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Hemoglobin A1c Testing Markets

  • September 2015
  • -
  • TriMark Publications
  • -
  • 137 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

Hemoglobin A1c Testing Markets










TABLE OF CONTENTS



1. Overview 9

1.1 Statement of Report 9

1.2 About this Report 9

1.3 Scope of the Report 10

1.4 Methodology 11

1.5 Executive Summary 12

2. Diabetes 14

2.1 Demographics of Diabetes 15

2.1.1 Worldwide Diabetes Incidence 15

2.1.2 Diabetes in the U.S. 19

2.2 Understanding the Metabolic Conditions Underlying and Associated with
Diabetes 24

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 26

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 30

2.2.6.1 Preventing Complications and Co-Morbidities in Diabetes 34

2.2.6.2 Cardiovascular Disease Facts 35

2.3 Economics of Diabetes 38

2.3.1 Worldwide Costs of Diabetes 38

2.3.2 Costs of Diabetes in the U.S. 39

3. Market Analysis: Size, Growth, Share and Competitors 44

3.1 Worldwide HbA1c Testing Market 45

3.1.1 U.S. HbA1c Testing Market 46

3.2 HbA1c Self-Testing Market 47

3.3 Competitive Situation 49

3.3.1 Analyses of the Key Players, Current Market Conditions, and Product Mix 49

3.3.2 Competitive Strategies and Strategic Recommendations 50

3.3.3 Future Competing Technologies—Glycated Albumin 51

3.4 Market Drivers and Restraints 52

3.4.1 Market Drivers 52

3.4.2 Market Restraints 53

3.5 Market and Product Trends 53

3.5.1 Increase in POC HbA1c Testing 53

3.5.2 Move Towards Screening for Diabetes Using HbA1c Assays 54

3.6 Adjacent Markets 54

4. Overview of HbA1c Testing 55

4.1 Technology Platforms Used to Measure HbA1c 56

4.1.1 High-Performance Liquid Chromatography (HPLC) 56

4.1.2 Immunoassays 56

4.1.3 Boronate Affinity Chromatography 56

4.1.4 Enzymatic Assay 57

4.1.5 Micro-Optical Detection Methods 57

4.2 Development of HbA1c Testing: A Historical Evaluation 57

4.2.1 The Diabetes Control and Complications Trial (DCCT) 57

4.3 Standardization of HbA1c Testing and Certification Criteria 58

4.3.1 National Glycohemoglobin Standardization Program (NGSP) 58

4.3.2 International Federation of Clinical Chemistry (IFCC) 59

4.3.3 New NGSP Certification Criteria 59

4.3.4 ADAG (A1c Derived Average Glucose) 59

4.3.5 2010 Consensus Statement on the Worldwide Standardization of HbA1c 60

4.3.6 College of American Pathologists (CAP) Proficiency Program 60

4.3.7 Certifications and Selecting HbA1c Assays 61

4.4 Advantages and Disadvantages of HbA1c Assessment 61

4.5 HbA1c Testing Recommendations 63

4.5.1 Frequency of HbA1c Testing 63

4.5.2 Diagnostic HbA1c Testing 63

4.5.3 Screening for Pre-diabetes 65

4.5.4 HbA1c Testing for Diabetes Management and Glycemic Goals 66

4.5.5 New HbA1c Target Recommendation for Children with Type 1 Diabetes 67

4.6 Accuracy and Precision in HbA1c Testing 67

4.6.1 Biological Variation 67

4.6.2 Pre-Analytical Variation 68

4.6.3 Analytical Variation 68

4.7 Potential Interfering Variables Affecting HbA1c Testing 69

4.8 Potential Areas of Improvement in HbA1c Testing Performance 71

4.9 Optimizing of Point of Care (POC) HbA1c Testing 72

4.10 Key Issues for HbA1c Testing 72

4.11 HbA1c Testing and Blood Glucose Testing: Complementary Tools 73

5. HbA1c Testing Devices on the Market 74

5.1 HbA1c Self-Testing Devices 75

5.1.1 A1CNow SELFCHECK 75

5.1.2 DTI Laboratories, Inc. 76

5.2 Professional HbA1c Testing Devices 76

5.2.1 Point of Care HbA1c Testing 76

5.2.1.1 A. Menarini Diagnostics 76

5.2.1.2 Alere 76

5.2.1.3 Apex Biotechnology 77

5.2.1.4 Convergent Technologies GmbH andamp; Co. 77

5.2.1.5 DiaSys Diagnostic Systems 77

5.2.1.6 Diazyme Laboratories 77

5.2.1.7 EKF Diagnostics 78

5.2.1.8 Eurolyser 78

5.2.1.9 Green Cross Medis (formerly Ceragem Medisys) 78

5.2.1.10 HemoCue (a division of Radiometer) 78

5.2.1.11 Infopia 79

5.2.1.12 Roche 79

5.2.1.13 SD Biosensor 79

5.2.1.14 Siemens Healthcare Diagnostics 80

5.2.2 HbA1c Laboratory Testing 80

5.2.2.1 Abbott 80

5.2.2.2 Alere 81

5.2.2.3 AMS 81

5.2.2.4 Arkray 82

5.2.2.5 Beckman Coulter 82

5.2.2.5 Bio-Rad 83

5.2.2.7 DiaSys Diagnostic Systems 84

5.2.2.8 Diazyme Laboratories 85

5.2.2.9 Diatron 85

5.2.2.10 EKF Diagnostics 86

5.2.2.11 ELITechGroup 87

5.2.2.12 Green Cross Medis (formerly Ceragem Medisys) 87

5.2.2.13 Kyowa Medex, Co., Ltd. 87

5.2.2.14 Ortho Clinical Diagnostics (part of Johnson andamp; Johnson) 88

5.2.2.15 Pointe Scientific, Inc. (part of MedTest Holdings) 88

5.2.2.16 Randox Laboratories 89

5.2.2.17 Roche 89

5.2.2.18 Sebia 89

5.2.2.19 Siemens Healthcare Diagnostics 89

5.2.2.20 Tosoh 90

5.2.2.21 Trinity Biotech 91

5.3 New Product Innovations and Introductions 92

5.3.1 Roche's Cobas Integra 800 Tina-quant HbA1cDx Assay Is First FDA-approved
Test for Diagnosing Diabetes 92

5.3.2 Abbott Announces FDA Clearance for a its ARCHITECT Clinical Chemistry
Hemoglobin A1c Test for the Diagnosis and Monitoring of Diabetes 93

