Table of Contents
1 Table Of Contents 2
1.1 List of Tables 8
1.2 List of Figures 10
2 Introduction 11
2.1 What Is This Report About? 11
3 Definitions of
the Markets Covered in the Report 12
3.1 Diabetes Care Devices 12
3.2
Glucose Monitoring 12
3.2.1 Blood Glucose Meter 12
3.2.2 Blood Glucose
Strips 12
3.3 Insulin Delivery 12
3.3.1 Insulin Jet Injector 12
3.3.2 Insulin Pen 12
3.3.3 Insulin Pump 12
3.3.4 Insulin Syringes
13
4 Healthcare Sector Review 14
4.1 Healthcare Expenditure 14
4.2
Healthcare Infrastructure 19
4.2.1 Healthcare Personnel Data 21
4.2.2
Healthcare Facilities Data 24
5 Regulation System 26
5.1 Regulation
System 26
5.2 Medical Equipment Approval Process 26
5.2.1 Pre-market
Approval Process 27
5.2.2 Intended use and Indications for use 27
5.2.3 Predicate Device 28
5.2.4 Safe and Effective 28
5.2.5 Other
Category Devices 30
5.2.6 Post-Market Approval Process 31
5.2.7
Compliance and Enforcement 31
5.2.8 Registration Fee 32
5.2.9 Approval
Time 32
6 Pricing and Reimbursement 33
6.1 Government Policies 33
6.2 Private Insurance 34
6.3 Diagnosis Related Groups (DRG) 35
7
Distribution Structure 36
7.1 Distribution Structure 36
8 United
States Medical Equipment Cross Market Comparison 37
9 Diabetes Care
Devices Cross Country Comparison 39
10 Diabetes Care Devices in United
States 41
10.1 Diabetes Care Devices Overall Revenues by Category
(2000-2012) 41
10.2 Diabetes Care Devices Overall Company Share
(2006-2007) 45
11 Glucose Monitoring in United States 46
11.1 Glucose
Monitoring Revenues by Segment (2000-2012) 46
11.2 Glucose Monitoring
Volume by Segment (2000-2012) 48
11.3 Glucose Monitoring Average Price
(2000-2012) 49
11.4 Glucose Monitoring Distribution Share (2006-2007)
50
11.5 Glucose Monitoring Company Share (2006-2007) 51
12 Insulin
Delivery in United States 52
12.1 Insulin Delivery Revenues by Segment
(2000-2012) 52
12.2 Insulin Delivery Volume by Segment (2000-2012) 54
12.3 Insulin Delivery Average Price (2000-2012) 55
12.4 Insulin Delivery
Distribution Share (2006-2007) 56
12.5 Insulin Delivery Company Share
(2006-2007) 57
13 Overview Of Key Companies in the US Diabetes Care
Devices Market 58
13.1 F. Hoffmann-La Roche Ltd. Company Profile 58
13.1.1 Company Overview 58
13.1.2 Value Chain Analysis 59
13.1.2.1
Manufacturing 59
13.1.2.2 Product Development 60
13.1.2.3 Sales and
Marketing 61
13.2 LifeScan, Inc. Company Profile 62
13.2.1 Company
Overview 62
13.2.2 LifeScan, Inc. Pipeline Products 62
13.2.2.1
LifeScan, Inc. Pipeline Products By Equipment Type 62
13.2.2.2 LifeScan,
Inc. Pipeline Products By Development Stage 62
13.2.2.3 LifeScan, Inc.
Pipeline Products By Therapy Area 62
13.2.2.4 LifeScan, Inc. Pipeline
Products By Clinical Trials 63
13.2.2.5 LifeScan, Inc. Pipeline Products
By News Summary 63
13.3 Abbott Laboratories Company Profile 64
13.3.1
Company Overview 64
13.3.2 Value Chain Analysis 65
13.3.2.1
Manufacturing 65
13.3.2.2 Product Development 65
13.3.2.3 Clinical
Trials 66
13.3.2.4 Sales and Marketing 67
13.4 Novo Nordisk A/S
Company Profile 68
13.4.1 Company Overview 68
13.4.2 Novo Nordisk A/S
Pipeline Products 68
13.4.2.1 Novo Nordisk A/S Pipeline Products By
Equipment Type 68
13.4.2.2 Novo Nordisk A/S Pipeline Products By
Development Stage 68
13.4.2.3 Novo Nordisk A/S Pipeline Products By
Therapy Area 69
13.4.2.4 Novo Nordisk A/S Pipeline Products By Clinical
Trials 69
13.5 Bayer HealthCare AG Company Profile 70
13.5.1 Company
Overview 70
13.5.2 Value Chain Analysis 71
13.5.2.1 Manufacturing
71
13.5.2.2 Product Development 72
13.5.2.3 Sales and Marketing 72
13.5.3 Bayer HealthCare AG Pipeline Products 73
13.5.3.1 Bayer HealthCare
AG Pipeline Products By Equipment Type 73
13.5.3.2 Bayer HealthCare AG
Pipeline Products By Development Stage 73
13.5.3.3 Bayer HealthCare AG
Pipeline Products By Therapy Area 73
