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Hemoglobin A1c (HbA1c) Testing Devices Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2021 To 2029

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    Report

  • 90 Pages
  • October 2021
  • Region: Global
  • Acute Market Reports
  • ID: 5614669

Hemoglobin A1c Testing Devices market to exhibit dynamic growth during the forecast period


The global HbA1c testing devices market is growing at a significant rate, expected to grow at a CAGR of 10.1%. Worldwide, the increasing incidences of diabetes and other lifestyle diseases will drive the market growth globally. As per the data by International Diabetes Federation, in 2021, more than 430 Mn 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.

Increasing penetration of bench top and handheld devices with HPLC and immunoassay tests in the developing nations will drive the market growth globally. Increasing geriatric population worldwide with type I and II diabetes, and U.S. FDA clearance for top end devices and increased healthcare concern along with improved awareness will enhance the market growth in the emerging nations.

Handheld devices expected to register higher growth by the end of 2029


Advancement in benchtop and handheld devices with the development in the field of point of care testing will drive the market growth. For e.g. Afinion™ HbA1c Dx assay, by Abbott Laboratories. Increasing incidence of diabetes is a key factor for the overall HbA1c testing market globally. Major growth is observed for self-testing. Professional HbA1c testing also contribute a significant share on a global scale. Benchtop and compact devices hold more than 55% market share in the global market. Rapid diagnostic testing at point of care along with accurate results with no time will boost market growth. Manufacturing of advanced workstations in clinical laboratories, analyzers, kits & reagents, and point of care devices will support the global HbA1c devices market. Advancement in digital transformation along with miniaturizing tests (mobile pathology lab) for enhanced patient outcomes will drive the market growth in the near future. For e.g. dianax diagnostic technology, include main connector and disposable test cartridge.

HPLC to witness a significant CAGR


In 2020, the ion-exchange HPLC segment generated maximum revenue share in the HbA1c Testing Devices market globally and expected to contribute maximum revenue share in the coming years. High Performance Liquid Chromatography is used widely on a global scale, provide accurate results with higher accuracy as compared to other tests. New launch of analyzers along with improved test kits for home use, point of care settings and clinical laboratories will drive the market growth globally. As it has the capability to show results in real time of analyze variants along with increased ionic strength. For e.g. ADAMS A1c HA-8182, Glucose GA-1172. Launch of fully automated analyzers with advanced features will drive the market growth on a global scale. For e.g. HbA1c & HbA2/F-fully automated analyzer with unique CLE technology by Transasia Bio-Medicals, G8 HPLC Analyzer, i-Series Plus Integrated HPLC System and others.

Increased research and development with increased prevalence for diabetes in the developed regions


New device launch with automated features along with enhanced precision, FDA clearance for new analyzers and assay tests, technology expansion and partnerships in the developing and developed nations for HbA1c Testing Devices will drive the overall growth of the market during the forecast period. The North America region accounted for major revenue share globally. Presence of top manufacturers and suppliers along with top research centers with advanced diagnostic testing and approaches will hold the U.S market in dominant position. As per Centers for Disease Control and Prevention (CDC) report, in 2016, the prevalence of type 2 diabetes was around 21 Mn, and type 1 was 1.3 Mn adults. Increasing incidences in the U.S. will upsurge the demand for HbA1c devices across the region. Additionally, as per American Diabetes Association, in 2020, 34.2 Mn individuals were had diabetes, and every year more than 1.5 Mn US citizens are diagnosed with diabetes.

Key Developments:

  • In June 2021, the U.S. Food and Drug Administration (FDA) cleared the Afinion HbA1c Dx assay for rapid point-of-care test. Abbott laboratories declared that the Afinion HbA1c Dx assay is now accessible for AS100 analyzer and Afinion 2 analyzer.
  • In March 2021, 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 deliver physicians with enhanced precision and accurateness for detecting diabetes mellitus, and identifying individuals who may be at high risk of developing diabetes mellitus.
  • In Sep 2021, Abbott Laboratories and Sanofi are in 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

Historical & Forecast Period


This study report represents analysis for each segment from 2019 to 2029 considering 2020 to be the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period from 2021 to 2029.

The current report also comprehends qualitative and qualitative market valuation factors such as key market drivers, market trends, restraints and opportunities that gives a better market understanding of the overall HbA1c Testing Devices market. Additionally, the global report also comprises graphical representation of competitive landscape based on their market initiatives and strategies, product portfolio and business strengths.

Key questions answered in this report

  • What are the current market trends and dynamics in the HbA1c Testing Devices market and 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?
  • Regional trend for new 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 economies investing in the HbA1c Testing Devices market?
  • What is the market trend and dynamics in emerging markets such as Asia Pacific, Latin America and Middle East & Africa?


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Table of Contents

1. Preface
1.1. Report Description
1.1.1. Purpose of the Report
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology
1.3.1. Phase I - Secondary Research
1.3.2. Phase II - Primary Research
1.3.3. Phase III - Expert Panel Review
1.3.4. Approach Adopted
1.3.4.1. Top-Down Approach
1.3.4.2. Bottom-Up Approach
1.3.5. Assumptions
1.4. Market Segmentation
2. Executive Summary
2.1. Market Snapshot: Global HbA1c Testing Devices Market
2.2. Global HbA1c Testing Devices Market, by Type, 2020 (US$ Mn)
2.3. Global HbA1c Testing Devices Market, by Technology, 2020 (US$ Mn)
2.4. Global HbA1c Testing Devices Market, by End-user, 2020 (US$ Mn)
2.5. Global HbA1c Testing Devices Market, by Geography, 2020 (US$ Mn)
3. Market Dynamics
3.1. Introduction
3.1.1. Global HbA1c Testing Devices Market Value, 2019-2029, (US$ Mn)
3.2. Market Dynamics
3.2.1. Market Drivers
3.2.2. Market Restraints
3.3. Attractive Investment Proposition, by Geography, 2020
3.4. Market Positioning of Key Players, 2020
3.4.1. Major Strategies Adopted by Key Players
4. Global Hemoglobin A1c (HbA1c) Testing Devices Market, By Type , 2019-2029 (US$ Mn)
4.1. Overview
4.2. Bench Top Device
4.3. Handheld Device
5. Global Hemoglobin A1c (HbA1c) Testing Devices Market, by Technology, 2019-2029 (US$ Mn)
5.1. Overview
5.2. Ion-exchange High-performance Liquid Chromatography (HPLC)
5.3. Immunoassay
5.4. Boronate Affinity Chromatography
5.5. Direct Enzymatic Assay
5.6. Others
6. Global Hemoglobin A1c (HbA1c) Testing Devices Market, by End-user, 2019-2029 (US$ Mn)
6.1. Hospitals & Clinics
6.2. Diagnostic Laboratories
6.3. Home Care Settings
6.4. Research Institutes
6.5. Others
7. North America Hemoglobin A1c (HbA1c) Testing Devices Market Analysis, 2019-2029 (US$ Mn)
7.1. Overview
7.1.1. North America HbA1c Testing Devices Market Value and Growth, 2019-2029, (US$ Mn)
7.2. North America HbA1c Testing Devices Market Value, By Type, 2019-2029 (US$ Mn)
7.2.1. Market Analysis
7.3. North America HbA1c Testing Devices Market Value, By Technology, 2019-2029 (US$ Mn)
7.3.1. Market Analysis
7.4. North America HbA1c Testing Devices Market Value, By End-user, 2019-2029 (US$ Mn)
7.4.1. Market Analysis
7.5. North America HbA1c Testing Devices Market Value, By Region/Country, 2019-2029 (US$ Mn)
7.5.1. Market Analysis
7.5.2. U.S.
7.5.3. Rest of North America
8. Europe Hemoglobin A1c (HbA1c) Testing Devices Market Analysis, 2019-2029 (US$ Mn)
8.1. Overview
8.1.1. Europe HbA1c Testing Devices Market Value and Growth, 2019-2029, (US$ Mn)
8.2. Europe HbA1c Testing Devices Market Value, By Type, 2019-2029 (US$ Mn)
8.2.1. Market Analysis
8.3. Europe HbA1c Testing Devices Market Value, By Technology, 2019-2029 (US$ Mn)
8.3.1. Market Analysis
8.4. Europe HbA1c Testing Devices Market Value, By End-user, 2019-2029 (US$ Mn)
8.4.1. Market Analysis
8.5. Europe HbA1c Testing Devices Market Value, By Region/Country, 2019-2029 (US$ Mn)
8.5.1. Market Analysis
8.5.2. U.K.
8.5.3. Germany
8.5.4. France
8.5.5. Rest of Europe
9. Asia Pacific Hemoglobin A1c (HbA1c) Testing Devices Market Analysis, 2019-2029 (US$ Mn)
9.1. Overview
9.1.1. Asia Pacific HbA1c Testing Devices Market Value and Growth, 2019-2029, (US$ Mn)
9.2. Asia Pacific HbA1c Testing Devices Market Value, By Type, 2019-2029 (US$ Mn)
9.2.1. Market Analysis
9.3. Asia Pacific HbA1c Testing Devices Market Value, By Technology, 2019-2029 (US$ Mn)
9.3.1. Market Analysis
9.4. Asia Pacific HbA1c Testing Devices Market Value, By End-user, 2019-2029 (US$ Mn)
9.4.1. Market Analysis
9.5. Asia Pacific HbA1c Testing Devices Market Value, By Region/Country, 2019-2029 (US$ Mn)
9.5.1. Market Analysis
9.5.2. Japan
9.5.3. China
9.5.4. India
9.5.5. Rest of Asia Pacific
10. Rest of the World Hemoglobin A1c (HbA1c) Testing Devices Market Analysis, 2019-2029 (US$ Mn)
10.1. Overview
10.1.1. Rest of the World HbA1c Testing Devices Market Value and Growth, 2019-2029, (US$ Mn)
10.2. Rest of the World HbA1c Testing Devices Market Value, By Type, 2019-2029 (US$ Mn)
10.2.1. Market Analysis
10.3. Rest of the World HbA1c Testing Devices Market Value, By Technology, 2019-2029 (US$ Mn)
10.3.1. Market Analysis
10.4. Rest of the World HbA1c Testing Devices Market Value, By End-user, 2019-2029 (US$ Mn)
10.4.1. Market Analysis
10.5. Rest of the World HbA1c Testing Devices Market Value, By Region, 2019-2029 (US$ Mn)
10.5.1. Market Analysis
10.5.2. Middle East & Africa
10.5.3. Latin America
11. Company Profiles
11.1. Abbott Laboratories
11.2. Siemens Healthcare
11.3. Arkray, Inc.
11.4. Bio-Rad Laboratories, Inc.
11.5. Danaher Corporation
11.6. Trinity Biotech plc
11.7. Alere, Inc.
11.8. F. Hoffmann-La Roche Ltd.
11.9. Transasia Biomedicals Ltd
11.10. Tosoh Corporation
11.11. Polymer Technology Systems, Inc.
11.12. Menarini Group

Companies Mentioned

  • 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