United States HbA1c Testing Market 2031 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

HbA1c Testing Market growing with a High CAGR during the forecast period 2024-2031.

Get a Free Sample PDF Of This Report (Get Higher Priority for Corporate Email ID):- https://www.datamintelligence.com/download-sample/hba1c-testing-market?sb

Key Development:

United States: Recent HbA1c Testing Developments

✅ In January 2026, HbA1c testing platforms saw broader AI‐driven clinical interpretation and non‐invasive method research, including reduced sample volume and enhanced connectivity features for improved workflow in point‐of‐care and clinical settings.

✅ In December 2025, Trinity Biotech expanded the rollout of its next‐generation high‐capacity HbA1c column system for the Premier Hb9210 analyzer with regulatory clearances in multiple countries including the U.S., boosting laboratory throughput, automation and efficiency.

✅ In October 2025, Tosoh Bioscience received U.S. FDA 510(k) clearance for its next‐generation GR01 HbA1c analyzer (HLC‐723‐GR01), offering faster, accurate and efficient HbA1c testing for clinical diagnostics.

✅ In November 2025, Continued investment in faster, connected HbA1c tests, enabling real‐time data sharing and remote monitoring to integrate with digital health ecosystems.

Buy Now & Unlock 360° Market Intelligence: https://www.datamintelligence.com/buy-now-page?report=hba1c-testing-market

Japan: Recent HbA1c Testing Developments

✅ In December 2025, Japan's POC HbA1c testing market was projected to grow significantly as adoption of innovative point‐of‐care and automated HbA1c testing solutions accelerates amid rising diabetes awareness and supportive regulatory frameworks.

✅ In November 2025, Japan's Ministry of Health, Labour and Welfare (MHLW) published Cabinet Order No. 362 of 2025, which designates the U.S. FDA as an equivalent regulatory authority for priority review expected to speed up approvals of advanced diagnostics including HbA1c testing devices.

✅ In October 2025, Enhanced connectivity and reduced turnaround innovations in HbA1c testing systems globally, aligning with Japan's focus on tech‐driven diabetes diagnostics.

✅ In recent months (2025), Japan's HbA1c testing devices market continued to expand, with point‐of‐care as the largest and fastest segment due to high uptake of convenient, near‐patient tests.

Key Players:

=> Abbott Laboratories, Arkray, Inc, Bio-Rad Laboratories Inc, EKF Diagnostics Holdings Plc, Siemens Healthineers, PTS Diagnostics, Inc, Getein Biotech, Inc, Thermo Fisher Scientific Inc., Roche Diagnostics Corporation, Meril Life Sciences Pvt. Ltd among others.

Speak to Our Analyst and Get Customization in the report as per your requirements: https://www.datamintelligence.com/customize/hba1c-testing-market?sb

Key Segments:

By Product Type

Kits - ~55% share

Widely used in clinical diagnostics and research laboratories; preferred for ready-to-use testing and standardization across labs.

Reagents - ~45% share

Used in both routine testing and specialized assays; growing demand in hospitals and research facilities for custom and high-throughput testing.

By Technology

Immunoassay - ~35% share

Dominant technology for biomarker detection, disease screening, and point-of-care diagnostics; strong adoption in clinical laboratories and hospitals.

High-Performance Liquid Chromatography (HPLC) - ~25% share

Used for precise quantitative analysis of biomolecules, drugs, and metabolites; prevalent in research labs and specialized hospital labs.

Boronate Affinity Chromatography - ~15% share

Applied in glycoprotein analysis and diabetes-related diagnostics; niche but growing in advanced diagnostics labs.

Enzymatic Assays - ~25% share

Common in metabolic and biochemical testing; widely applied in diagnostics laboratories for cost-effective and reliable results.

By End-User

Diagnostics Laboratories - ~50% share

Main consumers of kits and reagents; demand driven by routine testing, high-throughput screening, and research purposes.

Hospitals - ~40% share

Kits and reagents used for in-house diagnostic services and patient monitoring; adoption increasing with hospital lab expansion.

Others - ~10% share

Includes research institutes, academic labs, and specialty testing facilities.

By Region

North America - ~35% share

Dominated by U.S. and Canada; high adoption of advanced technologies, strong research infrastructure, and well-established diagnostics labs.

Europe - ~25% share

Germany, U.K., France, Italy - Mature diagnostics market with stringent regulatory compliance; high adoption of HPLC and immunoassays.

Asia Pacific - ~25% share

China, India, Japan, Australia - Rapid growth due to rising healthcare infrastructure, expanding hospital networks, and increasing R&D investments.

South America - ~10% share

Brazil, Argentina - Growing diagnostics laboratories; demand mainly for cost-effective kits and reagents.

Middle East & Africa - ~5% share

Increasing focus on modernizing healthcare systems and expanding lab networks; growth driven by government initiatives and foreign investments.

Unlock 360° Market Intelligence with DataM Subscription Services: https://www.datamintelligence.com/reports-subscription

Power your decisions with real-time competitor tracking, strategic forecasts, and global investment insights all in one place.

✅ Competitive Landscape
✅ Sustainability Impact Analysis
✅ KOL / Stakeholder Insights
✅ Unmet Needs & Positioning, Pricing & Market Access Snapshots
✅ Market Volatility & Emerging Risks Analysis
✅ Quarterly Industry Report Updated
✅ Live Market & Pricing Trends
✅ Import-Export Data Monitoring

Have a look at our Subscription Dashboard: https://www.youtube.com/watch?v=x5oEiqEqTWg

Contact Us -

Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -

DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.

Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

This release was published on openPR.