Sepsis causes 11 million deaths every year, while new biomarkers are paving the way for a more precise approach

Sunday, 13 September 2026, Madrid, Spain. – Sepsis remains one of the major global public health challenges. This medical emergency, caused by an extreme response of the body to an infection, can lead to organ dysfunction, multiple organ failure and death if it is not identified and treated quickly.

The global estimates used as a reference by the World Health Organization put its impact at 48.9 million cases and 11 million deaths related to sepsis, accounting for approximately 20% of all deaths worldwide. In Spain, around 50,000 people are affected each year and approximately 17,000 die. Its high mortality rate and the speed at which it can progress make time a critical factor in its management.

Despite advances, significant challenges remain in terms of early detection, the heterogeneity of the immune response, and the identification and stratification of patients at greatest risk of deterioration. Against this backdrop, biotechnology is opening up new possibilities for moving towards an earlier and more personalised approach through new diagnostic tools and biomarkers related to the immune response.

Earlier detection and a better understanding of each patient

One of the main challenges is identifying which patients are developing a dysregulated response to infection before irreversible organ damage occurs. For Dr Ricard Ferrer, Head of the Shock, Organ Dysfunction and Resuscitation Group at the Vall Hebron Institut de Recerca and Head of the Intensive Care Medicine Department at Vall d’Hebron Hospital Universitari, room for improvement lies in combining clinical assessment with more precise biomarkers and clinical decision-support tools.

This progress should also make it possible to recognise the differences between patients. “Sepsis management is clearly moving towards precision medicine,” says Ferrer, who points out that the future lies in biomarker panels providing complementary information on inflammation, immune response, organ damage and prognosis.

Early detection also has important implications for intensive care units and hospital resources. According to Dr Carlos García-Palenciano, Head of the Anaesthesia and Resuscitation Department at Hospital Virgen de la Arrixaca, approximately 30% of patients treated in an ICU have sepsis, and of these, between 30% and 46% die during their stay.

Currently, diagnosis is based on laboratory tests and clinical observations which, in many cases, become apparent when the condition has already progressed. “Early diagnosis facilitates early treatment and increases survival,” García-Palenciano stresses. Added to this is the consumption of resources associated with supporting organs damaged as a result of sepsis.

New biomarkers to advance precision medicine

Research is enabling a deeper understanding of the biological differences between patients. Dr. Gerardo Aguilar, Head of the Critical Care Unit of the Department of Anaesthesiology and Critical Care at Hospital Clínic Universitari de València, explains that transcriptomics, proteomics and immune cell analysis are making it possible to identify different endotypes associated with severity and prognosis.

In this context, biomarkers can help determine how each patient’s immune system is responding. “A static biomarker will probably not be enough. We need functional biomarkers and, whenever possible, serial measurements,” says Aguilar. The aim is to obtain information that can help identify the risk of deterioration earlier, monitor the immune response and, in the future, select treatments according to the predominant biological mechanism.

Viva In Vitro Diagnostics, an AseBio member, is working in this area on the development and clinical and translational validation of functional biomarkers related to NLRP3 inflammasome activation. Its VIVA-ELISA® technology is being evaluated in collaboration with different Spanish hospitals and research centres.

For Toni Vilaplana, CEO of Viva In Vitro Diagnostics, biotechnology can provide deeper insights into what is happening in each patient. “Precision medicine in sepsis will require biomarkers that not only indicate the presence of infection or inflammation, but also help stratify risk, identify biological profiles and support better clinical decisions,” he explains.

The challenge now is to translate these advances into clinical practice, turning scientific discoveries into robust, reproducible, scalable tools that are useful in real-world clinical settings. This process requires collaboration between hospitals, clinicians, researchers, regulatory experts and quality systems. For Viva In Vitro Diagnostics, sepsis is its first clinical indication for clinical and translational validation, with the aim of generating robust evidence and developing a technology that can eventually be integrated into clinical pathways in a way that is “useful, safe and sustainable.”