HbA1c Testing Market Research Report, Size, Share, Analysis, Growth by Region, Forecast to 2028

Global HbA1c Testing Market Overview:

The global HbA1c testing market is projected to grow at a compound annual growth rate (CAGR) of approximately 9–12% through 2028. This growth is primarily driven by the rising global prevalence of diabetes, increasing awareness of the importance of routine HbA1c testing in long-term diabetes management, growing patient preference for minimally invasive testing methods, and continuous technological innovations that enhance test accuracy, efficiency, and accessibility.

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HbA1c testing—also referred to as glycated hemoglobin testing—is a cornerstone of diabetes diagnosis and management, particularly for individuals with type 2 diabetes. The test evaluates average blood glucose levels over the previous two to three months by measuring the amount of glucose bound to hemoglobin in red blood cells. Because red blood cells typically have a lifespan of about 120 days, HbA1c results provide a reliable indicator of long-term glycemic control.

Healthcare professionals rely on HbA1c test results to adjust treatment regimens, monitor disease progression, and evaluate the risk of diabetes-related complications, including cardiovascular disease, neuropathy, and kidney damage. Elevated HbA1c levels indicate sustained hyperglycemia, which, if left unmanaged, can lead to serious long-term health consequences. As a result, regular HbA1c testing is widely recommended to ensure effective diabetes control and to reduce the risk of complications.

Key Drivers Fueling Market Growth

HbA1c testing plays a critical role in diabetes monitoring and treatment, and the market’s expansion is supported by several key factors. These include the rapidly increasing incidence of diabetes worldwide, heightened awareness of the need for routine HbA1c monitoring, and ongoing technological advancements that improve test precision, speed, and accessibility.

For example, in May 2019, Siemens Healthineers launched the Atellica CH Enzymatic Hemoglobin A1c (A1c_E) Assay globally. This assay was designed to deliver highly accurate and precise results while integrating seamlessly into existing chemistry testing platforms, supporting clinicians in both diagnosing and monitoring diabetes.

The growing adoption of point-of-care testing (POCT) devices further underscores the importance of timely HbA1c measurement across diverse healthcare settings. Market growth is also reinforced by initiatives aimed at early diabetes detection, regulatory emphasis on standardized HbA1c testing, patient demand for less invasive procedures, and the integration of test results into electronic health record (EHR) systems to improve clinical decision-making. Together, these trends reflect a shift toward more patient-centered and data-driven diabetes care.

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Technological Innovations Enhancing Diabetes Outcomes

The HbA1c testing landscape is evolving rapidly, with innovation playing a central role in improving patient outcomes. One major trend is the increasing adoption of continuous glucose monitoring (CGM) systems, which provide real-time glucose data and complement traditional HbA1c testing by offering more comprehensive glycemic insights.

There is also growing interest in portable and smartphone-enabled HbA1c testing devices, which support at-home monitoring and facilitate telemedicine-based diabetes management. Significant progress has been made in assay development, with a focus on improving accuracy, sensitivity, and specificity. In parallel, personalized medicine approaches are gaining traction, enabling clinicians to tailor treatment strategies based on individual HbA1c levels and patient-specific factors.

For instance, in June 2023, Abbott announced that its FreeStyle Libre 2 system became the first continuous glucose monitoring system to receive nationwide reimbursement in France for patients using once-daily basal insulin. This milestone expanded access to CGM technology and followed similar reimbursement advancements in markets such as Japan and the United States.

Recent innovations also include HbA1c testing kits with reduced sample volume requirements and faster turnaround times, improving workflow efficiency in both clinical and point-of-care settings. The integration of artificial intelligence (AI) into HbA1c testing platforms enables advanced data analysis and clinical interpretation, supporting more informed treatment decisions. Additionally, research is underway to develop non-invasive or minimally invasive testing methods, including saliva- or breath-based assays, to further enhance patient comfort. Enhanced connectivity features now allow seamless data sharing and remote monitoring, aligning HbA1c testing with broader digital health ecosystems.

Market Constraints and Challenges

Despite strong growth prospects, the HbA1c testing market faces several challenges. Regulatory approval processes can be complex and vary significantly across regions, requiring sustained investment in compliance and research. High device costs and limited reimbursement coverage in certain markets may restrict adoption, particularly in resource-constrained settings. Furthermore, limited awareness of HbA1c testing in developing regions and potential interference from hemoglobin variants can affect test reliability, prompting manufacturers to develop more robust and adaptable solutions.

Regional Market Insights

North America holds the largest share of the global HbA1c testing market, supported by a high prevalence of diabetes, advanced healthcare infrastructure, strong awareness of disease management, and the presence of major industry players. Technological innovation and widespread adoption of advanced diagnostic tools further contribute to regional growth.

In Europe, stringent regulatory standards and government-led initiatives focused on diabetes prevention and management significantly influence market dynamics. Rising healthcare expenditure and increased use of point-of-care testing devices also support market expansion.

The Asia Pacific region is expected to experience the fastest growth, driven by a rapidly increasing diabetic population—particularly in countries such as China and India—along with expanding healthcare investments, improving infrastructure, and growing awareness of the importance of routine HbA1c monitoring.

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Competitive Landscape and Strategic Developments

The HbA1c testing market is highly competitive, with key players including Abbott Laboratories, Bio-Rad Laboratories, ARKRAY, Danaher, F. Hoffmann-La Roche, Siemens Healthineers, TransAsia Bio-Medicals, Trinity Biotech, EKF Diagnostics, Beckman Coulter, and Randox Laboratories, among others.

Market participants are actively pursuing both organic and inorganic growth strategies—such as product innovation, partnerships, expansions, and acquisitions—to strengthen their market position. For example, in September 2023, Abbott completed its acquisition of Bigfoot Biomedical, enhancing its diabetes care portfolio and reinforcing its focus on personalized and integrated diabetes management solutions. Similarly, in December 2021, ARKRAY expanded its European presence by establishing multiple sales offices and a manufacturing facility in Ireland.

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