Regulatory and market influences on innovation pathways for the development of new antimicrobial drugs

Focusing on Europe and the United States, and using policy/regulatory document analysis, qualitative interviews and quantitative cost-scenario analysis, we explore regulatory and market influences on the commercial development of novel antimicrobial drugs and diagnostics to meet the global antimicrobial resistance (AMR) crisis. We show that the regulation of clinical trials previously inhibited firms’ ability to develop commercially viable...