1 Table Of Contents
1 Table Of Contents 2
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 Nephrology and Urology Devices 12
3.2 Incontinence Devices 12
3.2.1 Protective garments for incontinence 12
3.2.2 Urine Bags 12
3.2.3 Urinary Catheters 12
3.3 Renal Dialysis Equipment 12
3.3.1 Hemodialysis Machines 12
3.3.2 Peritoneal Dialysis Solutions 12
3.3.3 Continuous Renal Replacement Therapy Machines 13
3.3.4 Dialysis Accessories 13
3.3.4.1 AV Fistula Needles 13
3.3.4.2 Blood Tubing Sets 13
3.3.4.3 Dialysis Catheters 13
3.3.4.4 Dialyzers 13
3.4 Lithotripters 13
4 Healthcare Sector Review 14
4.1 Healthcare Expenditure 14
4.2 Healthcare Infrastructure 15
4.3 Healthcare Policy 19
5 Regulation System 20
5.1 Medical Equipment Approval Process 20
5.1.1 Classification of medical devices 20
5.1.2 Conformity Assessment Process 29
5.1.2.1 Class I devices 29
5.1.2.2 Class IIa devices 30
5.1.2.3 Class IIb devices 31
5.2 Post Market Surveillance (PMS) 32
6 Pricing and Reimbursement 33
6.1 Pricing and Reimbursement Policies 33
7 Distribution Structure 34
8 Nephrology and Urology Devices In Spain 35
8.1 Nephrology and Urology Devices Cross Country Comparison (2000-2012) 35
8.2 Nephrology and Urology Devices, Spain, Overall Revenues ($ mn), 2000-2012 36
8.3 Nephrology and Urology Devices, Spain, Category Volume (Units), 2000-2012 39
8.4 Nephrology and Urology Devices, Spain Company share (2006-2007) 40
9 Incontinence Devices In Spain 41
9.1 Incontinence Devices Overall Revenue (2000-2012) 41
9.2 Incontinence Devices Overall Volume (2000-2012) 43
9.3 Incontinence Devices Average Price (2000-2012) 45
9.4 Incontinence Devices Distribution Share (2006-2007) 45
9.5 Incontinence Devices, Spain Company share (2006-2007) 46
10 Lithotripters In Spain 47
10.1 Lithotripters Overall Revenue (2000-2012) 47
10.2 Lithotripters Overall Volume (2000-2012) 49
10.3 Lithotripters Average Price (2000-2012) 51
10.4 Lithotripters Distribution Share (2006-2007) 51
10.5 Lithotripters, Spain Company share (2006-2007) 52
11 Renal Dialysis Equipment In Spain 53
11.1 Renal Dialysis Equipment Overall Revenue (2000-2012) 53
11.1.1 Dialysis Accessories Overall Revenue (2000-2012) 55
11.2 Renal Dialysis Equipment Overall Volume (2000-2012) 57
11.2.1 Dialysis Accessories Overall Volume (2000-2012) 58
11.3 Renal Dialysis Equipment Average Price (2000-2012) 60
11.4 Renal Dialysis Equipment Distribution Share (2006-2007) 61
11.5 Renal Dialysis Equipment, Spain Company share (2006-2007) 62
12 Svenska Celullosa Aktiebolaget SCA Company Profile 63
12.1 Company Overview 63
13 HARTMANN GROUP Company Profile 64
13.1 Company Overview 64
13.2 Value Chain Analysis 64
13.2.1 Manufacturing 65
13.2.1.1 Outsourcing 65
13.2.1.2 In House Manufacturing 65
13.2.2 Product Development 65
13.2.2.1 Regulatory Approvals 65
13.2.2.2 Research and Development 65
13.2.3 Sales and Marketing 65
13.2.3.1 Partnerships and Alliances 65
14 Fresenius Medical Care AG & Co. KGaA Company Profile 66
14.1 Company Overview 66
14.2 Value Chain Analysis 67
14.2.1 Manufacturing 67
14.2.1.1 In House Manufacturing 67
14.2.2 Product Development 68
14.2.2.1 Regulatory Approvals 68
14.2.2.2 Research and Development 68
14.2.3 Sales and Marketing 68
14.2.3.1 Partnerships and Alliances 68
14.2.3.2 Licensing Agreements 68
15 ONTEX International N.V. Company Profile 69
15.1 Company Overview 69
16 Coloplast A/S Company Profile 70
16.1 Company Overview 70
16.2 Value Chain Analysis 70
16.2.1 Manufacturing 71
16.2.1.1 In House Manufacturing 71
16.2.2 Product Development 71
16.2.2.1 Regulatory Approvals 71
16.2.2.2 Clinical Trials 71
16.2.2.3 Research and Development 72
16.2.3 Sales and Marketing 72
16.2.3.1 Partnerships and Alliances 72
16.2.3.2 Licensing Agreements 72
17 Baxter International Inc. Company Profile 73
17.1 Company Overview 73
17.2 Value Chain Analysis 74
17.2.1 Manufacturing 75
17.2.1.1 In House Manufacturing 75
17.2.2 Product Development 75
17.2.2.1 Research and Development 75
17.2.2.2 Regulatory Approvals 75
17.2.2.3 Clinical Trials 75
17.2.3 Sales and Marketing 76
17.2.3.1 E-distribution 76
17.2.3.2 Licensing Agreements 76
17.2.3.3 Partnerships and Alliances 76
17.3 Baxter International Inc. Pipeline Products 77
17.3.1 Baxter International Inc. Pipeline Products By Equipment Type 77
17.3.2 Baxter International Inc. Pipeline Products By Development Stage 77
17.3.3 Baxter International Inc. Pipeline Products By Therapy Area 77
17.3.4 Baxter International Inc. Pipeline Products By News Summary 77
18 SENDAL S.A Company Profile 78
18.1 Company Overview 78
19 Appendix 79
19.1 Global Markets Direct Research Methodology 79
19.2 Coverage 80
19.3 Secondary Research 80
19.4 Primary Research 81
19.5 Models 81
19.6 Forecasts 82
19.7 Expert Panels 82
19.8 Currency Conversion 83
19.9 Contact Us 84
19.10 Disclaimer 84
1.1 List of Tables
Table 1: Number of Doctors by Specialty in Spain, 2003-2007 16
Table 2: Number of Hospital Wards by Specialty in Spain, 2003-2007 17
Table 3: Healthcare Institutions in Spain, 2005 18
Table 4: Hospital Beds by Type in Spain, 2005 18
Table 5: Number of Healthcare Personnel in Spain, 2005 18
Table 6: Number of Medical Equipment in Spain, 2005 19
Table 7: Nephrology and Urology Devices Cross Country Comparison (2000-2012) 35
Table 8: Nephrology and Urology Devices, Spain, Overall Revenues ($ mn), 2000-2012 36
Table 9: Nephrology and Urology Devices, Spain, Overall Revenues ($ mn), Historic, 2000-2007 37
Table 10: Nephrology and Urology Devices, Spain, Overall Revenues ($ mn), Forecast, 2007-2012 38
Table 11: Nephrology and Urology Devices, Spain, Category Volume (Units), 2000-2012 39
Table 12: Nephrology and Urology Devices, Spain, Category Volume (Units), Historic, 2000-2007 39
Table 13: Nephrology and Urology Devices, Spain, Category Volume (Units), Forecast, 2007-2012 39
Table 14: Nephrology and Urology Devices, Spain Company share by Revenue ($ mn), 2006-2007 40
Table 15: Incontinence Devices, Spain, Revenue ($ mn) by Segment , Historic, 2000-2007 41
Table 16: Incontinence Devices, Spain, Revenue ($ mn) by Segment , Forecast, 2007-2012 42
Table 17: Incontinence Devices, Spain, Overall Volume (Units), Historic, 2000-2007 43
Table 18: Incontinence Devices, Spain, Overall Volume (Units), Forecast, 2007-2012 44
Table 19: Incontinence Devices, Spain, Average Price ($), Historic, 2000-2007 45
Table 20: Incontinence Devices, Spain, Average Price ($), Forecast,, 2007-2012 45
Table 21: Incontinence Devices, Spain, Distribution Share by Revenue, 2006-2007 45
Table 22: Incontinence Devices, Spain Company share by Revenue ($ mn), 2006-2007 46
Table 23: Lithotripters, Spain, Revenue ($ mn) by Segment , Historic, 2000-2007 47
Table 24: Lithotripters, Spain, Revenue ($ mn) by Segment , Forecast, 2007-2012 48
Table 25: Lithotripters, Spain, Overall Volume (Units), Historic, 2000-2007 49
Table 26: Lithotripters, Spain, Overall Volume (Units), Forecast, 2007-2012 50
Table 27: Lithotripters, Spain, Average Price ($), Historic, 2000-2007 51
Table 28: Lithotripters, Spain, Average Price ($), Forecast,, 2007-2012 51
Table 29: Lithotripters, Spain, Distribution Share by Revenue, 2006-2007 51
Table 30: Lithotripters, Spain Company share by Revenue ($ mn), 2006-2007 52
Table 31: Renal Dialysis Equipment, Spain, Revenue ($ mn) by Segment , Historic, 2000-2007 53
Table 32: Renal Dialysis Equipment, Spain, Revenue ($ mn) by Segment , Forecast, 2007-2012 54
Table 33: Dialysis Accessories, Spain, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 55
Table 34: Dialysis Accessories, Spain, Revenues ($ mn) by Sub-Segment, Forecast,, 2007-2012 56
Table 35: Renal Dialysis Equipment, Spain, Overall Volume (Units), Historic, 2000-2007 57
Table 36: Renal Dialysis Equipment, Spain, Overall Volume (Units), Forecast, 2007-2012 57
Table 37: Dialysis Accessories, Spain, Volume (Units) by Sub-Segment, Historic, 2000-2007 58
Table 38: Dialysis Accessories, Spain, Volume (Units) by Sub-Segment, Forecast,, 2007-2012 59
Table 39: Renal Dialysis Equipment, Spain, Average Price ($), Historic, 2000-2007 60
Table 40: Renal Dialysis Equipment, Spain, Average Price ($), Forecast,, 2007-2012 60
Table 41: Renal Dialysis Equipment, Spain, Distribution Share by Revenue, 2006-2007 61
Table 42: Renal Dialysis Equipment, Spain Company share by Revenue ($ mn), 2006-2007 62
Table 43: Baxter International Inc. Pipeline Products by Equipment Type 77
Table 44: Baxter International Inc. Pipeline Products By Development Stage 77
Table 45: Baxter International Inc. Pipeline Products By Therapy Area 77
Table 46: Baxter International Inc. Pipeline Products By News Summaries 77
Table 47: Currency Conversion from USD to Local Currency at 2007 Constant Rate 83
1.2 List of Figures
Figure 1: Total Healthcare Expenditure in Spain, 2000 – 2006 15
Figure 2: Flowchart for Classification of Non-invasive Devices in Spain, 2007 21
Figure 3: Flowchart for Classification of Invasive Devices in Spain, 2007 22
Figure 4: Flowchart for Classification of Invasive Devices in Spain, 2007 23
Figure 5: Flowchart for Classification of Invasive Devices in Spain, 2007 24
Figure 6: Flowchart for Classification of Invasive Devices in Spain, 2007 25
Figure 7: Flowchart for Classification of Active Devices in Spain, 2007 26
Figure 8: Flowchart for Classification of Active Devices in Spain, 2007 27
Figure 9: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Spain, 2007 28
Figure 10: Conformity Assessment of Class-I Medical Devices in Spain, 2007 29
Figure 11: Conformity Assessment of Class-IIa Medical Devices in Spain, 2007 30
Figure 12: Conformity Assessment of Class-IIb Medical Devices in Spain, 2007 31
Figure 13: Conformity Assessment of Class-III Medical Devices in Spain, 2007 32
Figure 14: Nephrology and Urology Devices Cross Country Comparison (2000-2012) 35
Figure 15: Nephrology and Urology Devices, Spain, Overall Revenues ($ mn), 2000-2012 36
Figure 16: Nephrology and Urology Devices, Spain, Overall Revenues ($ mn), Historic, 2000-2007 37
Figure 17: Nephrology and Urology Devices, Spain, Overall Revenues ($ mn), Forecast, 2007-2012 38
Figure 18: Nephrology and Urology Devices, Spain Company share (%), 2007 40
Figure 19: Incontinence Devices, Spain, Revenue ($ mn) by Segment , Historic, 2000-2007 41
Figure 20: Incontinence Devices, Spain, Revenue ($ mn) by Segment , Forecast, 2007-2012 42
Figure 21: Incontinence Devices, Spain, Overall Volume (Units), Historic, 2000-2007 43
Figure 22: Incontinence Devices, Spain, Overall Volume (Units), Forecast, 2007-2012 44
Figure 23: Incontinence Devices, Spain Company share (%), 2007 46
Figure 24: Lithotripters, Spain, Revenue ($ mn) by Segment , Historic, 2000-2007 47
Figure 25: Lithotripters, Spain, Revenue ($ mn) by Segment , Forecast, 2007-2012 48
Figure 26: Lithotripters, Spain, Overall Volume (Units), Historic, 2000-2007 49
Figure 27: Lithotripters, Spain, Overall Volume (Units), Forecast, 2007-2012 50
Figure 28: Lithotripters, Spain Company share (%), 2007 52
Figure 29: Renal Dialysis Equipment, Spain, Revenue ($ mn) by Segment , Historic, 2000-2007 53
Figure 30: Renal Dialysis Equipment, Spain, Revenue ($ mn) by Segment , Forecast, 2007-2012 54
Figure 31: Dialysis Accessories, Spain, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 55
Figure 32: Dialysis Accessories, Spain, Revenues ($ mn) by Sub-Segment, Forecast,, 2007-2012 56
Figure 33: Dialysis Accessories, Spain, Volume (Units) by Sub-Segment, Historic, 2000-2007 58
Figure 34: Dialysis Accessories, Spain, Volume (Units) by Sub-Segment, Forecast,, 2007-2012 59
Figure 35: Renal Dialysis Equipment, Spain Company share (%), 2007 62
Figure 36: Hartmann Group Value Chain Analysis 64
Figure 37: Fresenius Medical Care AG & Co. KGaA Value Chain Analysis 67
Figure 38: Coloplast A/S Value Chain Analysis 70
Figure 39: Baxter International Inc. Value Chain Analysis 74
Figure 40: Global Markets Direct Methodology 79