Global Sepsis Diagnostics Market Size, Share & Trends Analysis Report By Product (Assay Kits & Reagents, Blood Culture Media), By Technology, By Pathogen, By Testing Type, By Method, By End-user, By Region,- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

Sepsis Diagnostics Market Size and Research

The global sepsis diagnostics market size was exhibited at USD 1.55 billion in 2023 and is projected to hit around USD 3.41 billion by 2033, growing at a CAGR of 8.2% during the forecast period 2024 to 2033.

Sepsis Diagnostics Market Key Takeaways:

• The market is driven by technological advancements, such as molecular diagnostic technologies, multiplex assays, and biomarkers.
• Based on product type, blood culture media dominated the market in 2023 with a revenue share of more than 38.9%, as blood culture is considered the most cost-effective and convenient testing mode. 
• The microbiology technology segment dominated the market in 2023 and held the largest share of more than 48.9% of the overall revenue.
• Bacterial segment held the largest revenue share of 86.0% of the market in 2023.
• The fungal segment is expected to grow at a significant CAGR over the forecast period.
• The conventional diagnostics segment held the largest revenue share of 57.6% of the market in 2023.
• The hospital and clinics segment held the largest revenue size of 79.5% of the market in 2023.
• The laboratory testing type segment dominated the market in 2023 with a share of 82.6%.
• PoC testing is estimated to grow at a significant CAGR over the forecast period.
• North America dominated the market in 2023 and held the largest revenue share of more than 44.4%.

Report Scope of Sepsis Diagnostics Market

Factors such as the introduction of technologically advanced diagnostic and treatment solutions, high prevalence of sepsis, and increasing awareness are responsible for market growth over the forecast period. Sepsis is the leading cause of death in high-income countries, such as the U.S., with approximately 270,000 people dying from the condition annually, according to the Centers for Disease Control and Prevention (CDC).

It is also prevalent in low and middle-income countries, where it often is undiagnosed and untreated due to limited access to healthcare. In 2020, the Global Sepsis Alliance reported that it is responsible for an estimated 11 million deaths worldwide each year, which is more than the combined number of deaths from breast cancer, prostate cancer, and HIV/AIDS. The situation is particularly severe in low-income countries, where disease-related mortality is the highest. As such, there is an urgent need for improving awareness, prevention, and treatment, particularly in these regions.

Pneumonia is the leading cause of sepsis and septic shock, affecting individuals of all ages. While community-acquired pneumonia and hospital-acquired pneumonia differ in symptom duration, both can result in severe pneumonia and an increased risk of developing sepsis. Recent studies indicate that sepsis is a direct outcome of pneumonia, with more than half of patients having suffered from pneumonia. Pneumonia and sepsis cases have significantly increased globally as a result of the COVID-19 pandemic. A study published in The Lancet Respiratory Medicine in August 2021 indicates that the prevalence of sepsis and mortality linked to sepsis have considerably increased throughout the pandemic.

The COVID-19 pandemic has further highlighted the importance of early diagnosisand treatment, as it can lead to organ dysfunction and increasing risk of developing sepsis. While the pathogenesis of COVID-19 is not yet fully understood, research suggests that cytokine and chemokine levels in severe COVID-19 patients are similar to those found in patients, highlighting the need for improved diagnostic tools for sepsis. Some companies offering advanced diagnostics for the disease are T2 Biosystems, Becton, Dickinson and Company (BD), and F. Hoffmann-La Roche. These companies are actively involved in developing diagnostic tools to provide faster and more accurate diagnosis, improve patient outcomes, and reduce the global burden of disease.

Hospital-acquired infections continue to be a major contributor to the development of sepsis diagnostics, particularly among patients with chronic conditions, such as diabetes. CDC reports that approximately 1 in 31 hospital patients in the U.S. acquires hospital-acquired infection each year. These infections often result from invasive medical procedures, such as catheter insertions, and can lead to sepsis. Catheter-Associated Urinary Tract Infections (CAUTIs) and Surgical Site Infections (SSIs) are the most common types of hospital-acquired infections.

Sepsis Diagnostics Market By Market Dynamics

The market is driven by technological advancements, such as molecular diagnostic technologies, multiplex assays, and biomarkers. For example, Roche Diagnostics offers products, such as the Elecsys BRAHMS PCT assay, which measures the levels of PCT in the blood. Several emerging trends are likely to shape market in the future. These include developing POC diagnostic tools, integrating Al & machine learning algorithms into diagnostics, and using biomarkers for disease diagnosis.

