세계의 HbA1c 검사 기기 시장 평가 : 장비 유형별, 기술별, 최종 사용자별, 지역별, 기회 및 예측(2017-2031년)

Global HbA1c testing devices market is projected to witness a CAGR of 7.51% during the forecast period 2024-2031, growing from USD 2372 million in 2023 to USD 4233.56 million in 2031. The market demand for HbA1c testing devices is anticipated to thrive drastically in the forecast years due to the increasing prevalence of diabetes and the growing interest of investors and market players.

The global HbA1c testing device market is thus witnessing many growth opportunities due to the fast spreading of diabetes across the globe. More cases of diabetes are being reported, especially type 2 cases, for which people look for effective and regular monitoring for this disease. Thus, HbA1c testing becomes a necessity-measuring long-term blood glucose levels, including technological advancements such as point-of-care testing devices. The prevalence of diabetes is very high in low- and middle-income countries. In fact, about three-quarters of the affected people reside in low- and middle-income countries. Diabetes is a chronic condition that results from a lack of production or ineffective use of insulin by the body. As a result, the blood glucose level (blood sugar level) increases in the body, which leads to even more severe complications such as cardiovascular diseases, kidney disease, and vision problems. More than 422 million people suffer from diabetes, of which a vast majority live in low- and middle-income countries. Out of these, around 1.5 million die each year due to diabetes. For instance, in February 2024, HemoCue announced a partnership with Novo Nordisk A/S to improve point-of-care diagnostic testing for children with type 1 diabetes in low- and middle-income countries.

Increased Prevalence of Diabetes to Support HbA1c Testing Devices Market Growth

The increasing incidence of diabetes is driving the market for HbA1c testing devices. Rising burdens, especially due to changing lifestyle, aging population, and increasing obesity rates, have spurred demand for adequate management tools for diabetes. The HbA1c testing device measures blood glucose levels over the long term to evaluate the efficiency of a treatment regime and the potential risks of complications. As the number of diabetes patients increases, healthcare providers rely more on these tests for routine diabetes care to advance diabetes management. The devices have become necessary for having steady and accurate monitoring in clinical and home settings, driving better outcomes for patients and better management of the disease at large. For instance, in April 2023, FIND announced a partnership with Abbott, i-SENS, Inc., and Siemens Healthineers AG to improve hemoglobin (HbA1c) testing for diabetes diagnosis and management by offering a special price for point-of-care test kits for low and middle-income countries (LMICs).

Technological Advancement in Testing Devices to Drive Market Growth

Advancements in the technology of devices used for HbA1c testing have played a significant role in the growth of this market. Technological advancements have made the tests more accurate and convenient to access. Innovations such as point-of-care (POC) devices have allowed testing outside traditional laboratories, which could provide immediate results in minutes. Portable analyzers that are friendly to the user have made it easier for healthcare providers to monitor the glycemic control of their patients in real time and improve their decisions based on clinical judgment. Furthermore, developing automated systems and integrated platforms with HbA1c testing that integrate with other diagnostic procedures helps streamline the procedure and reduce the number of visits to the healthcare provider to conduct the test. Such advancements improve patient outcomes by making regular HbA1c monitoring available, even in hard-to-reach or underserved areas, and support increased demand for personalized diabetes management. For instance, in July 2024, EKF Diagnostics Holdings plc, a global diagnostics business, announced the launch of its new Biosen C-Line, an advanced version of its industry-leading rapid benchtop glucose and lactate analyzer. The Biosen C-Line analyzer measures glucose and lactate levels in whole blood, plasma, and serum using enzymatic sensor technology to give precise results.

Point-of-Care Testing Devices Segment to Dominate the HbA1c Testing Devices Market Share

The point-of-care (POC) testing devices segment is anticipated to dominate the market of HbA1c testing devices primarily due to the rising demand for fast, accessible, and reliable diabetic management solutions. POC testing devices enable one to carry out HbA1c testing on-site and thereby provide healthcare providers and patients with real-time information in various settings, such as clinics, pharmacies, and home settings. This gives an opportunity for the modification of treatment plans in a timely manner, thus providing better patient outcomes and satisfaction. With patients continuously getting affected with diabetes around the globe, POC testing devices will play an important role in the effective management of diabetes and hence prove to be a big growth driver in the HbA1c testing device market. For instance, in December 2023, F. Hoffmann-La Roche Ltd signed a deal to acquire LumiraDx point-of-care testing technology for USD 295 million, with an extra USD 55 million committed to supporting Lumira's platform development until the acquisition is finalized.

North America to Dominate the HbA1c Testing Devices Market Share

North America leads the share of the global HbA1c testing devices market due to the high prevalence of diabetes, higher healthcare expenditure, and advanced healthcare infrastructure in the region. Driving factors behind this region's growth are strong awareness of diabetes management, early adoption of advanced diagnostic technologies, and a well-established healthcare system. Moreover, a growing obese population and an aging population also require more HbA1c tests because the control of this condition requires timely monitoring of blood glucose levels. So, North America leads the HbA1c testing device market due to these technological innovations and strategic tie-ups by the key players in this industry. For instance, in June 2024, Abbott announced receiving approval from the U.S. Food and Drug Administration (FDA) for two new over-the-counter continuous glucose monitoring (CGM) systems, Lingo and Libre Rio. Lingo targets general consumers focused on improving overall health and wellness. Libre Rio is tailored for adults with Type 2 diabetes who manage their condition through lifestyle changes and do not use insulin.

Future Market Scenario (2024-2031F)

The HbA1c testing device market is expected to grow significantly in the future because of a continuously increasing rate of diabetes across the globe, increased focus on preventive care, and new developments in diagnostic technology. A better understanding and higher adoption rate of point-of-care devices will drive demand. The high ease of use, greater accuracy in testing, and compatibility with digital health platforms for the management of diseases will allow for greater ease of accessibility and patient engagement in the market. In particular, emerging economies with expanding healthcare infrastructure and increased healthcare spending will provide significant market opportunities. Overall, the market is likely to expand due to continuous R&D, strategic alliances, and regulatory approvals to improve diabetes monitoring and patient outcomes. For instance, in December 2023, Tosoh Bioscience partnership with Sysmex Corporation America to connect its HLC-723G8 automated glycohemoglobin analyzers with Sysmex's XN-9000 and XN-9100 hematology systems across the U.S., Latin America, and Canada. This collaboration aims to expand Tosoh's HbA1c testing capabilities for high-volume labs and enhance automation in HbA1c testing.

Key Players Landscape and Outlook

The HbA1c testing devices market is highly dynamic and driven by many key market players. Market activity reported in recent years includes business agreements and regulatory approvals of market players' products. The market has witnessed many business activities, such as strategic mergers, acquisitions, and collaborations.

For instance, in February 2024, Dexcom, Inc. launched Dexcom ONE+ in Spain, Belgium, and Poland-a customizable, real-time continuous glucose monitoring (CGM) system solution wearable in three body locations. The Dexcom ONE+ system includes a water-resistant sensor, a transmitter for real-time glucose data, and a smartphone-compatible app for convenient monitoring.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global HbA1c Testing Devices Market Outlook, 2017-2031F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Type of Devices
    • 4.2.1.1. Laboratory-based Testing Devices
    • 4.2.1.2. Point-of-Care Testing Devices
  • 4.2.2. By Technology
    • 4.2.2.1. Immunoassay
    • 4.2.2.2. Enzymatic Assays
    • 4.2.2.3. Chromatography
    • 4.2.2.4. High-performance Liquid Chromatography
    • 4.2.2.5. Boronate Affinity Chromatography
    • 4.2.2.6. Others
  • 4.2.3. By End-user
    • 4.2.3.1. Hospitals and Clinics
    • 4.2.3.2. Diagnostic Laboratories
    • 4.2.3.3. Homecare Settings
    • 4.2.3.4. Others
  • 4.2.4. By Region
    • 4.2.4.1. North America
    • 4.2.4.2. Europe
    • 4.2.4.3. Asia-Pacific
    • 4.2.4.4. South America
    • 4.2.4.5. Middle East and Africa
  • 4.2.5. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Type of Devices
  • 4.3.2. By Technology
  • 4.3.3. By End-user
  • 4.3.4. By Region

5. North HbA1c Testing Devices Market Outlook, 2017-2031F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Type of Devices
    • 5.2.1.1. Laboratory-based Testing Devices
    • 5.2.1.2. Point-of-Care Testing Devices
  • 5.2.2. By Technology
    • 5.2.2.1. Immunoassay
    • 5.2.2.2. Enzymatic Assays
    • 5.2.2.3. Chromatography
    • 5.2.2.4. High-performance Liquid Chromatography
    • 5.2.2.5. Boronate Affinity Chromatography
    • 5.2.2.6. Others
  • 5.2.3. By End-user
    • 5.2.3.1. Hospitals and Clinics
    • 5.2.3.2. Diagnostic Laboratories
    • 5.2.3.3. Homecare Settings
    • 5.2.3.4. Others
  • 5.2.4. By Country Share
    • 5.2.4.1. United States
    • 5.2.4.2. Canada
    • 5.2.4.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States HbA1c Testing Devices Market Outlook, 2017-2031F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Type of Devices
        • 5.3.1.2.1.1. Laboratory-based Testing Devices
        • 5.3.1.2.1.2. Point-of-Care Testing Devices
      • 5.3.1.2.2. By Technology
        • 5.3.1.2.2.1. Immunoassay
        • 5.3.1.2.2.2. Enzymatic Assays
        • 5.3.1.2.2.3. Chromatography
        • 5.3.1.2.2.4. High-performance Liquid Chromatography
        • 5.3.1.2.2.5. Boronate Affinity Chromatography
        • 5.3.1.2.2.6. Others
      • 5.3.1.2.3. By End-user
        • 5.3.1.2.3.1. Hospitals and Clinics
        • 5.3.1.2.3.2. Diagnostic Laboratories
        • 5.3.1.2.3.3. Homecare Settings
        • 5.3.1.2.3.4. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe HbA1c Testing Devices Market Outlook, 2017-2031F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific HbA1c Testing Devices Market Outlook, 2017-2031F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America HbA1c Testing Devices Market Outlook, 2017-2031F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa HbA1c Testing Devices Market Outlook, 2017-2031F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Market Dynamics

• 14.1. Market Drivers
• 14.2. Market Challenges

15. Market Trends and Developments

16. Regulatory Framework and Innovation

• 16.1. Regulatory Approvals
• 16.2. Innovations

17. Patent Landscape

18. Case Studies

19. Competitive Landscape

• 19.1. Competition Matrix of Top 5 Market Leaders
• 19.2. SWOT Analysis for Top 5 Players
• 19.3. Key Players Landscape for Top 10 Market Players
  • 19.3.1. Abbott.
    • 19.3.1.1. Company Details
    • 19.3.1.2. Key Management Personnel
    • 19.3.1.3. Products and Services
    • 19.3.1.4. Financials (As Reported)
    • 19.3.1.5. Key Market Focus and Geographical Presence
    • 19.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 19.3.2. Bio-Rad Laboratories, Inc.
  • 19.3.3. Trinity Biotech
  • 19.3.4. Siemens Healthineers AG
  • 19.3.5. F.Hoffmann-La Roche Ltd
  • 19.3.6. Danaher Corporation
  • 19.3.7. SAKAE CO, LTD.
  • 19.3.8. ARKRAY, Inc.
  • 19.3.9. HUMAN Gesellschaft fur Biochemica und Diagnostica
  • 19.3.10. Menarini Diagnostics s.r.l

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

20. Strategic Recommendations

21. About Us and Disclaimer