1 Table of Contents 2
1.1 List of Tables 10
1.2 List of Figures 13
2 Introduction 15
2.1 What Is This Report About? 15
3 Definitions of Markets Covered in This Report 16
3.1 Diabetic Care Devices 16
3.2 Glucose Monitoring Devices 16
3.2.1 Blood Glucose Meters 16
3.2.1.1 Traditional Glucose Meters 16
3.2.1.2 Continuous Glucose Monitoring Systems 16
3.2.2 Blood Glucose Strips 16
3.3 Insulin Delivery 16
3.3.1 InsulinPens 16
3.3.1.1 Reusable Insulin Pens 16
3.3.1.2 Disposable Insulin Pens 16
3.3.2 Insulin Syringes 17
3.3.3 Insulin Pumps 17
3.3.3.1 Traditional Insulin Pumps 17
3.3.3.2 Disposable Insulin Pumps 17
3.3.4 Traditional Insulin Pump Accessories 17
4 Healthcare Sector Review 18
4.1 Healthcare Expenditure 18
4.2 Healthcare Infrastructure 22
4.2.1 Healthcare Personnel Data 23
4.2.2 Healthcare Facilities Data 27
4.3 United States Healthcare Trade Statistics 29
5 Regulation System 30
5.1 Regulation System 30
5.2 Medical Equipment Approval Process 30
5.2.1 Pre-market Approval Process 31
5.2.2 Intended use and Indications for use 31
5.2.3 Predicate Device 32
5.2.4 Safe and Effective 32
5.2.5 Other Category Devices 34
5.2.6 Post-Market Approval Process 35
5.2.7 Compliance and Enforcement 35
5.2.8 Registration Fee 36
5.2.9 Approval Time 36
6 Pricing and Reimbursement 37
6.1 Government Policies 37
6.2 Private Insurance 38
6.3 Diagnosis Related Groups (DRG) 39
7 Distribution Structure 40
7.1 Distribution Structure 40
8 Diabetes Care Devices In United States 41
8.1 Diabetes Care Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 41
8.2 Diabetes Care Devices, United States, Overall Revenue ($ mn), 2000-2015 42
8.3 Diabetes Care Devices, United States, Category Volume (Units), 2000-2015 46
8.4 Diabetes Care Devices, United States, Company Share (2007-2008) 49
9 Glucose Monitoring In United States 50
9.1 Glucose Monitoring Overall Revenue (2000-2015) 50
9.1.1 Blood Glucose Meters Revenue (2000-2015) 52
9.2 Glucose Monitoring Overall Volume (2000-2015) 54
9.2.1 Blood Glucose Meters Volume (2000-2015) 56
9.3 Glucose Monitoring Average Price (2000-2015) 58
9.4 Glucose Monitoring Distribution Share (2007-2008) 59
9.5 Glucose Monitoring, United States, Company Share (2007-2008) 60
10 Insulin Delivery In United States 61
10.1 Insulin Delivery Overall Revenue (2000-2015) 61
10.1.1 Insulin Pens Revenue (2000-2015) 63
10.1.2 Insulin Pumps Revenue (2000-2015) 65
10.2 Insulin Delivery Overall Volume (2000-2015) 67
10.2.1 Insulin Pens Volume (2000-2015) 68
10.2.2 Insulin Pumps Volume (2000-2015) 70
10.3 Insulin Delivery Average Price (2000-2015) 72
10.4 Insulin Delivery Distribution Share (2007-2008) 73
10.5 Insulin Delivery, United States, Company Share (2007-2008) 74
11 Overview of Key Companies in United States Diabetes Care Devices Market 75
11.1 LifeScan, Inc. 75
11.1.1 Company Overview 75
11.1.2 LifeScan, Inc. Pipeline Products 75
11.1.2.1 LifeScan, Inc. Pipeline Products By Equipment Type 75
11.1.2.2 LifeScan, Inc. Pipeline Products By Development Stage 75
11.1.2.3 LifeScan, Inc. Pipeline Products By Therapy Area 76
11.1.2.4 LifeScan, Inc. Pipeline Products By Clinical Trials 76
11.1.2.5 LifeScan, Inc. Pipeline Products By News Summary 76
11.2 F. Hoffmann-La Roche Ltd. 77
11.2.1 Company Overview 77
11.2.2 Value Chain Analysis 77
11.2.2.1 Manufacturing 78
11.2.2.2 Product Development 78
11.2.2.3 Sales and Marketing 79
11.2.3 F. Hoffmann-La Roche Ltd Pipeline Products 79
11.2.3.1 F. Hoffmann-La Roche Ltd Pipeline Products By Equipment Type 79
11.2.3.2 F. Hoffmann-La Roche Ltd Pipeline Products By Development Stage 79
11.2.3.3 F. Hoffmann-La Roche Ltd Pipeline Products By Therapy Area 80
11.3 Abbott Laboratories 81
11.3.1 Company Overview 81
11.3.2 Value Chain Analysis 81
11.3.2.1 Manufacturing 82
11.3.2.2 Product Development 82
11.3.2.3 Sales and Marketing 83
11.3.3 Abbott Laboratories Pipeline Products 83
