Diabetes Diagnostics Enters New Era: Kalorama Highlights Digital Shift and Global Surge in HbA1c Testing

ARLINGTON, Va., July 24, 2025 /PRNewswire/ -- The global fight against diabetes is accelerating—and diagnostic innovation is leading the charge. According to a new market study from Kalorama Information, Digital Diabetes: Global Market Opportunities in HbA1c Testing 2025, the worldwide HbA1c testing market is on track to surpass $2.3 billion by 2029, propelled by decentralized testing, digital platforms, and expanding access in underserved regions.

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The report outlines how point-of-care (POC) diagnostics, mobile-connected analyzers, and AI-enabled decision support are transforming how diabetes is monitored and managed. In 2024, the HbA1c market reached $1.7 billion, and Kalorama projects a 5.7% compound annual growth rate (CAGR) over the next five years—driven not just by technology, but by rising diabetes prevalence and changing clinical workflows.

"What we're seeing isn't just market growth—it's a diagnostic shift," said Mary Ann Crandall, Senior Analyst at Kalorama Information. "The rise of portable, connected HbA1c platforms means that testing can now happen closer to the patient, in community clinics, retail settings, or even at home."

New Frontiers in Diabetes Testing

Kalorama's findings spotlight the increasing dominance of POC testing, particularly in emerging markets where centralized lab access is limited. At least 35 companies offer HbA1c assays across both core lab and POC settings, but innovators are racing to win market share in the fast-growing decentralized segment.

Key growth drivers include:

• Mobile-integrated HbA1c analyzers with cloud connectivity for remote monitoring
  
  
• CLIA-waived and CE-marked devices enabling wider access to testing in retail health, dental, and at-home environments
  
  
• Government screening initiatives targeting early diagnosis in high-risk populations
  
  
• Increasing demand for real-time, data-driven chronic disease management tools

North America and Europe still account for over 73% of global revenues, but Asia Pacific and Latin America are gaining share due to rapid urbanization, aging populations, and public health investments. HbA1c testing has become a cornerstone of care for over 38.9 million Americans with diabetes, and similar patterns are emerging globally.

Leading Players & Market Trends

Top companies in the HbA1c testing market include:

• Abbott (the leader with 17% market share)
  
  
• Roche (11% market share)
  
  
• and the trio of Bio-Rad, Siemens Healthineers, and Danaher (through Beckman Coulter and HemoCue), who round out the top market leaders and combine for 17% of global revenues

Kalorama's report also delves into emerging diagnostic trends, including:

• Mass spectrometry migration for HbA1c quantification
  
  
• Racial disparities in HbA1c interpretation and outcomes
  
  
• Reporting challenges and regulatory pressures under PAMA
  
  
• Reimbursement bottlenecks and lab-developed test (LDT) scrutiny

Digitalization, AI integration, and biosensor innovation are rapidly changing how HbA1c results are interpreted and used in clinical practice.

Why This Matters Now

The report's timing is critical. With diabetes now the 8th leading cause of death in the U.S. and estimated national costs reaching $413 billion annually, accurate and accessible testing is essential. The shift toward value-based care, remote monitoring, and chronic disease prevention makes HbA1c testing a focal point for healthcare systems worldwide.

The report offers strategic guidance for diagnostic developers, investors, policymakers, and provider networks, detailing:

• Where the fastest growth segments are (by region, setting, and tech)
  
  
• How to compete and gain share in a fragmented market
  
  
• What regulatory and reimbursement hurdles must be navigated
  
  
• Where R&D investments and product development should focus

Get the Report and Webinar Replay

Kalorama's report, Digital Diabetes: Global Market Opportunities in HbA1c Testing 2025, is now available. It is accompanied by an expert-led webinar exploring the future of HbA1c testing in clinical and non-traditional settings.

To access the report or schedule a custom briefing, contact:
Sheri Davie - Kalorama Information Sales Team
[email protected] 

For media inquiries:
Richa Singh – VP, Strategic & Insights Sales
[email protected]

About Kalorama Information
For more than two decades, Kalorama Information has been a go-to source for strategic intelligence in healthcare diagnostics, medical devices, life sciences, and pharma. From trend forecasting to market sizing, Kalorama's reports are used by industry leaders, investors, and analysts to drive decisions that shape the future of healthcare.

SOURCE Kalorama Information