HbA1c Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global HbA1c Testing Devices Market is projected to expand from USD 2.26 Billion in 2025 to USD 3.41 Billion by 2031, reflecting a compound annual growth rate of 7.10%. These testing devices are specialized instruments capable of quantifying glycated hemoglobin levels to evaluate average blood glucose control over a period of two to three months. The primary catalyst for this market is the rising prevalence of diabetes, which requires frequent screening to avert serious complications. This demand is further bolstered by the growing utility of rapid diagnostic solutions that enable immediate clinical decision-making. As reported by the International Diabetes Federation in 2024, approximately 589 million adults globally were living with diabetes, highlighting the critical necessity for dependable monitoring tools.

However, a significant obstacle to market growth is the high cost associated with advanced testing platforms and their recurring consumables. These financial constraints hinder the adoption of modern diagnostic technologies in developing nations where healthcare budgets are limited. Consequently, the inability of economically restricted regions to procure these devices creates a substantial gap in market accessibility. This situation impedes expansion in areas that suffer from high disease burdens, thereby limiting the widespread deployment of essential health monitoring solutions.

Market Drivers

Technological advancements in Point-of-Care (POC) HbA1c testing are aggressively fueling market growth by providing laboratory-grade accuracy combined with exceptional speed and convenience. Modern devices are becoming increasingly miniaturized and automated, enabling healthcare providers to perform rapid assessments during routine office visits rather than relying on centralized laboratories. This capability allows for immediate therapeutic adjustments and improves patient compliance by simplifying the diagnostic process. For example, Clinical Lab Products reported in October 2025 that Tosoh Bioscience received FDA clearance for a new automated glycohemoglobin analyzer capable of delivering precise HbA1c results in under one minute, a development crucial for high-volume clinical settings where efficiency impacts patient care.

Additionally, rising government initiatives aimed at diabetes screening and awareness are propelling the demand for HbA1c testing devices by systematically eliminating financial and regulatory barriers to access. Governments and public health bodies are actively integrating comprehensive screening protocols into national healthcare strategies to mitigate the long-term economic impact of chronic diabetes complications. According to the 'CMS Diabetes Strategy - Impact Report 2024' by the Centers for Medicare & Medicaid Services, the agency expanded Medicare coverage to include the hemoglobin A1c test for diabetes screening without coinsurance, aiming to improve early detection rates among at-risk populations. This shift towards preventative funding is essential, as the International Diabetes Federation estimated in 2024 that diabetes was responsible for USD 1.02 trillion in global health expenditure, necessitating cost-effective monitoring solutions.

Market Challenges

The substantial cost involved in acquiring advanced HbA1c testing platforms and purchasing recurring consumables constitutes a significant barrier to market expansion. This financial burden limits the adoption of diagnostic technologies, particularly in developing regions where healthcare budgets are constrained. Medical institutions in these areas often prioritize acute care over preventive monitoring tools due to funding shortages, which directly hampers the sales volume of testing devices. Consequently, manufacturers face difficulties in penetrating these price-sensitive markets, resulting in a disparity between global disease prevalence and the deployment of monitoring solutions.

This economic divide restricts the market from reaching its full potential in high-burden territories. According to the International Diabetes Federation, in 2024, 75 percent of adults with diabetes were living in low- and middle-income countries, yet these regions commanded a disproportionately small share of global diabetes expenditure. This data indicates that the high price of testing devices prevents market growth in the exact geographic areas where the patient population is largest, effectively creating a ceiling on global revenue opportunities.

Market Trends

The market is currently experiencing a transformative shift towards non-invasive and minimally invasive methodologies, driven by the need to enhance patient compliance and eliminate the discomfort associated with traditional blood draws. Innovations in optical sensing and transdermal analysis are enabling the development of devices that quantify glycated hemoglobin levels without requiring fingersticks, thereby facilitating more frequent and pain-free monitoring. This technological leap is exemplified by emerging product showcases that highlight the industry's move towards needle-free diagnostics. According to the Consumer Technology Association in January 2025, during the 'CES 2025 Innovation Awards', the QuickGly non-invasive HbA1c monitoring device was recognized for its breakthrough capability to measure real-time values without blood extraction, a technology currently supported by 9 registered patents.

Concurrently, there is a growing focus on sustainable and eco-friendly device manufacturing as stakeholders prioritize the reduction of the healthcare industry's environmental footprint. Manufacturers are increasingly adopting green chemistry principles and biodegradable materials to minimize hazardous waste and plastic consumption associated with single-use diagnostic consumables. This trend is reshaping production lines to align with global environmental standards while maintaining analytical precision. According to Siemens Healthineers in November 2025, in the 'Siemens Healthineers Sets New Sustainability Benchmark' press release, the company became the first in vitro diagnostic manufacturer to receive the My Green Lab ACT Ecolabel for more than 150 of its immunoassay and clinical chemistry reagents, underscoring the rapid industry-wide transition towards environmentally responsible laboratory solutions.

Key Players Profiled in the HbA1c Testing Devices Market

• Bio-Rad Laboratories, Inc.
• Abbott Laboratories Inc.
• F. Hoffmann-La Roche Ltd.
• Siemens Healthineers AG
• Human Inc.
• Trinity Biotech plc
• A. Menarini Diagnostics s.r.l
• SAKAE CO. LTD.
• SEKISUI MEDICAL CO., LTD.

Report Scope

In this report, the Global HbA1c Testing Devices Market has been segmented into the following categories:

HbA1c Testing Devices Market, by Type of Device:

• Laboratory-based Testing Devices
• Point-of-care (POC) Testing Devices

HbA1c Testing Devices Market, by Technology:

• Immunoassays
• Chromatography
• Enzymatic Assays
• Boronate Affinity Chromatography
• High-Performance Liquid Chromatography
• Others

HbA1c Testing Devices Market, by End User:

• Hospitals & Clinics
• Diagnostic Laboratories
• Homecare Settings

HbA1c Testing Devices Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global HbA1c Testing Devices Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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