HbA1c Testing Market, By Type (Laboratory-based Testing, Point-of-Care Testing), Technology (Immunoassays, Chromatography, Boronate Affinity Chromatography, HPLC), End-use (Hospital, Diagnostic Labs, Homecare) –Forecast (2024 – 2032)

HbA1c Testing Market Size

HbA1c Testing Market size was valued at around USD 2.3 billion in 2023 and is estimated to grow at 8.6% CAGR from 2024 to 2032. HbA1c testing, also known as glycated hemoglobin testing, is a common and important blood test used to measure the average level of blood glucose (sugar) over the past two to three months. This test is primarily used to diagnose and monitor diabetes.
 

HbA1c testing is a crucial tool in the management of diabetes, providing valuable insights into long-term blood glucose control and helping to prevent complications by enabling timely and appropriate medical interventions. This test is especially beneficial for drivers with diabetes, as maintaining optimal blood glucose control is essential for safe driving. Poorly managed diabetes can lead to fluctuating blood sugar levels, potentially causing symptoms like dizziness, confusion, or loss of consciousness, which can be dangerous when operating a vehicle. Regular HbA1c testing helps drivers monitor their glucose control, adjust their treatment plans accordingly, and reduce the risk of diabetes-related complications that could impair their ability to drive safely. Ensuring HbA1c levels are within the recommended range enhances overall health and safety, both on and off the road.
 

Furthermore, according to the International Diabetes Federation, the number of adults living with diabetes is projected to increase substantially in the coming decades, fueling demand for reliable and efficient rapid diagnostic tools like HbA1c tests. Another major driver is the increasing awareness of the importance of early diagnosis and regular monitoring of diabetes to prevent complications. As both healthcare providers and patients recognize the benefits of maintaining tight blood glucose control, the adoption of HbA1c testing as a standard practice is expanding. Additionally, advancements in medical technology have led to the development of more accurate, convenient, and cost-effective HbA1c testing methods, further boosting market growth.
 

HbA1c Testing Market Trends

• Technological advancements, such as the development of point-of-care testing devices, are enhancing convenience and efficiency, allowing for rapid, real-time glucose monitoring. Additionally, the increased adoption of self-testing kits, accelerated by the COVID-19 pandemic, is empowering patients to manage their diabetes more effectively from home. The global rise in diabetes prevalence, driven by lifestyle factors and an aging population, is significantly boosting demand for these tests.
   
• Furthermore, the market is benefiting from government initiatives and regulatory support promoting regular diabetes screening and monitoring. Emerging markets in Asia and Latin America are also contributing to growth due to improved healthcare access and rising healthcare expenditures. Innovations in testing methods, including non-invasive options, and integration with mobile health platforms are further enhancing patient compliance and data management. These trends collectively indicate a robust and expanding market poised for continued advancement.
   

HbA1c Testing Market Analysis

Based on type, the market is bifurcated into laboratory-based testing and point-of-care (POC) testing. The point-of-care (POC) testing segment of the industry is forecast to reach USD 3.5 billion by 2032.
 

• The point-of-care (POC) HbA1c testing industry is being driven by the increasing need for accessible and rapid diabetes management solutions, advancements in testing technology, and a broader shift towards personalized and preventive healthcare. The ability to provide immediate and accurate results at the site of care significantly enhances the management of diabetes, enabling timely treatment adjustments and improving overall patient outcomes.
   
• The increasing prevalence of diabetes globally necessitates more frequent and accessible testing options. POC testing meets this demand by offering immediate results, which is crucial for timely clinical decision-making and treatment adjustments.
   
• Furthermore, the shift towards personalized medicine emphasizes the need for patient-specific data, which POC testing can provide promptly, thereby enhancing individualized treatment plans. Technological advancements have improved the accuracy, reliability, and ease of use of POC devices, making them more appealing to healthcare providers., thereby boosting the segment growth over the forecast period.
   

Based on technology, the market is segmented into immunoassays, chromatography, enzymatic assays, boronate affinity chromatography, high-performance liquid chromatography, and other technologies. The immunoassays segment accounted for USD 817.1 million in 2023.
 

• The HbA1c testing industry using immunoassays is expanding due to the rising diabetes prevalence, technological advancements in testing methodologies, and the growing demand for efficient point-of-care solutions. Immunoassay technology provides accurate, reliable, and timely measurement of glycated hemoglobin, facilitating better diabetes management and patient outcomes.
   
• Furthermore, there is an increasing demand for point-of-care testing solutions that deliver rapid results without the need for extensive laboratory infrastructure, and immunoassay-based POC devices meet this need effectively. Additionally, regulatory agencies and healthcare organizations globally are emphasizing the importance of regular HbA1c monitoring as part of comprehensive diabetes management strategies, further driving segment growth.
   

Based on end-use, the HbA1c testing market is segmented into hospitals and clinics, diagnostic laboratories, homecare settings, and other end-users. The hospitals and clinics segment accounted for USD 943.1 million in 2023.
 

• HbA1c testing in hospitals and clinics is driven by the rising diabetes burden, technological advancements in testing methods, and the focus on value-based care and patient outcomes. Regular HbA1c monitoring is essential for effective diabetes management, enabling timely adjustments to treatment plans and reducing the risk of complications. The support from regulatory bodies and the integration with digital health systems enhance the adoption and utility of HbA1c testing in clinical settings, ultimately improving the quality of care provided to patients with diabetes.
   
• HbA1c testing is a crucial component of diabetes management and monitoring in hospitals and clinics, providing essential data on patients' long-term blood glucose control. The integration of HbA1c testing with electronic health records (EHRs) facilitates comprehensive patient data management and improves coordination of care among healthcare providers, thereby boosting the segment growth over the forecast period.
   

