Bloodstream Infection Testing Market – Global Industry Size, Share, Trends, Opportunity, & Forecast Segmented By Product (Reagents & Consumables, Instruments), By Sample Type (Whole Blood, Blood Culture), By Technology (PCR, Mass Spectroscopy, In Situ Hybridization, Others), By End User (Hospitals & Diagnostic Centers, Custom Laboratory Service Providers, Academic & Research Institutes, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 850.50 Million
CAGR (2026-2031)	5.01%
Fastest Growing Segment	Reagents and Consumables
Largest Market	North America
Market Size (2031)	USD 1140.41 Million

Market Overview

The Global Bloodstream Infection Testing Market will grow from USD 850.50 Million in 2025 to USD 1140.41 Million by 2031 at a 5.01% CAGR. The Global Bloodstream Infection Testing Market comprises diagnostic instruments, consumables, and software designed to detect and identify pathogens, including bacteria and fungi, within blood samples. The market’s growth is primarily driven by the escalating prevalence of sepsis and the urgent need to manage antimicrobial resistance through precise etiological diagnosis. Underscoring this critical demand, the European Centre for Disease Prevention and Control reported that in 2024, the estimated total EU incidence of third-generation cephalosporin-resistant Escherichia coli bloodstream infections was 11.03 per 100,000 population. These figures highlight the vital role of accurate testing solutions in guiding appropriate therapeutic interventions and improving patient outcomes.

However, a significant challenge impeding broader market expansion is the substantial cost and technical complexity associated with automated molecular diagnostic platforms. Many healthcare facilities, particularly in developing regions, face budgetary constraints that prevent the adoption of these rapid testing systems, forcing reliance on slower, traditional culture methods. This financial barrier delays time-sensitive treatment decisions and restricts the global penetration of modern diagnostic technologies, limiting their accessibility where they are often most needed.

Key Market Drivers

The increasing burden of antimicrobial resistance is a primary catalyst propelling the Global Bloodstream Infection Testing Market. As pathogens evolve mechanisms to withstand standard treatments, healthcare providers are prioritizing diagnostic solutions that can not only identify the causative agent but also determine its antibiotic susceptibility profile. This escalation in resistant strains necessitates the adoption of advanced testing platforms to guide precise therapeutic interventions and prevent mortality. Highlighting this critical trend, according to the UK Health Security Agency, November 2024, in the 'English surveillance of antibiotic prescribing and utilisation report', cases of bacteraemia caused by antibiotic resistance in England increased by 9.3% year-over-year, reaching 20,484 cases in 2024. Such data underscores the urgent market demand for diagnostics capable of managing complex, resistant bloodstream infections effectively.

Simultaneously, advancements in rapid molecular diagnostic technologies are revolutionizing the speed and accuracy of pathogen detection. Traditional culture-based methods often require days to yield results, a delay that can be fatal in sepsis cases; however, modern platforms now offer actionable insights within hours, significantly improving clinical workflows. Demonstrating this technical leap, according to T2 Biosystems, March 2024, in a study published in the 'Journal of Clinical Microbiology', the T2Resistance Panel achieved 94.7% sensitivity and delivered results in just 4.4 hours, compared to over 58 hours for standard blood culture methods. This functional superiority is attracting substantial capital to the sector to support commercial scaling. According to Respiratory Therapy, in 2024, diagnostic company Cytovale raised $100 million in Series D funding to accelerate the expansion of its rapid sepsis testing technology across hospital systems.

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Key Market Challenges

The substantial cost and technical complexity associated with automated molecular diagnostic platforms constitute a significant challenge impeding the growth of the Global Bloodstream Infection Testing Market. High acquisition costs and the requirement for specialized technical proficiency render these systems inaccessible to many healthcare facilities, particularly in regions with strict budgetary limitations. This financial and operational barrier forces laboratories to depend on slower, traditional culture methods, delaying time-sensitive treatment decisions and restricting the global penetration of modern testing technologies.

This economic pressure is further evidenced by the minimal allocation of healthcare funds towards diagnostic solutions, which limits the purchasing power of medical institutions. According to MedTech Europe, in 2024, expenditure on in vitro diagnostics represented only 0.6% of total healthcare expenditure in Europe. Such limited financial investment highlights the difficulty facilities face in securing budgets for high-cost automated platforms. Consequently, the market’s expansion is directly hampered, as the advanced capabilities of these instruments remain out of reach for a large segment of the global healthcare sector due to persistent funding constraints.

Key Market Trends

The Integration of Artificial Intelligence and Machine Learning Algorithms is fundamentally reshaping clinical workflows by moving beyond simple pathogen detection to predictive risk stratification. Unlike traditional diagnostics that identify an organism after infection is established, AI models analyze host-immune responses and vital sign volatility to forecast sepsis onset hours in advance. This capability allows clinicians to intervene during the critical early stages before organ damage becomes irreversible, effectively creating a new market segment for algorithmic diagnostics. Validating this shift, according to Prenosis, April 2024, in the press release 'Prenosis Announces FDA De Novo Marketing Authorization of the Sepsis ImmunoScore', the company received the first-ever marketing authorization for its AI tool that evaluates 22 diverse parameters to assess a patient's risk of developing sepsis.

Strategic Industry Consolidations and Collaborative Partnerships are driving market evolution as major diagnostic players seek to offer comprehensive, end-to-end sepsis management solutions. Market leaders are increasingly acquiring niche software and technology firms to bridge the gap between diagnostic hardware and antimicrobial stewardship, transforming standalone instruments into integrated data ecosystems that support hospital-wide decision-making. This trend minimizes operational fragmentation and aligns testing protocols with pharmacy cost-containment goals, making these unified platforms more attractive to budget-conscious healthcare systems. Illustrating this corporate strategy, according to bioMérieux, January 2024, in the press release 'bioMérieux acquires LUMED to reinforce its software portfolio', the company completed an investment close to 9 million euros to acquire the remaining capital of the software developer, fully integrating its clinical decision support systems into their global offer.

Segmental Insights

The Reagents and Consumables segment represents the fastest-growing category within the Global Bloodstream Infection Testing Market. This sustained expansion is primarily attributed to the recurring nature of demand, as laboratories must purchase fresh supplies for every diagnostic procedure, unlike instruments which are one-time capital investments. Leading market research indicates that the rising global prevalence of sepsis and hospital-acquired infections has significantly increased testing volumes, directly amplifying the consumption of blood culture media and molecular assay kits. Consequently, healthcare facilities maintain a continuous procurement cycle for these essential components to support frequent patient screening and diagnosis.

Regional Insights

North America maintains a leading position in the global bloodstream infection testing market, driven by a highly developed healthcare sector and a strong emphasis on early disease detection. The region benefits from a high concentration of key market participants that actively develop diagnostic technologies. Additionally, the U.S. Food and Drug Administration plays a critical role by streamlining product approvals, which accelerates market entry for new testing panels. High healthcare spending and favorable reimbursement policies further support the adoption of rapid diagnostic methods across hospitals and reference laboratories in the region.

Recent Developments

• In November 2024, Pattern Bioscience announced that it was awarded a contract worth up to $40.9 million by the Biomedical Advanced Research and Development Authority to advance its rapid diagnostic technologies. The funding will support the late-stage development and validation of the company's single-cell microbiology system and specific testing panels designed for pneumonia and bacteremia. This public-private collaboration aims to accelerate the creation of diagnostic tools that can rapidly identify bacterial pathogens and their susceptibility to antibiotics. By providing critical information days sooner than traditional methods, this initiative seeks to improve clinical outcomes for critically ill patients and reduce the burden of antimicrobial resistance in the bloodstream infection testing market.
• In October 2024, T2 Biosystems announced that it had entered into a multi-year exclusive agreement with Cardinal Health to distribute its FDA-cleared direct-from-blood diagnostic products across the United States. Under the terms of the partnership, the distributor obtained exclusive rights to sell the company's rapid detection instrument and associated panels, which are capable of identifying sepsis-causing pathogens directly from whole blood without the need for a positive blood culture. This strategic collaboration is intended to significantly broaden the commercial reach of the company's culture-independent testing solutions, thereby increasing access for hospitals and aiming to improve the speed and accuracy of diagnosis for patients with life-threatening bloodstream infections.
• In June 2024, bioMérieux announced that it had obtained 510(k) clearance from the U.S. Food and Drug Administration for the VITEK REVEAL antimicrobial susceptibility testing system. This diagnostic platform utilizes metabolomic signature technology to deliver actionable results for Gram-negative bacteria directly from positive blood cultures in approximately five to six hours. The regulatory clearance enables the company to commercially launch the system in the United States, offering healthcare providers a tool to make faster, more informed treatment decisions for patients suffering from sepsis and other severe bloodstream infections. This launch underscores the industry's shift towards rapid diagnostics that can streamline workflow and improve antimicrobial stewardship.
• In February 2024, Selux Diagnostics announced that it had received 510(k) clearance from the U.S. Food and Drug Administration for its proprietary Positive Blood Culture Separator. This regulatory approval allows the company to commercially market the device as a key component of its Next Generation Phenotyping System, which is engineered to provide rapid antibiotic susceptibility testing results directly from positive blood culture samples. By bypassing the traditional subculture step, the technology aims to significantly reduce the turnaround time required to determine the most effective antimicrobial treatment for patients with bloodstream infections. This advancement addresses a critical gap in clinical microbiology, potentially improving patient survival rates and aiding in the global fight against antibiotic resistance.

Key Market Players

• bioMérieux SA
• Becton, Dickinson and Company
• Cepheid
• Seegene Inc
• T2 Biosystems, Inc
• F. Hoffmann-La Roche Ltd
• Siemens Healthcare Private Limited
• Luminex Corporation
• Bruker Corporation
• Accelerate Diagnostics, Inc

By Product	By Sample Type	By Technology	By End User	By Region
Reagents & Consumables Instruments	Whole Blood Blood Culture	PCR Mass Spectroscopy In Situ Hybridization Others	Hospitals & Diagnostic Centers Custom Laboratory Service Providers Academic & Research Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Bloodstream Infection Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Bloodstream Infection Testing Market, By Product:

• Reagents & Consumables
• Instruments

• Bloodstream Infection Testing Market, By Sample Type:

• Whole Blood
• Blood Culture

• Bloodstream Infection Testing Market, By Technology:

• PCR
• Mass Spectroscopy
• In Situ Hybridization
• Others

• Bloodstream Infection Testing Market, By End User:

• Hospitals & Diagnostic Centers
• Custom Laboratory Service Providers
• Academic & Research Institutes
• Others

• Bloodstream Infection Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE