Global Hemoglobin A1c Testing Devices Market - 2025 - 2033

The global hemoglobin A1c testing devices market reached US$ 1.5 billion in 2024 and is expected to reach US$ 3.2 billion by 2033, growing at a CAGR of 8.8% during the forecast period 2025-2033.

Hemoglobin A1c (HbA1c) testing devices are medical instruments designed to measure the percentage of hemoglobin in the blood that is bound to glucose, providing an indication of long-term blood glucose control in individuals, primarily for the diagnosis and monitoring of diabetes. The HbA1c test reflects the average blood sugar levels over the past 2 to 3 months, making it a critical tool for assessing the effectiveness of diabetes management plans and the risk of complications from poorly controlled blood sugar levels. These devices vary in design and technology but generally work by either separating glycated hemoglobin (HbA1c) from other forms of hemoglobin or by using chemical or enzymatic reactions to directly measure the amount of glucose-bound hemoglobin.

The Hemoglobin A1c (HbA1c) testing devices market is experiencing significant growth. Innovations in testing technologies, such as the development of point-of-care (POC) devices, have made HbA1c testing more accessible and efficient. These devices offer rapid results, enhancing convenience for patients and healthcare providers. For instance, in May 2022, Labcorp launched a first-of-its-kind at-home collection device Labcorp OnDemand, which measures hemoglobin A1c (HbA1c) from a small blood sample.

Market Dynamics: Drivers & Restraints

Rising prevalence of diabetes

The rising prevalence of diabetes is significantly driving the growth of the hemoglobin A1c testing devices market and is expected to drive the market over the forecast period. As the global incidence of diabetes continues to rise, the demand for reliable and accurate methods for diagnosing, monitoring and managing the disease has significantly increased. HbA1c testing is crucial for assessing long-term glucose control and for diagnosing diabetes and prediabetes.

For instance, according to the International Diabetes Federation, in 2021, 536.6 million adults (20-79 years) are living with diabetes i.e., 1 in 10 people. This number is predicted to rise to 642.8 million by 2030 and 783.7 million by 2045. Over 3 in 4 adults with diabetes live in low- and middle-income countries. Diabetes is responsible for 6.7 million deaths in 2021 - 1 every 5 seconds. 541 million adults have Impaired Glucose Tolerance (IGT), which places them at high risk of type 2 diabetes. With the increasing number of diabetic patients, the need for frequent HbA1c testing devices is growing to manage and monitor the disease.

According to the National Institute of Health (NIH), nondiabetes usually falls within the 4.0%-5.6% HbA1c range. Prediabetes usually has HbA1c levels of 5.7%-6.4%, while those with 6.4% or higher HbA1c levels have diabetes. Since diabetes is associated with several comorbidities, the recommendations for individuals with diabetes include a healthy lifestyle (diet and exercise) and maintaining HbA1c levels below 7.0%. This increases the demand for HbA1c testing devices.

The adoption of point-of-care (POC) devices and home testing kits has surged due to their ability to provide quick results and facilitate at-home monitoring. These devices are especially valuable for individuals with diabetes who need to track their HbA1c levels regularly to optimize their management plan.

Competition from alternative testing methods

Competition from alternative testing methods is one of the factors hampering the growth of the Hemoglobin A1c (HbA1c) testing devices market. Although HbA1c testing remains a gold standard for long-term blood glucose control monitoring, several alternative methods are being increasingly used, which may limit the adoption and growth of HbA1c testing devices in certain scenarios.

Continuous Glucose Monitoring (CGM) systems offer real-time, continuous tracking of glucose levels, allowing patients to monitor fluctuations in blood glucose throughout the day. This real-time data gives more detailed information than periodic HbA1c testing and provides insights into short-term glucose changes, which is crucial for effective diabetes management.

Home glucose meters, widely used by diabetic patients for daily monitoring, provide immediate blood glucose readings, which allow patients to make timely decisions about their insulin dosages and meal planning. These meters, although not offering the long-term insights provided by HbA1c tests, allow for frequent self-monitoring that may decrease the perceived need for routine HbA1c testing.

Additionally, other biomarkers like fructosamine or 1,5-anhydroglucitol are also used to measure blood glucose control over a shorter time frame (typically 1-2 weeks) and can provide an alternative to HbA1c testing for patients with specific conditions, such as those with fluctuating blood glucose or hemoglobin variants that may interfere with HbA1c measurements.

