In 2017, at least 2.8 million people in the U.S. acquired serious infections with bacteria that are resistant to one or more antimicrobial drugs and 35,000 have died as a result. Resistance to antimicrobials is viewed as a global threat with antimicrobial drug use in human and animal health driving resistance. Compounding the problem is an insufficiently robust global antimicrobial drug pipeline which currently includes a total of 43 antimicrobial compounds in different stages of development with only 15 showing promise against pathogens showing resistance to most of the antimicrobials available. There are over 100 antimicrobial drugs that are used to treat a variety of bacterial diseases at present (Powers, 2004; Stephens, 2021). However, without the development of new drugs, expansion of resistance will continue to reduce the effectiveness of currently available antimicrobial drugs and leave many patients with few, if any, treatment options. Stakeholders have proposed that pharmaceutical companies are avoiding antimicrobial drug development because they anticipate poor market performance (i.e., low sales revenues) for these drugs.
This study examines how recently approved antimicrobial drugs are performing relative to their added clinical benefit and the contributing factors to this performance compared to other types of drugs. Using public and proprietary data sources coupled with expert interviews, we estimate the development cost and comparative added clinical benefit of a total of 32 drugs of which 12 are antimicrobials (AM cohort), 14 are oncology drugs (oncology cohort), and the remaining 6 are other types of drugs that are similar to antimicrobials with respect to certain characteristics such as treatment duration and DRG-style reimbursement (non-AM comparator cohort). We then compare the comparative added clinical benefit of each drug to its market performance within each drug cohort.
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