Bloodstream Infection Testing Market Size Analysis:

The Bloodstream Infection Testing Market was valued at USD 797.62 Million in 2023 and is expected to reach USD 1213.99 Million by 2032, growing at a CAGR of 4.80% over the forecast period 2024-2032. This report presents trends in treatment and prescription following testing by region, as determined by changing antimicrobial stewardship programs and variability in healthcare infrastructure. The research delves into the growing uptake of automated and rapid testing systems due to pressure for earlier pathogen detection and better patient outcomes. Further, it looks into the developing menace of multidrug-resistant (MDR) pathogens in bloodstream infections and its profound influence on testing demand as well as treatment regimens. The report explores the influence of hospital-acquired infections (HAIs) on BSI testing due to increased infection rates compelling healthcare institutions to adopt more stringent screening procedures. Geographic inequalities in the availability and accuracy of BSI testing are also examined, focusing on the problems of low-resource settings. Additionally, the contribution of artificial intelligence (AI) and digital solutions to BSI diagnostics is revolutionizing the industry by improving test accuracy and simplifying laboratory processes.

The U.S. Bloodstream Infection Testing Market was valued at USD 289.29 Million in 2023 and is expected to reach USD 377.36 Million by 2032, growing at a CAGR of 3.02% over the forecast period 2024-2032. In the United States, the market for BSI testing is growing because of higher healthcare expenditure, higher regulatory attention on infection control, and rising investments in artificial intelligence-based diagnostic solutions to fight antimicrobial resistance.

Bloodstream Infection Testing Market Dynamics

Drivers

• Rising Incidence of Bloodstream Infections and Technological Advancements

The bloodstream infection (BSI) testing market is fueled by the rising incidence of bloodstream infections, sepsis, and hospital-acquired infections (HAIs), which need to be diagnosed early and accurately. Sepsis, as per the World Health Organization (WHO), occurs in almost 49 million individuals every year, with more than 11 million deaths globally. The increasing trend of multidrug-resistant (MDR) pathogens has made rapid diagnostic solutions even more necessary, as time delay in treatment can result in serious complications or even mortality. Moreover, the emergence of newer technologies for molecular diagnostics like real-time PCR, next-generation sequencing (NGS), and automated blood culture systems has greatly enhanced diagnostic precision and turnaround time. The trend toward point-of-care (POC) testing is also driving market growth since these solutions help in fast detection and early intervention, especially in critical care conditions. Increased investment in healthcare infrastructure and government incentives for the detection of infections early are further encouraging market growth. For example, initiatives like the U.S. CDC's Antibiotic Resistance Solutions Initiative are increasing funding for quick diagnostic products to fight antimicrobial resistance (AMR). The incorporation of AI-based diagnostic platforms is also optimizing the speed of infection detection and resistance profiling, enabling sophisticated diagnostic solutions to become more accessible to different healthcare facilities.

Restraints

• High Cost and Limited Accessibility of Advanced Diagnostic Solutions

Although the bloodstream infection testing market is growing at a very fast pace, it is hindered by huge restraints because of the very high cost of sophisticated diagnostic technology and their restricted availability, especially in low- and middle-income nations. Molecular diagnostic tests, including PCR-based and NGS-based testing, are very costly, with each test costing between USD 100 and USD 500, and hence not affordable for most healthcare facilities with limited budgets. Moreover, automated blood culture systems are capital-intensive, requiring huge investments in laboratory facilities, skilled staff, and maintenance, hence restricting their implementation in resource-constrained environments. The reimbursement policy for the diagnosis of bloodstream infection also differs from one healthcare system to another, resulting in uneven affordability for patients. In most parts of the world, conventional culture-based approaches remain the first choice because of their lower expense, even though they are labor-intensive and less sensitive. In addition, unawareness and trained personnel shortages in growing markets hinder the uptake of technologically sophisticated solutions. Regulatory approval delays for new diagnostic products also limit market growth since strict compliance can extend the time and expense of new product introduction to the marketplace. Such cost and infrastructure issues still impede the mass adoption of rapid and molecular diagnostic solutions, especially in sub-developed healthcare systems.

Opportunities

• The bloodstream infection testing market presents significant opportunities with the expansion of rapid diagnostic technologies and AI-driven diagnostic platforms.

