Bendamustine Hydrochloride Market

The Bendamustine Hydrochloride market is witnessing a CAGR of 5.5% during the forecast period of 2025-2035. Bendamustine hydrochloride is an anticancer drug used to treat certain cancers, like chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). It has a dual mechanism that is both alkylating and antimetabolite in nature, interfering with the DNA replication of cancer cells and causing them to die. The U.S. Food and Drug Administration (FDA) has licensed several versions of bendamustine hydrochloride, including TREANDA and generic alternatives, for these conditions.

Bendamustine hydrochloride comes in various forms in the pharmaceutical sector to serve different needs of patients. TREANDA comes as a lyophilized powder that is reconstituted and diluted for intravenous injection. For CLL, the suggested dose is 100 mg/m² by intravenous infusion over 30 minutes on Days 1 and 2 of a 28-day cycle for a maximum of 6 cycles. For NHL, the dose is 120 mg/m² intravenous infusion over 60 minutes on Days 1 and 2 of a 21-day schedule, for a maximum of 8 cycles.

To enhance patient convenience, newer formulations like BENDeka have been developed, offering a more rapid intravenous infusion time of 10 minutes compared to the 60 minutes required for TREANDA. This formulation also exhibits compatibility with closed system transfer devices (CSTDs) and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS), addressing safety concerns associated with drug preparation and administration. ​

The manufacture and distribution of bendamustine hydrochloride are under strict regulatory control to guarantee product quality and patient safety. The FDA oversees the pharmaceutical supply chain, including API manufacturers, to ensure that products are not contaminated and that good manufacturing practices are followed.