Global Hemoglobin A1C Testing Devices Market $3.7 Billion by 2029

The global market for hemoglobin A1C testing devices estimated to reach $3.7 billion by 2029, expanding at a CAGR of 8.2% over the forecast period, driven by rising diabetic patient population, rapid adoption of new products, and growing elderly population worldwide. 

The A1C test is the primary test used for diabetes management, used to diagnose type 2 diabetes and prediabetes. The A1C test is also called the hemoglobin A1C, HbA1c, glycated hemoglobin, or glycohemoglobin test.

• Hemoglobin A1C testing is used to measure average blood glucose level over an extended period of time, along with other blood glucose measurements, including random blood sugar testing, fasting blood sugar testing, and oral glucose tolerance testing.
  • Advantages of A1C testing over glucose testing in diabetes include, no need for fasting, cost-effective and standardized test, shows blood glucose levels over time, indicator of future complications, and it reflects the course of diabetes and need for different levels of treatment.
    • Glycated hemoglobin (A1C) is a marker in the blood used to monitor glycemic, or blood sugar, control in people with diabetes.
      • Hemoglobin A1c is an indicator of mean blood glucose concentrations and plays an important role in the assessment of glucose control and cardiovascular risk.

The global hemoglobin A1C testing devices market report provides market size ($million 2019 to 2029), market share, growth trends and forecast (CAGR%, 2023 to 2029). 

The global market for hemoglobin A1c diabetes testing devices segmented by technology (boronate affinity chromatography, direct enzymatic assay, immunoassay, ion-exchange HPLC, micro-optical detection method, capillary electrophoresis, others), end user (laboratory testing devices, point-of-care testing devices), and geography.

• Based on technologies, the ion-exchange HPLC segment accounted for the largest share of the total market, while the boronate affinity chromatography segment predicted to grow at the fastest rate during the forecast period.
  • Ion-exchange HPLC technique has been the most preferred standard method used for HbA1c testing, due to its consistency and quick response time. Most laboratory HbA1c testing instruments are based on ion-exchange HPLC technology.
  • On the other hand, the boronate affinity chromatography offers resistive technology against hemoglobin variants such as HbAS, HbAC, HbAD, and HbAE, and offers faster and more reliable results.
    • The boronate affinity chromatography is widely used, and the method has lately been improved and designed for HbA1c measurements.
• By end users, the laboratory testing devices segment dominated the total market, while the point-of-care testing (POCT) devices expected to witness double-digit growth rate over the next few years.
  • The laboratory testing devices are available in a large number of healthcare settings providing reliable and accurate results.
    • However, there has been a surge in demand for point-of-care testing devices from hospitals and physician laboratories located at remote places that offers accurate results with reduced turnaround time.
    • POC A1C testing is common in clinical settings, where POC results correlate highly with laboratory measurements.
      • The POC hemoglobin A1c testing provides clinicians and diabetic patients real-time information on glycemic control. The community POC testing programs are feasible and relatively accurate, where the POC testing may expand its reach to remote patients.

The global HbA1c testing (diabetes) devices market research report is further divided by geography into North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), Latin America (Brazil, Mexico, Rest of LA), and Rest of the World.

• In terms of geography, the North America region led market for hemoglobin A1c testing devices, due to high prevalence of diabetes, availability of modern healthcare facilities, and high awareness among patients and physicians.
  • Many point-of-care A1C testing devices have US regulatory approval for use in monitoring glycemic control in people with diabetes, but, as yet, none have been cleared by the FDA for the diagnosis of type 2 diabetes.
    • The American Diabetes Association (ADA) recommends routine A1C testing for all patients with diabetes.
      • For example, in the US, Abbott Laboratories is seeking FDA clearance for its Afinion HbA1c Dx system for the point-of-care diagnosis of type 2 diabetes and as a test to identify people at risk for developing diabetes.
• However, the Asia Pacific market expected to register the fastest growth rate, owing to increasing prevalence of diabetes, rising awareness and unmet needs. The prevalence of diabetes is increasing markedly worldwide, especially in China.

The global testing devices for glycated hemoglobin A1C market report also provides the detailed market landscape (market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments.

Major competitors operating in the global HbA1c testing devices for diabetes market and included in this report are Abbott Laboratories, Inc., Arkray, Inc., Danaher Corporation, Bio-Rad Laboratories, Inc., Chek Diagnostics (Polymer Technology Systems, Inc.), Menarini Group, Roche Holding AG (F. Hoffmann-La Roche AG), Sebia, Siemens Healthineers AG, Tosoh Corporation, and Trinity Biotech plc.

• Technology
  • Boronate Affinity Chromatography
  • Direct Enzymatic Assay
  • Immunoassay
  • Ion-Exchange HPLC
  • Micro-Optical Detection Method, Capillary Electrophoresis, others
• End User
  • Laboratory Testing Devices
  • Point-of-Care (POC) Testing Devices
• Geography
  • North America (U.S., Canada)
  • Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
  • Asia Pacific (Japan, China, India, Rest of APAC)
  • Latin America (Brazil, Mexico, Rest of LA)
  • Rest of the World
• Company Profiles
  • Abbott Laboratories, Inc.
  • Arkray, Inc.
  • Bio-Rad Laboratories, Inc.
  • Chek Diagnostics (Polymer Technology Systems, Inc.)
  • Danaher Corporation (Beckman Coulter)
  • EKF Diagnostics Holdings plc
  • Menarini Group
  • Roche Holding AG (F. Hoffmann-La Roche AG)
  • Sebia
  • Siemens Healthineers AG
  • Tosoh Corporation
  • Trinity Biotech plc

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