Global HbA1c Testing Devices Market 2025 – 2034

Reports Description

Global HbA1c Testing Devices Market 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 Device Market HbA1c testing devices are the medical devices that are used to determine the level of glycated hemoglobin (HbA1c) in individual blood that acts as an important biomarker in diagnosing and regulating diabetes. Laboratory devices and point-of-care testing (POCT) devices constitute this group of devices, being able to provide relatively rapid and accurate results.

HbA1c Testing Devices Market Growth Factors

Rising Diabetes Prevalence Driving Demand for HbA1c Testing

Diabetes is on the rise, especially Type 2 Diabetes Mellitus (T2DM), and it is driving the growth of the HbA1c testing devices market. According to the International Diabetes Federation (IDF) Diabetes Atlas 2021 estimate, approximately 537 million adults globally were living with diabetes, with 8.3% of the adult population affected.

The rising number of cases can largely be attributed to changing lifestyles, obesity, population aging, and negative diet habits. Thus, these devices turn out to be an outdoor boon in a healthcare scenario, as levels of HbA1c need to be tracked frequently in diabetic management.

Increasing healthcare awareness among the population and various government initiatives promoting early diagnosis are other factors contributing to the growth of the market. In December 2021, the U.S. Centers for Medicare and Medicaid Services (CMS) declared coverage of all continuous glucose monitoring (CGM) systems for Medicare patients.

Along with this, it phased the growth of HbA1c testing devices to enhance patient care. By focusing on this, we have been rewarded in the US market with acceptance by healthcare providers and patients. In addition, increasing diabetes among developing countries like India and China is driving heavy investment in their diagnostic infrastructure, which is driving market growth.

Technological Advancements Enhancing Accuracy and Efficiency

This has played a major role in empowering the patients with HbA1c testing devices. However, traditional laboratory-based methods are typically more expensive and take longer to process despite their high accuracy.

The newly developed point-of-care (POC) devices that include A1CNow and LumiraDx’s HbA1c test now deliver rapid results in 5–7 minutes that allow for diabetes control in real time. For example, LumiraDx’s HbA1c test, which received CE certification in May 2022, delivers rapid and reliable results using microfluidic assay technology, offering the potential for decentralized healthcare provision.

Moreover, Roche’s purchase of LumiraDx’s POC technology for USD 295 million in January 2024 demonstrates that the same market should be redirected toward fast, automated, and portable diagnostic tools. These technologies greatly enhance patient outcomes by decreasing the turnaround times of diagnostic testing while also allowing for faster treatment decisions.

HbA1c Testing Devices Market Restraints

Stringent Regulatory Approvals Hindering Market Expansion

HbA1c test devices must go through a cumbersome regulatory approval process that is often a bottleneck for bringing a device to market for new-entry players. Devices are subject to stringent FDA, CE, and other global regulatory standards, which include long clinical trials, voluminous paperwork, and adherence to quality control rules.

The actual time for approval of new DX devices is between 4 and 14 years, which makes it a very challenging process for manufacturers, especially startups and research-based organizations. The recent controversy with the approval of non-invasive HbA1c testing methods is a good example of how regulators react more cautiously to this method of testing based on the perceived untrustworthiness of commercially developed tests.

Promising as they are, companies find it difficult to get approvals for such solutions, as validation methods are not standardized. This has resulted in a greater dependence on traditional methods, hindering the progress of newer technologies. Similarly, post-market surveillance requirements, along with firm implementation costs, limit market entry, creating barriers to competition and innovation in the industry.

High Cost of Devices and Testing Limiting Adoption in Low-Income Regions

HbA1c test devices are not affordable in low- and middle-income economies. Laboratory-based analyzers and high-end POC devices are expensive to deliver and, as such, out of reach for smaller clinics and at-home users.

The CO2 costs of consumables, maintenance costs, and the need for trained personnel also add to the economic burden and limit widespread adoption. For example, a recent study conducted at Kenyatta National Hospital in Kenya demonstrated the significance of HbA1c testing in diabetes care, although cost proved to be an obstacle for patients with limited resources.

