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Hemoglobin A1c Testing Markets
Date:3/25/2013

r/>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 (I
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