5.3.3 Sebia Announces a New HbA1c Test 93

5.3.4 Sebia's CAPILLARYS 2 FLEX Piercing System 93

5.3.5 Sebia's MINICAP Flex Piercing 93

5.3.6 Shelf-life of EKF Diagnostics' Quo-Lab HbA1c Test Extended 93

5.3.7 Convergent Technologies Launches Convergys® HbA1c 94

5.3.8 Beckman Coulter Receives FDA Clearance on Next Generation Hemoglobin A1c
Test 94

5.3.9 Trinity Biotech Launches the Premier Hb9210 94

5.3.10 Trivitron to Enter HbA1c Market 94

5.3.11 Siemens Healthcare Announced a New Version of the DCA Vantage Analyzer 94

5.3.12 EKF Diagnostics to Launch the Quo-Lab HbA1c 94

5.3.13 Tosoh Introduces the ST AIA-PACK HbA1c Assay 95

5.3.14 Tosoh Introduces a Comprehensive HbA1c Product Line 95

5.3.15 Abnova's Personal A1c Diabetes Rapid Test 95

5.3.16 FDA Clears Ortho-Clinical Diagnostics' Enhanced HbA1c Reagent Kit 96

5.4 Recent Industry Activity andamp; Corporate Developments 96

5.4.1 PTS, Inc. (now Chek Diagnostics) Acquires A1CNow from Bayer Diabetes Care
96

5.4.2 Polymer Technology Systems, Inc. (PTS, Inc.) Changes Name to Chek
Diagnostics 96

5.4.3 EKF Diagnostics Quo-Test and Quo-Lab HbA1c POCT Analyzers Comparable to
Laboratory HPLC 96

5.4.4 Radiometer Medical ApS Acquires HemoCue AB 96

5.4.5 Axis-Shield Acquired by Alere 97

5.4.6 EKF Diagnostics Opens New Manufacturing Facility at its Quotient
Diagnostics Base 97

5.4.7 EKF Diagnostics Acquires Quotient Diagnostics 97

5.4.8 EKF Diagnostics Acquires Stanbio Laboratories 97

5.4.9 Geonostics Acquires FlexSite's Diagnostics 97

5.4.10 Trinity Biotech Signs Distribution Agreements with Fisher and Menarini
Diagnostics 98

5.4.11 Pointe Scientific Acquired by MedTest Holdings 98

6. Business Trends in HbA1c Testing 99

6.1 Drivers and Trends of Clinical HbA1c Testing 99

6.2 Healthcare Cost Controls 99

6.3 Affordable Care Act Excise Tax on Medical Devices 99

6.4 Changes in Patient Management 99

6.5 Regionalization of Laboratory Care 100

6.6 Satellite Facilities 101

6.7 Professional Point of Care Testing 101

6.7.1 Key Issues in the POC Diagnostic Testing Sector 102

6.7.2 Current Market Trends and Drivers 102

6.7.3 POC HbA1c 104

6.7.4 Effectiveness of POCT 104

6.7.5 Key Customer Segments 104

6.7.5.1 DELTA Dentists of New Jersey to Offer In-Office A1c Diabetes Testing 105

6.8 Factors Affecting OTC Medical Product Distribution 105

6.9 Drivers and Restraints of OTC and Self-Testing HbA1c Markets 107

7. Regulatory Environment and Insurance Reimbursements 108

7.1 U.S. Government Regulation of Medical Devices 108

7.2 E.U. Regulation of Medical Devices 109

7.3 FDA Labeling Requirements 114

7.4 Clinical Laboratory Improvement Act (CLIA) 114

7.5 HbA1c Testing Insurance Coverage and Reimbursement 117

7.6 Managed Care 118

8. Company Profiles 119

8.1 Abbott Laboratories 119

8.2 Alere, Inc. 122

8.3 A. Menarini Diagnostics 123

8.4 AMS Alliance 123

8.5 Apex Biotechnology Corporation 123

8.6 ARKRAY USA, Inc. 124

8.7 Axis-Shield Plc 124

8.8 Bayer Healthcare Diagnostics 124

8.9 Beckman Coulter, Inc 126

8.10 Bio-Rad Laboratories, Inc. 131

8.11 Convergent Technologies GmbH 132

8.12 DiaSys Diagnostics 132

8.13 Diazyme Laboratories (a Division of General Atomics) 132

8.14 Diatron 132

8.15 DTI Laboratories, Inc. 132

8.16 EKF Diagnostics 133

8.17 ELITechGroup 134

8.18 Eurolyser 134

8.19 Green Cross Medis (formerly Ceragem Medisys) 134

8.20 HemoCue AB (now part of Radiometer Medical) 134

8.21 Infopia Co., Ltd. 134

8.22 Kyowa Medex 135

8.23 Ortho Clinical Diagnostics (part of Johnson andamp; Johnson) 135

8.24 Pointe Diagnostics 135

8.25 PTS Diagnostics 135

8.26 Randox Laboratories 136

8.27 Roche Diagnostics 136

8.28 SD Biosensor 138

8.29 Sebia 138

8.30 Siemens AG 138

8.31 Tosoh Bioscience, Inc. 138

8.32 Trinity Biotech Plc 139



INDEX OF FIGURES



Figure 2.1: Worldwide Diabetes Cases, 2014 and 2035 15

Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years) 16

Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age
20

Figure 2.4: Prevalence of Diabetes by Age in the U.S. 20

Figure 2.5: Diagnosed Diabetes by Age in the U.S. 21

Figure 2.6: Percentage of U.S. Adults Diagnosed Diabetes by State 22

Figure 2.7: Number of Deaths from Diabetes by Age in the U.S. 23

Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S. 23

Figure 2.9: Maintenance of Normal Blood Sugar Levels 24

Figure 2.10: Prevalence of Self-Reported Obesity (BMI ³30) Among U.S. Adults 28

Figure 2.11: Prevalence of Obesity (BMI =30) Among Adults in the U.S. 28

Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S. 29

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. 31

Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility
Limitation, by Age, United States 33

Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with
Diagnosed Diabetes Reporting Visual Impairment, United States 34

Figure 2.16: Mean Diabetes Healthcare-related Expenditures Per Adult (20-79
Years) with Diabetes (USD) 39

