Hemoglobin A1c Testing Devices: Comprehensive Study Explores Huge Growth in Future

Transparency Market Research (TMR) has published a new report titled, ‘Hemoglobin A1c Testing Devices Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019–2027’. According to the report, the global Hemoglobin A1c Testing Devices market was valued at US$ 1,676.3 Mn in 2018 and is projected to expand at a CAGR of 10.7% from 2019 to 2027.


  • Hemoglobin A1c testing devices are used to determine and monitor hemoglobin A1c levels in diabetic patients. For more than 500 million people affected with diabetes across the world, blood testing has become a routine part of managing the disease. A1C tests measure average blood glucose over the past two to three months. It is also known as glycosylated hemoglobin test, glycohemoglobin test, glycated hemoglobin test, or A1C.
  • In terms of technology, ion-exchange HPLC segment dominated the market owing to the establishment of this technology as gold standard method of determination of HbA1c due to its excellent specificity and reproducibility. A clinical study by the company indicated that 205 patients with SC and diabetes were analyzed using immunoassay and HPLC instrument. The immunoassay study produced lower HBA1c compared to HPLC method.
  • In terms of end-user, hemoglobin A1c testing devices are mostly used in laboratories and point-of-care units such as hospitals, clinics, home care, and others.
  • North America dominated the global Hemoglobin A1c Testing Devices market in 2018 and the trend is anticipated to continue during the forecast period. High prevalence of different types of diabetes and rise in the geriatric population in the region are some of the factors augmenting the market in North America are expected to drive the market in North America.
  • Asia Pacific is likely to be a highly lucrative market for retinal disorders and it is expected to expand at a high CAGR during the forecast period

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Recent approval of HBA1C tests in year 2018 to Drive Market

  • A1CNow systems developed by PTS Diagnostics got approved in year 2018 which provides accurate A1C results in the office or home comes in a convenient 2-test pack or 4-test pack.
  • Abbott laboratories got its Afinion assay product approved which is the first-ever rapid point-of-care test approved to help diagnose diabetes and assess patients’ risk of developing the disease
  • Bio-Rad Laboratories, Inc product VARIANT II System got its approval which offers fully automated high-volume hemoglobin A1c and β-thalassemia testing, with Clinical Data Management Software and a LIS interface.

Faster adoption and Increase in point-of-care testing to Drive Market

  • Point-of-care testing provides results within time limit, offers consumer convenience, reduces needle stick injuries, and minimizes contamination
  • It has also led to development of the smaller devices, portable, and minimally invasive product. Hence, several laboratories are being converted into POC testing laboratories, as these can be operated by person not necessarily biologist. POC laboratories are also considered an easy way of providing clinical microbiology testing for people far away from core laboratories in developed and developing countries

Ion-exchange HPLC Segment to Dominate Market

  • Based on technology, the global Hemoglobin A1c Testing Devices market has been divided into Ion-exchange HPLC, Immunoassay, Boronate Affinity Chromatography, Direct Enzymatic Assay, and others. The Ion-exchange HPLC, dominates the market in year 2018, owing to the excellent specificity and reproducibility, and ability to detect the most common Hb variants through HPLC. According to Bio-Rad Laboratories, Inc., the American Diabetes Association (ADA) recommends HbA1c equal to or more than 6.5% to diagnose diabetes using HPLC. ADA considers HPLC as the gold standard method for the determination of HbA1c.
  • However, cost of HbA1c treatment using HPLC method compared to other techniques is high, which is likely to induce patients to adopt other techniques.

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  • Point-of-care settings to be Highly Lucrative Segment
  • In terms of end-user, the global Hemoglobin A1c Testing Devices market has been classified into laboratories, and point-of-care settings.
  • The laboratories segment dominated the Hemoglobin A1c Testing Devices market owing to rise in the number of cases of diabetes type II disorders, enhanced diagnostic care services, and availability of a wide range of services at a single site in commercial laboratories. However, rise in diagnostic costs and changes in reimbursement models are estimated to hamper the segment during the forecast period.
  • The point-of-care settings segment expected to expand at faster pace during forecast period. According to the American Diabetes Association, point-of-care (POC) testing for HbA1c to offers the opportunity for more timely treatment changes. The International Diabetes Federation (IDF) recommends determination of HbA1c either at the POC or in the laboratory should be done before clinical consultation.

North America to Dominate Global Market

  • In terms of region, the global Hemoglobin A1c Testing Devices market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global Hemoglobin A1c Testing Devices market in 2018, followed by Europe.
  • North America accounted for major share of the global Hemoglobin A1c Testing Devices market in 2018, owing to increase in demand for direct enzyme assay techniques; technological advancements in HPLC technology; and rise in the adoption of various chromatographic devices by hospitals, diagnostic labs, and clinics are likely to propel the market in the region during the forecast period
  • The Hemoglobin A1c Testing Devices market in Asia Pacific is anticipated to expand at a high CAGR from 2019 to 2027. This can be attributed to increasing population in the region, unmet medical needs, rise in prevalence and incidence of diabetes diseases are some of the factors expected to drive the hemoglobin A1c testing devices market in Asia Pacific during the forecast period. Moreover, development in the field of science, high disposable income, and rise in per capita health care expenditure propel the market in the region.

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Competitive Landscape

  • The global Hemoglobin A1c Testing Devices market is fragmented in terms of number of players. Key players in the global market include Abbott Laboratories, ARKRAY, Inc., Bio-Rad Laboratories, Inc., Polymer Technology Systems, Inc., Danaher Corporation (Beckman Coulter), EKF Diagnostics Holdings plc, F. Hoffmann-La Roche Ltd., Menarini Group, Sebia, Tosoh Corporation, Trinity Biotech plc. and other prominent players.

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