Sepsis Diagnostics Market

Global Sepsis Diagnostics Market:

The global sepsis diagnostics market size reached USD 744.0 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 1,520.3 Million by 2033, exhibiting a growth rate (CAGR) of 7.6% during 2025-2033. The market is primarily driven by the rising incidences of infectious diseases, the expanding healthcare sector, the widespread adoption of advanced data analytics tools, and the continuous technological advancements.

Sepsis Diagnostics Market Analysis:

• Major Market Drivers: The growing prevalence of sepsis, owing to the aging population and the escalating cases of chronic illnesses, is catalyzing the sepsis diagnostics market growth. Besides this, the ongoing innovations, such as the development of molecular diagnostics and biomarker-based tests are further stimulating the sepsis diagnostics market statistics.
• Key Market Trends: The emerging trend of automation and the extensive utilization of machine learning and AI technologies for accurate diagnosis are propelling the sepsis diagnostics market demand. Moreover, the widespread adoption of point-of-care testing in intensive care units, emergency departments, and other healthcare facilities is also bolstering the sepsis diagnostics market overview.
• Competitive Landscape: Some of the major market players in the sepsis diagnostics market share include Abbott Laboratories, Becton and Dickinson Company (BD), Biomerieux SA, Bruker Corporation, EKF Diagnostics Holding Plc, Epic Systems Corporation, Luminex Corporation, Roche Holding AG, Sysmex Corporation, and T2 Biosystems Inc.
• Geographical Trends: North America is among the major drivers of the sepsis diagnostics market forecast, owing to its advanced healthcare infrastructure and strong regulatory framework. Besides this, the increasing focus of Europe on healthcare infrastructure and quality is further catalyzing the market forward. Moreover, in the Asia Pacific region, countries, including India and China are spreading awareness about sepsis and its diagnosis. Moreover, the inflating medical care spending by individuals across Latin America and Middle East and Africa is augmenting the market growth.
• Challenges and Opportunities: One of the major challenges in the market includes the lack of specific biomarkers that can conclusively diagnose the condition. However, the continuous advances in technology, including microfluidics, molecular diagnostics, and artificial intelligence assist in developing more accurate testing techniques, which present significant growth opportunities for the market.

Sepsis Diagnostics Market Trends:

Increasing Prevalence of Hospital-acquired Infections

The rising cases of hospital-acquired infections (HAIs) are bolstering the demand for improved diagnostic strategies, which are primarily driving the sepsis diagnostics market statistics. Moreover, HAIs lead to increased mortality, morbidity, and healthcare costs, which is anticipated to influence the market forecast. Therefore, various medical facilities are focusing highly on control measures and infection prevention to minimize the cases of HAIs. For instance, according to a report published by the Centers for Disease Control and Prevention (CDC), about 24%, 35%, and 15% increase was seen in central line-associated bloodstream infections, ventilator-associated events, and Methicillin-resistant Staphylococcus Aureus (MRSA) bacteremia in the United States. Additionally, according to another study conducted, COVID-19 patients were at the highest risk of developing sepsis. Furthermore, according to the Centers for Disease Control and Prevention (CDC), approximately 1.7 million people are affected by sepsis in the U.S. each year, and more than 270,000 people die from sepsis annually.

Technological Advancements in Diagnostic Tests

The ongoing technological advances, including the utilization of artificial intelligence, molecular diagnostics, and microfluidics for the development of more efficient and accurate tests are augmenting the sepsis diagnostics market growth. Moreover, the emerging trend of device miniaturization and automation in the healthcare sector and the growing popularity of point-of-care testing methods for quick diagnosis and treatment are also catalyzing the global market. Besides this, the introduction of biomarker-based diagnostic tests that can identify sepsis with high specificity and sensitivity is also positively influencing the market growth. For example, Abbott Laboratories developed a new diagnostic test that can detect sepsis and other bloodstream infections in as little as five hours. Furthermore, according to the Canadian Institutes of Health Research report, the Government of Canada invested US$ 5.7 Million to support Sepsis Canada, a new national research network that is expected to improve the treatment and recovery of sepsis patients. 190 clinicians, scientists, and patient representatives from all over Canada came together as part of Sepsis Canada.

