Glycated Haemoglobin Testing Market By Product (Instruments, Consumables), By Methodology (High-Performance Liquid Chromatography, Immunoassay, Boronate-Affinity Chromatography, Capillary Electrophoresis, Enzymatic Assays, Other Methods), By Testing Mode (Laboratory-Based Testing, Point-of-Care Testing), By End User (Hospitals, Diagnostic and Reference Laboratories, Physician Offices, Diabetes Clinics, Homecare Settings, Community Healthcare Centers), By Geography, Segment Revenue Estimation, Forecast, 2026–2032

Glycated Haemoglobin Testing Market: Expanding Diabetes Screening and Long-Term Glucose Monitoring

The Global Glycated Haemoglobin Testing Market was valued at USD 2.48 billion in 2025 and is projected to reach USD 4.06 billion by 2032, expanding at a CAGR of 7.3% during 2026–2032, according to internal projections by Strategic Market Research.

 

Glycated haemoglobin testing relies on laboratory-based HbA1c analyzers and point-of-care testing systems to diagnose prediabetes and diabetes and to monitor whether treatment plans are controlling blood sugar effectively. The market includes HPLC-based laboratory systems, immunoassays, boronate-affinity methods, capillary electrophoresis platforms, enzymatic assays, compact analyzers, cartridges, reagents, calibrators, and quality-control materials.

 

The glycosylated haemoglobin test, commonly known as the HbA1c test, measures the proportion of haemoglobin carrying glucose and indicates average blood sugar levels over the previous two to three months. Because fasting is generally not required, the test can be performed during routine doctor visits, preventive health checks, diabetes-clinic appointments, hospital consultations, and community screening programs.

 

Depending on treatment progress and glucose control, patients may require HbA1c testing every three to six months. This creates recurring demand for testing cartridges, reagents, quality controls, laboratory services, and analyser capacity.

 

Clinical Guidelines Establish HbA1c as a Standardized Diagnostic Pathway

Glycated haemoglobin testing is recognized by the World Health Organization and the American Diabetes Association for diagnosing diabetes and monitoring long-term blood sugar control. An HbA1c result of 6.5%, equivalent to 48 mmol/mol, supports a diabetes diagnosis when the test is performed using a standardized method with appropriate quality assurance and when no medical condition is present that could distort the result. In patients without clear symptoms, an abnormal result is generally confirmed through repeat HbA1c testing or another accepted diabetes test.

An HbA1c level between 5.7% and 6.4%, or approximately 39–47 mmol/mol, indicates prediabetes and an increased risk of developing type 2 diabetes. A result below 5.7% is generally considered normal. People within the prediabetes range may require regular reassessment, preventive support, and closer primary-care follow-up.

For people with diagnosed diabetes, HbA1c is commonly assessed at least twice a year when treatment goals are being achieved and approximately every three months when treatment changes or targets are not met. This recurring schedule supports predictable demand for consumables and laboratory services.

Recognized HbA1c analysis methods include high-performance liquid chromatography, immunoassays, boronate-affinity chromatography, capillary electrophoresis, and enzymatic assays. HPLC remains prominent in high-volume laboratories, while immunoassay and boronate-affinity systems are used across laboratory and point-of-care settings. Enzymatic assays are commonly incorporated into automated clinical chemistry workflows. Certification, quality control, and result traceability remain important supplier requirements across all methods.

 

Undiagnosed Diabetes Expands the Testing Population

The global diabetes burden provides a large and recurring patient base for glycated haemoglobin testing. According to the International Diabetes Federation, approximately 589 million adults aged 20–79 were living with diabetes worldwide in 2024, representing nearly one in nine adults.

Around 252 million people, or approximately 43% of adults with diabetes, were unaware that they had the condition. The global diabetic population is projected to reach approximately 853 million by 2050 as populations age, cities expand, physical activity declines, and dietary patterns change.

Four in five adults with diabetes live in low- and middle-income countries. These markets have large screening needs but continue to face limitations related to affordability, laboratory access, trained personnel, equipment servicing, and regular reagent supply. In parts of South Asia and other underserved regions, fasting plasma glucose and basic finger-prick testing remain more widely used because formal HbA1c testing is not consistently available outside major cities.

The United States represents a well-established testing market with a substantial screening gap. CDC estimates indicate that approximately 40.1 million Americans had diagnosed or undiagnosed diabetes in 2023, representing around 12% of the population. About 29.1 million had been diagnosed, while nearly 11 million adults remained unaware of their condition.

Prediabetes creates an even broader addressable population. Approximately 115.2 million American adults have prediabetes, equal to more than two in five adults, and nearly eight in ten are unaware of it. This gap supports wider use of HbA1c testing in preventive care, workplace health programs, community clinics, pharmacies, and primary-care practices.

 

Diabetes Costs Strengthen the Case for Earlier Testing

Diabetes creates a substantial financial burden for patients, healthcare providers, insurers, and governments. The International Diabetes Federation estimated that diabetes-related global health expenditure reached approximately USD 1.02 trillion in 2024.

