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The World Market for HbA1c Testing: Trends, Technologies, and Growth Opportunities, 2025
Publication Date: February 26, 2025
Tags: Artificial Intelligence (AI), Clinical Chemistry, Coagulation, Diagnostic Instruments, Hematology, Immunoassay, In Vitro Diagnostics (IVD), Point-of-Care (POC) Testing
Pages: 120
SKU: 25-070KA
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: Global HbA1c Test Sales Market and Distribution by Technology Platform, 2024-2029 ($ million)
| Technology Platform | 2024 | % Market | 2029 | % Market | CAGR |
| HPLC | $XX Million | XX% | $XX Million | XX% | XX% |
| Immunoassay | $XX Million | XX% | $XX Million | XX% | XX% |
| Enzymatic/MODM | $XX Million | XX% | $XX Million | XX% | XX% |
| Others | $XX Million | XX% | $XX Million | XX% | XX% |
| Total | $XX Million | XX% | $XX Million | XX% | XX% |
Source: Kalorama Information
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Table of Contents
Chapter 1: Executive Summary
Introduction
Scope and Methodology
Market Summary
Table 1-1: Global HbA1c Testing Market Analysis, 2024-2029 ($ 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)
- 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 (€ 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
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