1 Table Of Contents
1 Table Of Contents 2
1.1 List of Tables 8
1.2 List of Figures 10
2 Introduction 12
2.1 What Is This Report About? 12
3 Definitions of the March kets Covered in the Report 13
3.1 Nephrology and Urology Devices 13
3.2 Incontinence Devices 13
3.2.1 Protective garments for incontinence 13
3.2.2 Urine Bags 13
3.2.3 Urinary Catheters 13
3.3 Renal Dialysis Equipment 13
3.3.1 Hemodialysis Machines 13
3.3.2 Peritoneal Dialysis Solutions 13
3.3.3 Continuous Renal Replacement Therapy Machines 14
3.3.4 Dialysis Accessories 14
3.3.4.1 AV Fistula Needles 14
3.3.4.2 Blood Tubing Sets 14
3.3.4.3 Dialysis Catheters 14
3.3.4.4 Dialyzers 14
3.4 Lithotripters 14
4 Healthcare Segment Review 15
4.1 Healthcare Segment Review 15
4.2 Healthcare Expenditure 15
4.3 Healthcare Infrastructure 18
4.4 Healthcare Policy 21
5 Regulation System 22
5.1 Medical Equipment Approval Process 22
5.1.1 Classification of Medical Devices 22
5.1.2 Conformity Assessment Process 31
5.1.2.1 Class I devices 31
5.1.2.2 Class IIa devices 32
5.1.2.3 Class IIb devices 33
5.1.2.4 Class III devices 34
5.2 Classificazione Nazionale Dispositivi (CND) - New Medical Device Classification 35
5.3 Post March ket Surveillance 35
6 Pricing and Reimbursement 36
6.1 March ket Pricing 36
6.2 Government Policies for Reimbursement 36
7 Distribution Structure 37
8 Italy Medical Equipment Cross March ket Comparison 38
9 Nephrology and Urology Devices In Italy 40
9.1 Nephrology and Urology Devices Cross Country Comparison (from 2000 to 2012 ) 40
9.2 Nephrology and Urology Devices, Italy, Overall Revenues ($ mn), from 2000 to 2012 41
9.3 Nephrology and Urology Devices, Italy, Category Volume (Units), from 2000 to 2012 45
9.4 Nephrology and Urology Devices, Italy, Firms Share (2006-2007) 46
10 Incontinence Devices In Italy 47
10.1 Incontinence Devices Overall Revenue (from 2000 to 2012 ) 47
10.2 Incontinence Devices Overall Volume (from 2000 to 2012 ) 49
10.3 Incontinence Devices Average Price (from 2000 to 2012 ) 51
10.4 Incontinence Devices Distribution Share (2006-2007) 51
10.5 Incontinence Devices, Italy, Firms Share (2006-2007) 52
11 Lithotripters In Italy 53
11.1 Lithotripters Overall Revenue (from 2000 to 2012 ) 53
11.2 Lithotripters Overall Volume (from 2000 to 2012 ) 55
11.3 Lithotripters Average Price (from 2000 to 2012 ) 57
11.4 Lithotripters Distribution Share (2006-2007) 57
11.5 Lithotripters, Italy, Firms Share (2006-2007) 58
12 Renal Dialysis Equipment In Italy 59
12.1 Renal Dialysis Equipment Overall Revenue (from 2000 to 2012 ) 59
12.1.1 Dialysis Accessories Overall Revenue (from 2000 to 2012 ) 61
12.2 Renal Dialysis Equipment Overall Volume (from 2000 to 2012 ) 63
12.2.1 Dialysis Accessories Overall Volume (from 2000 to 2012 ) 64
12.3 Renal Dialysis Equipment Average Price (from 2000 to 2012 ) 66
12.4 Renal Dialysis Equipment Distribution Share (2006-2007) 67
12.5 Renal Dialysis Equipment, Italy, Firms Share (2006-2007) 68
13 Svenska Celullosa Aktiebolaget SCA Firms Profile 69
13.1 Corporate Presentation 69
14 Fresenius Medical Care AG & Co. KGaA Firms Profile 70
14.1 Corporate Presentation 70
14.2 Value Chain Analysis 70
14.2.1 Manufacturing 71
14.2.1.1 In House Manufacturing 71
14.2.2 Product Development 71
14.2.2.1 Regulatory Approvals 71
14.2.2.2 Research and Development 71
14.2.3 Sales and March keting 71
