1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 9
1.2 List of Figures 10
2 Introduction 12
2.1 What Is This Report About? 12
3 Definitions of the Markets Covered in the Report 13
3.1 Diabetes Care Devices 13
3.2 Glucose Monitoring 13
3.2.1 Blood Glucose Meter 13
3.2.2 Blood Glucose Strips 13
3.3 Insulin Delivery 13
3.3.1 Insulin Jet Injector 13
3.3.2 Insulin Pen 13
3.3.3 Insulin Pump 13
3.3.4 Insulin Syringes 13
4 Healthcare Sector Review 15
4.1 Healthcare Sector 15
4.2 Healthcare Expenditure 15
4.3 Healthcare Infrastructure 20
4.3.1 Healthcare Personnel Data 20
4.3.2 Healthcare Facilities Data 22
4.4 Healthcare Policy 27
5 Regulation System 28
5.1 Medical Equipment Approval Process 28
5.1.1 Classification of Medical Devices 28
5.2 Conformity Assessment Process 37
5.2.1 Class I devices 37
5.2.2 Class IIa devices 38
5.2.3 Class IIb devices 39
5.2.4 Class III devices 40
5.3 Post Market Surveillance 40
6 Pricing and Reimbursement 41
6.1 SHI 41
6.1.1 Private Health Insurance 41
6.1.2 Diagnosis Related Groups (DRG) 41
7 Distribution Structure 42
8 Germany Medical Equipment Cross Market Comparison 43
9 Diabetes Care Devices Cross Country Comparison 45
10 Diabetes Care Devices in Germany 47
10.1 Diabetes Care Devices Overall Revenues by Category (2000-2012) 47
10.2 Diabetes Care Devices Overall Volume by Category (2000-2012) 51
10.3 Diabetes Care Devices Overall Company Share (2006-2007) 54
11 Glucose Monitoring in Germany 55
11.1 Glucose Monitoring Revenues by Segment (2000-2012) 55
11.2 Glucose Monitoring Volume by Segment (2000-2012) 57
11.3 Glucose Monitoring Average Price (2000-2012) 59
11.4 Glucose Monitoring Distribution Share (2006-2007) 60
11.5 Glucose Monitoring Company Share (2006-2007) 61
12 Insulin Delivery in Germany 62
12.1 Insulin Delivery Revenue by Segment (2000-2012) 62
12.2 Insulin Delivery Volume by Segment (2000-2012) 64
12.3 Insulin Delivery Average Price (2000-2012) 65
12.4 Insulin Delivery Distribution Share (2006-2007) 66
12.5 Insulin Delivery Company Share (2006-2007) 67
13 F. Hoffmann-La Roche Ltd. Company Profile 68
13.1 Company Overview 68
13.2 Major Products and Services 68
13.2.1 Products: 68
13.3 Value Chain Analysis 69
13.3.1 Manufacturing 70
13.3.1.1 In House Manufacturing 70
13.3.1.2 Outsourcing 70
13.3.2 Product Development 70
13.3.2.1 Regulatory Approvals 70
13.3.2.2 Clinical Trials 70
13.3.2.3 Research and Development 71
13.3.3 Sales and Marketing 71
13.3.3.1 Partnerships and Alliances 71
13.4 F. Hoffmann-La Roche Ltd. Pipeline Products 72
13.4.1 Automated Pancreas 72
13.4.1.1 Products Overview 72
13.4.1.2 Product Description 72
13.4.1.3 Product Status 72
13.4.2 Accu-Chek Aviva Nano 72
13.4.2.1 Products Overview 72
13.4.2.2 Product Description 72
13.4.2.3 Product Status 73
14 LifeScan, Inc. Company Profile 74
14.1 Company Overview 74
14.2 Major Products and Services 74
14.2.1 Products: 74
14.3 LifeScan, Inc. Pipeline Products 74
14.3.1 Blood Glucose Test 74
14.3.1.1 Product Overview 74
14.3.1.2 Product Description 74
14.3.1.3 Product Status 74
14.3.2 OneTouch glucose meter 74
14.3.2.1 Product Overview 74
14.3.2.2 Product Description 75
14.3.2.3 Product Status 75
14.3.2.4 Product Milestone 75
14.3.2.5 Product Patent Details 75
15 Abbott Laboratories Company Profile 77
15.1 Company Overview 77
15.2 Major Products and Services 77
15.2.1 Products: 77
15.3 Value Chain Analysis 78
15.3.1 Manufacturing 78
15.3.1.1 In House Manufacturing 78
15.3.2 Product Development 78
15.3.2.1 Regulatory Approvals 78
15.3.2.2 Clinical Trials 79
15.3.2.3 Research and Development 79
15.3.3 Sales and Marketing 80
15.3.3.1 Partnerships and Alliances 80
15.4 Abbott Laboratories Pipeline Products 80
15.4.1 FreeStyle Navigator Continuous Glucose Monitoring System 80
15.4.1.1 Product Overview 80
15.4.1.2 Product Description 80
15.4.1.3 Product Status 81
15.4.1.4 Clinical Trials 81
15.4.1.5 Product Milestone 82
16 Novo Nordisk A/S Company Profile 83
16.1 Company Overview 83
16.2 Major Products and Services 83
16.2.1 Products: 83
16.3 Novo Nordisk A/S Pipeline Products 83
16.3.1 Future insulin infusion systems 83
16.3.1.1 Product Overview 83
16.3.1.2 Product Description 83
16.3.1.3 Product Status 83
16.3.2 Next generation durable pen 83
16.3.2.1 Product Overview 83
16.3.2.2 Product Description 83
16.3.2.3 Product Status 83
16.3.3 Next generation needles 83
16.3.3.1 Product Overview 84
16.3.3.2 Product Description 84
16.3.3.3 Product Status 84
17 Becton, Dickinson and Company Profile 85
17.1 Company Overview 85
17.2 Major Products and Services 85
17.2.1 Products: 85
17.3 Value Chain Analysis 86
17.3.1 Manufacturing 86
17.3.1.1 In House Manufacturing 86
17.3.2 Product Development 86
17.3.2.1 Regulatory Approvals 87
17.3.2.2 Research and Development 87
17.3.3 Sales and Marketing 87
17.3.3.1 Partnerships and Alliances 87
18 B. Braun Melsungen AG Company Profile 88
18.1 Company Overview 88
18.2 Major Products and Services 88
18.2.1 Products: 88
18.3 Value Chain Analysis 89
18.3.1 Manufacturing 89
18.3.1.1 In House Manufacturing 89
18.3.1.2 Outsourcing 90
18.3.2 Product Development 90
18.3.2.1 Regulatory Approvals 90
18.3.2.2 Clinical Trials 90
18.3.2.3 Research and Development 91
18.3.3 Sales and Marketing 91
18.3.3.1 Partnerships and Alliances 91
18.3.3.2 Licensing Agreements 91
19 Bayer HealthCare AG Company Profile 92
19.1 Company Overview 92
19.2 Major Products and Services 92
19.2.1 Products: 92
19.3 Value Chain Analysis 93
19.3.1 Manufacturing 93
19.3.1.1 In House Manufacturing 93
19.3.1.2 Outsourcing 93
19.3.2 Product Development 94
19.3.2.1 Regulatory Approvals 94
19.3.2.2 Clinical Trials 94
19.3.2.3 Research and Development 94
19.3.3 Sales and Marketing 94
19.3.3.1 Partnerships and Alliances 94
19.3.3.2 Licensing Agreements 95
20 Sanofi-Aventis 96
20.1 Company Overview 96
20.2 Major Products and Services 96
20.2.1 Products: 96
21 EKF-diagnostic GmbH Company Review 97
21.1 Company Overview 97
21.2 Major Products and Services 97
22 Appendix 98
22.1 Global Markets Direct Research Methodology 98
22.2 Coverage 99
22.3 Secondary Research 99
22.4 Primary Research 99
22.5 Models 100
22.6 Forecasts 100
22.7 Expert Panels 101
22.8 Currency Conversion 102
22.9 Contact Us 103
22.10 Disclaimer 103
1.1 List of Tables
Table 1: Healthcare Personnel by Region in Germany, 2006 20
Table 2: Doctors by Specialty in Germany, 2005-2007 21
Table 3: Hospitals by Region in Germany, 2006 22
Table 4: Hospital Beds by Region in Germany, 2006 23
Table 5: Rehabilitation Centers by Region in Germany, 2004 24
Table 6: Rehabilitation Center Beds by Region in Germany, 2004 25
Table 7: Discharges by Diagnosis in Germany, 2004 26
Table 8: Germany, Medical Equipment Market Comparison 44
Table 9: Diabetes Care Devices Market, Country Comparison 46
Table 10: Diabetes Care Devices, Germany, Category Revenues ($ mn), 2000-2012 47
Table 11: Diabetes Care Devices Market, Germany, Portfolio Analysis 48
Table 12: Diabetes Care Devices, Germany, Category Revenues ($ mn), Historic, 2000-2007 49
Table 13: Diabetes Care Devices, Germany, Category Revenues ($ mn), Forecast, 2007-2012 50
Table 14: Diabetes Care Devices, Germany, Category Volume (Units), 2000-2012 51
Table 15: Diabetes Care Devices, Germany, Category Volume (Units), Historic, 2000-2007 52
Table 16: Diabetes Care Devices, Germany, Category Volume (Units), Forecast, 2007-2012 53
Table 17: Diabetes Care Devices, Germany, Overall Company Share by Revenue ($ mn), 2006-2007 54
Table 18: Glucose Monitoring, Germany, Revenue ($ mn) by Segment, Historic, 2000-2007 55
Table 19: Glucose Monitoring, Germany, Revenue ($ mn) by Segment, Forecast, 2007-2012 56
Table 20: Glucose Monitoring, Germany, Volume (Units) by Segment, Historic, 2000-2007 57
Table 21: Glucose Monitoring, Germany, Volume (Units) by Segment, Forecast, 2007-2012 58
Table 22: Glucose Monitoring, Germany, Average Price ($), Historic, 2000-2007 59
Table 23: Glucose Monitoring, Germany, Average Price ($), Forecast, 2007-2012 59
Table 24: Glucose Monitoring, Germany, Distribution Share by Revenue ($ mn), 2006-2007 60
Table 25: Glucose Monitoring, Germany, Company Share by Revenue ($ mn), 2006-2007 61
Table 26: Insulin Delivery , Germany, Revenue ($ mn) by Segment, Historic, 2000-2007 62
Table 27: Insulin Delivery , Germany, Revenue ($ mn) by Segment, Forecast, 2007-2012 63
Table 28: Insulin Delivery , Germany, Volume (Units) by Segment, Historic, 2000-2007 64
Table 29: Insulin Delivery , Germany, Volume (Units) by Segment, Forecast, 2007-2012 64
Table 30: Insulin Delivery, Germany, Average Price ($), Historic, 2000-2007 65
Table 31: Insulin Delivery, Germany, Average Price ($), Forecast, 2007-2012 65
Table 32: Insulin Delivery , Germany, Distribution Share by Revenue ($ mn), 2006-2007 66
Table 33: Insulin Delivery , Germany, Company Share by Revenue ($ mn), 2006-2007 67
Table 34: Currency Conversion from USD to Local Currency at 2007 Constant Rate 102
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Germany, 2000 - 2006 16
Figure 2: Healthcare Structure in Germany, 2000 - 2006 17
Figure 3: Healthcare Expenditure Sources in Germany, 2003 18
Figure 4: Healthcare Expenditure by Disease Type, (%), 2004 18
Figure 5: Healthcare Financing Framework in Germany, 2007 19
Figure 6: Flowchart for Classification of Non-invasive Devices in Germany, 2007 29
Figure 7: Flowchart for Classification of Invasive Devices in Germany, 2007 30
Figure 8: Flowchart for Classification of Invasive Devices in Germany, 2007 31
Figure 9: Classification of Invasive Devices in Germany, 2007 32
Figure 10: Classification of Invasive Devices in Germany, 2007 33
Figure 11: Flowchart for Classification of Active Devices in Germany, 2007 34
Figure 12: Flowchart for Classification of Active Devices in Germany, 2007 35
Figure 13: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Germany, 2007 36
Figure 14: Conformity Assessment of Class-I Medical Devices in Germany, 2007 37
Figure 15: Conformity Assessment of Class-IIa Medical Devices in Germany, 2007 38
Figure 16: Conformity Assessment of Class-IIb Medical Devices in Germany, 2007 39
Figure 17: Conformity Assessment of Class-III Medical Devices in Germany, 2007 40
Figure 18: Germany, Medical Equipment Market Comparison,2007 43
Figure 19: Diabetes Care Devices, Revenues ($ mn) by Country, 2000-2012 45
Figure 20: Diabetes Care Devices Market, Country Comparison 46
Figure 21: Diabetes Care Devices, Germany, Category Revenues ($ mn), 2000-2012 47
Figure 22: Diabetes Care Devices Market, Germany, Portfolio Analysis 48
Figure 23: Diabetes Care Devices, Germany, Category Revenues ($ mn), Historic, 2000-2007 49
Figure 24: Diabetes Care Devices, Germany, Category Revenues ($ mn), Forecast, 2007-2012 50
Figure 25: Diabetes Care Devices, Germany, Category Volume (Units), 2000-2012 51
Figure 26: Diabetes Care Devices, Germany, Category Volume (Units), Historic, 2000-2007 52
Figure 27: Diabetes Care Devices, Germany, Category Volume (Units), Forecast, 2007-2012 53
Figure 28: Diabetes Care Devices, Germany, Overall Company Share (%), 2007 54
Figure 29: Glucose Monitoring, Germany, Revenue ($ mn) by Segment, Historic, 2000-2007 55
Figure 30: Glucose Monitoring, Germany, Revenue ($ mn) by Segment, Forecast, 2007-2012 56
Figure 31: Glucose Monitoring, Germany, Volume (Units) by Segment, Historic, 2000-2007 57
Figure 32: Glucose Monitoring, Germany, Volume (Units) by Segment, Forecast, 2007-2012 58
Figure 33: Glucose Monitoring, Germany, Company Share (%), 2007 61
Figure 34: Insulin Delivery , Germany, Revenue ($ mn) by Segment, Historic, 2000-2007 62
Figure 35: Insulin Delivery , Germany, Revenue ($ mn) by Segment, Forecast, 2007-2012 63
Figure 36: Insulin Delivery , Germany, Company Share (%), 2007 67
Figure 37: F. Hoffmann-La Roche Ltd., Value Chain Analysis 69
Figure 38: Abbott Laboratories, Value Chain Analysis 78
Figure 39: Becton, Dickinson and Company, Value Chain Analysis 86
Figure 40: B. Braun Melsungen AG, Value Chain Analysis 89
Figure 41: Bayer HealthCare AG, Value Chain Analysis 93
Figure 42: Global Markets Direct Methodology 98