HbA1c Testing Devices Market – Global Industry Size, Share, Trends, Opportunity, & Forecast Segmented By Type of Device (Laboratory-based Testing Devices, Point-of-care (POC) Testing Devices), By Technology (Immunoassays, Chromatography, Enzymatic Assays, Boronate Affinity Chromatography, High-Performance Liquid Chromatography, Others), By End User (Hospitals & Clinics, Diagnostic Laboratories, Homecare Settings), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.26 Billion
CAGR (2026-2031)	7.10%
Fastest Growing Segment	Point-of-care (POC) testing devices
Largest Market	North America
Market Size (2031)	USD 3.41 Billion

Market Overview

The Global HbA1c Testing Devices Market will grow from USD 2.26 Billion in 2025 to USD 3.41 Billion by 2031 at a 7.10% CAGR. HbA1c testing devices are specialized instruments designed to quantify glycated hemoglobin levels and assess average blood glucose control over two to three months. The primary market driver is the escalating prevalence of diabetes which necessitates frequent screening to prevent severe complications. This demand is supported by the increasing utility of rapid diagnostic solutions that facilitate immediate clinical decisions. According to the International Diabetes Federation, in 2024, approximately 589 million adults were living with diabetes globally, a statistic that underscores the critical need for reliable monitoring tools.

A significant challenge impeding expansion is the substantial cost associated with advanced testing platforms and their recurring consumables. These financial barriers limit the adoption of modern diagnostic technologies in developing nations where healthcare budgets remain restricted. Consequently, the inability of economically constrained regions to procure these devices creates a considerable gap in market accessibility and hampers growth in areas with high disease burdens.

Key Market Drivers

Technological advancements in Point-of-Care (POC) HbA1c testing are aggressively driving market expansion by delivering laboratory-grade accuracy with unprecedented speed and convenience. Modern devices are increasingly miniaturized and automated, allowing healthcare providers to conduct rapid assessments during routine office visits rather than sending samples to centralized laboratories. This capability facilitates immediate therapeutic adjustments and enhances patient compliance by streamlining the diagnostic process. For instance, according to Clinical Lab Products, October 2025, in the article 'FDA Clears Next-Generation HbA1c Analyzer with 50-Second Results', Tosoh Bioscience received FDA clearance for its new automated glycohemoglobin analyzer that provides precise HbA1c results in under one minute. Such innovations are pivotal in high-volume clinical settings where time efficiency is directly correlated with patient throughput and quality of care.

Rising government initiatives for diabetes screening and awareness further propel the demand for HbA1c testing devices by systematically removing 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 Centers for Medicare & Medicaid Services, in the 'CMS Diabetes Strategy — Impact Report 2024', 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 financial stakes are high; according to the International Diabetes Federation, in 2024, diabetes was responsible for an estimated 1.02 trillion USD in global health expenditure, necessitating cost-effective monitoring solutions.

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Key Market Challenges

The substantial cost associated with 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.

Key Market Trends

The market is 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, January 2025, in the 'CES 2025 Innovation Awards' announcement, 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, 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.

Segmental Insights

The Point-of-care (POC) testing devices segment represents the fastest-growing category within the Global HbA1c Testing Devices Market, primarily driven by the increasing demand for immediate diagnostic results. This capability expedites clinical decision-making, allowing healthcare providers to modify treatment plans during a single patient consultation rather than awaiting laboratory feedback. The segment's expansion is further supported by the proliferation of CLIA-waived analyzers, which permit testing in decentralized settings such as physician office laboratories and community clinics. Consequently, the industry shift towards patient-centric care models that prioritize convenience and rapid turnaround times continues to accelerate the adoption of these diagnostic tools.

Regional Insights

North America maintains a leading position in the Global HbA1c Testing Devices Market due to the high prevalence of diabetes and a well-established healthcare infrastructure. The region benefits from favorable reimbursement policies that make diagnostic testing accessible to a broader patient population. Additionally, consistent guidelines from the American Diabetes Association recommending regular monitoring drive the sustained demand for testing devices. The active involvement of the U.S. Food and Drug Administration in approving effective diagnostic tools further supports market expansion, ensuring widespread adoption across hospitals and home-care settings.

Recent Developments

• In August 2025, PocDoc launched a smartphone-based HbA1c testing solution in the United Kingdom to facilitate the screening of type 2 diabetes. The system integrated a lateral flow test with a proprietary mobile application, enabling users to determine their average blood glucose levels using a finger-prick sample. This digital diagnostic tool allowed patients to obtain results within minutes without visiting a clinical laboratory. The release aimed to support healthcare providers by expanding community-based testing capabilities and increasing early detection rates for individuals at risk, thereby aligning with national strategies to manage chronic conditions more effectively.
• In January 2025, Orange Biomed presented the OBM rapid A1c system at the Consumer Electronics Show (CES). The company displayed this portable device which utilized microfluidic technology to measure glycated hemoglobin from a small blood sample. The system employed a single-cell analysis method designed to reduce sampling errors and maintain accuracy even in the presence of hemoglobin variants. This technology was developed to facilitate precise long-term glucose monitoring in non-clinical settings, aiming to improve accessibility for patients. The presentation highlighted the device's potential to provide immediate, reliable data to assist in the effective management of diabetes.
• In November 2024, Nova Biomedical received 510(k) clearance from the U.S. Food and Drug Administration for its Nova Allegro HbA1c Assay. This regulatory approval authorized the use of the automated assay with the Nova Allegro Analyzer to quantitatively determine glycated hemoglobin levels in capillary finger-stick whole blood samples. Designed specifically for point-of-care environments, the test was intended to monitor long-term glucose control in individuals with diabetes mellitus. The system utilized a latex-enhanced turbidimetric immunoassay method to deliver rapid and accurate results, assisting clinicians in making timely treatment decisions during patient consultations.
• In July 2024, Siemens Healthineers introduced the Atellica DCA Analyser, a point-of-care system developed to streamline diabetes management and support early diagnosis. The compact device allowed healthcare professionals to conduct hemoglobin A1c (HbA1c) and albumin-to-creatinine ratio (ACR) testing during a single patient visit, providing laboratory-equivalent results in minutes. This launch addressed clinical needs for efficient testing in space-constrained environments, reducing the necessity for follow-up appointments. The analyzer incorporated automated internal checks to prevent sample loss and ensure result accuracy, enabling clinicians to deliver immediate medical guidance and improve workflow efficiency in diverse healthcare settings.

Key Market Players

• 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.

By Type of Device	By Technology	By End User	By Region
Laboratory-based Testing Devices Point-of-care (POC) Testing Devices	Immunoassays Chromatography Enzymatic Assays Boronate Affinity Chromatography High-Performance Liquid Chromatography Others	Hospitals & Clinics Diagnostic Laboratories Homecare Settings	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global HbA1c Testing Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• 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
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE