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Hemoglobin A1c Testing Markets
Date:3/25/2013

>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.,
196
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