2014

Hemoglobin A1c Testing Markets

NEW YORK, March 25, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Hemoglobin A1c Testing Markets
http://www.reportlinker.com/p01138843/Hemoglobin-A1c-Testing-Markets.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

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 Reprt 6
1.2 About this Report 7
1.3 Scope of the Report 7
1.4 Methodology 8
1.5 Executive Summary 9

2. Diabetes 12
2.1 Demographics of Diabetes 13
2.1.1 Worldwide Diabetes Incidence 13
2.1.2 Diabetes in the U.S. 16
2.2 Understanding the Metabolic Conditions Underlying and Associated with
Diabetes 19
2.2.1 Pre-Diabetes Syndrome 21
2.2.2 Metabolic Syndrome 21
2.2.3 Progression of Diabetes 21
2.2.4 Diabetes and Inflammation 21
2.2.5 Risk Factors and Diabetes 22
2.2.5.1 Obesity 23
2.2.5.2 Stress-Induced Hyperglycemia 25
2.2.6 Complications and Co-Morbidities in Diabetes 25
2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 28
2.2.6.2 Cardiovascular Disease Facts 30
2.3 Economics of Diabetes 33

3. Market Analysis: Size, Growth, Share and Competitors 38
3.1 Worldwide HbA1c Testing Market 39
3.1.1 U.S. HbA1c Testing Market 40
3.2 HbA1c Self-Testing Market 41
3.3 Competitive Situation 43
3.3.1 Analyses of the Key Players, Current Market Conditions, and Product Mix 43
3.3.2 Competitive Strategies and Strategic Recommendations 44
3.3.3 Future Competing Technologies—Glycated Albumin 45
3.4 Market Drivers and Restraints 46
3.4.1 Market Drivers 46
3.4.2 Market Restraints 46
3.5 Market and Product Trends 47
3.5.1 Increase in POC AC1 Testing 47
3.5.2 Move Towards Screening for Diabetes Using HbA1c Assays 48
3.6 Adjacent Markets 48

4. Overview of HbA1c Testing 49
4.1 Technology Platforms Used to Measure HbA1c 50
4.1.1 High-Performance Liquid Chromatography (HPLC) 50
4.1.2 Immunoassays 50
4.1.3 Boronate Affinity Chromatography 50
4.1.4 Enzymatic Assay 51
4.1.5 Micro-Optical Detection Methods 51
4.2 Development of HbA1c Testing: A Historical Evaluation 51
4.2.1 The Diabetes Control and Complications Trial (DCCT) 51
4.3 Standardization of HbA1c Testing and Certification Criteria 52
4.3.1 National Glycohemoglobin Standardization Program (NGSP) 52
4.3.2 International Federation of Clinical Chemistry (IFCC) 53
4.3.3 New NGSP Certification Criteria Beginning in September 53
4.3.4 ADAG (A1c Derived Average Glucose) 53
4.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c 53
4.3.6 College of American Pathologists (CAP) Proficiency Program 54
4.3.7 Certifications and Selecting HbA1c Assays 54
4.4 Advantages and Disadvantages of HbA1c Assessment 54
4.5 HbA1c Testing Recommendations 56
4.5.1 Frequency of HbA1c Testing 56
4.5.2 Diagnostic HbA1c Testing 57
4.5.3 Screening for Pre-diabetes 59
4.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals 59
4.6 Accuracy and Precision in HbA1c Testing 60
4.6.1 Biological Variation 60
4.6.2 Pre-Analytical Variation 61
4.6.3 Analytical Variation 61
4.7 Potential Interfering Variables Affecting HbA1c Testing 63
4.8 Potential Areas of Improvement in HbA1c Testing Performance 64
4.9 Optimizing of Point of Care (POC) HbA1c Testing 65
4.10 Key Issues for HbA1c Testing 65
4.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools 66