Growing Number of Government Initiatives

The launch of several policies and initiatives by government bodies across countries, including public health campaigns to raise awareness about sepsis, its symptoms, and the importance of early detection and treatment is positively influencing the market growth. In addition to this, the inflating investments by regulatory authorities in research and development efforts for the introduction of latest and improved diagnostic tests and technologies are also propelling the sepsis diagnostics market. Moreover, the advancing healthcare infrastructure and the increasing number of education and training programs and seminars for medical professionals on sepsis recognition, diagnosis, and management are further catalyzing the global market. For instance, in May 2022, Phathom Pharmaceuticals, Inc. received the United States Food and Drug Administration (FDA) approval for VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults. Furthermore, the FDA has approved T2Bacteria Panel, which detects the disease-causing bacteria directly from the blood sample of the patient, without waiting for cultures to grow.

Sepsis Diagnostics Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional and country levels for 2025-2033. Our report has categorized the market based on diagnosis, product, mode of testing, technology, pathogen, and end user.

Breakup by Diagnosis:

• Automated Diagnostics
• Conventional Diagnostics
   

The report has provided a detailed breakup and analysis of the market based on the diagnosis. This includes automated diagnostics and conventional diagnostics.

Conventional diagnostics for sepsis generally involve a series of laboratory tests and clinical assessments to identify the presence of infection and the body's response to it. They rely on manual processing and interpretation of test results by healthcare professionals. On the other hand, automated diagnostics streamline and expedite the diagnostic process by using advanced automated systems and technologies. They can significantly minimize turnaround times for test results, allowing for earlier detection and treatment of sepsis.

Breakup by Product:

• Instruments
• Assay Kits and Reagents
• Blood Culture Media
• Software
   

The report has provided a detailed breakup and analysis of the market based on the product. This includes instruments, assay kits and reagents, blood culture media, and software.

Instruments, assay kits and reagents, blood culture media, and software represent the essential components of the sepsis diagnostics workflow, enabling healthcare providers to accurately and efficiently diagnose sepsis and initiate timely treatment, as they reduce the risk of errors in the overall treatment procedures. For example, BD launched the BD BACTEC platelet quality control media, which can identify and decrease the incidence in patients receiving platelet transfusion. It enables blood banks, microbiology laboratories, and transfusion services to detect contaminated platelet units.

Breakup by Mode of Testing:

• Laboratory Tests
• Point-of-Care Tests
   

The report has provided a detailed breakup and analysis of the market based on the mode of testing. This includes laboratory tests and point-of-care tests.

Laboratory tests offer more comprehensive and sensitive diagnostics of sepsis and require specialized equipment and trained personnel. On the other hand, point-of-care tests provide rapid results that can be obtained at the patient's bedside, enabling quicker diagnosis and treatment initiation. For instance, Inflammatix gained US$ 32 Million in Series C funding to support the commercial launch of its rapid HostDx test in the European market and its submission to the FDA.

Breakup by Technology:

• Molecular Diagnostics
• Immunoassays
• Biomarkers
• Flow Cytometry
• Microfluidics
• Blood Culture
   

The report has provided a detailed breakup and analysis of the market based on technology. This includes molecular diagnostics, immunoassays, biomarkers, flow cytometry, microfluidics, and blood culture.

Molecular diagnostics, such as polymerase chain reaction (PCR) and nucleic acid sequencing, can quickly identify the genetic material of pathogens in blood or other body fluids. Moreover, immunoassays, including enzyme-linked immunosorbent assay (ELISA), can detect specific biomarkers associated with sepsis, such as procalcitonin (PCT) or C-reactive protein (CRP). Additionally, in sepsis diagnostics, biomarkers, such as PCT, CRP, and interleukins can aid in diagnosis, risk stratification, and monitoring of treatment response. Besides this, flow cytometry is used for analyzing the immune response in sepsis by quantifying and characterizing immune cells in the blood. Furthermore, microfluidic devices perform multiple tests simultaneously utilizing very small amounts of blood or other body fluids and blood culture is required for identifying the causative organism in sepsis.

Breakup by Pathogen:

• Bacterial Sepsis
  • Gram-Positive Bacterial Sepsis
  • Gram-Negative Bacterial Sepsis
• Viral Sepsis
• Fungal Sepsis
• Others
   

The report has provided a detailed breakup and analysis of the market based on the pathogen. This includes bacterial sepsis (gram-positive bacterial sepsis and gram-negative bacterial sepsis), viral sepsis, fungal sepsis, and others.