11.3.3.1 Abbott Laboratories Pipeline Products By Equipment Type 83
11.3.3.2 Abbott Laboratories Pipeline Products By Development Stage 84
11.3.3.3 Abbott Laboratories Pipeline Products By Therapy Area 84
11.3.3.4 Abbott Laboratories Pipeline Products By Clinical Trials 84
11.3.3.5 Abbott Laboratories Pipeline Products By News Summary 84
11.4 Bayer HealthCare AG 85
11.4.1 Company Overview 85
11.4.2 Value Chain Analysis 85
11.4.2.1 Manufacturing 86
11.4.2.2 Product Development 86
11.4.2.3 Sales and Marketing 87
11.4.3 Bayer HealthCare AG Pipeline Products 87
11.4.3.1 Bayer HealthCare AG Pipeline Products By Equipment Type 87
11.4.3.2 Bayer HealthCare AG Pipeline Products By Development Stage 87
11.4.3.3 Bayer HealthCare AG Pipeline Products By Therapy Area 88
11.4.3.4 Bayer HealthCare AG Pipeline Products By News Summary 88
11.5 Becton, Dickinson and Company 89
11.5.1 Company Overview 89
11.5.2 Value Chain Analysis 89
11.5.2.1 Manufacturing 90
11.5.2.2 Product Development 90
11.5.2.3 Sales and Marketing 90
11.6 Medtronic, Inc. 91
11.6.1 Company Overview 91
11.6.2 Value Chain Analysis 91
11.6.2.1 Manufacturing 92
11.6.2.2 Product Development 92
11.6.2.3 Sales and Marketing 92
11.6.3 Medtronic, Inc. Pipeline Products 93
11.6.3.1 Medtronic, Inc. Pipeline Products By Equipment Type 93
11.6.3.2 Medtronic, Inc. Pipeline Products By Development Stage 95
11.6.3.3 Medtronic, Inc. Pipeline Products By Therapy Area 96
11.6.3.4 Medtronic, Inc. Pipeline Products By Clinical Trials 98
11.6.3.5 Medtronic, Inc. Pipeline Products By News Summary 99
11.7 Novo Nordisk A/S 100
11.7.1 Company Overview 100
11.7.2 Novo Nordisk A/S Pipeline Products 100
11.7.2.1 Novo Nordisk A/S Pipeline Products by Equipment Type 100
11.7.2.2 Novo Nordisk A/S Pipeline Products by Development Stage 100
11.7.2.3 Novo Nordisk A/S Pipeline Products By Therapy Area 100
11.7.2.4 Novo Nordisk A/S Pipeline Products By Clinical Trials 100
11.8 Eli Lilly and Company 101
11.8.1 Company Overview 101
11.8.2 Value Chain Analysis 101
11.8.2.1 Manufacturing 102
11.8.2.2 Product Development 102
11.8.2.3 Sales and Marketing 103
11.8.3 Eli Lilly and Company Pipeline Products 103
11.8.3.1 Eli Lilly and Company Pipeline Products by Equipment Type 103
11.8.3.2 Eli Lilly and Company Pipeline Products by Development Stage 104
11.8.3.3 Eli Lilly and Company Pipeline Products by Therapy Area 104
11.8.3.4 Eli Lilly and Company Pipeline Products by Clinical Trials 104
11.8.3.5 Eli Lilly and Company Pipeline Products by News Summary 104
11.9 Terumo Corporation 105
11.9.1 Company Overview 105
11.9.2 Value Chain Analysis 105
11.9.2.1 Manufacturing 106
11.9.2.2 Product Development 106
11.9.2.3 Sales and Marketing 107
11.10 Animas Corporation 108
11.10.1 Company Overview 108
11.11 Sanofi-Aventis 108
11.11.1 Company Overview 108
11.12 Apex Biotechnology Corp. 108
11.12.1 Company Overview 108
11.13 Smiths Medical 109
11.13.1 Company Overview 109
11.13.2 Value Chain Analysis 109
11.13.2.1 Manufacturing 110
11.13.2.2 Product Development 110
11.13.2.3 Sales and Marketing 110
11.14 Abbott Diabetes Care, Inc. 111
11.14.1 Company Overview 111
11.15 Home Diagnostics, Inc. 111
11.15.1 Company Overview 111
11.16 Metrika, Inc. 112
11.16.1 Company Overview 112
11.17 Nipro Diabetes Systems,Inc. 112
11.17.1 Company Overview 112
11.18 WR Medical Electronics Co. 112
11.18.1 Company Overview 112
11.19 AgaMatrix, Inc. 113
11.19.1 Company Overview 113
11.19.2 AgaMatrix, Inc. Pipeline Products 113
11.19.2.1 AgaMatrix, Inc. Pipeline Products By Equipment Type 113
11.19.2.2 AgaMatrix, Inc. Pipeline Products By Development Stage 113
11.19.2.3 AgaMatrix, Inc. Pipeline Products By Therapy Area 113
11.20 DexCom, Inc. 114
11.20.1 Company Overview 114
11.20.2 DexCom, Inc. Pipeline Products 114
11.20.2.1 DexCom, Inc. Pipeline Products By Equipment Type 114
11.20.2.2 DexCom, Inc. Pipeline Products By Development Stage 114
