Sepsis Diagnostic Market, By Product (Assay and Reagents, Blood Culture Media, and Instruments), By Pathogen (Fungal Sepsis and Bacterial Sepsis), By Method (Immunoassays, Flow Cytometry, Molecular Diagnosis, and Biomarker Diagnosis), By Diagnostic Method (Conventional and Automated), By End User (Hospital Laboratories, Diagnostic Laboratories, Academic and Research Laboratories) - Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2018-2026

Sepsis is life threatening complication caused due to the infection, which can result into organ failure, tissue damage, and ultimately lead to death if left untreated. If sepsis progresses to septic shock, it cause sudden drop in blood pressure and may leads to death of patient. Sepsis occurs due the infection in any part of the body. However the most common site of infections leading to the sepsis are lungs, abdomen, pelvis, and urinary tract.

Patients suffering from impaired immune system due to illness or drugs, cancer treatment with chemotherapy, splenectomy, sickle cell disease, and people who consume steroids and immunosuppressant drugs are prone to sepsis. The symptoms associated with sepsis includes high fever with temperature above 1010 F or temperature below 96.8 F, increased heart rate to 90 beats per minute, high breathing rate to around 20 breaths per minute, tissue swelling and confirmed infection. According to the Healthcare Cost and Utilization Project (HCUP) report submitted by Agency for Healthcare Research and Quality (AHRQ) in 2016, septicemia accounted for the leading cause of hospitalization in the U.S., owing to consuming more than US$ 24 billion each year.

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Increasing prevalence of sepsis is resulting into high demand for sepsis diagnostic devices in the market. According to the World Health Organization 2018 statistics, sepsis affected over 30 million people worldwide and more than 3 million newborns and 1.2 million children suffers from sepsis globally each year. According to the Sepsis Alliance report 2016, sepsis affects over 26 million people worldwide and more than 5 million children each year. According to the Centers for Disease Control and Prevention (CDC), more than 1.5 million people in the U.S. suffer from sepsis annually and around 2,50,000 Americans die each year due to sepsis.

The treatment for sepsis varies depending upon the site and cause of infections. Early symptoms of sepsis can be treated by visiting hospitals for diagnosis and treatment. However, severe sepsis and sepsis shock are medical emergencies, which need quick medical attention. The treatment includes rapid administration of antibiotic and intravenous fluid (IV fluid) to the patient detected with symptoms of sepsis, as the risk of death form sepsis increases by 7.6% with every hour from the time of treatment begins. Antibiotic treatment mainly includes broad spectrum antibiotic given by intravenous. The antibiotics used in the sepsis treatment includes vancomycin, piperacillin, tazobactam, cefepime, tobramycin, and aztreonam.

F.Hoffmann-La Roche in June 2016 receives the FDA clearance for its Procalcitonin (PCT) assay, which helps clinicians to effectively assist sepsis risk and manage sepsis patients. The assay provides the testing solution for people with severe sepsis or septic shock. Roche is the first company from U.S. to provide fully integrated solution for sepsis risk assessment and management.

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Singulex, Inc. an immunodiagnostic company engaged in developing single molecule counting (SMC) technology for clinical diagnosis and scientific research, in December 2016 signed a license and supply agreement with Thermo Fisher Scientific Inc. The agreement allows Singulex access to Thermo Fisher’s BRAHMS PCT biomarker, which is used to diagnose systemic bacterial infection and treatment of sepsis in Europe.

Recent advances in product development and rising product approval is expected to drive the market over the forecast period. For instance in May 2018, T2 Biosystems, a U.S. based Biotechnology Company providing in-vitro diagnostics, received U.S. Food and Drug Administration approval for its bacterial sepsis panel called T2Bacteria. It is a test, which helps to detects six of the most serious sepsis causing Gram-negative and Gram-positive bacterial species with results in 3-5 hours.

In February 2017 Immunexpress a technology based company provides solutions for sepsis diagnostics, received U.S. Food and Drug Administration approval for the SeptiCyte test as an aid in differentiating patients that have sepsis caused due to systemic inflammatory response syndrome (SIRS)

Moreover, key players in market are focusing on strategic collaboration in order to expand their product portfolio and increasing their market presence. For instance in 2018, Immunexpress a technology based company provides solutions for sepsis diagnostics, collaborated with Belgium-based Biocartis, an innovative molecular diagnostics company. This collaboration includes immunexpress would test the response of SeptiCyte host response sepsis by using the Biocartis Idylla point-of-care platform. Idylla is a fully integrated sample-to-answer platform that can produce test results in 1-2 hours.

Key players in the sepsis diagnostic market:

Some of the key players operating in the sepsis diagnostic market includes BioMerieux SA, Cepheid, Thermo Fisher Scientific Inc., T2 Biosystems, Inc., Abbott Laboratories, Inc., F. Hoffmann-La Roche Ltd, Luminex Corporation, Becton, Dickinson and Company, Bruker Corporation, and Beckman Coulter, Inc.

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