HbA1c Testing Device Market Dominated by Kits Segment for Standardized Testing Solutions

The global HbA1c Testing Device Market size reached US$ 2.01 Billion in 2024 and is expected to reach US$ 5.69 Billion by 2033, growing at a CAGR of 10.6% from  2025 to 2033., according to DataM Intelligence.

HbA1c testing measures average blood glucose levels over 2-3 months via diagnostic tools, essential for diabetes monitoring and diagnosis. Elevated levels indicate poor control, raising risks of complications like cardiovascular disease. The market is driven by rising diabetes prevalence, home testing adoption, and point-of-care advancements, though high kit costs may limit accessibility in resource-constrained areas.

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Market Segmentation

By Product Type
The market is segmented into kits and reagents. Kits dominate the market as they provide a complete, standardized solution for specific tests, ensuring consistency, ease of use, and reduced risk of error. They are especially valuable in clinical settings for routine high-throughput testing. Reagents form the essential consumables used in various analytical procedures. While kits offer convenience, reagents provide flexibility for customized assays and are a recurring revenue source for manufacturers. The demand for ready-to-use, reliable diagnostic solutions drives the dominance of kits in standardized testing environments.

By Technology
Key technologies include immunoassay, high-performance liquid chromatography (HPLC), boronate affinity chromatography, and enzymatic assays. Immunoassay is the most widely adopted technology due to its high sensitivity, specificity, and suitability for automated high-volume testing, making it the gold standard for many clinical markers. HPLC offers high precision for separation and quantification of complex mixtures. Boronate affinity chromatography is a specialized technique for analyzing glycated proteins like HbA1c. Enzymatic assays are valued for their simplicity and cost-effectiveness in measuring specific metabolites. The choice of technology depends on the required accuracy, throughput, and analyte characteristics.

By End User
Diagnostics laboratories are the largest end-users, utilizing these products for a high volume of routine and specialized tests. Their operations rely heavily on the efficiency and reliability provided by standardized kits and automated immunoassay systems. Hospitals represent a significant segment, using these tests for both inpatient and outpatient care, with a focus on rapid turnaround times for critical results. Other end-users include research institutes, academic centers, and point-of-care testing facilities, which may require more flexible reagent-based approaches for specialized research or decentralized testing. The centralization of testing in core laboratories reinforces the dominance of the diagnostics laboratories segment.

Market Share

North America holds the largest market share, approximately 32.4% in 2022, driven by high diabetes incidence (over 30 million diagnosed and 84 million pre-diabetic in the US) and advanced infrastructure. Asia-Pacific is expected to witness the fastest growth due to increasing diabetes cases, urbanization, and expanding healthcare access.

Market Drivers

The market is propelled by the increasing availability of home diagnostic tests, boosted by COVID-19's push for decentralized monitoring. Product launches, such as OmegaQuant’s at-home HbA1c kit (May 2022) and Labcorp’s OnDemand kit (May 2022), enhance convenience. Demand for point-of-care testing rises with innovations like Healthyr’s HbA1c + Glucose Test (October 2023) and Hurdle’s at-home test (February 2023). However, high kit costs (e.g., A1CNow Self Check at USD 64.95–72.33) and limited insurance in some regions restrain growth.

Key Players

Prominent companies in the HbA1c testing market include:

• Abbott Laboratories

• Arkray, Inc

• Bio-Rad Laboratories Inc

• EKF Diagnostics Holdings Plc

• Siemens Healthineers

• PTS Diagnostics, Inc

• Getein Biotech, Inc

• Thermo Fisher Scientific Inc.

• Roche Diagnostics Corporation

• Meril Life Sciences Pvt. Ltd

Recent Developments

• In April 2023, Abbott, Siemens Healthineers, and i-SENS partnered with FIND to provide discounted point-of-care HbA1c tests for low- and middle-income countries, including Abbott's Afinion, Siemens Healthineers' DCA Vantage, and i-SENS' A1Care.

• In March 2022, LumiraDx Limited received CE Marking for its HbA1c test, delivering results in under seven minutes for diabetes monitoring and screening at the point of care.

• In October 2023, Healthyr launched six at-home tests available at Walmart, including an HbA1c + Glucose Test for diabetes screening.

Conclusion

The HbA1c testing market is poised for steady growth, fueled by escalating diabetes prevalence in North America and rapid healthcare advancements in Asia-Pacific. Innovations in home and point-of-care testing, alongside partnerships for accessibility, offset challenges like high costs. With ongoing product launches and a focus on early diagnosis, HbA1c testing will remain vital in diabetes management and complication prevention through 2031 and beyond.

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