14.2.3.1 Partnerships and Alliances 71
14.2.3.2 Licensing Agreements 72
15 Gambro AB Firms Profile 73
15.1 Corporate Presentation 73
15.2 Value Chain Analysis 73
15.2.1 Manufacturing 74
15.2.1.1 In House Manufacturing 74
15.2.2 Product Development 74
15.2.2.1 Regulatory Approvals 74
15.2.2.2 Clinical Trials 74
15.2.2.3 Research and Development 74
15.2.3 Sales and March keting 74
15.2.3.1 Partnerships and Alliances 74
15.2.3.2 Licensing Agreements 75
15.3 Gambro AB Pipeline Products 75
15.3.1 Gambro AB Pipeline Products By Equipment Type 75
15.3.2 Gambro AB Pipeline Products By Development Stage 75
15.3.3 Gambro AB Pipeline Products By Therapy Area 75
16 ONTEX International N.V. Firms Profile 76
16.1 Corporate Presentation 76
17 Coloplast A/S Firms Profile 77
17.1 Corporate Presentation 77
17.2 Value Chain Analysis 77
17.2.1 Manufacturing 78
17.2.1.1 In House Manufacturing 78
17.2.2 Product Development 78
17.2.2.1 Regulatory Approvals 78
17.2.2.2 Clinical Trials 78
17.2.2.3 Research and Development 79
17.2.3 Sales and March keting 79
17.2.3.1 Partnerships and Alliances 79
17.2.3.2 Licensing Agreements 79
18 Baxter International Inc. Firms Profile 80
18.1 Corporate Presentation 80
18.2 Value Chain Analysis 80
18.2.1 Manufacturing 81
18.2.1.1 In House Manufacturing 81
18.2.2 Product Development 81
18.2.2.1 Research and Development 81
18.2.2.2 Regulatory Approvals 81
18.2.2.3 Clinical Trials 81
18.2.3 Sales and March keting 82
18.2.3.1 E-distribution 82
18.2.3.2 Licensing Agreements 82
18.2.3.3 Partnerships and Alliances 82
18.3 Baxter International Inc. Pipeline Products 83
18.3.1 Baxter International Inc. Pipeline Products by Equipment Type 83
18.3.2 Baxter International Inc. Pipeline Products by Development Stage 83
18.3.3 Baxter International Inc. Pipeline Products by Therapy Area 83
18.3.4 Baxter International Inc. Pipeline Products by News Summary 83
19 Gallini Medical s.r.I. Firms Profile 84
19.1 Corporate Presentation 84
20 SI.EM Sistemi Elettromedicali S.r.l. Firms Profile 85
20.1 Corporate Presentation 85
21 Sorin S.p.A. Firms Profile 86
21.1 Corporate Presentation 86
21.2 Value Chain Analysis 86
21.2.1 Manufacturing 87
21.2.1.1 In House Manufacturing 87
21.2.2 Product Development 87
21.2.2.1 Regulatory Approvals 87
21.2.2.2 Clinical Trials 87
21.2.2.3 Research and Development 87
21.2.3 Sales and March keting 88
21.2.3.1 Partnerships and Alliances 88
21.3 Sorin S.p.A. Pipeline Products 89
21.3.1 Sorin S.p.A. Pipeline Products by Equipment Type 89
21.3.2 Sorin S.p.A. Pipeline Products by Development Stage 90
21.3.3 Sorin S.p.A. Pipeline Products by Therapy Area 91
21.3.4 Sorin S.p.A. Pipeline Products by Clinical Trials 92
21.3.5 Sorin S.p.A. Pipeline Products by News Summary 92
22 Recent Developments 93
22.1 Product News 93
22.1.1 July 21, 2008: PLC Systems Defers Pivotal Study Of RenalGuard In The US 93
22.1.2 30, 2008: PLC Systems Announces Approval Of First European Study To Evaluate RenalGuard 93
22.1.3 12, 2008: PLC Medical Systems To Demonstrate RenalGuard At EuroPCR 2008 94
22.1.4 March 28, 2008: PLC Systems Enters Into The First International Distribution Agreement For RenalGuard System 94
23 APPENDIX 95
23.1 Global March kets Direct Research Methodology 95
23.2 Coverage 96
23.3 Secondary Research 96
23.4 Primary Research 97
23.5 Models 97
23.6 Projections 98
