HbA1c Testing Device Market Size, Share, Growth, and Industry Analysis by Type (Bench Top, Compact, and Portable) By Application (Hospital, Homecare, and Others), Regional Insights and Forecast From 2025 To 2034

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HBA1c TESTING DEVICE MARKET OVERVIEW

The global HbA1c Testing Device Market was valued is expected to rise to USD 0.15 billion in 2025, eventually reaching USD 0.29 billion by 2034, expanding at a CAGR of 8.91% from 2025 to 2034.

The United States HbA1c Testing Device market is forecasted to reach USD 0.049 billion in 2025, with Europe at USD 0.035 billion, and China at USD 0.041 billion.

Hemoglobin A1C, often known as HbA1c, is a glucose-bound type of hemoglobin. Many healthcare organizations employ the HbA1c blood test to diagnose type 1 and type 2 diabetes. The HBA1c level, which is typically less than 6%, directs how well diabetes is controlled. HbA1c test kits make it easy to test complete blood for HbA1c in a semi-quantitative manner.

The global HbA1c testing device market is expanding as the global diabetes incidence rate continues to rise. Diabetes is a chronic metabolic disease in which the body is unable to generate or use insulin effectively, leading glucose to build up in the blood flow. Furthermore, rising technological advancements in diabetes management devices, and an increased diabetes awareness, are likely to propel the HbA1c testing device market forward. For example, on March 13, 2020, the Indian Council of Medical Research (ICMR) announced the development of "SuChek," a 100 percent indigenous glucometer that is inexpensive and validated according to international standards.

Key Findings 

• Market Size and Growth: The global HbA1c Testing Device Market was valued is expected to rise to USD 0.15 billion in 2025, eventually reaching USD 0.29 billion by 2034, expanding at a CAGR of 8.91% from 2025 to 2034.
• Key Market Driver: Over 463 million people worldwide were living with diabetes in 2019, expected to reach 700 million by 2045, significantly increasing the demand for regular HbA1c testing devices.
• Major Market Restraint: HbA1c test accuracy was compromised in patients with hemoglobin variants, with up to 8.5% deviation observed in clinical trials involving sickle cell and thalassemia carriers.
• Emerging Trends: More than 62% of newly launched POC devices in 2023 incorporated automation and digital interfaces for single-visit diagnostics and remote data sharing.
• Regional Leadership: North America accounted for over 38% of global usage volume in 2023, fueled by early adoption in primary care and specialist clinics across the U.S. and Canada.
• Competitive Landscape: The top five companies—Abbott, Roche, Siemens, Bio-Rad, and Danaher—collectively contributed to over 57% of total devices sold globally by unit share in 2023.
• Market Segmentation: Point-of-care (POC) devices held a 52% share, while hospitals remained the largest end-user, accounting for over 60% of installations worldwide in 2023.
• Recent Development: In June 2019, a major diagnostic company launched a 3-minute rapid HbA1c test with FDA approval, improving diagnostic turnaround by over 45% compared to previous methods.

COVID-19 IMPACT

Supply Chain Disruption and Stringent Lockdown Restrictions to Hinder Industry Growth

The severe disruptions in their respective manufacturing and supply-chain operations due to various precautionary lockdowns and other limitations imposed by governments all over the world. The global Hba1c testing device market is no exception. Furthermore, consumer demand has decreased as people are now more focused on removing non-essential expenses from their budgets since the general economic situation of most people has been badly impacted by the outbreak. Over the forecast period, these factors are likely to weigh on the global Hba1c testing device market growth. The global Hba1c testing device market is predicted to revive as respective government agencies begin to lift these enforced lockdowns.

LATEST TRENDS

Technological Advancement to Foster Market Growth

Technological advancements in HbA1C testing are assisting laboratories in completing the tests more quickly. Major market competitors are investing in innovative technology that can deliver rapid, precise findings in a short amount of time, allowing laboratories to keep up with the growing demand for testing. In June 2019, Abbott released the AfinionTM HbA1c Dx assay, an in vitro diagnostic test for the quantitative assessment of HbA1c in human venous and capillary whole blood for use on the Afinion 2 Analyzer and the Afinion AS100 Analyzer. The Afinion HbA1c Dx assay is the only quick point-of-care test approved by the US Food and Drug Administration (FDA) to help healthcare providers diagnose diabetes and determine a patient's risk of getting the disease. In only three minutes, the test offers consistent and accurate findings for 1,2 glycated hemoglobin, assisting physicians in evaluating patients and formulating tailored care programs during a single visit to the doctor's office. The market for HbA1C testing device will grow as a result of these improvements.

• According to the U.S. Food and Drug Administration (FDA), the launch of the Afinion™ HbA1c Dx assay in 2019 enabled physicians to receive HbA1c results in under 3 minutes, significantly accelerating diabetes diagnosis and treatment planning in outpatient settings.

• As per the International Diabetes Federation (IDF) 2021 report, more than 64% of diabetes care centers in urban Asia integrated point-of-care HbA1c devices for real-time results to streamline patient management.

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HBA1c TESTING DEVICE MARKET SEGMENTATION

By Type

By type, the market is segmented into Point-of-care (POC) Testing Devices,Laboratory-based Testing Devices.

By Application

Based on application, it is categorized into hospital, homecare, and others. 

The hospital sector is likely to lead the market in terms of highest share over the forecast period due to advancements in the field of healthcare services. However, due to the rising usage of hba1c portable testing devices, the homecare setting segment is expected to increase at the fastest rate throughout the projection period. These factors may fuel HbA1c testing device market development. 

DRIVING FACTORS

Research & Development Activities to Enhance Market Expansion

Manufacturers are putting up extra effort to meet specific consumer wants as competition remains fierce. With over 300 diagnostic methods available in the healthcare business, the availability, cost, convenience of use, and precision of HbA1c analyzer are all important factors to consider. Portability can be a deciding factor in sales closure as end users want convenient equipment. Manufacturers might also concentrate on enhancing the sample throughput of HbA1c analyzers. During the forecast period, the overall growth of the market will be driven by new device launches with automated features and better precision, FDA clearance for new analyzers and assay tests, technology expansion, and partnerships in developing and developed countries for HbA1c Testing Devices.

Increasing Number of Diabetic Patients and Geriatric Population to Stimulate Growth

Over the forecast period, rising diabetes prevalence is expected to drive growth in the global HbA1C testing device market. According to a study published in September 2019 in the journal Diabetes Research and Clinical Practice titled "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition," 463 million people are expected to have diabetes in 2019, rising to 578 million by 2030 and 700 million by 2045. Furthermore, the industry is predicted to rise as the geriatric population grows. The geriatric population in the U.S. is predicted to reach 77 million by 2034, according to the United States Census Bureau.

• According to the United States Census Bureau, the geriatric population is projected to reach 77 million by 2034, leading to higher routine screening demand and increased use of HbA1c devices across primary care and eldercare facilities.

• As per the International Diabetes Federation (IDF), global diabetes prevalence reached 463 million in 2019 and is expected to hit 700 million by 2045, increasing the diagnostic burden and pushing the adoption of automated HbA1c testing devices.

RESTRAINING FACTORS

Testing Devices' Inability to Assess All Blood Types to Impede Market Growth

The unavailability of these devices to assess all blood types limits the market for HbA1C testing devices. Patients of African, Mediterranean, or Southeast Asian descent, or those with a family member suffering from skin diseases such as sickle cell anemia or thalassemia, for example, should avoid the HbA1C test because they are likely to have a different type of hemoglobin a1c testing devices, known as a hemoglobin variant, which can interfere with HbA1C results.

• According to the National Institutes of Health (NIH), hemoglobin variants such as HbS and HbC can distort HbA1c test results by up to 15%, limiting device reliability in patients of African, Mediterranean, or Southeast Asian descent.

• As reported by the Centers for Disease Control and Prevention (CDC), HbA1c tests may underperform in patients with anemia or chronic kidney disease, affecting approximately 20% of older diabetic adults and leading to inaccurate diagnosis or monitoring.

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HBA1c TESTING DEVICE MARKET REGIONAL INSIGHTS

Introduction of New Technologies and Infrastructural Development to Fuel Industry Development in North America

North America is expected to dominate the HbA1c testing device market share. Because of the well-established healthcare infrastructure and the introduction of new technologies in diabetes management, and increased diabetes awareness among individuals. Because of increased activities such as research, awareness campaigns, and cooperative ventures by public and private organizations in the US and Canada, the HbA1c testing market in North America is leading. Because of rapid expansion in healthcare facilities and rising per capita disposable incomes.

Asia Pacific HbA1c testing device market is expected to develop the fastest. The predicted period's growth rate increases the number of diabetes laboratory tests and well-qualified healthcare workers such as diabetologists and clinicians due to the growing burden of diabetes. According to the International Diabetes Federation (IDF), by 2035, around 382 million people globally would have diabetes. Around 60% of them will live in Asia, with one-third in China. The predicted period's growth rate increases the number of diabetes laboratory tests and well-qualified healthcare workers such as diabetologists and clinicians due to the growing burden of diabetes.

KEY INDUSTRY PLAYERS

Manufacturers Focus on R&D Activities to Strengthen their Position

The market is moderately fragmented, with only a few major and generic manufacturers. The level of competition among the players is great, as each is attempting to build a new product and sell it at a low price. Furthermore, to expand their market shares, businesses are entering new areas, particularly emerging economies, where demand is outstripping supply.

• Abbott Laboratories (U.S.): According to company reports, Abbott’s Afinion systems are used in over 50,000 clinics worldwide, offering HbA1c results in under 180 seconds and supporting rapid clinical decision-making.

• Roche (Switzerland): Roche’s Cobas systems processed over 12 million HbA1c tests globally in 2022 across centralized labs, according to the company’s diagnostics division data.

List of Top HbA1c Testing Device Companies

• Abbott Laboratories (U.S.)
• Roche (Switzerland)
• Siemens (Germany)
• Bio-Rad Laboratories (U.S.)
• Tosoh (Japan)
• Danaher Corporation (U.S.)
• Trinity Biotech (Ireland)
• HUMAN Diagnostics (India)
• Arkray (Japan)
• OSANG Healthcare (South Korea)

INDUSTRY DEVELOPMENT

June 2019: Abbott released the Afinion HbA1c Dx assay for the Afinion 2 Analyzer and the Afinion AS100 Analyzer. The Afinion HbA1c Dx assay is the first and only quick point-of-care test approved by the US Food and Drug Administration (FDA) to assist healthcare providers in the diagnosis of diabetes and the risk of developing the disease.

REPORT COVERAGE

The scope of the market research for the HbA1c testing device is covered in this study. The market estimates in the report are based on a combination of secondary research, primary interviews, and in-house expert reviews. The impact of various social, political, and economic aspects, and current market dynamics, on the growth of the HbA1c testing device industry, was examined to arrive at these market estimates.