GSK has the largest pipeline for new antimicrobial medicines and vaccines
The pipeline has grown modestly, with seven out of eight companies remaining engaged.
As drug resistance rates rise, medicines become less effective, increasing the need for new ones that can replace them. Yet few new antimicrobial medicines have reached the market in recent decades, and the collective pipeline remains small.
The World Health Organisation (WHO) and US Centers for Disease Control and Prevention (CDC) have identified drug-resistant bacteria and fungi that pose the greatest threat to human health.
These include the superbug C. difficile, and carbapenem-resistant Enterobacteriaceae, and comprise the priority targets for researchers working in antibacterial and antifungal R&D. The 2021 AMR Benchmark examines the R&D projects that target these pathogens in the pipelines of eight large research-based pharmaceutical companies.
The aim is to capture how these companies are supporting global efforts to replenish and protect the antimicrobial pipeline.
Sustained involvement in antimicrobial R&D from seven out of the eight companies
Collectively, the companies evaluated have 92 active medicine and vaccine projects that target infections caused by priority bacteria and fungi. Almost a third of projects target M. tuberculosis, which accounts for the bulk of drug-resistant infections worldwide.
A further third target gram-negative bacteria, mainly Enterobacteriaceae. The majority of projects aim to develop new medicines (62 out of 92). Novartis is the only company evaluated that is not currently active in R&D targeting priority pathogens.
The remaining seven companies have sustained their involvement in antimicrobial R&D. Several companies have expanded their pipelines since the 2020 Benchmark report was published. Pfizer and GSK stand out for expanding their pipelines by five and four projects, respectively.
GSK leads in R&D, with 31 R&D projects, about half of them vaccines, and including two novel medicine candidates in clinical development. Eleven of its projects target pathogens that WHO and CDC place in the highest risk categories due to AMR.
Which companies does the 2021 Benchmark examine in R&D?
The 2021 Antimicrobial Resistance Benchmark examines the antibacterial and antifungal pipelines of eight large research-based pharmaceutical companies. By volume and value of sales, these are the largest players in the global market for antibacterial medicines that are active in innovative R&D today.
The Benchmark compares the size and quality of their R&D pipelines. It also looks at the steps these companies are taking to ensure new medicines can be made accessible swiftly yet responsibly for people living in low and middle-income countries (LMICs), where rates of resistance are highest.
As antimicrobials underpin treatment regimes in many areas of health, these companies have both a business interest in, and a public health responsibility toward, antimicrobial R&D. Furthermore, they have the scale, resources and expertise to support antimicrobial R&D in other ways, for example by partnering with or acquiring smaller companies to help advance their candidates.
Most antibacterial and antifungal R&D is currently being carried out by small and medium-sized enterprises: 75% of the antibacterial and antifungal R&D pipeline targeting priority pathogens is being developed by such companies.
Yet these companies generally lack the financing and other resources, such as regulatory expertise, to commercialise new products. While partnerships with larger companies can help secure the resources they need, several small drugmakers are turning to local companies based in emerging economies, mainly China, to reach global markets.
Which are the pathogens in scope?
The Benchmark focuses on R&D projects that target the priority bacteria and fungi identified by WHO and the CDC as being of particular concern due to drug resistance, for which there is an urgent global need for new treatments.***
There are three levels of prioritisation in the WHO priority list: critical, high, and medium, and four levels of threat in the CDC list: urgent, serious, concerning and watch. Six of the pathogens fall into one of these categories, including Candida auris, one of only two fungal pathogens on either list. Many strains of C. auris are proving resistant to all three existing classes of antifungal medicines.
Antibacterial and antifungal medicines and vaccines are crucial to effective infection prevention and control programmes. Furthermore, antimicrobial medicines also make other procedures and treatments safer, such as surgery, cancer therapy and immunesuppresant treatments.
WHO and the CDC have each published lists of bacterial and fungal pathogens that they view as posing the greatest risk to human health due to resistance.
Large research-based pharmaceutical companies have the resources, capacities, and expertise to ramp up antibacterial and antifungal R&D considerably, and to support development by smaller R&D-focused enterprises.
*Acinetobacter baumanii is the species designated as a critical/urgent priority.
** Candida auris is the species designated as a critical/urgent priority.
***I.e., those bacteria and fungi that were identified and prioritised by the WHO in its 2017 Global Priority List of AntibioticResistant Bacteria, and the CDC’s 2019 Antibiotic Resistance Threats report. See Appendix V.
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2. WHO. Global Priority List of Antibiotic Resistant Bacteria to Guide Research, Discovery, and Development of New Antibiotics.; 2017. doi:10.1590/S0100-15742013000100018
3. Centers for Disease Control U. Antibiotic Resistance Threats in the United States, 2019.; 2019. www.cdc.gov/DrugResistance/Biggest-Threats. html. Accessed November 20, 2019.