The incidence and scale of drug shortages have both increased markedly during the past several years. As a result, regulatory agencies, drug manufacturers, and policy makers have been focusing more attention on understanding drug shortages and mitigating associated risk. This session includes information on a 2012 study capturing robust descriptive and detailed data on the incidence of, and longitudinal trends in, drug shortages and where and why they occur. This session will also discuss the anticipated increase in the incidence of drug shortages under the rising proportion of biosimilars in the market and the impact of other forecasted drug development and commercialization trends.