Sepsis Diagnostics: Global Markets

Executive Summary

Sepsis is a life-threatening condition marked by severe organ dysfunction. According to the World Health Organization’s (WHO) global report on the Epidemiology and Burden of Sepsis, there were 49 million cases and 11 million sepsis-related deaths in 2017, accounting for nearly 20% of all annual global deaths. Sepsis is considered as the common pathway to death for several diseases, including infectious diseases. In the recent report on sepsis, the WHO observed that even non-communicable or chronic diseases and injuries can also lead to sepsis. Studies indicate that the incidence of sepsis is increasing, but the mortality rate is decreasing. The burden of the disease, however, is very high in low-and middle income countries with poor healthcare infrastructures. Elderly patients, neonates and immunocompromised patients are at high risk of sepsis.

Sepsis is also associated with high economic burden and is the most expensive condition for hospitalised patients. For this reason, theWHO and World Health Assembly (WHA) have adopted a resolution in 2017 to improve, prevent, diagnose and manage sepsis.

There is no specific laboratory test to diagnose sepsis. The current diagnosis is based on various technologies, including microbiological tests, molecular diagnostics and biomarkers. Microbiological tests are the most preferred method. Despite advances in molecular diagnostic methods, blood culture is considered the gold standard for the diagnosis of sepsis. Molecular techniques have been limited due to high cost and the need for a skilled workforce. Microbial identification is restricted to the specified panels used in the technique. The blood culture method has both advantages and limitations. Blood cultures are time-consuming and may result in false negatives. It is for this reason that there is
high need for a rapid and accurate diagnostic method. Thus, there is scope for point-of-care tests that would be helpful in bedside sepsis diagnosis. Rapid diagnosis and early treatment lead to better patient outcomes, with survival rates are as high as 80%. Delay in diagnosis also leads to increased risk of antimicrobial resistance, as patients with sepsis are initially started with antimicrobials. It is based on the culture results that physicians start with targeted antimicrobials and look into escalation or de-escalation of the ongoing antimicrobial therapy.

Thus, increasing prevalence, awareness and various government initiatives will lead to growth in the sepsis diagnostic market. The market has also witnessed technological advancements with novel instruments that use whole blood for detection and do not rely on positive blood cultures. Research is also focused on studying the benefit of biomarker combinations, as each biomarker represents a different aspect of sepsis and would help in early detection. Research is focused on microfluidics, machine learning and artificial intelligence tools for rapid diagnosis.

Major players in the market include BioMerieux, Becton, Dickinson and Company, DanaherCorporation, Thermo Fisher Scientific, T2 Biosystems, Luminex, Roche Diagnostics, BrukerCorporation, Abbott Laboratories and Immunexpress.

In this report, the market is segmented based on technology, product, method, test, pathogen, end user and region. The North American market currently holds the highest market share, followed by Europe.

Companies Mentioned

• Abbott Laboratories
• Axis-Shield Diagnostics Ltd.
• Becton, Dickinson & Company
• Biomerieux
• Bruker Corp.
• Danaher
• Ekf Diagnostics Holdings plc
• Immunexpress
• Luminex Corp.
• Qiagen Nv
• Roche Diagnostics Corp.
• Seegene
• Siemens Healthineers AG
• T2 Biosystems
• Thermo Fisher Scientific Inc.