New report highlights critical gaps in antibiotic research and diagnostics amid rising resistance

The World Health Organization (WHO) has sounded the alarm over the slow progress in developing new antibiotics and diagnostic tools to tackle drug-resistant bacterial infections, warning that the global pipeline remains “insufficient” to counter the growing threat of antimicrobial resistance (AMR).

The organization released two companion reports, one on antibacterial agents in clinical and preclinical development, and another mapping the availability and innovation of diagnostic tools, both aimed at guiding global research and investment to better respond to AMR.

Too few antibacterials in development

The Analysis of Antibacterial Agents in Clinical and Preclinical Development: Overview and Analysis 2025 shows that the number of antibacterial drugs in the clinical pipeline has declined from 97 in 2023 to just 90 this year.

Of these, only 15 are considered “innovative,” while data on 10 of them are too limited to rule out cross-resistance, a phenomenon where resistance to one drug can compromise the effectiveness of others. Just five candidates are effective against bacteria in WHO’s “critical” priority category, the highest level of threat.

Among 50 traditional antibiotics under development, 45 target priority pathogens, with 18 focused on drug-resistant Mycobacterium tuberculosis. Yet, gaps persist in paediatric formulations, oral treatments for outpatient use, and combination therapies with non-traditional agents.

Since 2017, 17 new antibacterial agents targeting priority pathogens have received marketing authorization, but only two represent entirely new chemical classes.

The report also highlights the fragility of the antibacterial R&D ecosystem. Of the 148 groups involved in preclinical research worldwide, 90% are small companies with fewer than 50 employees.

“WHO urges developers to publish data on antibacterial activity to foster collaboration, attract investment, and accelerate innovation,” the report notes.

Diagnostic tools lag behind

The second report, Landscape Analysis of Commercially Available and Pipeline In Vitro Diagnostics for Bacterial Priority Pathogens, underscores the equally critical role of diagnostics in the fight against AMR and the major gaps that remain, particularly in low- and middle-income countries.

Key weaknesses include the lack of multiplex platforms capable of identifying bloodstream infections directly from whole blood, limited access to biomarker tests to distinguish bacterial from viral infections, and the absence of simple, point-of-care diagnostics for primary and secondary care facilities.

“These limitations disproportionately affect patients in low-resource settings, where most people first seek care,” the report warns. It calls for affordable, robust, and easy-to-use diagnostic systems that can provide “sample-in, result-out” outputs for a range of specimen types including blood, urine, and respiratory samples.

A call for investment and equitable access

“Antimicrobial resistance is escalating, but the pipeline of new treatments and diagnostics is insufficient to tackle the spread of drug-resistant bacterial infections,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems.

“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.”

WHO is urging increased investment in tools designed for low-resource environments and new funding models to support the small and medium-sized enterprises that currently drive most antibacterial and diagnostic innovation.

Both reports aim to steer global action and investment across the antibacterial and diagnostics landscape, from early drug discovery and clinical development to equitable access and sustainable innovation.