Experts have warned bacteria are getting resistant to more antibiotics yet the pace of developing new drugs is disturbingly slow.
The World Health Organization also said the Covid-19 pandemic hampered progress, delayed clinical trials, and diverted the attention of the already limited investors.
The 2021 annual pipeline report by the WHO describes the antibacterial clinical and preclinical pipeline as stagnant and far from meeting global needs.
It says since 2017, only 12 antibiotics have been approved, ten of which belong to existing classes which are facing antimicrobial resistance (AMR).
On average, resistance is reported to most new agents two to three years after entry into the market.
“Time is running out to get ahead of antimicrobial resistance, the pace and success of innovation are far below what we need to secure the gains of modern medicine against age-old but devastating conditions like neonatal sepsis,” said Dr Haileyesus Getahun, WHO director of AMR global coordination.
Approximately 30 per cent of newborns with sepsis die due to bacterial infections resistant to first-line antibiotics.
Last week, experts noted that newborns at Kenyan referral hospitals are already being overprescribed antibiotics, and the majority do not complete doses, raising the prospect of drug resistance.
According to the WHO analysis, 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.
More broadly the report describes that, of the 77 antibacterial agents in clinical development, 45 are traditional direct-acting small molecules and 32 are non-traditional agents.
Examples of the latter are monoclonal antibodies and bacteriophages, which are viruses that can destroy bacteria.
Since antibiotics now have a limited lifespan before drug resistance emerges, non-traditional approaches offer new opportunities to tackle infections from resistant bacteria, WHO said.
Barriers to the 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.
“There is a major gap in the discovery of antibacterial treatments, and more so in the discovery of innovative treatments,” said 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.”
