WHO Warns of Weak Antibiotic Pipeline and Critical Diagnostic Gaps in AMR Fight

The analysis shows a troubling decline in the number of antibacterials in clinical development, which dropped from 97 candidates in 2023 to just 90 in 2025.

The World Health Organization (WHO) has released two major reports assessing the state of antibacterial research and diagnostics worldwide, raising alarm about the sluggish progress in the global response to antimicrobial resistance (AMR). Despite ongoing efforts, the findings reveal an urgent need for innovation, investment, and accessibility to prevent drug-resistant bacterial infections from escalating into a full-scale public health crisis.

Declining Pipeline of Antibacterials

The first report, Analysis of antibacterial agents in clinical and preclinical development: overview and analysis 2025, updates WHO’s ongoing review of antibacterial research and development since its first release in 2017. The analysis shows a troubling decline in the number of antibacterials in clinical development, which dropped from 97 candidates in 2023 to just 90 in 2025.

Of these:

• 50 are traditional antibacterial agents

• 40 are non-traditional approaches, including bacteriophages, antibodies, and microbiome-modulating agents

Yet, only 15 of these candidates are classified as innovative, and for 10 of them, the available data remain insufficient to rule out cross-resistance. This means resistant bacteria could potentially undermine the effectiveness of multiple treatments. Alarmingly, only five agents are active against at least one of WHO’s “critical” priority pathogens, the highest risk category in its Bacterial Priority Pathogens List (BPPL).

Traditional antibiotic research remains disproportionately focused on drug-resistant Mycobacterium tuberculosis, with 18 of the 50 candidates (40%) targeting TB. While important, this narrow focus leaves major gaps in treatments for other high-risk infections, particularly those caused by Gram-negative bacteria.

Since July 2017, only 17 antibacterial agents targeting priority pathogens have reached market authorization, and just two of those represent a truly new chemical class. The pace of innovation remains far too slow compared to the speed at which resistant bacteria are spreading.

Preclinical Research: Active but Fragile

The preclinical pipeline remains relatively vibrant, with 232 programmes across 148 organizations worldwide. However, 90% of these are being developed by small companies with fewer than 50 employees, raising concerns about the sustainability and resilience of the R&D ecosystem.

WHO warns that without better funding models and stronger partnerships with larger pharmaceutical firms, many of these small-scale innovators risk collapse before their discoveries can progress to clinical stages.

Persistent Gaps in Diagnostics

The second report, Landscape analysis of commercially available and pipeline in vitro diagnostics for bacterial priority pathogens, highlights diagnostic gaps that are impeding effective AMR control. Diagnostics are essential to ensuring patients receive the right treatment, yet frontline facilities, especially in low- and middle-income countries, lack critical tools.

Key shortcomings include:

• No multiplex diagnostic platforms suitable for intermediate-level laboratories to identify bloodstream infections directly from blood samples without culture.

• Limited access to biomarker tests such as C-reactive protein and procalcitonin, which can help distinguish bacterial from viral infections.

• A lack of simple, point-of-care diagnostics for use in primary and secondary healthcare settings.

These diagnostic gaps mean that in many low-resource environments, clinicians continue to rely on empirical treatment – prescribing antibiotics without precise diagnosis – which drives further resistance.

WHO stresses the urgent need for affordable, robust, and easy-to-use diagnostics, including sample-in/result-out systems compatible with a range of specimen types such as blood, urine, stool, and respiratory samples.

The Call for Action

“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.

Dr Nakatani emphasized that without increased investment in R&D, alongside strategies to ensure equitable access, the world risks losing ground in the fight against AMR.

The Way Forward

WHO is urging governments, investors, and the private sector to take coordinated action across the antibacterial and diagnostic innovation ecosystems, focusing on:

• Expanding drug discovery and development of both traditional and non-traditional agents

• Strengthening diagnostic platforms, particularly for resource-limited settings

• Ensuring equitable access to new and existing products

• Supporting small and medium-sized enterprises (SMEs) that currently drive most antibacterial and diagnostic innovation

• Developing novel funding models to stabilize and scale promising pipelines

Global Stakes

The reports serve as a reminder that AMR is one of the greatest health threats of the 21st century. Without urgent global cooperation, resistant infections could make routine surgeries, childbirth, and cancer treatments far riskier, while threatening decades of progress in modern medicine.

The WHO’s latest analysis reinforces that innovation alone is not enough—systemic support, investment, and equitable distribution are critical to ensuring life-saving treatments and diagnostics reach the people who need them most.