Segment Analysis

The global hemoglobin A1c testing devices market is segmented based on type, technology, end-user and region.

Technology:

The chromatography segment is expected to dominate the hemoglobin A1c testing devices market share

The chromatography segment is a dominant segment in the Hemoglobin A1c (HbA1c) testing devices market due to its high accuracy, reliability, and ability to separate and quantify HbA1c from other hemoglobin variants. Chromatography techniques, particularly high-performance liquid chromatography (HPLC) and ion-exchange chromatography have long been considered the gold standard for HbA1c testing in clinical laboratories. These methods effectively separate HbA1c from other forms of hemoglobin, providing highly precise measurements that are crucial for accurate diabetes management and diagnosis.

For instance, in June 2021, Trivitron Healthcare launched two innovation-driven products for HbA1c and Hb variant detection. The new product includes NANO H5 & NANO H110 which are high-performance liquid chromatography analyzers for HbA1c detection in less than 3 minutes. These HPLC-based HbA1c analyzers will be used for monitoring diabetes, thalassemia & hemoglobin variants.

Chromatography-based HbA1c testing devices are heavily used in clinical laboratories due to their high throughput, robustness, and consistency. For instance, Siemens Healthineers offers the DCA Vantage Analyzer, which uses HPLC technology to perform rapid, accurate HbA1c tests. The widespread presence of such devices in diagnostic labs globally supports the chromatography segment's dominance in the market.

Geographical Analysis

North America is expected to hold a significant position in the hemoglobin A1c testing devices market share

North America especially the United States has one of the highest rates of diabetes globally. According to the Centers for Disease Control and Prevention (CDC), 38.4 million people of all ages or 11.6% of the U.S. population had diabetes. This high prevalence of diabetes directly drives the demand for HbA1c testing devices to monitor long-term glucose control and manage the disease effectively. The rising burden of diabetes in North America underscores the need for accurate and regular HbA1c testing, fueling market growth. In addition, the increasing focus on early diagnosis and prevention strategies further drives the need for HbA1c testing devices.

North America is a hub for innovation in the medical device industry. Leading players in the HbA1c testing devices market, such as Abbott Laboratories, Siemens Healthineers, Danaher Corporation, and Bio-Rad Laboratories, are based in this region, contributing to advancements in point-of-care (POC) devices and home testing kits.

For instance, Abbott's Afinion HbA1c Analyzer and Siemens Healthineers' DCA Vantage Analyzer have revolutionized point-of-care testing for HbA1c, making it quicker, more accessible, and affordable for both healthcare providers and patients.

Asia-Pacific is growing at the fastest pace in the hemoglobin A1c testing devices market

In recent years, there has been a notable increase in health awareness in Asia-Pacific, with a growing focus on preventative healthcare and early diagnosis of chronic diseases like diabetes. Awareness campaigns, such as the World Diabetes Day observed in many APAC countries, have contributed to a greater public understanding of the importance of regular HbA1c testing.

For instance, in India, World Diabetes Day, observed annually on November 14, serves as a crucial platform for raising global awareness about diabetes, a significant public health challenge impacting millions worldwide. This observance spotlights the urgent need for comprehensive action in diabetes prevention, early diagnosis, effective management, and equitable care access. In 2024, "Breaking Barriers, Bridging Gaps" encourages a focus on inclusivity in healthcare, emphasizing collaboration among governments, health organizations, and communities to address disparities in diabetes care. This rising awareness increases the demand for hemoglobin A1c testing devices in the region.

Governments in APAC countries are prioritizing the prevention and management of diabetes through various health programs and initiatives. For instance, India has launched campaigns like the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases & Stroke (NPCDCS), which encourages regular testing for HbA1c as part of routine healthcare.

Competitive Landscape

The major global players in the hemoglobin A1c testing devices market include Abbott Laboratories, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., EKF Diagnostics Holdings plc., Trinity Biotech Plc., A. Menarini Diagnostics s.r.l, ARKRAY, Inc., Tosoh India Pvt. Ltd., PTS Diagnostics, Siemens Healthcare Private Limited and among others.

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• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
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• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
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• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
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• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global hemoglobin A1c testing devices market report delivers a detailed analysis with 62 key tables, more than 54 visually impactful figures, and 179 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

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