Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 8
2
Introduction 10
2.1 What Is This Report About? 10
3 Definitions of
Markets Covered in the Report 11
3.1 Diabetic Care Devices 11
3.2
Glucose Monitoring Devices 11
3.2.1 Blood Glucose Meters 11
3.2.2
Blood Glucose Strips 11
3.3 Insulin Delivery 11
3.3.1 Insulin Pens
11
3.3.2 Insulin Syringes 12
3.3.3 Insulin Pumps 12
3.3.4
Traditional Insulin Pump Accessories 12
4 Healthcare Sector Review 13
4.1 Healthcare Sector 13
4.2 Healthcare Expenditure 13
4.3 Healthcare
Infrastructure 16
4.3.1 Healthcare Personnel Data 16
4.3.2 Healthcare
Facilities Data 18
4.4 Healthcare Policy 23
5 Regulation System 24
5.1 Regulation System 24
5.2 Medical Equipment Approval Process 24
5.2.1 Classification of Medical Devices 24
5.3 Conformity Assessment
Process 33
5.3.1 Class I devices 33
5.3.2 Class IIa devices 34
5.3.3 Class IIb devices 35
5.3.4 Class III devices 36
5.4 Post Market
Surveillance 37
6 Pricing and Reimbursement 38
6.1 SHI 38
6.1.1
Private Health Insurance 38
6.1.2 Diagnosis Related Groups (DRG) 38
7
Distribution Structure 39
8 Diabetes Care Devices In Germany 40
8.1
Diabetes Care Devices, Cross Country Comparison, Revenue ($ mn), 2000-2015
40
8.2 Diabetes Care Devices, Germany, Overall Revenue ($ mn), 2000-2015
41
8.3 Diabetes Care Devices, Germany, Category Volume (Units), 2000-2015
45
8.4 Diabetes Care Devices, Germany, Company Share (2007-2008) 48
9
Glucose Monitoring In Germany 49
9.1 Glucose Monitoring Overall Revenue
(2000-2015) 49
9.1.1 Blood Glucose Meters Overall Revenue (2000-2015)
51
9.2 Glucose Monitoring Overall Volume (2000-2015) 53
9.2.1 Blood
Glucose Meters Overall Volume (2000-2015) 55
9.3 Glucose Monitoring
Average Price (2000-2015) 56
9.4 Glucose Monitoring Distribution Share
(2007-2008) 57
9.5 Glucose Monitoring, Germany, Company Share (2007-2008)
58
10 Insulin Delivery In Germany 59
10.1 Insulin Delivery Overall
Revenue (2000-2015) 59
10.1.1 Insulin Pens Overall Revenue (2000-2015)
61
10.2 Insulin Delivery Overall Volume (2000-2015) 63
10.2.1 Insulin
Pens Overall Volume (2000-2015) 64
10.3 Insulin Delivery Average Price
(2000-2015) 66
10.4 Insulin Delivery Distribution Share (2007-2008) 67
10.5 Insulin Delivery, Germany, Company Share (2007-2008) 68
11 Overview
of Key Companies in Germany Diabetes Care Devices Market 69
11.1 F.
Hoffmann-La Roche Ltd. 69
11.1.1 Company Overview 69
11.1.2 Value
Chain Analysis 70
11.1.3 F. Hoffmann-La Roche Ltd Pipeline Products 72
11.2 Medtronic, Inc. 73
11.2.1 Company Overview 73
11.2.2 Value Chain
Analysis 74
11.2.3 Medtronic, Inc. Pipeline Products 76
11.3 LifeScan,
Inc. 84
11.3.1 Company Overview 84
11.3.2 LifeScan, Inc. Pipeline
Products 84
11.4 Abbott Laboratories 86
11.4.1 Company Overview 86
11.4.2 Value Chain Analysis 87
11.4.3 Abbott Laboratories Pipeline
Products 89
11.5 Novo Nordisk A/S 91
11.5.1 Company Overview 91
11.5.2 Novo Nordisk A/S Pipeline Products 91
11.6 Becton, Dickinson and
Company 92
11.6.1 Company Overview 92
11.6.2 Value Chain Analysis
92
11.7 Eli Lilly and Company 94
11.7.1 Company Overview 94
11.7.2
Value Chain Analysis 94
11.7.3 Eli Lilly and Company Pipeline Products
97
11.8 Bayer HealthCare AG 98
11.8.1 Company Overview 98
11.8.2
Value Chain Analysis 99
11.8.3 Bayer HealthCare AG Pipeline Products
101
11.9 ARKRAY, Inc. 102
11.9.1 Company Overview 102
11.9.2
ARKRAY, Inc. Pipeline Products 102
11.10 Terumo Corporation 104
11.10.1 Company Overview 104
11.10.2 Value Chain Analysis 104
11.11
Animas Corporation 107
11.11.1 Company Overview 107
11.12
Sanofi-Aventis 107
11.12.1 Company Overview 107
11.13 Smiths Medical
107
11.13.1 Company Overview 107
11.13.2 Value Chain Analysis 108
11.14 EKF-diagnostic GmbH 110
11.14.1 Company Overview 110
12 Appendix
111
12.1 Global Markets Direct Research Methodology 111
12.2 Coverage
112
12.3 Secondary Research 112
12.4 Primary Research 113
12.5
Models 113
12.6 Forecasts 114
12.7 Expert Panel Validation 114
12.8 Currency Conversion 115
12.9 Contact Us 116
12.10 Disclaimer
116
1.1 List of Tables
Table 1: Healthcare Expenditure in
Germany, (€m), 2000 – 2006 13
Table 2: Healthcare Personnel by
Region in Germany, 2007 16
Table 3: Doctors by Specialty in Germany,
2000-2004 17
Table 4: Hospitals by Region in Germany, 2004 18
Table 5:
Hospitals and Beds by Region in Germany, 2007 19
Table 6: Rehabilitation
Centers by Region in Germany, 2004 20
Table 7: Rehabilitation Center Beds
by Region in Germany, 2004 21
Table 8: Discharges by Diagnosis in Germany,
2004 22
Table 9: Diabetes Care Devices, Cross Country Comparison,
Revenue ($ mn), 2000-2015 40
Table 10: Diabetes Care Devices,
Germany, Overall Revenue ($ mn), 2000-2015 41
Table 11: Diabetes Care
Devices, Germany, Cross-Category Analysis, 2000-2015 42
Table 12:
Diabetes Care Devices, Germany, Overall Revenue ($ mn), Historic, 2000-2008
43
Table 13: Diabetes Care Devices, Germany, Overall Revenue ($ mn),
Forecast, 2008-2015 44
Table 14: Diabetes Care Devices, Germany,
Category Volume (Units), 2000-2015 45
Table 15: Diabetes Care
Devices, Germany, Category Volume (Units), Historic, 2000-2008 46
Table
16: Diabetes Care Devices, Germany, Category Volume (Units), Forecast,
2008-2015 47
Table 17: Diabetes Care Devices, Germany, Company Share
by Revenue ($ mn), 2007-2008 48
Table 18: Glucose Monitoring,
Germany, Revenue ($ mn) by Segment, Historic, 2000-2008 49
Table 19:
Glucose Monitoring, Germany, Revenue ($ mn) by Segment, Forecast, 2008-2015
50
Table 20: Blood Glucose Meters, Germany, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 51
Table 21: Blood Glucose Meters,
Germany, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 52
Table 22:
Glucose Monitoring, Germany, Volume (Units) by Segment, Historic, 2000-2008
53
Table 23: Glucose Monitoring, Germany, Volume (Units) by Segment,
Forecast, 2008-2015 54
Table 24: Blood Glucose Meters, Germany,
Volume (Units) by Sub-Segment, Historic, 2000-2008 55
Table 25: Blood
Glucose Meters, Germany, Volume (Units) by Sub-Segment, Forecast, 2008-2015
55
Table 26: Glucose Monitoring, Germany, Average Price ($),
Historic, 2000-2008 56
Table 27: Glucose Monitoring, Germany, Average
Price ($), Forecast, 2008-2015 56
Table 28: Glucose Monitoring,
Germany, Distribution Share by Revenue ($mn), 2007-2008 57
Table 29:
Glucose Monitoring, Germany, Company Share by Revenue ($ mn), 2007-2008 58
Table 30: Insulin Delivery, Germany, Revenue ($ mn) by Segment, Historic,
2000-2008 59
Table 31: Insulin Delivery, Germany, Revenue ($ mn) by
Segment, Forecast, 2008-2015 60
Table 32: Insulin Pens, Germany,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 61
Table 33:
Insulin Pens, Germany, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
62
Table 34: Insulin Delivery, Germany, Volume (Units) by Segment,
Historic, 2000-2008 63
Table 35: Insulin Delivery, Germany, Volume
(Units) by Segment, Forecast, 2008-2015 63
Table 36: Insulin Pens,
Germany, Volume (Units) by Sub-Segment, Historic, 2000-2008 64
Table 37:
Insulin Pens, Germany, Volume (Units) by Sub-Segment, Forecast, 2008-2015
65
Table 38: Insulin Delivery, Germany, Average Price ($), Historic,
2000-2008 66
Table 39: Insulin Delivery, Germany, Average Price ($),
Forecast, 2008-2015 66
Table 40: Insulin Delivery, Germany,
Distribution Share by Revenue ($mn), 2007-2008 67
Table 41: Insulin
Delivery, Germany, Company Share by Revenue ($ mn), 2007-2008 68
Table 42:
F. Hoffmann-La Roche Ltd Pipeline Products by Equipment Type 72
Table
43: F. Hoffmann-La Roche Ltd Pipeline Products by Development Stage
72
Table 44: F. Hoffmann-La Roche Ltd Pipeline Products by Therapy
Area 72
Table 45: Medtronic, Inc. Pipeline Products by Equipment Type
76
Table 46: Medtronic, Inc. Pipeline Products By Development Stage
78
Table 47: Medtronic, Inc. Pipeline Products By Therapy Area 80
Table 48: Medtronic, Inc. Pipeline Products By Clinical Trials 82
Table 49: Medtronic, Inc. Pipeline Products By News Summary 83
Table
50: LifeScan, Inc. Pipeline Products by Equipment Type 84
Table 51:
LifeScan, Inc. Pipeline Products by Development Stage 84
Table 52:
LifeScan, Inc. Pipeline Products by Therapy Area 84
Table 53:
LifeScan, Inc. Pipeline Products by Clinical Trials 85
Table 54:
LifeScan, Inc. Pipeline Products by News Summary 85
Table 55: Abbott
Laboratories Pipeline Products by Equipment Type 89
Table 56: Abbott
Laboratories Pipeline Products by Development Stage 89
Table 57:
Abbott Laboratories Pipeline Products by Therapy Area 89
Table 58:
Abbott Laboratories Pipeline Products by Clinical Trials 90
Table 59:
Abbott Laboratories Pipeline Products by News Summary 90
Table 60:
Novo Nordisk A/S Pipeline Products by Equipment Type 91
Table 61:
Novo Nordisk A/S Pipeline Products By Development Stage 91
Table 62:
Novo Nordisk A/S Pipeline Products By Therapy Area 91
Table 63: Novo
Nordisk A/S Pipeline Products By Clinical Trials 91
Table 64: Eli
Lilly and Company Pipeline Products by Equipment Type 97
Table 65:
Eli Lilly and Company Pipeline Products by Development Stage 97
Table 66:
Eli Lilly and Company Pipeline Products by Therapy Area 97
Table 67:
Eli Lilly and Company Pipeline Products by Clinical Trials 97
Table 68:
Eli Lilly and Company Pipeline Products by News Summary 97
Table 69:
Bayer HealthCare AG Pipeline Products by Equipment Type 101
Table 70:
Bayer HealthCare AG Pipeline Products by Development Stage 101
Table
71: Bayer HealthCare AG Pipeline Products by Therapy Area 101
Table
72: Bayer HealthCare AG Pipeline Products by News Summary 101
Table
73: ARKRAY, Inc. Pipeline Products by Equipment Type 102
Table 74:
ARKRAY, Inc. Pipeline Products by Development Stage 102
Table 75:
ARKRAY, Inc. Pipeline Products by Clinical Trials 103
Table 76:
ARKRAY, Inc. Pipeline Products by News Summary 103
Table 77: USD to
Local Currency, Average Exchange Rate 2008 115
1.2 List of
Figures
Figure 1: Healthcare Expenditure Sources in Germany, 2006 14
Figure 2: Healthcare Financing Framework in Germany, 2007 15
Figure 3:
Flowchart for Classification of Non-invasive Devices in Germany, 2007 25
Figure 4: Flowchart for Classification of Invasive Devices in Germany, 2007
26
Figure 5: Flowchart for Classification of Invasive Devices in Germany,
2007 27
Figure 6: Classification of Invasive Devices in Germany, 2007
28
Figure 7: Classification of Invasive Devices in Germany, 2007 29
Figure 8: Flowchart for Classification of Active Devices in Germany, 2007
30
Figure 9: Flowchart for Classification of Active Devices in Germany,
2007 31
Figure 10: Flowchart for Classification of Devices except
Non-invasive, Invasive and Active Devices in Germany, 2007 32
Figure 11:
Conformity Assessment of Class-I Medical Devices in Germany, 2007 33
Figure 12: Conformity Assessment of Class-IIa Medical Devices in Germany, 2007
34
Figure 13: Conformity Assessment of Class-IIb Medical Devices in
Germany, 2007 35
Figure 14: Conformity Assessment of Class-III Medical
Devices in Germany, 2007 36
Figure 15: Diabetes Care Devices, Cross
Country Comparison, Revenue ($ mn), 2000-2015 40
Figure 16: Diabetes
Care Devices, Germany, Overall Revenue ($ mn), 2000-2015 41
Figure 17:
Diabetes Care Devices, Germany, Cross-Category Analysis, 2000-2015 42
Figure 18: Diabetes Care Devices, Germany, Overall Revenue ($ mn),
Historic, 2000-2008 43
Figure 19: Diabetes Care Devices, Germany,
Overall Revenue ($ mn), Forecast, 2008-2015 44
Figure 20: Diabetes
Care Devices, Germany, Category Volume (Units), 2000-2015 45
Figure 21:
Diabetes Care Devices, Germany, Category Volume (Units), Historic, 2000-2008
46
Figure 22: Diabetes Care Devices, Germany, Category Volume
(Units), Forecast, 2008-2015 47
Figure 23: Diabetes Care Devices,
Germany, Company Share (%), 2008 48
Figure 24: Glucose Monitoring,
Germany, Revenue ($ mn) by Segment, Historic, 2000-2008 49
Figure 25:
Glucose Monitoring, Germany, Revenue ($ mn) by Segment, Forecast, 2008-2015
50
Figure 26: Blood Glucose Meters, Germany, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 51
Figure 27: Blood Glucose Meters,
Germany, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 52
Figure 28:
Glucose Monitoring, Germany, Volume (Units) by Segment, Historic,
2000-2008 53
Figure 29: Glucose Monitoring, Germany, Volume (Units)
by Segment, Forecast, 2008-2015 54
Figure 30: Glucose Monitoring,
Germany, Company Share (%), 2008 58
Figure 31: Insulin Delivery,
Germany, Revenue ($ mn) by Segment, Historic, 2000-2008 59
Figure 32:
Insulin Delivery, Germany, Revenue ($ mn) by Segment, Forecast, 2008-2015
60
Figure 33: Insulin Pens, Germany, Revenue ($ mn) by Sub-Segment,
Historic, 2000-2008 61
Figure 34: Insulin Pens, Germany, Revenue ($
mn) by Sub-Segment, Forecast, 2008-2015 62
Figure 35: Insulin Pens,
Germany, Volume (Units) by Sub-Segment, Historic, 2000-2008 64
Figure 36:
Insulin Pens, Germany, Volume (Units) by Sub-Segment, Forecast, 2008-2015
65
Figure 37: Insulin Delivery, Germany, Company Share (%), 2008
68
Figure 38: F. Hoffmann-La Roche Ltd Value Chain Analysis 70
Figure 39: Medtronic, Inc. Value Chain Analysis 74
Figure 40:
Abbott Laboratories Value Chain Analysis 87
Figure 41: Becton,
Dickinson and Company Value Chain Analysis 92
Figure 42: Eli Lilly
and Company Value Chain Analysis 94
Figure 43: Bayer HealthCare AG
Value Chain Analysis 99
Figure 44: Terumo Corporation Value Chain
Analysis 104
Figure 45: Smiths Medical Value Chain Analysis 108
Figure 46: Global Markets Direct Methodology 111
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