United States Sepsis Diagnostics Market US$ 1,435.24 million by 2031: Trends, Challenges & Market Opportunities

Global Sepsis Diagnostics Market reached US$ 710.13 million in 2023 and is expected to reach US$ 1,435.24 million by 2031, growing at a CAGR of 9.5% during the forecast period 2024-2031.

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United States: Recent Industry Developments

✅ November 2025: Abbott Laboratories launched an advanced rapid sepsis diagnostic test improving early detection in ICU settings.

✅ October 2025: BioMérieux received FDA clearance for a new point-of-care sepsis detection device that reduces diagnosis time.

✅ September 2025: Increased adoption of AI-powered diagnostic platforms enhanced sepsis prognosis and personalized treatment protocols.

GCC: Recent Industry Developments

✅ November 2025: Dubai Health Authority partnered with diagnostic firms to implement rapid sepsis screening in emergency departments.

✅ October 2025: Saudi Arabia's Ministry of Health initiated nationwide programs to standardize sepsis diagnostic guidelines.

✅ September 2025: Investment in molecular diagnostic technologies grew to support early sepsis detection in GCC hospitals.

MENA: Recent Industry Developments

✅ November 2025: Egypt's health sector expanded capabilities for sepsis biomarker testing through public-private partnerships.

✅ October 2025: Jordan introduced training programs to improve healthcare professionals' proficiency in sepsis diagnostics.

✅ September 2025: Increased funding for research on regional sepsis epidemiology supported development of tailored diagnostic tools.

Major Growing Players:

Thermo Fisher Scientific Inc., Bruker Corporation, Merck Millipore, Siemens Healthineers, Becton, Dickinson, and Company, Hoffmann-LA Roche Ltd, T2 Biosystems, Inc., Response Biomedical Corp., BioMérieux SA, and Immunexpress Inc.

Latest M&A/Partnerships

Strategic collaborations dominate:

1. Danaher-Oxford (Nov 2023, active 2025): Cepheid molecular diagnostics for sepsis subtypes/personalized care.​

2. Roche-Prenosis (Apr 2024): ImmunoScore AI SaMD for rapid sepsis risk prediction.​

3. Asep Medical-Sansure Biotech (Jan 2023): Sepset(ER) commercialization in China. No outright acquisitions; M&A expected 2025 as big players (bioMérieux/Abbott/BD) acquire AI/POC startups.

Forecast Projection:

The Global Sepsis Diagnostic Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Global Sepsis Diagnostic Market report is built on solid intelligence - powered by both primary and secondary research. Our analysts have deep-dived into every factor that can influence your business roadmap, including government regulations, competitive landscape, tech innovations, historical market behavior, upcoming breakthroughs, adjacent industry trends, market volatility, growth prospects, and potential risks.

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Key Segments:

By Product: (Instruments, Software, Blood Culture Media, Assays & Reagents, Others)

By Technology: (Flow Cytometry, Microbiology, Biomarkers, Molecular Diagnostics, Microfluidics, Others)

By Diagnostic Method: (Automated Diagnostics,Conventional Diagnostics)

By Pathogen: (Fungal Sepsis, Bacterial Sepsis, Other Pathogens)

By End-user: (Hospitals, Pathology & Reference Laboratories, Others

Regional Analysis for Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: sets the stage by defining the full scope of the report and delivering an executive summary of key market segments across regions, product types, and applications. It provides a comprehensive snapshot of current market sizes and reveals future growth potential, offering a clear vision of how the market will evolve in the short, mid, and long term.

Chapter 2: uncovers critical insights and highlights the most impactful emerging trends shaping the Sepsis Diagnostic market's future - essential knowledge for investors and strategists looking to stay ahead.

Chapter 3: dives deep into the competitive landscape, delivering an in-depth analysis of Sepsis Diagnostic manufacturers. It covers market share dynamics, strategic developments, and the latest mergers and acquisitions that are redefining the industry.

Chapter 4: profiles the market's leading players, offering detailed views of their revenue streams, profit margins, product portfolios, and recent innovations - arming you with the intel to benchmark and strategize effectively.

Chapters 5 & 6: break down revenue performance by region and country, providing a quantitative analysis that spotlights growth hotspots, development prospects, and the unique opportunities each market offers across the globe.

Chapter 7: explores market segmentation by type, revealing the size and untapped potential of each segment - guiding you toward lucrative "blue ocean" opportunities that competitors may have overlooked.

Chapter 8: analyzes the market by application, evaluating downstream sectors with the highest growth potential and identifying promising areas for expansion and investment.

Chapter 9: maps the entire industry supply chain, tracing upstream suppliers to downstream distributors, giving you full visibility into critical business linkages and value drivers.

Chapter 10: wraps up with a powerful summary of the report's key findings and strategic takeaways, delivering the must-know insights every industry stakeholder needs to make confident, forward-looking decisions.

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Government Regulations

FDA:

1. TriVerity (Inflammatix, Jan 2025): 510(k) clearance for host-response (29-gene) bacterial/viral/sepsis risk test; Breakthrough Designation (Nov 2023).​

2. HCT/Ps guidance (Jan 2025): Reduces sepsis transmission risk via donor screening.​

3. EMA: Mid-year report emphasizes rapid diagnostics/antimicrobials; S3 guidelines update (Jul 2025). Global HAI/sepsis focus drives POC/molecular mandates.​

Supply Chain

1. Demand: Hospitals (60%+), rising HAIs/AMR; molecular diagnostics fastest (PCR/NGS).​
Challenges:

2. Reagents/instruments shortages (post-COVID); high CAPEX limits emerging markets.​

3. Tariffs/supply volatility: Asia-Pacific sourcing disruptions.​

4. Mitigation: Automation/AI integration; outsourcing to reference labs (fastest segment).

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