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Worldwide Sepsis Diagnostic Products: Market Insights and Forecasts to 2031
Publication Date: November 12, 2025
Tags: Diagnostics, In Vitro Diagnostics (IVD), IVD, Mass Spectrometry, Molecular
Pages: 190
SKU: 25-077KA
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.
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® 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® System
Accelerate Arc™ System
Future Innovation: Accelerate WAVE™ 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
bioMérieux
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™
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™ Sepsis Real-time Test
Underlying Technology
Clinical Benefits
Limitations
Siemens Healthineers
T2 Biosystems
The T2Dx® Instrument
T2Candida® Panel
T2Bacteria® Panel
T2Resistance® Panel
The T2MR Technology
Tempus
Thermo Fisher Scientific
Immunoassays
Microbiology
Blood Culture
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