HbA1c 검사 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the HbA1c testing market size was valued at USD 2.34 billion in 2025 and estimated to grow from USD 2.48 billion in 2026 to reach USD 3.33 billion by 2031, at a CAGR of 6.06% during the forecast period (2026-2031).

This report is Segmented by Device Type (Handheld and POCT Devices, Benchtop Laboratory Analyzers), Technology (HPLC, Immunoassay, Enzymatic Assay, Capillary Electrophoresis, Others), End-User (Hospitals and Clinics, Diagnostic and Reference Laboratories, More), Patient Age Group (Adults, Pediatric, Geriatric), and Geography (North America, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global HbA1c Testing Market Trends and Insights

Rising global diabetes prevalence & earlier screening guidelines

Diabetes prevalence is projected to reach 1.31 billion individuals by 2025, intensifying demand for accessible HbA1c testing solutions. Earlier screening recommended by the American Diabetes Association places HbA1c as the primary diagnostic metric, prompting laboratories to expand throughput . Health systems face rising economic burdens, with the United States spending USD 413 billion on diabetes care in 2022, reinforcing the push for early detection. The World Health Organization includes HbA1c on its Essential Diagnostics List, underscoring its global relevance . Greater awareness in low-income regions is stimulating procurement of cost-efficient test kits suitable for decentralized programs.

Growing uptake of point-of-care HbA1c analyzers in primary care settings

Devices such as the Siemens DCA Vantage deliver results in under 7 minutes, complying with NGSP performance criteria. Real-time feedback improves glycemic control by enabling immediate treatment adjustments. Roche's cobas b 101 provides finger-stick results in 5 minutes and benefits from Medicare reimbursement, expanding use in family practices. Comparative studies show 76% uptake for capillary HbA1c screening versus 37.5% for venous draws in community programs. Chinese cost-utility analyses confirm favorable economics with incremental ratios below urban and rural willingness-to-pay thresholds.

High capital and maintenance cost of HPLC analyzers for small labs

Initial purchase prices range from USD 50,000 to USD 200,000 and annual service contracts can exceed 15% of acquisition cost. CLIA 2024 updates tightened performance targets to +-8%, adding operational complexity for laboratories with limited budgets. Consumable costs, including ion-exchange columns and calibration standards, further strain finances, prompting smaller facilities to shift toward immunoassay analyzers.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of HbA1c-based reimbursement metrics in value-based care contracts
2. Rapid price declines in microfluidic single-use HbA1c cartridges for LMIC mass-screening
3. Analytical interference from hemoglobin variants lowering test confidence

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Benchtop analyzers accounted for the largest share in 2025, capturing 59.42% of the HbA1c testing market. They remain the backbone of high-throughput laboratories that process thousands of specimens daily. Systems such as Beckman Coulter's DxC 500 AU accept whole blood without manual preparation, sustaining workflow efficiency. In contrast, handheld devices drive the fastest expansion at a 6.92% CAGR as health services prioritize patient-centric delivery. The Siemens DCA Vantage, which delivers NGSP-traceable results in 6 minutes, exemplifies the reliability that now characterizes decentralized testing.

Growth momentum for handheld formats reflects rising chronic disease management in primary care and retail clinics. Many providers integrate data into electronic health records through middleware solutions, enabling population health analytics and AI-driven decision support. Manufacturers are layering cybersecurity features to comply with data protection regulations while safeguarding wireless connectivity in ambulatory environments. The price curve for single-use test cartridges is trending downward as production scales in Asia, further encouraging adoption among community practitioners and remote outreach programs. Consequently, the HbA1c market is witnessing a dual-track investment pattern where centralized laboratories upgrade high-volume HPLC lines while distributed care sites procure compact analyzers to meet on-the-spot diagnostic needs.

HPLC commanded 61.12% of 2025 revenue, supported by its established accuracy and variant detection. Recent chemistry enhancements, such as ARKRAY's HA-8160 buffer optimization, have improved precision to coefficients of variation below 1% across 4.4%-17.3% HbA1c ranges. Yet immunoassay systems are posting a 7% CAGR, driven by compatibility with point-of-care devices and lower operator training requirements. The Biolabo Kenza 450TX immunoturbidimetric assay demonstrates strong correlation with HPLC while operating on benchtop photometric analyzers that many small laboratories already use.

Hybrid architectures are emerging. Vendors now ship combined HPLC-immunoassay platforms that auto-route specimens based on sample type, urgency or suspected variant presence. Capillary electrophoresis and MALDI-TOF mass spectrometry occupy niche segments but introduce high sensitivity alternatives for complex hemoglobinopathies. These advances diversify the HbA1c market, allowing laboratories to match technique to clinical requirement, throughput and budget. As immunoassay reagents mature, they are expected to reduce the historical performance gap while maintaining immunity to common hemoglobin variants, thereby sustaining their near-term growth advantage.

Complete Report Scope:

• By Device Type
  • Handheld and POCT Devices
  • Benchtop Laboratory Analyzers
• By Technology
  • HPLC
  • Immunoassay
  • Enzymatic Assay
  • Capillary Electrophoresis
  • Others
• By End-User
  • Hospitals and Clinics
  • Diagnostic and Reference Laboratories
  • Homecare Settings
  • Others
• By Patient Age Group
  • Adults
  • Pediatric
  • Geriatric
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Malaysia
    • Indonesia
    • Thailand
    • Philippines
    • Vietnam
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America maintained leadership with 41.12% revenue share in 2025 as insurers expanded screening coverage and employer wellness programs mandated annual biometric checks. Medicare's 2024 addition of HbA1c to the diabetes screening benefit notably increased test volumes in federally funded clinics. Europe ranks second, supported by coordinated national diabetes plans across Germany, the United Kingdom and France. Laboratory networks have modernized with integrated LIS-middleware infrastructures to meet ISO 15189 accreditation standards, fostering timely result transmission to primary care teams.

Asia-Pacific is forecast to grow at a 7.13% CAGR, driven by surging prevalence and infrastructure investment. India's diabetes burden is projected to rise from 74 million cases in 2021 to 124 million by 2045, catalyzing laboratory expansion and point-of-care deployment. China's urban and rural cost-utility analyses validate the economic logic of decentralized screening, encouraging provincial health budgets to fund pilot programs. Southeast Asian countries are integrating dried blood spot sampling into outreach initiatives to overcome transportation barriers in archipelagic regions, thus broadening test reach.

The Middle East and Africa region faces variant-related analytical complexity. Hemoglobin S and C prevalence requires method selection sensitive to interference profiles, directing some laboratories toward immunoassay or capillary electrophoresis systems. South America experiences steady testing uptick as public health campaigns raise diabetes awareness and private laboratories align their service menus with international guidelines. Across all regions, the HbA1c market is benefiting from policy emphasis on early detection and the broader shift toward value-based healthcare financing.

1. Abbott Laboratories
2. Roche
3. Siemens Healthineers
4. Danaher
5. Bio-Rad Laboratories
6. Tosoh
7. Thermo Fisher Scientific
8. Arkray
9. Trinity Biotech
10. EKF Diagnostics
11. PTS Diagnostics
12. Sebia
13. Menarini Diagnostics
14. Mindray
15. Randox Laboratories
16. Nova Biomedical
17. HORIBA Medical
18. Ortho Clinical Diagnostics
19. Alere (Abbott POC)
20. Aysan BioScience

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Global Diabetes Prevalence & Earlier Screening Guidelines
  • 4.2.2 Growing Uptake of Point-Of-Care HbA1c Analyzers in Primary Care Settings
  • 4.2.3 Expansion Of HbA1c-Based Reimbursement/Quality Metrics in Value-Based Care Contracts
  • 4.2.4 Rapid Price Declines in Microfluidic Single-Use HbA1c Cartridges for LMIC Mass-Screening
  • 4.2.5 Employer-Funded Wellness Programs Mandating Annual HbA1c Checks
  • 4.2.6 AI-Enabled Decision-Support Improving Demand for Lab-Quality HbA1c Datasets
• 4.3 Market Restraints
  • 4.3.1 High Capital/Maintenance Cost of HPLC Analyzers for Small Labs
  • 4.3.2 Analytical Interference from Hemoglobin Variants Lowering Test Confidence
  • 4.3.3 Periodic Shortages of Ion-Exchange Resins & HPLC Columns Disrupting Supply Chain
  • 4.3.4 Ethnicity-Specific HbA1c Bias Delaying Regulatory Harmonization in Emerging Markets
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porters Five Forces Analysis
  • 4.6.1 Bargaining Power of Suppliers
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Threat of New Entrants
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Device Type
  • 5.1.1 Handheld and POCT Devices
  • 5.1.2 Benchtop Laboratory Analyzers
• 5.2 By Technology
  • 5.2.1 HPLC
  • 5.2.2 Immunoassay
  • 5.2.3 Enzymatic Assay
  • 5.2.4 Capillary Electrophoresis
  • 5.2.5 Others
• 5.3 By End-User
  • 5.3.1 Hospitals and Clinics
  • 5.3.2 Diagnostic and Reference Laboratories
  • 5.3.3 Homecare Settings
  • 5.3.4 Others
• 5.4 By Patient Age Group
  • 5.4.1 Adults
  • 5.4.2 Pediatric
  • 5.4.3 Geriatric
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Malaysia
    • 5.5.3.7 Indonesia
    • 5.5.3.8 Thailand
    • 5.5.3.9 Philippines
    • 5.5.3.10 Vietnam
    • 5.5.3.11 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level overview, Market level overview, Core segments, Financials, Strategic information, Market rank/share, Products & Services, Recent developments)
  • 6.3.1 Abbott
  • 6.3.2 F. Hoffmann-La Roche
  • 6.3.3 Siemens Healthineers
  • 6.3.4 Danaher (Beckman Coulter)
  • 6.3.5 Bio-Rad Laboratories
  • 6.3.6 Tosoh Bioscience
  • 6.3.7 Thermo Fisher Scientific
  • 6.3.8 Arkray
  • 6.3.9 Trinity Biotech
  • 6.3.10 EKF Diagnostics
  • 6.3.11 PTS Diagnostics
  • 6.3.12 Sebia
  • 6.3.13 Menarini Diagnostics
  • 6.3.14 Mindray
  • 6.3.15 Randox Laboratories
  • 6.3.16 Nova Biomedical
  • 6.3.17 HORIBA Medical
  • 6.3.18 Ortho Clinical Diagnostics
  • 6.3.19 Alere (Abbott POC)
  • 6.3.20 Aysan BioScience

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment