World Sepsis Day, which takes place annually on 13 September, aims to raise awareness and understanding of this life-threatening condition. This year’s theme focuses on media engagement and public awareness by highlighting key messages on the global burden of sepsis, and policy and advocacy actions that can be undertaken by policymakers, healthcare leaders and advocates to help save millions of lives.
World Sepsis Day 2025 also marks one year since the launch of the 2030 Global Agenda for Sepsis by the Global Sepsis Alliance. This strategy aims to reduce the global incidence of sepsis by at least 25% and improve survival rates by more than 20% by 2030, compared to 2017–2020 baseline levels. The launch of the first global strategy to avert millions of preventable deaths and disabilities from sepsis was a major accomplishment for the field. However, sepsis remains significantly underprioritised and greater political investment will be required in the coming years to meet these targets.
Sepsis refers to a hyperactive immune response to a localised infection that leads to tissue damage and organ dysfunction. It is a medical emergency and can lead to septic shock (a hypotensive state), multi-organ failure and death, especially if it is not recognised and treated early enough.
The global burden of sepsis is extremely high, with the condition a leading cause of death worldwide. Despite this, significant gaps remain in the awareness and understanding of sepsis, even among healthcare professionals. Many symptoms of sepsis, such as fever and confusion, are non-specific, which leads to diagnostic delays and contributes to the high mortality rate. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3), published in 2016, recommends the use of Sequential Organ Failure Assessment to diagnose a patient with sepsis. According to key opinion leaders (KOLs) interviewed by GlobalData, the more specific focus on organ dysfunction compared to the previous criteria (Sepsis-2) has improved diagnosis rates. However, KOLs acknowledge that there is still a need for further improvement.
According to GlobalData epidemiologists, there were 7.8 million diagnosed incident cases of sepsis and 2 million attributable deaths across the eight major markets (8MM: China, France, Germany, Italy, Japan, Spain, the UK and the US) in 2024, equating to a mortality rate of 26%. Among patients with septic shock, the mortality rate reached 49.7%, with 1.4 million diagnosed incident cases and 697,600 deaths across the 8MM in the same year.
There is a clear unmet need to improve understanding of sepsis so that more cases are recognised, diagnosed and treated earlier. However, there is also a strong unmet need for new therapeutics that can provide patients with more efficacious and targeted treatment options.
At present, sepsis treatment predominantly relies on generic antimicrobials alongside supportive therapies, such as fluids, vasopressors or immunomodulators. The Surviving Sepsis Campaign guidelines, which were revised in 2021, provide recommendations on the usage of these therapeutics. According to a GlobalData survey of 170 high-prescribing physicians conducted across the 8MM in 2025, the most commonly used antimicrobials are piperacillin/tazobactam, vancomycin and meropenem. But these types of drugs have efficacy limitations as they do not specifically target the underlying pathophysiological processes, which can vary across patient subsets.
According to GlobalData’s pipeline product database, there are 11 products in current late-stage development across the 8MM, many of which employ novel mechanisms of action or therapeutic approaches. For example, Adrenomed’s monoclonal antibody enibarcimab utilises a precision medicine approach. In the AdrenOSS-2 Phase II trial, two biomarkers — bio-ADM and DPP3 — were used to identify septic shock patients who were most likely to benefit from enibarcimab treatment. Enibarcimab was found to improve organ function and reduce 28-day mortality in targeted patient groups.
Historically, the sepsis clinical trial landscape has been characterised by a high failure rate for drug candidates, resulting in companies being reluctant to invest in sepsis therapeutics. Nonetheless, the degree of novelty in the current late-stage pipeline is promising. Continued research and development investment in innovative therapeutics should be an important area of focus to provide diverse patient groups with improved treatment options.