There is a major gap in the discovery of antibacterial treatments and other innovative treatments to address the mounting threat of antibiotic resistance, according to the World Health Organization (WHO).

A new report shows that the antibacterial clinical and preclinical pipeline as stagnant with only 12 antibiotics being approved since 2012. Of these, 10 belong to existing classes with established mechanisms of antimicrobial resistance (AMR).

Dr Hanan Balkhy, WHO Assistant Director-General on AMR. “This presents a serious challenge to overcoming the escalating pandemic of antimicrobial resistance and leaves every one of us increasingly vulnerable to bacterial infections including the simplest infections.”  

In 2021 there were only 27 new antibiotics in clinical development against priority pathogens, down from 31 products in 2017. In the preclinical stage – before clinical trials can start – the number of products has remained relatively constant over the last three years.

Development of new antibacterial treatments is inadequate

Barriers to development of new products include the lengthy pathway to approval, high cost and low success rates. It currently takes approximately 10–15 years to progress an antibiotic candidate from the preclinical to the clinical stages. For antibiotics in existing classes, on average, only one of every 15 drugs in preclinical development will reach patients. For new classes of antibiotics, only one in 30 candidates will reach patients.

Of the 27 antibiotics in the clinical pipeline that address priority pathogens, only six fulfil at least one of WHO’s criteria for innovation. The lack of innovation rapidly undermines the effectiveness of the limited number of new antibiotics that reach the market. On average resistance is reported to most new agents 2–3 years post market entry.

Dr Haileyesus Getahun, WHO Director of AMR Global Coordination, added: “Time is running out to get ahead of antimicrobial resistance, the pace and success of innovation is far below what we need to secure the gains of modern medicine against age-old but devastating conditions."