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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

Published: | Report ID: 6416 | Report Format : PDF

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.

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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.

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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?

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, 2018 (US$ Mn)
2.3. Global HbA1c Testing Devices Market, by Technology, 2018 (US$ Mn)
2.4. Global HbA1c Testing Devices Market, by End-user, 2018 (US$ Mn)
2.5. Global HbA1c Testing Devices Market, by Geography, 2018 (US$ Mn)

3. Market Dynamics
3.1. Introduction
3.1.1. Global HbA1c Testing Devices Market Value, 2017-2027, (US$ Mn)
3.2. Market Dynamics
3.2.1. Market Drivers
3.2.2. Market Restraints
3.3. Attractive Investment Proposition, by Geography, 2018
3.4. Market Positioning of Key Players, 2018
3.4.1. Major Strategies Adopted by Key Players

4. Global Hemoglobin A1c (HbA1c) Testing Devices Market, By Type , 2017-2027 (US$ Mn)
4.1. Overview
4.2. Bench Top Device
4.3. Handheld Device

5. Global Hemoglobin A1c (HbA1c) Testing Devices Market, by Technology, 2017-2027 (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, 2017-2027 (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, 2017-2027 (US$ Mn)
7.1. Overview
7.1.1. North America HbA1c Testing Devices Market Value and Growth, 2017-2027, (US$ Mn)
7.2. North America HbA1c Testing Devices Market Value, By Type, 2017-2027 (US$ Mn)
7.2.1. Market Analysis
7.3. North America HbA1c Testing Devices Market Value, By Technology, 2017-2027 (US$ Mn)
7.3.1. Market Analysis
7.4. North America HbA1c Testing Devices Market Value, By End-user, 2017-2027 (US$ Mn)
7.4.1. Market Analysis
7.5. North America HbA1c Testing Devices Market Value, By Region/Country, 2017-2027 (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, 2017-2027 (US$ Mn)
8.1. Overview
8.1.1. Europe HbA1c Testing Devices Market Value and Growth, 2017-2027, (US$ Mn)
8.2. Europe HbA1c Testing Devices Market Value, By Type, 2017-2027 (US$ Mn)
8.2.1. Market Analysis
8.3. Europe HbA1c Testing Devices Market Value, By Technology, 2017-2027 (US$ Mn)
8.3.1. Market Analysis
8.4. Europe HbA1c Testing Devices Market Value, By End-user, 2017-2027 (US$ Mn)
8.4.1. Market Analysis
8.5. Europe HbA1c Testing Devices Market Value, By Region/Country, 2017-2027 (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, 2017-2027 (US$ Mn)
9.1. Overview
9.1.1. Asia Pacific HbA1c Testing Devices Market Value and Growth, 2017-2027, (US$ Mn)
9.2. Asia Pacific HbA1c Testing Devices Market Value, By Type, 2017-2027 (US$ Mn)
9.2.1. Market Analysis
9.3. Asia Pacific HbA1c Testing Devices Market Value, By Technology, 2017-2027 (US$ Mn)
9.3.1. Market Analysis
9.4. Asia Pacific HbA1c Testing Devices Market Value, By End-user, 2017-2027 (US$ Mn)
9.4.1. Market Analysis
9.5. Asia Pacific HbA1c Testing Devices Market Value, By Region/Country, 2017-2027 (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, 2017-2027 (US$ Mn)
10.1. Overview
10.1.1. Rest of the World HbA1c Testing Devices Market Value and Growth, 2017-2027, (US$ Mn)
10.2. Rest of the World HbA1c Testing Devices Market Value, By Type, 2017-2027 (US$ Mn)
10.2.1. Market Analysis
10.3. Rest of the World HbA1c Testing Devices Market Value, By Technology, 2017-2027 (US$ Mn)
10.3.1. Market Analysis
10.4. Rest of the World HbA1c Testing Devices Market Value, By End-user, 2017-2027 (US$ Mn)
10.4.1. Market Analysis
10.5. Rest of the World HbA1c Testing Devices Market Value, By Region, 2017-2027 (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

List of Figures

FIG. 1 Global Hemoglobin A1c (HbA1c) Testing Devices Market: Research Methodology
FIG. 2 Market Size Estimation – Top Down & Bottom up Approach
FIG. 3 Global HbA1c Testing Devices Market Segmentation
FIG. 4 Global HbA1c Testing Devices Market, by Type, 2018 (US$ Mn)
FIG. 5 Global HbA1c Testing Devices Market, by Technology, 2018 (US$ Mn)
FIG. 6 Global HbA1c Testing Devices Market, by End User, 2018 (US$ Mn)
FIG. 7 Global HbA1c Testing Devices Market, by Geography, 2018 (US$ Mn)
FIG. 8 Attractive Investment Proposition, by Geography, 2087
FIG. 9 Global Market Positioning of Key HbA1c Testing Devices Market Manufacturers, 2018
FIG. 10 Global HbA1c Testing Devices Market Value Share, by Type, 2018 & 2027 (Value %)
FIG. 11 Global Bench Top Device Market, 2017–2027 (US$ Mn)
FIG. 12 Global Handheld Device Market, 2017–2027 (US$ Mn)
FIG. 13 Global HbA1c Testing Devices Market Value Share, by Technology, 2018 & 2027 (Value %)
FIG. 14 Global Ion-exchange High-performance Liquid Chromatography (HPLC) Market, by Technology, 2017–2027 (US$ Mn)
FIG. 15 Global Immunoassay Market, by Technology, 2017–2027 (US$ Mn)
FIG. 16 Global Boronate Affinity Chromatography Market, by Technology, 2018 & 2027 (Value %)
FIG. 17 Global Direct Enzymatic Assay Market, by Technology, 2017–2027 (US$ Mn)
FIG. 18 Global Others Market, by Technology, 2017–2027 (US$ Mn)
FIG. 19 Global HbA1c Testing Devices Market Value Share, by End User, 2018 & 2027 (Value %)
FIG. 20 Global Hospitals and Clinics Market, 2017–2027 (US$ Mn)
FIG. 21 Global Diagnostic Laboratories Market, 2017–2027 (US$ Mn)
FIG. 22 Global Home Care Settings Market, 2017–2027 (US$ Mn)
FIG. 23 Global Research Institutes Market, 2017–2027 (US$ Mn)
FIG. 24 North America HbA1c Testing Devices Market, 2017–2027 (US$ Mn)
FIG. 25 Europe HbA1c Testing Devices Market, 2017–2027 (US$ Mn)
FIG. 26 Asia Pacific HbA1c Testing Devices Market, 2017–2027 (US$ Mn)
FIG. 27 RoW HbA1c Testing Devices Market, 2017–2027 (US$ Mn)

List of Tables

TABLE 1 Market Snapshot: Global Hemoglobin A1c (HbA1c) Testing Devices Market
TABLE 2 Impact Indicators
TABLE 3 Impact Analysis of Drivers and Restraints
TABLE 4 Global HbA1c Testing Devices Market, by Type, 2017–2027 (US$ Mn)
TABLE 5 Global HbA1c Testing Devices Market, by Technology, 2017–2027 (US$ Mn)
TABLE 6 Global HbA1c Testing Devices Market, by End User, 2017–2027 (US$ Mn)
TABLE 7 Global HbA1c Testing Devices Market, by Geography, 2017–2027 (US$ Mn)
TABLE 8 North America HbA1c Testing Devices Market, by Type, 2017–2027 (US$ Mn)
TABLE 9 North America HbA1c Testing Devices Market, by Technology, 2017–2027 (US$ Mn)
TABLE 10 North America HbA1c Testing Devices Market, by End User, 2017–2027 (US$ Mn)
TABLE 11 North America HbA1c Testing Devices Market, by Country, 2017–2027 (US$ Mn)
TABLE 12 Europe HbA1c Testing Devices Market, by Type, 2017–2027 (US$ Mn)
TABLE 13 Europe HbA1c Testing Devices Market, by Technology, 2017–2027 (US$ Mn)
TABLE 14 Europe HbA1c Testing Devices Market, by End User, 2017–2027 (US$ Mn)
TABLE 15 Europe HbA1c Testing Devices Market, by Country/Region, 2017–2027 (US$ Mn)
TABLE 16 Asia Pacific HbA1c Testing Devices Market, by Type, 2017–2027 (US$ Mn)
TABLE 17 Asia Pacific HbA1c Testing Devices Market, by Technology, 2017–2027 (US$ Mn)
TABLE 18 Asia Pacific HbA1c Testing Devices Market, by End User, 2017–2027 (US$ Mn)
TABLE 19 Asia Pacific HbA1c Testing Devices Market, by Country/Region, 2017–2027 (US$ Mn)
TABLE 20 Rest of the World HbA1c Testing Devices Market, by Type, 2017–2027 (US$ Mn)
TABLE 21 Rest of the World HbA1c Testing Devices Market, by Technology, 2017–2027 (US$ Mn)
TABLE 22 Rest of the World HbA1c Testing Devices Market, by End User, 2017–2027 (US$ Mn)
TABLE 23 Rest of the World HbA1c Testing Devices Market, by Region, 2017–2027 (US$ Mn)
FIG. 28 Abbott Laboratories: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 29 Siemens Healthcare: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 30 Arkray, Inc.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 31 Bio-Rad Laboratories, Inc.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 32 Danaher Corporation: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 33 Trinity Biotech plc: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 34 Alere, Inc.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 35 F. Hoffmann-La Roche Ltd.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 36 Transasia Biomedicals Ltd.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 37 Tosoh Corporation: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 38 Polymer Technology Systems, Inc.: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)
FIG. 39 Menarini Group: Company Snapshot (Company Overview; Product Portfolio; Financial Information; Key Developments)

Frequently Asked Questions

What is the size of Hemoglobin A1c (HbA1c) Testing Devices Market?

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

What is the Hemoglobin A1c (HbA1c) Testing Devices Market CAGR?

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

What is the Forecast period considered for Hemoglobin A1c (HbA1c) Testing Devices Market?

The report is forecasted from 2019-2027.

What is the base year considered for Hemoglobin A1c (HbA1c) Testing Devices Market?

The base year of this report is 2018.

Who are the major players in this market?

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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