세계의 HbA1c 검사 시장 : 동향, 기술, 성장 기회(2025년)

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