Figure 2.17: How Diabetes Dollars are Spent in the U.S. 41

Figure 3.1: Worldwide HbA1c Testing Market 46

Figure 3.2: U.S. HbA1c Testing Market 47

Figure 3.3: Global HbA1c Self-Testing Market 48

Figure 4.1: Non-Enzymatic Glycation of Hemoglobin 55

Figure 4.2: Boronate Affinity Binding of Glycated Protein 57

Figure 4.3: Comparison of HbA1C and Blood Glucose Measurements over a Four-Day
Period 62

Figure 4.4: Range of Variation in HbA1c Assay 69

Figure 4.5: Range of Variation in the FPG Assay 69

Figure 7.1: CLIA Laboratories by Certificate Types 115



INDEX OF TABLES



Table 2.1: Regional Estimates of the Number of Diabetes (20-79 Years) in
Millions, 2013 and 2035 16

Table 2.2: Countries with the Largest Numbers of Diabetics 17

Table 2.3: Countries with the Largest Estimated Numbers of Diabetics, 2035 17

Table 2.4: Worldwide Undiagnosed Diabetes in Adults (20-79 Years) by Region and
Income Group 18

Table 2.5: Countries with the Largest Number of Deaths Attributable to Diabetes
18

Table 2.6: New Cases of Diagnosed Diabetes Among U.S. Adults Aged 20 Years or
Older 19

Table 2.7: U.S. Population of Diagnosed Diabetics Aged 20-79 Years, 2013 20

Table 2.8: Percentage of U.S. Adults with Diagnosed Diabetes by State, 2013 21

Table 2.9: Ten Leading Diagnoses for Co-Morbid Chronic Diseases in the U.S. 30

Table 2.10: Odds Ratio of Progression to Complications Associated with Type 2
Diabetes 32

Table 2.11: Prevalence of Complications Among Patients with Diabetes 32

Table 2.12: Major Causes of End-stage Renal Disease 32

Table 2.13: Novel Risk Factors and Possible Mechanisms of the Excess Risk of
Coronary Heart Disease in Type 2 Diabetes Mellitus 33

Table 2.14: Clinical Recommendations for Adults with Diabetes 34

Table 2.15: Laboratory Assessment of Diabetic Vascular Disease 35

Table 2.16: Average Years Gained Free of Diabetes-related Disease with Intensive
Management 35

Table 2.17: Estimated Direct and Indirect Costs of Major Cardiovascular Diseases
and Stroke in the U.S. 37

Table 2.18: Cost of Diagnosed Diabetes in the U.S. 40

Table 2.19: Annual Cost of Care of United Healthcare Adult Members with Diabetes
41

Table 2.20: Healthcare Utilization by Diabetic Patients 42

Table 3.1: Worldwide HbA1c Testing Market, 2010-2019 45

Table 3.2: U.S. HbA1c Testing Market, 2010-2019 47

Table 3.3: Global HbA1c Self-Testing Market, 2010-2019 48

Table 3.4: Key Players in the HbA1c Clinical Laboratory Market 49

Table 3.5: Key Players in the HbA1c POC Market 50

Table 3.6: Key Players in the HbA1c Self-Testing Market 50

Table 3.7: Key Market Drivers for HbA1c Testing 52

Table 4.1: Summary of NGSP Certification Criteria 59

Table 4.2: Summary of the 2010 Consensus Statement on the Worldwide
Standardization of HbA1c 60

Table 4.3: Advantages of HbA1c versus Blood Glucose Testing 62

Table 4.4: Disadvantages of HbA1c versus Blood Glucose Testing 62

Table 4.5: HbA1c Testing Recommendations 63

Table 4.6: Criteria for the Diagnosis of Diabetes 64

Table 4.7: Categories of Increased Risk for Diabetes (Pre-Diabetes) 65

Table 4.8: Glycemic Recommendations for Non-Pregnant Adults with Diabetes 66

Table 4.9: Glycemic Recommendations for Women with Gestational Diabetes 66

Table 4.10: Glycemic Recommendations for Pregnant Women with Pre-existing
Diabetes 66

Table 4.11: Conditions Known to Interfere with HbA1c Assays 70

Table 4.12: Interference from Hb Variants in Select HbA1c Testing Systems 71

Table 4.13: History of NGSP Manufacturer Certification Criteria 72

Table 4.14: Correlation of HbA1c with Mean Blood Glucose 73

Table 5.1: HbA1c Testing Devices and Assays on the Market 74

Table 5.2: Premier Hb9210 Placements Worldwide 92

Table 7.1: Financial Comparison for Moderate and Waived CLIA Labs 116








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