HbA1c Testing Devices Market Opportunities

Expansion of Point-of-Care Testing in Decentralized Healthcare Settings

Economically superior point-of-care (POC) devices for HbA1c are a prime opportunity, especially in times of increasing decentralization of healthcare. The growing demand for rapid, on-site diagnostic testing—especially in clinical, pharmacy, and home-care settings—continues to drive the development of many types of portable diagnostic analyzers, and HbA1c analyzers have been no exception.

These devices can provide feedback and adjust their treatment in real time for the provider, which in turn leads to better outcomes for the patient. One example is LumiraDx’s rapid microfluidic assay technology that provides accurate test results as quickly as seven minutes—directly meeting a clinical need for an easy, reliable method for diabetes screening.

Filling in the spectrum from medical laboratory clinicians to point-of-care testing continues, with Roche acquiring LumiraDx’s technology in January 2024, and reflects the ongoing attention to rapid diagnostics for use in both primary care and telemedicine settings.

Thus, the rise of the COVID-19 pandemic with the decent rise in petty testing also propelled the need for home-based devices for HbA1c monitoring. POC testing, which is a major focus of governments and healthcare providers, is anticipated to encourage the development of this market during the forecast period.

Integration of Digital Health and AI-Driven Analytics

The integration of digital health platforms with HbA1c testing devices, as well as the application of AI analytics, is revolutionizing diabetes management. With real-time patient data being available via smart analyzers with cloud connectivity, all medications can be claimed in time to be able to track the micro- and macro-physiological glucose trends at home and any medication adjustments.

Some, such as Abbott, Siemens Healthineers, and others, are already moving toward potential connected diagnostic solutions, with integration both into EHRs and into wearable glucose monitors. For example, Abbott’s FreeStyle Libre system provides real-time glucose results and, when paired with HbA1c readings, gives us a complete view of a patient’s glycemic control.

Globally, healthcare systems are adopting personalised, data-driven strategies and leveraging AI-powered analytics with current HbA1c testing devices to revolutionise diabetes care.

HbA1c Testing Devices Market Trends

Growing Preference for Home-Based HbA1c Testing

The convenience and independence provided by home-based HbA1c testing devices are witnessing increased demand among patients with diabetes. The development of user-friendly, non-invasive devices capable of self-monitoring has reduced the frequency of hospital visits. The COVID-19 pandemic accelerated this transition with an emphasis on remote monitoring solutions.

A case in point is the HemoCue HbA1c 501 System, launched in partnership with Novo Nordisk in 30 countries, which plans to increase to 100,000 children by 2030, the number of those with this device, unlocking access to diabetes care.

Likewise, nonprescription HbA1c monitoring devices, which provide rapid at-home testing, are gaining traction in North America and Europe, where prevention and early diagnosis of the disorder have been emphasized in healthcare systems. It will also help drive this trend during the forecast period as more companies invest in portable and connected HbA1c analyzers.

HbA1c Testing Devices Market Segmentation Analysis

The segment of point-of-care (POC) testing devices dominated the market in 2024, with a market share of 76.53%, and it is estimated that it will register the fastest CAGR during the forecast period. The need for prompt diagnostic results in clinical settings, the push for healthcare decentralization, and the increasing incidence of diabetes are a few of the significant factors that are driving the demand for POC testing devices, including HbA1c testing devices.

In particular, the need for the microfluidic assay technology includes the growing clinical need for tests that are quick, near-patient, and readily accessible, such as the LumiraDx HbA1c test technology, which is a need in some cases where rapid results are required from the clinic to enable quicker results in better managing their patients.

Additionally, several factors, such as strategic acquisitions and product launches, have played a major role in the expansion of the market. In January 2024, Roche entered into a contract with LumiraDx, a point-of-care testing company, to acquire its point-of-care testing technology for USD 295 million, plus up to USD 55 million dedicated to maintaining Lumira’s point-of-care technology platform until the completion of the acquisition.

Additionally, in May 2022, the company obtained CE marking for its HbA1c test deployed on its point-of-care LumiraDx platform for enhanced diabetes screening and monitoring capabilities. The microfluidic assay results in less than seven minutes, helping to identify patient risk.

