HbA1c Testing Devices Market By Product Type (HbA1c Analyzers [Point-of-Care Analyzers, Laboratory-Based Analyzers], Reagents and Consumables [Test Cartridges, Reagent Kits, Calibrators and Controls, Columns and Other Assay Materials]); By Technology (High-Performance Liquid Chromatography, Immunoassay, Boronate Affinity Chromatography, Enzymatic Assay, Capillary Electrophoresis); By Application (Diabetes Screening, Diabetes Diagnosis, Routine Glycemic Monitoring, Treatment-Response Monitoring); By End User (Hospitals, Diagnostic Laboratories, Physician Offices, Diabetes and Endocrinology Clinics, Ambulatory Care Centers, Academic and Research Institutions); By Geography, Segment Revenue Estimation, Forecast, 2026–2032

HbA1c Testing Devices Market: Recurring Consumables, Point-of-Care Expansion, and Laboratory Competition Reshape Supplier Revenue

The Global HbA1c Testing Devices Market will witness a robust CAGR of 9.2%, valued at USD 2.13 billion in 2025 and expected to reach USD 3.95 billion by 2032, according to Strategic Market Research.

 

The HbA1c testing devices market is built around recurring diagnostic demand rather than one-time equipment sales. Hospitals, independent laboratories, physician offices, diabetes clinics, and primary-care practices purchase analyzers and continue ordering cartridges, reagents, columns, calibrators, controls, proficiency-testing materials, software, and maintenance services. Completed tests determine the economic value of each installed system, while instrument placements create the base for future consumable revenue.

 

The International Diabetes Federation attributed 3.4 million deaths among adults aged 20–79 to diabetes in 2024. WHO separately reported 1.6 million deaths directly caused by diabetes in 2021, with 47% occurring before age 70. Diabetes also contributed to around 530,000 kidney-disease deaths, while high blood glucose was associated with about 11% of cardiovascular deaths.

 

The United States recorded approximately 94,445 deaths with diabetes as the underlying cause in 2024. CDC estimates for 2023 placed the total diabetes population at 40.1 million, including 29.1 million diagnosed patients and 11 million undiagnosed adults. More than one in four adults with diabetes therefore remained outside the diagnosed-care pathway, limiting current testing revenue while preserving a large screening opportunity.

 

Routine Monitoring Supports Repeat Test Consumption

Diagnosed patients normally require HbA1c assessment at least twice yearly when glycemic control is stable and more often when treatment changes or targets are not achieved. Applying two annual tests to the 29.1 million diagnosed US population produces an analytical scenario of 58.2 million monitoring opportunities. Quarterly testing would produce 116.4 million opportunities. These figures are not reported test volumes because missed appointments, inconsistent follow-up, payer restrictions, and alternative monitoring methods reduce actual utilization.

New insulin use, medication adjustments, poor control, or post-acute review can bring the next test forward. Drug use influences demand indirectly, but suppliers earn revenue only when the patient completes the test.

Consumables provide a more durable revenue stream than analyzer shipments. Abbott’s Afinion uses single-test cartridges, Siemens sells dedicated DCA reagent kits, and laboratory systems from Bio-Rad, Tosoh, and ARKRAY require columns, calibrators, controls, and assay materials. Manufacturers may lower instrument prices or bundle service, then recover value through recurring test use.

 

Abbott and Siemens Defend Established Physician-Office Workflows

Abbott competes through the Afinion 2 Analyzer and the earlier Alere Afinion AS100. Afinion 2 supports HbA1c and albumin-to-creatinine ratio testing in the United States, while international menus may also include lipids and C-reactive protein. The multiparameter format allows clinics to spread instrument costs across glycemic, kidney-risk, and broader chronic-disease monitoring.

Abbott’s single-test cartridge model ties revenue to completed testing. Connectivity, clinical familiarity, and a broad distribution network help protect placements, while lower-cost desktop systems and central-laboratory contracts remain the main price threats.

Siemens Healthineers competes through the DCA Vantage Analyzer, which is widely used in physician offices and hospital point-of-care programs. The platform measures HbA1c and albumin-to-creatinine ratio, allowing buyers to combine diabetes and kidney-disease monitoring. Siemens also markets Atellica DCA in selected markets, giving existing customers an upgrade path rather than forcing migration to another supplier.

DCA Vantage generates recurring reagent revenue. Siemens can link decentralized testing with wider hospital diagnostics relationships, but it must defend older accounts against suppliers offering different cartridge economics.

