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PROGRESS IN PHARMACEUTICAL SCIENCES 2014,3838 9 :686-698 686  Spotlight on Antidiabetic Drugs Thomson Reuters The diabetes market is currently one of the biggest value and fastest growing in the pharma industry, fueled by the vast number of patients needing pharmaceutical intervention to control their disease. Since the discovery of insulin, the industry has developed a raft of multibillion dollar-selling drugs to treat the disease. The future explosion in patient number predicted by the World Health Organization (WHO), as the global population leads a more sedentary lifestyle, offers ample opportunity for the development of new blockbuster antidiabetic agents. Driven by these new products, as well as entrenched insulin analogs, the value of the market is forecast to almost double in the next fi ve years.This review looks at current market dynamics and the effect that an increasingly hostile regulatory environment is having on product development. While novel drugs face increased scrutiny by the national regulatory agencies, legislation allowing the development of insulin biosimilars is just around the corner and may shape the diabetes market beyond recognition in the long term. In this review,we discuss the key challenges in bringing insulin generics to the market, and evaluate the magnitude of the threat. diabetes; new