HbA1c Testing Devices Market Forecast 2035

How large is the HbA1c testing devices market today, and what growth opportunities does it offer for investors and diagnostic manufacturers?

The global HbA1c testing devices market was valued at USD 705.00 million in 2025 and is projected to grow at a CAGR of 8.20% between 2026 and 2035, reaching approximately USD 1,550.46 million by 2035.

The strong growth trajectory is fueled by the rising global prevalence of diabetes, increasing demand for long-term glucose monitoring, and rapid technological advancements in point-of-care (POC) diagnostic devices. For investors, analysts, and business decision-makers, the HbA1c testing devices market represents a high-growth segment within the broader in-vitro diagnostics (IVD) industry, characterized by recurring demand, innovation-led competition, and expanding regional opportunities.

What Is the HbA1c Testing Devices Market and Why Is It Strategically Important?

The HbA1c testing devices market comprises instruments and systems used to measure glycated hemoglobin (HbA1c) levels in blood. HbA1c testing provides a 2–3 month average of blood glucose levels and is considered a gold standard for diagnosing and monitoring diabetes.

Why HbA1c Testing Devices Matter

• Enable long-term glycemic control monitoring

• Support early diagnosis of diabetes and prediabetes

• Reduce complications through proactive treatment adjustments

• Generate recurring revenue due to periodic testing requirements

As healthcare systems shift toward preventive and value-based care models, HbA1c testing devices are becoming indispensable tools in chronic disease management.

What Is Driving Growth in the HbA1c Testing Devices Market?

1. Rising Global Diabetes Prevalence

The increasing incidence of:

• Type 2 diabetes

• Obesity-related metabolic disorders

• Gestational diabetes

continues to expand the addressable patient base. Aging populations and sedentary lifestyles further amplify demand.

2. Growing Adoption of Point-of-Care Testing

POC HbA1c devices provide:

• Rapid results within minutes

• Convenience in primary care settings

• Improved patient compliance

POC systems are particularly valuable in emerging markets and rural healthcare environments.

3. Expansion of Preventive Healthcare Programs

Governments and insurers are implementing:

• National diabetes screening programs

• Workplace health check-ups

• Community-based diagnostic initiatives

These programs directly increase device utilization rates.

4. Technological Advancements

Innovation in:

• Microfluidics

• Automated analyzers

• AI-enabled diagnostics

• Connectivity with electronic health records (EHRs)

is enhancing device accuracy, speed, and workflow efficiency.

How Is the HbA1c Testing Devices Market Segmented?

By Product Type

Laboratory HbA1c Testing Products

• High-throughput automated analyzers

• Suitable for centralized laboratories

• Superior analytical precision

Point of Care (POC) HbA1c Testing Products

• Portable, compact systems

• Immediate test results

• Ideal for clinics and decentralized care settings

POC devices are expected to register faster growth due to increasing decentralization of healthcare delivery.

What Technologies Are Dominating the Market?

Chromatography

• High-performance liquid chromatography (HPLC) widely adopted

• Gold standard for accuracy and reliability

• Common in hospital laboratories

Immunoassay

• Antibody-based detection methods

• Cost-effective and scalable

• Frequently integrated into POC devices

Others

• Enzymatic assays

• Capillary electrophoresis

• Emerging biosensor technologies

Chromatography remains dominant in centralized labs, while immunoassays drive innovation in portable systems.

Who Are the Key End Users of HbA1c Testing Devices?

Hospitals

• Largest market share

• Integrated diabetes management programs

• High patient volumes

Diagnostic Centers

• Specialized chronic disease testing

• Frequent repeat testing

Physical Examination Institutions

• Corporate wellness programs

• Routine health screenings

Research Institutions

• Clinical trials

• Epidemiological studies

Hospitals and diagnostic centers remain the largest contributors, but physical examination institutions are gaining momentum due to preventive care trends.

Which Regions Lead the HbA1c Testing Devices Market?

North America

• High diabetes prevalence

• Advanced diagnostic infrastructure

• Strong reimbursement systems

The U.S. dominates regional revenue due to frequent HbA1c testing guidelines and widespread insurance coverage.

Europe

• Universal healthcare access

• Aging population

• Government-backed screening programs

Asia Pacific

• Fastest-growing region

• Rising diabetes burden in China and India

• Expanding healthcare investments

Asia Pacific is projected to record the highest CAGR through 2035.

Latin America

• Improving access to diagnostic services

• Growing awareness of chronic disease monitoring

Middle East and Africa

• Rising obesity and diabetes rates

• Expanding private healthcare sector

Who Are the Major Companies in the HbA1c Testing Devices Market?

The competitive landscape includes global diagnostic leaders and specialized testing device manufacturers.

Key Players

• Abbott Laboratories

• Siemens AG

• Danaher Corp.

• Bio-Rad Laboratories, Inc.

• Beckman Coulter, Inc.

• Randox Laboratories Ltd.

• Arkray, Inc.

• Others

Competitive Strategies

• Launch of compact, high-accuracy POC analyzers

• Integration of automation and AI

• Strategic acquisitions and partnerships

• Geographic expansion into emerging markets

Innovation, connectivity, and cost-efficiency are primary competitive differentiators.

What Emerging Trends Are Shaping the Market?

Digital Connectivity and Remote Monitoring

Modern HbA1c testing devices increasingly feature:

• Cloud-based data storage

• Integration with telehealth platforms

• Automated data sharing with physicians

AI and Predictive Analytics

AI-driven algorithms enhance:

• Diagnostic accuracy

• Risk stratification

• Personalized treatment plans

Miniaturization and Portability

Device manufacturers are focusing on:

• Compact designs

• Reduced sample requirements

• Battery-powered systems

These innovations support decentralized and home-based testing models.

What Challenges Could Restrain Market Growth?

High Initial Equipment Costs

Advanced laboratory analyzers require significant capital investment.

Reimbursement Limitations

In emerging economies, inconsistent insurance coverage may limit testing frequency.

Regulatory Compliance

Manufacturers must meet stringent regulatory standards across different regions.

Competitive Pricing Pressure

Intense competition may compress margins, particularly in price-sensitive markets.

How Does This Market Compare to Other Diabetes Diagnostic Segments?

Compared to glucose monitoring devices:

• HbA1c testing devices provide long-term insights

• They support physician-driven decision-making

• They generate recurring diagnostic demand

The HbA1c testing devices market is closely aligned with broader diabetes management and chronic disease diagnostic markets, offering consistent and predictable growth potential.

What Is the Future Outlook for the HbA1c Testing Devices Market Through 2035?

The market is expected to nearly double in value, reaching USD 1,550.46 million by 2035.

Key Future Growth Drivers

• Increasing global diabetes screening initiatives

• Expansion of POC technologies

• Integration with AI-powered healthcare systems

• Rising geriatric population

Companies that focus on innovation, affordability, and digital integration will be best positioned to capitalize on emerging opportunities.

Uncover More Reports

Genomics Market

Legal Marijuana Market

Telemedicine Market

Skincare Devices Market

About Us:

Expert Market Research is a leading market research firm delivering data-driven insights to the pharmaceutical, biotechnology, and medical device industries. Our comprehensive research solutions include market research reports, providing in-depth analysis of industry trends and competitive landscapes; drug pipeline reports, tracking drug development progress, clinical trials, and regulatory approvals; epidemiology reports, offering detailed disease prevalence and patient population studies; and patent reports, assessing intellectual property landscapes and innovation trends, among others.

Leveraging proprietary data, advanced analytics, and expert methodologies, we help businesses navigate complex markets, optimize strategies, and drive innovation. We empower clients with actionable intelligence, enabling them to make informed decisions and stay ahead in the rapidly evolving healthcare sector.

Media Contact:

Company Name: Claight Corporation
Contact Person: Roshan Kumar, Digital Marketing
Email: sales@expertmarketresearch.com
Toll-Free Number: US +1-415-325-5166 | UK +44-702-402-5790
Address: 30 North Gould Street, Sheridan, WY 82801, USA
Website: www.expertmarketresearch.com