Report warns of 'worryingly thin' antimicrobial treatments pipeline

Amsterdam-based NGO Access To Medicine Foundation (AMF) has published the fourth edition of its Antimicrobial Resistance Benchmark report. Chief Executive Officer, Jayasree K. Iyer, says that there are some positive signs with recent regulatory approvals for three antibiotics with innovative characteristics and seven promising products in late-stage development, but that overall the pipeline remains “worryingly thin” and far from picking up pace “industry investment has lost momentum.”

Smaller firms filling innovation gap

The report covers 25 companies, including large and - for the first time - small companies, and ten generic manufacturers. It focuses on three main areas: R&D, responsible manufacturing and appropriate access and stewardship.

The authors estimate that the number of projects from large research-based pharmaceutical companies has declined by 35% between 2021 and 2026. Iyer says that smaller biotech firms have stepped in to fill some gaps, but they have limited access to capital and lack the global reach of larger companies.

Availability in lower income countries 'woefully inadequate'

A concern is that people in low- and middle-income countries are particularly badly hit, as they often have limited access to antimicrobials in general and cannot access newer ones. The report singles out Otsuka and Innoviva for product plans that explicitly address access issues, including affordability, availability, and supply. Iyer says that availability is “woefully inadequate” in LMICs, especially when it comes to products for children.

Among the large companies, GSK is the lead performer, with Shionogi making the greatest progress over the last year. Aurobindo is the top performer among the generic companies, the authors noting that it is one of only six generic producers to provide a detailed methodology for calculating patient reach for specific antimicrobial products in LMICs. However, generic companies have also lost momentum.

By 2050, it is estimated that direct and indirect deaths could rise to nearly two million and more than eight million, respectively. AMF calls for strengthening of the pipeline and of stewardship, but adds that what is needed now is more comprehensive action across the board, “it is up to all stakeholders to deliver”.

Commercial incentives

The report acknowledges that governments in high-income countries have been trying to introduce commercial incentives to develop new drugs. The UK adopted a Netflix-style subscription model in 2024 that pays fixed annual fees to pharmaceutical companies for access to certain new antimicrobials, encouraging development, while decoupling revenue from sales.

The recently agreed EU Pharma Package has chosen to go with a ‘transferable exclusivity voucher’ (TEV), which allows a marketing authorisation holder to add a year of data protection for a medicine, or to transfer it to another company, its value has been capped at gross sales of more than €490 million in the four preceding years to limit potential costs on healthcare systems.

MEP Tiemo Wölken (S&D, Germany) said after the negotiation that he wasn’t wholly in favour of the voucher scheme, preferring a subscription model, but added that MEPs had ensured that TEV would not be misused and that the possibility of a subscription remained.

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Without stronger incentives, broader access measures and coordinated global action, efforts to contain antimicrobial resistance risk falling far behind a rapidly growing public health threat.