세계의 패혈증 진단 시장(2025년판)

The global sepsis diagnostics market was valued at US$835.40 million in 2023. The market value is expected to reach US$1.39 billion by 2029. Sepsis diagnostics is a crucial area of medical research and healthcare, focusing on the timely and accurate identification of sepsis, a life-threatening condition caused by the body's extreme response to infection. This response can lead to tissue damage, organ failure, and death if not promptly treated. In the forthcoming years, the global sepsis diagnostics market is expected to continue its growth trajectory due to the sustained efforts to improve healthcare infrastructure, ongoing technological advancements, and increasing awareness about sepsis. The expanding adoption of point-of-care testing, particularly in remote and underserved areas, will further drive market growth by enabling timely diagnosis and treatment in settings with limited healthcare resources. Additionally, the continued focus on research and innovation, coupled with strategic collaborations between healthcare providers, diagnostic companies, and research institutions, will contribute to the development of next-generation diagnostic tools, ensuring the market's robust expansion in the years to come. The market is expected to grow at a CAGR of approx. 9% during the forecasted period of 2024-2029.

Market Segmentation Analysis:

By Technology: The report provides the bifurcation of the global sepsis diagnostics market based on the technology: Microbiology, Molecular Diagnostics, Immunoassays, Flow Cytometry, and Others. The microbiology segment held the highest share of the market, whereas the molecular diagnostics segment is expected to be the fastest-growing segment in the forecasted period. Microbiology remains a cornerstone in sepsis diagnostics due to its proven efficacy in identifying pathogens responsible for infections. The traditional blood culture method, despite being time-consuming, provides comprehensive data about bacterial strains and their antibiotic susceptibilities, which is crucial for tailoring specific treatments. On the other hand, the demand for molecular diagnostics in sepsis has surged due to its ability to provide rapid and precise pathogen identification directly from clinical samples. Techniques such as polymerase chain reaction (PCR) and next-generation sequencing (NGS) enable the detection of bacterial, viral, and fungal DNA or RNA within a few hours, significantly faster than traditional culture methods. This rapid turnaround is crucial in the early stages of sepsis, where timely intervention can drastically improve patient outcomes.

By Type: The global molecular sepsis diagnostics market can be further divided into four segments based on the type: Polymerase Chain Reaction, Peptide Nucleic Acid-Fluorescent in Situ Hybridization, Syndromic Panel-Based Testing, and Microarrays. The polymerase chain reaction segment held the highest share of the market, whereas the microarrays segment is expected to be the fastest-growing segment in the forecasted period. Microarrays are gaining popularity in the molecular sepsis diagnostics market due to their capability to analyze multiple genetic markers simultaneously, offering a high-throughput approach to pathogen identification and characterization. This technology involves hybridizing patient sample nucleic acids to a chip containing numerous probes, enabling the detection of a wide range of sepsis-related pathogens and resistance genes in a single test.

By Product: The report further provides the segmentation based on the following products: Blood Culture Media, Instruments, Assays & Reagents, and Software. The blood culture media held the highest share of the market, whereas the software segment is expected to be the fastest-growing segment in the forecasted period. The demand for blood culture media in the global sepsis diagnostics market is rising due to its critical role in the initial detection and identification of pathogens responsible for sepsis. Blood culture media are essential for cultivating bacteria, fungi, and other microorganisms from blood samples, which is a fundamental step in diagnosing sepsis. On the other hand, software is becoming increasingly important in the global sepsis diagnostics market due to its role in managing and analyzing complex diagnostic data. Advanced diagnostic software integrates with various diagnostic instruments and systems to streamline data collection, analysis, and reporting. This integration facilitates real-time monitoring of patient data, enabling healthcare providers to make timely and informed decisions.

By Method: The report provides the glimpse of the sepsis diagnostics market based on the following methods: Conventional and Automated. Conventional diagnostics segment held the highest share of the market, whereas automated diagnostics segment is expected to be the fastest-growing segment in the forecasted period. The demand for automated diagnostics in the global sepsis diagnostics market is surging due to the need for efficiency, accuracy, and rapid turnaround in diagnosing sepsis. Automated diagnostic systems, such as automated blood culture systems, molecular diagnostic platforms, and high-throughput assay systems, streamline the diagnostic process by reducing manual intervention, minimizing human error, and accelerating result generation.

By Pathogen Type: The global sepsis diagnostics market can be divided into three segments based on the pathogen type: Bacterial Sepsis, Fungal Sepsis, and Other Pathogen. Bacterial sepsis held the highest share of the market and is expected to be the fastest-growing segment in the forecasted period. Bacterial sepsis is a significant driver of growth in the global sepsis diagnostics market due to its high prevalence and severe impact on patient outcomes. Bacterial infections are among the most common causes of sepsis, resulting from pathogens such as Escherichia coli, Staphylococcus aureus, and Klebsiella pneumoniae. The increasing incidence of bacterial sepsis is driven by factors such as antibiotic resistance, rising rates of chronic diseases, and the prevalence of invasive medical procedures that heighten infection risk.

By Test Type: The global sepsis diagnostics market can be divided into two segments based on the test type: Laboratory Tests and Point-of-Care Tests. Laboratory tests held the highest share in the market, whereas point-of-care tests segment is expected to be the fastest-growing segment in the forecasted period. The demand for point-of-care (POC) tests are surging due to their ability to provide rapid, on-site results that are crucial for timely intervention in sepsis management. POC tests are designed to be used at or near the patient's bedside, offering immediate diagnostic information that facilitates quick decision-making and treatment initiation. This is particularly important in critical care settings where every minute counts. Innovations in POC testing, such as portable molecular diagnostic devices and rapid immunoassays, have improved the accessibility and convenience of sepsis diagnostics.

By End-User: The report provides the glimpse of the global sepsis diagnostics market based on the following end-users: Hospitals, Pathology & Reference Laboratories, and Research Institutes and Others. Hospitals held the highest share of the market, whereas pathology & reference laboratories segment is expected to be the fastest-growing segment in the forecasted period. Pathology and reference laboratories play a vital role in the global sepsis diagnostics market by providing comprehensive and specialized diagnostic services. These laboratories are equipped with advanced technologies and expertise to perform a wide range of diagnostic tests, including blood cultures, molecular assays, and immunoassays. The increasing complexity of sepsis cases, along with the need for precise identification of pathogens and their resistance profiles, drives the demand for sophisticated diagnostic methods offered by these labs.

By Region: The report provides insight into the sepsis diagnostics market based on the regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America held the major share of the market. In the US, Government initiatives, such as the Sepsis Alliance and the Centers for Disease Control and Prevention's (CDC) sepsis awareness programs, have significantly contributed to increasing awareness and early detection of sepsis. Additionally, the National Sepsis Data Trust Initiative (NSDTI) is an independent, consensus-driven initiative that focuses on improving the diagnosis and treatment of sepsis patients and survivors through the creation of a National Sepsis Data Trust. Moreover, the US has a high incidence rate of sepsis, which necessitates the need for effective diagnostic solutions. For example, the CDC reports that over 1.7 million adults in America develop sepsis each year, with around 350,000 fatalities, underscoring the critical demand for efficient diagnostics.

Germany's sepsis diagnostics market is thriving due to its advanced healthcare system, strong research and development capabilities, and significant government and institutional support. Germany has one of the highest healthcare expenditures in Europe, enabling extensive investment in cutting-edge diagnostic technologies. The country's focus on precision medicine and personalized healthcare solutions aligns well with the need for rapid and accurate sepsis diagnostics. Organizations like the German Sepsis Society (Deutsche Sepsis-Gesellschaft, DSG) play a crucial role in raising awareness and improving sepsis outcomes through education and advocacy.

