HbA1c检验的全球市场:趋势，技术，成长机会(2025年)

自 1990 年代以来，HbA1c 测试对于监测糖尿病患者的长期血糖控制至关重要，并且补充了诊断性血糖测试。最近的研究强调了 HbA1c 测试在糖尿病筛检和患者监测中的实用性，尤其是与空腹血糖 (FBG) 测试相结合时。该报告涵盖了实验室和临床点 HbA1c 检测设备，并提供了全球视角以及特定的区域分析。

HbA1c 检测产业面临独特的挑战，包括集团采购组织和政府的报销审批和价格谈判。持续的研发投入对于创新和市场成功至关重要。儘管面临这些挑战，但 HbA1c 检测产业仍受益于全球人口老化和新兴市场医疗保健支出的增加。

表面化学、奈米技术和分析科学的进步有望实现更方便、更准确、非侵入性的 HbA1c 测量。深度机器学习演算法与糖尿病管理行动应用程式的整合有望减少住院治疗并改善患者治疗效果，开创医疗保健创新的新时代。

本报告研究了全球 HbA1c 检测市场，并提供了有关 HbA1c 总市场价值以及检测应用、技术和市场参与者细分市场的资讯。详细的公司简介提供了竞争见解。市场数据反映的是製造商层面的全球市场，基准年为 2024 年。在人口趋势、技术创新和全球市场扩张的推动下，我们预测了 2024 年至 2029 年的复合年增长率 (CAGR)，并提供 2024 年的竞争分析和区域细分。

目录

第1章 摘要整理

第2章 简介

• 概要
  • 诊断
  • 分类
  • 妊娠
  • 其他
  • 风险要素
  • 糖尿病的人口统计
  • 国际统计
  • 美国的盛行率
  • 美国的发生率
  • 美国的死亡人数
  • 美国成本
• HbA1c

第3章 按HbA1c检验，场所

• 简介
  • 实验室中的 HbA1c 检测
  • 护理点糖化血红素 (HbA1c) 检测
• 地区划分的 HbA1c 检测市场

第4章 HbA1c检验市场，技术各平台

• 概要
  • 层析法
  • 高效液相层析法 (HPLC)
  • 硼酸盐亲和力
  • 免疫测定
  • 酶法和微光学法
  • 其他
• 各技术市场

第5章 与HbA1c检验市场概要竞争

• 全球HbA1c市场全体
• 各国市场分析
• 北美
• 欧洲
  • 德国
  • 法国
  • 义大利
  • 英国
  • 西班牙
• 亚太地区
  • 日本
  • 中国
  • 印度
• 南美
• 其他
• 竞争分析

第6章 HbA1c检验市场课题和趋势

• 世界卫生组织基本体外诊断试剂清单
• 糖白蛋白测试
• 报告变更
• PAMA 面临的挑战
• A1c 的种族差异
• 远距医疗
• LDT 更新
• 医疗保险和 HbA1c 测试
• IT 和人工智慧
• 糖尿病与老化社会
• 老化的影响
• 医疗效率
• 糖尿病併发症
• 监理问题
• 牙医诊所的 HbA1c 检测

第7章 HbA1c检验市场企业简介

• 简介
• Abbott
• A. Menarini Diagnostics, S.r.l.
• ARKRAY, Inc
• Beckman Coulter/Danaher
• Bio-Rad
• DiaSys Diagnostics Systems GmbH
• Diazyme Laboratories, Inc
• EKF Diagnostics Holdings Plc
• HemoCue/Danaher
• HUMAN Diagnostics
• OSANG Healthcare Co, Ltd
• PTS Diagnostics, Inc
• QuidelOrtho Corporation
• Roche Diagnostics Corporation
• Sebia
• Sekisui Diagnostics, LLC
• Siemens Healthineers GmbH
• Tosoh Bioscience, LLC
• Trinity Biotech

Kalorama Information's "The World Market for HbA1c Testing: Trends, Technologies, and Growth Opportunities, 2025" provides a comprehensive analysis of the global HbA1c testing market, highlighting key trends, technological advancements, and growth opportunities. This report delves into the geographical distribution, demographic influences, and critical market issues shaping the industry. It offers a detailed examination of market values, regional dynamics, and competitive landscapes, with insights into leading providers.

Since the 1990s, HbA1c testing has been pivotal in monitoring long-term glycemic control in diabetics, complementing glucose tests for diagnosis. Recent research underscores the HbA1c test's utility in diabetes screening and patient monitoring, especially when combined with fasting blood glucose (FBG) tests. The report covers both lab-based and point-of-care HbA1c test devices, providing a global perspective with specific regional analyses.

The market summary includes total HbA1c market values, segmented by test usage, technology, and market participation. Detailed company profiles offer competitive insights. The report's data is derived from extensive primary and secondary research, including interviews with over 20 industry experts, healthcare providers, and government officials. Additional insights were gathered from company representatives, ensuring a robust and accurate market overview.

Market data reflects the world market at the manufacturers' level, with 2024 as the base year. Compound annual growth rates (CAGRs) are projected for the 2024-2029 period, supported by demographic trends, technological innovations, and global market expansion. Competitive analysis and regional breakdowns for 2024 are also provided.

The HbA1c testing industry faces unique challenges, including reimbursement approvals and price negotiations by group purchasing organizations and governments. Continuous R&D investments are crucial for innovation and market success. Despite these challenges, the industry benefits from an aging global population and increased healthcare spending in emerging markets. The report highlights the potential for new competitors, investors, and venture capitalists in the HbA1c testing market.

Advancements in surface chemistry, nanotechnology, and analytical sciences are expected to yield more convenient, accurate, and non-invasive HbA1c assays. The integration of deep machine learning algorithms and mobile apps for diabetes management promises to reduce hospitalizations and improve patient outcomes, heralding a new era of healthcare innovation.

Table of Contents

Chapter 1: Executive Summary

• Introduction
• Scope and Methodology
• Market Summary
  • Table 1-1: Global HbA1c Testing Market Analysis, 2024-2029 ($ million)
  • Figure 1-1: Global HbA1c Testing Market, 2024-2029 ($ million)
• Market Segmentation
• Issues and Trends Affecting the HbA1c Testing Market
• Competitive Analysis

Chapter 2: Introduction

• Overview
  • Diagnosis
  • Type 1
  • Type 2
  • Classification
  • Type 1
  • Type 2
  • Gestational
  • Other
  • Risk Factors
  • Demographics of Diabetes
  • International Statistics
  • US Prevalence
  • US Incidence
  • US Deaths
  • US Cost
• HbA1c

Chapter 3: HbA1c Testing by Setting

• Introduction
  • Laboratory-based HbA1c Testing
  • POC HbA1c Testing
• Market by HbA1c Testing Setting
  • Table 3-1: Global l HbA1c Test Sales Market and Distribution by Setting, 2024-2029 ($ million) estimated [HbA1c Lab and HbA1c POC]
  • Table 3-2: Selected POC Professional HbA1c Products
  • Table 3-3: Selected POC Self-Testing HbA1c Products

Chapter 4: HbA1c Testing Market by Technology Platforms

• Overview
  • Chromatography
  • High-Performance Liquid Chromatography (HPLC)
  • Boronate Affinity
  • Immunoassay
  • Enzymatic and Micro-optical Methods
  • Others
• Market by Technology
  • Table 4-1: Global HbA1c Test Sales Market and Distribution by Technology Platform, 2024-2029 ($ million) estimated [Enzymatic/MODM, HPLC, Immunoassay, Others]
  • Figure 4-1: Global HbA1c Test Sales Market by Technology Platform, 2024-2029 ($ million) estimated (Enzymatic/MODM, HPLC, Immunoassay, Others)
  • Figure 4-2: Global HbA1c Test Distribution by Technology Platform, 2024 (%) (Enzymatic/MODM, HPLC, Immunoassay, Others)

Chapter 5: HbA1c Testing Market Summary and Competitive

• Total Global HbA1c Market
  • Table 5-1: Global HbA1c Testing Market Analysis, 2024-2029 ($ million)
  • Figure 5-1: Global HbA1c Testing Market Analysis, 2024-2029 ($ million)
• Market Analysis by Country
  • Table 5-2: Global HbA1c Testing Market by Region, Revenues and % Market, 2024-2029 ($ million) estimated [Asia Pacific, Europe, Latin America, North America, ROW]
  • Figure 5-2: Global HbA1c Testing Market by Region, 2024-2029 ($ million) estimated (Asia Pacific, Europe, Latin America, North America, ROW)
  • Figure 5-3: Global HbA1c Testing Market Share, by Region, 2024 (%) (Asia Pacific, Europe, Latin America, North America, ROW)
• North America
  • Table 5-3: North America HbA1c Testing Market Analysis, 2024-2029 ($ million)
• Europe
  • Table 5-4: Europe HbA1c Testing Market Analysis, 2024-2029 ($ million)
  • Germany
  • France
  • Italy
  • United Kingdom
  • Spain
    • Figure 5-4: Europe HbA1c Testing Percentage Participation, by Country, 2024 (%) (France, German, Italy, Spain, United Kingdom, Rest of Europe)
• Asia Pacific
  • Table 5-5: Asia Pacific HbA1c Testing Market Analysis, 2024-2029 ($ million)
  • Japan
  • China
  • India
    • Figure 5-5: Asia Pacific HbA1c Testing Percentage Participation, by Country 2024 (%) (Australia, China, India, Japan, South Korea, Rest of Asia Pacific)
• Latin America
  • Table 5-6: Latin America HbA1c Testing Market Analysis, 2024-2029 ($ million)
  • Figure 5-6: Latin America HbA1c Testing Percentage Participation, by Country, 2024 (%) (Brazil, Chile, Columbia, Mexico, Rest of Latin America)
• Rest of World
  • Table 5-7: Rest of World HbA1c Testing Market Analysis, 2024-2029 ($ million)
• Competitive Analysis
  • Table 5-8: Global HbA1c Testing Market Estimated Revenues and Market Share of Leading Suppliers, 2024 ($ million) [Abbott, Bio-Rad, Danaher (HemoCue and Beckman Coulter), Roche, Siemens Healthineers, Others]
  • Figure 5-7: Global HbA1c Testing Market Estimated Revenues, Leading Suppliers, 2024 ($ million) [Abbott, Bio-Rad, Danaher (HemoCue and Beckman Coulter), Roche, Siemens Healthineers, Others]
  • Figure 5-8: Global HbA1c Testing Market Share of Leading Suppliers, 2024 (%) [Abbott, Bio-Rad, Danaher (HemoCue and Beckman Coulter), Roche, Siemens Healthineers, Others]

