Global HbA1c Testing Devices Market Size Likely to Expand at a CAGR of 5.64% By 2034

Global HbA1c Testing Devices Market size was valued at USD 2.31 Billion in 2025 and is expected to reach USD 3.56 Billion by 2034, at a CAGR of 5.64% during the forecast period 2025 to 2034.

HbA1c Testing Devices Market Overview

The introduction of new technologies and supportive collaborations and the rising diabetes patients worldwide will drive the growth of the global HbA1c testing devices market. The rising need for home-based monitoring and point-of-care (POC) testing is one of the key factors driving the growth of this market, as patients are increasingly opting for faster and convenient diagnostic solutions that enable early disease management.

The trend for self-testing, real-time disease monitoring, and on-site results is rapidly growing, and hence, multiple companies are putting in a lot of effort and investments to come up with small, portable HbA1c devices that provide results with high precision in less than a few minutes.

The growing demand for integrated solutions guaranteeing increased user-friendliness, affordability, and accuracy has enabled the companies to develop advanced technologies providing advanced imaging diagnostic solutions to patients and healthcare professionals.

The emergence of Artificial Intelligence (AI) in the development of the diagnostic systems is going to be the single most game-changing technological advancement the industry has seen in decades, completely altering how the HbA1c testing is performed and the accuracy and efficiency of that testing.

Implementation of the same will support improved monitoring in cases where the patient is diabetic or is hyperglycemic and will furthermore assist the health practitioners in administering treatment in the future to the glucose levels.

The insights driven by an AI model help healthcare providers make better decisions to prevent misdiagnosis and even let them implement an early intervention protocol that can save the patient from further complications.

However, as the industry expands, companies need to get past rigorous regulatory obstacles, including stringent compliance standards set forth by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to make sure their testing devices are safe, accurate, and reliable.

Fortunately for the innovators, in a bid to clear the pathway for regulators as well as patients to the new developments and grow product launches around fertility awareness, manufacturers are increasingly committed to undertaking large-scale clinical validation studies and investing in regulatory compliance frameworks.

The HbA1c testing devices market in North America accounted for the highest share, owing to the increasing prevalence of diabetes, well-established healthcare infrastructure, and high adoption of advanced diagnostic technologies.

The U.S. dominates the region due to the increasing spending on diabetes management, high insurance coverage for diabetes management, and research and development of novel products by key companies in the market. Similarly, government initiatives working towards the progress of diabetes awareness programs and also early diagnosis activities have positively impacted the adoption of the market for HbA1c testing devices.

Moreover, the domination of the region in the market is largely attributed to the participation of major market players investing in research and development.

The Asia–Pacific region is forecasted to register the maximum growth, driven by the rising burden of diabetes in countries such as China, India, and Japan, where lifestyle changes, growing obesity rates, and an aging population are responsible for disease prevalence.

The rising prevalence of government programs for early diabetes detection, along with rising healthcare expenses in the developing economies, is driving the market growth. Continue Reading Overcoming Barriers to Provide More Access to COVID-19 Testing.

Leading experts argue that there is an urgent need for more affordable, at-home COVID-19 testing options, particularly within rural and underserved populations. Market growth in this region will also be helped by the growing use of digital health solutions and telemedicine platforms.

Report Scope

CMI has comprehensively analyzed the Global HbA1c Testing Devices market. The driving forces, restraints, challenges, opportunities, and key trends have been explained in depth to depict the in-depth scenario of the market. Segment-wise market size and market share during the forecast period are duly addressed to portray the probable picture of this Global HbA1c Testing Devices industry.

The competitive landscape includes key innovators, after-market service providers, and market giants, as niche players are studied and analyzed extensively for their strengths and weaknesses as value-addition prospects. In addition, this report covers key player profiling, market shares, mergers and acquisitions, consequent market fragmentation, new trends, and dynamics in partnerships.

List of the prominent players in the HbA1c Testing Devices Market:

• Abbott Laboratories
• Roche Diagnostics
• Siemens Healthineers
• Bio-Rad Laboratories
• ARKRAY Inc.
• Trinity Biotech
• EKF Diagnostics
• HemoCue AB (Danaher Corporation)
• PTS Diagnostics
• Diazyme Laboratories Inc.
• OSANG Healthcare Co. Ltd.
• Tosoh Corporation
• SD Biosensor Inc.
• Sebia
• TransAsia Bio-Medicals Ltd.
• Hoffmann-La Roche Ltd.
• MannKind Corporation
• ApexBio Diagnostics
• Lite-On Technology Corporation
• Wellion
• Others

The HbA1c Testing Devices Market is segmented as follows:

By Type of Device

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

By End User

• Hospitals & Clinics
• Diagnostic Laboratories
• Homecare Settings

By Technology

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

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America