The U.S. HbA1c testing industry is forecast to reach USD 2 billion by 2032, driven by a combination of technological advancements, regulatory compliance, patient safety concerns, and operational efficiency needs.
 

• The U.S. market is being driven by the increasing diabetes prevalence, technological advancements in diagnostic methods, and a strong focus on preventive healthcare and early diagnosis. The integration of testing with digital health platforms and comprehensive healthcare coverage further supports the widespread adoption of HbA1c testing in the U.S. These factors collectively ensure that HbA1c testing remains a critical component of effective diabetes management and care in the country.
   
• Furthermore, there is a growing emphasis on preventive healthcare and early diagnosis, with healthcare policies and guidelines increasingly recommending regular HbA1c testing as a standard part of diabetes management and screening protocols. These factors are expected to boost the U.S. market growth over the forecast period.
   

The HbA1c testing market in UK is expected to experience significant and promising growth from 2024 to 2032.
 

• The increasing prevalence of diabetes in the UK, particularly type 2 diabetes, is a primary driver. This rise is associated with lifestyle factors such as poor diet, obesity, and physical inactivity, necessitating more frequent and reliable monitoring of blood glucose levels. Additionally, advancements in diagnostic technologies, including the development of highly accurate and efficient point-of-care (POC) testing devices, have made HbA1c testing more accessible and convenient in both clinical and home settings.
   
• Additionally, the UK National Health Service (NHS) and other health authorities are emphasizing preventive healthcare and early diagnosis. Guidelines from organizations like the National Institute for Health and Care Excellence (NICE) recommend regular HbA1c testing for diabetes management and screening, reinforcing the importance of these tests in routine care. The growing awareness among healthcare providers and patients about the benefits of regular HbA1c monitoring for preventing complications and optimizing diabetes management also drives segment growth.
   

Japan market is anticipated to witness lucrative growth between 2024 – 2032.
 

• The HbA1c testing industry in Japan is driven by the aging population, technological advancements, growing awareness about the importance of glycemic control, supportive government policies, and the integration with digital health systems. These factors collectively contribute to the widespread adoption of HbA1c testing as a critical component of diabetes management in Japan.
   
• Additionally, there is a growing awareness among healthcare providers and patients about the importance of glycemic control in preventing diabetes-related complications. Guidelines from organizations like the Japan Diabetes Society (JDS) recommend regular HbA1c testing for monitoring blood glucose levels and adjusting treatment plans, accordingly, contributing to segment growth over the forecast period.
   

The HbA1c testing market in Saudi Arabia is expected to experience significant and promising growth from 2024 to 2032.
 

• The increasing prevalence of diabetes in the country is a significant driver. Saudi Arabia has one of the highest rates of diabetes globally, with both type 1 and type 2 diabetes affecting a large segment of the population. This high prevalence necessitates frequent monitoring of blood glucose levels, driving demand for HbA1c testing. 
   
• Additionally, there is a growing awareness among healthcare providers and patients about the importance of glycemic control in preventing diabetes-related complications. Guidelines from organizations like the Saudi Society of Endocrinology and Metabolism (SSEM) recommend regular HbA1c testing for monitoring blood glucose levels and adjusting treatment plans, accordingly, contributing to market growth.
   

HbA1c Testing Market Share

The global market for HbA1c testing is highly competitive, driven by technological innovation, increased emphasis on personalized and preventive healthcare, and a rising global diabetes burden. These companies invest heavily in research and development to enhance their product portfolios, expand their market reach, and gain a competitive edge. The competitive scenario in the market is dynamic and characterized by continuous innovation, strategic partnerships, and a focus on delivering value to customers while meeting regulatory requirements and quality standards.
 

HbA1c Testing Market Companies

Some of the eminent market participants operating in the HbA1c testing industry include:

• Abbott Laboratories
• ARKRAY, Inc.
• Bio-Rad Laboratories, Inc.
• Ceragem Medisys Inc.
• Danaher Corporation
• EKF Diagnostics
• F. Hoffmann-La Roche Ltd.
• HUMAN
• Menarini Diagnostics s.r.l
• PTS Diagnostics
• Randox Laboratories Ltd.
• SAKAE CO. LTD.
• SEKISUI MEDICAL CO., LTD.
• Siemens Healthineers AG
• Trinity Biotech plc
   

HbA1c Testing Industry News:

• In April 2023, the Foundation for Innovative New Diagnostics (FIND) established strategic partnerships with leading industry players, including Abbott, i-SENS Inc, and Siemens Healthineers. This collaboration aimed to facilitate the provision of discounted point-of-care HbA1c test kits tailored for deployment in low- and middle-income countries. The initiative was driven by a collective commitment to addressing healthcare disparities and enhancing diabetes diagnosis and management in underserved regions.
   
• In May 2022, LumiraDx achieved CE Marking for its HbA1c test, marking a significant milestone in enhancing diabetes screening and monitoring capabilities on its point-of-care LumiraDx Platform. This rapid microfluidic assay delivers results within a remarkably short timeframe of under seven minutes, thereby substantially speeding up patient risk identification.
   

The HbA1c testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Type

• Laboratory-based testing
• Point-of-care (POC) testing

Market, By Technology

• Immunoassays
• Chromatography
• Enzymatic assays
• Boronate affinity chromatography
• High-performance liquid chromatography
• Other technologies

Market, By End-use

• Hospitals & clinics
• Diagnostic laboratories
• Homecare settings
• Other end-users

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada 
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific 
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America 
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa