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市場調查報告書
商品編碼
1953400
HbA1c檢測設備市場-全球產業規模、佔有率、趨勢、機會及預測(按設備類型、技術、最終用戶、地區和競爭格局分類,2021-2031年)HbA1c Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, & Forecast Segmented By Type of Device, By Technology, By End User, By Region & Competition, 2021-2031F |
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全球 HbA1c 監測市場預計將從 2025 年的 22.6 億美元成長到 2031 年的 34.1 億美元,複合年成長率為 7.10%。
這些測量設備是專門用於量化糖化血紅蛋白濃度的儀器,用於評估兩到三個月內的平均血糖控制情況。推動該市場發展的主要因素是糖尿病盛行率的不斷上升,這需要頻繁篩檢以避免嚴重併發症。快速診斷解決方案的效用進一步促進了這一需求,這些解決方案能夠幫助醫生做出即時的臨床決策。根據國際糖尿病聯盟 (IDF) 發布的《2024 年報告》,全球約有 5.89 億成年人將患有糖尿病,凸顯了可靠監測工具的迫切需求。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模:2025年 | 22.6億美元 |
| 市場規模:2031年 | 34.1億美元 |
| 複合年成長率:2026-2031年 | 7.1% |
| 成長最快的細分市場 | 即時偵測(POC)設備 |
| 最大的市場 | 北美洲 |
然而,先進檢測平台及其耗材的高成本是市場成長的主要障礙。這些經濟限制阻礙了醫療預算有限的開發中國家採用現代診斷技術。因此,經濟拮据的地區無法採購這些設備,造成了巨大的市場准入缺口。這種情況阻礙了疾病負擔重地區的擴張,從而限制了基本健康監測解決方案的廣泛應用。
照護現場檢測(POC)糖化血紅蛋白(HbA1c)技術的進步是推動市場成長的強勁動力,它將實驗室級的精準度與卓越的速度和便利性完美結合。現代設備正變得越來越小型化和自動化,使醫療服務提供者能夠在日常就診期間進行快速評估,而無需依賴中心檢查室。這種能力有助於即時調整治療方案,簡化診斷流程,進而提高患者的遵從性。例如,《臨床實驗室產品》雜誌在2025年10月報道稱,東曹生物科技公司(Tosoh Biosciences)的新型自動化糖化血紅蛋白分析儀獲得了FDA的核准,該分析儀可在不到一分鐘的時間內提供準確的HbA1c結果。這項進展對於高通量臨床環境至關重要,因為效率直接影響患者照護。
此外,政府主導的旨在提高糖尿病篩檢和認知度的各項舉措不斷擴大,透過系統性地消除財務和監管障礙,推動了對糖化血紅蛋白(HbA1c)檢測設備的需求。各國政府和公共衛生機構正積極將全面的篩檢通訊協定納入國家醫療保健策略,以減輕慢性糖尿病併發症帶來的長期經濟影響。根據美國醫療保險和醫療補助服務中心(CMS)發布的《2024年糖尿病戰略影響報告》,該機構已擴大醫療保險對糖化血紅蛋白(HbA1c)篩檢的覆蓋範圍,使其無需自付費用,旨在提高高危險群的早期檢出率。這種向預防性投入資金的轉變至關重要,因為國際糖尿病聯盟(IDF)估計,到2024年,糖尿病將佔全球醫療費用支出的1.02兆美元,因此,經濟高效的監測解決方案必不可少。
實施先進的糖化血紅蛋白(HbA1c)檢測平台的高昂成本以及持續的耗材採購,對市場擴張構成重大障礙。這種經濟負擔限制了診斷技術的廣泛應用,尤其是在醫療預算有限的發展中地區。由於資金短缺,這些地區的醫療機構往往優先考慮急性治療而非預防性監測工具,這直接影響了檢測設備的銷售。因此,製造商在進入這些價格敏感型市場時面臨挑戰,導致全球疾病盛行率與監測解決方案的普及率之間存在差距。
這種經濟差距阻礙了高負擔地區市場潛力的充分發揮:根據國際糖尿病聯盟(IDF)預測,到2024年,75%的糖尿病成人患者將居住在中低收入國家,然而這些地區在全球糖尿病支出中所佔佔有率卻顯著較低。這些數據表明,檢測設備的高昂成本正在阻礙高發地區的市場成長,從而有效地限制了全球商機。
目前,市場正經歷著向非侵入性和微創調查方法的變革時期。這主要源自於提高病患依從性並消除傳統抽血所帶來的不適感的需求。光學感測和經皮分析技術的創新使得無需指尖採血即可量化糖化血紅蛋白水平的設備得以開發,從而實現了更頻繁、更無痛的監測。新興產品的展出充分體現了這項技術飛躍,展現了產業向無針診斷技術的轉變。在2025年1月舉行的CES 2025創新獎頒獎典禮上,QuickGly無創HbA1c監測設備憑藉其無需抽血即可即時測量的突破性功能而備受讚譽。該技術目前擁有九項註冊專利。
同時,致力於減少醫療產業環境影響的相關人員越來越關注永續和環保的醫療器材製造。製造商正在加速採用綠色化學原理和可生物分解材料,以最大限度地減少與一次性診斷耗材相關的有害廢棄物和塑膠消耗。這一趨勢正在推動生產線進行重組,以符合全球環境標準,同時保持分析準確性。 2025年11月,西門子醫療在一份題為「西門子醫療樹立新的永續性標準」的新聞稿中宣布,該公司已成為首家獲得「My Green Lab ACT生態標籤」認證的體外診斷製造商,其150多種免疫檢測和臨床化學試劑均獲此認證。這印證了整個產業正迅速向環保實驗室解決方案轉型。
The Global HbA1c Testing Devices Market is projected to expand from USD 2.26 Billion in 2025 to USD 3.41 Billion by 2031, reflecting a compound annual growth rate of 7.10%. These testing devices are specialized instruments capable of quantifying glycated hemoglobin levels to evaluate average blood glucose control over a period of two to three months. The primary catalyst for this market is the rising prevalence of diabetes, which requires frequent screening to avert serious complications. This demand is further bolstered by the growing utility of rapid diagnostic solutions that enable immediate clinical decision-making. As reported by the International Diabetes Federation in 2024, approximately 589 million adults globally were living with diabetes, highlighting the critical necessity for dependable monitoring tools.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 2.26 Billion |
| Market Size 2031 | USD 3.41 Billion |
| CAGR 2026-2031 | 7.1% |
| Fastest Growing Segment | Point-of-care (POC) testing devices |
| Largest Market | North America |
However, a significant obstacle to market growth is the high cost associated with advanced testing platforms and their recurring consumables. These financial constraints hinder the adoption of modern diagnostic technologies in developing nations where healthcare budgets are limited. Consequently, the inability of economically restricted regions to procure these devices creates a substantial gap in market accessibility. This situation impedes expansion in areas that suffer from high disease burdens, thereby limiting the widespread deployment of essential health monitoring solutions.
Market Driver
Technological advancements in Point-of-Care (POC) HbA1c testing are aggressively fueling market growth by providing laboratory-grade accuracy combined with exceptional speed and convenience. Modern devices are becoming increasingly miniaturized and automated, enabling healthcare providers to perform rapid assessments during routine office visits rather than relying on centralized laboratories. This capability allows for immediate therapeutic adjustments and improves patient compliance by simplifying the diagnostic process. For example, Clinical Lab Products reported in October 2025 that Tosoh Bioscience received FDA clearance for a new automated glycohemoglobin analyzer capable of delivering precise HbA1c results in under one minute, a development crucial for high-volume clinical settings where efficiency impacts patient care.
Additionally, rising government initiatives aimed at diabetes screening and awareness are propelling the demand for HbA1c testing devices by systematically eliminating financial and regulatory barriers to access. Governments and public health bodies are actively integrating comprehensive screening protocols into national healthcare strategies to mitigate the long-term economic impact of chronic diabetes complications. According to the 'CMS Diabetes Strategy - Impact Report 2024' by the Centers for Medicare & Medicaid Services, the agency expanded Medicare coverage to include the hemoglobin A1c test for diabetes screening without coinsurance, aiming to improve early detection rates among at-risk populations. This shift towards preventative funding is essential, as the International Diabetes Federation estimated in 2024 that diabetes was responsible for USD 1.02 trillion in global health expenditure, necessitating cost-effective monitoring solutions.
Market Challenge
The substantial cost involved in acquiring advanced HbA1c testing platforms and purchasing recurring consumables constitutes a significant barrier to market expansion. This financial burden limits the adoption of diagnostic technologies, particularly in developing regions where healthcare budgets are constrained. Medical institutions in these areas often prioritize acute care over preventive monitoring tools due to funding shortages, which directly hampers the sales volume of testing devices. Consequently, manufacturers face difficulties in penetrating these price-sensitive markets, resulting in a disparity between global disease prevalence and the deployment of monitoring solutions.
This economic divide restricts the market from reaching its full potential in high-burden territories. According to the International Diabetes Federation, in 2024, 75 percent of adults with diabetes were living in low- and middle-income countries, yet these regions commanded a disproportionately small share of global diabetes expenditure. This data indicates that the high price of testing devices prevents market growth in the exact geographic areas where the patient population is largest, effectively creating a ceiling on global revenue opportunities.
Market Trends
The market is currently experiencing a transformative shift towards non-invasive and minimally invasive methodologies, driven by the need to enhance patient compliance and eliminate the discomfort associated with traditional blood draws. Innovations in optical sensing and transdermal analysis are enabling the development of devices that quantify glycated hemoglobin levels without requiring fingersticks, thereby facilitating more frequent and pain-free monitoring. This technological leap is exemplified by emerging product showcases that highlight the industry's move towards needle-free diagnostics. According to the Consumer Technology Association in January 2025, during the 'CES 2025 Innovation Awards', the QuickGly non-invasive HbA1c monitoring device was recognized for its breakthrough capability to measure real-time values without blood extraction, a technology currently supported by 9 registered patents.
Concurrently, there is a growing focus on sustainable and eco-friendly device manufacturing as stakeholders prioritize the reduction of the healthcare industry's environmental footprint. Manufacturers are increasingly adopting green chemistry principles and biodegradable materials to minimize hazardous waste and plastic consumption associated with single-use diagnostic consumables. This trend is reshaping production lines to align with global environmental standards while maintaining analytical precision. According to Siemens Healthineers in November 2025, in the 'Siemens Healthineers Sets New Sustainability Benchmark' press release, the company became the first in vitro diagnostic manufacturer to receive the My Green Lab ACT Ecolabel for more than 150 of its immunoassay and clinical chemistry reagents, underscoring the rapid industry-wide transition towards environmentally responsible laboratory solutions.
Report Scope
In this report, the Global HbA1c Testing Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global HbA1c Testing Devices Market.
Global HbA1c Testing Devices Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: