1 Table Of Contents
1 Table Of Contents 2
1.1 List of Tables 9
1.2 List of Figures 11
2 Introduction 13
2.1 What Is This Report About? 13
3 Definitions of Markets Covered in the Report 14
3.1 Nephrology and Urology Devices 14
3.2 Incontinence Devices 14
3.2.1 Protective garments for incontinence 14
3.2.2 Urine Bags 14
3.2.3 Urinary Catheters 14
3.3 Renal Dialysis Equipment 14
3.3.1 Hemodialysis Machines 14
3.3.2 Peritoneal Dialysis Solutions 14
3.3.3 Continuous Renal Replacement Therapy Machines 15
3.3.4 Dialysis Accessories 15
3.3.4.1 AV Fistula Needles 15
3.3.4.2 Blood Tubing Sets 15
3.3.4.3 Dialysis Catheters 15
3.3.4.4 Dialyzers 15
3.4 Lithotripters 15
4 Healthcare Sector Review 16
4.1 Healthcare Sector 16
4.2 Healthcare Expenditure 16
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 Regulation System 28
5.2 Medical Equipment Approval Process 28
5.2.1 Classification of Medical Devices 28
5.3 Conformity Assessment Process 37
5.3.1 Class I devices 37
5.3.2 Class IIa devices 38
5.3.3 Class IIb devices 39
5.3.4 Class III devices 40
5.4 Post Market Surveillance 41
6 Pricing and Reimbursement 42
6.1 SHI 42
6.1.1 Private Health Insurance 42
6.1.2 Diagnosis Related Groups (DRG) 42
7 Distribution Structure 43
8 Nephrology and Urology Devices In Germany 44
8.1 Nephrology and Urology Devices Cross Country Comparison (2000-2012) 44
8.2 Nephrology and Urology Devices, Germany, Overall Revenues ($ mn), 2000-2012 45
8.3 Nephrology and Urology Devices, Germany, Category Volume (Units), 2000-2012 48
8.4 Nephrology and Urology Devices, Germany Company share (2006-2007) 50
9 Incontinence Devices In Germany 51
9.1 Incontinence Devices Overall Revenue (2000-2012) 51
9.2 Incontinence Devices Overall Volume (2000-2012) 53
9.3 Incontinence Devices Average Price (2000-2012) 55
9.4 Incontinence Devices Distribution Share (2006-2007) 56
9.5 Incontinence Devices, Germany Company share (2006-2007) 57
10 Lithotripters In Germany 58
10.1 Lithotripters Overall Revenue (2000-2012) 58
10.2 Lithotripters Overall Volume (2000-2012) 60
10.3 Lithotripters Average Price (2000-2012) 62
10.4 Lithotripters Distribution Share (2006-2007) 63
10.5 Lithotripters, Germany Company share (2006-2007) 64
11 Renal Dialysis Equipment In Germany 65
11.1 Renal Dialysis Equipment Overall Revenue (2000-2012) 65
11.1.1 Dialysis Accessories Overall Revenue (2000-2012) 67
11.2 Renal Dialysis Equipment Overall Volume (2000-2012) 69
11.2.1 Dialysis Accessories Overall Volume (2000-2012) 70
11.3 Renal Dialysis Equipment Average Price (2000-2012) 72
11.4 Renal Dialysis Equipment Distribution Share (2006-2007) 73
11.5 Renal Dialysis Equipment, Germany Company share (2006-2007) 74
12 Svenska Celullosa Aktiebolaget SCA Company Profile 75
12.1 Company Overview 75
13 HARTMANN GROUP Company Profile 76
13.1 Company Overview 76
13.2 Value Chain Analysis 76
13.2.1 Manufacturing 77
13.2.1.1 Outsourcing 77
13.2.1.2 In House Manufacturing 77
13.2.2 Product Development 77
13.2.2.1 Regulatory Approvals 77
13.2.2.2 Research and Development 77
13.2.3 Sales and Marketing 77
13.2.3.1 Partnerships and Alliances 77
14 Fresenius Medical Care AG & Co. KGaA Company Profile 78
14.1 Company Overview 78
14.2 Value Chain Analysis 79
14.2.1 Manufacturing 79
14.2.1.1 In House Manufacturing 79
14.2.2 Product Development 80
14.2.2.1 Regulatory Approvals 80
14.2.2.2 Research and Development 80
14.2.3 Sales and Marketing 80
14.2.3.1 Partnerships and Alliances 80
14.2.3.2 Licensing Agreements 80
15 Gambro AB Company Profile 81
15.1 Company Overview 81
15.2 Value Chain Analysis 82
15.2.1 Manufacturing 82
15.2.1.1 In House Manufacturing 82
15.2.2 Product Development 83
15.2.2.1 Regulatory Approvals 83
15.2.2.2 Clinical Trials 83
15.2.2.3 Research and Development 83
15.2.3 Sales and Marketing 83
15.2.3.1 Partnerships and Alliances 83
15.2.3.2 Licensing Agreements 83
15.3 Gambro AB Pipeline Products 84
15.3.1 Gambro AB Pipeline Products By Equipment Type 84
15.3.2 Gambro AB Pipeline Products By Development Stage 84
15.3.3 Gambro AB Pipeline Products By Therapy Area 84
16 Coloplast A/S Company Profile 85
16.1 Company Overview 85
16.2 Value Chain Analysis 85
16.2.1 Manufacturing 86
16.2.1.1 In House Manufacturing 86
16.2.2 Product Development 86
16.2.2.1 Regulatory Approvals 86
16.2.2.2 Clinical Trials 86
16.2.2.3 Research and Development 87
16.2.3 Sales and Marketing 87
16.2.3.1 Partnerships and Alliances 87
16.2.3.2 Licensing Agreements 87
17 Baxter International Inc. Company Profile 88
17.1 Company Overview 88
17.2 Value Chain Analysis 89
17.2.1 Manufacturing 89
17.2.1.1 In House Manufacturing 89
17.2.2 Product Development 89
17.2.2.1 Research and Development 89
17.2.2.2 Regulatory Approvals 90
17.2.2.3 Clinical Trials 90
17.2.3 Sales and Marketing 91
17.2.3.1 E-distribution 91
17.2.3.2 Licensing Agreements 91
17.2.3.3 Partnerships and Alliances 91
17.3 Baxter International Inc. Pipeline Products 92
17.3.1 Baxter International Inc. Pipeline Products By Equipment Type 92
17.3.2 Baxter International Inc. Pipeline Products By Development Stage 92
17.3.3 Baxter International Inc. Pipeline Products By Therapy Area 92
17.3.4 Baxter International Inc. Pipeline Products By News Summary 92
18 B. Braun Melsungen AG Company Profile 93
18.1 Company Overview 93
18.2 Value Chain Analysis 93
18.2.1 Manufacturing 94
18.2.1.1 In House Manufacturing 94
18.2.1.2 Outsourcing 94
18.2.2 Product Development 94
18.2.2.1 Regulatory Approvals 94
18.2.2.2 Clinical Trials 95
18.2.2.3 Research and Development 95
18.2.3 Sales and Marketing 95
18.2.3.1 Partnerships and Alliances 95
18.2.3.2 Licensing Agreements 95
18.3 B. Braun Melsungen AG Pipeline Products 95
18.3.1 B. Braun Melsungen AG Pipeline Products By Equipment Type 95
18.3.2 B. Braun Melsungen AG Pipeline Products By Development Stage 96
18.3.3 B. Braun Melsungen AG Pipeline Products By Therapy Area 96
18.3.4 B. Braun Melsungen AG Pipeline Products By Clinical Trials 96
18.3.5 B. Braun Melsungen AG Pipeline Products By News Summary 96
19 Dornier MedTech GmbH Company Profile 97
19.1 Company Overview 97
20 Endosmart GmbH Company Profile 98
20.1 Company Overview 98
21 Fresenius SE Company Profile 99
21.1 Company Overview 99
21.2 Value Chain Analysis 100
21.2.1 Manufacturing 100
21.2.1.1 In House Manufacturing 100
21.2.2 Product Development 101
21.2.2.1 Regulatory Approvals 101
21.2.2.2 Clinical Trials 101
21.2.2.3 Research and Development 101
21.2.3 Sales and Marketing 101
21.2.3.1 Partnerships and Alliances 101
21.2.3.2 Licensing Agreements 101
21.2.3.3 E-distribution 101
22 Recent Developments 102
22.1 Strategy and Business Planning 102
22.1.1 Mar 06, 2008: Fresenius Expands Dialyzer Production Capacity In Germany 102
23 Appendix 103
23.1 Global Markets Direct Research Methodology 103
23.2 Coverage 104
23.3 Secondary Research 104
23.4 Primary Research 105
23.5 Models 105
23.6 Forecasts 106
23.7 Expert Panels 106
23.8 Currency Conversion 107
23.9 Contact Us 108
23.10 Disclaimer 108
1.1 List of Tables
Table 1: Healthcare Personnel by Region in Germany, 2004 20
Table 2: Doctors by Specialty in Germany, 2000-2004 21
Table 3: Hospitals by Region in Germany, 2004 22
Table 4: Hospital Beds by Region in Germany, 2004 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: Nephrology and Urology Devices Cross Country Comparison (2000-2012) 44
Table 9: Nephrology and Urology Devices, Germany, Overall Revenues ($ mn), 2000-2012 45
Table 10: Nephrology and Urology Devices, Germany, Overall Revenues ($ mn), Historic, 2000-2007 46
Table 11: Nephrology and Urology Devices, Germany, Overall Revenues ($ mn), Forecast, 2007-2012 47
Table 12: Nephrology and Urology Devices, Germany, Category Volume (Units), 2000-2012 48
Table 13: Nephrology and Urology Devices, Germany, Category Volume (Units), Historic, 2000-2007 48
Table 14: Nephrology and Urology Devices, Germany, Category Volume (Units), Forecast, 2007-2012 49
Table 15: Nephrology and Urology Devices, Germany Company share by Revenue ($ mn), 2006-2007 50
Table 16: Incontinence Devices, Germany, Revenue ($ mn) by Segment , Historic, 2000-2007 51
Table 17: Incontinence Devices, Germany, Revenue ($ mn) by Segment , Forecast, 2007-2012 52
Table 18: Incontinence Devices, Germany, Overall Volume (Units), Historic, 2000-2007 53
Table 19: Incontinence Devices, Germany, Overall Volume (Units), Forecast, 2007-2012 54
Table 20: Incontinence Devices, Germany, Average Price ($), Historic, 2000-2007 55
Table 21: Incontinence Devices, Germany, Average Price ($), Forecast,, 2007-2012 55
Table 22: Incontinence Devices, Germany, Distribution Share by Revenue, 2006-2007 56
Table 23: Incontinence Devices, Germany Company share by Revenue ($ mn), 2006-2007 57
Table 24: Lithotripters, Germany, Revenue ($ mn) by Segment , Historic, 2000-2007 58
Table 25: Lithotripters, Germany, Revenue ($ mn) by Segment , Forecast, 2007-2012 59
Table 26: Lithotripters, Germany, Overall Volume (Units), Historic, 2000-2007 60
Table 27: Lithotripters, Germany, Overall Volume (Units), Forecast, 2007-2012 61
Table 28: Lithotripters, Germany, Average Price ($), Historic, 2000-2007 62
Table 29: Lithotripters, Germany, Average Price ($), Forecast,, 2007-2012 62
Table 30: Lithotripters, Germany, Distribution Share by Revenue, 2006-2007 63
Table 31: Lithotripters, Germany Company share by Revenue ($ mn), 2006-2007 64
Table 32: Renal Dialysis Equipment, Germany, Revenue ($ mn) by Segment , Historic, 2000-2007 65
Table 33: Renal Dialysis Equipment, Germany, Revenue ($ mn) by Segment , Forecast, 2007-2012 66
Table 34: Dialysis Accessories, Germany, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 67
Table 35: Dialysis Accessories, Germany, Revenues ($ mn) by Sub-Segment, Forecast,, 2007-2012 68
Table 36: Renal Dialysis Equipment, Germany, Overall Volume (Units), Historic, 2000-2007 69
Table 37: Renal Dialysis Equipment, Germany, Overall Volume (Units), Forecast, 2007-2012 69
Table 38: Dialysis Accessories, Germany, Volume (Units) by Sub-Segment, Historic, 2000-2007 70
Table 39: Dialysis Accessories, Germany, Volume (Units) by Sub-Segment, Forecast,, 2007-2012 71
Table 40: Renal Dialysis Equipment, Germany, Average Price ($), Historic, 2000-2007 72
Table 41: Renal Dialysis Equipment, Germany, Average Price ($), Forecast,, 2007-2012 72
Table 42: Renal Dialysis Equipment, Germany, Distribution Share by Revenue, 2006-2007 73
Table 43: Renal Dialysis Equipment, Germany Company share by Revenue ($ mn), 2006-2007 74
Table 44: Gambro AB Pipeline Products by Equipment Type 84
Table 45: Gambro AB Pipeline Products By Development Stage 84
Table 46: Gambro AB Pipeline Products By Therapy Area 84
Table 47: Baxter International Inc. Pipeline Products by Equipment Type 92
Table 48: Baxter International Inc. Pipeline Products By Development Stage 92
Table 49: Baxter International Inc. Pipeline Products By Therapy Area 92
Table 50: Baxter International Inc. Pipeline Products By News Summaries 92
Table 51: B. Braun Melsungen AG Pipeline Products by Equipment Type 95
Table 52: B. Braun Melsungen AG Pipeline Products By Development Stage 96
Table 53: B. Braun Melsungen AG Pipeline Products By Therapy Area 96
Table 54: B. Braun Melsungen AG Pipeline Products By Clinical Trials 96
Table 55: B. Braun Melsungen AG Pipeline Products By News Summaries 96
Table 56: Currency Conversion from USD to Local Currency at 2007 Constant Rate 107
1.2 List of Figures
Figure 1: Healthcare Structure in Germany, 2000 - 2006 17
Figure 2: Healthcare Expenditure Sources in Germany, 2003 18
Figure 3: Healthcare Financing Framework in Germany, 2007 19
Figure 4: Flowchart for Classification of Non-invasive Devices in Germany, 2007 29
Figure 5: Flowchart for Classification of Invasive Devices in Germany, 2007 30
Figure 6: Flowchart for Classification of Invasive Devices in Germany, 2007 31
Figure 7: Classification of Invasive Devices in Germany, 2007 32
Figure 8: Classification of Invasive Devices in Germany, 2007 33
Figure 9: Flowchart for Classification of Active Devices in Germany, 2007 34
Figure 10: Flowchart for Classification of Active Devices in Germany, 2007 35
Figure 11: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Germany, 2007 36
Figure 12: Conformity Assessment of Class-I Medical Devices in Germany, 2007 37
Figure 13: Conformity Assessment of Class-IIa Medical Devices in Germany, 2007 38
Figure 14: Conformity Assessment of Class-IIb Medical Devices in Germany, 2007 39
Figure 15: Conformity Assessment of Class-III Medical Devices in Germany, 2007 40
Figure 16: Nephrology and Urology Devices Cross Country Comparison (2000-2012) 44
Figure 17: Nephrology and Urology Devices, Germany, Overall Revenues ($ mn), 2000-2012 45
Figure 18: Nephrology and Urology Devices, Germany, Overall Revenues ($ mn), Historic, 2000-2007 46
Figure 19: Nephrology and Urology Devices, Germany, Overall Revenues ($ mn), Forecast, 2007-2012 47
Figure 20: Nephrology and Urology Devices, Germany Company share (%), 2007 50
Figure 21: Incontinence Devices, Germany, Revenue ($ mn) by Segment , Historic, 2000-2007 51
Figure 22: Incontinence Devices, Germany, Revenue ($ mn) by Segment , Forecast, 2007-2012 52
Figure 23: Incontinence Devices, Germany, Overall Volume (Units), Historic, 2000-2007 53
Figure 24: Incontinence Devices, Germany, Overall Volume (Units), Forecast, 2007-2012 54
Figure 25: Incontinence Devices, Germany Company share (%), 2007 57
Figure 26: Lithotripters, Germany, Revenue ($ mn) by Segment , Historic, 2000-2007 58
Figure 27: Lithotripters, Germany, Revenue ($ mn) by Segment , Forecast, 2007-2012 59
Figure 28: Lithotripters, Germany, Overall Volume (Units), Historic, 2000-2007 60
Figure 29: Lithotripters, Germany, Overall Volume (Units), Forecast, 2007-2012 61
Figure 30: Lithotripters, Germany Company share (%), 2007 64
Figure 31: Renal Dialysis Equipment, Germany, Revenue ($ mn) by Segment , Historic, 2000-2007 65
Figure 32: Renal Dialysis Equipment, Germany, Revenue ($ mn) by Segment , Forecast, 2007-2012 66
Figure 33: Dialysis Accessories, Germany, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 67
Figure 34: Dialysis Accessories, Germany, Revenues ($ mn) by Sub-Segment, Forecast,, 2007-2012 68
Figure 35: Dialysis Accessories, Germany, Volume (Units) by Sub-Segment, Historic, 2000-2007 70
Figure 36: Dialysis Accessories, Germany, Volume (Units) by Sub-Segment, Forecast,, 2007-2012 71
Figure 37: Renal Dialysis Equipment, Germany Company share (%), 2007 74
Figure 38: Hartmann Group Value Chain Analysis 76
Figure 39: Fresenius Medical Care AG & Co. KGaA Value Chain Analysis 79
Figure 40: Gambro AB Value Chain Analysis 82
Figure 41: Coloplast A/S Value Chain Analysis 85
Figure 42: Baxter International Inc. Value Chain Analysis 89
Figure 43: B. Braun Melsungen AG Value Chain Analysis 93
Figure 44: Fresenius SE Value Chain Analysis 100
Figure 45: Global Markets Direct Methodology 103