Gram-positive bacteria, such as Staphylococcus aureus, Streptococcus pneumoniae, and Enterococcus faecalis, and Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa, are among the common causes of sepsis. Besides this, viral sepsis is caused by infections, such as influenza, herpes simplex virus (HSV), and human immunodeficiency virus (HIV). Moreover, fungal infections, including the Candida and Aspergillus species also cause sepsis. For instance, according to the study published by SAGE Journals, bacterial segment is the most common type, with 62.2% of patients infected with gram-negative bacteria and 46.8% with gram-positive bacteria.

Breakup by End User:

• Diagnostic Clinics
• Hospitals
• Research Laboratories
   

The report has provided a detailed breakup and analysis of the market based on the end user. This includes diagnostic clinics, hospitals, and research laboratories.

Diagnostic clinics perform rapid tests for sepsis diagnostics, such as blood gas analysis and biomarker assays, to provide quick results. Besides this, various services, such as complete blood count (CBC), blood cultures, and imaging and coagulation studies, are offered by hospitals. Moreover, research laboratories may characterize and identify novel biomarkers for sepsis diagnostics. For instance, in January 2023, FDA authorized IntelliSep, a novel diagnostic test that could assist in identifying patients with sepsis before the potentially fatal condition became too difficult to treat.

Breakup by Region:

• North America
  • United States
  • Canada
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Others
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • Singapore
  • Others
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Others
• Middle East and Africa
  • Saudi Arabia
  • United Arab Emirates
  • South Africa
  • Others
     

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa (Saudi Arabia, United Arab Emirates, South Africa, Others).

North America is among the major regions in the market, owing to its advanced healthcare infrastructure and strong regulatory framework. For instance, according to the Centers for Disease Control and Prevention, approximately 1.7 million adults in America develop sepsis, and nearly 270,000 Americans die due to sepsis. It was also found that 1 in 3 patients who died in a hospital had sepsis. Additionally, the Providence Health Care September 2022 article stated that sepsis is most prominent in infants and children. It affects 40,000 to 50,000 individuals each year in Canada and is the 12th leading cause of death in the country. The article also stated that according to the Canadian Sepsis Foundation US$ 325 Million is spent annually on treating sepsis in Canada. Besides this, the increasing focus of Europe on advancing medical services is further catalyzing the market forward.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided. Some of the major market players in the Sepsis Diagnostics industry include:

• Abbott Laboratories
• Becton, Dickinson Company (BD)
• Biomerieux SA
• Bruker Corporation
• EKF Diagnostics Holding Plc
• Epic Systems Corporation
• Luminex Corporation
• Roche Holding AG
• Sysmex Corporation
• T2 Biosystems Inc.
   

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Sepsis Diagnostics Market News:

• November 2023: Inflammatix, Inc., a pioneering molecular diagnostics company, announced that the company completed technical development for its TriVerity Acute Infection and Sepsis Test System, which incorporated the Myrna Instrument, and the TriVerity Cartridge. TriVerity was intended to be used in emergency department settings in patients with suspected acute infection and sepsis to assess the likelihood of a bacterial infection, a viral illness, and the risk of acute decompensation (the need for ICU-level care).
• August 2023: The Centers for Disease Control and Prevention (CDC) commenced the Hospital Sepsis Program Core Elements to support all U.S. hospitals in ensuring that effective teams and resources were in place to be able to quickly identify sepsis and save more lives. The new, critical resource was intended to assist hospitals in implementing, monitoring, and optimizing sepsis programs and improving survival rates.
• May 2022: Sepsis Alliance launched the Sepsis Innovation Collaborative (SIC) with the goals of enhancing early diagnosis and developing better antimicrobial therapies and host modifying agents. It was one of the first public-private collaborative communities dedicated to innovation in combatting sepsis. The members included Beckman Coulter, Merck, BioAegis Therapeutics, Roche, and other companies.

Sepsis Diagnostics Market Report Scope:

Key Questions Answered in This Report:

• How has the global sepsis diagnostics market performed so far and how will it perform in the coming years?
• What is the impact of COVID-19 on the global sepsis diagnostics market?
• What are the key regional markets?
• What is the breakup of the market based on the diagnosis?
• What is the breakup of the market based on the product?
• What is the breakup of the market based on the mode of testing?
• What is the breakup of the market based on the technology?
• What is the breakup of the market based on the pathogen?
• What is the breakup of the market based on the end user?
• What are the various stages in the value chain of the industry?
• What are the key driving factors and challenges in the market?
• What is the structure of the global sepsis diagnostics market and who are the key players?
• What is the degree of competition in the market?

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the sepsis diagnostics market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global sepsis diagnostics market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the sepsis diagnostics industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.