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Add to CartHemoglobin A1C (HbA1c) Testing Market
By Technology;
Ion-Exchange High Performance Liquid Chromatography (HPLC), Immunoassays, Boronate Affinity Chromatography, Direct Enzymatic Assays and OthersBy Product;
Reagents & Kits and InstrumentsBy End User;
Hospitals & Clinics, Diagnostic & Reference Laboratories and MoreBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa and Latin America - Report Timeline (2021 - 2031)Hemoglobin A1C (HbA1c) Testing Market Overview
Hemoglobin A1C (HbA1c) Testing Market (USD Million)
Hemoglobin A1C Testing Market was valued at USD 1,899.37 million in the year 2024. The size of this market is expected to increase to USD 3,297.62 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 8.2%.
Hemoglobin A1C (HbA1c) Testing Market
*Market size in USD million
CAGR 8.2 %
| Study Period | 2025 - 2031 |
|---|---|
| Base Year | 2024 |
| CAGR (%) | 8.2 % |
| Market Size (2024) | USD 1,899.37 Million |
| Market Size (2031) | USD 3,297.62 Million |
| Market Concentration | Medium |
| Report Pages | 303 |
Major Players
- Abbott Laboratories
- ARKRAY Inc
- Bio-Rad Laboratories Inc.
- Polymer Technology Systems Inc.
- Danaher Corporation (Beckman Coulter)
- F.Hoffmann-La Roche Ltd.
- Menarini Group.
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Hemoglobin A1C (HbA1c) Testing Market
Fragmented - Highly competitive market without dominant players
The Hemoglobin A1C (HbA1c) Testing Market is experiencing consistent expansion due to the rising prevalence of diabetes and prediabetes worldwide. More than 10% of adults globally are estimated to live with diabetes, driving continuous demand for accurate diagnostic tools. HbA1c tests, which measure average blood sugar levels over three months, are considered essential in diabetes screening, monitoring, and management.
Rising Diabetes BurdenThe growing number of diabetic patients is a major factor shaping the market. Nearly 50% of individuals with diabetes remain undiagnosed, highlighting the need for efficient and accessible testing solutions. HbA1c testing is now incorporated into over 70% of standard diabetes care programs, making it a critical tool for timely diagnosis and effective treatment planning.
Technological AdvancementsInnovations in diagnostic technologies are strengthening the HbA1c testing market. Automated analyzers, point-of-care (POC) devices, and high-performance liquid chromatography (HPLC) systems now account for nearly 55% of total test adoption. These systems ensure faster results and improved accuracy, enhancing patient outcomes and reducing clinical workload.
Growing Preference for Preventive HealthcareThe market is also benefiting from the global shift toward preventive healthcare. More than 40% of healthcare facilities are integrating HbA1c tests into routine checkups to identify early signs of diabetes and metabolic syndrome. This shift is creating sustainable growth opportunities as testing becomes a part of preventive health strategies.
Hemoglobin (HbA1c) Testing Market Recent Developments
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In February 2023, Bio-Rad Laboratories, Inc. (US) introduced the D-100 Hemoglobin A1c assay. This high-performance liquid chromatography (HPLC) method enables precise HbA1c measurement on Bio-Rad’s D-Series analyzers, enhancing diagnostic accuracy.
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In October 2023, Abbott Laboratories (US) received FDA clearance for the FreeStyle Libre 3 system, a continuous glucose monitoring (CGM) device with 14-day wear and enhanced accuracy. Although not a direct HbA1c test, its CGM data can be used to estimate HbA1c levels, aiding in diabetes management.
Hemoglobin A1c Testing Market Segment Analysis
In this report, the hemoglobin a1c testing market has been segmented by Technology, Product, End User and geography.
Hemoglobin A1C Testing Market, Segmentation by Technology
In this report, the hemoglobin a1c testing market has been segmented by Technology into Ion-Exchange High Performance Liquid Chromatography (HPLC), Immunoassays, Boronate Affinity Chromatography, Direct Enzymatic Assays and Others.
Ion-Exchange High Performance Liquid Chromatography (HPLC)
Accounts for nearly 45% of the market due to its high accuracy, reproducibility, and ability to detect hemoglobin variants. It is widely adopted in clinical laboratories for reliable long-term glucose monitoring.
Immunoassays
Hold about 25% share, driven by their cost-effectiveness, faster turnaround time, and suitability for point-of-care testing in primary healthcare settings.
Boronate Affinity Chromatography
Captures nearly 15% of the market, valued for its high specificity in binding glycated hemoglobin and its efficiency in detecting HbA1c levels without interference from most hemoglobin variants.
Direct Enzymatic Assays
Represent around 10% share, preferred for their simplicity and compatibility with automated clinical analyzers, enabling integration into high-volume diagnostic workflows.
Others
Contribute approximately 5%, including emerging novel technologies aimed at improving accuracy, reducing cost, and expanding access to HbA1c testing in resource-limited settings.
Hemoglobin A1C Testing Market, Segmentation by Product
In this report, the hemoglobin a1c testing market has been segmented by Product into Reagents & kits and Instruments.
Reagents & KitsHold nearly 60% of the market, driven by the recurring demand for testing consumables in routine HbA1c monitoring. Their consistent use across clinical laboratories and point-of-care settings ensures a steady revenue stream for manufacturers.
InstrumentsAccount for about 40% share, comprising advanced analyzers and diagnostic equipment designed for high-throughput and automated testing. Increasing adoption in hospitals and diagnostic centers supports growth in this segment.
Hemoglobin A1C Testing Market, Segmentation by End User
In this report, the hemoglobin a1c testing market has been segmented by End User into Laboratory Testing - Commercial Laboratories & Others, Point-Of-Care (POC) Testing - Hospitals, Homecare, Clinics and Others.
Laboratory Testing - Commercial Laboratories & Others
Represents nearly 55% of the market, with commercial laboratories and diagnostic centers handling high volumes of HbA1c tests. Their advanced analytical capabilities and centralized operations ensure accuracy, consistency, and scalability for diverse patient populations.
Point-Of-Care (POC) Testing - Hospitals, Homecare, Clinics and Others
Accounts for about 45% share, driven by the rising adoption of POC devices in hospitals, homecare, and clinics. These solutions enable rapid HbA1c results, improving diabetes management and patient convenience in decentralized care settings.
Hemoglobin A1C Testing Market, Segmentation by Geography
In this report, the Hemoglobin A1C Testing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa and Latin America.
Regions and Countries Analyzed in this Report
Hemoglobin A1C Testing Market Share (%), by Geographical Region
North AmericaHolds around 40% share of the Hemoglobin A1C testing market, supported by advanced diagnostic infrastructure, widespread diabetes screening programs, and increasing adoption of point-of-care testing technologies across hospitals, clinics, and homecare settings.
EuropeAccounts for nearly 28% share, driven by strong government healthcare policies, rising diabetes prevalence, and expanded availability of automated HbA1c analyzers in both primary and specialty care environments.
Asia PacificRepresents about 22% share, experiencing rapid growth due to rising awareness campaigns, higher diabetes detection rates, and growing demand for affordable testing solutions in emerging economies.
Middle East & AfricaCaptures close to 6% share, with market expansion supported by increasing screening initiatives, improved access to diagnostic facilities, and rising healthcare investments in urban regions.
Latin AmericaHolds approximately 4% share, driven by the rising adoption of HbA1c testing kits, government-supported diabetes management programs, and expanding laboratory networks in underserved areas.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Hemoglobin A1C Testing Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers:
- Increasing Prevalence of Diabetes
- Technological Advancements in Testing Methods
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Growing Awareness about Early Disease Detection - The global hemoglobin A1C testing market is experiencing significant growth, primarily driven by the increasing awareness about early disease detection. Hemoglobin A1C testing plays a crucial role in the diagnosis and management of diabetes mellitus. With the rising prevalence of diabetes worldwide, there has been a growing emphasis on regular screening and monitoring of blood glucose levels, which has propelled the demand for A1C testing. Healthcare professionals are increasingly advocating for routine A1C testing, not only for diabetic patients but also for individuals at risk of developing diabetes, contributing to the expansion of the market.
The shift towards preventive healthcare measures has further boosted the adoption of hemoglobin A1C testing. Early detection of diabetes through A1C testing enables healthcare providers to implement timely interventions and lifestyle modifications to prevent complications associated with the disease. This proactive approach has garnered attention among both healthcare professionals and individuals, driving the market growth. Additionally, advancements in technology, such as the development of rapid and accurate A1C testing methods, have enhanced the accessibility and convenience of testing, further fueling market expansion. As awareness continues to increase and healthcare systems prioritize preventive care, the global hemoglobin A1C testing market is poised for continued growth in the foreseeable future.
Restraints:
- High Cost of Testing Equipment
- Limited Accessibility in Developing Regions
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Lack of Skilled Healthcare Personnel - The global hemoglobin A1C testing market faces a significant challenge due to the scarcity of skilled healthcare personnel. Despite the growing demand for hemoglobin A1C testing, particularly in the management of diabetes, the availability of trained professionals to administer these tests remains insufficient. This shortage not only impedes the timely and accurate diagnosis of diabetes but also hampers the effective monitoring of patients' glucose levels over time.
Without an adequate number of skilled healthcare personnel, there is a risk of delays in testing, misinterpretation of results, and suboptimal patient care. Moreover, the complexity of interpreting hemoglobin A1C test results requires knowledgeable healthcare professionals who can provide patients with appropriate guidance and treatment recommendations based on their individual circumstances. Addressing this shortage will be crucial in ensuring widespread access to quality hemoglobin A1C testing and improving diabetes management outcomes globally.
Opportunities:
- Emerging Markets with Untapped Potential
- Development of Point-of-Care Testing Solutions
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Integration of A1C Testing into Routine Health Screenings - As healthcare systems worldwide prioritize preventive measures, the integration of Hemoglobin A1C testing into routine health screenings has emerged as a pivotal strategy. This glycosylated hemoglobin test offers a comprehensive snapshot of an individual's average blood sugar levels over the past two to three months, aiding in the early detection and management of diabetes. By seamlessly incorporating A1C testing into routine check-ups, healthcare providers can swiftly identify individuals at risk or those with undiagnosed diabetes, enabling timely interventions and lifestyle modifications to prevent complications.
The integration of A1C testing into routine health screenings fosters a proactive approach to population health management. By routinely monitoring A1C levels alongside other standard tests, such as cholesterol and blood pressure measurements, healthcare professionals gain valuable insights into patients' overall health status and disease risk profiles. This holistic approach not only facilitates early intervention for diabetes but also supports personalized care plans tailored to individuals' specific needs and risk factors. Ultimately, the seamless integration of A1C testing into routine health screenings underscores a paradigm shift towards proactive, preventive healthcare, aiming to improve patient outcomes and reduce the burden of chronic diseases on healthcare systems globally.
Competitive Landscape Analysis
Key players in Global Hemoglobin A1C Testing Market include:
- Abbott Laboratories
- ARKRAY Inc
- Bio-Rad Laboratories Inc.
- Polymer Technology Systems Inc.
- Danaher Corporation (Beckman Coulter)
- F.Hoffmann-La Roche Ltd.
- Menarini Group.
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Technology
- Market Snapshot, By Product
- Market Snapshot, By Patient Age Group
- Market Snapshot, By End User
- Market Snapshot, By Region
- Hemoglobin A1C (HbA1c) Testing Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Prevalence of Diabetes
- Technological Advancements in Testing Methods
- Growing Awareness about Early Disease Detection
- Restraints
- High Cost of Testing Equipment
- Limited Accessibility in Developing Regions
- Lack of Skilled Healthcare Personnel
- Opportunities
- Emerging Markets with Untapped Potential
- Development of Point-of-Care Testing Solutions
- Integration of A1C Testing into Routine Health Screenings
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Hemoglobin A1C (HbA1c) Testing Market, By Technology, 2021 - 2031 (USD Million)
- Ion-Exchange High Performance Liquid Chromatography (HPLC)
- Immunoassays
- Boronate Affinity Chromatography
- Direct Enzymatic Assays
- Others
- Hemoglobin A1C (HbA1c) Testing Market, By Product, 2021 - 2031 (USD Million)
- Reagents & kits
- Instruments
- Hemoglobin A1C (HbA1c) Testing Market, By End User, 2021 - 2031 (USD Million)
- Hospitals & Clinics
- Diagnostic & Reference Laboratories
- More
- Hemoglobin A1C (HbA1c) Testing Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Hemoglobin A1C (HbA1c) Testing Market, By Technology, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Abbott Laboratories
- ARKRAY Inc
- Bio-Rad Laboratories Inc.
- Polymer Technology Systems Inc.
- Danaher Corporation (Beckman Coulter)
- F.Hoffmann-La Roche Ltd.
- Menarini Group.
- Company Profiles
- Analyst Views
- Future Outlook of the Market