 

Bio-Rad and Tosoh Compete for High-Volume Laboratory Accounts

Bio-Rad Laboratories targets medium- and high-volume laboratories through the VARIANT II TURBO and D-100 systems. VARIANT II TURBO can report results in approximately 97 seconds per sample, while both platforms support automated HPLC workflows, chromatogram review, and hemoglobin-variant information.

Bio-Rad earns continuing revenue from reagents, columns, controls, software, and maintenance. Validated laboratory methods carry switching costs because replacement requires new validation, workflow changes, and quality review.

Tosoh Corporation competes through automated HPLC systems including the HLC-723G8 and related A1c products. Core laboratories value its rapid processing, low analytical variation, and established workflows, while instrument placements generate recurring column, control, and assay sales.

Bio-Rad and Tosoh face less direct pressure from compact physician-office systems than from automated immunoassay platforms, ARKRAY’s laboratory portfolio, and newer HPLC entrants. Throughput, variant handling, service coverage, and cost per test will remain the main retention factors.

 

EKF, HemoCue, ARKRAY, and ACON Expand Decentralized Testing

EKF Diagnostics sells the Quo-Test and Quo-Lab analyzers. Quo-Test is a fully automated point-of-care system, while Quo-Lab is a semi-automated desktop platform designed for clinics and smaller laboratories. Both use boronate-affinity methodology, and results are available in under four minutes. The two-tier portfolio lets distributors address buyers with different capital budgets and automation needs.

EKF is positioned for private clinics, smaller laboratories, and emerging markets. Reagent availability, distributor quality, local service, and recognized standardization are central to retention.

HemoCue, part of Radiometer, provides the HbA1c 501 System for decentralized testing. The fully automated platform delivers results in about five minutes and uses individually packaged cartridge kits. HemoCue’s partnership with Novo Nordisk placed HbA1c 501 systems in more than 400 clinics across 30 countries in Africa, Latin America, and Southeast Asia through the Changing Diabetes in Children program. The disclosed footprint gives the company a meaningful position in settings where laboratory access is limited.

Partnership-led placements create cartridge demand, although long-term revenue depends on funding continuity, training, supply reliability, and instrument uptime.

ARKRAY serves both decentralized and laboratory settings. PocketChem A1c targets compact point-of-care testing, while the ADAMS A1c range includes automated HPLC systems such as the HA-8180V. The portfolio allows ARKRAY to retain customers as testing volume rises, moving them from compact equipment to higher-throughput systems without losing the account.

ACON Laboratories competes through the On Call A1c and On Call MultiPro platforms. Cartridge-based, multiparameter testing gives clinics a lower-cost option, although limited US availability and a smaller service footprint restrict enterprise health-system penetration.

 

Quality Requirements Raise the Cost of Weak Performance

HbA1c results influence diagnosis, treatment adjustment, quality reporting, and long-term diabetes management. Measurement bias can lead to patient recalls, repeat testing, regulatory action, and damage to laboratory credibility.

NGSP reported in 2025 that more than 400 methods and approximately 130 laboratories were certified through its standardization network. Broad certification indicates a crowded supplier base and makes traceability to recognized reference standards a basic market-entry condition.

NGSP reported that only 60% of laboratories in its reviewed survey used methods with coefficients of variation of 2.5% or less at all five HbA1c levels. Method-specific variation ranged from 0.4% to 4.0%, pushing buyers to examine calibration consistency, external quality results, maintenance, and service rather than reagent price alone.

Updated CLIA rules added HbA1c to the analytes requiring formal proficiency testing in nonwaived US laboratories, with the relevant requirements effective in July 2024. Compliance increases recurring quality costs and favors suppliers with dependable controls, documentation, and technical support.

The UK Medicines and Healthcare products Regulatory Agency reported positive bias in results from the Trinity Biotech Premier Hb9210 analyzer in July 2025. Some patients had been incorrectly diagnosed, prompting recommendations for recalls and retesting. Laboratories may need to review historical results, contact clinicians, repeat tests, and respond to regulators, giving competitors an opening to displace the affected platform.

 

Public-Payer Targets Support Recurring Demand in Mature Markets

NHS England reported approximately four million people living with diagnosed diabetes in March 2025. The 2026/27 Quality and Outcomes Framework includes HbA1c measurement and other diabetes-care processes completed during the preceding 12 months. In the financial year ending March 2025, 64.7% of people with type 2 or other diabetes achieved an HbA1c result of 58 mmol/mol or below, compared with 41.5% of people with type 1 diabetes. Incomplete target achievement keeps testing tied to treatment review and annual performance reporting.

Australia also reports direct utilization. In July 2025, 72.1% of regular primary-care clients with recorded type 2 diabetes had an HbA1c result documented within the previous 12 months. The rate was 57.3% for type 1 diabetes. Canada had 3.9 million people aged one year and older living with diagnosed diabetes in 2023–24, while around 260,000 people were newly diagnosed during the year. These systems provide a more dependable demand signal than prevalence alone because public care frameworks convert diagnosed populations into scheduled monitoring activity.

 

India Offers Scale but Requires Affordable Repeat Testing

The ICMR-INDIAB study estimated that India had 101 million people with diabetes and 136 million with prediabetes in 2021. Private diagnostic chains, hospitals, diabetes clinics, and public screening programs face a substantial potential workload, but the full epidemiological population cannot be treated as commercial demand.

Testing frequency varies with diagnosis, income, physician access, public funding, and laboratory coverage. IDF regional data reported that 42.7% of adults living with diabetes in South-East Asia were undiagnosed. The region represented 18.2% of the global diabetes population but only about 1% of global diabetes expenditure.

Manufacturers seeking scale in India and similar markets need affordable cartridges, dependable distribution, low service complexity, and coverage beyond major urban centers. Premium analyzer specifications alone will not overcome limited repeat-testing access.

 

Continuous Glucose Monitoring Changes the Testing Mix

Continuous glucose monitoring provides daily measures that HbA1c cannot show and may reduce dependence on HbA1c as the sole therapy-adjustment measure, particularly among insulin-treated patients.

HbA1c remains standardized, widely available, embedded in payer and quality frameworks, and applicable to patients who do not use sensors. Health systems also use it for population-level comparison across different treatment and monitoring methods. Suppliers are therefore more likely to gain from integrating HbA1c results with broader diabetes data than from treating CGM as a replacement threat.

 

Market Outlook

Competition will be divided between two purchasing models. Abbott and Siemens are strongest in established physician-office workflows; Bio-Rad and Tosoh compete for high-volume laboratory accounts; EKF, HemoCue, ARKRAY, and ACON address decentralized and price-sensitive settings with different levels of automation.

The projected increase from USD 2.13 billion in 2025 to USD 3.95 billion by 2032 will depend on repeat monitoring, screening coverage, point-of-care adoption, and uninterrupted assay supply. Mature markets will reward automation, connectivity, proficiency support, and lower workflow costs. Emerging markets will favor affordable consumables, reliable distribution, and systems that operate across uneven laboratory infrastructure. Suppliers that secure high-utilization accounts and maintain recurring cartridge or reagent demand will capture more value than companies relying mainly on analyzer shipments.

 

Report Coverage Table

Report Attribute	Details
Forecast Period	2026 – 2032
Market Size Value in 2025	USD 2.13 Billion
Revenue Forecast in 2032	USD 3.95 Billion
Overall Growth Rate	CAGR of 9.2% (2026 – 2032)
Base Year for Estimation	2025
Historical Data	2019 – 2024
Unit	USD Million, CAGR (2026 – 2032)
Segmentation	By Product Type, By Technology, By Application, By End User, By Geography
By Product Type	HbA1c Analyzers [Point-of-Care Analyzers, Laboratory-Based Analyzers], Reagents and Consumables [Test Cartridges, Reagent Kits, Calibrators and Controls, Columns and Other Assay Materials]
By Technology	High-Performance Liquid Chromatography, Immunoassay, Boronate Affinity Chromatography, Enzymatic Assay, Capillary Electrophoresis
By Application	Diabetes Screening, Diabetes Diagnosis, Routine Glycemic Monitoring, Treatment-Response Monitoring
By End User	Hospitals, Diagnostic Laboratories, Physician Offices, Diabetes and Endocrinology Clinics, Ambulatory Care Centers, Academic and Research Institutions
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East and Africa
Country Scope	U.S., Canada, UK, Germany, France, Italy, Spain, China, Japan, South Korea, India, Australia, Brazil, Mexico, Saudi Arabia, UAE, South Africa
Market Drivers	Rising diabetes prevalence, wider adoption of point-of-care HbA1c testing, demand for faster treatment decisions, growth in routine glycemic monitoring, expanding diagnostic infrastructure in emerging economies
Customization Option	Available upon request