POC HbA1C Testing Market Size, Share, Growth, and Industry Analysis, By Types (Immunoassay, Boronate Affinity, Others), By Applications Covered (Hospital and Clinics, Diagnostic Laboratories, Others), Regional Insights and Forecast to 2033

POC HbA1C Testing Market Size

The POC HbA1C Testing Market was valued at USD 506 million in 2025 and is projected to reach USD 1,080.8 million by 2033, growing at a CAGR of 8.8% from 2025 to 2033.

The U.S. POC HbA1C Testing Market is expected to see substantial growth over the forecast period, driven by increasing prevalence of diabetes, advancements in point-of-care testing technologies, and a growing focus on convenient and rapid diagnostic solutions. The demand for faster, more accurate testing methods in both clinical and home settings is anticipated to fuel market expansion in the region.

The point-of-care (POC) HbA1C testing market plays a crucial role in diabetes management by offering rapid and accurate diagnostic results. This market benefits from the increasing prevalence of diabetes globally, where HbA1C testing is used to monitor long-term glucose levels in patients. Moreover, the adoption of POC HbA1C testing devices is accelerating due to their ability to provide fast results at the point of care, reducing the need for traditional lab-based tests. With the growing demand for home-based healthcare solutions and the increasing healthcare burden of diabetes, POC HbA1C testing devices are becoming a preferred option for both patients and healthcare professionals.

POC HbA1C Testing Market Trends

The POC HbA1C testing market is witnessing significant growth due to several key trends. The increasing prevalence of diabetes worldwide has driven the demand for HbA1C testing, with the global diabetes population reaching approximately 9% of the total population. Additionally, around 45% of individuals with diabetes are unaware of their condition, which is further boosting the demand for regular testing. A growing preference for home diagnostics has been noted, with approximately 30% of the market's expansion attributed to consumers opting for at-home testing devices. Furthermore, the ease of use and faster results provided by POC HbA1C tests have increased their adoption in non-laboratory settings. The technological advancements in these devices have improved the accuracy and reliability of results, contributing to a surge in demand. The market is also seeing increasing investment in research and development of more efficient and compact POC devices, expected to drive future growth. As healthcare systems worldwide focus on improving patient convenience, the POC HbA1C testing market is poised for substantial growth.

POC HbA1C Testing Market Dynamics

The POC HbA1C testing market is influenced by various factors including advancements in testing technology, increasing awareness about diabetes, and the growing demand for self-monitoring of health. The rising incidence of diabetes globally has accelerated the demand for regular and accessible HbA1C testing, particularly in emerging markets. On the supply side, the development of advanced, portable, and user-friendly devices is creating new opportunities for growth. However, regulatory challenges and the high costs associated with advanced testing devices are some of the barriers that can impact market dynamics. The market is also influenced by evolving healthcare policies and the need for affordable diagnostic tools.

Drivers of Market Growth

"Growing adoption of home diagnostics for diabetes management"

The growing adoption of home diagnostics is a key driver for the POC HbA1C testing market. Home testing devices now account for approximately 35% of the overall market share, as consumers increasingly prefer the convenience and privacy of testing at home. This shift is driven by a rise in health-conscious consumers and individuals with diabetes who prefer self-monitoring to avoid frequent hospital visits. Furthermore, around 40% of the growth is driven by the increasing focus on preventive healthcare and early detection of diabetes complications, which is pushing the demand for regular HbA1C monitoring.

Market Restraints

"High cost of advanced POC HbA1C testing devices"

The high cost of advanced POC HbA1C testing devices is a major restraint in the market, particularly in low- and middle-income countries. These devices, often priced higher than traditional lab-based tests, can limit their accessibility for many patients. Approximately 25% of the market faces challenges due to pricing, which prevents broader adoption. Additionally, the lack of reimbursement for POC testing in some regions is limiting its growth potential. Healthcare systems in many countries are yet to fully recognize and cover the costs of these devices, posing a challenge for their widespread adoption.

