Hemoglobin A1c Testing Markets

  • March 2014
  • -
  • TriMark Publications
  • -
  • 131 pages

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.

Table Of Contents

1. Overview 6
1.1 Statement of Report 6
1.2 About This Report 6
1.3 Scope of the Report 7
1.4 Methodology 8
1.5 Executive Summary 9

2. Diabetes 13
2.1 Demographics of Diabetes 14
2.1.1 Worldwide Diabetes Incidence 14
2.1.2 Diabetes in the U.S. 18
2.2 Understanding the Metabolic Conditions Underlying and Associated with Diabetes 23
2.2.1 Pre-Diabetes Syndrome 25
2.2.2 Metabolic Syndrome 25
2.2.3 Progression of Diabetes 25
2.2.4 Diabetes and Inflammation 25
2.2.5 Risk Factors and Diabetes 26
2.2.5.1 Obesity 27
2.2.5.2 Stress-Induced Hyperglycemia 29
2.2.6 Complications and Co-Morbidities in Diabetes 29
2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 33
2.2.6.2 Cardiovascular Disease Facts 34
2.3 Economics of Diabetes 37
2.3.1 Worldwide Costs of Diabetes 38
2.3.2 Costs of Diabetes in the U.S. 38

3. Market Analysis: Size, Growth, Share and Competitors 43
3.1 Worldwide HbA1c Testing Market 44
3.1.1 U.S. HbA1c Testing Market 45
3.2 HbA1c Self-Testing Market 46
3.3 Competitive Situation 48
3.3.1 Analyses of the Key Players, Current Market Conditions, and Product Mix 48
3.3.2 Competitive Strategies and Strategic Recommendations 49
3.3.3 Future Competing Technologies—Glycated Albumin 50
3.4 Market Drivers and Restraints 51
3.4.1 Market Drivers 51
3.4.2 Market Restraints 52
3.5 Market and Product Trends 52
3.5.1 Increase in POC HbA1c Testing 52
3.5.2 Move Towards Screening for Diabetes Using HbA1c Assays 53
3.6 Adjacent Markets 53

4. Overview of HbA1c Testing 54
4.1 Technology Platforms Used to Measure HbA1c 55
4.1.1 High-Performance Liquid Chromatography (HPLC) 55
4.1.2 Immunoassays 55
4.1.3 Boronate Affinity Chromatography 55
4.1.4 Enzymatic Assay 56
4.1.5 Micro-Optical Detection Methods 56
4.2 Development of HbA1c Testing: A Historical Evaluation 56
4.2.1 The Diabetes Control and Complications Trial (DCCT) 57
4.3 Standardization of HbA1c Testing and Certification Criteria 57
4.3.1 National Glycohemoglobin Standardization Program (NGSP) 57
4.3.2 International Federation of Clinical Chemistry (IFCC) 58
4.3.3 New NGSP Certification Criteria Beginning in January 2014 58
4.3.4 ADAG (A1c Derived Average Glucose) 58
4.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c 58
4.3.6 College of American Pathologists (CAP) Proficiency Program 59
4.3.7 Certifications and Selecting HbA1c Assays 60
4.4 Advantages and Disadvantages of HbA1c Assessment 60
4.5 HbA1c Testing Recommendations 61
4.5.1 Frequency of HbA1c Testing 61
4.5.2 Diagnostic HbA1c Testing 62
4.5.3 Screening for Pre-Diabetes 64
4.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals 65
4.6 Accuracy and Precision in HbA1c Testing 66
4.6.1 Biological Variation 66
4.6.2 Pre-Analytical Variation 67
4.6.3 Analytical Variation 67
4.7 Potential Interfering Variables Affecting HbA1c Testing 68
4.8 Potential Areas of Improvement in HbA1c Testing Performance 70
4.9 Optimizing of Point of Care (POC) HbA1c Testing 71
4.10 Key Issues for HbA1c Testing 71
4.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools 72

