Global mapping of insulin manufacturers

This report presents a global mapping of insulin manufacturers conducted between October 2024 and June 2025. It identifies 22 full-chain manufacturers, 34 fill-and-finish manufacturers and one manufacturer producing insulin crystals exclusively. The findings show that insulin manufacturing is geographically concentrated and characterized by fragmented and often opaque relationships between insulin crystal producers and fill-and-finish manufacturers, limiting supply-chain transparency and traceability. They also highlight uneven regulatory capacity, limited harmonization of pathways for biosimilar insulin registration and low manufacturer engagement with the WHO Prequalification Programme.

Only three full-chain manufacturers had marketed insulin products in a jurisdiction with stringent regulatory requirements, and relatively few manufacturers prioritized human insulin despite its importance for people living with type 1 diabetes. The report outlines proposed actions that may inform efforts to improve transparency in manufacturing partnerships, strengthen regulatory capacity and harmonization, expand awareness of WHO technical support and prequalification, facilitate collaborative registration procedures, and support the development of both human and analogue insulins.