Hemoglobin A1c Testing Markets

  • ID: 2497047
  • September 2015
  • Region: Global
  • 138 Pages
  • TriMark Publications
1 of 4


  • A. Menarini Diagnostics
  • Alere, Inc.
  • Axis-Shield Plc
  • EKF Diagnostics
  • Quotient Diagnostics
  • Roche Diagnostics
  • MORE

Hemoglobin A1c (HbA1c) testing is the most recent major technology to have entered the diabetes testing market. As the global prevalence of diabetes mellitus continues to increase rapidly, with more than 366 million diabetics worldwide, hemoglobin A1c testing is now an essential assay in the diabetes testing repertoire. Its clinical utility and improvements in its accuracy and implementation of standardized protocols have translated into continued market growth. This report describes the specific market segment that encompasses hemoglobin A1c testing for diagnosing and monitoring diabetes.

The study reviews all of the generally accepted clinical analytical methods that are currently in use today for measuring HbA1c levels. Moreover, it examines clinical measurement devices and reagents as utilized in hospitals, clinics, doctor's offices and at-home care locations. The report also analyzes almost all of the companies known to be marketing, manufacturing or developing hemoglobin A1c testing. Detailed tables and charts with sales forecasts and marketshare data are also included.

Note: Product cover images may vary from those shown
2 of 4


  • A. Menarini Diagnostics
  • Alere, Inc.
  • Axis-Shield Plc
  • EKF Diagnostics
  • Quotient Diagnostics
  • Roche Diagnostics
  • MORE

1. Overview
1.1 Statement of Report
1.2 About this Report
1.3 Scope of the Report
1.4 Methodology
1.5 Executive Summary

2. Diabetes
2.1 Demographics of Diabetes
2.1.1 Worldwide Diabetes Incidence
2.1.2 Diabetes in the U.S.
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes
2.2.1 Pre-Diabetes Syndrome
2.2.2 Metabolic Syndrome
2.2.3 Progression of Diabetes
2.2.4 Diabetes and Inflammation
2.2.5 Risk Factors and Diabetes Obesity Stress-Induced Hyperglycemia
2.2.6 Complications and Co-Morbidities in Diabetes Preventing Complications and Co-Morbidities in Diabetes Cardiovascular Disease Facts
2.3 Economics of Diabetes
2.3.1 Worldwide Costs of Diabetes
2.3.2 Costs of Diabetes in the U.S.

3. Market Analysis: Size, Growth, Share and Competitors
3.1 Worldwide HbA1c Testing Market
3.1.1 U.S. HbA1c Testing Market
3.2 HbA1c Self-Testing Market
3.3 Competitive Situation
3.3.1 Analyses of the Key Players, Current Market Conditions, and Product Mix
3.3.2 Competitive Strategies and Strategic Recommendations
3.3.3 Future Competing Technologies—Glycated Albumin
3.4 Market Drivers and Restraints
3.4.1 Market Drivers
3.4.2 Market Restraints
3.5 Market and Product Trends
3.5.1 Increase in POC HbA1c Testing
3.5.2 Move Towards Screening for Diabetes Using HbA1c Assays
3.6 Adjacent Markets

4. Overview of HbA1c Testing
4.1 Technology Platforms Used to Measure HbA1c
4.1.1 High-Performance Liquid Chromatography (HPLC)
4.1.2 Immunoassays
4.1.3 Boronate Affinity Chromatography
4.1.4 Enzymatic Assay
4.1.5 Micro-Optical Detection Methods
4.2 Development of HbA1c Testing: A Historical Evaluation
4.2.1 The Diabetes Control and Complications Trial (DCCT)
4.3 Standardization of HbA1c Testing and Certification Criteria
4.3.1 National Glycohemoglobin Standardization Program (NGSP)
4.3.2 International Federation of Clinical Chemistry (IFCC)
4.3.3 New NGSP Certification Criteria
4.3.4 ADAG (A1c Derived Average Glucose)
4.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c
4.3.6 College of American Pathologists (CAP) Proficiency Program
4.3.7 Certifications and Selecting HbA1c Assays
4.4 Advantages and Disadvantages of HbA1c Assessment
4.5 HbA1c Testing Recommendations
4.5.1 Frequency of HbA1c Testing
4.5.2 Diagnostic HbA1c Testing
4.5.3 Screening for Pre-diabetes
4.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals
4.5.5 New HbA1c Target Recommendation for Children with Type 1 Diabetes
4.6 Accuracy and Precision in HbA1c Testing
4.6.1 Biological Variation
4.6.2 Pre-Analytical Variation
4.6.3 Analytical Variation
4.7 Potential Interfering Variables Affecting HbA1c Testing
4.8 Potential Areas of Improvement in HbA1c Testing Performance
4.9 Optimizing of Point of Care (POC) HbA1c Testing
4.10 Key Issues for HbA1c Testing
4.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools

5. HbA1c Testing Devices on the Market
5.1 HbA1c Self-Testing Devices
5.1.2 DTI Laboratories, Inc.
5.2 Professional HbA1c Testing Devices
5.2.1 Point of Care HbA1c Testing A. Menarini Diagnostics Alere Apex Biotechnology Convergent Technologies GmbH & Co. DiaSys Diagnostic Systems Diazyme Laboratories EKF Diagnostics Eurolyser Green Cross Medis (formerly Ceragem Medisys) HemoCue (a division of Radiometer) Infopia Roche SD Biosensor Siemens Healthcare Diagnostics
5.2.2 HbA1c Laboratory Testing Abbott Alere AMS Arkray Beckman Coulter Bio-Rad DiaSys Diagnostic Systems Diazyme Laboratories Diatron EKF Diagnostics ELITechGroup Green Cross Medis (formerly Ceragem Medisys) Kyowa Medex, Co., Ltd. Ortho Clinical Diagnostics (part of Johnson & Johnson) Pointe Scientific, Inc. (part of MedTest Holdings) Randox Laboratories Roche Sebia Siemens Healthcare Diagnostics Tosoh Trinity Biotech
5.3 New Product Innovations and Introductions
5.3.1 Roche’s Cobas Integra 800 Tina-quant HbA1cDx Assay Is First FDA-approved Test for Diagnosing Diabetes
5.3.2 Abbott Announces FDA Clearance for a its ARCHITECT Clinical Chemistry Hemoglobin A1c Test for the Diagnosis and Monitoring of Diabetes
5.3.3 Sebia Announces a New HbA1c Test
5.3.4 Sebia’s CAPILLARYS 2 FLEX Piercing System
5.3.5 Sebia’s MINICAP Flex Piercing
5.3.6 Shelf-life of EKF Diagnostics’ Quo-Lab HbA1c Test Extended
5.3.7 Convergent Technologies Launches Convergys® HbA1c
5.3.8 Beckman Coulter Receives FDA Clearance on Next Generation Hemoglobin A1c Test
5.3.9 Trinity Biotech Launches the Premier Hb9210
5.3.10 Trivitron to Enter HbA1c Market
5.3.11 Siemens Healthcare Announced a New Version of the DCA Vantage Analyzer
5.3.12 EKF Diagnostics to Launch the Quo-Lab HbA1c
5.3.13 Tosoh Introduces the ST AIA-PACK HbA1c Assay
5.3.14 Tosoh Introduces a Comprehensive HbA1c Product Line
5.3.15 Abnova’s Personal A1c Diabetes Rapid Test
5.3.16 FDA Clears Ortho-Clinical Diagnostics’ Enhanced HbA1c Reagent Kit
5.4 Recent Industry Activity & Corporate Developments
5.4.1 PTS, Inc. (now Chek Diagnostics) Acquires A1CNow from Bayer Diabetes Care
5.4.2 Polymer Technology Systems, Inc. (PTS, Inc.) Changes Name to Chek Diagnostics
5.4.3 EKF Diagnostics Quo-Test and Quo-Lab HbA1c POCT Analyzers Comparable to Laboratory HPLC
5.4.4 Radiometer Medical ApS Acquires HemoCue AB
5.4.5 Axis-Shield Acquired by Alere
5.4.6 EKF Diagnostics Opens New Manufacturing Facility at its Quotient Diagnostics Base
5.4.7 EKF Diagnostics Acquires Quotient Diagnostics
5.4.8 EKF Diagnostics Acquires Stanbio Laboratories
5.4.9 Geonostics Acquires FlexSite’s Diagnostics
5.4.10 Trinity Biotech Signs Distribution Agreements with Fisher and Menarini Diagnostics
5.4.11 Pointe Scientific Acquired by MedTest Holdings

6. Business Trends in HbA1c Testing
6.1 Drivers and Trends of Clinical HbA1c Testing
6.2 Healthcare Cost Controls
6.3 Affordable Care Act Excise Tax on Medical Devices
6.4 Changes in Patient Management
6.5 Regionalization of Laboratory Care
6.6 Satellite Facilities
6.7 Professional Point of Care Testing
6.7.1 Key Issues in the POC Diagnostic Testing Sector
6.7.2 Current Market Trends and Drivers
6.7.3 POC HbA1c
6.7.4 Effectiveness of POCT
6.7.5 Key Customer Segments DELTA Dentists of New Jersey to Offer In-Office A1c Diabetes Testing
6.8 Factors Affecting OTC Medical Product Distribution
6.9 Drivers and Restraints of OTC and Self-Testing HbA1c Markets

7. Regulatory Environment and Insurance Reimbursements
7.1 U.S. Government Regulation of Medical Devices
7.2 E.U. Regulation of Medical Devices
7.3 FDA Labeling Requirements
7.4 Clinical Laboratory Improvement Act (CLIA)
7.5 HbA1c Testing Insurance Coverage and Reimbursement
7.6 Managed Care

8. Company Profiles
8.1 Abbott Laboratories
8.2 Alere, Inc.
8.3 A. Menarini Diagnostics
8.4 AMS Alliance
8.5 Apex Biotechnology Corporation
8.6 ARKRAY USA, Inc.
8.7 Axis-Shield Plc
8.8 Bayer Healthcare Diagnostics
8.9 Beckman Coulter, Inc
8.10 Bio-Rad Laboratories, Inc.
8.11 Convergent Technologies GmbH
8.12 DiaSys Diagnostics
8.13 Diazyme Laboratories (a Division of General Atomics)
8.14 Diatron
8.15 DTI Laboratories, Inc.
8.16 EKF Diagnostics
8.17 ELITechGroup
8.18 Eurolyser
8.19 Green Cross Medis (formerly Ceragem Medisys)
8.20 HemoCue AB (now part of Radiometer Medical)
8.21 Infopia Co., Ltd.
8.22 Kyowa Medex
8.23 Ortho Clinical Diagnostics (part of Johnson & Johnson)
8.24 Pointe Diagnostics
8.25 PTS Diagnostics
8.26 Randox Laboratories
8.27 Roche Diagnostics
8.28 SD Biosensor
8.29 Sebia
8.30 Siemens AG
8.31 Tosoh Bioscience, Inc.
8.32 Trinity Biotech Plc

List of Figures
Figure 2.1: Worldwide Diabetes Cases, 2014 and 2035
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years)
Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age
Figure 2.4: Prevalence of Diabetes by Age in the U.S.
Figure 2.5: Diagnosed Diabetes by Age in the U.S.
Figure 2.6: Percentage of U.S. Adults Diagnosed Diabetes by State
Figure 2.7: Number of Deaths from Diabetes by Age in the U.S.
Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S.
Figure 2.9: Maintenance of Normal Blood Sugar Levels
Figure 2.10: Prevalence of Self-Reported Obesity (BMI ³30) Among U.S. Adults
Figure 2.11: Prevalence of Obesity (BMI =30) Among Adults in the U.S.
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S.
Figure 2.13: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex, in the U.S.
Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, United States
Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment, United States
Figure 2.16: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD)
Figure 2.17: How Diabetes Dollars are Spent in the U.S.
Figure 3.1: Worldwide HbA1c Testing Market
Figure 3.2: U.S. HbA1c Testing Market
Figure 3.3: Global HbA1c Self-Testing Market
Figure 4.1: Non-Enzymatic Glycation of Hemoglobin
Figure 4.2: Boronate Affinity Binding of Glycated Protein
Figure 4.3: Comparison of HbA1C and Blood Glucose Measurements over a Four-Day Period
Figure 4.4: Range of Variation in HbA1c Assay
Figure 4.5: Range of Variation in the FPG Assay
Figure 7.1: CLIA Laboratories by Certificate Types

List of Tables
Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035
Table 2.2: Countries with the Largest Numbers of Diabetics
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group
Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes
Table 2.6: New Cases of Diagnosed Diabetes Among U.S. Adults Aged 20 Years or Older
Table 2.7: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013
Table 2.8: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2013
Table 2.9: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.
Table 2.10: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes
Table 2.11: Prevalence of Complications Among Patients with Diabetes
Table 2.12: Major Causes of End-stage Renal Disease
Table 2.13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
Table 2.14: Clinical Recommendations for Adults with Diabetes
Table 2.15: Laboratory Assessment of Diabetic Vascular Disease
Table 2.16: Average Years Gained Free of Diabetes-related Disease with Intensive Management
Table 2.17: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.
Table 2.18: Cost of Diagnosed Diabetes in the U.S.
Table 2.19: Annual Cost of Care of United Healthcare Adult Members with Diabetes
Table 2.20: Healthcare Utilization by Diabetic Patients
Table 3.1: Worldwide HbA1c Testing Market, 2010-2019
Table 3.2: U.S. HbA1c Testing Market, 2010-2019
Table 3.3: Global HbA1c Self-Testing Market, 2010-2019
Table 3.4: Key Players in the HbA1c Clinical Laboratory Market
Table 3.5: Key Players in the HbA1c POC Market
Table 3.6: Key Players in the HbA1c Self-Testing Market
Table 3.7: Key Market Drivers for HbA1c Testing
Table 4.1: Summary of NGSP Certification Criteria
Table 4.2: Summary of the 2010 Consensus Statement on the Worldwide Standardization of HbA1c
Table 4.3: Advantages of HbA1c versus Blood Glucose Testing
Table 4.4: Disadvantages of HbA1c versus Blood Glucose Testing
Table 4.5: HbA1c Testing Recommendations
Table 4.6: Criteria for the Diagnosis of Diabetes
Table 4.7: Categories of Increased Risk for Diabetes (Pre-Diabetes)
Table 4.8: Glycemic Recommendations for Non-Pregnant Adults with Diabetes
Table 4.9: Glycemic Recommendations for Women with Gestational Diabetes
Table 4.10: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes
Table 4.11: Conditions Known to Interfere with HbA1c Assays
Table 4.12: Interference from Hb Variants in Select HbA1c Testing Systems
Table 4.13: History of NGSP Manufacturer Certification Criteria
Table 4.14: Correlation of HbA1c with Mean Blood Glucose
Table 5.1: HbA1c Testing Devices and Assays on the Market
Table 5.2: Premier Hb9210 Placements Worldwide
Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs

Note: Product cover images may vary from those shown
3 of 4

- Abbott Laboratories
- A. Menarini Diagnostics
- Alere, Inc.
- Axis-Shield Plc
- Bayer Healthcare Diagnostics
- Beckman Coulter, Inc
- Bio-Rad Laboratories, Inc.
- EKF Diagnostics
- Infopia Co., Ltd.
- Ortho Clinical Diagnostics (part of Johnson & Johnson)
- Quotient Diagnostics
- Randox Laboratories
- Roche Diagnostics
- Siemens AG
- Tosoh Bioscience, Inc.
- Trinity Biotech Plc

Note: Product cover images may vary from those shown
4 of 4
Question Does this product provide market size provided in dollars or test volume segmented by geography?
Answer Market size is provided in dollars but is not segmented by geography. There are several tables and figures that include information from 2008-2017.
Note: Product cover images may vary from those shown


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