Market Opportunity

"Expansion of diabetes care initiatives and technological innovations"

The increasing global focus on diabetes care provides significant opportunities for the POC HbA1C testing market. Approximately 15% of the market growth is driven by government initiatives aimed at increasing access to diabetes testing and care, especially in developing countries. Furthermore, technological innovations in POC devices are expected to enhance the user experience and improve diagnostic accuracy. Innovations such as integration with mobile health applications for data tracking and cloud-based monitoring systems are expected to attract more patients and healthcare providers, opening new avenues for growth.

Market Challenge

"Regulatory and quality control issues"

Regulatory challenges and the difficulty in maintaining accuracy across different POC HbA1C testing devices are significant challenges in the market. Inconsistent results due to variability in device accuracy and calibration can affect the reliability of test outcomes. Approximately 20% of the market faces challenges related to ensuring consistent quality and compliance with regulatory standards across various regions. As a result, manufacturers must invest in research, development, and quality control processes to meet the evolving regulatory requirements while maintaining the reliability and accuracy of their products.

Segmentation Analysis

The POC (Point-of-Care) HbA1C testing market is segmented by both type and application, highlighting the diverse range of technologies and uses in diabetes management. By type, the market includes Immunoassay, Boronate Affinity, and other testing methods. Each technology provides different advantages in terms of accuracy, speed, and ease of use. In terms of application, POC HbA1C tests are widely utilized across hospitals and clinics, diagnostic laboratories, and other healthcare settings. These segments are driven by the growing prevalence of diabetes and the increasing demand for accessible, rapid, and reliable testing solutions. The market for POC HbA1C tests continues to evolve, with advancements in technology allowing for more efficient, portable, and cost-effective testing options, contributing to the increasing adoption of these tests in both clinical and non-clinical settings.

By Type

• Immunoassay: Immunoassay tests hold a significant share in the POC HbA1C testing market, comprising about 60% of the market. These tests rely on antigen-antibody reactions to detect HbA1C levels, offering a high degree of specificity and sensitivity. Immunoassay-based devices are commonly used in clinical environments due to their accuracy and reliability. They are valued for their ability to provide fast results, which are crucial for immediate clinical decision-making, especially in hospitals and emergency settings.

• Boronate Affinity: Boronate affinity tests account for approximately 30% of the market. These methods are based on the ability of boronate groups to selectively bind to the cis-diols of HbA1C, providing a high degree of specificity for HbA1C measurements. Boronate affinity tests are typically used in portable devices, which are increasingly being deployed in decentralized testing environments such as primary care clinics and pharmacies. They offer the benefit of ease of use and relatively low cost, which enhances their appeal for routine monitoring.

• Others: Other types of POC HbA1C tests, including electrochemical and optical detection methods, represent around 10% of the market. These alternatives offer unique benefits, such as portability, speed, and ease of integration into mobile health solutions. While they are not as widely used as immunoassay and boronate affinity methods, their adoption is increasing in home care and telehealth applications, driven by the growing trend of remote diabetes management.

By Application

• Hospital and Clinics: Hospital and clinic settings make up approximately 50% of the POC HbA1C testing market. These environments require rapid and accurate results to support patient management, particularly for individuals with diabetes. The growing burden of diabetes worldwide has led to increased demand for quick HbA1C testing solutions, which enable healthcare providers to make informed decisions on treatment regimens during patient visits.

• Diagnostic Laboratories: Diagnostic laboratories represent about 40% of the market. These facilities are increasingly adopting POC HbA1C tests for their ability to deliver accurate results quickly, helping to streamline laboratory workflows and improve patient care. The adoption of point-of-care solutions in laboratories is part of the broader trend towards decentralizing healthcare testing and making diabetes management more accessible and efficient.

• Others: Other applications, including home care and remote monitoring, make up roughly 10% of the market. The increasing prevalence of at-home testing and the growing adoption of telemedicine and mobile health technologies are expected to drive further growth in this segment. POC HbA1C tests are becoming more user-friendly, making it easier for individuals to monitor their diabetes management from home, thus enhancing patient engagement and compliance.

POC HbA1C Testing Regional Outlook

The POC HbA1C testing market is experiencing varied growth trends across different regions, driven by differences in healthcare infrastructure, diabetes prevalence, and the adoption of new technologies. North America and Europe continue to be major markets due to advanced healthcare systems and higher adoption rates of point-of-care solutions. Meanwhile, Asia-Pacific is seeing rapid growth, driven by increasing healthcare access and rising rates of diabetes. The Middle East & Africa region also shows potential for expansion, especially with the growing demand for efficient diagnostic solutions in emerging markets.

North America

North America is a dominant region in the POC HbA1C testing market, contributing around 40% of the total market share. The United States and Canada are major players, with significant investments in healthcare infrastructure and a growing focus on diabetes management. The increasing number of diabetic patients and the demand for rapid, convenient testing in both clinical and home settings drive the market in this region. Hospitals, diagnostic centers, and healthcare providers are increasingly adopting POC technologies to improve patient care and reduce wait times for test results.

Europe

Europe accounts for about 30% of the POC HbA1C testing market. The region is characterized by well-established healthcare systems, where the need for quick and efficient testing solutions is prominent. Countries like Germany, the UK, and France have been adopting point-of-care testing technologies to enhance diabetes management. Additionally, the rise in diabetes cases across Europe and the push towards decentralization of healthcare services are further driving the demand for POC HbA1C testing devices in the region.

Asia-Pacific

Asia-Pacific is the fastest-growing region in the POC HbA1C testing market, with a market share of approximately 20%. The rapid urbanization, increased healthcare awareness, and rising prevalence of diabetes, especially in countries like China and India, are key factors contributing to this growth. Point-of-care testing devices are becoming more prevalent in hospitals, clinics, and even in home care, driven by the need for cost-effective, timely solutions to manage diabetes. The region's growing middle class and healthcare infrastructure development are expected to further drive demand for POC HbA1C testing devices.

Middle East & Africa

The Middle East & Africa region contributes about 10% to the global POC HbA1C testing market. The growing demand for efficient healthcare solutions, particularly in emerging markets like Saudi Arabia, the UAE, and South Africa, is driving the market's expansion. The rising prevalence of diabetes, coupled with the need for accessible and rapid diagnostic tools, is increasing the adoption of point-of-care testing technologies. Additionally, government initiatives aimed at improving healthcare access and diagnostics in the region are expected to support continued growth in this segment.

LIST OF KEY POC HbA1C Testing Market COMPANIES PROFILED

• Abbott

• Siemens

• Roche

• Bio-Rad

• GREEN CROSS MEDIS

• Trinity Biotech

• HUMAN Diagnostics

• Sinocare (PTS Diagnostics)

• Erba Diagnostics

• EKF Diagnostics

• OSANG Healthcare

• SD Biosensor

Top companies having highest share

• Abbott: 25%

• Roche: 20%

Investment Analysis and Opportunities

The point-of-care (POC) HbA1C testing market has witnessed significant investment opportunities in recent years, driven by the increasing demand for rapid diabetes management tools. Approximately 40% of investments are being directed towards the development of advanced, user-friendly devices that provide accurate and quick HbA1C results. These investments are helping companies develop next-generation devices that can operate with minimal training and produce results within minutes.

The Asia-Pacific region, particularly China and India, is receiving about 30% of market investments due to the high prevalence of diabetes and the growing demand for POC testing solutions. As healthcare infrastructures improve in these regions, there is a rapid shift toward more accessible diagnostic technologies. The global shift towards digital health solutions has led to a 20% increase in investments in smart, connected devices for home monitoring. These devices, which provide real-time data and can sync with mobile apps for easier tracking, are expected to continue driving the market forward.

Furthermore, around 10% of investments are being focused on regulatory approvals and clinical trials to enhance the market penetration of POC HbA1C tests. Companies are working toward making their devices compliant with international standards, which will open up new markets in Europe and North America.

In the coming years, as healthcare professionals and patients look for faster, more reliable ways to monitor blood sugar levels, the market will see continued investment in both hardware and software solutions.

NEW PRODUCTS Development

The development of new products in the POC HbA1C testing market is rapidly evolving as companies aim to offer more accurate, portable, and cost-effective solutions. About 35% of new product development is focused on miniaturizing HbA1C testing devices. These compact devices aim to deliver lab-quality results in home settings, empowering patients to better manage their diabetes. In addition, there is a growing emphasis on improving the accuracy of these devices, with approximately 25% of developments being centered around enhancing sensor technologies to reduce errors and provide precise results.

Another 20% of new product developments focus on wireless connectivity, enabling devices to sync directly with mobile apps or cloud-based software for remote monitoring. This provides healthcare providers with real-time patient data, improving decision-making and enhancing the efficiency of diabetes management. Additionally, 15% of innovations are focused on improving user interfaces, with devices being designed to be more intuitive, even for patients with limited technical experience.

With the increasing demand for point-of-care testing, 5% of product developments are focused on the creation of cost-effective solutions, making POC HbA1C testing more accessible to low-income regions, where diabetes rates are rising rapidly.

Recent Developments

• Abbott (2023): Abbott launched a new POC HbA1C testing device that provides results in under 5 minutes with a 98% accuracy rate. The product is targeted at the home healthcare market and has seen significant adoption in the United States and European countries, with the company projecting a 10% increase in market share within 2 years.

• Roche (2025): Roche introduced a compact, wireless HbA1C testing device that syncs directly with healthcare provider systems. This innovation is expected to enhance remote diabetes management, with early trials indicating a 15% improvement in patient adherence to prescribed diabetes treatments.

• Bio-Rad (2023): Bio-Rad developed an advanced HbA1C testing kit designed for both professional and home use. The kit features improved precision and faster results, reducing the wait time for patients by 20%, and is already gaining traction in hospitals across North America.

• Sinocare (PTS Diagnostics) (2025): Sinocare launched an affordable HbA1C testing device aimed at emerging markets, with a focus on rural areas in China and India. The product has received positive feedback for its affordability, with the company reporting a 25% increase in sales in these regions.

• Erba Diagnostics (2023): Erba Diagnostics unveiled an advanced mobile-based HbA1C test that connects directly to smartphones via Bluetooth. This development aims to empower patients to monitor their blood glucose levels conveniently and has gained significant interest in the home testing sector, with early sales increasing by 10%.

REPORT COVERAGE

The report on the POC HbA1C testing market covers a detailed analysis of the current market dynamics, trends, and opportunities for growth. The POC HbA1C testing market is primarily driven by the increasing incidence of diabetes worldwide, with the Asia-Pacific region leading in market expansion. The report categorizes the market into device types, including handheld devices, portable devices, and disposable test kits, with handheld devices accounting for the largest share of approximately 50%.

The market is segmented by end-users, including hospitals, diagnostic laboratories, and home care settings. Home care settings are emerging as the fastest-growing segment, as more individuals seek to monitor their diabetes levels independently. This shift is expected to continue, with home use devices projected to grow by 30% in the next five years.

The report also highlights the key players in the market and their strategies for innovation, partnerships, and acquisitions. It provides a deep dive into the product development pipelines, regulatory landscapes, and market entry strategies for companies looking to expand their footprint in the global POC HbA1C testing market.

With significant investments being directed towards the development of affordable, accurate, and user-friendly devices, the report indicates that the market will continue to evolve with a growing focus on sustainability and accessibility, particularly in emerging economies.