cell transplantation (HSCT). The growing incidence of hematological malignancies and the rising demand for safer, less toxic alternatives to conventional chemotherapeutics such as busulfan are key drivers fueling market expansion.

The hematopoietic stem cell transplantation segment dominates the market, accounting for the largest share due to Treosulfan’s favorable toxicity profile and higher efficacy in myeloablative conditioning regimens, especially in pediatric and elderly patients. It is also gaining popularity in the treatment of both malignant (e.g., leukemia, lymphoma) and non-malignant conditions (e.g., thalassemia, sickle cell disease). The injectable formulation remains the key route of administration, with hospitals and specialized transplant centers serving as the primary end-users.

Europe holds the largest market share, led by Germany, where medac GmbH, the original developer and supplier of Treosulfan, is headquartered. Germany has witnessed widespread adoption in transplant centers and continues to drive regulatory and clinical advancements. Meanwhile, the Asia-Pacific region, particularly India and China, is emerging as a significant growth hub due to increasing generic API manufacturing, cost-effective production, and expanding clinical use.

Key players operating in the global Treosulfan API market include medac GmbH, Evonik Industries AG, ZCL Chemicals Ltd, Jubilant Pharmova, and LGM Pharma. These companies are focusing on capacity expansion, strategic collaborations, and regulatory approvals to strengthen their market presence. With rising transplantation rates, increasing clinical trials, and growing international approvals, the Treosulfan API market is set for robust growth over the next decade.

Recent Development

• In June 2024, Medexus Pharmaceuticals received approval from the US FDA for its resubmission of its treosulfan New Drug Application. The FDA expects to complete the review by October 30, 2024. The treosulfan NDA seeks approval for treosulfan in combination with fludarabine for allogeneic hematopoietic stem cell transplantation. Medexus launched treosulfan in Canada in September 2021, gaining experience in the market.