Regulatory and market influences on innovation pathways for the development of new antimicrobial drugs. Issue 3 (4th March 2021)

• Record Type: Journal Article
• Authors: Mittra, James; Bruce, Ann; Scannell, Jack W.; Tait, Joyce
• Is Part Of: Technology analysis & strategic management. Volume 33:Issue 3(2021)
• Page Start: 283
• Page End: 295
• Publication Date: 2021-03-04
• Subjects: Antimicrobial resistance -- regulation -- clinical trials -- R&D costs; Technological innovations -- Management -- Periodicals; Research, Industrial -- Management -- Periodicals; High technology industries -- Management -- Periodicals; Strategic planning -- Periodicals; 658.401205
• DOI: 10.1080/09537325.2019.1634253
• Languages: English
• ISSNs: 0953-7325

Abstract

ABSTRACT : 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 antimicrobials, but now unattractive commercial prospects are the main barrier. Our findings improve the understanding of the challenges of drug development in the context of market failure and highlight unique problems of AMR in terms of the alignment of different incentive structures and value(s), including clinical norms and practices.