Global insulin supply insecurity and the role of manufacturing innovation.

Insulin availability and affordability have long limited access in low- and middle-income countries (LMICs), and recent shortages and product withdrawals in higher-income settings underscore the need for reliable supply worldwide. While documented disruptions do not establish an aggregate global manufacturing deficit, commercial decisions, regulatory barriers, procurement, financing, and distribution can restrict access even where production capacity exists. Nevertheless, product prioritization and investment decisions can constrain the capacity allocated to insulin and reduce the ability to respond to changing demand. This narrative review examines global insulin demand, supply insecurity, market structure, affordability, and health-system barriers, distinguishing the circumstances of the United States, other high-income countries, and LMICs. We consider the potential effects of incretin therapies on insulin requirements and industrial investment and assess manufacturing modernization, including continuous production, as one component of a broader response. Proposed technological benefits require insulin-specific validation of quality, productivity, cost, and commercial feasibility. Priorities include stronger shortage surveillance, diversified qualified suppliers, regulatory cooperation, sustainable procurement, reduced waste, and dependable distribution. Supply security must extend through safe storage, administration, education, and glucose monitoring. Coordinated action across manufacturing and health systems is needed to maintain uninterrupted, affordable access to appropriate insulin treatment.