11.20.2.3 DexCom, Inc. Pipeline Products By Therapy Area 114
11.20.2.4 DexCom, Inc. Pipeline Products By News Summary 115
11.21 Freedom Meditech, Inc. 116
11.21.1 Company Overview 116
11.21.2 Freedom Meditech, Inc. Pipeline Products 116
11.21.2.1 Freedom Meditech, Inc. Pipeline Products By Equipment Type 116
11.21.2.2 Freedom Meditech, Inc. Pipeline Products By Development Stage 116
11.21.2.3 Freedom Meditech, Inc. Pipeline Products By Therapy Area 116
11.22 GlucoLight Corporation 117
11.22.1 Company Overview 117
11.22.2 GlucoLight Corporation Pipeline Products 117
11.22.2.1 GlucoLight Corporation Pipeline Products By Equipment Type 117
11.22.2.2 GlucoLight Corporation Pipeline Products By Development Stage 117
11.22.2.3 GlucoLight Corporation Pipeline Products By Therapy Area 117
11.22.2.4 GlucoLight Corporation Pipeline Products By Clinical Trials 118
11.22.2.5 GlucoLight Corporation Pipeline Products By News Summary 118
11.23 iSense Corporation 119
11.23.1 Company Overview 119
11.23.2 iSense Corporation Pipeline Products 119
11.23.2.1 iSense Corporation Pipeline Products By Equipment Type 119
11.23.2.2 iSense Corporation Pipeline Products By Development Stage 119
11.23.2.3 iSense Corporation Pipeline Products By Therapy Area 119
11.23.2.4 iSense Corporation Pipeline Products By News Summary 119
11.24 Sensys Medical, Inc. 120
11.24.1 Company Overview 120
11.24.2 Sensys Medical, Inc. Pipeline Products 120
11.24.2.1 Sensys Medical, Inc. Pipeline Products By Equipment Type 120
11.24.2.2 Sensys Medical, Inc. Pipeline Products By Development Stage 120
11.24.2.3 Sensys Medical, Inc. Pipeline Products By Therapy Area 120
11.24.2.4 Sensys Medical, Inc. Pipeline Products By Clinical Trials 120
12 Financial Deals Landscape 121
12.1 Acquisition 121
12.1.1 Mediscience Technology Acquires SensiVida Medical Systems 121
12.2 Partnerships 122
12.2.1 Ceapro Enters Into an Agreement with IR2Dx 122
12.2.2 Edwards Lifesciences Enters Into an Agreement with DexCom 123
13 Recent Developments 124
13.1 Strategy and Business Planning 124
13.1.1 May 22, 2009: DDI Plans To Add 100 Employees 124
13.1.2 May 21, 2009: Eli Lilly Launches Two Global Trials For Alzheimer’s Disease 124
13.1.3 May 21, 2009: Johnson & Johnson Acquires Cougar For $1b 124
13.1.4 May 11, 2009: Medtronic Announces San Antonio As Home Of New Diabetes Facility 125
13.1.5 Mar 25, 2009: Medtronic Leases Nearly 50,000 Square-Foot Facility For Ablation Frontiers Unit 126
13.1.6 Mar 10, 2009: Medtronic MiniMed Considers San Antonio and Kansas City For Expansion 126
13.1.7 Feb 24, 2009: Medtronic Plans To Reduce Global Workforce 127
13.1.8 Jan 30, 2009: Codman Plans To Close Its Manufacturing Operations In Miami Lakes 127
13.2 Legal and Regulatory 128
13.2.1 Mar 11, 2009: Medtronic Announces Dismissal Of Lawsuit 128
13.2.2 Jan 07, 2009: BD Settles Lawsuit With Ultimed 128
13.2.3 Jan 06, 2009: Court Rules In Favor Of Medtronic In Fidelis Litigation 128
13.3 Government and Public Interest 128
13.3.1 May 19, 2009: Piramal Launches Trial Material Packaging Capacity In UK 128
13.3.2 Mar 19, 2009: FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared 129
13.4 Product News 129
13.4.1 May 19, 2009: Piramal Launches Trial Material Packaging Capacity In UK 129
13.4.2 Mar 25, 2009: Smiths Medical Announces Intent to Stop Selling Deltec Cozmo Insulin Pumps 130
13.4.3 Feb 26, 2009: FDA Approves Sanofi-aventis' Apidra SoloSTAR 130
13.4.4 Feb 11, 2009: Insulet Corporation’s OmniPod System Selected as Finalist for the 2009 Edison Best New Product Awards 131
13.4.5 Feb 09, 2009: ARKRAY Announces FDA Approval to Market GLUCOCARD 01-mini Blood Glucose Monitoring System 131
14 Appendix 132
14.1 Global Markets Direct Research Methodology 132
14.2 Coverage 133
14.3 Secondary Research 133
14.4 Primary Research 134
14.5 Models 134
14.6 Forecasts 135
14.7 Expert Panel Validation 135
14.8 Currency Conversion 136
14.9 Contact Us 137
14.10 Disclaimer 137
1.1 List of Tables
Table 1: United States Healthcare Expenditure, 2000-2007 19
Table 2: United States Personal Healthcare Expenditure by Type, 2000-2007 20
Table 3: United States Personal Healthcare Expenditure by Source, 2000-2007 21
Table 4: Total Number of Doctors in the United States, 2003-2010 23
Table 5: Number of Doctors by Specialty in the United States, 2003-2010 24
Table 6: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 25
Table 7: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 26
Table 8: Total Hospitals in the United States, 2000-2004 27
Table 9: Community Hospitals by Number of Beds in the United States, 2000-2004 27
Table 10: Number of Hospital Beds in the United States, 2000-2004 27
Table 11: Number of Hospital Beds by Range in the United States, 2000-2004 28
Table 12: United States Healthcare Trade Statistics, 2001-2006 29
Table 13: Medical Equipment Registration Fee in United States, 2007 36
Table 14: Medical Device Approval Time in United States, 2007 36
Table 15: Diabetes Care Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 41
Table 16: Diabetes Care Devices, United States, Overall Revenue ($ mn), 2000-2015 42
Table 17: Diabetes Care Devices, United States, Portfolio Analysis, 2000-2015 43
Table 18: Diabetes Care Devices, United States, Overall Revenue ($ mn), Historic, 2000-2008 44
Table 19: Diabetes Care Devices, United States, Overall Revenue ($ mn), Forecast, 2008-2015 45
Table 20: Diabetes Care Devices, United States, Category Volume (Units), 2000-2015 46
Table 21: Diabetes Care Devices, United States, Category Volume (Units), Historic, 2000-2008 47
Table 22: Diabetes Care Devices, United States, Category Volume (Units), Forecast, 2008-2015 48
Table 23: Diabetes Care Devices, United States, Company Share by Revenue ($ mn), 2007-2008 49
Table 24: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 50
Table 25: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 51
Table 26: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 52
Table 27: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 53
Table 28: Glucose Monitoring, United States, Volume (Units), Historic, 2000-2008 54
Table 29: Glucose Monitoring, United States, Volume (Units), Forecast, 2008-2015 55
Table 30: Blood Glucose Meters, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 56
Table 31: Blood Glucose Meters, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 57
Table 32: Glucose Monitoring, United States, Average Price ($), Historic, 2000-2008 58
Table 33: Glucose Monitoring, United States, Average Price ($), Forecast, 2008-2015 58
Table 34: Glucose Monitoring, United States, Distribution Share by Revenue ($mn), 2007-2008 59
Table 35: Glucose Monitoring, United States, Company Share by Revenue ($ mn), 2007-2008 60
Table 36: Insulin Delivery, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 61
Table 37: Insulin Delivery, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 62
Table 38: Insulin Pens, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 63
Table 39: Insulin Pens, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 64
Table 40: Insulin Pumps, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 65
Table 41: Insulin Pumps, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 66
Table 42: Insulin Delivery, United States, Volume (Units), Historic, 2000-2008 67
Table 43: Insulin Delivery, United States, Volume (Units), Forecast, 2008-2015 67
Table 44: Insulin Pens, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 68
Table 45: Insulin Pens, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 69
Table 46: Insulin Pumps, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 70
Table 47: Insulin Pumps, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 71
Table 48: Insulin Delivery, United States, Average Price ($), Historic, 2000-2008 72
Table 49: Insulin Delivery, United States, Average Price ($), Forecast, 2008-2015 72
Table 50: Insulin Delivery, United States, Distribution Share by Revenue ($mn), 2007-2008 73
Table 51: Insulin Delivery, United States, Company Share by Revenue ($ mn), 2007-2008 74
Table 52: LifeScan, Inc. Pipeline Products by Equipment Type 75
Table 53: LifeScan, Inc. Pipeline Products By Development Stage 75
Table 54: LifeScan, Inc. Pipeline Products By Therapy Area 76
Table 55: LifeScan, Inc. Pipeline Products By Clinical Trials 76
Table 56: LifeScan, Inc. Pipeline Products By News Summary 76
Table 57: F. Hoffmann-La Roche Ltd Pipeline Products by Equipment Type 79
Table 58: F. Hoffmann-La Roche Ltd Pipeline Products By Development Stage 79
Table 59: F. Hoffmann-La Roche Ltd Pipeline Products By Therapy Area 80
Table 60: Abbott Laboratories Pipeline Products by Equipment Type 83
Table 61: Abbott Laboratories Pipeline Products By Development Stage 84
Table 62: Abbott Laboratories Pipeline Products By Therapy Area 84
Table 63: Abbott Laboratories Pipeline Products By Clinical Trials 84
Table 64: Abbott Laboratories Pipeline Products By News Summary 84
Table 65: Bayer HealthCare AG Pipeline Products by Equipment Type 87
Table 66: Bayer HealthCare AG Pipeline Products By Development Stage 87
Table 67: Bayer HealthCare AG Pipeline Products By Therapy Area 88
Table 68: Bayer HealthCare AG Pipeline Products By News Summary 88
Table 69: Medtronic, Inc. Pipeline Products by Equipment Type 93
Table 70: Medtronic, Inc. Pipeline Products By Development Stage 95
Table 71: Medtronic, Inc. Pipeline Products By Therapy Area 96
Table 72: Medtronic, Inc. Pipeline Products By Clinical Trials 98
Table 73: Medtronic, Inc. Pipeline Products By News Summary 99
Table 74: Novo Nordisk A/S Pipeline Products by Equipment Type 100
Table 75: Novo Nordisk A/S Pipeline Products By Development Stage 100
Table 76: Novo Nordisk A/S Pipeline Products By Therapy Area 100
Table 77: Novo Nordisk A/S Pipeline Products By Clinical Trials 100
Table 78: Eli Lilly and Company Pipeline Products by Equipment Type 103
Table 79: Eli Lilly and Company Pipeline Products by Development Stage 104
Table 80: Eli Lilly and Company Pipeline Products by Therapy Area 104
Table 81: Eli Lilly and Company Pipeline Products by Clinical Trials 104
Table 82: Eli Lilly and Company Pipeline Products by News Summary 104
Table 83: AgaMatrix, Inc. Pipeline Products by Equipment Type 113
Table 84: AgaMatrix, Inc. Pipeline Products By Development Stage 113
Table 85: AgaMatrix, Inc. Pipeline Products By Therapy Area 113
Table 86: DexCom, Inc. Pipeline Products by Equipment Type 114
Table 87: DexCom, Inc. Pipeline Products By Development Stage 114
Table 88: DexCom, Inc. Pipeline Products By Therapy Area 114
Table 89: DexCom, Inc. Pipeline Products By News Summary 115
Table 90: Freedom Meditech, Inc. Pipeline Products by Equipment Type 116
Table 91: Freedom Meditech, Inc. Pipeline Products By Development Stage 116
Table 92: Freedom Meditech, Inc. Pipeline Products By Therapy Area 116
Table 93: GlucoLight Corporation Pipeline Products by Equipment Type 117
Table 94: GlucoLight Corporation Pipeline Products By Development Stage 117
Table 95: GlucoLight Corporation Pipeline Products By Therapy Area 117
Table 96: GlucoLight Corporation Pipeline Products By Clinical Trials 118
Table 97: GlucoLight Corporation Pipeline Products By News Summary 118
Table 98: iSense Corporation Pipeline Products by Equipment Type 119
Table 99: iSense Corporation Pipeline Products By Development Stage 119
Table 100: iSense Corporation Pipeline Products By Therapy Area 119
Table 101: iSense Corporation Pipeline Products By News Summary 119
Table 102: Sensys Medical, Inc. Pipeline Products by Equipment Type 120
Table 103: Sensys Medical, Inc. Pipeline Products By Development Stage 120
Table 104: Sensys Medical, Inc. Pipeline Products By Therapy Area 120
Table 105: Sensys Medical, Inc. Pipeline Products By Clinical Trials 120
Table 106: Mediscience Technology Acquires SensiVida Medical Systems 121
Table 107: Ceapro Enters Into An Agreement With IR2Dx 122
Table 108: Edwards Lifesciences Enters Into An Agreement With DexCom 123
Table 109: USD to Local Currency, Average Exchange Rate 2008 136
1.2 List of Figures
Figure 1: United States, Healthcare Expenditure by Source, 2007 19
Figure 2: Healthcare Expenses Segmentation by End User, 2007 20
Figure 3: United States, Healthcare Infrastructure, Top Level View, 2007 23
Figure 4: Medical Equipment Approval Process in the United States, 2007 31
Figure 5: PMA Approval Process in the United States, 2007 33
Figure 6: The 510(k) Approval Process for Medical Devices in the United States, 2007 34
Figure 7: Reimbursement Structure in the United States, 2007 39
Figure 8: Distribution Structure of Medical Equipment in the United States, 2007 40
Figure 9: Diabetes Care Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 41
Figure 10: Diabetes Care Devices, United States, Overall Revenue ($ mn), 2000-2015 42
Figure 11: Diabetes Care Devices, United States, Cross-Category Analysis, 2000-2015 43
Figure 12: Diabetes Care Devices, United States, Overall Revenue ($ mn), Historic, 2000-2008 44
Figure 13: Diabetes Care Devices, United States, Overall Revenue ($ mn), Forecast, 2008-2015 45
Figure 14: Diabetes Care Devices, United States, Category Volume (Units), 2000-2015 46
Figure 15: Diabetes Care Devices, United States, Category Volume (Units), Historic, 2000-2008 47
Figure 16: Diabetes Care Devices, United States, Category Volume (Units), Forecast, 2008-2015 48
Figure 17: Diabetes Care Devices, United States, Company Share (%), 2008 49
Figure 18: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 50
Figure 19: Glucose Monitoring, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 51
Figure 20: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 52
Figure 21: Blood Glucose Meters, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 53
Figure 22: Glucose Monitoring, United States, Volume (Units), Historic, 2000-2008 54
Figure 23: Glucose Monitoring, United States, Volume (Units), Forecast, 2008-2015 55
Figure 24: Blood Glucose Meters, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 56
Figure 25: Blood Glucose Meters, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 57
Figure 26: Glucose Monitoring, United States, Company Share (%), 2008 60
Figure 27: Insulin Delivery, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 61
Figure 28: Insulin Delivery, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 62
Figure 29: Insulin Pens, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 63
Figure 30: Insulin Pens, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 64
Figure 31: Insulin Pumps, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 65
Figure 32: Insulin Pumps, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 66
Figure 33: Insulin Pens, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 68
Figure 34: Insulin Pens, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 69
Figure 35: Insulin Pumps, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 70
Figure 36: Insulin Pumps, United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 71
Figure 37: Insulin Delivery, United States, Company Share (%), 2008 74
Figure 38: F. Hoffmann-La Roche Ltd Value Chain Analysis 77
Figure 39: Abbott Laboratories Value Chain Analysis 81
Figure 40: Bayer HealthCare AG Value Chain Analysis 85
Figure 41: Becton, Dickinson and Company Value Chain Analysis 89
Figure 42: Medtronic, Inc. Value Chain Analysis 91
Figure 43: Eli Lilly and Company Value Chain Analysis 101
Figure 44: Terumo Corporation Value Chain Analysis 105
Figure 45: Smiths Medical Value Chain Analysis 109
Figure 46: Global Markets Direct Methodology 132