Regulatory bodies are crucial in driving the market and setting standards and guidelines for product development and approval. Recent trends focus on streamlining approval processes, promoting innovative technologies, and evidence-based clinical practices. The FDA has approved T2Bacteria Panel, which detects the disease-causing bacteria directly from a patient's blood sample without waiting for cultures to grow. This trend is likely to drive market growth during the forecast period.

Despite the advancements, several challenges still exist in the market. Some of the significant challenges facing the market include the high cost of diagnostics tests, the lack of awareness about the disease & its diagnosis, and the limited availability of diagnostic tools in developing countries.

Sepsis Diagnostics Market By Product Insights

Based on product type, blood culture media dominated the market in 2023 with a revenue share of more than 38.9%, as blood culture is considered the most cost-effective and convenient testing mode. In April 2019, BD launched the BD BACTEC platelet quality control media, which can help identify and decrease the incidence in patients receiving platelet transfusion. It enables blood banks, microbiology laboratories, and transfusion services to detect contaminated platelet units. Introduction of such new media is expected to fuel the segment’s growth.

Assay kits & reagents segment is estimated to register the fastest CAGR during the forecast period. Assay kits with different analyzers provide high-throughput analytical outcomes for disease detection. For instance, VIDAS B.R.A.H.M.S. PCT by bioMérieux SA aids in the early detection of sepsis causing microorganisms through PCT discovery in human serum or plasma; it provides results in approximately 20 minutes.Major kits & reagents by leading manufacturers are penetrating major markets through new product developments & launches. For instance, in May 2021, Ortho Clinical Diagnostics released the VITROS Immunodiagnostic Products IL-6 Reagent Pack as a part of the company’s VITROS Critical Care menu.

Sepsis Diagnostics Market By Technology Insights

The microbiology technology segment dominated the market in 2023 and held the largest share of more than 48.9% of the overall revenue. Microbial culture is the primary and gold standard method for detecting infectious disease-causing organisms in laboratory settings.In addition, new strategic initiatives by key players will further drive the segment growth in near future. For instance, in April 2019, BD launched BD BACTEC platelet quality control media, which enables users to identify and decrease the incidence in patients receiving platelet transfusion.

Molecular diagnostics segment is anticipated to expand at the fastest CAGR over the coming years. Molecular diagnostic technique is another crucial tool in the detection of sepsis. It also assists in reducing the time of pathogen identification, thus allowing early detection and initiation of treatment at a faster rate as compared to conventional diagnostic methods. Methicillin-resistant Staphylococcus Aureus (MRSA) most commonly causes skin infections.PCR and Nucleic Acid Sequence-based Amplification (NASBA) are used to detect MRSA. However, the molecular diagnostic technique is considered the standard pathogen identification technique after blood culture.

Sepsis Diagnostics Market By Pathogen Insights

Bacterial segment held the largest revenue share of 86.0% of the market in 2023. It is anticipated to lead over the forecast period due to the rise in cases of bacterial sepsis, higher occurrence of hospital-transmitted infections, and rising number of surgical procedures conducted. According to the study published by SAGE Journals in January 2019, bacterial segment is the most common type, with 62.2% of patients infected with gram-negative bacteria and 46.8% with gram-positive bacteria. In the bacterial segment, the gram-negative bacteria sub-segment is anticipated to dominate the market over the forecast period.

The fungal segment is expected to grow at a significant CAGR over the forecast period. One of the major drivers is the increasing availability and introduction of a new and wide range of disease diagnosis devices for pathogen detection. One of the vital tests used to detect fungal infections is an ELISA developed by Laboratory Corporation of America Holdings. This assay is used to detect IgG, IgA, and IgM antibodies to Candida albicans, a major cause of bloodstream infection leading to septic shock & sepsis. BacT/ALERT Culture Media by bioMérieux SA and BD BACTEC Media by BD are other crucial products available in the market for the isolation & identification of fungal sepsis.

Sepsis Diagnostics Market By Method Insights

The conventional diagnostics segment held the largest revenue share of 57.6% of the market in 2023. The conventional method relies on the expertise of healthcare professionals to evaluate the patient's clinical presentation and interpret laboratory and imaging results. Early detection and prompt treatment are crucial to improve patient outcomes.

The automated diagnostic method is the fastest-growing segment over the forecast period. Clinical Decision Support Systems (CDSS), Machine learning algorithms, biomarkers, and continuous monitoring systems are some of the automated diagnostics methods available for diagnostics. Continuous monitoring systems, such as wearable devices and implantable sensors, can track vital signs and other clinical data in real-time. These systems can detect changes in a patient's condition that may indicate the disease and alert healthcare professionals for prompt intervention.

Sepsis Diagnostics Market By End-user Insights

The hospital and clinics segment held the largest revenue size of 79.5% of the market in 2023, owing to an increase in hospitalization. Several ongoing developments to advance diagnostic tests are anticipated to boost the segment. In January 2023, FDA authorized IntelliSep, a novel diagnostic test that can assist in identifying patients with sepsis before the potentially fatal condition becomes too difficult to treat. Early detection is crucial for proper results as sepsis is responsible for one in three hospital deaths.

Pathology & reference laboratories are estimated to be the fastest end-user segment over the forecast period. Reference laboratories play an important role in sepsis diagnostics by providing specialized testing services unavailable in most hospitals or clinics. Presence of several pathology and reference laboratories globally, which offer a comprehensive range of testing services for sepsis, has further contributed to segment growth. For instance, Arup Laboratories offers specialized testing services for sepsis. Its offerings include blood culture testing, biomarker testing, and PCR testing for specific pathogens.

Sepsis Diagnostics Market By Testing Type Insights

The laboratory testing type segment dominated the market in 2023 with a share of 82.6%. Advancements in laboratory testing have made it easier and faster to detect sepsis, leading to better outcomes for patients. These tests use biomarkers, such as procalcitonin or cytokines, to identify the presence of infection in the body. The tests are sensitive and can provide results within hours, allowing for earlier detection and treatment of sepsis. Thus, these factors would further contribute to the development of more effective and personalized approaches to diagnosis.

PoC testing is estimated to grow at a significant CAGR over the forecast period. Technological advancements in POC test kits in terms of shorter turnaround times and error-free results are expected to boost the market in the future.Various manufacturers are focusing on the development of novel POC testing kits for early detection of the disease.In January 2021, Inflammatix gained USD 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 in the same year.

Sepsis Diagnostics Market By Regional Insights

North America dominated the market in 2023 and held the largest revenue share of more than 44.4%. High incidence of sepsis and infectious diseases is expected to fuel demand for novel diagnostic solutions. Several developments have been reported in the region, contributing to market growth. For instance, in January 2023, Cytovale announced receiving FDA authorization for its IntelliSep Sepsis Test for early detection of sepsis.

Asia Pacific is estimated to be the fastest-growing regional market from 2024 to 2030, majorly attributed to rising demand for diagnostic solutions in countries with a high prevalence of infectious diseases, such as China and India. Furthermore, constant developments in molecular diagnostics technology, such as the introduction of Point-Of-Care (POC) testing devices & next-generation sequencing technology, and integration of machine learning & artificial intelligence, contributing to the region’s market growth. For instance, In January 2023, Asep Medical Holdings, Inc. entered into a joint venture with Sansure Biotech Inc., a medical diagnostics company, in China to commercialize Sepset(ER) Sepsis Diagnostic Test in the country. 

Sepsis Diagnostics Market Recent Developments

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

Some of the prominent players in the global sepsis diagnostics market include:

• BD, Becton, Dickinson & Company
• bioMérieux SA
• Thermo Fisher Scientific, Inc.
• Danaher Corporation (Beckman Coulter, Inc.)
• F. Hoffmann-La Roche AG
• Cepheid
• Luminex Corp.
• Koninklijke Philips N.V.
• Bruker
• Immunexpress, Inc.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the global sepsis diagnostics market

Product

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

Technology

• Microbiology
• Molecular Diagnostics

• • Polymerase Chain Reaction (PCR)
  • DNA Microarrays
  • Syndromic Panel testing
  • Others

• Immunoassays
• Flow Cytometry
• Others

Pathogen

• Bacterial Sepsis

• • Gram-positive Bacteria
  • Gram-negative Bacteria

• Fungal Sepsis
• Viral Sepsis
• Others

Testing Type

• Laboratory Testing
• PoC Testing

Method

• Automated Diagnostics
• Conventional Diagnostics

End-user

• Hospitals & Clinics
• Pathology & Reference Laboratories
• Research Institutes and Others

Regional

• North America
• Europe
• Asia Pacific
• Latin America
• MEA