Growth in the demand for point-of-care (POC) testing and automated blood culture instruments is creating new opportunities for market participants to come up with quicker and more precise diagnostic products. The burgeoning global rate of antimicrobial resistance (AMR) has spurred spending on molecular diagnostic technology, including real-time PCR and NGS, which enables faster identification of pathogens and the targeting of therapy. Moreover, AI-based diagnostics are also revolutionizing the sector by enhancing test accuracy, eliminating human mistakes, and maximizing the efficiency of workflows. Firms such as Karius and T2 Biosystems are also utilizing AI and next-generation molecular methods to drive bloodstream infection detection. The increased implementation of digital healthcare products and cloud computing data management systems also pose attractive opportunities for business growth. Government grants and public-private partnerships also augment research and development in the field of rapid BSI diagnostics. For example, the U.S. Biomedical Advanced Research and Development Authority (BARDA) is making investments in cutting-edge diagnostic platforms to combat infectious diseases. With ongoing technology evolution, there is a strong potential for low-cost, fast, and decentralized diagnostic solutions, especially in developing countries where access to sophisticated healthcare is still scarce.

Challenges

• One of the biggest challenges facing the bloodstream infection testing market is the increasing prevalence of multidrug-resistant (MDR) pathogens, which complicates diagnosis and treatment.

MDR bacteria, including carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and vancomycin-resistant Enterococci (VRE), are among the major causes of bloodstream infections, so early and precise diagnosis is of prime importance. Yet, traditional blood culture techniques take 24-72 hours, which delays treatment decisions and poses higher mortality risks. The regulatory environment for diagnostic products is also extremely complex and differs between countries. Gaining approvals from agencies like the U.S. FDA, the European Medicines Agency (EMA), and China's NMPA demands rigorous clinical verification, which can delay product launch schedules. In addition, adherence to Good Manufacturing Practices (GMP) and rigorous quality control protocols increases the cost and length of new product development. A further challenge is the adoption of new diagnostic solutions into current healthcare workflows, as hospitals and labs need to install new infrastructure and provide training to staff to implement new technology. Meeting these challenges involves more investment in antimicrobial stewardship programs, simplified regulatory pathways, and international cooperation to enhance diagnostic availability and performance in the fight against bloodstream infections.

Bloodstream Infection Testing Market Segmentation Analysis

By Product

The Reagents & Consumables segment led the bloodstream infection (BSI) testing market in 2023, with a revenue share of 92.1%. This huge share is largely attributed to the frequent usage of consumables like blood culture bottles, PCR reagents, assay kits, and antimicrobial susceptibility testing materials. In contrast to instruments, which are bought only once, consumables are needed for each test, resulting in steady and recurring demand. The increase in bloodstream infections, such as sepsis and hospital-acquired infections (HAIs), has also increased the demand for diagnostic consumables in hospitals and diagnostic centers. Additionally, the increasing trend toward molecular diagnostics and automated testing platforms has raised the demand for sophisticated reagents that improve testing efficiency and accuracy. The segment is also expected to register the highest growth rate during the forecast period on account of ongoing technology advancements in diagnostic assays, growing funding for infectious disease testing, and increasing clinical laboratory networks. The rising awareness of early and precise diagnosis of bloodstream infections is also driving the uptake of top-notch consumables. Besides that, the advent of point-of-care and rapid testing solutions will propel the growth further, and the consumables and reagents will be an integral component of the growing BSI testing market.

By Sample Type

The Blood Culture segment accounted for the highest market share of 78.8% in 2023 and is the most commonly used sample type among tests for bloodstream infections. Blood culture is the standard test for detecting bacteremia and fungemia because it can detect a broad spectrum of pathogens, including antibiotic-resistant pathogens. The high incidence of bloodstream infections, especially in the hospital environment, has re-emphasized the role of blood culture in standard diagnostic processes. Moreover, advances in automated blood culture systems have improved the speed and accuracy of detection, making them an absolute necessity in critical care environments. Despite newly emerging molecular and rapid diagnostic methods, blood culture remains the method of choice in the diagnosis since it is cost-effective, very available, and can be used to guide antimicrobial susceptibility testing. The market for the segment is also anticipated to expand at the highest rate during the forecast period because of growing hospital admissions, an expanding geriatric population that is prone to infections, and growing usage of innovative blood culture systems that yield faster and more accurate results. In addition, government efforts towards early diagnosis of sepsis and bloodstream infections are propelling the usage of blood culture testing, thereby boosting the market further.

By Technology

The PCR (Polymerase Chain Reaction) segment held the highest revenue share of 63.7% in 2023 and is the leading technology for bloodstream infection testing. The increasing demand for PCR-based diagnostics is fueled by its high sensitivity, quick turnaround time, and capability to identify pathogens directly from blood samples without the need for culture. In contrast to the conventional methods, PCR gives faster and more accurate results, with the potential of initiating specific antimicrobial therapy early. This is especially important for sepsis, where rapid detection translates directly into the survival of the patient. The prevalence of multidrug-resistant (MDR) infections, which has seen a rising number of infections developing resistance, further stimulated the use of PCR tests, which facilitate the identification of individual resistance genes. The segment is also likely to see the quickest growth during the forecast period, mainly because of improved real-time PCR technology, higher spending on molecular diagnostics, and higher demand for point-of-care test solutions. The use of PCR along with automated platforms and artificial intelligence (AI) based diagnostic tools is also improving accuracy and efficiency, thus leading to PCR being adopted as a favored choice in hospitals as well as in research. The shifting trend towards fast and high-throughput diagnosis solutions is likely to further boost the growth of this segment.

By End-use

The Hospitals & Diagnostic Centers segment was the market leader in bloodstream infection testing in 2023 and contributed 48.4% of the overall revenue. The primary points of care for bloodstream infection patients are hospitals and diagnostic centers, so they are the biggest users of BSI test solutions. Growth in hospital-acquired infections (HAIs) and sepsis has prompted an increase in diagnostic testing across these facilities. Apart from this, access to sophisticated analytical equipment, for example, automated blood culture units and molecular testing platforms, has fueled the stronghold of the segment. The presence of a high inflow of patients in hospitals, particularly in emergency departments and ICUs, also fueled the acceptance of bloodstream infection testing. The segment is also anticipated to grow at the highest rate during the forecast period with increasing investments in healthcare infrastructure, growing diagnostic laboratory networks, and rising demand for early detection of infections. The convergence of AI-based diagnostic systems and automated testing platforms is anticipated to improve diagnostic efficiency, further driving market growth. Also, initiatives by the government to enhance the management of sepsis as well as hospital infection control strategies are expected to drive the utilization of bloodstream infections testing, thus further cementing the segment's dominance.

Bloodstream Infection Testing Market Regional Insights

North America was the leading region for the bloodstream infection (BSI) testing market in 2023, due to the vast incidence of bloodstream infections, well-developed healthcare facilities, and robust government incentives for infection control programs. The U.S. was the largest contributor, owing to its strong utilization of molecular tests, comprehensive antimicrobial stewardship programs, and funding for point-of-care diagnostic technologies. As reported by the CDC, sepsis occurs in at least 1.7 million individuals in the U.S. annually, calling for swift and precise diagnosis. Moreover, the involvement of major industry players, including T2 Biosystems, BioMérieux, and Becton Dickinson, has spurred technological innovation in rapid BSI testing.

Asia-Pacific will be the region with the fastest growth between 2024 and 2032, driven by rising healthcare spending, growing incidence of hospital-acquired infections, and increased awareness of bloodstream infection diagnosis. China, India, and Japan are seeing a strong demand for advanced molecular diagnostic equipment. The region is also seeing fast growth in healthcare infrastructure and government initiatives for enhancing infection surveillance. For example, the National Healthcare-Associated Infection Surveillance System (NHAISS) of China is driving the adoption of rapid diagnostic solutions. The rising antimicrobial resistance (AMR) burden and the move towards automated testing platforms also add to the region's growth, with Asia-Pacific emerging as a growth market for the future.

Bloodstream Infection Testing Market Key Players 

• bioMérieux SA – BACT/ALERT, VITEK MS, FilmArray BCID Panel

• BD (Becton, Dickinson and Company) – BD BACTEC, BD Phoenix, BD MAX

• Cepheid – Xpert MRSA/SA Blood Culture, Xpert vanA/vanB, Xpert Carba-R

• Seegene Inc. – Allplex Sepsis Panel, Allplex Blood Culture Assay

• T2 Biosystems, Inc. – T2Bacteria Panel, T2Candida Panel, T2Resistance Panel

• F. Hoffmann-La Roche Ltd – cobas Liat System, LightCycler PCR System

• Siemens Healthcare Limited – Atellica Solution, ADVIA Centaur XP Immunoassay System

• Luminex Corporation – Verigene Blood Culture Test, xMAP Multiplexing Technology

• Bruker – MALDI Biotyper, IR Biotyper

• Accelerate Diagnostics, Inc. – Accelerate Pheno System, Accelerate Arc System

Recent Developments in the Bloodstream Infection Testing Market

• In Dec 2024, Deepull, a medical diagnostics company specializing in culture-free pathogen identification, received FDA Breakthrough Device Designation for its UllCORE Bloodstream Infection (BSI) Test, enabling rapid detection of bloodstream infections.