Table of Contents
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 11
2.1 What Is This Report About? 11
3 Definitions of Markets Covered in the Report 12
3.1 Diabetic Care Devices 12
3.2 Glucose Monitoring Devices 12
3.2.1 Blood Glucose Meters 12
3.2.2 Blood Glucose Strips 12
3.3 Insulin Delivery 12
3.3.1 Insulin Pens 12
3.3.2 Insulin Syringes 13
3.3.3 Insulin Pumps 13
3.3.4 Traditional Insulin Pump Accessories 13
4 Healthcare Sector Review 14
4.1 Healthcare Sector 14
4.2 Healthcare Expenditure 14
4.3 Healthcare Infrastructure 17
4.3.1 Healthcare Personnel Data 17
4.3.2 Healthcare Facilities Data 19
4.4 Healthcare Policy 24
5 Regulation System 25
5.1 Regulation System 25
5.2 Medical Equipment Approval Process 25
5.2.1 Classification of Medical Devices 25
5.3 Conformity Assessment Process 34
5.3.1 Class I devices 34
5.3.2 Class IIa devices 35
5.3.3 Class IIb devices 36
5.3.4 Class III devices 37
5.4 Post Market Surveillance 38
6 Pricing and Reimbursement 39
6.1 SHI 39
6.1.1 Private Health Insurance 39
6.1.2 Diagnosis Related Groups (DRG) 39
7 Distribution Structure 40
8 Diabetes Care Devices In Germany 41
8.1 A Look In To the Chronic Disease 41
8.1.1 Type1 and Type2 Diabetes 41
8.1.2 Diabetes Accentuating Cardiovascular Disease 41
8.1.3 Diabetes Prevalence 42
8.2 Diabetes Care Devices, Germany, Overall Revenue ($ m), 2000-2015 43
8.3 Diabetes Care Devices, Germany, Category Volume (Units), 2000-2015 46
8.4 Diabetes Care Devices, Germany, Cross Category Analysis, 2000-2015 48
8.5 German Economic Recession: Impact on the Diabetes Care Devices Market 49
8.6 Market Dynamics 50
8.6.1 Market Drivers 50
8.6.2 Market Restraints 50
8.7 Diabetes Care Devices, Germany, Company Share (2007-2008) 51
8.8 Future Outlook 52
9 Glucose Monitoring In Germany 53
9.1 Overview 53
9.2 Glucose Monitoring Overall Revenue (2000-2015) 53
9.2.1 Blood Glucose Meters Overall Revenue (2000-2015) 56
9.3 Glucose Monitoring Overall Volume (2000-2015) 58
9.3.1 Blood Glucose Meters Overall Volume (2000-2015) 60
9.4 Glucose Monitoring Average Price (2000-2015) 61
9.5 Glucose Monitoring Market Dynamics 62
9.5.1 Market Drivers 62
9.5.2 Market Restraints 62
9.6 Glucose Monitoring Distribution Share (2007-2008) 63
9.7 Glucose Monitoring, Germany, Company Share (2007-2008) 64
10 Insulin Delivery In Germany 65
10.1 Overview 65
10.2 Insulin Delivery Overall Revenue (2000-2015) 65
10.2.1 Insulin Pens Overall Revenue (2000-2015) 68
10.3 Insulin Delivery Overall Volume (2000-2015) 70
10.3.1 Insulin Pens Overall Volume (2000-2015) 71
10.4 Insulin Delivery Average Price (2000-2015) 73
10.5 Insulin Delivery Market Dynamics 74
10.5.1 Market Drivers 74
10.5.2 Market Restraints 74
10.6 Insulin Delivery Devices Distribution Share (2007-2008) 75
10.7 Insulin Delivery, Germany, Company Share (2007-2008) 76
11 Overview of Key Companies in Germany Diabetes Care Devices Market 77
11.1 F. Hoffmann-La Roche Ltd. 77
11.1.1 Company Overview 77
11.1.2 Value Chain Analysis 78
11.1.3 F. Hoffmann-La Roche Ltd Pipeline Products 80
11.2 Medtronic, Inc. 81
11.2.1 Company Overview 81
11.2.2 Value Chain Analysis 82
11.2.3 Medtronic, Inc. Pipeline Products 84
11.3 LifeScan, Inc. 91
11.3.1 Company Overview 91
11.3.2 LifeScan, Inc. Pipeline Products 91
11.4 Abbott Laboratories 93
11.4.1 Company Overview 93
11.4.2 Value Chain Analysis 94
11.4.3 Abbott Laboratories Pipeline Products 96
11.5 Novo Nordisk A/S 98
11.5.1 Company Overview 98
11.5.2 Novo Nordisk A/S Pipeline Products 98
11.6 Becton, Dickinson and Company 100
11.6.1 Company Overview 100
11.6.2 Value Chain Analysis 101
11.7 Eli Lilly and Company 103
11.7.1 Company Overview 103
11.7.2 Value Chain Analysis 104
11.7.3 Eli Lilly and Company Pipeline Products 106
11.8 Bayer HealthCare AG 108
11.8.1 Company Overview 108
11.8.2 Value Chain Analysis 109
11.8.3 Bayer HealthCare AG Pipeline Products 111
11.9 ARKRAY, Inc. 113
11.9.1 Company Overview 113
11.9.2 ARKRAY, Inc. Pipeline Products 113
11.10 Terumo Corporation 115
11.10.1 Company Overview 115
11.10.2 Value Chain Analysis 115
11.11 Animas Corporation 118
11.11.1 Company Overview 118
11.12 Sanofi-Aventis 118
11.12.1 Company Overview 118
11.13 Smiths Medical 119
11.13.1 Company Overview 119
11.13.2 Value Chain Analysis 120
11.14 EKF-diagnostic GmbH 122
11.14.1 Company Overview 122
12 Appendix 123
12.1 Research Methodology 123
12.2 Coverage 124
12.3 Secondary Research 124
12.4 Primary Research 125
12.5 Models 125
12.6 Forecasts 125
12.7 Expert Panel Validation 126
12.8 Currency Conversion 127
12.9 Contact Us 128
12.10 Disclaimer 128
1.1 List of Tables
Table 1: Healthcare Expenditure in Germany, (€m), 2000 ¨C 2006 14
Table 2: Healthcare Personnel by Region in Germany, 2007 17
Table 3: Doctors by Specialty in Germany, 2000-2004 18
Table 4: Hospitals by Region in Germany, 2004 19
Table 5: Hospitals and Beds by Region in Germany, 2007 20
Table 6: Rehabilitation Centers by Region in Germany, 2004 21
Table 7: Rehabilitation Center Beds by Region in Germany, 2004 22
Table 8: Discharges by Diagnosis in Germany, 2004 23
Table 9: Diabetes Prevalence Rates, 2007 42
Table 10:Diabetes Care Devices, Germany, Overall Revenue ($ m), Historic, 2000-2008 43
Table 11:Diabetes Care Devices, Germany, Overall Revenue ($ m), Forecast, 2008-2015 45
Table 12:Diabetes Care Devices, Germany, Category Volume (Units), Historic, 2000-2008 46
Table 13:Diabetes Care Devices, Germany, Category Volume (Units), Forecast, 2008-2015 47
Table 14: Diabetes Care Devices, Germany, Cross-Category Analysis, 2000-2015 48
Table 15:Diabetes Care Devices, Germany, Company Share by Revenue ($ m), 2007-2008 51
Table 16:Glucose Monitoring, Germany, Revenue ($ m) by Segment, Historic, 2000-2008 54
Table 17:Glucose Monitoring, Germany, Revenue ($ m) by Segment, Forecast, 2008-2015 55
Table 18:Blood Glucose Meters, Germany, Revenue ($ m) by Sub-Segment, Historic, 2000-2008 56
Table 19:Blood Glucose Meters, Germany, Revenue ($ m) by Sub-Segment, Forecast, 2008-2015 57
Table 20:Glucose Monitoring, Germany, Volume (Units) by Segment, Historic, 2000-2008 58
Table 21:Glucose Monitoring, Germany, Volume (Units) by Segment, Forecast, 2008-2015 59
Table 22:Blood Glucose Meters, Germany, Volume (Units) by Sub-Segment, Historic, 2000-2008 60
Table 23:Blood Glucose Meters, Germany, Volume (Units) by Sub-Segment, Forecast, 2008-2015 60
Table 24:Glucose Monitoring, Germany, Average Price ($), Historic, 2000-2008 61
Table 25:Glucose Monitoring, Germany, Average Price ($), Forecast, 2008-2015 61
Table 26:Glucose Monitoring, Germany, Distribution Share by Revenue ($mn), 2007-2008 63
Table 27:Glucose Monitoring, Germany, Company Share by Revenue ($ m), 2007-2008 64
Table 28:Insulin Delivery, Germany, Revenue ($ m) by Segment, Historic, 2000-2008 66
Table 29:Insulin Delivery, Germany, Revenue ($ m) by Segment, Forecast, 2008-2015 67
Table 30:Insulin Pens, Germany, Revenue ($ m) by Sub-Segment, Historic, 2000-2008 68
Table 31:Insulin Pens, Germany, Revenue ($ m) by Sub-Segment, Forecast, 2008-2015 69
Table 32:Insulin Delivery, Germany, Volume (Units) by Segment, Historic, 2000-2008 70
Table 33:Insulin Delivery, Germany, Volume (Units) by Segment, Forecast, 2008-2015 70
Table 34:Insulin Pens, Germany, Volume (Units) by Sub-Segment, Historic, 2000-2008 71
Table 35:Insulin Pens, Germany, Volume (Units) by Sub-Segment, Forecast, 2008-2015 72
Table 36:Insulin Delivery, Germany, Average Price ($), Historic, 2000-2008 73
Table 37:Insulin Delivery, Germany, Average Price ($), Forecast, 2008-2015 73
Table 38:Insulin Delivery, Germany, Distribution Share by Revenue ($mn), 2007-2008 75
Table 39:Insulin Delivery, Germany, Company Share by Revenue ($ mn), 2007-2008 76
Table 40:F. Hoffmann-La Roche Ltd Pipeline Products by Equipment Type 80
Table 41:F. Hoffmann-La Roche Ltd Pipeline Products by Development Stage 80
Table 42:F. Hoffmann-La Roche Ltd Pipeline Products by Therapy Area 80
Table 43:Medtronic, Inc. Pipeline Products by Equipment Type 84
Table 44:Medtronic, Inc. Pipeline Products By Development Stage 86
Table 45:Medtronic, Inc. Pipeline Products By Therapy Area 87
Table 46:Medtronic, Inc. Pipeline Products By Clinical Trials 89
Table 47:Medtronic, Inc. Pipeline Products By News Summary 90
Table 48:LifeScan, Inc. Pipeline Products by Equipment Type 91
Table 49:LifeScan, Inc. Pipeline Products by Development Stage 91
Table 50:LifeScan, Inc. Pipeline Products by Therapy Area 91
Table 51:LifeScan, Inc. Pipeline Products by Clinical Trials 92
Table 52:LifeScan, Inc. Pipeline Products by News Summary 92
Table 53:Abbott Laboratories Pipeline Products by Equipment Type 96
Table 54:Abbott Laboratories Pipeline Products by Development Stage 97
Table 55:Abbott Laboratories Pipeline Products by Therapy Area 97
Table 56:Abbott Laboratories Pipeline Products by Clinical Trials 97
Table 57:Abbott Laboratories Pipeline Products by News Summary 97
Table 58:Novo Nordisk A/S Pipeline Products by Equipment Type 98
Table 59:Novo Nordisk A/S Pipeline Products By Development Stage 98
Table 60:Novo Nordisk A/S Pipeline Products By Therapy Area 98
Table 61:Novo Nordisk A/S Pipeline Products By Clinical Trials 99
Table 62:Eli Lilly and Company Pipeline Products by Equipment Type 106
Table 63:Eli Lilly and Company Pipeline Products by Development Stage 106
Table 64:Eli Lilly and Company Pipeline Products by Therapy Area 107
Table 65:Eli Lilly and Company Pipeline Products by Clinical Trials 107
Table 66:Eli Lilly and Company Pipeline Products by News Summary 107
Table 67:Bayer HealthCare AG Pipeline Products by Equipment Type 111
Table 68:Bayer HealthCare AG Pipeline Products by Development Stage 111
Table 69:Bayer HealthCare AG Pipeline Products by Therapy Area 112
Table 70:Bayer HealthCare AG Pipeline Products by News Summary 112
Table 71:ARKRAY, Inc. Pipeline Products by Equipment Type 113
Table 72:ARKRAY, Inc. Pipeline Products by Development Stage 113
Table 73:ARKRAY, Inc. Pipeline Products by Clinical Trials 113
Table 74:ARKRAY, Inc. Pipeline Products by News Summary 114
Table 75: USD to Local Currency, Average Exchange Rate 2008 127
1.2 List of Figures
Figure 1: Healthcare Expenditure Sources in Germany, 2006 15
Figure 2: Healthcare Financing Framework in Germany, 2007 16
Figure 3: Flowchart for Classification of Non-invasive Devices in Germany, 2007 26
Figure 4: Flowchart for Classification of Invasive Devices in Germany, 2007 27
Figure 5: Flowchart for Classification of Invasive Devices in Germany, 2007 28
Figure 6: Classification of Invasive Devices in Germany, 2007 29
Figure 7: Classification of Invasive Devices in Germany, 2007 30
Figure 8: Flowchart for Classification of Active Devices in Germany, 2007 31
Figure 9: Flowchart for Classification of Active Devices in Germany, 2007 32
Figure 10: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Germany, 2007 33
Figure 11: Conformity Assessment of Class-I Medical Devices in Germany, 2007 34
Figure 12: Conformity Assessment of Class-IIa Medical Devices in Germany, 2007 35
Figure 13: Conformity Assessment of Class-IIb Medical Devices in Germany, 2007 36
Figure 14: Conformity Assessment of Class-III Medical Devices in Germany, 2007 37
Figure 15:Diabetes Care Devices, Germany, Overall Revenue ($ m), Historic, 2000-2008 43
Figure 16:Diabetes Care Devices, Germany, Overall Revenue ($ m), Forecast, 2008-2015 44
Figure 17:Diabetes Care Devices, Germany, Category Volume (Units), Historic, 2000-2008 46
Figure 18:Diabetes Care Devices, Germany, Category Volume (Units), Forecast, 2008-2015 47
Figure 19:Diabetes Care Devices, Germany, Cross-Category Analysis, 2000-2015 48
Figure 20:Diabetes Care Devices, Germany, Company Share (%), 2008 51
Figure 21:Glucose Monitoring, Germany, Revenue ($ m) by Segment, Historic, 2000-2008 53
Figure 22:Glucose Monitoring, Germany, Revenue ($ m) by Segment, Forecast, 2008-2015 55
Figure 23:Blood Glucose Meters, Germany, Revenue ($ m) by Sub-Segment, Historic, 2000-2008 56
Figure 24:Blood Glucose Meters, Germany, Revenue ($ m) by Sub-Segment, Forecast, 2008-2015 57
Figure 25:Glucose Monitoring, Germany, Volume (Units) by Segment, Historic, 2000-2008 58
Figure 26:Glucose Monitoring, Germany, Volume (Units) by Segment, Forecast, 2008-2015 59
Figure 27:Glucose Monitoring, Germany, Company Share (%), 2008 64
Figure 28:Insulin Delivery, Germany, Revenue ($ m) by Segment, Historic, 2000-2008 65
Figure 29:Insulin Delivery, Germany, Revenue ($ m) by Segment, Forecast, 2008-2015 67
Figure 30:Insulin Pens, Germany, Revenue ($ m) by Sub-Segment, Historic, 2000-2008 68
Figure 31:Insulin Pens, Germany, Revenue ($ m) by Sub-Segment, Forecast, 2008-2015 69
Figure 32:Insulin Pens, Germany, Volume (Units) by Sub-Segment, Historic, 2000-2008 71
Figure 33:Insulin Pens, Germany, Volume (Units) by Sub-Segment, Forecast, 2008-2015 72
Figure 34:Insulin Delivery, Germany, Company Share (%), 2008 76
Figure 35:F. Hoffmann-La Roche Ltd Value Chain Analysis 78
Figure 36:Medtronic, Inc. Value Chain Analysis 82
Figure 37:Abbott Laboratories Value Chain Analysis 94
Figure 38:Becton, Dickinson and Company Value Chain Analysis 101
Figure 39:Eli Lilly and Company Value Chain Analysis 104
Figure 40:Bayer HealthCare AG Value Chain Analysis 109
Figure 41:Terumo Corporation Value Chain Analysis 115
Figure 42:Smiths Medical Value Chain Analysis 120
Figure 43: Methodology 123