세계의 패혈증 진단 제품 시장 동향 및 예측(-2031년)

Sepsis remains one of the most urgent and costly challenges in modern healthcare. Characterized by a life-threatening immune response to infection, sepsis affects an estimated 27 million people and causes 5 million deaths worldwide each year, including approximately 2 million cases and 270,000 deaths in the United States alone. Early detection is critical to survival, yet remains difficult due to the condition's complex and variable presentation across patients. As the most expensive condition treated in U.S. hospitals, the need for accurate, rapid, and accessible diagnostic tools has never been greater.

Kalorama Information's "Worldwide Sepsis Diagnostic Products: Market Insights and Forecasts to 2031" delivers a comprehensive assessment of the worldwide market for sepsis diagnostic products, including in vitro diagnostics (IVD), molecular diagnostics, and related testing approaches. The report provides global sales data and projections through 2031 for all major world regions and for key individual markets-the United States, China, India, and Japan.

Comprehensive Methodology and Reliable Data

Market estimates are presented in current U.S. dollars, representing total end-user spending on sepsis diagnostic products and consumables by clinical laboratories, hospitals, and physicians' offices. The analysis excludes the cost of diagnostic instruments and systems implementing these tests, ensuring that reported figures specifically reflect product utilization trends. All currency conversions were made using purchasing power indices for consistency across regions.

The study is built upon extensive primary and secondary research, including interviews with industry experts and manufacturers, government and trade data, and the latest public filings from market leaders. Selected Kalorama publications and industry reports were also leveraged to validate findings and identify evolving trends.

Why This Report Matters

With healthcare systems worldwide prioritizing early detection, cost containment, and patient outcomes, this report provides the critical market intelligence needed to evaluate the sepsis diagnostics landscape. It offers a data-driven foundation for:

• Market sizing and forecasting across key geographies
• Competitive benchmarking among diagnostic developers
• Strategic planning for investment, partnerships, and product expansion

As the clinical and economic burden of sepsis continues to drive innovation, "Worldwide Sepsis Diagnostic Products: Market Insights and Forecasts to 2031" equips decision-makers with the insights necessary to navigate a growing and essential area of global healthcare diagnostics.

TABLE OF CONTENTS

CHAPTER 1: EXECUTIVE SUMMARY

• OVERVIEW
• HIGHLIGHTS
  • Diagnostic Approaches and Technologies
  • Market Size and Competition
  • 3 Key Takeaways from This Report
• SCOPE AND METHODOLOGY
  • Methodology
  • Sources of Information
• ABOUT KALORAMA INFORMATION

CHAPTER 2: INTRODUCTION

• SEPSIS OVERVIEW
  • Diagnostic Tools
  • Scope of Use
• PROFESSIONAL GUIDELINES AND DEFINITIONS
  • SIRS Criteria and Sepsis-1
  • Sepsis-2
  • Sepsis-3
  • Surviving Sepsis Campaign
  • SOFA and qSOFA Scores
• MARKET CONSIDERATIONS
  • Table 2-1: Total Global Market for Sepsis Diagnostics, 2022-2031 ($ million) [Biomarkers, Mass Spectrometry (MS), Molecular Assays]
  • Figure 2-1: Total Global Market for Sepsis Diagnostics, 2022-2031 ($ million) [Biomarkers, Mass Spectrometry (MS), Molecular Assays]

CHAPTER 3: BIOMARKERS

• Table 3-1: Top Biomarkers Used in Sepsis, 2025
• Lactate, C-Reactive Protein (CRP), Procalcitonin (PCT) and Other Biomarkers
• Overview
  • Figure 3-1: Global Market Share of Biomarkers Used in Sepsis Diagnosis, by Test Volume, 2025 (%) [C-Reactive Protein (CRP), Lactate, Procalcitonin (PCT) and Others]
  • Figure 3-2: Global Market Share of Biomarkers Used in Sepsis Diagnosis, by Sales Revenues, 2025 (%) [C-Reactive Protein (CRP), Lactate, Procalcitonin (PCT) and Others]
• BIOMARKERS USED FOR SEPSIS
  • Procalcitonin (PCT)
• C-Reactive Protein (CRP)
  • Lactate
  • Cytokines
  • RNA, mRNA, microRNA (miRNA)
  • Proadrenomedullin (ProADM)
  • D-Dimer
• MULTI-MARKER APPROACHES
  • Key Companies and Platforms