5. HbA1c Testing Devices on the Market 68
5.1 HbA1c Self-Testing Devices 69
5.1.1 A1CNow SELFCHECK 69
5.1.2 DTI Laboratories, Inc. 69
5.1.3 Flexsite Diagnostics, Inc. 70
5.1.4 Heritage Labs International 70
5.2 Professional HbA1c Testing Devices 70
5.2.1 Point of Care HbA1c Testing 70
5.2.1.1 Axis-Shield (now part of Alere) 70
5.2.1.2 Bio-Rad 71
5.2.1.3 DiaSys Diagnostic Systems 71
5.2.1.4 Diazyme Laboratories 71
5.2.1.5 EKF Diagnostics 72
5.2.1.6 Infopia 72
5.2.1.7 Siemens Healthcare Diagnostics 72
5.2.2 HbA1c Laboratory Testing 73
5.2.2.1 Abbott 73
5.2.2.2 Arkray 73
5.2.2.3 Beckman Coulter 73
5.2.2.4 Bio-Rad 74
5.2.2.5 Diazyme Laboratories 75
5.2.2.6 EKF Diagnostics 75
5.2.2.7 Ortho Clinical Diagnostics (part of Johnson & Johnson) 75
5.2.2.8 Pointe Scientific, Inc. 75
5.2.2.9 Randox Laboratories 76
5.2.2.10 Roche 76
5.2.2.11 Siemens Healthcare Diagnostics 76
5.2.2.12 Tosoh 76
5.2.2.13 Trinity Biotech 77
5.3 New Product Innovations and Introductions 78
5.3.1 Trinity Biotech Launches the Premier Hb9210 78
5.3.2 Siemens Healthcare Announced a New Version of the DCA Vantage Analyzer 78
5.3.3 EKF Diagnostics to Launch the Quo-Lab HbA1c 78
5.3.4 Trivitron to Enter HbA1c Market 79
5.3.5 Tosoh Introduces the ST AIA-PACK HbA1c Assay 79
5.3.6 Tosoh Introduces a Comprehensive HbA1c Product Line 79
5.3.7 Axis-Shield Introduces the Afinion II 80
5.3.8 Infopia Obtains CE Certification of HbA1c Analyzer 80
5.3.9 Bio-Rad Introduces the in2it Analyzer 80
5.4 Recent Industry Activity & Corporate Developments 80
5.4.1 Axis-Shield Acquired by Alere 80
5.4.2 EKF Diagnostics Opens New Manufacturing Facility at its Quotient
Diagnostics Base 80
5.4.3 EKF Diagnostics Acquires Quotient Diagnostics 80
5.4.4 Beckman Coulter Acquires Olympus' Lab-based Diagnostics Business 81
5.4.5 Trinity Biotech Acquires Primus Corporation 81
5.4.6 Geonostics Acquires FlexSite's Diagnostics 81
5.4.7 Trinity Biotech Signs Distribution Agreements with Fisher and Menarini
Diagnostics 81
5.4.8 Bayer Divests Diagnostics Division to Siemens 81
5.4.9 Bayer Diabetes Care Acquires Metrika, Inc. 81
5.4.10 Sysmex America and Bio-Rad Sign Long-term Distribution Agreement 82

6. Business Trends in HbA1c Testing 83
6.1 Drivers and Trends of Clinical HbA1c Testing 83
6.2 Healthcare Cost Controls 83
6.3 Affordable Care Act Excise Tax on Medical Devices 83
6.4 Changes in Patient Management 84
6.5 Regionalization of Laboratory Care 84
6.6 Satellite Facilities 85
6.7 Point of Care Testing 86
6.7.1 Key Issues in the POC Diagnostic Testing Sector 86
6.7.2 Current Market Trends and Drivers 86
6.7.3 Effectiveness of POCT 89
6.7.4 Key Customer Segments 89
6.8 Factors Affecting OTC Medical Product Distribution 89
6.9 Drivers and Restraints of OTC and Self-Testing HbA1c Markets 91

7. Regulatory Environment and Insurance Reimbursements 92
7.1 U.S. Government Regulation of Medical Devices 92
7.2 FDA Labeling Requirements 93
7.3 Clinical Laboratory Improvement Act (CLIA) 93
7.4 HbA1c Testing Insurance Coverage and Reimbursement 96
7.5 Trends in U.S. Laboratory Testing Reimbursement Practices 97
7.6 Managed Care 98

8. Company Profiles 99
8.1 Abbott Laboratories 99
8.2 A. Menarini Diagnostics 102
8.3 Alere, Inc. 102
8.4 ARKRAY USA, Inc. 103
8.5 Axis-Shield Plc 103
8.6 Bayer Healthcare Diagnostics 104
8.7 Beckman Coulter, Inc 106
8.8 Bio-Rad Laboratories, Inc. 110
8.9 EKF Diagnostics 111
8.10 Infopia Co., Ltd. 112
8.11 Ortho Clinical Diagnostics (part of Johnson & Johnson) 112
8.12 Quotient Diagnostics 112
8.13 Randox Laboratories 113
8.14 Roche Diagnostics 113
8.15 Siemens AG 115
8.16 Tosoh Bioscience, Inc. 115
8.17 Trinity Biotech Plc 115

INDEX OF FIGURES

Figure 2.1: Worldwide Diabetes Cases, 2011 and 2030 13
Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years), 2011
14
Figure 2.3: Prevalence of Diabetes by Age in the U.S., 2010 17
Figure 2.4: New Cases of Diabetes Diagnosed in the U.S. Adult Population, 2010
17
Figure 2.5: County-specific Diabetes Prevalence in the U.S., 2008 18
Figure 2.6: Maintenance of Normal Blood Sugar Levels 20
Figure 2.7: Obesity (BMI =30) Prevalence in U.S. Adults, 2010 23
Figure 2.8: Percentage of Obese Adults in the U.S., 2009-2010 24
Figure 2.9: Percentage of Obese Children and Adolescents in the U.S., 2009-2010
24
Figure 2.10: Trends in Obesity Among Children and Adolescents in the U.S.,
1963-2008 25
Figure 2.11: Relative Risk of Diabetes Complications by Mean HbA1c 27
Figure 2.12: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79
Years) with
Diabetes (USD), 2011 34
Figure 3.1: Worldwide HbA1c Testing Market, 2008-2017 40
Figure 3.2: U.S. HbA1c Testing Market, 2008-2017 41
Figure 3.3: Global HbA1c Self-Testing Market, 2008-2017 42
Figure 4.1: Non-Enzymatic Glycation of Hemoglobin 49
Figure 4.2: Boronate Affinity Binding of Glycated Protein 51
Figure 4.3: Comparison of HbA1C and Blood Glucose Measurements over a Four-Day
Period 55
Figure 4.4: Range of Variation in HbA1c Assay 62
Figure 4.5: Range of Variation in the FPG Assay 62
Figure 7.1: CLIA Laboratories by Certificate Types 94

INDEX OF TABLES

Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years), 2011 and
2030 14
Table 2.2: Countries with the Largest Numbers of Diabetics, 2011 15
Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2030 15
Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and
Income Group, 2011 16
Table 2.5: U.S. Population of Diabetics (Diagnosed and Undiagnosed) Aged 20
Years or Older, 2010 17
Table 2.6: U.S. Incidence of Diagnosed Diabetes by Age, 2009 19
Table 2.7: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 26
Table 2.8: Odds Ratio of Progression to Complications Associated with Type 2
Diabetes 27
Table 2.9: Prevalence of Complications Among Patients with Diabetes 27
Table 2.10: Novel Risk Factors and Possible Mechanisms of the Excess Risk of
Coronary Heart Disease in Type 2 Diabetes Mellitus 28
Table 2.11: Major Causes of End-Stage Renal Disease 28
Table 2.12: Clinical Recommendations for Adults with Diabetes 29
Table 2.13: Laboratory Assessment of Diabetic Vascular Disease 29
Table 2.14: Average Years Gained Free of Diabetes-related Disease with Intensive
Management 29
Table 2.15: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases
and
Stroke in the U.S., 2008 31
Table 2.16: Worldwide Market for Cardiac Care Therapeutics, 2003-2010 31
Table 2.17: Top 20 Drugs for 2010 by U.S. Sales 32
Table 2.18: Cost of Diagnosed Diabetes in the U.S., 2007 34
Table 2.19: Medical Care Costs Attributable to Diabetes in the U.S., 2010 35
Table 2.20: Healthcare Utilization by Diabetic Patients, 2008 35
Table 2.21: Per-Event Costs of Diabetes Complications 36
Table 2.22: Annual Cost of Care of United Healthcare Adult Members with
Diabetes, 2009 36
Table 3.1: Worldwide HbA1c Testing Market, 2008-2017 39
Table 3.2: U.S. HbA1c Testing Market, 2008-2017 41
Table 3.3: Global HbA1c Self-Testing Market, 2008-2017 42
Table 3.4: Key Players in the HbA1c Clinical Laboratory Market 43
Table 3.5: Key Players in the HbA1c POC Market 44
Table 3.6: Key Players in the HbA1c Self-Testing Market 44
Table 3.7: Key Market Drivers for HbA1c Testing 46
Table 4.1: Summary of the 2010 Consensus Statement on the Worldwide
Standardization of HbA1c 53
Table 4.2: Advantages of HbA1c versus Blood Glucose Testing 55
Table 4.3: Disadvantages of HbA1c versus Blood Glucose Testing 56
Table 4.4: HbA1c Testing Recommendations 56
Table 4.5: Criteria for the Diagnosis of Diabetes 57
Table 4.6: Categories of Increased Risk for Diabetes (Pre-Diabetes) 57
Table 4.7: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 59
Table 4.8: Glycemic Recommendations for Women with Gestational Diabetes 60
Table 4.9: Glycemic Recommendations for Pregnant Women with Pre-existing
Diabetes 60
Table 4.10: Conditions Known to Interfere with HbA1c Assays 63
Table 4.11: Interference from Hb Variants in Select HbA1c Testing Systems 64
Table 4.12: History of NGSP Manufacturer Certification Criteria 65
Table 4.13: Correlation of HbA1c with Mean Blood Glucose 67
Table 5.1: HbA1c Testing Devices and Assays on the Market 68
Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs 95

To order this report:
Pathology Industry:
Hemoglobin A1c Testing Markets

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