Sepsis Diagnostics Market worth $1.22 billion by 2031 - Exclusive Report by MarketsandMarkets™

DELRAY BEACH, Fla., Sept. 11, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Sepsis Diagnostics Market is projected to reach USD 1.22 billion by 2031 from USD 0.83 billion in 2026, at a CAGR of 7.9% during the forecast period.

Browse 400 market data Tables and 310 Figures spread through 500 Pages and in-depth TOC on "Sepsis Diagnostics Market- Global Forecast to 2031"

Sepsis Diagnostics Market Size & Forecast:

• Market Size Available for Years: 2026–2031
• 2026 Market Size: USD 0.83 billion
• 2031 Projected Market Size: USD 1.22 billion
• CAGR (2026–2031): 7.9%

Sepsis Diagnostics Market Trends & Insights:

• North America accounted for the largest market share, by region, in 2025: 43.2%.
• By product, in 2025, the assays & kits & reagents segment had the largest share of 40.7%.
• Hospital & specialty clinics dominated the sepsis diagnostics market in 2025, with a share of 62.7%.

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Growth is driven by the high incidence of sepsis and bloodstream infections (BSIs), increasing adoption of rapid molecular and syndromic diagnostics, a growing focus on antimicrobial stewardship (AMS), the expansion of biomarker-based testing, and rising demand for faster pathogen identification and treatment decision support.

Assays & reagent kits accounted for the largest share of the global sepsis diagnostics market, by product, in 2025.

By product, the sepsis diagnostics market is segmented into blood culture media, assays & reagent kits, instruments, and software. In 2025, assays & reagent kits accounted for the largest share, driven by their recurring use across blood culture testing, immunoassays, molecular diagnostics, antimicrobial susceptibility testing, and biomarker-based sepsis assessment. Growing demand for pathogen detection kits, sepsis biomarker assays, PCR-based reagents, and syndromic testing panels continues to support this segment's dominance. Instruments also held a significant share, driven by the increasing installation of automated blood culture systems, molecular diagnostic platforms, mass spectrometry systems, and clinical chemistry analyzers in hospitals and reference laboratories.

Blood culture/microbiology testing accounted for the largest share of the sepsis diagnostics market, by technology, in 2025.

By technology, the market is segmented into blood culture/microbiology testing, immunoassays, molecular diagnostics, flow cytometry, mass spectrometry, and clinical chemistry and blood gas analysis. In 2025, blood culture/microbiology testing accounted for the largest share, reflecting its established role as the standard approach for detecting bloodstream infections and supporting antimicrobial susceptibility testing. Molecular diagnostics is expected to grow strongly over the forecast period, supported by increasing adoption of PCR/RT-PCR, multiplex PCR panels, microarrays, FISH/PNA-FISH, DNA sequencing, NGS, LAMP, and TMA-based methods for faster pathogen identification and resistance marker detection.

Bacterial sepsis accounted for the largest share of the sepsis diagnostics market, by pathogen type, in 2025.

By pathogen type, the market is segmented into bacterial sepsis, fungal sepsis, and other pathogen types, including parasitic and polymicrobial sepsis. In 2025, bacterial sepsis accounted for the largest share, supported by the high burden of bacterial bloodstream, hospital-acquired, and ICU-related infections, as well as the strong clinical need for pathogen identification and antimicrobial susceptibility testing. Gram-negative and Gram-positive bacterial sepsis remain key subsegments due to their significant role in severe infections and antimicrobial resistance concerns. Fungal sepsis is expected to attract attention as cases rise among immunocompromised patients, oncology patients, transplant recipients, and critically ill ICU patients.

Laboratory tests accounted for the largest share of the sepsis diagnostics market, by test type, in 2025.

By test type, the sepsis diagnostics market is segmented into laboratory and point-of-care tests. In 2025, laboratory tests accounted for the largest share, driven by the central role of hospital laboratories, microbiology departments, and reference laboratories in blood culture testing, molecular diagnostics, immunoassays, antimicrobial susceptibility testing, mass spectrometry, and clinical chemistry testing. Point-of-care tests are expected to grow rapidly due to rising demand for rapid sepsis screening, emergency department testing, ICU-based decision support, and decentralized biomarker-based assessment.

Whole blood accounted for the largest share of the sepsis diagnostics market, by sample type, in 2025.

By sample type, the sepsis diagnostics market is segmented into whole blood and serum. In 2025, whole blood accounted for the largest share, supported by its established use in blood culture testing, molecular pathogen detection, bloodstream infection diagnosis, and sepsis-related microbiology workflows. Whole blood remains central to sepsis diagnosis because detecting bloodstream infections and identifying pathogens require direct or culture-based analysis of blood samples. Serum-based testing also holds an important share due to its use in immunoassays, inflammatory biomarker testing, host-response assessment, and clinical chemistry-based evaluation of sepsis severity.

Hospitals & specialty clinics accounted for the largest share of the sepsis diagnostics market, by end user, in 2025.

By end user, the market is segmented into hospitals and specialty clinics, pathology and reference laboratories, and research laboratories, academic institutes, and CROs. In 2025, hospitals and specialty clinics accounted for the largest share, driven by the high sepsis burden in emergency departments, ICUs, inpatient wards, and critical care settings. Hospitals are the primary users of blood culture systems, rapid molecular tests, clinical chemistry analyzers, blood gas analyzers, and antimicrobial stewardship-linked diagnostic workflows. Pathology and reference laboratories also play an important role by supporting high-volume infectious disease testing, confirmatory diagnostics, molecular testing, and outsourced microbiology services.

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North America accounted for the largest regional share of the global sepsis diagnostics market in 2025.

The sepsis diagnostics market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2025, North America accounted for the largest share, driven by advanced hospital infrastructure, high adoption of automated blood culture systems and molecular diagnostics, strong antimicrobial stewardship initiatives, favorable adoption of rapid diagnostics, and the presence of leading diagnostic companies. Europe remains a significant market due to established microbiology laboratory networks, robust infectious disease testing infrastructure, and an increasing focus on sepsis management and antimicrobial resistance control. Asia Pacific is expected to grow fastest, driven by rising healthcare expenditure, expanding hospital infrastructure, a growing burden of infectious diseases and bloodstream infections, and increasing adoption of automated and molecular diagnostic platforms.

Key Players

Leading players in the Sepsis Diagnostics companies include F. Hoffmann-La Roche Ltd. (Switzerland), Danaher Corporation (US), PHC Holdings Corporation (Japan), Hologic, Inc. (US), Agilent Technologies, Inc. (US), Becton, Dickinson and Company (US), Koninklijke Philips N.V. (Netherlands), Merck KGaA (Germany), Bio SB (US), and Sakura Finetek Japan Co., Ltd. (Japan).

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Sepsis Diagnostics Market - Investment & funding +Merger & Acquisition

Investment Funding Context

Investment activity in sepsis diagnostics is enabling earlier recognition of sepsis, faster pathogen identification, and rapid antimicrobial susceptibility testing (AST). Recent financing reflects strong backing for diagnostic developers approaching or expanding commercialization. Cytovale raised USD 84 million in Series C financing in November 2023, led by Norwest Venture Partners, followed by USD 100 million in Series D financing in October 2024, led by Sands Capital, to expand adoption of IntelliSep in US hospitals. The Series C included the conversion of bridge notes. Inflammatix secured USD 57 million in Series E financing in September 2024, led by Khosla Ventures and Think.Health, to support regulatory work and early commercialization of its TriVerity acute infection and sepsis test.

Capital is also supporting treatment guidance and testing closer to patients. Selux Diagnostics announced in April 2024 that RA Capital Management led a USD 48 million funding round for US commercialization of its rapid AST platform, including testing of positive blood cultures. In October 2024, Ad Astra Diagnostics announced a USD 5 million BARDA contract, with potential total funding of up to USD 12.6 million, to develop a blood-count and severe-infection detection system. The latter amount is a potential contract ceiling; the award and Selux financing cover applications beyond sepsis alone.

Established suppliers also invest through internal development: bioMérieux reported EUR 507.4 million (USD 572.6 million) in group R&D expenses in 2025, though this is not a sepsis-specific investment figure. Commercial adoption remains a material constraint. Its EUR 141 million (USD 159.14 million) impairment of VITEK REVEAL technology in 2025 reflected slower market development and a more gradual commercial ramp-up. Analyst assessment: funding prospects depend on clinical utility, hospital implementation, sustained test utilization, and technical performance.

Revenue Shift Context

Sepsis diagnostics has an established consumables-led business model, with recurring demand for blood-culture bottles, molecular panels, AST consumables, and biomarker reagents. Revenue opportunities are expanding through additional diagnostic information per suspected-infection episode and greater use of rapid tests. As a broader company-level example, bioMérieux generated EUR 3,393.2 million in reagent revenue out of EUR 4,069.8 million in total revenue in 2025, equivalent to approximately 83.4%. The incremental revenue opportunity varies by technology. Roche's Elecsys BRAHMS PCT assay supports risk assessment and antibiotic-discontinuation decisions, including measurement over time. Danaher's Beckman Coulter reports monocyte distribution width through its Early Sepsis Indicator as part of a routine complete blood count with differential. Dedicated tests can generate additional consumable revenue, while markers embedded in existing workflows may strengthen analyzer adoption and utilization without a separately ordered assay.

Mergers and Acquisitions

Recent transactions show buyers adding complementary capabilities across sample preparation, pathogen detection, and treatment guidance. bioMérieux acquired Day Zero Diagnostics' sequencing assets, and Bruker added rapid AST technology, microbial sample preparation, and metagenomics capabilities. These deals signal strategic interest in combining novel technologies with established laboratory access. The Waters combination with BD's Biosciences & Diagnostic Solutions business represents a broader ownership change that also affects the competitive landscape in microbiology and infectious-disease diagnostics.

SEPSIS DIAGNOSTICS MARKET: MERGERS AND ACQUISITIONS, JANUARY 2023–JULY 2026

Company Revenue Share Details

The five leading companies in the supplied 2025 sepsis diagnostics market estimates are bioMérieux SA (France), Becton, Dickinson and Company (US), Danaher Corporation (US), F. Hoffmann-La Roche AG (Switzerland), and Thermo Fisher Scientific Inc. (US). Together, they account for around 56%-58% of the market. This indicates a market led by a relatively small group of established suppliers, with a substantial remaining share distributed among other participants. The leaders participate through different diagnostic workflows. bioMérieux's portfolio spans blood culture, molecular identification, AST, and procalcitonin testing; BD's BACTEC portfolio supports blood-culture testing. Danaher participates through Beckman Coulter's sepsis-related hematology offering, while Roche and Thermo Fisher Scientific offer procalcitonin assays. Existing analyzer placements and laboratory relationships can support repeat consumable purchasing and adoption of additional tests, but competitive advantages differ across these technology categories

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