13.5.3.4 Bayer HealthCare AG Pipeline
Products By News Summary 74
13.6 Eli Lilly and Company Company Profile
75
13.6.1 Company Overview 75
13.6.2 Value Chain Analysis 75
13.6.2.1 Manufacturing 76
13.6.2.2 Product Development 76
13.6.2.3
Sales and Marketing 77
13.6.3 Eli Lilly and Company Pipeline Products
77
13.6.3.1 Eli Lilly and Company Pipeline Products By Equipment Type
77
13.6.3.2 Eli Lilly and Company Pipeline Products By Development Stage
78
13.6.3.3 Eli Lilly and Company Pipeline Products By Therapy Area 78
13.6.3.4 Eli Lilly and Company Pipeline Products By Clinical Trials 78
13.7 Animas Corporation Company Profile 79
13.7.1 Company Overview 79
13.8 Cholestech Corporation Company Profile 79
13.8.1 Company Overview
79
13.9 Home Diagnostics, Inc. Company Profile 79
13.9.1 Company
Overview 79
13.10 Becton, Dickinson and Company Company Profile 80
13.10.1 Company Overview 80
13.10.2 Value Chain Analysis 81
13.10.2.1
Manufacturing 81
13.10.2.2 Product Development 81
13.10.2.3 Sales and
Marketing 82
13.11 DexCom, Inc. Company Profile 83
13.11.1 Company
Overview 83
13.11.2 DexCom, Inc. Pipeline Products 83
13.11.2.1
DexCom, Inc. Pipeline Products By Equipment Type 83
13.11.2.2 DexCom, Inc.
Pipeline Products By Equipment Type 83
13.11.2.3 DexCom, Inc. Pipeline
Products By Therapy Area 83
13.11.2.4 DexCom, Inc. Pipeline Products By
News Summary 83
13.12 Freedom Meditech, Inc. Company Profile 84
13.12.1 Company Overview 84
13.12.2 Freedom Meditech, Inc. Pipeline
Products 84
13.12.2.1 Freedom Meditech, Inc. Pipeline Products By
Equipment Type 84
13.12.2.2 Freedom Meditech, Inc. Pipeline Products By
Development Stage 84
13.12.2.3 Freedom Meditech, Inc. Pipeline Products By
Therapy Area 84
13.13 GlucoLight Corporation Company Profile 85
13.13.1 Company Overview 85
13.13.2 GlucoLight Corporation Pipeline
Products 85
13.13.2.1 GlucoLight Corporation Pipeline Products By
Equipment Type 85
13.13.2.2 GlucoLight Corporation Pipeline Products By
Development Stage 85
13.13.2.3 GlucoLight Corporation Pipeline Products By
Therapy Area 85
13.13.2.4 GlucoLight Corporation Pipeline Products By News
Summary 85
13.14 GlySens Incorporated Company Profile 86
13.14.1
Company Overview 86
13.14.2 GlySens Incorporated Pipeline Products 86
13.14.2.1 GlySens Incorporated Pipeline Products By Equipment Type 86
13.14.2.2 GlySens Incorporated Pipeline Products By Development Stage 86
14 United States Diabetes care Devices Market Financial Deals Landscape 87
14.1 Merger 87
14.1.1 Sontra Medical And Echo Therapeutics Completes
Merger 87
14.2 Venture Financing 89
14.2.1 Tandem Diabetes Care
Secures $13.05 Million In Series B Financing 89
14.2.2 Seattle Medical
Technologies Secures $21 Million In Series B Financing 90
14.2.3
GlucoLight Completes Third Tranche Of Series C Round Of Financing 91
14.2.4 Luminous Medical Secures $23.5 Million In Series B Financing 93
14.2.5 Critical Signal Technologies Raises $6 Million In Second Round
Financing 94
14.2.6 AgaMatrix Secures $23.7 Million In Series C Financing
Round 95
14.3 Debt Offerings 96
14.3.1 LifeScan Enters Into
Partnership With ResMed 96
14.3.2 Smiths Medical Enters Into Distribution
Agreement With Abbott Laboratories 97
14.3.3 DexCom Enters Into A Joint
Venture With Animas 99
14.3.4 Insulet Corporation And DexCom Form
Partnership 100
14.3.5 Bayer HealthCare Diabetes Care Signs An Agreement
With Medtronic 101
14.3.6 Roche Signs Licensing Agreement With Alnylam
Pharmaceuticals 103
15 United States Diabetes care Devices Market Recent
Developments 105
15.1 Government and Public Interest 105
15.1.1 May
05, 2008: FDA Study Finds Insulin Pumps Linked To Injuries, Deaths In
Teenagers 105
16 Appendix 106
16.1 Global Markets Direct Research
Methodology 106
16.2 Coverage 107
16.3 Secondary Research 107
16.4
Primary Research 108
16.5 Models 108
16.6 Forecasts 109
16.7
Expert Panels 109
16.8 Currency Conversion 110
16.9 Contact Us 111
16.10 Disclaimer 111
1.1 List of Tables
Table 1: United States
Healthcare Expenditure, 2003-2010 15
Table 2: United States Healthcare
Expenditure by Age (per person), 2000-2003 16
Table 3: United States
Healthcare Expenditure by Sex (per person), 2000-2003 16
Table 4: United
States Healthcare Expenditure by Race (per person), 2000-2003 16
Table 5:
United States Personal Healthcare Expenditure by Type, 2000-2004 17
Table
6: United States Personal Healthcare Expenditure by Source, 2000-2004 18
Table 7: Total Number of Doctors in the United States, 2003-2010 21
Table
8: Number of Doctors by Specialty in the United States, 2003-2010 22
Table
9: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 23
Table 10: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004
(Cont.) 24
Table 11: Total Hospitals in the United States, 2000-2004
24
Table 12: Community Hospitals by Number of Beds in the United States,
2000-2004 25
Table 13: Number of Hospital Beds in the United States,
2000-2004 25
Table 14: Number of Hospital Beds by Range in the United
States, 2000-2004 25
Table 15: Medical Equipment Registration Fee in
United States, 2007 32
Table 16: Medical Device Approval Time in United
States, 2004 32
Table 17: United States, Medical Equipment Market
Comparison 38
Table 18: Diabetes Care Devices, Revenues ($ mn) by Country,
2000-2012 40
Table 19: Diabetes Care Devices, United States, Category
Revenues ($ mn), 2000-2012 41
Table 20: Diabetes Care Devices Market,
United States, Portfolio Analysis 42
Table 21: Diabetes Care Devices,
United States, Category Revenues ($ mn), Historic, 2000-2007 43
Table 22:
Diabetes Care Devices, United States, Category Revenues ($ mn), Forecast,
2007-2012 44
Table 23: Diabetes Care Devices, United States, Overall
Company Share by Revenue ($ mn) 2006-2007 45
Table 24: Glucose Monitoring,
United States, Revenue ($ mn) by Segment, Historic, 2000-2007 46
Table 25:
Glucose Monitoring, United States, Revenue ($ mn) by Segment, Forecast,
2007-2012 47
Table 26: Glucose Monitoring, United States, Volume (Units)
by Segment, Historic, 2000-2007 48
Table 27: Glucose Monitoring, United
States, Volume (Units) by Segment, Forecast, 2007-2012 48
Table 28:
Glucose Monitoring, United States, Average Price ($), Historic, 2000-2007
49
Table 29: Glucose Monitoring, United States, Average Price ($),
Forecast, 2007-2012 49
Table 30: Glucose Monitoring, United States,
Distribution Share by Revenue ($ mn), 2006-2007 50
Table 31: Glucose
Monitoring, United States, Company Share by Revenue ($ mn), 2006-2007 51
Table 32: Insulin Delivery, United States, Revenue ($ mn) by Segment,
Historic, 2000-2007 52
Table 33: Insulin Delivery, United States, Revenue
($ mn) by Segment, Forecast, 2007-2012 53
Table 34: Insulin Delivery,
United States, Volume (Units) by Segment, Historic, 2000-2007 54
Table
35: Insulin Delivery, United States, Volume (Units) by Segment, Forecast,
2007-2012 54
Table 36: Insulin Delivery, United States, Average Price ($),
Historic, 2000-2007 55
Table 37: Insulin Delivery, United States, Average
Price ($), Forecast, 2007-2012 55
Table 38: Insulin Delivery, United
States, Distribution Share by Revenue ($ mn), 2006-2007 56
Table 39:
Insulin Delivery, United States, Company Share by Revenue ($ mn), 2006-2007
57
Table 40: LifeScan, Inc. Pipeline Products by Equipment Type
62
Table 41: LifeScan, Inc. Pipeline Products by Development Stage
62
Table 42: LifeScan, Inc. Pipeline Products By Therapy Area 62
Table 43: LifeScan, Inc. Pipeline Products By Clinical Trials 63
Table 44: LifeScan, Inc. Pipeline Products By News Summaries 63
Table
45: Novo Nordisk A/S Pipeline Products by Equipment Type 68
Table 46:
Novo Nordisk A/S Pipeline Products By Development Stage 68
Table 47:
Novo Nordisk A/S Pipeline Products By Therapy Area 69
Table 48:
Novo Nordisk A/S Pipeline Products By Clinical Trials 69
Table 49:
Bayer HealthCare AG Pipeline Products by Equipment Type 73
Table 50:
Bayer HealthCare AG Pipeline Products By Development Stage 73
Table 51:
Bayer HealthCare AG Pipeline Products By Therapy Area 73
Table 52:
Bayer HealthCare AG Pipeline Products By News Summaries 74
Table 53:
Eli Lilly and Company Pipeline Products by Equipment Type 77
Table 54:
Eli Lilly and Company Pipeline Products by Development Stage 78
Table 55:
Eli Lilly and Company Pipeline Products By Therapy Area 78
Table 56:
Eli Lilly and Company Pipeline Products By Clinical Trials 78
Table
57: DexCom, Inc. Pipeline Products by Equipment Type 83
Table 58:
DexCom, Inc. Pipeline Products By Development Stage 83
Table 59:
DexCom, Inc. Pipeline Products By Therapy Area 83
Table 60: DexCom,
Inc. Pipeline Products By News Summaries 83
Table 61: Freedom
Meditech, Inc. Pipeline Products by Equipment Type 84
Table 62:
Freedom Meditech, Inc. Pipeline Products By Development Stage 84
Table 63:
Freedom Meditech, Inc. Pipeline Products By Therapy Area 84
Table 64:
GlucoLight Corporation Pipeline Products by Equipment Type 85
Table
65: GlucoLight Corporation Pipeline Products by Development Stage 85
Table 66: GlucoLight Corporation Pipeline Products By Therapy Area 85
Table 67: GlucoLight Corporation Pipeline Products By News Summaries
85
Table 68: GlySens Incorporated Pipeline Products by Equipment Type
86
Table 69: GlySens Incorporated Pipeline Products by Development
Stage 86
Table 70: Currency Conversion from USD to Local Currency at
2007 Constant Rate 110
1.2 List of Figures
Figure 1: United
States, Healthcare Expenditure by Source, 2003 15
Figure 2: United States,
Healthcare Infrastructure, Top Level View, 2007 20
Figure 3: Healthcare
Expenses Segmentation by End User, 2003 21
Figure 4: Medical Equipment
Approval Process in the United States, 2007 27
Figure 5: PMA Approval
Process in the United States, 2007 29
Figure 6: The 510(k) Approval
Process for Medical Devices in the United States, 2007 30
Figure 7:
Reimbursement Structure in the United States, 2007 35
Figure 8:
Distribution Structure of Medical Equipment in the United States, 2006 36
Figure 9: United States, Medical Equipment Market Comparison, 2007 37
Figure 10: Diabetes Care Devices, Revenues ($ mn) by Country, 2000-2012 39
Figure 11: Diabetes Care Devices Market, Country Comparison 40
Figure 12:
Diabetes Care Devices, United States, Category Revenues ($ mn), 2000-2012
41
Figure 13: Diabetes Care Devices Market, United States, Portfolio
Analysis 42
Figure 14: Diabetes Care Devices, United States, Category
Revenues ($ mn), Historic, 2000-2007 43
Figure 15: Diabetes Care Devices,
United States, Category Revenues ($ mn), Forecast, 2007-2012 44
Figure 16:
Diabetes Care Devices, United States, Overall Company Share (%), 2007 45
Figure 17: Glucose Monitoring, United States, Revenue ($ mn) by Segment,
Historic, 2000-2007 46
Figure 18: Glucose Monitoring, United States,
Revenue ($ mn) by Segment, Forecast, 2007-2012 47
Figure 19: Glucose
Monitoring, United States, Company Share (%), 2007 51
Figure 20: Insulin
Delivery, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 52
Figure 21: Insulin Delivery, United States, Revenue ($ mn) by Segment,
Forecast, 2007-2012 53
Figure 22: Insulin Delivery, United States, Company
Share (%), 2007 57
Figure 23: F. Hoffmann-La Roche Ltd Value Chain
Analysis 59
Figure 24: Abbott Laboratories Value Chain Analysis
65
Figure 25: Bayer HealthCare AG Value Chain Analysis 71
Figure
26: Eli Lilly and Company Value Chain Analysis 75
Figure 27:
Becton, Dickinson and Company Value Chain Analysis 81
Figure 28: Global
Markets Direct Methodology 106
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