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全球血红素 A1c 测试设备市场 - 2025 - 2033Global Hemoglobin A1c Testing Devices Market - 2025 - 2033 |
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2024年,全球糖化血红素检测设备市场规模达15亿美元,预计2033年将达32亿美元,2025-2033年预测期间复合年增长率为8.8%。
A1c 血红蛋白 (HbA1c) 测试设备是一种医疗仪器,旨在测量血液中与葡萄糖结合的血红蛋白的百分比,为个人的长期血糖控制提供指示,主要用于糖尿病的诊断和监测。 HbA1c 测试反映了过去 2 至 3 个月的平均血糖水平,使其成为评估糖尿病管理计划有效性以及血糖水平控制不良引起併发症风险的重要工具。这些设备的设计和技术各不相同,但通常透过将糖化血红蛋白 (HbA1c) 与其他形式的血红蛋白分离或使用化学或酶反应直接测量葡萄糖结合血红蛋白的量来工作。
糖化血红蛋白 (HbA1c) 测试设备市场正在经历显着成长。检测技术的创新,例如护理点 (POC) 设备的开发,使 HbA1c 检测变得更加便捷和高效。这些设备可快速提供结果,为患者和医疗保健提供者提供更多便利。例如,2022 年 5 月,Labcorp 推出了首款家用采集设备 Labcorp OnDemand,可测量少量血液样本中的糖化血红蛋白 (HbA1c)。
驱动程式和限制
糖尿病盛行率上升
糖尿病盛行率的上升极大地推动了糖化血红蛋白检测设备市场的成长,预计将在预测期内推动该市场的发展。随着全球糖尿病发病率持续上升,对诊断、监测和管理该疾病的可靠、准确方法的需求显着增加。 HbA1c 测试对于评估长期血糖控制以及诊断糖尿病和糖尿病前期至关重要。
例如,根据国际糖尿病联盟的数据,2021 年,5.366 亿成年人(20-79 岁)患有糖尿病,即十分之一。预计到 2030 年,这一数字将增加至 6.428 亿,到 2045 年将增至 7.837 亿。 2021 年,糖尿病将导致 670 万人死亡——每 5 秒就有 1 人死于糖尿病。 5.41 亿成年人患有葡萄糖耐受性受损 (IGT),这使他们面临第 2 型糖尿病的高风险。随着糖尿病患者数量的不断增加,对频繁 HbA1c 检测设备来管理和监测疾病的需求也在不断增长。
根据美国国立卫生研究院 (NIH) 的数据,非糖尿病患者的 HbA1c 水平通常在 4.0%-5.6% 范围内。糖尿病前期的 HbA1c 水平通常为 5.7%-6.4%,而 HbA1c 水平为 6.4% 或更高的人则患有糖尿病。由于糖尿病与多种合併症有关,因此对糖尿病患者的建议包括健康的生活方式(饮食和运动)以及将 HbA1c 水平维持在 7.0% 以下。这增加了对 HbA1c 检测设备的需求。
护理点 (POC) 设备和家庭检测套件的采用激增,因为它们能够快速提供结果并促进家庭监测。这些设备对于需要定期追踪 HbA1c 水平以优化管理计划的糖尿病患者尤其有价值。
来自替代测试方法的竞争
来自替代测试方法的竞争是阻碍糖化血红蛋白 (HbA1c) 测试设备市场成长的因素之一。儘管 HbA1c 测试仍然是长期血糖控制监测的黄金标准,但几种替代方法正在被越来越多地使用,这可能会限制 HbA1c 测试设备在某些情况下的采用和成长。
连续血糖监测 (CGM) 系统可即时、连续追踪血糖水平,使患者能够监测全天血糖波动。这些即时资料提供比定期 HbA1c 测试更详细的信息,并提供对短期血糖变化的洞察,这对于有效的糖尿病管理至关重要。
糖尿病患者广泛使用家用血糖仪进行日常监测,可提供即时血糖读数,使患者能够及时决定胰岛素剂量和饮食计画。这些仪表虽然无法提供 HbA1c 测试提供的长期见解,但允许频繁的自我监测,这可能会减少对常规 HbA1c 测试的感知需求。
此外,果糖胺或1,5-脱水葡萄糖醇等其他生物标记也可用于测量较短时间范围(通常为1-2 週)内的血糖控制情况,并且可以为患有特定病症的患者(例如患有以下疾病的患者)提供HbA1c 测试的替代方案:血糖或血红素变异可能会干扰 HbA1c 测量。
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.
The global hemoglobin A1c testing devices market is segmented based on type, technology, end-user and region.
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.
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.
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.
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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