Chapter 6: Issues and Trends in the HbA1c Testing Market

• WHO Essential IVD List
  • Table 6-1: WHO Model List of Essential In Vitro Diagnostics (EDL)
• Glycated Albumin Test
• Reporting Changes
• The Challenge of PAMA
• Racial Differences in A1c
• Telemedicine
• LDT Update
• Medicare and HbA1c Testing
• IT and AI
• Diabetes and the Aging World
• Impact of Aging Populations
  • Figure 6-1: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
• Healthcare Efficiency
• Diabetes Complications
• Regulatory Issues
  • Table 6-2: Routine Chemistry CLIA Regulations Acceptable Limits (AP) Changes 2025
• Dental Office HbA1c Testing

Chapter 7: HbA1c Testing Market Company Profiles

• Introduction
• Abbott
  • Table 7-1: Abbott Corporate Summary
  • Company Overview
  • Products
  • Performance Review
    • Table 7-2: Abbott Revenues, 2020-2024 ($ million)
• A. Menarini Diagnostics, S.r.l.
  • Table 7-3: A. Menarini Diagnostics Corporate Summary
  • Company Overview
  • Products
• ARKRAY, Inc
  • Table 7-4: ARKRAY Corporate Summary
  • Company Overview
  • Products
• Beckman Coulter/Danaher
  • Table 7-5: Beckman Coulter Corporate Summary
  • Company Overview
  • Products
• Bio-Rad
  • Table 7-6: Bio-Rad Corporate Summary
  • Company Overview
  • Products
  • Financial Performance
    • Table 7-7: Bio-Rad Corporation Revenue, 2020-2024 ($ million)
• DiaSys Diagnostics Systems GmbH
  • Table 7-8: DiaSys Diagnostics Systems Corporate Summary
  • Company Overview
  • Products
• Diazyme Laboratories, Inc.
  • Table 7-9: Diazyme Laboratories Corporate Summary
  • Company Overview
  • Products
• EKF Diagnostics Holdings Plc
  • Table 7-10: EKF Diagnostics Corporate Summary
  • Company Overview
  • Products
• HemoCue/Danaher
  • Table 7-11: HemoCue Corporate Summary
  • Company Overview
  • Products
• HUMAN Diagnostics.
  • Table 7-12: HUMAN Diagnostics Corporate Summary
  • Company Overview
  • Products
• OSANG Healthcare Co, Ltd
  • Table 7-13: OSANG Healthcare Corporate Summary
  • Company Overview
  • Products
• PTS Diagnostics, Inc
  • Table 7-14: PTS Diagnostics Corporate Summary
  • Company Overview
  • Products
• QuidelOrtho Corporation
  • Table 7-15: QuidelOrtho Corporate Summary
  • Company Overview
  • Products
• Performance Review
  • Table 7-16: QuidelOrtho Revenues, 2020-2024 ($ million)
• Roche Diagnostics Corporation
  • Table 7-17: Roche Diagnostics Corporate Summary
  • Company Overview
  • Products
• Performance Review
  • Table 7-18: Roche Diagnostics, 2020-2024 (CHF millions)
• Sebia
  • Table 7-19: Sebia Corporate Summary
  • Company Overview
  • Products
• Sekisui Diagnostics, LLC
  • Table 7-20: Sekisui Diagnostics Corporate Summary
  • Company Overview
  • Products
• Siemens Healthineers GmbH
  • Table 7-21: Siemens Healthineers Corporate Summary
  • Company Overview
  • Products
• Performance Review
  • Table 7-22: Siemens Healthineers, 2020-2024 (Euro-million)
• Tosoh Bioscience, LLC
  • Table 7-23: Tosoh Bioscience Corporate Summary
  • Company Overview
  • Products
• Trinity Biotech
  • Table 7-24: Trinity Biotech Corporate Summary
  • Company Overview
  • Products