Blood Testing Market Size & Share 2026-2035

Blood Testing Market Size

The blood testing market reached approximately $89.5 billion in 2025 and is projected to reach approximately $179.8 billion by 2035, advancing at a 7.4% CAGR from 2026 to 2035.

Growth rests on recurrent clinical monitoring rather than one-time diagnostic episodes: chronic metabolic, cardiovascular, renal, hematologic, and infectious conditions require repeat testing across diagnosis, treatment selection, and longitudinal care.

Noncommunicable diseases caused at least 43 million deaths in 2021, including more than 19 million cardiovascular deaths and 10 million cancer deaths.^{[1]World Health Organization, Noncommunicable diseases, who.int} Diabetes is an especially consequential source of recurring testing demand. An estimated 589 million adults aged 20–79 years were living with diabetes in 2024, while 251.7 million remained undiagnosed; identifying that population depends on blood glucose and HbA1c testing.^{[2]National Center for Biotechnology Information, IDF Diabetes Atlas 11th edition, ncbi.nlm.nih.gov} The resulting demand extends beyond glucose measurement because diabetes management commonly requires lipid, renal, hematology, and cardiovascular-risk monitoring.

The market includes routine and specialized tests delivered through reagents and kits, analytical instruments, and software. Central laboratories remain the principal volume centers, while point-of-care systems, mobile phlebotomy, and at-home collection services broaden the settings in which blood samples can enter a clinical workflow. Automation is changing the economics of this model by coupling sample routing, analysis, quality checks, and reporting rather than treating the analyzer as an isolated capital asset. Beckman Coulter's DxA 5000, for example, is designed to process up to 4,500 samples per hour and inspect multiple specimen parameters before routing.

Five companies-F. Hoffmann-La Roche, Abbott Laboratories, Siemens Healthineers, Danaher, and Thermo Fisher Scientific-collectively hold approximately 60% of global market revenue. Their position reflects the combination of installed instrument bases, regulated assay portfolios, service networks, and recurring reagent relationships. Roche's Diagnostics Division recorded CHF 14.3 billion in 2024 sales, with base business growth supported by immunodiagnostic and clinical chemistry demand. Danaher's Diagnostics segment generated $9.787 billion in 2024.

Demand is also becoming more geographically uneven. Mature markets retain high testing intensity but face reimbursement pressure on routine panels, whereas Asia Pacific, Latin America, and parts of the Middle East are adding diagnostic infrastructure alongside chronic-disease screening capacity. The strategic challenge is to offer lower-cost, scalable systems in price-sensitive markets without diluting the premium economics available in oncology, critical care, and advanced laboratory automation.

The assessment covers complete blood count, blood glucose, heart, infectious disease, renal, lipid, cancer, urine, rheumatoid-factor antibody, and other test types; reagents and kits, instruments, and software; automated and manual methods; and hospitals, pathology labs, blood banks, diagnostic centers, and other end users. Regional coverage includes North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

Key Drivers

Growing burden of chronic and infectious diseases

Blood testing demand is anchored in diseases that require serial measurement rather than a single confirmatory test. Cardiovascular disease, cancer, diabetes, and chronic respiratory conditions account for most noncommunicable-disease mortality globally. Their management pathways rely on repeated biomarker testing: glucose and HbA1c for diabetes, lipid and renal panels for cardiometabolic risk, complete blood counts for treatment monitoring, and cardiac markers for acute-care assessment.

The diabetes burden creates both routine demand and a large screening opportunity. The International Diabetes Federation estimated global diabetes-related health expenditure at USD 1.015 trillion in 2024, or 11.9% of health spending, indicating the financial scale of disease-management activity around glucose testing and related laboratory monitoring. As care systems identify undiagnosed patients, demand expands across blood glucose, renal profile, lipid profile, and cardiovascular testing rather than in glucose testing alone.

Hematologic conditions reinforce the importance of high-frequency complete blood count testing. Approximately 100,000 people in the U.S. live with sickle cell disease, which requires lifelong hematology and organ-function monitoring.^{[3]Centers for Disease Control and Prevention, Data and statistics on sickle cell disease, cdc.gov} Leukemia also produces unusually intensive testing requirements; the U.S. population living with leukemia was estimated at 563,581 in 2023.^{[4]National Cancer Institute, Cancer Stat Facts: Leukemia, seer.cancer.gov} These conditions support demand for both routine analyzers and more specialized hematology workflows.

