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

• February 2023, Immunexpress commercialized its SeptiCyte Rapid test in the U.S., which can quickly diagnose sepsis in patients within an hour. The point-of-care test can help clinicians identify patients at an earlier stage, leading to timely intervention and better outcomes.

• January 2023, Cytovale announced launch of its new IntelliSep sepsis diagnostics test. The new test is launched to address patients in emergency department suffering from sepsis.

• January 2023, PERSOWN Inc. launched SMASH-H, a real-time sepsis monitoring system with an aim to address increasing burden of sepsis.

The Global Sepsis Diagnostic Market is segmented by Product into Instruments, Assays and Reagents, and Other. Instruments include diagnostic devices such as blood culture systems, PCR machines, and automated analyzers, which are vital for detecting sepsis-causing pathogens and analyzing patient samples. These instruments are particularly used in hospital settings for real-time diagnosis. Assays and Reagents are essential for conducting tests and include diagnostic kits that identify specific biomarkers for sepsis. As more advanced diagnostic methods emerge, Other products, such as software solutions and diagnostic panels, are playing an increasingly significant role in improving the accuracy and efficiency of sepsis diagnostics, integrating technologies for quicker and more precise results.

The market is further segmented by Pathogen into Bacterial Sepsis, Fungal Sepsis, and Other. Bacterial Sepsis is the most common and severe form of sepsis, often requiring swift identification through blood cultures and molecular diagnostics. Bacterial pathogens such as E. coli and Staphylococcus aureus are commonly responsible for sepsis, driving the demand for efficient bacterial detection methods. Fungal Sepsis represents a growing concern, especially in immunocompromised patients, requiring specialized tests like fungal cultures and antigen-based assays. The Other category captures rarer causes of sepsis, including viral or parasitic infections, where emerging diagnostic technologies are continuously developed to address these less common pathogens, helping broaden the scope of detection for sepsis.

The Technology segment of the sepsis diagnostic market includes Molecular Diagnostics, Microbiology, Immunoassay, and Other. Molecular Diagnostics, utilizing PCR, NGS, and other molecular techniques, is gaining prominence for its speed and accuracy in pathogen identification, especially for bacterial and fungal pathogens. Microbiology, which involves traditional culture-based methods, is still widely used but tends to take longer. Immunoassay techniques, such as ELISA and antigen detection, offer rapid and cost-effective solutions, particularly for identifying inflammatory biomarkers like procalcitonin (PCT) and C-reactive protein (CRP). The Other technologies include biosensors and next-generation diagnostics that are contributing to the rapid advancement of sepsis testing. Additionally, the market is segmented by Method, including Conventional Diagnostics and Automated Diagnostics, where conventional methods are slowly being replaced by automated, high-throughput systems that provide quicker results with minimal human intervention. The End-Use market is primarily driven by Hospitals and Pathology Laboratories, where the majority of sepsis testing takes place, with hospitals leading the demand due to the urgent need for timely and accurate diagnosis in critical care settings.

Global Sepsis Diagnostic Segment Analysis

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.

The Global Sepsis Diagnostic Market is segmented by Product into Instruments, Assays and Reagents, and Other, each of which plays a crucial role in the early detection and diagnosis of sepsis. Instruments are essential tools in the diagnostic process, and they include various automated analyzers and diagnostic devices used in hospitals and clinical laboratories. These instruments allow for rapid and accurate analysis of biomarkers, blood cultures, and other diagnostic parameters that help detect sepsis. The advancement of diagnostic technology has led to more efficient and precise instruments, enabling healthcare professionals to identify sepsis early, which is vital for improving patient outcomes.

Assays and Reagents are another critical component of the sepsis diagnostic market. These products include the chemicals and biological substances used in diagnostic tests, such as polymerase chain reaction (PCR) assays, enzyme-linked immunosorbent assays (ELISA), and other tests designed to detect sepsis biomarkers. Assays are vital for confirming the presence of infection, identifying the causative pathogens, and assessing the severity of sepsis. The growing adoption of molecular diagnostics has driven the demand for innovative assays that can detect a wide range of pathogens and help healthcare providers determine the most effective treatment plans. Additionally, the increasing shift towards point-of-care testing is fostering the development of rapid assays for quicker sepsis diagnosis.

The Other segment includes various complementary diagnostic products and technologies used in sepsis detection. This may encompass software solutions, diagnostic kits, and novel technologies that assist in identifying the early signs of sepsis. As the demand for faster and more accurate diagnostics increases, the "Other" segment is expected to witness significant growth, particularly with advancements in digital health and AI-based solutions. These innovations are improving diagnostic accuracy, enabling clinicians to detect sepsis more quickly and manage treatment more effectively. Collectively, these segments highlight the comprehensive nature of the sepsis diagnostic market, which relies on a combination of instruments, reagents, assays, and emerging technologies to enhance diagnostic capabilities and improve clinical outcomes for patients with sepsis.

Global Sepsis Diagnostic Market, Segmentation by Pathogen

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

The Global Sepsis Diagnostic Market is segmented by Pathogen into Bacterial Sepsis, Fungal Sepsis, and Other, as these pathogens require different diagnostic approaches for accurate detection and effective treatment. Bacterial Sepsis is the most common and critical type of sepsis, typically caused by bacteria such as Escherichia coli, Staphylococcus aureus, and Streptococcus pneumoniae. Diagnostic tests targeting bacterial pathogens often involve blood cultures, PCR assays, and antigen detection methods. Given the prevalence of bacterial sepsis and its high mortality rate, this segment is the largest in the market. Advanced technologies like multiplex PCR and next-generation sequencing (NGS) are increasingly used to detect a wide range of bacterial pathogens quickly and accurately, driving growth in the diagnostic market.

Fungal Sepsis is another significant segment, although less common than bacterial sepsis, it presents unique challenges for diagnosis and treatment. Fungal infections, such as those caused by Candida species, are especially prevalent in immunocompromised patients, such as those undergoing chemotherapy or organ transplants. Diagnosing fungal sepsis requires specialized tests, including fungal cultures, antigen detection, and molecular assays. As the number of immunocompromised individuals grows, the demand for diagnostic tests specific to fungal pathogens is increasing. The development of rapid diagnostic tools for fungal infections is gaining momentum to improve early detection, as delays in treatment can result in high morbidity and mortality in these vulnerable populations.

The Other segment in the sepsis diagnostic market covers a range of less common but still clinically significant pathogens, such as viral sepsis or parasitic infections, which can also lead to sepsis. Although these pathogens are less frequent causes of sepsis, they require different diagnostic methods, including viral PCR assays, serology, and specific antigen detection. As research into non-bacterial causes of sepsis continues to evolve, this segment is expected to grow, driven by emerging diagnostic technologies that can identify a broader array of pathogens. Additionally, the increasing use of multi-pathogen diagnostic tests is contributing to growth in this segment, providing healthcare providers with comprehensive tools to detect a wide range of infectious agents that can lead to sepsis.

Global Sepsis Diagnostic Market, Segmentation by Technology

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

The Global Sepsis Diagnostic Market is segmented by Technology into Molecular Diagnostics, Microbiology, Immunoassay, and Other, each playing a vital role in the identification and diagnosis of sepsis caused by various pathogens. Molecular Diagnostics is a rapidly growing technology segment in the sepsis diagnostic market, leveraging techniques such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and other molecular assays. These methods enable the rapid and precise identification of pathogens and their genetic markers, offering a high degree of specificity and sensitivity. The use of molecular diagnostics is particularly valuable for detecting bacterial and fungal infections, as well as for identifying antibiotic resistance patterns, which is crucial for guiding appropriate treatment.

Microbiology remains a cornerstone of sepsis diagnostics, involving traditional culture-based methods, microscopy, and biochemical tests. This technology segment is foundational in identifying the specific pathogens causing sepsis, particularly bacterial infections. Blood cultures, for example, continue to be one of the most reliable methods for identifying the causative organism. Although microbiological methods take longer compared to molecular diagnostics, they remain essential due to their ability to provide detailed information about pathogen characteristics, such as antibiotic susceptibility. In some cases, microbiology is combined with other technologies, such as molecular techniques, to expedite the diagnosis process while still providing comprehensive data on the pathogen.

The Immunoassay segment includes diagnostic tests that detect antibodies, antigens, or other biomarkers associated with sepsis. Techniques like enzyme-linked immunosorbent assays (ELISA), lateral flow immunoassays, and immunofluorescence assays are widely used for sepsis diagnosis. Immunoassays are valuable for detecting specific proteins or markers such as procalcitonin (PCT) or C-reactive protein (CRP), which are elevated in response to bacterial infections and inflammation. This technology provides a quicker, more cost-effective option compared to microbiological culture methods, making it particularly useful in emergency settings and for point-of-care diagnostics. The growing adoption of immunoassays is expected to continue due to their convenience, ease of use, and ability to provide rapid results. The Other segment includes emerging technologies such as biosensors and digital health solutions, which are being developed to further enhance the speed, accuracy, and accessibility of sepsis diagnostics.

Global Sepsis Diagnostic Market, Segmentation by Method

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

The global sepsis diagnostic market is segmented by method into several categories, each offering distinct advantages and applications in diagnosing this critical condition. One of the primary methods is biomarkers-based diagnostics, which involves the identification and measurement of specific biomolecules indicative of sepsis, such as procalcitonin (PCT) or C-reactive protein (CRP). These biomarkers provide valuable insights into the presence and severity of sepsis, aiding in timely intervention and treatment decisions.

Another significant method is molecular diagnostics, which utilizes techniques like polymerase chain reaction (PCR) or nucleic acid amplification to detect the genetic material of pathogens directly from patient samples. This approach offers rapid and accurate identification of causative agents, enabling targeted antimicrobial therapy and improving patient outcomes.

The market includes methods like blood culture diagnostics, which remain a gold standard for confirming sepsis by isolating and identifying infectious organisms from blood samples. Despite being time-consuming, advancements in automated blood culture systems have enhanced their efficiency and sensitivity, contributing to their continued relevance in sepsis diagnosis.

The segmentation of the global sepsis diagnostic market by method reflects the diverse approaches available to healthcare providers, each playing a crucial role in the early detection and management of sepsis, a condition with significant morbidity and mortality rates worldwide.

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 represent a significant portion of the market due to their role as primary care centers for patients with severe infections. Hospitals often have sophisticated diagnostic equipment and a wide range of testing capabilities, making them crucial for the early detection and management of sepsis cases.

Diagnostic laboratories also play a vital role in the sepsis diagnostic market, offering specialized testing services to healthcare providers. These laboratories employ advanced techniques such as blood culture analysis, polymerase chain reaction (PCR), and immunoassays to accurately diagnose sepsis and identify the causative pathogens.

Clinics, including both outpatient clinics and urgent care centers, are another key segment of the sepsis diagnostic market. These facilities provide rapid diagnostic testing for patients with suspected sepsis, enabling timely intervention and appropriate treatment. Point-of-care testing devices are particularly valuable in clinic settings, allowing for quick turnaround times and on-the-spot decision-making by healthcare providers.

The segmentation by end-use reflects the diverse settings in which sepsis diagnostics are performed, highlighting the importance of accessibility, efficiency, and accuracy in the detection and management of this life-threatening condition.

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 and 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 stands out as a prominent region in this market, owing to its advanced healthcare infrastructure, significant investments in research and development, and the presence of key market players. The region's proactive approach to healthcare, coupled with favorable reimbursement policies, fuels the adoption of advanced diagnostic technologies for sepsis detection. Moreover, increasing awareness among healthcare professionals and patients about the importance of early sepsis diagnosis further boosts market growth in North America.

In Europe, stringent regulatory frameworks and robust healthcare systems contribute to the expansion of the sepsis diagnostic market. Countries like Germany, the UK, and France are at the forefront of adopting innovative diagnostic solutions to address the growing burden of sepsis. The presence of leading diagnostic companies, coupled with increasing healthcare expenditure, drives market growth in the region. Additionally, collaborative efforts between government bodies, research institutions, and industry players facilitate the development of novel diagnostic tools for sepsis management.

Asia Pacific emerges as a rapidly growing market for sepsis diagnostics, fueled by factors such as increasing healthcare expenditure, rising prevalence of sepsis, and improving healthcare infrastructure. Countries like China, India, and Japan are witnessing a surge in demand for advanced diagnostic technologies to tackle infectious diseases like sepsis. Furthermore, initiatives aimed at raising awareness about sepsis and improving access to healthcare services contribute to market expansion in the region. As a result, both domestic and international companies are strategically investing in the Asia Pacific market to capitalize on emerging opportunities and address unmet medical needs related to sepsis diagnosis.

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