Table of Contents
1 Table of Contents 2
1.1 List of Tables 9
1.2 List of Figures 12
2 Introduction 14
2.1 What is This Report About? 14
3 Executive
Summary 15
4 Definitions of Markets Covered in the Report 16
4.1
Orthopedic Devices 16
4.2 Orthobiologics 16
4.2.1 Bone Allografts
16
4.2.2 Bone Graft Substitutes 16
4.2.3 Bone Growth and Spinal
Stimulation 16
4.2.4 Viscosupplementation 16
4.2.5 DBM 17
4.3
Joint Reconstruction 17
4.3.1 Ankle Replacement 17
4.3.2 Digits
Replacement 17
4.3.3 Elbow Replacement 17
4.3.4 Hip Replacement 17
4.3.5 Knee Replacement 18
4.3.6 Shoulder Replacement 18
4.3.7 Wrist
Replacement 19
4.4 Spinal Surgery 19
4.4.1 Spinal Fusion 19
4.4.2
Spinal Non-Fusion 20
4.5 Trauma Fixation 20
4.5.1 Internal Fixators
20
4.5.2 External Fixators 21
4.6 Arthroscopy 21
4.6.1 Arthroscope
21
4.7 Orthopedic Accessories 21
4.7.1 Bone Cement 21
4.7.2 Cast
Application and Removal Systems 21
4.8 Orthopedic Braces and Supports
22
4.8.1 Ankle Braces and Supports 22
4.8.2 Knee Braces and Supports
22
4.8.3 Wrist and other Braces and Supports 22
5 Healthcare Sector
Review 23
5.1 Healthcare Sector 23
5.2 Healthcare Expenditure 23
5.3 Healthcare Infrastructure 27
5.3.1 Healthcare Personnel Data 27
5.3.2 Healthcare Facilities Data 29
5.4 Healthcare Policy 35
6
Regulation System 36
6.1 Regulation System 36
6.2 Medical Equipment
Approval Process 36
6.2.1 Classification of Medical Devices 36
6.3
Conformity Assessment Process 45
6.3.1 Class I devices 45
6.3.2 Class
IIa devices 46
6.3.3 Class IIb devices 47
6.3.4 Class III devices
48
6.4 Post Market Surveillance 49
7 Pricing and Reimbursement 50
7.1 SHI 50
7.1.1 Private Health Insurance 50
7.1.2 Diagnosis Related
Groups (DRG) 50
8 Distribution Structure 51
9 Orthopedic Devices In
Germany 52
9.1 Orthopedic Devices, Germany, Overall Revenue 52
9.2
Orthopedic Devices, Germany, Category Volume 56
9.3 Orthopedic Devices,
Germany, Cross-Category Analysis 58
9.4 Orthopedic Devices Market Dynamics
59
9.4.1 Market Drivers 59
9.4.2 Market Restraints 59
9.4.3 Market
Trends 60
9.5 Orthopedic Devices, Germany, Competitive Landscape 60
10
Arthroscopy In Germany 62
10.1 Arthroscopy Overall Revenue 62
10.2
Arthroscopy Overall Volume 64
10.3 Arthroscopy Average Price 65
10.4
Arthroscopy Distribution Share 65
10.5 Arthroscopy, Germany, Competitive
Landscape 66
11 Joint Reconstruction In Germany 67
11.1 Joint
Reconstruction Overall Revenue 67
11.2 Joint Reconstruction Overall Volume
69
11.3 Joint Reconstruction, Germany, Cross-Segment Analysis 71
11.4
Joint Reconstruction Average Price 73
11.5 Joint Reconstruction
Distribution Share 75
11.6 Joint Reconstruction, Germany, Competitive
Landscape 76
12 Orthobiologics In Germany 77
12.1 Orthobiologics
Overall Revenue (2000-2015) 77
12.2 Orthobiologics Overall Volume
(2000-2015) 81
12.3 Orthobiologics, Germany, Cross-Segment Analysis,
2000-2015 82
12.4 Orthobiologics Average Price (2000-2015) 84
12.5
Orthobiologics Distribution Share 85
12.6 Orthobiologics, Germany,
Competitive Landscape 86
13 Orthopedic Accessories In Germany 87
13.1
Orthopedic Accessories Overall Revenue 87
13.2 Orthopedic Accessories
Overall Volume 89
13.3 Orthopedic Accessories, Germany, Cross-Segment
Analysis 90
13.4 Orthopedic Accessories Average Price 91
13.5
Orthopedic Accessories Distribution Share 92
13.6 Orthopedic Accessories,
Germany, Competitive Landscape 93
14 Orthopedic Braces and Supports In
Germany 94
14.1 Orthopedic Braces and Supports Overall Revenue 94
14.2
Orthopedic Braces and Supports Overall Volume 97
14.3 Orthopedic Braces
and Supports, Germany, Cross-Segment Analysis 98
14.4 Orthopedic Braces
and Supports Average Price 99
14.5 Orthopedic Braces and Supports
Distribution Share 100
14.6 Orthopedic Braces and Supports, Germany,
Competitive Landscape 101
15 Spinal Surgery In Germany 102
15.1 Spinal
Surgery Overall Revenue 102
15.2 Spinal Surgery Overall Volume 105
15.3 Spinal Surgery, Germany, Cross-Segment Analysis 106
15.4 Spinal
Surgery Average Price 107
15.5 Spinal Surgery Distribution Share 108
15.6 Spinal Surgery, Germany, Competitive Landscape 109
16 Trauma Fixation
In Germany 110
16.1 Trauma Fixation Overall Revenue 110
16.2 Trauma
Fixation Overall Volume 112
16.3 Trauma Fixation, Germany, Cross-Segment
Analysis 113
16.4 Trauma Fixation Average Price 114
16.5 Trauma
Fixation Distribution Share 115
16.6 Trauma Fixation, Germany, Competitive
Landscape 116
17 Overview of Key Companies in Germany Orthopedic Devices
Market 117
17.1 DePuy, Inc. 117
17.1.1 Company Overview 117
17.1.2
DePuy, Inc. Pipeline Products 117
17.2 Zimmer Holdings, Inc. 120
17.2.1 Company Overview 120
17.2.2 Value Chain Analysis 121
17.2.3
Zimmer Holdings, Inc. Pipeline Products 123
17.3 Stryker Corporation
125
17.3.1 Company Overview 125
17.3.2 Value Chain Analysis 125
17.3.3 Stryker Corporation Pipeline Products 127
17.4 Biomet, Inc. 129
17.4.1 Company Overview 129
17.4.2 Value Chain Analysis 129
17.4.3
Biomet, Inc. Pipeline Products 131
17.5 Smith & Nephew Plc 134
17.5.1
Company Overview 134
17.5.2 Value Chain Analysis 134
17.5.3 Smith &
Nephew Plc Pipeline Products 137
17.6 Synthes GmbH 139
17.6.1 Company
Overview 139
17.6.2 Value Chain Analysis 139
17.6.3 Synthes, Inc.
Pipeline Products 141
17.7 Medtronic, Inc. 142
17.7.1 Company Overview
142
17.7.2 Value Chain Analysis 142
17.7.3 Medtronic, Inc. Pipeline
Products 144
17.8 Arthrocare Corporation 151
17.8.1 Company Overview
151
17.8.2 Value Chain Analysis 152
17.8.3 Arthrocare Corporation
Pipeline Products 154
17.9 Bauerfeind AG 155
17.9.1 Company Overview
155
17.10 aap bio implants markets GmbH 155
17.10.1 Company Overview
155
17.11 aap Implantate AG 156
17.11.1 Company Overview 156
17.11.2 aap Implantate AG Pipeline Products 156
17.12 allgaier instrumente
GmbH 159
17.12.1 Company Overview 159
17.13 AristoTech Implant
Technologies GmbH 159
17.13.1 Company Overview 159
17.14 Bäramed
Instrumente GmbH 159
17.14.1 Company Overview 159
17.14.2 Company
Overview 160
17.14.3 ESKA IMPLANTS AG Pipeline Products 160
17.15
Friedrich Daniels GmbH 161
17.15.1 Company Overview 161
17.16 IO
International Orthopaedics Holding GmbH 161
17.16.1 Company Overview
161
17.17 medi GmbH & Co. KG 161
17.17.1 Company Overview 161
17.18 NORMED Medizin-Technik GmbH 162
17.18.1 Company Overview 162
17.19 Waldemar LINK GmbH & Co. KG 162
17.19.1 Company Overview 162
18
Recent Developments 163
18.1 Strategy and Business Planning 163
18.1.1
Feb 17, 2009: SBi Establishes SBi Deutschland 163
19 Appendix 165
19.1
GlobalData Research Methodology 165
19.2 Coverage 166
19.3 Secondary
Research 167
19.4 Primary Research 167
19.5 Models 168
19.6
Forecasts 168
19.7 Expert Panel Validation 169
19.8 Currency
Conversion 170
19.9 Contact Us 171
19.10 Disclaimer 171
1.1
List of Tables
Table 1: Healthcare Personnel by Region in Germany, 2004
27
Table 2: Doctors by Specialty in Germany, 2000-2004 28
Table 3:
Hospitals by Region in Germany, 2004 29
Table 4: Hospital Beds by Region
in Germany, 2004 30
Table 5: Rehabilitation Centers by Region in Germany,
2004 31
Table 6: Rehabilitation Center Beds by Region in Germany, 2004
32
Table 7: Discharges by Diagnosis in Germany, 2004 33
Table 8:
Orthopedic Devices, Germany, Overall Revenue ($m), Historic, 2000-2008 53
Table 9: Orthopedic Devices, Germany, Overall Revenue ($m), Forecast,
2008-2015 55
Table 10: Orthopedic Devices, Germany, Category Volume
(Units), Historic, 2000-2008 56
Table 11: Orthopedic Devices,
Germany, Category Volume (Units), Forecast, 2008-2015 57
Table 12:
Orthopedic Devices, Germany, Cross-Category Analysis, 2000-2015 58
Table
13: Orthopedic Devices, Germany, Company Share by Revenue ($m), 2007-2008
61
Table 14: Arthroscopy, Germany, Revenue ($m), Historic, 2000-2008
62
Table 15: Arthroscopy, Germany, Revenue ($m), Forecast, 2008-2015
63
Table 16: Arthroscopy, Germany, Volume (Units), Historic,
2000-2008 64
Table 17: Arthroscopy, Germany, Volume (Units),
Forecast, 2008-2015 64
Table 18: Arthroscopy, Germany, Average Price
($), Historic, 2000-2008 65
Table 19: Arthroscopy, Germany, Average
Price ($), Forecast, 2008-2015 65
Table 20: Arthroscopy, Germany,
Distribution Share by Revenue ($m), 2007-2008 65
Table 21:
Arthroscopy, Germany, Company Share by Revenue ($m), 2007-2008 66
Table
22: Joint Reconstruction, Germany, Revenue ($m) by Segment, Historic,
2000-2008 67
Table 23: Joint Reconstruction, Germany, Revenue ($m) by
Segment, Forecast, 2008-2015 68
Table 24: Joint Reconstruction,
Germany, Volume (Units) by Segment, Historic, 2000-2008 69
Table 25:
Joint Reconstruction, Germany, Volume (Units) by Segment, Forecast, 2008-2015
70
Table 26: Joint Reconstruction, Germany, Cross-Segment Analysis,
2000-2015 71
Table 27: Joint Reconstruction, Germany, Average Price
($), Historic, 2000-2008 73
Table 28: Joint Reconstruction, Germany,
Average Price ($), Forecast, 2008-2015 74
Table 29: Joint
Reconstruction, Germany, Distribution Share by Revenue ($m), 2007-2008 75
Table 30: Joint Reconstruction, Germany, Company Share by Revenue ($m),
2007-2008 76
Table 31: Orthobiologics, Germany, Revenue ($m) by
Segment, Historic, 2000-2008 78
Table 32: Orthobiologics, Germany,
Revenue ($m) by Segment, Forecast, 2008-2015 80
Table 33:
Orthobiologics, Germany, Volume (Units) by Segment, Historic, 2000-2008 81
Table 34: Orthobiologics, Germany, Volume (Units) by Segment, Forecast,
2008-2015 81
Table 35: Orthobiologics, Germany, Cross-Segment Analysis,
2000-2015 82
Table 36: Orthobiologics, Germany, Average Price ($),
Historic, 2000-2008 84
Table 37: Orthobiologics, Germany, Average
Price ($), Forecast, 2008-2015 84
Table 38: Orthobiologics, Germany,
Distribution Share by Revenue ($m), 2007-2008 85
Table 39:
Orthobiologics, Germany, Company Share by Revenue ($m), 2007-2008 86
Table
40: Orthopedic Accessories, Germany, Revenue ($m) by Segment, Historic,
2000-2008 87
Table 41: Orthopedic Accessories, Germany, Revenue ($m)
by Segment, Forecast, 2008-2015 88
Table 42: Orthopedic Accessories,
Germany, Volume (Units) by Segment, Historic, 2000-2008 89
Table 43:
Orthopedic Accessories, Germany, Volume (Units) by Segment, Forecast,
2008-2015 89
Table 44: Orthopedic Accessories, Germany, Cross-Segment
Analysis, 2000-2015 90
Table 45: Orthopedic Accessories, Germany,
Average Price ($), Historic, 2000-2008 91
Table 46: Orthopedic
Accessories, Germany, Average Price ($), Forecast, 2008-2015 91
Table 47:
Orthopedic Accessories, Germany, Distribution Share by Revenue ($m),
2007-2008 92
Table 48: Orthopedic Accessories, Germany, Company Share
by Revenue ($m), 2007-2008 93
Table 49: Orthopedic Braces and
Supports, Germany, Revenue ($m) by Segment, Historic, 2000-2008 94
Table
50: Orthopedic Braces and Supports, Germany, Revenue ($m) by Segment,
Forecast, 2008-2015 96
Table 51: Orthopedic Braces and Supports,
Germany, Volume (Units) by Segment, Historic, 2000-2008 97
Table 52:
Orthopedic Braces and Supports, Germany, Volume (Units) by Segment, Forecast,
2008-2015 97
Table 53: Orthopedic Braces and Supports, Germany,
Cross-Segment Analysis, 2000-2015 98
Table 54: Orthopedic Braces and
Supports, Germany, Average Price ($), Historic, 2000-2008 99
Table 55:
Orthopedic Braces and Supports, Germany, Average Price ($), Forecast,
2008-2015 99
Table 56: Orthopedic Braces and Supports, Germany,
Distribution Share by Revenue ($m), 2007-2008 100
Table 57:
Orthopedic Braces and Supports, Germany, Company Share by Revenue ($m),
2007-2008 101
Table 58: Spinal Surgery, Germany, Revenue ($m) by
Segment, Historic, 2000-2008 102
Table 59: Spinal Surgery, Germany,
Revenue ($m) by Segment, Forecast, 2008-2015 104
Table 60: Spinal
Surgery, Germany, Volume (Units) by Segment, Historic, 2000-2008 105
Table
61: Spinal Surgery, Germany, Volume (Units) by Segment, Forecast,
2008-2015 105
Table 62: Spinal Surgery, Germany, Cross-Segment Analysis,
2000-2015 106
Table 63: Spinal Surgery, Germany, Average Price ($),
Historic, 2000-2008 107
Table 64: Spinal Surgery, Germany, Average
Price ($), Forecast, 2008-2015 107
Table 65: Spinal Surgery, Germany,
Distribution Share by Revenue ($m), 2007-2008 108
Table 66: Spinal
Surgery, Germany, Company Share by Revenue ($m), 2007-2008 109
Table 67:
Trauma Fixation, Germany, Revenue ($m) by Segment, Historic, 2000-2008
110
Table 68: Trauma Fixation, Germany, Revenue ($m) by Segment,
Forecast, 2008-2015 111
Table 69: Trauma Fixation, Germany, Volume
(Units) by Segment, Historic, 2000-2008 112
Table 70: Trauma
Fixation, Germany, Volume (Units) by Segment, Forecast, 2008-2015 112
Table 71: Trauma Fixation, Germany, Cross-Segment Analysis, 2000-2015 113
Table 72: Trauma Fixation, Germany, Average Price ($), Historic,
2000-2008 114
Table 73: Trauma Fixation, Germany, Average Price ($),
Forecast, 2008-2015 114
Table 74: Trauma Fixation, Germany,
Distribution Share by Revenue ($m), 2007-2008 115
Table 75: Trauma
Fixation, Germany, Company Share by Revenue ($m), 2007-2008 116
Table 76:
DePuy, Inc. Pipeline Products by Equipment Type 117
Table 77:
DePuy, Inc. Pipeline Products by Development Stage 118
Table 78:
DePuy, Inc. Pipeline Products by Therapy Area 118
Table 79: DePuy,
Inc. Pipeline Products by Clinical Trials 119
Table 80: DePuy, Inc.
Pipeline Products by News Summaries 119
Table 81: Zimmer Holdings,
Inc. Pipeline Products by Equipment Type 123
Table 82: Zimmer
Holdings, Inc. Pipeline Products by Development Stage 123
Table 83:
Zimmer Holdings, Inc. Pipeline Products by Therapy Area 124
Table 84:
Zimmer Holdings, Inc. Pipeline Products by Clinical Trials 124
Table 85:
Stryker Corporation Pipeline Products by Equipment Type 127
Table 86:
Stryker Corporation Pipeline Products by Development Stage 128
Table
87: Stryker Corporation Pipeline Products by Therapy Area 128
Table
88: Stryker Corporation Pipeline Products by Clinical Trials 128
Table 89: Biomet, Inc. Pipeline Products by Equipment Type 131
Table
90: Biomet, Inc. Pipeline Products by Development Stage 132
Table 91:
Biomet, Inc. Pipeline Products by Therapy Area 132
Table 92:
Biomet, Inc. Pipeline Products by Clinical Trials 133
Table 93: Smith
& Nephew Plc Pipeline Products by Equipment Type 137
Table 94: Smith
& Nephew Plc Pipeline Products by Development Stage 137
Table 95:
Smith & Nephew Plc Pipeline Products by Therapy Area 138
Table 96:
Synthes, Inc. Pipeline Products by Equipment Type 141
Table 97:
Synthes, Inc. PipeAline Products by Development Stage 141
Table 98:
Synthes, Inc. Pipeline Products by Therapy Area 141
Table 99:
Synthes, Inc. Pipeline Products by Clinical Trials 141
Table 100:
Medtronic, Inc. Pipeline Products by Equipment Type 144
Table 101:
Medtronic, Inc. Pipeline Products by Development Stage 145
Table 102:
Medtronic, Inc. Pipeline Products by Therapy Area 147
Table 103:
Medtronic, Inc. Pipeline Products by Clinical Trials 148
Table 104:
Medtronic, Inc. Pipeline Products by News Summaries 149
Table 105:
Arthrocare Corporation Pipeline Products by Equipment Type 154
Table 106:
Arthrocare Corporation Pipeline Products by Development Stage 154
Table 107: Arthrocare Corporation Pipeline Products by Therapy Area
155
Table 108: Arthrocare Corporation Pipeline Products by News
Summary 155
Table 109: aap Implantate AG Pipeline Products by
Equipment Type 156
Table 110: aap Implantate AG Pipeline Products by
Development Stage 157
Table 111: aap Implantate AG Pipeline Products
by Therapy Area 158
Table 112: ESKA IMPLANTS AG Pipeline Products by
Equipment Type 160
Table 113: ESKA IMPLANTS AG Pipeline Products by
Development Stage 160
Table 114: ESKA IMPLANTS AG Pipeline Products
by Therapy Area 160
Table 115: USD to Local Currency, Average Exchange
Rate 2008 170
1.2 List of Figures
Figure 1: Healthcare Structure
in Germany, 2000 - 2006 24
Figure 2: Healthcare Expenditure Sources in
Germany, 2003 25
Figure 3: Healthcare Financing Framework in Germany
26
Figure 4: Flowchart for Classification of Non-invasive Devices in
Germany, 2007 37
Figure 5: Flowchart for Classification of Invasive
Devices in Germany, 2007 38
Figure 6: Flowchart for Classification of
Invasive Devices in Germany, 2007 39
Figure 7: Classification of Invasive
Devices in Germany, 2007 40
Figure 8: Classification of Invasive Devices
in Germany, 2007 41
Figure 9: Flowchart for Classification of Active
Devices in Germany, 2007 42
Figure 10: Flowchart for Classification of
Active Devices in Germany, 2007 43
Figure 11: Flowchart for Classification
of Devices except Non-invasive, Invasive and Active Devices in Germany, 2007
44
Figure 12: Conformity Assessment of Class-I Medical Devices in Germany,
2007 45
Figure 13: Conformity Assessment of Class-IIa Medical Devices in
Germany, 2007 46
Figure 14: Conformity Assessment of Class-IIb Medical
Devices in Germany, 2007 47
Figure 15: Conformity Assessment of Class-III
Medical Devices in Germany, 2007 48
Figure 16: Orthopedic Devices,
Germany, Overall Revenue ($m), Historic, 2000-2008 52
Figure 17:
Orthopedic Devices, Germany, Overall Revenue ($m), Forecast, 2008-2015 54
Figure 18: Orthopedic Devices, Germany, Cross-Category Analysis, 2000-2015
58
Figure 19: Orthopedic Devices, Germany, Company Share (%), 2008
60
Figure 20: Arthroscopy, Germany, Revenue ($m), Historic, 2000-2008
62
Figure 21: Arthroscopy, Germany, Revenue ($m), Forecast, 2008-2015
63
Figure 22: Arthroscopy, Germany, Company Share (%), 2008 66
Figure 23: Joint Reconstruction, Germany, Cross-Segment Analysis,
2000-2015 71
Figure 24: Joint Reconstruction, Germany, Company Share
(%), 2008 76
Figure 25: Orthobiologics, Germany, Revenue ($m) by
Segment, Historic, 2000-2008 77
Figure 26: Orthobiologics, Germany,
Revenue ($m) by Segment, Forecast, 2008-2015 79
Figure 27:
Orthobiologics, Germany, Cross-Segment Analysis, 2000-2015 82
Figure 28:
Orthobiologics, Germany, Company Share (%), 2008 86
Figure 29:
Orthopedic Accessories, Germany, Revenue ($m) by Segment, Historic, 2000-2008
87
Figure 30: Orthopedic Accessories, Germany, Revenue ($m) by
Segment, Forecast, 2008-2015 88
Figure 31: Orthopedic Accessories,
Germany, Cross-Segment Analysis, 2000-2015 90
Figure 32: Orthopedic
Accessories, Germany, Company Share (%), 2008 93
Figure 33:
Orthopedic Braces and Supports, Germany, Revenue ($m) by Segment, Historic,
2000-2008 94
Figure 34: Orthopedic Braces and Supports, Germany,
Revenue ($m) by Segment, Forecast, 2008-2015 95
Figure 35: Orthopedic
Braces and Supports, Germany, Cross-Segment Analysis, 2000-2015 98
Figure
36: Orthopedic Braces and Supports, Germany, Company Share (%), 2008
101
Figure 37: Spinal Surgery, Germany, Revenue ($m) by Segment,
Historic, 2000-2008 102
Figure 38: Spinal Surgery, Germany, Revenue
($m) by Segment, Forecast, 2008-2015 103
Figure 39: Spinal Surgery,
Germany, Cross-Segment Analysis, 2000-2015 106
Figure 40: Spinal
Surgery, Germany, Company Share (%), 2008 109
Figure 41: Trauma
Fixation, Germany, Revenue ($m) by Segment, Historic, 2000-2008 110
Figure
42: Trauma Fixation, Germany, Revenue ($m) by Segment, Forecast,
2008-2015 111
Figure 43: Trauma Fixation, Germany, Cross-Segment
Analysis, 2000-2015 113
Figure 44: Trauma Fixation, Germany, Company
Share (%), 2008 116
Figure 45: Zimmer Holdings, Inc. Value Chain
Analysis 121
Figure 46: Stryker Corporation Value Chain Analysis
125
Figure 47: Biomet, Inc. Value Chain Analysis 129
Figure 48:
Smith & Nephew Plc Value Chain Analysis 134
Figure 49: Synthes,
Inc. Value Chain Analysis 139
Figure 50: Medtronic, Inc. Value Chain
Analysis 142
Figure 51: Arthrocare Corporation Value Chain Analysis
152
Figure 52: GlobalData Methodology 166
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