Infectious disease screening supplies a separate institutional volume floor. U.S. blood-safety guidance requires donor testing for markers including HIV, hepatitis B, hepatitis C, HTLV, West Nile virus, syphilis, and Zika, depending on the applicable donor-screening protocol. NHS England's emergency-department opt-out program similarly expanded testing for HIV, hepatitis B, and hepatitis C in high-prevalence settings. Such programs convert public-health objectives into contracted laboratory volume and favor systems with strong throughput, traceability, and quality-assurance capabilities.

Technological advancements in blood testing devices

Automation is moving laboratory competition from analyzer specifications toward end-to-end workflow performance. The Atellica Solution combines clinical chemistry and immunoassay testing with sample-management functions designed to automate sorting, decapping, sealing, and archiving. In high-volume laboratories, these capabilities can reduce manual handling while making turnaround time and staffing requirements more predictable.

Artificial intelligence is adding value at the interpretation layer. A 2024 review of machine-learning applications in routine blood analysis identified differences between conventional clinical-rule variables and features selected by predictive models. The commercial relevance lies in the potential to extract additional clinical signal from tests already being performed, although implementation remains dependent on validation, laboratory governance, and integration with clinical workflows.

Point-of-care systems expand blood testing into settings where central-laboratory turnaround is impractical. Abbott's i-STAT system provides blood gas, electrolyte, chemistry, and coagulation results from a small whole-blood sample in approximately two minutes. In emergency, intensive-care, and perioperative settings, immediate availability can influence treatment sequencing and patient flow, making speed and connectivity as important as assay menu breadth.

Liquid biopsy is extending blood testing into oncology pathways that historically depended on tissue sampling. Circulating tumor DNA testing can support molecular characterization and treatment selection from plasma, but its clinical use requires careful interpretation because clonal hematopoiesis can produce false-positive signals. NHS England expanded a lung-cancer liquid-biopsy initiative involving Guardant Health and The Royal Marsden to more than 10,000 patients with suspected advanced non-small-cell lung cancer.

Burgeoning number of point-of-care testing centers

Point-of-care deployment is broadening from emergency-use testing to a distributed diagnostic infrastructure spanning hospital wards, urgent-care facilities, physician offices, pharmacies, and community health sites. This model is most compelling where a same-visit clinical decision can avoid delay, repeat attendance, or sample transport. The opportunity is therefore concentrated in acute cardiac assessment, sepsis management, anticoagulation, blood gas monitoring, and chronic-disease follow-up.

India illustrates why decentralized systems are commercially important in fragmented diagnostic markets. The country's diagnostic ecosystem includes more than 100,000 laboratories, many of which are smaller standalone facilities for which large automation tracks are uneconomic. In these settings, compact analyzers and networked sample-collection models can extend testing access while preserving referral relationships with central laboratories.

Remote collection is creating another route into the testing workflow. Labcorp's collaboration with Getlabs supports mobile blood collection across 76 U.S. markets. Hims & Hers acquired Trybe Labs in February 2025 to add at-home blood draws to telehealth services, while ixLayer launched an at-home complete blood count collection offering for direct-to-patient biopharma programs in October 2024. These models do not eliminate laboratory processing; they relocate the collection event and make logistics, specimen integrity, and digital result delivery central competitive variables.

Increasing healthcare expenditure and favorable policies

Healthcare spending determines whether clinical demand becomes funded testing volume. The World Health Organization reported that government health spending declined from its pandemic-period peak but remained above pre-pandemic patterns in several settings. Diagnostic infrastructure built during the pandemic has also left health systems with greater familiarity with molecular testing, decentralized collection, and laboratory-network planning.

Regulation can simultaneously increase testing demand and raise supplier qualification requirements. The EU In Vitro Diagnostic Medical Devices Regulation requires more rigorous clinical evidence, performance evaluation, and post-market oversight for in vitro diagnostics. This raises the cost of market access, particularly for smaller suppliers, while advantaging companies with established quality systems and clinical-validation capabilities.

Public reimbursement and screening programs create more direct demand signals. NHS England allocated £20 million over three years to blood-borne-virus opt-out testing in emergency departments. In Brazil, the size of the public and private health system, together with a diabetes prevalence of 10.6% among adults in 2024, supports sustained demand for glucose, renal, and lipid testing. The strategic implication is that public procurement and reimbursement policy can determine the pace at which disease burden converts into analyzer placements and recurring reagent consumption.

Key Restraints

High-throughput analyzers and laboratory automation tracks require substantial capital expenditure, specialized installation, service coverage, and trained operators. The financial burden extends beyond the instrument purchase because proprietary reagents, calibration materials, quality controls, and maintenance contracts determine the lifetime cost of ownership. This is most restrictive in rural hospitals, small diagnostic centers, and lower-income markets where test volumes may not justify a large automated platform.

Laboratory reimbursement intensifies the pressure. The Protecting Access to Medicare Act has exposed clinical laboratories to downward payment adjustments for common tests, including complete blood counts and metabolic panels. When payment falls while consumable and labor costs rise, laboratories become more sensitive to utilization, service-contract terms, and test-menu profitability.

Price variation by care setting further complicates procurement. The Health Care Cost Institute found that employer-sponsored insurance paid hospital outpatient departments about three times more than physician offices and independent laboratories for identical common laboratory tests, with blood counts showing an even larger differential. This creates divergent economics: hospitals can support more advanced infrastructure, while independent laboratories are pushed toward scale, automation, and lower-cost service models.

Errors associated with blood testing process

Analytical performance does not eliminate errors introduced before measurement. Pre-analytical failures-including hemolysis, insufficient sample volume, clotting, incorrect tube selection, labeling errors, and transport problems-remain a major source of rejected or misleading results. A hematology laboratory study involving approximately 40 million test results found that 97% of documented errors occurred in the pre-analytical phase, with hemolysis accounting for 47.2% of those errors.

The operational effect is material. A compromised specimen can require repeat venipuncture, delay treatment decisions, consume staff capacity, and increase patient dissatisfaction. In certain tests, the consequences may be clinically significant: hemolysis can distort potassium measurement, while clotted EDTA samples can interfere with platelet and white-cell counts.

This restraint creates an important product opportunity. Pre-analytical automation, specimen-quality checks, phlebotomy training, barcode traceability, and connectivity tools can reduce error exposure, but their adoption adds cost. Vendors that demonstrate measurable reductions in rejected samples or repeat collections can defend higher system prices in laboratories where quality failures create expensive downstream disruption.

Technology creates a second layer of differentiation. Routine testing remains a volume business where workflow efficiency determines profitability, while oncology, critical care, and advanced infectious-disease testing can support higher-value assays. Suppliers that combine specimen-quality controls with automation and connectivity can address a persistent source of laboratory error while making a more defensible case for premium equipment and recurring software revenue.

Blood Testing Market Segment Analysis

By Test Type

Complete blood count test accounted for 14.74% of the market in 2025, equivalent to approximately $13.2 billion. Its leading position arises from unusually broad clinical utility: the same test supports anemia assessment, infection evaluation, perioperative care, emergency triage, oncology monitoring, and hematologic-disease management. Because it is embedded in routine hospital and outpatient workflows, complete blood count testing is less dependent on a single disease category than most specialized assays.

Blood glucose test represented 13.15% of 2025 value, or approximately $11.8 billion. Diabetes prevalence and the large undiagnosed population sustain demand for laboratory glucose and HbA1c testing, patient self-monitoring, and connected glucose-management systems. This segment is becoming more contested as domestic suppliers expand in large Asian markets and as care shifts toward remote monitoring.

Heart test held 11.12% of 2025 market value, or approximately $10.0 billion. Troponin, natriuretic peptide, D-dimer, and related assays are integral to acute cardiovascular assessment. Their economic value is linked to faster rule-in or rule-out decisions in emergency settings, where turnaround time can affect observation periods and downstream resource use.

Infectious disease screening represented 10.71% of the market, or approximately $9.6 billion in 2025. Donor-screening requirements provide a stable baseline for HIV, hepatitis, HTLV, and other pathogen testing. Public-health programs add episodic volume, but blood-bank testing remains distinguished by regulated traceability, high-throughput requirements, and limited tolerance for false-negative results.

Kidney test – renal profile accounted for 10.00% of 2025 value, or approximately $9.0 billion. Creatinine, estimated glomerular filtration rate, blood urea nitrogen, and electrolyte testing are strongly linked to diabetes and hypertension management. The segment benefits from clinical protocols that require periodic renal monitoring rather than symptom-led testing alone.

Cholesterol test – lipid profile test captured 8.32% of 2025 market value, or approximately $7.5 billion. Lipid testing is central to primary cardiovascular-risk assessment and medication monitoring. Demand is widening from conventional cholesterol panels toward more specialized markers in patients with elevated cardiovascular risk.

Cancer test represented 7.30% of 2025 value, or approximately $6.5 billion. Conventional tumor markers remain important, but liquid-biopsy platforms are changing the segment's economics by introducing molecular and bioinformatics-intensive testing. Their adoption is likely to be governed by clinical evidence, reimbursement, and oncology-pathway integration rather than laboratory capacity alone.^{[5] [6]}

Urine test accounted for 6.34% of the market, or approximately $5.7 billion. Although urine testing is a companion modality within many blood-testing workflows, it is often ordered alongside renal, endocrine, infectious-disease, and metabolic panels, particularly for chronic kidney disease monitoring.

Antibodies test – rheumatoid factor represented 3.21% of 2025 value, or approximately $2.9 billion. Rheumatoid factor, anti-CCP, ANA, and related serological assays support diagnosis and monitoring of autoimmune conditions. The segment depends on specialist referral pathways and the use of immunomodulatory therapies that require ongoing laboratory surveillance.

Other test types comprised 15.11% of 2025 value, or approximately $13.5 billion. The category includes thyroid, hormone, coagulation, liver-function, vitamin, and specialized metabolic testing. Its size reflects the breadth of clinical conditions that depend on blood-derived biomarkers beyond the major named categories.

By Product

Reagents and kits held 58.84% of the market in 2025, equivalent to approximately $52.7 billion. Their dominance is structural: once a laboratory installs a compatible analyzer, assay chemistry, calibration, and quality-control requirements often tie it to a recurring consumables relationship. This makes installed-base growth more consequential than a single instrument sale.

Instruments accounted for 30.74% of 2025 value, or approximately $27.5 billion. Instrument placements are capital intensive and cyclical, but they establish the foundation for future reagent sales. Large automation tracks are concentrated in hospital and reference laboratories, while point-of-care systems provide a route into decentralized settings.

Software represented 10.42% of the market, or approximately $9.3 billion. Laboratory information systems, middleware, quality-management tools, connectivity solutions, and AI-enabled analytics are becoming more important as laboratories seek to manage data from multiple analyzers and care sites. Software can reduce switching costs when it is embedded deeply in workflow and electronic medical record integration.

By Method

Automated testing represented 71.32% of 2025 market value, or approximately $63.8 billion. It dominates high-volume hospitals, reference laboratories, and diagnostic chains because it standardizes sample handling, improves throughput, and reduces routine manual processing. The strongest automation case arises where test volume, staffing constraints, and turnaround-time requirements coincide.

Manual testing retained a 28.68% share, or approximately $25.7 billion. It remains relevant in resource-limited settings, small laboratories, niche assays, peripheral smear review, and lower-volume point-of-care environments. Its persistence indicates that cost, workforce capability, and test complexity still limit the universal adoption of automation.

By End Use

Hospitals held 47.19% of 2025 market value, equivalent to approximately $42.2 billion. Their leading position reflects the aggregation of emergency, critical-care, surgical, oncology, cardiology, hematology, and transfusion-testing needs within one institution. The concentration of high-acuity patients also supports investment in automation and point-of-care systems.

Pathology labs represented 12.19% of the market, or approximately $10.9 billion. These laboratories process specialty hematology, immunology, molecular, and pathology-associated assays that require advanced platforms, technical expertise, and rigorous quality systems. Their role is particularly important where hospitals outsource lower-volume or complex testing.

Blood banks accounted for 6.09% of 2025 value, or approximately $5.4 billion. Screening every donated unit for blood group and infectious-disease markers makes this segment highly regulated and operationally non-discretionary. Demand is linked to donation volumes, national safety protocols, and the capacity of transfusion services.

Diagnostic centers held 20.45% of 2025 market value, or approximately $18.3 billion. Their role is expanding in markets with fragmented outpatient care and growing private insurance coverage. Chain operators can centralize high-complexity testing while using collection sites and smaller centers to capture local demand.

Other end users represented 14.07% of 2025 value, or approximately $12.6 billion. This group includes home care, workplace health programs, public-health laboratories, research institutions, and remote-monitoring services. At-home collection is the most commercially significant emerging component because it can route patients into clinical testing without requiring a conventional laboratory visit.

The product mix confirms that competitive power is tied to installed-base economics. Reagents and kits account for 58.84% of market value because analyzers create continuing consumable demand. Software is smaller but strategically important: as testing moves across central labs, point-of-care devices, and remote collection models, the ability to connect results, manage quality, and support interpretation can become a more durable differentiator than hardware specifications alone.

Blood Testing Market Regional Analysis

North America

North America accounted for approximately $28.6 billion in 2025, or about 32.0% of global market value, and is forecast to grow at a 6.66% CAGR through 2035. The U.S. contributed approximately $25.3 billion in 2025, rising from $22.1 billion in 2022 and $24.1 billion in 2024, while Canada accounted for approximately $3.3 billion.

The region's scale reflects high laboratory utilization, mature reimbursement systems, extensive hospital infrastructure, and large installed bases of global diagnostic suppliers. Its principal constraint is pricing pressure on routine tests. Medicare laboratory-payment reform and the substantial price differential between hospital outpatient departments and independent laboratories make workflow efficiency a commercial necessity rather than a discretionary investment.^{[7]American Society for Clinical Pathology, A primer on PAMA April 2024, ascp.org [8]Health Care Cost Institute, Price markups for clinical labs, healthcostinstitute.org}

Europe

Europe represented approximately $23.9 billion in 2025, or 26.7% of global value, and is projected to grow at a 6.05% CAGR through 2035. Germany, the UK, France, Spain, Italy, and the Netherlands form the core regional markets.

European growth is shaped by the transition to the EU IVDR framework, which raises the clinical-evidence and post-market-surveillance requirements for in vitro diagnostics. In Germany, reagents accounted for 89.8% of in vitro diagnostics market value in 2022, illustrating the importance of recurring consumables in a mature laboratory market. In the UK, NHS blood-borne-virus opt-out testing demonstrates how public-health policy can generate sustained infectious-disease test volumes.

Asia Pacific

Asia Pacific accounted for approximately $24.4 billion in 2025, or 27.3% of global market value, and is expected to record the highest regional CAGR at 8.84% through 2035. China, India, Japan, Australia, and South Korea anchor regional demand.

China combines a large installed diagnostic base with intensifying domestic competition. Sinocare reported RMB 4,443 million in 2024 revenue and serves more than 25 million users through its chronic-disease monitoring portfolio. Domestic suppliers are expanding in glucose monitoring, chemistry, hematology, and point-of-care testing, increasing price pressure while improving local availability.

India's market is characterized by a large but fragmented laboratory network, expanding health coverage, and rising chronic-disease prevalence. The presence of more than 100,000 laboratories makes decentralized analyzers, collection networks, and scalable diagnostic-chain models commercially relevant. Japan, South Korea, and Australia provide more mature demand centers, where aging populations, technology adoption, and broad clinical test menus support specialized diagnostics.

Latin America

Latin America represented approximately $7.7 billion in 2025, or 8.6% of global value, and is forecast to grow at an 8.37% CAGR through 2035. Brazil, Mexico, and Argentina are the principal markets.

Brazil is the regional anchor because of its large public and private healthcare system. The country has 7,309 hospitals, 63% of which are private, and health expenditure equal to 9.7% of GDP. Its diabetes burden supports sustained testing demand, while investment in digital health, decentralized care, and infectious-disease surveillance supports adoption of point-of-care and laboratory-network solutions.

Middle East and Africa

The Middle East and Africa market reached approximately $4.9 billion in 2025, representing 5.5% of global value, and is projected to expand at a 7.93% CAGR through 2035. Saudi Arabia, South Africa, and the UAE are the most significant covered markets.

Saudi Arabia and the UAE are advancing laboratory modernization through hospital investment, digital-health initiatives, and procurement of automated diagnostic systems. South Africa has the most developed public laboratory infrastructure in sub-Saharan Africa, while high HIV prevalence supports continuing infectious-disease screening demand. Across the wider region, cold-chain limitations, workforce shortages, reimbursement constraints, and uneven laboratory access continue to favor robust, lower-complexity systems over capital-intensive automation tracks.

Asia Pacific and Latin America offer stronger volume expansion, but their commercial conditions are less uniform. China's domestic competition, India's fragmented laboratory landscape, and Brazil's mix of public and private care require localized pricing and distribution strategies. Companies that can pair affordable decentralized systems with centralized reference-lab capability are better positioned than those relying solely on premium automation placements.

Blood Testing Market Share & Competitive Landscape

The competitive environment is led by diversified diagnostics companies with installed analyzer bases, regulated assay portfolios, and recurring consumables revenue. Scale matters because laboratories require instrument reliability, service coverage, assay validation, quality-control support, and connectivity over long procurement cycles.

Danaher operates in blood diagnostics through Beckman Coulter, Radiometer, HemoCue, Cepheid, and related platforms. Its Diagnostics segment generated $9.787 billion in 2024.^{[9]Danaher, 2024 Annual Report, filecache.investorroom.com} Beckman Coulter's automation portfolio is positioned around high-throughput laboratory workflow integration.

F. Hoffmann-La Roche Ltd. maintains a leading position in clinical chemistry, immunodiagnostics, molecular diagnostics, and companion diagnostics. Roche Diagnostics recorded CHF 14.3 billion in 2024 sales, with 8% base-business growth excluding COVID-19 products.

Abbott Laboratories competes across core laboratory, transfusion diagnostics, point-of-care, molecular, and rapid testing. Its systems screen more than half of the world's blood and plasma supply. The i-STAT platform extends Abbott's presence into bedside blood testing.

BioMerieux SA is particularly important in clinical microbiology, blood culture, and antimicrobial susceptibility testing. The company reported €3.98 billion in 2024 revenue and 10.3% organic growth. Its VITEK REVEAL system was cleared for U.S. marketing in 2024 for direct antimicrobial susceptibility testing from positive blood cultures.

Grifols is focused on transfusion medicine, blood typing, molecular donor screening, and plasma-derived diagnostics. Its Diagnostic division generated EUR 644.9 million in 2024. The company's Blood Typing Solutions business expanded across North America, Latin America, and EMEA.

Becton, Dickinson and Company participates through blood collection, microbiology, molecular diagnostics, and point-of-care offerings. BD reported FY2024 revenue of $20.2 billion and announced plans to separate its Biosciences and Diagnostic Solutions business.

Bio-Rad Laboratories Inc. supplies quality-control materials, blood-typing products, HbA1c systems, autoimmune diagnostics, and flow-cytometry solutions. Its Clinical Diagnostics segment generated $1,537.9 million in 2024.

Siemens Healthineers competes across general laboratory, specialty laboratory, hematology, hemostasis, diabetes, urinalysis, blood gas, and point-of-care diagnostics. Its Diagnostics segment generated €4,417 million in 2024. The Atellica portfolio positions the company in integrated chemistry and immunoassay workflow automation.

Sinocare Inc. is a major Chinese chronic-disease testing supplier with a portfolio spanning blood glucose, lipids, HbA1c, uric acid, microalbumin, and point-of-care testing.

Trinity Biotech participates in diabetes monitoring, hemoglobin A1c, coagulation, autoimmune testing, and infectious-disease diagnostics. Its narrower product focus differentiates it from broad laboratory-platform suppliers.

Thermo Fisher Scientific Inc. participates through specialty diagnostics, immunodiagnostics, allergy and autoimmune testing, thyroid testing, and culture-media offerings. The company reported $42.88 billion in FY2024 revenue.

B. Braun Melsungen AG participates in the pre-analytical blood-testing workflow through blood collection, vascular-access, and infusion-related products. Its role is concentrated in specimen collection rather than in core analytical instrumentation.

Recent Industry Developments

Abbott completed its acquisition of Exact Sciences in March 2026. The approximately $21 billion transaction added Cologuard, Oncotype DX, Oncodetect, and Cancerguard to Abbott's cancer-diagnostics portfolio. The deal strengthens Abbott's presence in screening, genomic profiling, and blood-based cancer detection.

NHS England expanded liquid-biopsy testing for lung cancer in 2024. The program, developed with The Royal Marsden and Guardant Health, supported circulating tumor DNA testing for more than 10,000 patients with suspected advanced non-small-cell lung cancer.

BioMerieux received FDA 510(k) clearance for VITEK REVEAL in 2024. The system is designed to provide antimicrobial susceptibility results directly from positive blood cultures, supporting faster treatment decisions in bloodstream infection and sepsis workflows.

BD announced the planned separation of its Biosciences and Diagnostic Solutions business in 2024. The unit reported approximately $3.4 billion in FY2024 revenue and includes molecular diagnostics, microbiology, cervical cancer screening, and point-of-care offerings.

At-home collection platforms expanded in 2024 and 2025. Hims & Hers acquired Trybe Labs in February 2025, Labcorp expanded its Getlabs collaboration, and ixLayer introduced at-home complete blood count collection for biopharma programs.

Grifols launched the Erytra Eflexis blood-grouping analyzer in China in 2024 and received European approval for a multiplex arboviral in vitro diagnostic test. The test detects dengue, Zika, chikungunya, and West Nile virus in one assay.