According to the Asia Pacific Sepsis Alliance, the Asia Pacific region is home to 4.6 billion people, which is 60% of the world's population. The estimated national sepsis incidences in this region range from 120 to 1,600 per 100,000, with mortality rates related to sepsis up to 35%, which are much higher than in Western and other high-income countries. Consequently, the Asia Pacific region has a higher burden of sepsis proportional to population, as well as the highest number of patients affected by sepsis globally. Moreover, India is expected to experience robust growth in the sepsis diagnostics market, driven by factors such as a large and diverse population, a high burden of infectious diseases, and significant improvements in healthcare infrastructure.

Market Dynamics:

Growth Drivers: The global sepsis diagnostics market has been growing over the past few years, due to factors such as aging population, rising healthcare expenditure, rising number of sepsis cases, increasing collaboration and partnerships, regulatory approvals and reimbursement policies, growing government initiatives for creating sepsis awareness, increasing incidence of hospital-acquired infections (HAIs), increase in funding and support for sepsis diagnostics research, and many other factors. Infection is the root cause of sepsis. Sepsis mainly occurs in immunocompromised people, such as those taking chemotherapy, having a splenectomy, and suffering from AIDS and chronic illnesses like diabetes. Among several types of infections, Hospital-acquired Infections (HAIs) are the primary cause of morbidity and mortality among hospitalized patients. According to the World Health Organization (WHO), 7 in 100 patients in high-income countries and 15 in low- and middle-income countries acquire at least one HAI during their hospital stay. On average, 1 in 10 affected patients will die from their HAI. Most deaths can be prevented through early diagnosis and appropriate clinical management. Thus, the high incidence rate of sepsis due to HAIs is expected to boost the demand for sepsis diagnostic products, thereby supporting the sepsis diagnostics market growth during the forecast period.

Challenges: However, the market growth would be negatively impacted by various challenges such as high cost of automated diagnostic devices, lack of skilled professionals, etc.

Trends: The market is projected to grow at a fast pace during the forecast period, due to development of rapid diagnostic tests, increasing use of biomarker-based diagnostics, increasing availability of point-of-care diagnostic tools, integration of artificial intelligence (AI) and machine learning (ML), rising technological advancements in sepsis diagnosis, integration of electronic health records (EHR), etc. The development of rapid diagnostic tests and techniques is poised to significantly accelerate the growth of the sepsis diagnostics market in the forthcoming years by drastically reducing the time required to identify sepsis and its causative pathogens. Traditional diagnostic methods often take several days to yield results, leading to delays in treatment and higher mortality rates. In contrast, rapid diagnostic tests, such as those utilizing polymerase chain reaction (PCR) and next-generation sequencing (NGS), can provide results within hours, enabling prompt and precise medical interventions. This swift turnaround is crucial in the management of sepsis, where every hour of delay can significantly impact patient outcomes.

Impact Analysis of COVID-19 and Way Forward:

The COVID-19 pandemic has had a profound impact on the global sepsis diagnostics market. As healthcare systems worldwide were overwhelmed by the influx of COVID-19 patients, the need for rapid and accurate diagnostics became more critical than ever. The similarities in the inflammatory responses of severe COVID-19 and sepsis necessitated the use of sepsis diagnostic tools to distinguish between the two conditions, optimize patient management, and ensure appropriate treatment strategies. This increased demand for sepsis diagnostics during the pandemic significantly boosted market growth and innovation in this sector.

Competitive Landscape:

The global sepsis diagnostics market is consolidated in nature. The key players in the global sepsis diagnostics market are:

BioMerieux SA

Abbott Laboratories

Danaher Corporation (Beckman Coulter Inc.)

Thermo Fisher Scientific Inc.

F. Hoffmann-La Roche Ltd

Becton, Dickinson and Company

Koninklijke Philips NV

Siemens Healthineers AG

DiaSorin (Luminex Corporation)

Bruker Corporation

T2 Biosystems, Inc.

Immunexpress, Pty Ltd.

Table of Contents

1. Executive Summary

2. Introduction

• 2.1 Sepsis Diagnostics: An Overview
  • 2.1.1 Introduction to Sepsis Diagnostics
  • 2.1.2 Symptoms of Sepsis
• 2.2 Sepsis Diagnostics Segmentation: An Overview

3. Global Market Analysis

• 3.1 Global Sepsis Diagnostics Market: An Analysis
  • 3.1.1 Global Sepsis Diagnostics Market: An Overview
  • 3.1.2 Global Sepsis Diagnostics Market by Value
  • 3.1.3 Global Sepsis Diagnostics Market by Technology (Microbiology, Molecular Diagnostics, Immunoassays, Flow Cytometry, and Others)
  • 3.1.4 Global Sepsis Diagnostics Market by Product (Blood Culture Media, Instruments, Assays & Reagents, and Software)
  • 3.1.5 Global Sepsis Diagnostics Market by Method (Conventional Diagnostics and Automated Diagnostics)
  • 3.1.6 Global Sepsis Diagnostics Market by Pathogen Type (Bacterial Sepsis, Fungal Sepsis, and Other Pathogen)
  • 3.1.7 Global Sepsis Diagnostics Market by Test Type (Laboratory Tests and Point-of-Care Tests)
  • 3.1.8 Global Sepsis Diagnostics Market by End-User (Hospitals, Pathology & Reference Laboratories, and Research Institutes and Others)
  • 3.1.9 Global Sepsis Diagnostics Market by Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)
• 3.2 Global Sepsis Diagnostics Market: Technology Analysis
  • 3.2.1 Global Sepsis Diagnostics Market by Technology: An Overview
  • 3.2.2 Global Microbiology Sepsis Diagnostics Market by Value
  • 3.2.3 Global Molecular Sepsis Diagnostics Market by Value
  • 3.2.4 Global Molecular Sepsis Diagnostics Market by Type (Polymerase Chain Reaction, Peptide Nucleic Acid-Fluorescent in Situ Hybridization, Syndromic Panel-Based Testing, and Microarrays)
  • 3.2.5 Global Molecular Sepsis Diagnostics Market Type by Value
  • 3.2.6 Global Immunoassays Sepsis Diagnostics Market by Value
  • 3.2.7 Global Flow Cytometry Sepsis Diagnostics Market by Value
  • 3.2.8 Global Others Sepsis Diagnostics Market by Value
• 3.3 Global Sepsis Diagnostics Market: Product Analysis
  • 3.3.1 Global Sepsis Diagnostics Market by Product: An Overview
  • 3.3.2 Global Sepsis Diagnostics Blood Culture Media Market by Value
  • 3.3.3 Global Sepsis Diagnostics Instruments Market by Value
  • 3.3.4 Global Sepsis Diagnostics Assays & Reagents Market by Value
  • 3.3.5 Global Sepsis Diagnostics Software Market by Value
• 3.4 Global Sepsis Diagnostics Market: Method Analysis
  • 3.4.1 Global Sepsis Diagnostics Market by Method: An Overview
  • 3.4.2 Global Conventional Sepsis Diagnostics Market by Value
  • 3.4.3 Global Automated Sepsis Diagnostics Market by Value
• 3.5 Global Sepsis Diagnostics Market: Pathogen Type Analysis
  • 3.5.1 Global Sepsis Diagnostics Market by Pathogen Type: An Overview
  • 3.5.2 Global Bacterial Sepsis Diagnostics Market by Value
  • 3.5.3 Global Fungal Sepsis Diagnostics Market by Value
  • 3.5.4 Global Other Pathogen Sepsis Diagnostics Market by Value
• 3.6 Global Sepsis Diagnostics Market: Test Type Analysis
  • 3.6.1 Global Sepsis Diagnostics Market by Test Type: An Overview
  • 3.6.2 Global Laboratory Sepsis Diagnostics Tests Market by Value
  • 3.6.3 Global Point-of-Care Sepsis Diagnostics Tests Market by Value
• 3.7 Global Sepsis Diagnostics Market: End-User Analysis
  • 3.7.1 Global Sepsis Diagnostics Market by End-User: An Overview
  • 3.7.2 Global Sepsis Diagnostics Hospitals Market by Value
  • 3.7.3 Global Sepsis Diagnostics Pathology & Reference Laboratories Market by Value
  • 3.7.4 Global Sepsis Diagnostics Research Institutes and Others Market by Value

4. Regional Market Analysis

• 4.1 North America Sepsis Diagnostics Market: An Analysis
  • 4.1.1 North America Sepsis Diagnostics Market: An Overview
  • 4.1.2 North America Sepsis Diagnostics Market by Value
  • 4.1.3 North America Sepsis Diagnostics Market by Region (The US, Canada, and Mexico)
  • 4.1.4 The US Sepsis Diagnostics Market by Value
  • 4.1.5 The US Sepsis Diagnostics Market by Technology (Microbiology, Molecular Diagnostics, Immunoassays, Flow Cytometry, and Others)
  • 4.1.6 The US Sepsis Diagnostics Market by Product (Blood Culture Media, Instruments, Assays & Reagents, and Software)
  • 4.1.7 The US Sepsis Diagnostics Market by Method (Conventional Diagnostics and Automated Diagnostics)
  • 4.1.8 The US Sepsis Diagnostics Market by Pathogen Type (Bacterial Sepsis, Fungal Sepsis, and Other Pathogen)
  • 4.1.9 The US Sepsis Diagnostics Market by Test Type (Laboratory Tests and Point-of-Care Tests)
  • 4.1.10 The US Sepsis Diagnostics Market by End-User (Hospitals, Pathology & Reference Laboratories, and Research Institutes and Others)
  • 4.1.11 Canada Sepsis Diagnostics Market by Value
  • 4.1.12 Mexico Sepsis Diagnostics Market by Value
• 4.2 Europe Sepsis Diagnostics Market: An Analysis
  • 4.2.1 Europe Sepsis Diagnostics Market: An Overview
  • 4.2.2 Europe Sepsis Diagnostics Market by Value
  • 4.2.3 Europe Sepsis Diagnostics Market by Region (Germany, The UK, France, Italy, Spain, and Rest of the Europe)
  • 4.2.4 Germany Sepsis Diagnostics Market by Value
  • 4.2.5 The UK Sepsis Diagnostics Market by Value
  • 4.2.6 France Sepsis Diagnostics Market by Value
  • 4.2.7 Italy Sepsis Diagnostics Market by Value
  • 4.2.8 Spain Sepsis Diagnostics Market by Value
  • 4.2.9 Rest of Europe Sepsis Diagnostics Market by Value
• 4.3 Asia Pacific Sepsis Diagnostics Market: An Analysis
  • 4.3.1 Asia Pacific Sepsis Diagnostics Market: An Overview
  • 4.3.2 Asia Pacific Sepsis Diagnostics Market by Value
  • 4.3.3 Asia Pacific Sepsis Diagnostics Market by Region (China, Japan, India, and Rest of the Asia Pacific)
  • 4.3.4 China Sepsis Diagnostics Market by Value
  • 4.3.5 Japan Sepsis Diagnostics Market by Value
  • 4.3.6 India Sepsis Diagnostics Market by Value
  • 4.3.7 Rest of Asia Pacific Sepsis Diagnostics Market by Value
• 4.4 Latin America Sepsis Diagnostics Market: An Analysis
  • 4.4.1 Latin America Sepsis Diagnostics Market: An Overview
  • 4.4.2 Latin America Sepsis Diagnostics Market by Value
• 4.5 Middle East & Africa Sepsis Diagnostics Market: An Analysis
  • 4.5.1 Middle East & Africa Sepsis Diagnostics Market: An Overview
  • 4.5.2 Middle East & Africa Sepsis Diagnostics Market by Value