5. HbA1c Testing Devices on the Market 73
5.1 HbA1c Self-Testing Devices 74
5.1.1 A1CNow SELFCHECK 74
5.1.2 DTI Laboratories, Inc. 74
5.1.3 Heritage Labs International (part of Hooper Holmes) 75
5.1.4 Solana Health 75
5.2 Professional HbA1c Testing Devices 75
5.2.1 Point of Care HbA1c Testing 75
5.2.1.1 A. Menarini Diagnostics 75
5.2.1.2 Alere 75
5.2.1.3 Bio-Rad 76
5.2.1.4 Convergent Technologies GmbH andamp; Co. 76
5.2.1.5 DiaSys Diagnostic Systems 76
5.2.1.6 Diazyme Laboratories 77
5.2.1.7 EKF Diagnostics 77
5.2.1.8 HemoCue 77
5.2.1.9 Infopia 78
5.2.1.10 Roche 78
5.2.1.11 Siemens Healthcare Diagnostics 78
5.2.2 HbA1c Laboratory Testing 79
5.2.2.1 Abbott 79
5.2.2.2 Arkray 79
5.2.2.3 Beckman Coulter 80
5.2.2.4 Bio-Rad 81
5.2.2.5 DiaSys Diagnostic Systems 82
5.2.2.6 Diazyme Laboratories 82
5.2.2.7 EKF Diagnostics 83
5.2.2.8 Kyowa Medex, Co., Ltd. 83
5.2.2.9 Ortho Clinical Diagnostics (part of Johnson andamp; Johnson) 84
5.2.2.10 Pointe Scientific, Inc. 84
5.2.2.11 Randox Laboratories 84
5.2.2.12 Roche 84
5.2.2.13 Sebia 85
5.2.2.14 Siemens Healthcare Diagnostics 85
5.2.2.15 Tosoh 85
5.2.2.16 Trinity Biotech 87
5.3 New Product Innovations and Introductions 88
5.3.1 Roche’s Cobas Integra 800 Tina-quant HbA1cDx Assay is First FDA-Approved Test for Diagnosing Diabetes 88
5.3.2 Abbott Announces FDA Clearance for a its ARCHITECT Clinical Chemistry Hemoglobin A1c Test for the Diagnosis and Monitoring of Diabetes 88
5.3.3 Sebia Announces a New HbA1c Test 88
5.3.4 Sebia’s CAPILLARYS 2 FLEX Piercing System 88
5.3.5 Sebia’s MINICAP Flex Piercing 89
5.3.6 Shelf-Life of EKF Diagnostics’ Quo-Lab HbA1c Test Extended 89
5.3.7 Convergent Technologies Launches Convergys HbA1c at Medica 2013 89
5.3.8 Beckman Coulter Receives FDA Clearance on Next Generation Hemoglobin A1c Test 89
5.3.9 Trinity Biotech Launches the Premier Hb9210 89
5.3.10 Trivitron to Enter HbA1c Market 89
5.3.11 Siemens Healthcare Announced a New Version of the DCA Vantage Analyzer 90
5.3.12 EKF Diagnostics to Launch the Quo-Lab HbA1c 90
5.3.13 Tosoh Introduces the ST AIA-PACK HbA1c Assay 90
5.3.14 Tosoh Introduces a Comprehensive HbA1c Product Line 91
5.4 Recent Industry Activity and Corporate Developments 91
5.4.1 PTS, Inc. (now Chek Diagnostics) Acquires A1CNow from Bayer Diabetes Care 91
5.4.2 Polymer Technology Systems, Inc. (PTS, Inc.) Changes Name to Chek Diagnostics 91
5.4.3 EKF Diagnostics Quo-Test and Quo-Lab HbA1c POCT Analyzers Comparable to
Laboratory HPLC 91
5.4.4 Radiometer Medical ApS Acquires HemoCue AB 92
5.4.5 Axis-Shield Acquired by Alere 92
5.4.6 EKF Diagnostics Opens New Manufacturing Facility at its Quotient Diagnostics Base 92
5.4.7 EKF Diagnostics Acquires Quotient Diagnostics 92
5.4.8 EKF Diagnostics Acquires Stanbio Laboratories 92
5.4.9 Geonostics Acquires FlexSite’s Diagnostics 92
5.4.10 Trinity Biotech Signs Distribution Agreements with Fisher and Menarini Diagnostics 93

6. Business Trends in HbA1c Testing 94
6.1 Drivers and Trends of Clinical HbA1c Testing 94
6.2 Healthcare Cost Controls 94
6.3 Affordable Care Act Excise Tax on Medical Devices 94
6.4 Changes in Patient Management 94
6.5 Regionalization of Laboratory Care 95
6.6 Satellite Facilities 96
6.7 Professional Point of Care Testing 96
6.7.1 Key Issues in the POC Diagnostic Testing Sector 97
6.7.2 Current Market Trends and Drivers 97
6.7.3 POC HbA1c 99
6.7.4 Effectiveness of POCT 99
6.7.5 Key Customer Segments 99
6.8 Factors Affecting OTC Medical Product Distribution 100
6.9 Drivers and Restraints of OTC and Self-Testing HbA1c Markets 101

7. Regulatory Environment and Insurance Reimbursements 103
7.1 U.S. Government Regulation of Medical Devices 103
7.2 E.U. Regulation of Medical Devices 104
7.3 FDA Labeling Requirements 109
7.4 Clinical Laboratory Improvement Act (CLIA) 110
7.5 HbA1c Testing Insurance Coverage and Reimbursement 112
7.6 Managed Care 113

8. Company Profiles 114
8.1 Abbott Laboratories 114
8.2 A. Menarini Diagnostics 117
8.3 Alere, Inc. 117
8.4 ARKRAY USA, Inc. 118
8.5 Axis-Shield Plc 118
8.6 Bayer Healthcare Diagnostics 119
8.7 Beckman Coulter, Inc 121
8.8 Bio-Rad Laboratories, Inc. 125
8.9 Chek Diagnostics 126
8.10 Convergent Technologies GmbH 126
8.11 DiaSys Diagnostics 126
8.12 Diazyme Laboratories (a Division of General Atomics) 127
8.13 EKF Diagnostics 127
8.14 HemoCue AB (now part of Radiometer Medical) 128
8.15 Infopia Co., Ltd. 128
8.16 Ortho Clinical Diagnostics (part of Johnson andamp; Johnson) 128
8.17 Quotient Diagnostics 128
8.18 Randox Laboratories 129
8.19 Roche Diagnostics 129
8.20 Sebia 131
8.21 Siemens AG 131
8.22 Tosoh Bioscience, Inc. 131
8.23 Trinity Biotech Plc 132


INDEX OF FIGURES

Figure 2.1: Worldwide Diabetes Cases, 2013 and 2035 14
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2013 15
Figure 2.3: Annual Number of New Cases of Diagnosed Diabetes Among U.S. Adults Aged 18-79 Years,
1980-2011 19
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age, 2010 19
Figure 2.5: Prevalence of Diabetes by Age in the U.S., 2010 20
Figure 2.6: Diagnosed Diabetes by Age in the U.S., 2013 20
Figure 2.7: Number of Deaths from Diabetes by Age in the U.S., 2010 22
Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S., 2010 23
Figure 2.9: Maintenance of Normal Blood Sugar Levels 24
Figure 2.10: Prevalence of Self-Reported Obesity (BMI ?30) Among U.S. Adults, 2012 27
Figure 2.11: Prevalence of Obesity Among Adults in the U.S., 2009-2010 28
Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S., 1988-2010 28
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., 1997-2011 30
Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S., 1997-2011 32
Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment, in the U.S., 1997-2011 33
Figure 2.16: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes (in U.S. Dollars), 2013 38
Figure 2.17: How Diabetes Dollars are Spent in the U.S., 2012 40
Figure 3.1: Worldwide HbA1c Testing Market, 2010-2019 45
Figure 3.2: U.S. HbA1c Testing Market, 2010-2019 46
Figure 3.3: Global HbA1c Self-Testing Market, 2010-2019 47
Figure 4.1: Non-Enzymatic Glycation of Hemoglobin 54
Figure 4.2: Boronate Affinity Binding of Glycated Protein 56
Figure 4.3: Comparison of HbA1c and Blood Glucose Measurements Over a Four-Day-Period 61
Figure 4.4: Range of Variation in HbA1c Assay 67
Figure 4.5: Range of Variation in the FPG Assay 68
Figure 7.1: CLIA Laboratories by Certificate Types 111


INDEX OF TABLES

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in Millions, 2013 and 2035 15
Table 2.2: Countries with the Largest Numbers of Diabetics, 2013 16
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035 16
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and Income Group, 2013 17
Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes, 2013 17
Table 2.6: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 20
Table 2.7: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2010 21
Table 2.8: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 30
Table 2.9: Odds Ratio of Progression to Complications Associated with Type 2 Diabetes 31
Table 2.10: Prevalence of Complications Among Patients with Diabetes 31
Table 2.11: Novel Risk Factors and Possible Mechanisms of the Excess Risk of Coronary Heart Disease in Type 2 Diabetes Mellitus 32
Table 2.12: Major Causes of End-Stage Renal Disease 32
Table 2.13: Clinical Recommendations for Adults with Diabetes 34
Table 2.14: Laboratory Assessment of Diabetic Vascular Disease 34
Table 2.15: Average Years Gained Free of Diabetes-Related Disease with Intensive Management 34
Table 2.16: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases and Stroke in the U.S.,
2010 36
Table 2.17: Cost of Diagnosed Diabetes in the U.S., 2012 39
Table 2.18: Annual Cost of Care of United Healthcare Adult Members with Diabetes, 2009 41
Table 2.19: Healthcare Utilization by Diabetic Patients, 2012 41
Table 3.1: Worldwide HbA1c Testing Market, 2010-2019 44
Table 3.2: U.S. HbA1c Testing Market, 2010-2019 46
Table 3.3: Global HbA1c Self-Testing Market, 2010-2019 47
Table 3.4: Key Players in the HbA1c Clinical Laboratory Market 48
Table 3.5: Key Players in the HbA1c POC Market 49
Table 3.6: Key Players in the HbA1c Self-Testing Market 49
Table 3.7: Key Market Drivers for HbA1c Testing 51
Table 4.1: Summary of the 2010 Consensus Statement on the Worldwide Standardization of HbA1c 59
Table 4.2: Advantages of HbA1c versus Blood Glucose Testing 60
Table 4.3: Disadvantages of HbA1c versus Blood Glucose Testing 61
Table 4.4: HbA1c Testing Recommendations 62
Table 4.5: Criteria for the Diagnosis of Diabetes 63
Table 4.6: Categories of Increased Risk for Diabetes (Pre-Diabetes) 63
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 65
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 65
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-Existing Diabetes 65
Table 4.10: Conditions Known to Interfere with HbA1c Assays 68
Table 4.11: Interference from Hb Variants in Select HbA1c Testing Systems 70
Table 4.12: History of NGSP Manufacturer Certification Criteria 71
Table 4.13: Correlation of HbA1c with Mean Blood Glucose 72
Table 5.1: HbA1c Testing Devices and Assays on the Market 73
Table 5.2: Premier Hb9210 Placements Worldwide, 2012-2014 87
Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs 111

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