Hemoglobin A1c (HbA1c) Testing Devices Market By Type (Bench Top Device, Handheld Device), By Technology (Ion-exchange High-performance Liquid Chromatography (HPLC), Immunoassay, Boronate Affinity Chromatography, Direct Enzymatic Assay, Others), By End-user (Hospitals & Clinics, Diagnostic Laboratories, Home Care Settings, Research Institutes, Others) - Growth, Share, Opportunities & Competitive Analysis, 2019 -2027

The hemoglobin A1c testing devices market is expected to exhibit dynamic growth during the forecast period.

The global HbA1c testing devices market is growing at a significant rate and is expected to grow at a CAGR of 10.1%. Worldwide, the increasing incidences of diabetes and other lifestyle diseases will drive the market's growth. As per the data from the International Diabetes Federation, in 2019, more than 430 million people were reported to have diabetes, i.e., 9.3% of the world's population. The rate is going to increase by 10.3% by 2030 and 10.9% by 2045, i.e., around 700 Mn.

Increased penetration of benchtop and handheld devices with HPLC and immunoassay tests in developing countries will drive global market growth. An aging global geriatric population with type I and II diabetes, FDA clearance for high-end devices, increased healthcare concern, and improved awareness will boost the market growth in emerging markets.

Market Synopsis

Handheld devices are expected to register higher growth by the end of 2027.

Advancements in benchtop and handheld devices, along with developments in the field of point-of-care testing, will drive market growth. For example, the AfinionTM HbA1c Dx assay by Abbott Laboratories. The increasing incidence of diabetes is a key factor in the overall HbA1c testing market globally. Major growth is observed in self-testing. Professional HbA1c testing also contributes a significant share on a global scale. Benchtop and compact devices hold more than 55% of the global market share. Rapid diagnostic testing at the point of care, along with accurate results in no time, will boost market growth. The global HbA1c devices market will be supported by the production of advanced workstations in clinical laboratories, analyzers, kits and reagents, and point-of-care devices. Advancements in digital transformation, along with miniaturizing tests (mobile pathology lab) for enhanced patient outcomes, will drive market growth in the near future. Diana's diagnostic technology, for example, includes the main connector and a disposable test cartridge.

HPLC will experience a significant CAGR.

In 2018, the ion-exchange HPLC segment generated the largest revenue share in the HbA1c Testing Devices market globally and is expected to contribute the largest revenue share in the coming years. High-performance liquid chromatography is used widely on a global scale and provides accurate results with higher accuracy as compared to other tests. New launches of analyzers, along with improved test kits for home use, point-of-care settings, and clinical laboratories, will drive the market growth globally because it can display results of analyzing variants in real-time, as well as increased ionic strength, for example, ADAMS A1C HA-8182 and glucose GA-1172. The launch of fully automated analyzers with advanced features will drive market growth on a global scale, for e.g., HbA1c and HbA2/F-fully automated analyzers with unique CLE technology by Transasia Bio-Medicals, the G8 HPLC Analyzer, the i-Series Plus Integrated HPLC System, and others.

Diabetes prevalence has increased in developed regions, resulting in increased research and development.

During the forecast period, the market will be driven by new device launches with automated features and enhanced precision, FDA clearance for new analyzers and assay tests, technology expansion, and partnerships in developing and developed nations for HbA1c Testing Devices. The North American region accounted for a major revenue share globally. The presence of top manufacturers and suppliers, along with top research centers with advanced diagnostic testing and approaches, will hold the U.S. market in a dominant position. According to the Centers for Disease Control and Prevention (CDC), the prevalence of type 2 diabetes was around 21 million people in 2016, with type 1 diabetes accounting for 1.3 million people. Increasing incidences in the U.S. will increase the demand for HbA1c devices across the region. Additionally, as per the American Diabetes Association, in 2018, 34.2 million individuals had diabetes, and every year more than 1.5 million US citizens are diagnosed with the disease.

Key Developments:

  • In June 2019, the U.S. Food and Drug Administration (FDA) cleared the Afinion HbA1c Dx assay for rapid point-of-care testing. Abbott Laboratories declared that the Afinion HbA1c Dx assay is now accessible for the AS100 analyzer and the Afinion 2 analyzer.
  • In March 2019, the fully automated hemoglobin A1c (HbA1c) Advanced assay received CE mark certification and U.S. FDA 501(k) clearance. It is now available on the DxC 700 AU analyzers. It enables high-volume clinical laboratories to provide physicians with enhanced precision and accuracy for detecting diabetes mellitus and identifying individuals who may be at high risk of developing diabetes mellitus.
  • In September 2019, Abbott Laboratories and Sanofi announced a partnership to develop diabetes management technology for its future smart pens, cloud software, and insulin titration apps.

Top Companies:

  • Abbott Laboratories
  • Siemens Healthcare
  • Arkray, Inc.
  • Bio-Rad Laboratories, Inc.
  • Danaher Corporation
  • Trinity Biotech plc
  • Alere, Inc.
  • F. Hoffmann-La Roche Ltd.
  • Transasia Biomedicals Ltd.
  • Tosoh Corporation
  • Polymer Technology Systems, Inc.
  • Menarini Group
  • Others

Periods of History and Forecast

This study report includes an analysis of each segment from 2017 to 2027, with 2018 as the base year. The compound annual growth rate (CAGR) for each of the respective segments is estimated for the forecast period from 2019 to 2027.

Market Segmentation

The current report also includes qualitative and quantitative market valuation factors such as key market drivers, market trends, restraints, and opportunities, which provide a more comprehensive understanding of the overall HbA1c Testing Devices market. Additionally, the global report also comprises a graphical representation of the competitive landscape based on their market initiatives and strategies, product portfolios, and business strengths.

Key questions are answered in this report.

  • What are the current market trends and dynamics in the HbA1c Testing Devices market, and what are the valuable opportunities for emerging players?
  • Which segment accounts for the fastest CAGR during the forecast period and why?
  • What is the global trend for handheld devices?
  • The regional trend for newly launched products, along with consumer preference for clinical testing methods?
  • Which technology segment holds a larger market share and why?
  • Are low- and middle-income countries investing in the market for HbA1c Testing Devices?
  • What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and the Middle East and Africa?

Frequently Asked Questions:

The market for Hemoglobin A1c (HbA1c) Testing Devices Market is expected to reach US$ XX Mn by 2027.

The Hemoglobin A1c (HbA1c) Testing Devices Market is expected to see significant CAGR growth over the coming years, at 10.1%.

The report is forecasted from 2019-2027.

The base year of this report is 2018.

Abbott Laboratories, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., Transasia Biomedicals Ltd., Polymer Technology Systems, Inc. are some of the major players in the global market.

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Published Date:  Feb 2020
Category:  Medical Devices
Report ID:   59381
Report Format:   PDF
Pages:   120
Rating:    4.1 (69)
Delivery Time: 24 Hours to 48 Hours   
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