Sepsis Diagnostics Market to Reach US$ 1,226.52 Million by 2028, Growing at 9.2% CAGR from 2021 Baseline Amid AI and POC Advances

United States of America – December 30, 2025 – According to The Insight Partners, the sepsis diagnostics market is projected to reach US$ 1,226.52 million by 2028 from US$ 661.83 million in 2021; it is expected to grow at a CAGR of 9.2% from 2021 to 2028. The sepsis diagnostics market continues to evolve rapidly, fueled by cutting-edge technologies that enable quicker pathogen identification and host-response profiling. Healthcare providers worldwide now rely on advanced instruments, molecular diagnostics, and point-of-care tests to combat this life-threatening condition, where every hour counts in preventing organ failure. Recent launches, such as Roche Diagnostics' AI-powered sepsis alerts and bioMérieux's enhanced PCT assays, underscore the push toward precision medicine in critical care settings.​

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Market Leaders Spearhead Innovation

Industry frontrunners like Abbott, F. Hoffmann-La Roche Ltd., and Thermo Fisher Scientific Inc. lead the charge in sepsis diagnostics advancements. These companies dominate with comprehensive portfolios covering instruments, reagents, and software tailored for automated workflows. For instance, BD and Danaher integrate monocyte distribution width parameters into routine lab testing, allowing early sepsis screening without specialized equipment.​

Immunexpress Inc. stands out with its SeptiCyte platform, now expanding into point-of-care genomics for non-pathogen-specific detection. bioMérieux SA bolsters its position through VITEK systems for rapid antimicrobial susceptibility testing, while Luminex Corporation and T2 Biosystems focus on multiplex assays that differentiate bacterial from viral causes. Such innovations reflect a collaborative effort among market leaders to shorten turnaround times from days to hours, transforming sepsis management in hospitals and clinics.​

Key Segments Driving Growth

The sepsis diagnostics landscape spans diverse products, technologies, methods, and test types, each addressing unique clinical needs. Instruments hold a commanding presence, powering PCR analyzers and immunoassay systems for high-throughput results. Reagents and assays complement these by enabling biomarker detection like procalcitonin and C-reactive protein, essential for risk stratification.​

Molecular diagnostics emerges as the fastest-growing technology, outpacing microbiology with PCR and next-generation sequencing for pathogen and resistance gene identification. Automated diagnostics surpass conventional methods by integrating AI for error-free processing and electronic health record alerts. Point-of-care tests gain traction alongside laboratory diagnostics, offering bedside results in under 30 minutes via cartridge-based systems.​

• By Product: Instruments lead for speed; reagents and assays for precision; blood culture media for cost-effectiveness; software for data integration.​
• By Technology: Molecular diagnostics surges ahead; flow cytometry and microfluidics enable real-time analysis; immunoassay and biomarkers support host-response profiling.​
• By Method: Automated diagnostics dominate workflows; conventional methods provide confirmatory depth.​
• By Test Type: Point-of-care tests accelerate triage; laboratory tests ensure comprehensive pathogen profiling.​

These segments align with global demands for scalable solutions in emergency departments and ICUs, were sepsis claims lives without swift intervention.​

Market Size, Share, Trends, Analysis, and Forecast by 2031

Experts project steady expansion in the sepsis diagnostics market through 2031, driven by rising sepsis incidence, technological integration, and policy mandates for early screening. While exact figures vary by source, consensus points to robust growth from current valuations toward USD 1.8-2.0 billion globally by the early 2030s, with a CAGR around 8%.​

• Market Size and Share: Instruments capture the largest share; bioMérieux SA holds a leading position, followed by Roche, Thermo Fisher, Danaher, and Immunexpress among key players.​
• Key Trends: Shift to AI-driven decision support and multiplex panels; point-of-care expansion reduces lab dependency; host-response biomarkers like gene expression profiles rise.​
• Analysis: Microbiology remains the gold standard, but molecular diagnostics grows fastest due to hour-level results; automated methods cut errors by integrating with EHRs.​
• Forecast to 2031: Anticipate 7-9% CAGR, propelled by POC adoption and antimicrobial stewardship; sustainability focus on recyclable kits emerges.​

Global and Regional Analysis

North America commands the largest share, benefiting from high sepsis prevalence, regulatory approvals like IntelliSep, and strong reimbursement policies for advanced tools. Europe follows closely with initiatives like NHS protocols in the UK and EU digitization efforts in Germany and France, emphasizing standardized sepsis diagnostics approaches.​

Asia-Pacific accelerates as the fastest-growing region, driven by infectious disease burdens in China, India, and Japan alongside rapid infrastructure upgrades. Latin America and the Middle East & Africa show emerging promise through international partnerships and increasing healthcare investments, gradually closing the gap with developed markets.​

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Updated Market News Highlights

Recent developments signal a transformative phase. In 2025, Roche introduced AI sepsis alerts for cobas platforms, while Thermo Fisher launched gene expression-based biomarker indices. Danaher enhanced hematology analyzers with automated flags, and Immunexpress deployed SeptiCyte RAPID globally.​

October 2024 saw Trinity Biotech acquire stakes in Novus Diagnostics for POC acceleration. April 2024 brought Roche-Prenosis collaboration on ImmunoScore AI software. These moves, alongside FDA nods for cartridge systems like TriVerity, highlight 2025's focus on bedside precision and reduced mortality.​

The sepsis diagnostics market stands at a pivotal juncture, where innovation meets urgency. As providers adopt these tools, patient outcomes improve, antimicrobial resistance eases, and global healthcare systems strengthen against this silent killer. Stakeholders anticipate continued momentum through 2031.

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