Sepsis Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (Molecular Diagnostics, Microbiology, Immunoassay, and Other Technologies), By Product (Instruments, Assays and Reagents, and Other Products), By Diagnostic Method (Conventional Diagnostics and Automated Diagnostics), By Pathogen (Bacterial Sepsis, Fungal Sepsis, and Other Pathogens), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 657.19 Million
CAGR (2026-2031)	8.19%
Fastest Growing Segment	Bacterial Sepsis
Largest Market	North America
Market Size (2031)	USD 1053.93 Million

Market Overview

The Global Sepsis Diagnostics Market is projected to grow from USD 657.19 Million in 2025 to USD 1053.93 Million by 2031 at a 8.19% CAGR. Sepsis diagnostics consist of the laboratory assays and platforms utilized to detect biomarkers and pathogens indicative of sepsis. The primary drivers supporting market growth include the increasing prevalence of infections acquired in healthcare settings and the expanding global geriatric population. Furthermore the critical necessity for rapid diagnostic results to lower mortality rates accelerates the demand for efficient testing solutions. According to Sepsis Alliance, in 2025, sepsis accounted for an estimated $62 billion in annual hospitalization costs within the United States.

A significant challenge impeding market expansion is the high capital expenditure required for automated diagnostic systems. This financial barrier restricts the adoption of advanced testing capabilities in developing regions and smaller healthcare facilities with limited operational budgets. Consequently the lack of adequate reimbursement frameworks for new molecular technologies further complicates market penetration and hinders the widespread implementation of these diagnostic tools.

Key Market Drivers

Technological advancements in rapid molecular diagnostics are revolutionizing the Global Sepsis Diagnostics Market by addressing the critical need for speed and accuracy in clinical decision-making. Conventional blood cultures often require days to yield results, whereas emerging host-response and molecular platforms can now provide actionable insights in under an hour. This shift towards precision medicine is exemplified by recent regulatory milestones that validate the clinical utility of these next-generation tools. According to Inflammatix, January 2025, in the 'Inflammatix Receives FDA Clearance for First-in-Class TriVerity Test' announcement, the company received FDA marketing authorization for its TriVerity Test System, a novel molecular diagnostic that measures the expression of 29 genes to rapidly evaluate infection and sepsis risk. Such innovations enable clinicians to distinguish between bacterial and viral infections more effectively, thereby reducing inappropriate antibiotic use and improving patient outcomes in critical care settings.

The rising incidence of sepsis and hospital-acquired infections acts as a primary catalyst for market expansion, necessitating robust diagnostic protocols globally. The prevalence of sepsis has surged due to an aging population and the increasing complexity of medical interventions, creating a sustained demand for early detection capabilities to mitigate mortality. According to the Global Sepsis Alliance, October 2025, in the 'New Global Estimates from The Lancet' report, updated data indicates that there were an estimated 21.4 million sepsis-related deaths globally in a single year, underscoring the escalating burden of this condition. This growing health crisis has triggered extensive public health efforts to improve recognition and management, directly influencing market adoption. According to Sepsis Alliance, in September 2025, awareness of the term 'sepsis' among United States adults reached a record high of 75%, significantly driving the prioritization of diagnostic procurement in healthcare facilities.

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Key Market Challenges

The substantial capital investment required for automated sepsis diagnostic systems presents a formidable barrier to market growth. These advanced platforms necessitate significant upfront costs for instrumentation, alongside ongoing expenses for maintenance and specialized reagents. Consequently, smaller healthcare facilities and community hospitals with restricted operational budgets often cannot justify the procurement of such expensive technology. This financial threshold effectively limits the adoption of high-throughput diagnostic tools to large, well-funded medical centers, thereby narrowing the addressable market for manufacturers.

This economic constraint is particularly acute in developing regions where the clinical need is highest but financial resources are scarce. The disparity between the high cost of advanced diagnostics and the available healthcare infrastructure in emerging economies creates a significant impediment to widespread implementation. According to the Global Sepsis Alliance, in 2025, approximately 85% of global sepsis cases occurred in low- and middle-income countries, where health system constraints and limited diagnostic capacity continue to hinder effective patient care. This disconnect between the geographical concentration of disease burden and the affordability of automated testing solutions restricts market expansion in regions that offer significant volume-based growth potential.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning for Early Prediction is shifting sepsis management from reactive treatment to predictive risk stratification. Advanced algorithmic models now analyze electronic health records in real-time to identify subtle physiological patterns hours before clinical deterioration, offering a significant advantage over traditional scoring systems that rely on late-stage vital signs. This capability to preemptively flag high-risk patients allows for earlier intervention bundles, directly addressing the time-sensitive nature of the condition. According to the Association for Diagnostics & Laboratory Medicine, May 2025, in the 'The emergence of AI as a powerful addition to the sepsis toolbox' report, the implementation of a deep learning prediction tool was associated with a 17% relative decrease in in-hospital sepsis mortality, validating the efficacy of these computational solutions.

Miniaturization of Diagnostic Devices Using Microfluidic Technology enables the rapid assessment of host immune responses directly at the point of care. By leveraging micro-channels to measure the biophysical deformation of white blood cells, these platforms provide objective data on immune dysregulation in minutes, effectively bypassing the prolonged wait times associated with culture-based methods. This approach facilitates immediate, precision-guided triage, ensuring that antibiotics are administered effectively while preventing the progression of septic shock. According to Infectious Disease Special Edition, December 2025, in the 'IntelliSep rapid sepsis diagnostic test' article, patients with suspected infection evaluated using this microfluidic technology had a 42% lower mortality rate compared to those receiving standard care.

Segmental Insights

The bacterial sepsis segment is anticipated to register the fastest growth within the Global Sepsis Diagnostics Market, driven by the high prevalence of hospital-acquired infections. Bacteria remain the primary cause of sepsis globally, with pathogens such as Staphylococcus aureus frequently identified in intensive care units. This segment is expanding as healthcare providers prioritize rapid detection to mitigate the risks of antimicrobial resistance and ensure appropriate therapeutic intervention. Furthermore, the focus of institutions like the Centers for Disease Control and Prevention on reducing healthcare-associated infections supports the increasing adoption of diagnostic solutions tailored for bacterial identification.

Regional Insights

North America maintains a leading position in the global sepsis diagnostics market, driven by a well-established healthcare infrastructure and substantial investments in medical research. This dominance is primarily supported by the strong presence of key industry players and favorable reimbursement policies that encourage the adoption of rapid testing methods. Furthermore, the region benefits from a supportive regulatory environment, where agencies like the U.S. Food and Drug Administration facilitate the approval of diagnostic devices. Collaborative efforts involving institutions such as the Centers for Disease Control and Prevention also prioritize effective sepsis management, reinforcing the region's market stability.

Recent Developments

• In January 2025, Inflammatix announced that it received marketing authorization from the U.S. Food and Drug Administration (FDA) for its TriVerity Test System. The first-in-class molecular diagnostic test was designed to assist in the evaluation of patients with suspected acute infection or sepsis by measuring the expression of 29 immune response genes. The system provided scores indicating the likelihood of bacterial or viral infections and the risk of severe illness, enabling clinicians to make more informed decisions regarding patient management. The clearance was supported by data from the SEPSIS-SHIELD study, which validated the test's accuracy across diverse patient populations.
• In November 2024, T2 Biosystems entered into a multi-year exclusive distribution agreement with Cardinal Health to expand access to its direct-from-blood sepsis diagnostics in the U.S. market. Under the terms of the collaboration, Cardinal Health agreed to sell the company’s FDA-cleared products, including the T2Dx Instrument and associated panels for detecting sepsis-causing bacterial and fungal pathogens. The partnership aimed to leverage Cardinal Health’s extensive commercial infrastructure and capital equipment specialists to increase the adoption of culture-independent diagnostic technologies in hospitals, thereby facilitating faster targeted antimicrobial therapy for patients suffering from bloodstream infections.
• In May 2024, Cytovale announced the publication of study results in Academic Emergency Medicine demonstrating the performance of its IntelliSep test. The research, which analyzed data from over 1,000 patients in U.S. emergency departments, showed that the test achieved a negative predictive value of 97.5%, effectively aiding in the rapid rule-out of sepsis. The IntelliSep technology, which assesses the immune system's response by analyzing the mechanical properties of white blood cells, provided results in approximately eight minutes. These findings highlighted the test's capability to support rapid triage and clinical decision-making, allowing physicians to confidently identify patients at low risk.
• In April 2024, Prenosis Inc. announced that the U.S. Food and Drug Administration (FDA) granted De Novo marketing authorization for its Sepsis ImmunoScore artificial intelligence software. This diagnostic tool integrates 22 diverse parameters, including biomarkers and clinical data from electronic health records, to assess a patient's risk of sepsis and its progression within 24 hours. The authorization marked the first time an AI-driven diagnostic and predictive solution for sepsis received such regulatory approval. The tool classifies patients into four discrete risk categories to predict deterioration, mortality, and care escalation needs, aiding clinicians in early diagnosis and treatment decisions.

Key Market Players

• Abbott Laboratories
• DiaSorin SpA
• Becton, Dickinson, and Company
• BioMerieux Inc.
• F. Hoffmann-La Roche AG
• Danaher Corporation
• Thermo Fisher Scientific Inc
• Siemens Healthineers AG
• Seegene, Inc.
• Roche Diagnostics Corporation

By Technology	By Product	By Diagnostic Method	By Pathogen	By Region
Molecular Diagnostics Microbiology Immunoassay Other Technologies	Instruments Assays and Reagents Other Products	Conventional Diagnostics Automated Diagnostics	Bacterial Sepsis Fungal Sepsis Other Pathogens	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Sepsis Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Sepsis Diagnostics Market, By Technology:

• Molecular Diagnostics
• Microbiology
• Immunoassay
• Other Technologies

• Sepsis Diagnostics Market, By Product:

• Instruments
• Assays and Reagents
• Other Products

• Sepsis Diagnostics Market, By Diagnostic Method:

• Conventional Diagnostics
• Automated Diagnostics

• Sepsis Diagnostics Market, By Pathogen:

• Bacterial Sepsis
• Fungal Sepsis
• Other Pathogens

• Sepsis Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE