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市場調査レポート
商品コード
1634214
ヘモグロビンA1c検査機器の世界市場-2025~2033年Global Hemoglobin A1c Testing Devices Market - 2025 - 2033 |
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カスタマイズ可能
適宜更新あり
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ヘモグロビンA1c検査機器の世界市場-2025~2033年 |
出版日: 2025年01月13日
発行: DataM Intelligence
ページ情報: 英文 179 Pages
納期: 即日から翌営業日
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世界のヘモグロビンA1c検査機器市場は2024年に15億米ドルに達し、2033年には32億米ドルに達すると予測され、予測期間2025年のCAGRは8.8%で成長します。
ヘモグロビンA1c(HbA1c)検査機器は、血液中のヘモグロビンのうちグルコースと結合している割合を測定するように設計された医療機器であり、主に糖尿病の診断とモニタリングのために、個人の長期的な血糖コントロールの指標を提供します。HbA1c検査は、過去2~3ヵ月間の平均血糖値を反映するため、糖尿病管理計画の有効性と血糖値コントロール不良による合併症のリスクを評価するための重要なツールとなります。ヘモグロビンA1c検査は、糖化ヘモグロビン(HbA1c)と他の形態のヘモグロビンを分離するか、化学反応または酵素反応を利用してグルコースと結合したヘモグロビンの量を直接測定します。
ヘモグロビンA1c(HbA1c)検査機器市場は大きな成長を遂げています。ポイントオブケア(POC)機器の開発など検査技術の革新により、HbA1c検査はより身近で効率的なものとなりました。これらの機器は迅速な結果を提供し、患者やヘルスケアプロバイダーの利便性を高めています。例えば、Labcorpは2022年5月、少量の血液サンプルからヘモグロビンA1c(HbA1c)を測定する、世界初の家庭用採取機器Labcorp OnDemandを発売しました。
促進要因と抑制要因
糖尿病有病率の上昇
糖尿病有病率の上昇は、ヘモグロビンA1c検査機器市場の成長を大きく後押ししており、予測期間中も市場を牽引していくと予測されます。糖尿病の世界の罹患率が上昇を続ける中、糖尿病の診断、モニタリング、管理のための信頼性が高く正確な方法に対する需要が著しく高まっています。HbA1c検査は、長期的なグルコースコントロールの評価、糖尿病および糖尿病前症の診断に極めて重要です。
例えば、国際糖尿病連合によると、2021年には5億3,660万人の成人(20~79歳)が糖尿病と共存しています。この数は、2030年には6億4,280万人、2045年には7億8,370万人に増加すると予測されています。成人の糖尿病患者の4人に3人以上が低・中所得国に住んでいます。2021年の糖尿病による死亡者数は670万人で、これは5秒に1人の割合です。5億4,100万人の成人が耐糖能障害(IGT)で、2型糖尿病のリスクが高いです。糖尿病患者の増加に伴い、糖尿病を管理・監視するためにHbA1c検査機器を頻繁に使用する必要性が高まっています。
米国国立衛生研究所(NIH)によると、非糖尿病は通常HbA1cが4.0%~5.6%の範囲内にあります。糖尿病予備軍は通常HbA1c値が5.7%~6.4%で、HbA1c値が6.4%以上の人は糖尿病です。糖尿病にはいくつかの合併症があるため、糖尿病患者には健康的なライフスタイル(食事療法と運動療法)とHbA1c値を7.0%未満に維持することが推奨されています。このため、HbA1c検査機器の需要が高まっています。
POC(ポイントオブケア)機器や家庭用検査キットの採用が急増しているのは、迅速な結果が得られ、家庭でのモニタリングが容易だからです。これらの機器は、管理計画を最適化するためにHbA1c値を定期的に追跡する必要がある糖尿病患者にとって特に価値があります。
代替検査法との競合
代替検査法との競合は、ヘモグロビンA1c(HbA1c)検査機器市場の成長を妨げる要因の一つです。HbA1c検査は依然として長期的な血糖コントロールモニタリングのゴールドスタンダードですが、いくつかの代替方法の利用が増加しており、特定の状況ではHbA1c検査機器の採用と成長が制限される可能性があります。
持続グルコースモニタリング(CGM)システムは、グルコースレベルをリアルタイムで継続的に追跡できるため、患者は1日を通して血糖値の変動をモニターすることができます。このリアルタイムのデータは、定期的なHbA1c検査よりも詳細な情報を提供し、効果的な糖尿病管理に不可欠な短期的なグルコースの変化に関する洞察を提供します。
糖尿病患者が日々のモニタリングに広く使用している家庭用グルコース測定器は、血糖値を即座に測定することができるため、患者はインスリンの投与量や食事計画をタイムリーに決定することができます。これらの測定器は、HbA1c検査が提供する長期的な洞察を提供するものではありませんが、頻繁な自己測定を可能にし、定期的なHbA1c検査の必要性を減少させる可能性があります。
さらに、フルクトサミンや1,5-アンヒドログルシトールのような他のバイオマーカーも、より短期間(通常1~2週間)の血糖コントロール測定に使用され、HbA1c測定の妨げとなるような血糖変動やヘモグロビンの変異を有する患者のような特定の条件を有する患者にとって、HbA1c検査の代替となり得ます。
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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