The U.S. Diabetes Glucose Monitoring Market--Forecasts and Competitor Analysis

EXECUTIVE SUMMARY ES-1

Scope and Methodology ES-2

Diabetes Overview ES-3

• Types of Diabetes ES-3
• Incidence and Prevalence ES-4
• Mortality Rates ES-5
• Complications ES-6

Disease Management Programs ES-7

• Diabetes Prevention and Control Trial (DCCT) ES-7
• Patient Compliance and Education ES-7

Reimbursement ES-9

Serum/Plasma Chemistry Testing Systems ES-10

• Glucose Testing ES-10
• The Clinical Laboratory ES-10
• General Chemistry Analyzer Products ES-10
• Quality Assurance/Quality Control Procedures ES-11

Point-of Care (POC) Blood Glucose Monitoring Devices ES-12

• Glucose Meters ES-12
• Blood Glucose Test Strips ES-12
• Lancets and Lancing Devices ES-13
• Noninvasive and Minimally Invasive Monitoring Devices ES-13
• Glycated Hemoglobin Testing Products ES-13
• Urine Glucose/Metabolite Monitoring Strips ES-14

Market Analysis ES-15

TABLE OF CONTENTS

Chapter 1. Clinical And Statistical Overview 1-1

Overview 1-2

Types of Diabetes 1-4

• Type 1 Diabetes 1-4
• Type 2 Diabetes 1-6
• Gestational Diabetes 1-8
• Pre-Diabetes (Formerly Impaired Glucose Tolerance) 1-9

Incidence and Prevalence 1-12

• Type 1 Statistics 1-12
• Type 2 Statistics 1-14

Mortality Rates 1-16

• Complications 1-16
• Eye Diseases 1-16
• Cardiovascular Disease 1-17
• Renal Disease 1-19
• Neuropathy 1-20
• Other Complications 1-20

Disease Management Programs 1-22

• Rationale For Program Development 1-23
• Program Types and Sponsors 1-24

Patient Compliance and Education 1-31

Prevention and Management of Complications 1-33

Patient Outcomes 1-34

Reimbursement 1-36

Chapter 2: Serum/Plasma Chemistry Testing Systems 2-1

Overview 2-2

• Glucose Testing 2-2
• The Clinical Laboratory 2-2
• Test Volumes 2-4
• Product Development 2-6

Laboratory Automation 2-7

General Chemistry Analyzer Products 2-9

Dedicated Glucose Analyzers 2-12

Quality Assurance/Quality Control Procedures 2-13

• Capillary Versus Venous Blood 2-14

Market Forecast and Analysis 2-16

• Capital Equipment Market Forecasts 2-17
• Consumables Market Forecasts 2-19

Market Shares and Competitor Analysis 2-20

Chapter 3: pOINT-OF-cARE (POC) Blood Glucose Meters?Consumer and Professional Models 3-1

Overview 3-2

Point-of-Care (POC) Blood Glucose Meters 3-3

• Blood Glucose Self Testing 3-4
• Self-Monitoring with Personal Blood Glucose Meters 3-6
• Professional Meters 3-10
• Alternative Site Meters 3-10
• Data-Management Systems 3-11
• Web-based Systems 3-11
• Glucose Meters and Personal Digital Assistants (PDAs) 3-12
• Market Forecasts and Analysis 3-20

Blood Glucose Test Strips 3-23

• Market Shares and Competitive Analysis 3-26
• Market Forecasts and Analysis 3-29

Lancets and Lancing Devices 3-31

• Market Shares and Competitive Analysis 3-37
• Market Forecasts and Analysis 3-38

Noninvasive and Minimally Invasive Monitoring Devices 3-41

• Technological Developments 3-41
• Market Shares and Competitive Analysis 3-45
• Market Forecasts and Analysis 3-51

Glycated Hemoglobin Testing Products 3-51

• Testing Methods 3-54
• Competitive Strategies 3-55
• Market Shares and Competitive Analysis 3-59
• Market Forecasts and Analysis 3-59

Urine Glucose/Metabolite Monitoring Strips 3-61

• Urine Ketone Tests 3-61
• Urine Glucose Tests 3-61
• Market Shares and Competitive Analysis 3-63
• Market Forecasts and Analysis 3-64

Chapter 4: COMPANY PROFILES 4-1

• Abbott Laboratories (MediSense) 4-2
• Beckman Coulter, Inc. 4-4
• Bayer Diagnostics, Inc./Bayer AG 4-6
• Becton Dickinson and Company 4-7
• Cell Robotics International, Inc. 4-8
• Cygnus, Inc. 4-10
• Dade Behring, Inc. 4-11
• Home Diagnostics, Inc. 4-12
• Hypoguard USA (MediSys) 4-13
• InLight Solutions, Inc. 4-15
• Kendall Healthcare (a Tyco company) 4-16
• LifeScan, Inc. (Johnson and Johnson) 4-17
• LighTouch Medical Inc. 4-19
• LifeTrac Systems, Inc. 4-20
• Owen Mumford 4-21
• Roche Diagnostics, Inc./F. Hoffmann La Roche ltd 4-22
• Spectrx, Inc. 4-24
• TheraSense USA 4-26

Appendix A: Company Listing A-1

LIST OF TABLES

EXECUTIVE SUMMARY ES-1

Table ES-1: Diabetes Prevalence Forecast, 2002-2008 ES-5

Table ES-2: U.S. Diabetes Point-of-Care (POC) Glucose Monitoring

Market Forecasts, 2003, 2008 ES-17

Chapter 1. Clinical And Statistical Overview 1-1

Table 1-1: Diabetes Prevalence Forecast, 2002-2008 1-12

Table 1-2: U.S. Diagnosed Diabetes Population, 2002-2008 1-14

Chapter 2: Serum/Plasma Chemistry Testing Systems 2-1 Table 2-1: Most Commonly Performed General Chemistry Tests 2-4

Table 2-2: General Chemistries Test Volumes, 2002-2008 2-6

Table 2-3: General Chemistry Testing Products, Market Forecast,

2002-2008 2-17

Table 2-4: General Chemistry Testing Equipment, Market Forecast,

2002-2008 2-18

Table 2-5: General Chemistry Testing Reagents and Supplies,

Market Forecast, 2002-2008 2-19

Table 2-6: 2002, General Chemistry Testing Products Market,

Share by Supplier 2-21

Chapter 3: Point-of-Care (POC) Blood Glucose Meters?Consumer and Professional Models 3-1

Table 3-1: Self-monitoring U.S. Diabetes Patient Population, 2002-2008 3-5

Table 3-2: Selected Glucose Systems Currently Available, 2003 3-8

Table 3-3: 2002, Invasive Blood Glucose Meter Market,

Share by Supplier 3-13

Table 3-4: U.S. Market for POC Invasive Blood Glucose Meters,

Market Forecast, 2002-2008 3-21

Table 3-5: Selected Blood Glucose Test Strips Currently

Available, 2003 3-24

Table 3-6: 2002, Glucose Test Strips, Share by Supplier 3-27

Table 3-7: U.S. Glucose Test Strip, Market Forecast, 2002-2008 3-30

Table 3-8: Selected Lancets and Lancing Devices Currently Available 3-34

Table 3-9: 2002, Lancets and Lancing Devices, Market Share by Supplier 3-38

Table 3-10: U.S. Lancets and Lancing Devices, Market Forecast,

2002-2008 3-40

Table 3-11: Selected Minimally and Noninvasive Blood Glucose

Monitoring Products in Development, 2003 3-42

Chapter 3: Continued

Table 3-12: U.S. Noninvasive and Minimally Invasive Glucose Meters, Market Forecast, 2002-2008 3-53

Table 3-13: Selected Glycated Hemoglobin Testing Products Currently

Available, 2003 3-57

Table 3-14: Selected Mail-in At-home Glycated Hemoglobin

Testing Services, 2003 3-58

Table 3-15: 2002, POC Glycated Hemoglobin (HbA1c )Test Supplies and Disposables, Share by Supplier 3-59

Table 3-16: U.S. POC Glycated Hemoglobin (HbA1c)Tests Disposables,

Market Forecast, 2002-2008 3-60

Table 3-17: Selected Glucose and Ketone Urine Tests Currently

Available, 2003 3-63

Table 3-18: 2002, Glucose and Ketone Urine Tests, Share by Supplier 3-64

Table 3-19: U.S. Glucose and Ketone Urine Tests,

Market Forecast, 2002-2008 3-65