CHAPTER 4: MOLECULAR ASSAYS AND MASS SPECTROMETRY

• PATHOGEN IDENTIFICATION AND CHARACTERIZATION
• MULTIPLEX MOLECULAR ASSAYS
  • Multiplex Molecular Assays Used for Sepsis
    • Table 4-1: Multiplex Molecular Assays Used for Sepsis, 2025
  • Mass Spectrometry
  • Products for Microbe Identification and AST
    • Table 4-2: Selected Mass Spectrometry Products Used for Microbial ID and AST, 2025
    • Table 4-3: Systems and Products for Bacterial Culture, Staining, Incubation, 2025
  • Personalized Medicine

CHAPTER 5: MAJOR SEPSIS-RELATED PRODUCTS ON THE MARKET AND UNDER DEVELOPMENT

• DIAGNOSTIC PRODUCTS AND EMERGING TECHNOLOGIES
  • Table 5-1: Sepsis Diagnostic Products on the Market, 2025
• PRODUCT DEVELOPMENT ISSUES
  • The Challenge in Modern Sepsis Management
  • The Financial Incentive vs. The Adoption Hurdle
  • The Chasm Between Innovation and Practice
  • The Verification and Liability Problem
  • Current Status
• ARTIFICIAL INTELLIGENCE AND MACHINE LEARNING IN SEPSIS DIAGNOSIS
  • Applications of AI/ML in Sepsis Diagnosis
  • Currently Available AI/ML Products for Sepsis Diagnosis
  • AI/ML Products Under Development and Emerging Trends
  • Future AI/ML Systems Are Integrating Diverse Data Types Beyond Standard EHRs
  • Challenges to Adoption and Performance
  • Future Trends

CHAPTER 6: SEPSIS DIAGNOSTICS MARKET ESTIMATES

• Total Sepsis Diagnostics Market
  • Table 6-1: Total Global Market for Sepsis Diagnostics, 2022-2031 ($ million) [Biomarkers, Mass Spectrometry (MS), Molecular Assays]
  • Figure 6-1: Total Global Market for Sepsis Diagnostics, 2022-2031 ($ million) [Biomarkers, Mass Spectrometry (MS), Molecular Assays]
  • Figure 6-2: Total Global Market Share for Sepsis Diagnostics, 2025 vs. 2031 (%) [Biomarkers, Mass Spectrometry (MS), Molecular Assays]
  • Table 6-2: Global Market for Sepsis Diagnostics, by Region, 2022-2031 ($ million) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
  • Figure 6-3: Global Market for Sepsis Diagnostics, by Region, 2022-2031 ($ million) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
  • Figure 6-4: Global Market for Sepsis Diagnostics, Share by Region, 2025 vs. 2031 (%) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
• Sepsis Biomarker Market
  • Table 6-3: Total Market for Sepsis Biomarkers, 2022-2031 ($ million) [Lab Immunoassay Tests, Rapid Immunoassay Tests]
  • Figure 6-5: Global Market for Sepsis Biomarkers, 2022-2031 ($ million) [Lab Immunoassay Tests, Rapid Immunoassay Tests]
  • Table 6-4: Global Market for Sepsis Biomarkers, by Region, 2022-2031 ($ million) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
  • Figure 6-6: Global Market for Sepsis Biomarkers, Share by Region, 2025 vs. 2031 (%) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
• Market for Sepsis Molecular Assays and Mass Spectrometry
  • Table 6-5: Total Market for Sepsis Molecular Assays and Mass Spectrometry (MS) Tests, 2022-2031 ($ million)
  • Figure 6-7: Global Market for Sepsis Molecular Assays and Mass Spectrometry (MS) Tests, 2022-2031 ($ million)
  • Table 6-6: Global Market for Sepsis Molecular Assays and Mass Spectrometry (MS) Tests, by Region, 2022-2031 ($ million) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
  • Figure 6-8: Global Market for Sepsis Molecular Assays and Mass Spectrometry (MS) Tests, by Region, 2022-2031 ($ million) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
  • Figure 6-9: Global Market for Sepsis Molecular Assays and Mass Spectrometry (MS) Tests, by Region, 2025 vs. 2031 (%) [Africa/Middle East, Asia/Pacific (China, Japan, Other), Central/South America, Eastern Europe, North America (Canada/Mexico, United States), Western Europe]
• Competitive Positions of the Major Players
  • Table 6-7: Leading Providers of Sepsis Diagnostic Products, by 2025 Sales ($ million) and Share (%)
  • Figure 6-10: Leading Providers of Sepsis Diagnostic Products, by Sales, 2025 ($ million)
  • Figure 6-11: Leading Providers of Sepsis Diagnostic Products, by Share, 2025 (%)
• Market Leader Discussion

CHAPTER 7: COMPANY PROFILES

• MARKET DYNAMICS
  • Inactive Companies and Products
  • Companies No Longer Focused on Sepsis Diagnostics
  • Companies Currently Active in the Sepsis Diagnostics Market
• ABBOTT
  • Immunoassay Biomarkers
  • Molecular Diagnostics
  • Point-of-Care (POC) Solutions
  • Microbiology and Culture Systems
• ABIONIC
  • abioSCOPE-R Platform and PSP Test
  • Pancreatic Stone Protein (PSP) as a Sepsis Biomarker
  • Testing Process and Interpretation
  • Clinical Benefits of PSP Detection
  • Limitations and Future Outlook
• ACCELERATE DIAGNOSTICS
  • Core Technologies for Sepsis Management
  • Accelerate Pheno-R System
  • Accelerate Arc(TM) System
  • Future Innovation: Accelerate WAVE(TM) System
  • Strategic Impact on Sepsis Care
• BAYESIAN HEALTH
  • Sepsis Detection with TREWS
  • Workflow Integration and Explainability
  • Clinical Validation and Impact
  • Challenges and Future Outlook
  • Broader Applications
• BECTON, DICKINSON AND COMPANY (BD)
  • Blood Culture
  • Mass Spectrometry
• BIOMERIEUX
  • Traditional Microbiology
  • Biomarkers for Sepsis
  • Blood Culture Systems
  • Immunoassays
  • Mass Spectrometry
• BRUKER CORPORATION
  • Mass Spectrometry
  • Molecular Diagnostics
  • Strategic Acquisitions
• CELLECTRIC BIOSCIENCES
  • Benefits for Sepsis Diagnosis and Management
  • Limitations and Challenges
• CUBE DX
  • Core Technology and Applications
  • Technology Platform: hybcell
  • Benefits for Sepsis Management
  • Limitations and Considerations
• CYTOVALE
  • IntelliSep: Technology Overview
  • Risk Stratification Bands
  • Clinical Impact and Benefits
  • Limitations and Considerations
• DANAHER CORPORATION
  • Cepheid
  • Integrated Strategy
• DIASORIN
  • Molecular Diagnostics Expansion
• FLUILUX
  • Technology Overview
  • Clinical Impact on Sepsis Management
  • Limitations and Considerations
• GENMARK DIAGNOSTICS/HOLOGIC
• GRADIENTECH
• HELIXBIND
• IMMUNEXPRESS
  • SeptiCyte RAPID
  • Next Generation Products
• KARIUS
• INFLAMMATIX
  • TriVerity(TM)
  • Research
• MEMED
  • MeMed BV
  • MeMed Severity
• MOLZYM GMBH
  • MolYsis Technology
  • Diagnostic Products
  • Clinical Impact and Considerations
• MOMENTUM BIOSCIENCES
• NOVUS DIAGNOSTICS
• OCEAN DX
• PRENOSIS
• Q-LINEA
• QIAGEN
  • QIAstat-Dx
  • Sample Preparation Technologies
  • Digital PCR (dPCR)
  • Antimicrobial Resistance (AMR) Research Solutions
• QUIDELORTHO
  • VITROS Sepsis Assay Menu
  • Point-of-Care (POC) Testing Solutions
  • Benefits in Sepsis Management
  • Limitations and Considerations
• RADIOMETER
  • Blood Gas Analysis
  • Immunoassays
  • Integrated Solutions and Clinical Intelligence
• ROCHE
  • Biomarkers
  • Molecular Assays
  • Point-of-Care and Critical Care Solutions
  • Digital and Integrated Solutions
• SEEGENE
  • Magicplex(TM) Sepsis Real-time Test
  • Underlying Technology
  • Clinical Benefits
  • Limitations
• SIEMENS HEALTHINEERS
• T2 BIOSYSTEMS
  • The T2Dx-R Instrument
  • T2Candida-R Panel
  • T2Bacteria-R Panel
  • T2Resistance-R Panel
  • The T2MR Technology
• TEMPUS
• THERMO FISHER SCIENTIFIC
  • Immunoassays
  • Microbiology
  • Blood Culture