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U.S. Glucose Testing Industry Capacity, Production, Revenue, Price, Cost, Gross Margin Analysis

Friday, September 30, 2016 2:38
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U.S. glucose testing is undergoing a significant transition, driven by new analytical technologies and developments in diabetes treatment. Although the blood glucose testing segment of the in vitro diagnostics (IVD) industry is mature, several segments of the market, such as home testing devices for diabetes management and point of care (POC) instruments for use in professional settings, will exhibit strong growth. Direct access testing has emerged as a strong force in the blood glucose testing segment and non-invasive and minimally-invasive testing now represent major new areas for the application of IVD testing.

This report describes the specific market segments for blood glucose testing and diabetes management in the U.S. market. It reviews all of the generally-accepted clinical analytical methods that are currently in use today for measuring serum, plasma or whole-blood glucose concentrations. Additionally, this study examines clinical measurement devices, reagents and supplies as utilized in hospitals, clinics, doctor’s offices and at-home care locations. Moreover, it analyzes almost all of the companies known to be marketing, manufacturing or developing glucose testing products for the U.S. market. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company’s market position. Detailed tables and charts with sales forecasts and market data are also included.

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Table of Contents

1. Overview 14

2. Diabetes 19

3. Market Analysis: Size, Growth, Share and Competitors 45

4. Glucose Diagnostic and Monitoring Recommendations 70

5. Glucose Testing Technology Platforms and Consumable Products 86

6. Glucose Testing Devices on the Market 128

7. Business Trends in Glucose Testing 211

8. Technology Trends 229

9. Company Profiles 252

List of Figures

Figure 2.1: New Cases of Diabetes Diagnosed in the U.S. Adult Population by Age 21
Figure 2.2: Prevalence of Diabetes by Age in the U.S. 21
Figure 2.3: Diagnosed Diabetes by Age in the U.S. 22
Figure 2.4: Percentage of U.S. Adults Diagnosed Diabetes by State 24
Figure 2.5: Number of Deaths from Diabetes by Age in the U.S. 24
Figure 2.6: Number of Diabetes Deaths by Race and Sex in the U.S. 25
Figure 2.7: Maintenance of Normal Blood Sugar Levels 26
Figure 2.8: Prevalence of Self-Reported Obesity (BMI ³30) Among U.S. Adults 29
Figure 2.9: Prevalence of Obesity (BMI =30) Among Adults in the U.S. 30
Figure 2.10: Trends in Obesity Among Children and Adolescents in the U.S. 30
Figure 2.11: Age-Adjusted Percentage of People with Diabetes Aged 35 Years or Older Reporting Heart Disease or Stroke, by Sex, in the U.S. 32
Figure 2.12: Percentage of Adults with Diagnosed Diabetes Reporting Any Mobility Limitation, by Age, in the U.S. 35
Figure 2.13: Number (in Millions) of Adults Aged 18 Years or Older with Diagnosed Diabetes Reporting Visual Impairment, in the U.S. 35
Figure 2.14: How Diabetes Dollars are Spent in the U.S. 42
Figure 3.1: Forecasted Test Strip Usage by Different Diabetic Populations 48
Figure 4.1: Approach to Management of Hypoglycemia 76
Figure 4.2: Glycemic Status—Ranges and Health Implications 81
Figure 5.1: EGA Zones of Clinical Accuracy 96
Figure 5.2: Single-Day Continuous Blood Glucose Data 101
Figure 5.3: Factors that may Adversely Affect Glucose Testing 103
Figure 5.4: Personal Lancet Unit Sales Market Share by Geographic Region 121
Figure 6.1: Medtronic’s Threshold Suspend Feature 185

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