T he World Health Organization (WHO) has identi f ied antimicrobial resistance (AMR) as one of the biggest global health threats facing humanity. As bacteria evolve and become resistant to existing antibiotics, the challenge of AMR is growing. Some estimates suggest that without reversing this trend, AMR could lead to 10 million deaths each year by 2050, a significant disruption to common surgical and medical interventions and a further 24 million people driven into extreme poverty.
AMR is also estimated to lead to a global annual GDP loss of between 1.1% and 3.8% by 2050, with an annual shortfall of up to $3.
4 trillion by 2030. In 2019 , there were 15,700 deaths attributable to AMR and 56,700 deaths associated with AMR in the Philippines. Our country has the 128 th highest age-standardized mortality rate per 100,000 population associated with AMR across 204 countries.
To avert the threat of AMR, we need to ensure that we have a continuous pipeline that delivers new, innovative antibiotics to treat patients with infections that have become resistant to existing antibiotics. These new antibiotics should be used carefully and should be available to patients wherever in the world they live. Unfortunately, the current antibiotic pipeline is not sufficient to protect against increasing AMR, according to a new report by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Entitled “From resistance to resilience: What could the future antibiotic pipeline look like?,” the report reviews the antibiotic pipeline data against bacterial pathogens identified by the WHO and other public health agencies as of the greatest concern, and presents modelling data on the future of the pipeline. The findings of the report are worrying. There have been only 10 new antibiotics or combinations approved by stringent regulatory authorities between 2017 and 2023, only two of which are defined as innovative by the WHO.
None are considered to constitute a new class of antibiotics. There is currently just one antibiotic candidate in Phase III clinical trials across the four bacterial pathogens defined as a critical priority by WHO. Just two of the seven high-priority pathogens have innovative candidate antibiotics in development, with five having three or fewer candidates at any stage of clinical development.
There is consensus from the WHO and many other experts that the pipeline is not sufficient to meet the demands of increasing resistance in the priority pathogens. Working with predictive health intelligence and data analytics experts from Airfinity, the IFPMA report presents new modelling that helps to build an understanding of how this pipeline might evolve over the next 10 years. Based on a number of key assumptions, two scenarios were developed.
Scenario one: no new incentives are introduced that could encourage investment into antibiotic R&D. Without additional investment, the pipeline is expected to continue to gradually decline. This is particularly apparent from 2026 onwards when existing funding for late-stage (Phase II and III) studies is expected to decline.
Under this scenario, in 10 years’ time, the pipeline is expected to contain 26 treatments, of which only six are in the late stages of development. Scenario two: effective pull incentives are successfully introduced in 2025. The introduction of effective pull incentives will attract significant additional investment, primarily from private investors, leading to a substantial impact on the future antibiotic pipeline.
In this scenario, in 10 years’ time, it is expected there would be 19 new antibiotics approved and a pipeline consisting of 72 treatments in different stages of clinical research. The report also looks at the potential population health benefits from a more robust pipeline of antibiotics, suggesting a significant reduction in the burden of resistant infections across four WHO critical priority pathogens. Without new incentives and with no new antibiotics to treat these resistant infections, the burden in high-income countries (HICs) would be expected to increase by about 35% on average in 10 years compared to today.
However, if effective incentives are introduced, and new antibiotics against these pathogens are approved as a result, these are expected to help deliver a reduction in the disability-adjusted life years (DALY) burden of more than 50% compared to no new antibiotics. One DALY represents the loss of the equivalent of one year of full health. While this impact was only modelled for HICs due to data and model limitations, a similar benefit may be expected globally.
The report notes the broad consensus to strengthen the pipeline of new antibiotics in order to manage resistance as it continues to worsen. But despite repeated warnings, the bankruptcies of specialized antibiotic biotech companies, the exodus of expert antibiotic researchers to other areas, and the recognition that the pipeline is insufficient, action remains limited. “This analysis demonstrates why urgent action is needed if we are going to reinforce our pipeline of antibiotics and protect the world from rising drug resistance,’’ said James Anderson, Executive Director, Global Health, IFPMA.
Indeed, robust pull incentives are crucial in encouraging the research and development investment needed, and for everyone to act boldly against AMR. Teodoro B. Padilla is the executive director of Pharmaceutical and Healthcare Association of the Philippines which represents the biopharmaceutical medicines and vaccines industry in the country.
Its members are in the forefront of research and development efforts for COVID-19 and other diseases that affect Filipinos..
