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The World Market for HbA1c Testing: Trends, Technologies, and Growth Opportunities, 2025

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SKU: 25-070KA Categories: Clinical Chemistry, Diagnostics Market Research, Immunoassays, Point-of-Care Diagnostics Tags: blood sugar, diabetes, Diabetes HbA1c lab, glucose, HbA1c POC Market, HbA1c Self-Testing Market, HbA1c Testing, HPLC, Immunoassay, Remove term: Enzymatic/Micro-optical detection method (MODM) Enzymatic/Micro-optical detection method (MODM) Pages: 120
  • Description
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Description

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)

  1. 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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    The World Market for HbA1c Testing: Trends, Technologies, and Growth Opportunities, 2025
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