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.
The NCD Policy Lab provided technical support to the development of the report.
The aim of this White Book is threefold. Firstly, to describe what is known about type 1 diabetes in Denmark from different angles including epidemiology, causes of death, use of health system resources, costs, complications, quality of care and policy environment. Next to learn how this data is used by decision makers for policies and health systems responses. Finally, combining these first two elements to take lessons learned and apply these to other contexts through the development of a Road Map. Type 1 diabetes is a complex chronic condition requiring various elements of the health system to be present and is described as a useful tracer condition for other Noncommunicable diseases. Health systems intrinsically generate data for a variety of purposes, but in many cases in Low- and Middle-Income countries the quality of the data and systems put in place are donor driven and focus on communicable diseases versus diabetes. This means that at national and sub-national level, health systems and policy makers are reliant on estimates provided by academics versus “real life” data from their own context. Different data are required to document the complexity and multi-faceted issues of type 1 diabetes, including: epidemiology; incidence and prevalence; disease outcomes, including patient reported outcomes; morbidity; mortality; causes of death; complications; costs and satisfaction. All these data are needed to develop appropriate clinical and policy responses. Globally, Denmark can be seen as a pioneering country in the collection of health-related data including data for diabetes. Specifically for diabetes the Register of Selected Chronic Disease and Severe Mental Disorders created in 2012 based on a history of different diabetes related registers. In addition, research databases comprising persons with registered diabetes have been established in Danish research environments using data from the central Danish health registers mentioned above.
