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全球血紅素 A1c 測試設備市場 - 2025 - 2033Global Hemoglobin A1c Testing Devices Market - 2025 - 2033 |
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2024年,全球糖化血紅素檢測設備市場規模達15億美元,預計2033年將達32億美元,2025-2033年預測期間複合年成長率為8.8%。
A1c 血紅蛋白 (HbA1c) 測試設備是一種醫療儀器,旨在測量血液中與葡萄糖結合的血紅蛋白的百分比,為個人的長期血糖控制提供指示,主要用於糖尿病的診斷和監測。 HbA1c 測試反映了過去 2 至 3 個月的平均血糖水平,使其成為評估糖尿病管理計劃有效性以及血糖水平控制不良引起併發症風險的重要工具。這些設備的設計和技術各不相同,但通常透過將糖化血紅蛋白 (HbA1c) 與其他形式的血紅蛋白分離或使用化學或酶反應直接測量葡萄糖結合血紅蛋白的量來工作。
糖化血紅蛋白 (HbA1c) 測試設備市場正在經歷顯著成長。檢測技術的創新,例如照護端 (POC) 設備的開發,使 HbA1c 檢測變得更加便捷和高效。這些設備可快速提供結果,為患者和醫療保健提供者提供更多便利。例如,2022 年 5 月,Labcorp 推出了首款家用採集設備 Labcorp OnDemand,可測量少量血液樣本中的糖化血紅蛋白 (HbA1c)。
驅動程式和限制
糖尿病盛行率上升
糖尿病盛行率的上升極大地推動了糖化血紅蛋白檢測設備市場的成長,預計將在預測期內推動該市場的發展。隨著全球糖尿病發病率持續上升,對診斷、監測和管理該疾病的可靠、準確方法的需求顯著增加。 HbA1c 測試對於評估長期血糖控制以及診斷糖尿病和糖尿病前期至關重要。
例如,根據國際糖尿病聯盟的數據,2021 年,5.366 億成年人(20-79 歲)患有糖尿病,即十分之一。預計到 2030 年,這一數字將增加至 6.428 億,到 2045 年將增至 7.837 億。 2021 年,糖尿病將導致 670 萬人死亡——每 5 秒就有 1 人死於糖尿病。 5.41 億成年人患有葡萄糖耐受性受損 (IGT),這使他們面臨第 2 型糖尿病的高風險。隨著糖尿病患者數量的不斷增加,對頻繁 HbA1c 檢測設備來管理和監測疾病的需求也在不斷成長。
根據美國國立衛生研究院 (NIH) 的數據,非糖尿病患者的 HbA1c 水平通常在 4.0%-5.6% 範圍內。糖尿病前期的 HbA1c 水平通常為 5.7%-6.4%,而 HbA1c 水平為 6.4% 或更高的人則患有糖尿病。由於糖尿病與多種合併症有關,因此對糖尿病患者的建議包括健康的生活方式(飲食和運動)以及將 HbA1c 水平維持在 7.0% 以下。這增加了對 HbA1c 檢測設備的需求。
照護端 (POC) 設備和家庭檢測套件的採用激增,因為它們能夠快速提供結果並促進家庭監測。這些設備對於需要定期追蹤 HbA1c 水平以最佳化管理計劃的糖尿病患者尤其有價值。
來自替代測試方法的競爭
來自替代測試方法的競爭是阻礙糖化血紅蛋白 (HbA1c) 測試設備市場成長的因素之一。儘管 HbA1c 測試仍然是長期血糖控制監測的黃金標準,但幾種替代方法正在被擴大使用,這可能會限制 HbA1c 測試設備在某些情況下的採用和成長。
連續血糖監測 (CGM) 系統可即時、連續追蹤血糖水平,使患者能夠監測全天血糖波動。這些即時資料提供比定期 HbA1c 測試更詳細的資訊,並提供對短期血糖變化的洞察,這對於有效的糖尿病管理至關重要。
糖尿病患者廣泛使用家用血糖儀進行日常監測,可提供即時血糖讀數,使患者能夠及時決定胰島素劑量和飲食計畫。這些儀表雖然無法提供 HbA1c 測試提供的長期見解,但允許頻繁的自我監測,這可能會減少對常規 HbA1c 測試的感知需求。
此外,果糖胺或1,5-脫水葡萄糖醇等其他生物標記也可用於測量較短時間範圍(通常為1-2 週)內的血糖控制情況,並且可以為患有特定病症的患者(例如患有以下疾病的患者)提供HbA1c 測試的替代方案:血糖或血紅素變異可能會干擾 HbA1c 測量。
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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