5. Impact of COVID-19

• 5.1 Impact of COVID-19 on Global Sepsis Diagnostics Market
• 5.2 Post COVID-19 Impact on Global Sepsis Diagnostics Market

6. Market Dynamics

• 6.1 Growth Drivers
  • 6.1.1 Aging Population
  • 6.1.2 Rising Healthcare Expenditure
  • 6.1.3 Growing Government Initiatives for Creating Sepsis Awareness
  • 6.1.4 Increasing Incidence of Hospital-acquired Infections (HAIs)
  • 6.1.5 Rising Number of Sepsis Cases
  • 6.1.6 Increase in Funding and Support for Sepsis Diagnostics Research
  • 6.1.7 Surging Collaboration and Partnerships
  • 6.1.8 Regulatory Approvals and Reimbursement Policies
• 6.2 Challenges
  • 6.2.1 High Cost of Automated Diagnostic Devices
  • 6.2.2 Lack of Skilled Professionals
• 6.3 Market Trends
  • 6.3.1 Development of Rapid Diagnostic Tests
  • 6.3.2 Increasing Availability of Point-of-Care Diagnostic Tools
  • 6.3.3 Integration of Artificial Intelligence (AI) and Machine Learning (ML)
  • 6.3.4 Increasing Use of Biomarker-Based Diagnostics
  • 6.3.5 Rising Technological Advancements in Sepsis Diagnosis
  • 6.3.6 Integration of Electronic Health Records (EHR)

7. Competitive Landscape

• 7.1 Global Sepsis Diagnostics Market: Competitive Landscape
• 7.2 Global Sepsis Diagnostics Market Players: Product Comparison

8. Company Profiles

• 8.1 BioMerieux SA
  • 8.1.1 Business Overview
  • 8.1.2 Revenue by Technology and Application
  • 8.1.3 Business Strategy
• 8.2 Abbott Laboratories
  • 8.2.1 Business Overview
  • 8.2.2 Operating Segments
  • 8.2.3 Business Strategy
• 8.3 Danaher Corporation (Beckman Coulter Inc.)
  • 8.3.1 Business Overview
  • 8.3.2 Operating Segments
  • 8.3.3 Business Strategy
• 8.4 Thermo Fisher Scientific Inc.
  • 8.4.1 Business Overview
  • 8.4.2 Operating Segments
  • 8.4.3 Business Strategy
• 8.5 F. Hoffmann-La Roche Ltd
  • 8.5.1 Business Overview
  • 8.5.2 Sales by Operating Business
  • 8.5.3 Business Strategy
• 8.6 Becton, Dickinson and Company
  • 8.6.1 Business Overview
  • 8.6.2 Operating Segments
  • 8.6.3 Business Strategy
• 8.7 Koninklijke Philips NV
  • 8.7.1 Business Overview
  • 8.7.2 Operating Segments
  • 8.7.3 Business Strategy
• 8.8 Siemens Healthineers AG
  • 8.8.1 Business Overview
  • 8.8.2 Operating Segments
  • 8.8.3 Business Strategy
• 8.9 DiaSorin (Luminex Corporation)
  • 8.9.1 Business Overview
  • 8.9.2 Operating Segments
  • 8.9.3 Business Strategy
• 8.10 Bruker Corporation
  • 8.10.1 Business Overview
  • 8.10.2 Operating Segments
  • 8.10.3 Business Strategy
• 8.11 T2 Biosystems, Inc.
  • 8.11.1 Business Overview
  • 8.11.2 Revenue by Source
  • 8.11.3 Business Strategy
• 8.12 Immunexpress, Pty Ltd
  • 8.12.1 Business Overview
  • 8.12.2 Business Strategy