Glucose Self-Testing Industry Capacity, Production, Revenue, Price, Cost, Gross Margin Analysis

The worldwide incidence of diabetes is dramatically increasing, and it is estimated that 439 million people will have developed the disease by 2030. As such, the global market for blood glucose self-testing products is undergoing a significant transition driven by the advent of new analytical technologies and new recommendations for tight glucose control for monitoring diabetes. In addition, the proliferation of the middle class within developing nations, particularly China and India, has resulted in both a substantial rise in Type 2 diabetes and the financial means to manage the disease. The purpose of this report is to provide a comprehensive analysis of the specific segment of the over-the-counter diagnostics sector known as the glucose self-testing market.

The term “self-testing” is used to distinguish it from in vitro diagnostics testing for blood glucose in hospitals, commercial labs and doctor’s offices, the so-called “professional” component of the glucose testing market. This study reviews the viable technology drivers and assesses the market dynamics of the glucose self-testing market worldwide. This report also looks at the industry challenges and potential threats, and it makes strategic recommendations for boosting market share. Detailed tables and charts with sales forecasts and market share data are also included.

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Table of Contents

1. Overview 13

2. Diabetes 20

3. Market Analysis: Size, Growth, Share and Competitors 47

4. Glucose Diagnostic and Monitoring Recommendations 78

5. Glucose Self-Testing Technology Platforms and Consumable Products 91

6. Glucose Self-Testing Meters on the Market: Description of Test Meters 148

7. Business Trends in the Industry 208

8. Technology Trends 231

9. OTC Testing: Critical Issues 246

10. Current Issues for OTC and Diagnostic Self-Testing 248

11. SWOT Analysis 257

12. Company Profiles 260

List of Figures

Figure 2.1: Worldwide Diabetes Cases, 2014 and 2035 21

Figure 2.2: Worldwide Prevalence of Diabetes (%) in Adults (20-79 Years) 22

Figure 2.3: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age 26

Figure 2.4: Prevalence of Diabetes by Age in the U.S. 26

Figure 2.5: Diagnosed Diabetes by Age in the U.S. 27

Figure 2.6: Percentage of U.S. Adults Diagnosed Diabetes by State 28

Figure 2.7: Number of Deaths from Diabetes by Age in the U.S. 29

Figure 2.8: Number of Diabetes Deaths by Race and Sex in the U.S. 29

Figure 2.9: Maintenance of Normal Blood Sugar Levels 30

Figure 2.10: Prevalence of Self-Reported Obesity (BMI ³30) Among U.S. Adults 34

Figure 2.11: Prevalence of Obesity (BMI =30) Among Adults in the U.S. 34

Figure 2.12: Trends in Obesity Among Children and Adolescents in the U.S. 35

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. 37

Figure 2.14: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S. 39

Figure 2.15: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment in the U.S. 40

Figure 2.16: Mean Diabetes Healthcare-Related Expenditures Per Adult (20-79 Years) with Diabetes 42

Figure 2.17: How Diabetes Dollars are Spent in the U.S. 44

Figure 3.1: Geographic Segments of the Worldwide Glucose Self-Testing Market 50

Figure 3.2: Worldwide Glucose Self-Testing Market by Region 50

Figure 3.3: Worldwide Glucose Self-Testing Market Segments 51

Figure 4.1: Approach to Management of Hypoglycemia 84

Figure 4.2: Glycemic Status—Ranges and Health Implications 90

Figure 5.1: EGA Zones of Clinical Accuracy 100

Figure 5.2: Single-Day Continuous Blood Glucose Data 107

Figure 5.3: Factors that may Adversely Affect Glucose Testing 108

Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region, 2014 124

Figure 6.1: Medtronic’s Threshold Suspend Feature 183

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