Based on end users, the industry market is segmented by Hospitals & Clinics, Diagnostic Laboratories, and Homecare settings. In 2024, hospitals held the end-use segment with a 41.38% market share. Healthcare facilities such as hospitals and clinics have the right technologies and infrastructures in place to use these well.

Such institutions need fast and reliable methods for checking patients’ glycemic control in diabetes, prompting the use of these devices for HbA1c. POC diagnostics can streamline patient data access at the point of care, which helps with timely intervention.

The cost-effectiveness of such devices, which is catered by the ability to perform multiple tests and reduce the total time for testing, will appeal to healthcare facilities even more in a scenario with high upfront investment costs.

Additionally, advanced testing methods like ion-exchange high-performance liquid chromatography (HPLC) and TINIA have a high accuracy and reliability, which complies with the quality standards and regulatory requirements of hospitals and clinics.

The homecare settings segment is expected to register the highest CAGR during the forecast period. While diabetes cases are rapidly increasing globally, patients need to continuously monitor their blood glucose levels, so homecare environments are very effective for providing convenient and personalized care.

The growing demand for the use of home disease-diagnostic equipment is being fueled by the rising demand for home-based medical assistance, along with increased home diagnostics convenience and overall cost-effectiveness of treatment. This trend fosters the need for the rising demand for HbA1c testing devices in home-based environments.

Additionally, improved diagnostic technology guarantees precision, dependability, and ease of use, enhancing patient safety and comfort. Home care is gaining prominence, primarily because people want more convenience and comfort, but it’s dogged into being through technological developments that make testing easier. The cost-efficiency and remote monitoring ability of home testing devices also drive demand.

Report Scope

HbA1c Testing Devices Market Regional Analysis

North America held 43.16% of the market share worldwide in 2024. Several factors have contributed to this dominating share, including the incidence and prevalence of diabetes, the presence of established market players, and the availability of reimbursement for certain diabetes care products.

The U.S. Centres for Medicare and Medicaid Services announced in December 2023 that it would cover all continuous glucose monitoring systems (CGMs) through its program, this has improved the market in the U. S. as well as the rising use of HbA1c testing devices.

Asia Pacific is estimated to be the fastest-growing regional market for HbA1c testing devices during the forecast period. The expected large target population, high unmet clinical needs, and developing healthcare infrastructure in the region are the factors that exhibit high growth potentials for the market.

Key players functioning in the region continuously emphasize developing novel point-of-care solutions due to the increasing incidence of geriatric population, as well as prevalence of diabetes. This also integrates well with your glide when there is a focus on geographic spread of having new manufacturing units launched in the region.

For example, in October 2023, Tosoh Bioscience Inc., a Japan-based company, collaborated with Sysmex America to link HLC723G8 analysers to Sysmex XN-9000 and XN-9100 haematology systems, to automate A1c testing in the U.S., Latin America, and Canada.

The growing focus towards improvement of healthcare R&D along with the development of novel technologies is expected to drive the China HbA1c testing devices market during the forecast period.

In Japan, the HbA1c testing devices market is expected to show growth throughout the forecast period, primarily because the country has a highly developed healthcare system with a high uptake of advanced diagnostic tests and therapies, which will be the driving force behind the growth of the market.

This setting facilitates the prevalence of an HbA1c testing device for good diabetes detection and treatment or diabetes, which is one of those most common conditions that need to be flushed out from the regular screening.

HbA1c Testing Devices Market Recent Developments

• In April 2023, FIND partnered with Abbott, i-SENS Inc., and Siemens Healthineers to supply safe point-of-care HbA1c test kits at discounted prices to low- and middle-income settings that aim to improve diabetes diagnosis and management for underserved populations.

• The extension of the commercial availability of its HbA1c test to support the management of diabetes in a variety of care settings has been announced by LumiraDx in November 2022. Now available on the LumiraDx Platform, the test offers rapid results that can aid in the screening and monitoring of patients infected with the pathogen and supports patient outcomes.

• In May 2022, Labcorp released an at-home collection kit for diabetes risk assessment with a new device created by Weavr Health. This offers affordability and accessibility to help individuals monitor their health at home.

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