Global Sepsis Diagnostic Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In February 2023, Immunexpress launched its SeptiCyte Rapid test in the United States, a groundbreaking point-of-care diagnostic tool designed to detect sepsis in under an hour. This rapid testing solution enables healthcare providers to identify sepsis at an early stage, facilitating prompt clinical intervention. By significantly reducing the time to diagnosis, SeptiCyte Rapid supports improved patient outcomes and enhances decision-making in critical care settings.

• In January 2023, Cytovale announced the launch of its innovative IntelliSep sepsis diagnostic test, specifically developed to support early identification of sepsis in patients arriving at the emergency department. Designed to deliver rapid and reliable results, IntelliSep helps clinicians quickly assess sepsis risk, enabling faster treatment decisions and improving outcomes for critically ill patients.

• In January 2023, PERSOWN Inc. introduced SMASH-H, an advanced real-time sepsis monitoring system developed to combat the growing global burden of sepsis. This innovative platform is designed to provide continuous monitoring and early detection of sepsis, enabling faster clinical responses and improving patient outcomes in critical care environments.

In this report, the Global Sepsis Diagnostic Market has been segmented by Product, Pathogen, Technology, Method, End-Use, and Geography.

Global Sepsis Diagnostic Market, Segmentation by Product

The Global Sepsis Diagnostic Market has been segmented by Product into Instruments, Assays and Reagents, and Other.

Instruments: Essential Tools for Rapid Sepsis Detection
Instruments play a pivotal role in the global sepsis diagnostic market, contributing to around 35% of the overall share. These include advanced automated analyzers and diagnostic systems used extensively across hospitals and laboratories. They facilitate the accurate analysis of sepsis-related biomarkers and blood cultures, enabling early diagnosis. As technology evolves, modern instruments offer faster and more precise results, significantly improving clinical outcomes by allowing early intervention.

Assays and Reagents: Critical Components for Biomarker Testing
Accounting for nearly 45% of the market, assays and reagents are vital for detecting pathogens and assessing the severity of sepsis. These include ELISA, PCR assays, and various other diagnostic reagents used in molecular testing. Their ability to identify infections at the molecular level makes them indispensable in sepsis diagnostics. The shift towards molecular diagnostics and point-of-care testing has fueled demand for rapid, accurate, and multi-pathogen assays, supporting timely clinical decision-making.

Other Diagnostic Technologies: Digital and AI-Driven Advancements
Comprising approximately 20% of the sepsis diagnostics market, the “Other” segment includes a variety of supporting technologies such as software, digital platforms, and AI-based diagnostic tools. These innovations are gaining momentum due to their ability to analyze clinical data and assist in early sepsis detection. The integration of AI and machine learning into diagnostic workflows is transforming sepsis management, improving speed and accuracy. As the healthcare sector continues to digitize, this segment is anticipated to experience rapid growth.

Global Sepsis Diagnostic Market, Segmentation by Pathogen

The Global Sepsis Diagnostic Market has been segmented by Pathogen into Bacterial Sepsis, Fungal Sepsis, and Other

Bacterial Sepsis: The Leading Segment in Sepsis Diagnostics
Bacterial sepsis dominates the global sepsis diagnostic market, comprising approximately 70% of total cases. Common bacterial pathogens include E. coli, Staphylococcus aureus, and Streptococcus pneumoniae, all of which require precise diagnostic interventions. Technologies such as blood cultures, PCR assays, and antigen detection kits are widely utilized for identifying these infections. The increasing adoption of high-speed tools like multiplex PCR and next-generation sequencing (NGS) is enhancing the accuracy and efficiency of diagnostics, further strengthening this segment's market share.

Fungal Sepsis: A Growing Concern in High-Risk Patients
Representing about 20% of the market, fungal sepsis poses serious risks, especially to immunocompromised individuals, such as cancer patients or transplant recipients. Candida species are among the most common fungal culprits. Timely diagnosis relies on advanced tools, including fungal cultures, antigen tests, and molecular-based assays. As the global immunocompromised population increases, so does the demand for rapid and reliable fungal diagnostic solutions. The development of novel detection methods is helping to reduce the time-to-treatment and improve clinical outcomes in these vulnerable groups.

Other Pathogens: Emerging Focus on Non-Bacterial Sepsis
The remaining 10% of the sepsis diagnostic market addresses infections caused by less common but clinically significant pathogens such as viruses and parasites. These infections require unique diagnostic solutions, including viral PCR, serological testing, and specific antigen assays. Continued research into non-bacterial sepsis is spurring innovation in diagnostic technologies that can handle a broader spectrum of pathogens. The use of multi-pathogen detection platforms is accelerating in clinical settings, offering healthcare providers a more comprehensive approach to sepsis diagnosis.

Global Sepsis Diagnostic Market, Segmentation by Technology

The Global Sepsis Diagnostic Market has been segmented by Technology into Molecular Diagnostics, Microbiology, Immunoassay, and Other.

Molecular Diagnostics: Leading the Innovation Curve
Molecular diagnostics represents roughly 40% of the global sepsis diagnostic market and continues to grow rapidly. Technologies such as PCR and next-generation sequencing (NGS) offer high precision in detecting the genetic markers of sepsis-causing pathogens. These methods are especially useful in identifying bacterial and fungal infections, as well as antibiotic resistance genes. Their speed and accuracy make them vital for early intervention and personalized treatment planning in critical care scenarios.

Microbiology: Foundational but Time-Intensive
Accounting for about 30% of the market, microbiology remains a vital part of sepsis diagnosis. Techniques like blood cultures and biochemical testing are considered gold standards for identifying bacterial pathogens and determining their antibiotic susceptibility. Although the diagnostic process can take longer, microbiology provides in-depth data that complements faster molecular techniques. This synergy is essential for thorough and effective sepsis management.

Immunoassay: Rapid Biomarker-Based Testing
With approximately 25% market share, immunoassays play an essential role in sepsis diagnostics by targeting biomarkers linked to inflammation and infection. Tests such as ELISA, lateral flow assays, and immunofluorescence enable rapid detection of markers like procalcitonin (PCT) and C-reactive protein (CRP). Their cost-effectiveness, simplicity, and quick turnaround make them ideal for emergency care and point-of-care diagnostics.

Other Technologies: Emerging Digital and Biosensor Solutions
The remaining 5% of the market is attributed to novel and emerging technologies, including biosensors and digital diagnostic tools. These innovations are designed to offer faster, more user-friendly solutions for sepsis detection, especially in remote or under-resourced healthcare settings. As research in digital health continues, these technologies are expected to play a greater role in expanding diagnostic accessibility and improving clinical outcomes.

Global Sepsis Diagnostic Market, Segmentation by Method

The Global Sepsis Diagnostic Market has been segmented by Method into Conventional diagnostics, and Automated diagnostics.

Conventional Diagnostics: Reliable but Time-Consuming Methods
Conventional diagnostics continue to hold a significant share in the global sepsis diagnostic market, accounting for about 55% of total usage. These methods include traditional techniques like blood cultures, microscopy, and biochemical assays, which remain highly reliable for identifying sepsis-causing pathogens. However, the major drawback lies in their longer turnaround time, which can delay the initiation of targeted treatment. Despite their reliability, the slower pace of conventional diagnostics is pushing healthcare providers to explore faster, automated alternatives.

Automated Diagnostics: Rapid, Accurate, and Growing in Demand
Automated diagnostics currently represent around 45% of the market and are quickly gaining popularity due to their efficiency and speed. These include advanced platforms such as real-time PCR, automated culture systems, and point-of-care devices that can deliver rapid results. Their ability to provide high-throughput, error-free testing with minimal human intervention makes them highly suitable for emergency care and intensive care units. As the demand for immediate diagnostic information increases, automated methods are emerging as the preferred choice in modern clinical settings.

Market Trends Driving the Shift Toward Automation
The increasing emphasis on reducing sepsis-related mortality is fueling the transition from conventional to automated diagnostics. Hospitals and healthcare systems are adopting advanced technologies to ensure earlier intervention and better clinical outcomes. Additionally, the integration of automated diagnostics with digital health systems and AI-powered analytics is streamlining workflows and supporting real-time clinical decision-making, further strengthening the role of automation in sepsis diagnostics.

Global Sepsis Diagnostic Market, Segmentation by End-Use

The Global Sepsis Diagnostic Market has been segmented by End-Use into Hospitals and Pathology laboratories.

Hospitals: The Primary Drivers of Sepsis Diagnostic Demand
Hospitals contribute nearly 65% of the global sepsis diagnostic market, making them the dominant end-user segment. This is primarily due to their role in managing emergency and intensive care patients, where timely diagnosis is critical. Equipped with advanced diagnostic tools, hospitals can perform a wide range of tests—from blood cultures to molecular assays—to quickly identify pathogens. The rising prevalence of sepsis, especially in ICU settings, continues to drive the adoption of both conventional and automated diagnostic methods in hospitals worldwide.

Pathology Laboratories: Specialized and Supportive Diagnostic Centers
Pathology laboratories represent approximately 35% of the market and serve as essential support hubs for accurate and detailed sepsis diagnosis. These labs often process diagnostic samples from both hospitals and outpatient facilities, utilizing microbiology and molecular techniques to detect infectious agents. Their ability to provide confirmatory testing and handle large volumes of diagnostic data makes them vital players in the broader sepsis detection ecosystem. In regions with less access to hospital infrastructure, pathology labs often serve as the primary point for sepsis testing.

Collaborative Models Enhancing Diagnostic Efficiency
The increasing integration between hospitals and pathology labs is enhancing the efficiency and accuracy of sepsis diagnostics. Shared data systems, digital platforms, and centralized laboratory services are enabling faster communication and reduced turnaround times. As healthcare continues to evolve toward precision medicine and rapid-response diagnostics, both hospitals and pathology labs will remain crucial to delivering timely and effective sepsis care.

Global Sepsis Diagnostic Market, Segmentation by Geography

In this report, the Global Sepsis Diagnostic Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

Global Sepsis Diagnostic Market Share (%), by Geographical Region, 2024

The global sepsis diagnostic market is a dynamic landscape influenced by various geographical regions, each presenting unique challenges and opportunities.

North America
North America leads the global sepsis diagnostic market with around 38% share, driven by high healthcare expenditure, early adoption of diagnostic innovations, and elevated awareness of sepsis. The United States, in particular, is a major contributor due to its robust hospital networks and the presence of top-tier diagnostic companies. Government support for sepsis detection initiatives and continuous investment in R&D further reinforce the region's leadership in the market.

Europe
Europe accounts for nearly 28% of the market and continues to benefit from well-developed healthcare systems and regulatory support for diagnostic advancements. Key countries such as Germany, France, and the UK are actively incorporating molecular diagnostics and immunoassays into routine clinical workflows. The region's emphasis on reducing hospital-acquired infections has further strengthened the demand for rapid sepsis detection solutions.

Asia Pacific
Holding approximately 22% of the global market, Asia Pacific is the fastest-growing region due to rapid healthcare infrastructure development and increasing disease awareness. Countries like India, China, and Japan are heavily investing in healthcare technology and diagnostics to manage a growing population and rising infection rates. Government-led healthcare reforms and an expanding diagnostic ecosystem are paving the way for broader sepsis diagnostic access.

Middle East & Africa
With a 7% market share, the Middle East & Africa are in the early stages of diagnostic adoption. However, ongoing investments in healthcare modernization, particularly in Gulf countries and South Africa, are expected to improve diagnostic access and capabilities. Efforts to address infectious disease management and critical care enhancement are laying the groundwork for future market growth.

Latin America
Latin America contributes about 5% of the sepsis diagnostic market. While infrastructure challenges persist, the region is making progress through increased public-private investments in healthcare. Brazil and Mexico are showing improved diagnostic uptake, supported by growing awareness and the introduction of portable, point-of-care diagnostic solutions in underserved areas.

This report provides an in depth analysis of various factors that impact the dynamics of Global Sepsis Diagnostic Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Key players in Global Sepsis Diagnostic Market include:

• Abbott
• Axis-Shield Diagnostics
• Biomrieux
• Becton Dickinson
• Bruker
• Cytosorbents
• Danaher
• Immunexpress
• Luminex
• Roche

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis