Hemoglobin A1c Testing Markets

  • ID: 2497047
  • July 2014
  • Region: Global
  • 131 Pages
  • TriMark Publications


  • 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 TriMark Publications 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


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

1. Overview
1.1 Statement of Reprt
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

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 AC1 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 Beginning in September
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
4.6 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.
5.1.3 Flexsite Diagnostics, Inc.
5.1.4 Heritage Labs International
5.2 Professional HbA1c Testing Devices
5.2.1 Point of Care HbA1c Testing Axis-Shield (now part of Alere) Bio-Rad DiaSys Diagnostic Systems Diazyme Laboratories EKF Diagnostics Infopia Siemens Healthcare Diagnostics
5.2.2 HbA1c Laboratory Testing Abbott Arkray Beckman Coulter Bio-Rad Diazyme Laboratories EKF Diagnostics Ortho Clinical Diagnostics (part of Johnson & Johnson) Pointe Scientific, Inc. Randox Laboratories Roche Siemens Healthcare Diagnostics Tosoh Trinity Biotech
5.3 New Product Innovations and Introductions
5.3.1 Trinity Biotech Launches the Premier Hb9210
5.3.2 Siemens Healthcare Announced a New Version of the DCA Vantage Analyzer
5.3.3 EKF Diagnostics to Launch the Quo-Lab HbA1c
5.3.4 Trivitron to Enter HbA1c Market
5.3.5 Tosoh Introduces the ST AIA-PACK HbA1c Assay
5.3.6 Tosoh Introduces a Comprehensive HbA1c Product Line
5.3.7 Axis-Shield Introduces the Afinion II
5.3.8 Infopia Obtains CE Certification of HbA1c Analyzer
5.3.9 Bio-Rad Introduces the in2it Analyzer
5.4 Recent Industry Activity & Corporate Developments
5.4.1 Axis-Shield Acquired by Alere
5.4.2 EKF Diagnostics Opens New Manufacturing Facility at its Quotient Diagnostics Base
5.4.3 EKF Diagnostics Acquires Quotient Diagnostics
5.4.4 Beckman Coulter Acquires Olympus? Lab-based Diagnostics Business
5.4.5 Trinity Biotech Acquires Primus Corporation
5.4.6 Geonostics Acquires FlexSite?s Diagnostics
5.4.7 Trinity Biotech Signs Distribution Agreements with Fisher and Menarini Diagnostics
5.4.8 Bayer Divests Diagnostics Division to Siemens
5.4.9 Bayer Diabetes Care Acquires Metrika, Inc.
5.4.10 Sysmex America and Bio-Rad Sign Long-term Distribution Agreement

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 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 Effectiveness of POCT
6.7.4 Key Customer Segments
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 FDA Labeling Requirements
7.3 Clinical Laboratory Improvement Act (CLIA)
7.4 HbA1c Testing Insurance Coverage and Reimbursement
7.5 Trends in U.S. Laboratory Testing Reimbursement Practices
7.6 Managed Care

8. Company Profiles
8.1 Abbott Laboratories
8.2 A. Menarini Diagnostics
8.3 Alere, Inc.
8.4 ARKRAY USA, Inc.
8.5 Axis-Shield Plc
8.6 Bayer Healthcare Diagnostics
8.7 Beckman Coulter, Inc
8.8 Bio-Rad Laboratories, Inc.
8.9 EKF Diagnostics
8.10 Infopia Co., Ltd.
8.11 Ortho Clinical Diagnostics (part of Johnson & Johnson)
8.12 Quotient Diagnostics
8.13 Randox Laboratories
8.14 Roche Diagnostics
8.15 Siemens AG
8.16 Tosoh Bioscience, Inc.
8.17 Trinity Biotech Plc


Figure 2.1: Worldwide Diabetes Cases, 2011 and 2030
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011
Figure 2.3: Prevalence of Diabetes by Age in the U.S., 2010
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010
Figure 2.5: County-specific Diabetes Prevalence in the U.S., 2008
Figure 2.6: Maintenance of Normal Blood Sugar Levels
Figure 2.7: Obesity (BMI =30) Prevalence in U.S. Adults, 2010
Figure 2.8: Percentage of Obese Adults in the U.S., 2009-2010
Figure 2.9: Percentage of Obese Children and Adolescents in the U.S., 2009-2010
Figure 2.10: Trends in Obesity Among Children and Adolescents in the U.S., 1963-2008
Figure 2.11: Relative Risk of Diabetes Complications by Mean HbA1c
Figure 2.12: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79 Years) with Diabetes (USD), 2011
Figure 3.1: Worldwide HbA1c Testing Market, 2008-2017
Figure 3.2: U.S. HbA1c Testing Market, 2008-2017
Figure 3.3: Global HbA1c Self-Testing Market, 2008-2017
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


Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years), 2011 and 2030
Table 2.2: Countries with the Largest Numbers of Diabetics, 2011
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2030
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2011
Table 2.5: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20 Years or Older, 2010
Table 2.6: U.S. Incidence of Diagnosed Diabetes by Age, 2009
Table 2.7: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S.
Table 2.8: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes
Table 2.9: Prevalence of Complications Among Patients with Diabetes
Table 2.10: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus
Table 2.11: Major Causes of End-Stage Renal Disease
Table 2.12: Clinical Recommendations for Adults with Diabetes
Table 2.13: Laboratory Assessment of Diabetic Vascular Disease
Table 2.14: Average Years Gained Free of Diabetes-related Disease with Intensive Management
Table 2.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S., 2008
Table 2.16: Worldwide Market for Cardiac Care Therapeutics, 2003-2010
Table 2.17: Top 20 Drugs for 2010 by U.S. Sales
Table 2.18: Cost of Diagnosed Diabetes in the U.S., 2007
Table 2.19: Medical Care Costs Attributable to Diabetes in the U.S., 2010
Table 2.20: Healthcare Utilization by Diabetic Patients, 2008
Table 2.21: Per-Event Costs of Diabetes Complications
Table 2.22: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009
Table 3.1: Worldwide HbA1c Testing Market, 2008-2017
Table 3.2: U.S. HbA1c Testing Market, 2008-2017
Table 3.3: Global HbA1c Self-Testing Market, 2008-2017
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 the 2010 Consensus Statement on the Worldwide Standardization of HbA1c
Table 4.2: Advantages of HbA1c versus Blood Glucose Testing
Table 4.3: Disadvantages of HbA1c versus Blood Glucose Testing
Table 4.4: HbA1c Testing Recommendations
Table 4.5: Criteria for the Diagnosis of Diabetes
Table 4.6: Categories of Increased Risk for Diabetes (Pre-Diabetes)
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-existing Diabetes
Table 4.10: Conditions Known to Interfere with HbA1c Assays
Table 4.11: Interference from Hb Variants in Select HbA1c Testing Systems
Table 4.12: History of NGSP Manufacturer Certification Criteria
Table 4.13: Correlation of HbA1c with Mean Blood Glucose
Table 5.1: HbA1c Testing Devices and Assays on the Market
Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs

Note: Product cover images may vary from those shown

- 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
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


  • Quick Help: The report will be emailed to you. The report is sent in PDF format. This is a single user license, allowing one specific user access to the product.

  • Quick Help: The report will be emailed to you. The report is sent in PDF format. This is a 1-10 user licence, allowing up to ten users have access to the product.

  • Quick Help: The report will be emailed to you. The report is sent in PDF format. This is an enterprise license, allowing all employees within your organisation access to the product.


If you have a more general question about our products please try our



Our Clients

  • Pfizer, Inc.
  • Grünenthal GmbH
  • GlaxoSmithKline PLC
  • Abbott Laboratories Ltd.
  • Roche Diagnostics Ltd.
  • Novo Nordisk A/S