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 crisis. We show that regulation of clinical trials previously inhibited firms’ ability to develop commercially viable antimicrobials, but now unattractive commercial prospects are the main barrier. Our findings improve understanding of the challenges of drug development in the context of market failure and highlight unique problems of antimicrobial resistance in terms of the alignment of different incentive structures and value(s), including clinical norms and practices.