In the United States, the American Diabetes Association estimated that the total economic cost of diabetes reached USD 412.9 billion in 2022. Direct medical costs accounted for approximately USD 306.6 billion, while the remaining burden came from reduced productivity, absenteeism, disability, and premature mortality.

People with diagnosed diabetes account for approximately one-quarter of U.S. healthcare spending. Hospital admissions and complications become more expensive when diabetes is detected late or remains poorly controlled.

These costs encourage healthcare systems to expand screening and monitor treatment more regularly. HbA1c testing provides a longer-term view of glucose control than a single blood glucose reading, helping payers and providers identify high-risk patients and track whether treatment targets are being achieved.

Reimbursement also influences market access. In the United States, HbA1c testing is covered through the Medicare Clinical Laboratory Fee Schedule when medical and billing requirements are met. Countries including Australia provide reimbursement through national healthcare systems, although payment levels, frequency rules, and eligible care settings vary.

 

Routine Screening Moves Testing into Primary Care

Diabetes screening is increasingly being incorporated into routine primary care rather than being limited to specialist departments. The U.S. Preventive Services Task Force recommends screening adults aged 35–70 who have overweight or obesity for prediabetes and type 2 diabetes.

HbA1c is one of the accepted screening methods because it can be performed without fasting. A patient can provide a blood sample during a regular appointment instead of returning after avoiding food overnight, reducing inconvenience and potentially improving screening completion.

People with HbA1c levels between 5.7% and 6.4% may undergo repeat testing every one to two years, depending on age, weight, family history, and other risk factors. Patients who progress into the diabetic range require more frequent monitoring.

 

Laboratory and Point-of-Care Systems Shape Competition

High-performance liquid chromatography, commonly known as HPLC, remains one of the most widely used HbA1c testing methods in hospitals, reference laboratories, and large diagnostic centres. It is particularly suited to laboratories handling high sample volumes and requiring consistent performance across thousands of tests. Published market benchmarks indicate that HPLC accounted for approximately 61.12% of the market by testing method in 2025. Applied to Strategic Market Research’s base-year valuation, this represents an estimated revenue contribution of approximately USD 1.52 billion.

Laboratory buyers assess testing capacity, result accuracy, equipment reliability, sample handling, connectivity, and ongoing reagent and maintenance expenses. HPLC platforms also create recurring revenue after installation through continued purchases of columns, buffers, calibrators, controls, and other consumables.

Recent regulatory clearances indicate continued investment in central-laboratory systems. In June 2025, the U.S. Food and Drug Administration granted 510(k) clearance to the Medconn Glycated Hemoglobin Test System. In October 2025, the FDA cleared Tosoh Bioscience’s HLC-723GR01 automated glycohaemoglobin analyser. Both systems support diabetes diagnosis and long-term glucose monitoring.

Point-of-care testing is also gaining commercial importance because it brings HbA1c measurement into physician offices, diabetes clinics, outpatient centres, pharmacies, and community settings. Published estimates indicate that point-of-care settings represented approximately 60% of market revenue in 2025, equivalent to around USD 1.49 billion when applied to Strategic Market Research’s valuation. This share relates to the testing location and can overlap with market estimates classified by analytical method. Handheld point-of-care systems are projected to expand at approximately 6.92% annually through 2031, reflecting demand for faster testing outside centralised laboratories.

Siemens Healthineers’ DCA Vantage Analyser, for example, can produce an HbA1c result from a small whole-blood sample in approximately six minutes. This allows physicians and patients to discuss the result during the same appointment.

 

Testing Methods Serve Different Buyer Priorities

A variety of analytical approaches are used in the market, including HPLC, immunoassays, boronate-affinity chromatography, capillary electrophoresis, enzymatic assays, and others, with each method selected based on testing needs, setting, and throughput requirements.

Immunoassays are widely used in both central laboratories and compact point-of-care systems. The segment is projected to grow at approximately 7% annually through 2031, supported by its use across automated analysers and smaller testing platforms. Boronate-affinity methods are commonly used in benchtop and rapid-testing systems and may be less affected by certain haemoglobin variants. Capillary electrophoresis is mainly used by reference laboratories requiring detailed haemoglobin separation, while enzymatic assays can be integrated into established automated chemistry workflows.

Consumables provide an important source of recurring revenue. Each test requires a cartridge, reagent pack, chromatography column, control material, or another assay-specific product, allowing suppliers to generate continued sales after the initial instrument installation. Demand for point-of-care cartridges, HPLC columns, reagents, calibrators, and controls therefore increases with testing volumes, even when instrument replacement cycles remain comparatively slow.

 

Standardization and Accuracy Shape Purchasing Decisions

HbA1c results influence diagnosis, treatment changes, public-health reporting, and healthcare quality targets. Small differences can change whether a patient is placed in the normal, prediabetes, or diabetes category, particularly when the result is close to a clinical threshold.

The National Glycohemoglobin Standardization Program certifies testing methods and aligns HbA1c results with evidence from major diabetes studies. Laboratories increasingly consider NGSP certification, quality controls, and result traceability when purchasing instruments and assays.

Anaemia, kidney disease, recent blood loss, transfusion, pregnancy, and inherited haemoglobin variants can affect HbA1c results. Platforms can respond differently to haemoglobin traits such as HbS, HbC, HbE, and HbD, making patient demographics an important purchasing consideration.

During 2024 and 2025, UK authorities reported concerns involving positive bias in results produced by certain HbA1c analyzers. Incorrectly elevated results can lead to repeat testing, unnecessary patient reviews, laboratory investigations, and loss of supplier confidence. Manufacturers are therefore expected to provide consistent reagent batches, dependable service, and evidence of reliable performance across different patient populations.

 

Regional Growth Drivers

North America holds a strong position due to its large diagnosed population, broad insurance coverage, established laboratory network, and routine monitoring practices. The region accounted for approximately 43.2% of global HbA1c testing-device revenue in a published industry benchmark, demonstrating the concentration of testing infrastructure and supplier activity in the region. The U.S. market alone was estimated at approximately USD 942.73 million in 2025, equivalent to about 38% of the Strategic Market Research global base, and is forecast to grow at approximately 6.71% annually through 2035. Demand will come from repeat testing, analyzer replacement, outpatient services, and efforts to identify the estimated 11 million U.S. adults with undiagnosed diabetes.

Europe benefits from national screening programs, primary-care monitoring, centralized purchasing, and strong laboratory quality requirements. National Diabetes Audit data for England and Wales showed that 41.5% of people with type 1 diabetes who received an HbA1c check achieved a level of 58 mmol/mol or below in 2024–2025, up from 39.8% in the previous year.

Asia-Pacific combines advanced testing systems in Japan, South Korea, Singapore, and Australia with substantial unmet demand in India, China, Indonesia, and other densely populated countries. Published estimates indicate that Asia-Pacific represented approximately 30.9% of global HbA1c testing-device revenue in 2025. Applying this share to the Strategic Market Research market base produces an estimated regional value of approximately USD 0.77 billion. The region is projected to expand at approximately 8.34% annually from 2026 to 2033, exceeding the global market growth rate, while laboratory-based devices held around 58.25% of Asia-Pacific revenue in 2025.

Australia estimated that approximately 1.3 million adults were living with diabetes during 2022–2024. As of July 2025, around 72% of regular primary-care patients with type 2 diabetes had an HbA1c result recorded within the previous 12 months. The continuing monitoring gap supports additional demand for laboratory and point-of-care testing.

 

Competitive Landscape and Commercial Growth Dynamics

The Glycated Haemoglobin Testing Market will continue to include high-volume laboratory systems and decentralized point-of-care devices. Central laboratories benefit from automation, large sample volumes, and recurring reagent contracts. Diagnostic and reference laboratories accounted for approximately 46.87% of the market in 2025, corresponding to around USD 1.16 billion when applied to the Strategic Market Research global market value. Homecare settings remain smaller but are projected to record approximately 7.05% annual growth through 2031 as sample-collection services and compact testing systems become more accessible.

Point-of-care suppliers benefit from healthcare providers seeking same-visit results. Competition will increasingly depend on result consistency, cartridge and reagent pricing, quality certification, electronic health-record connectivity, recognition of haemoglobin variants, low sample requirements, and local service availability.

The largest commercial opportunity remains the gap between diabetes prevalence and actual testing coverage. Around 252 million adults worldwide are estimated to have undiagnosed diabetes, while diagnosed patients require regular monitoring throughout treatment. Suppliers that can serve both centralized laboratories and community-level care will be better positioned to capture demand.

 

Glycated Haemoglobin Testing Market Report Coverage Table

Report Attribute	Details
Forecast Period	2026–2032
Market Size Value in 2025	USD 2.48 Billion
Revenue Forecast in 2032	USD 4.06 Billion
Overall Growth Rate	CAGR of 7.3% (2026–2032)
Base Year for Estimation	2025
Historical Data	2019–2024
Unit	USD Million, CAGR (2026–2032)
Segmentation	By Product, By Methodology, By Testing Mode, By End User, By Geography
By Product	Instruments, Consumables
By Methodology	High-Performance Liquid Chromatography, Immunoassay, Boronate-Affinity Chromatography, Capillary Electrophoresis, Enzymatic Assays, Other Methods
By Testing Mode	Laboratory-Based Testing, Point-of-Care Testing
By End User	Hospitals, Diagnostic and Reference Laboratories, Physician Offices, Diabetes Clinics, Homecare Settings, Community Healthcare Centers
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 and prediabetes prevalence; large undiagnosed patient population; recurring HbA1c monitoring requirements; wider diabetes screening in primary-care settings; growing adoption of point-of-care testing systems
Customization Option	Available upon request