The latest report from the World Health Organization (WHO) looking at the new tests and treatments in development for treating bacterial infections has warned of a dual crisis of "scarcity and lack of innovation” and warns that, without more action, 39 million deaths will be attributable to antimicrobial resistance (AMR) by 2050.
The WHO’s Analysis of antibacterial agents in clinical and preclinical development: overview and analysis 2025 tracks whether current R&D efforts are keeping pace with the need for new treatments against the most drug resistant bacteria.
The latest report finds that the number of antibacterials in the clinical pipeline fell from 97 in 2023 to 90 as of February 2025. Of these, 40 are classified as non-traditional approaches, such as bacteriophages, antibodies and microbiome-modulating, while the other 50 are classified as traditional antibacterial agents.
Of the 90 antibacterials in development, only 15 could be classed as innovative and only five of these antibacterials are effective against at least one the ‘critical’ bacteria that the WHO has put on the Bacterial Priority Pathogens List (BPPL).
The WHO said: “Gaps persist in specific areas, including paediatric formulations, oral treatments for outpatient use, and solutions to address escalating resistance such as combination strategies with non-traditional agents." Since July 2017, 17 new antibacterial agents against priority bacterial pathogens have obtained marketing authorisation, but only two represent a new chemical class.
Recently authorized traditional agents include the β-lactam/β-lactamase inhibitor combination, cefepime/enmetazobactam, which was approved by both the US Food and Drug Administration and the European Medicines Agency for use in adults with complicated urinary tract infections.
While emphasising the urgent need for innovation, the report does say that there is an active preclinical pipeline, with 232 programmes across 148 groups around the world conducting research. However, the majority of these programmes, 90%, are being conducted by small companies with less than 50 employees. This highlights the fragility of the R&D ecosystem, the WHO said.
Much of the research is focused on Gram-negative bacteria, where innovation is most urgently needed, the WHO said, and it is calling for developers to publish data on antibacterial activity to foster collaboration, attract investment and accelerate innovation.
“Antimicrobial resistance is escalating. But the pipeline of new treatments and diagnostics is insufficient to tackle the spread of drug-resistant bacterial infections. Without more investment in R&D, together with dedicated efforts to ensure that new and existing products reach the people who most need them, drug-resistant infections will continue to spread,” said Dr Yukiko Nakatani, WHO assistant director-general for health systems.
The report calls for the adoption of a culture of continuous innovation to ensure a sustainable pipeline of innovative therapies. The therapies should be able to overcome multiple steps of resistance, to ensure a quick and complete pathogen eradication. “We need substantial investments in the R&D of antibiotics targeting the most serious infections, with a strong emphasis on innovation to stay ahead of bacterial evolution,” the report said.
Further reading:
- AMR: Researchers map antibiotic resistance in livestock waste
- Antimicrobial resistance: How microplastics can increase the spread of AMR
- New UK plan aims to reduce antibiotic misuse and drive AMR innovation
- What is AMR? Here’s what you need to know about antimicrobial resistance
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