糖尿病におけるグルコースモニタリング：米国市場の予測と競争企業の分析

The study, The U.S. Diabetes Glucose Monitoring Market?Forecasts and Competitor Analysis, examines all the major trends and issues affecting the diabetes monitoring device industry. The report provides a detailed analysis of each of the six major device categories?

• Point-of-Care (POC) blood glucose meters
• Blood glucose meter test strips,
• Lancets and lancing devices,
• Non- and minimally-invasive blood glucose meters,
• POC glycated hemoglobin testing products, and
• Urine glucose/metabolite monitoring strips.

The report provides: market forecasts in wholesale dollars, units and average wholesale prices for years 2002-2008 for all product categories; analyses of product trends, including discussions of new products and technology, line extensions, and pipeline information; a detailed market environment; pricing and distribution trends; and competitor strategies? Including market shares and company profiles of all the major manufacturers. The report also covers diabetes incidence and prevalence by type; disease management; patient compliance; complications of diabetes; managed care; and prevention. Finally, an entire chapter is devoted to clinical laboratory testing and its position in the market in terms of point-of-care (POC) in the professional setting.

Both primary and secondary research was conducted for this report. Secondary information contributed to background information and was provided through literature searches, directories, journal articles, and medical textbooks.

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