HbA1c Testing Devices Market

The global HbA1c Testing Devices Market is valued at USD 1.80 Billion in 2024 and is projected to reach a value of USD 7.269 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 13.55% between 2025 and 2035.

Premium Insights

The global industry for hemoglobin A1c testing devices is anticipated to grow significantly, mainly due to the increasing prevalence of diabetes. North America, specifically the United States, has many diabetic patients, which is projected to increase further in the coming years. According to estimates, there are over 29 million diabetic patients in North America, and by 2027, this number is expected to reach 34 million. In 2021, the United States reported more than 26 million diabetes cases. Moreover, the World Health Organization (WHO) has indicated a rising risk of type II diabetes among 541 million adults worldwide. One of the key drivers for growth is the growing recognition among patients about the importance of early diagnosis and effective management of diabetes. The increasing elderly population is expected to contribute to the markets expansion. According to the U.S. Census Bureau, the number of elderly individuals in the United States is projected to reach 77 million by 2034. Obesity, a significant factor contributing to diabetes, also fuels the demand for hemoglobin A1c testing devices. The WHO predicts the global aging population will reach 2 billion by 2050, further fueling the markets growth.

• Increasing prevalence of diabetes, raising awareness about diabetes management, and technological advancements in HbA1c Testing Devices s will bolster market growth.
• North America accounted for the largest revenue share of 43.20% in 2022.
• The Asia Pacific region is expected to dominate the market with the largest growth rate during the forecast period.
• The laboratory Testing Devices segment accounted for the most prominent market growth in 2022 because they are widely used in diagnostic laboratories, hospitals, and clinics due to their accuracy and precision in measuring HbA1c levels.
• Based on Technology, the Immunoassay segment accounted for the potential market growth in 2022 due to the growing prevalence of diabetes worldwide and the need for efficient and convenient testing solutions.
• North America dominates global sales owing to the high prevalence of diabetes in the region and the growing emphasis on early diagnosis and management of the disease.

Top Market Trends

1. The HbA1c Testing Devices industry is expected to grow notably due to the rising prevalence of Diabetes worldwide. Recent studies by AACE (American Association of Clinical Endocrinologists) have shown that of those hospitalized for severe disease, 22.2% to 26.9% reported living with Diabetes. This rise in diabetes cases will drive the demand for HbA1c Testing Devices s, as regularly checking blood sugar levels is crucial for diabetes treatment.
2. There is a growing trend towards point-of-care testing in the healthcare industry. HbA1c Testing Devices s that can provide quick and reliable results at the point of care are gaining popularity among healthcare providers. These devices offer convenience, faster turnaround time, and cost-effectiveness. For example, in 2019, Abbott launched the First-ever Rapid Point-of-Care HbA1c Test to Aid in diagnosing Diabetes.
3. Technological advancements have been instrumental in developing more accurate and user-friendly HbA1c Testing Devices s. The market growth has been positively influenced by creating a wide range of promising glucose-sensing technologies, as highlighted in a research study conducted by Ziyi Yu et al. and published in the IOP Science Journal in March 2021. These technologies include traditional electrochemical-based glucose sensors and innovative optical and other electrical glucose sensors.
4. HbA1c testing is not only used for diagnosing and monitoring Diabetes but also for identifying individuals at risk of developing the disease. Studies have shown that HbA1c levels can be used as a predictor of future diabetes risk in non-diabetic individuals. As a result, HbA1c Testing Devices s is increasingly used in preventive healthcare to screen and monitor individuals with prediabetes and assess their risk of developing Diabetes.
5. There is a rising demand for portable and home-based HbA1c Testing Devices s, driven by the need for convenience and self-management. These instruments are easy to use, require less training, and provide quick and accurate results, empowering patients to take control of their diabetes management. According to Abbotts published data, the global number of FreeStyle Libre users grew from 3.0 million in 2020 to 4.0 million in 2021.

Economic Insights

The economic landscape of the HbA1c Testing Devices industry is poised for major growth, driven by the introduction of novel products and an increased public awareness of diabetes prevention. According to the USA CDC, an estimated 37.3 million Americans had diabetes in 2019, underlining the substantial market potential. The market is anticipated to expand further with the growing utilization of continuous monitoring devices among individuals managing diabetes. However, its worth noting that while recent CGM models, such as the Abbott Freestyle Libre and the Dexcom G6, have surmounted technical challenges, their widespread adoption among individuals with Type-2 diabetes has been impeded by concerns surrounding high costs and uncertainties regarding their efficacy and necessity. To address this, Abbott introduced a new, more affordable category with the Libre, priced between USD 75 to USD 150 per month, offering a cost-effective solution for diabetic patients in the United States. This pricing strategy is expected to play a pivotal role in driving accessibility and usage of CGM devices, potentially reshaping the market dynamics soon.

Market Segmentation

The Global HbA1c Testing Devices Market is segregated into the segments as mentioned below:

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Based on Test Type

Test Type to Lead Maximum Market Share Due to Their Proven Track Record and Trustworthiness Among Healthcare Professionals

In 2022, Laboratory Testing Devices dominated the market. These instruments are widely used in hospitals, clinics, and diagnostic labs due to their accuracy and reliability in measuring glycated hemoglobin levels in the blood. They provide precise results and are operated by trained professionals, ensuring the highest testing standards. Laboratory testing devices offer advanced features like automation, data management, and integration with laboratory information systems, making them preferred choices for healthcare providers. Their dominance in the market signifies the importance of accurate and efficient HbA1c testing for monitoring and managing diabetes.

Based on Technology

Immunoassay Segment Expects Dominion Owing to Its Advanced Technology Analysis

As HbA1c testing plays a crucial role in diabetes management, the immunoassay segment is expected to continue its dominance in the market. Immunoassay methods utilize specific antibodies to detect and measure the levels of HbA1c in blood samples, ensuring accurate and reliable results. These devices offer high sensitivity, specificity, and precision, making them a primary choice for healthcare professionals. Immunoassay devices are more cost-effective and faster than other methods, further contributing to their market dominance.

Based on Region

North America to Dominate Global Sales Owing to High Prevalence of Diabetes Among the Population, Growing Awareness About Diabetes Management, And Well-established Healthcare Infrastructure

North America dominated the HbA1c Testing Devices market in 2022. The United States emerged as a significant player in this market in North America. One of the critical reasons for the United States' dominance is the rapidly increasing incidence and prevalence of diabetic patients, coupled with a rise in healthcare expenditure. This indicates a greater utilization of diabetes care products in the country. Additionally, the availability of reimbursements has further fuelled market expansion in the United States. A significant development occurred in December 2021 when the US Centers for Medicare and Medicaid Services announced that all CGMs (continuous glucose monitoring systems), including adjunctive and non-adjunctive CGMs, would be covered under Medicare. This announcement has positively impacted the market, contributing to its growth and the increased usage of HbA1c Testing Devicess.

The Asia Pacific industry holds great promise for expansion, with several growth opportunities. One of the key factors contributing to this is the increasing prevalence of diabetes in countries like India and China. There is also a growing awareness about the importance of early diagnosis and management of diabetes, which further fuels market potential.

Competitive Landscape

Major players emphasize product development, partnerships, and strategic collaborations to stay ahead in the highly competitive industry and uphold their market position. Abbott Laboratories, ARKRAY Inc., Bio-Rad Laboratories Inc., Chek Diagnostics (Polymer Technology Systems Inc.), Danaher Corporation (Beckman Coulter), and F. Hoffmann-La Roche Ltd. are among the leading players in the market. For instance, Siemens Healthineers introduced its innovative Atellica CH Enzymatic Hemoglobin A1c Assay in 2019 to diagnose and monitor diabetes.

The key players in the global HbA1c Testing Devices market include - Abbott Laboratories (U.S.) among others.

Recent Market Developments

• In March 2023, Abbott received the U.S. FDA approval for its FreeStyle Libre 2 and FreeStyle Libre 3 integrated CGM sensors for integration with automated insulin delivery systems.
• In February 2023, Dexcom, Inc. received the U.S. CMS approval for coverage for its G7 CGM system.
• In September 2022, Nemaura Medical Inc. partnered with Eversana to introduce Nemauras diabetes management system in the U.S.

Segmentation of the Global HbA1c Testing Devices Market