23.7 Expert Panels 98
23.8 Currency Conversion 99
23.9 Contact Us 100
23.10 Disclaimer 100
1.1 List of Tables
Table 1: Number of Doctors by Specialty in Italy, from 2003 to 2007 19
Table 2: Number of Hospital Wards by Specialty in Italy, from 2003 to 2007 20
Table 3: Italy, Medical Equipment March ket Comparison 39
Table 4: Nephrology and Urology Devices Cross Country Comparison (from 2000 to 2012 ) 40
Table 5: Nephrology and Urology Devices, Italy, Overall Revenues ($ mn), from 2000 to 2012 41
Table 6: Nephrology and Urology Devices March ket, Italy, Portfolio Analysis 42
Table 7: Nephrology and Urology Devices, Italy, Overall Revenues ($ mn), Historic, from 2000 to 2007 43
Table 8: Nephrology and Urology Devices, Italy, Overall Revenues ($ mn), Projection , from 2007 to 2012 44
Table 9: Nephrology and Urology Devices, Italy, Category Volume (Units), from 2000 to 2012 45
Table 10: Nephrology and Urology Devices, Italy, Category Volume (Units), Historic, from 2000 to 2007 45
Table 11: Nephrology and Urology Devices, Italy, Category Volume (Units), Projection , from 2007 to 2012 45
Table 12: Nephrology and Urology Devices, Italy, Firms Share by Revenue ($ mn), from 2006 to 2007 46
Table 13: Incontinence Devices, Italy, Revenue ($ mn) by Segment, Historic, from 2000 to 2007 47
Table 14: Incontinence Devices, Italy, Revenue ($ mn) by Segment, Projection , from 2007 to 2012 48
Table 15: Incontinence Devices, Italy, Overall Volume (Units), Historic, from 2000 to 2007 49
Table 16: Incontinence Devices, Italy, Overall Volume (Units), Projection , from 2007 to 2012 50
Table 17: Incontinence Devices, Italy, Average Price ($), Historic, from 2000 to 2007 51
Table 18: Incontinence Devices, Italy, Average Price ($), Projection , from 2007 to 2012 51
Table 19: Incontinence Devices, Italy, Distribution Share by Revenue ($ mn), from 2006 to 2007 51
Table 20: Incontinence Devices, Italy, Firms Share by Revenue ($ mn), from 2006 to 2007 52
Table 21: Lithotripters, Italy, Revenue ($ mn) by Segment, Historic, from 2000 to 2007 53
Table 22: Lithotripters, Italy, Revenue ($ mn) by Segment, Projection , from 2007 to 2012 54
Table 23: Lithotripters, Italy, Overall Volume (Units), Historic, from 2000 to 2007 55
Table 24: Lithotripters, Italy, Overall Volume (Units), Projection , from 2007 to 2012 56
Table 25: Lithotripters, Italy, Average Price ($), Historic, from 2000 to 2007 57
Table 26: Lithotripters, Italy, Average Price ($), Projection , from 2007 to 2012 57
Table 27: Lithotripters, Italy, Distribution Share by Revenue ($ mn), from 2006 to 2007 57
Table 28: Lithotripters, Italy, Firms Share by Revenue ($ mn), from 2006 to 2007 58
Table 29: Renal Dialysis Equipment, Italy, Revenue ($ mn) by Segment , Historic, from 2000 to 2007 59
Table 30: Renal Dialysis Equipment, Italy, Revenue ($ mn) by Segment , Projection , from 2007 to 2012 60
Table 31: Dialysis Accessories, Italy, Revenues ($ mn) by Sub-Segment, Historic, from 2000 to 2007 61
Table 32: Dialysis Accessories, Italy, Revenues ($ mn) by Sub-Segment, Projection ,, from 2007 to 2012 62
Table 33: Renal Dialysis Equipment, Italy, Overall Volume (Units), Historic, from 2000 to 2007 63
Table 34: Renal Dialysis Equipment, Italy, Overall Volume (Units), Projection , from 2007 to 2012 63
Table 35: Dialysis Accessories, Italy, Volume (Units) by Sub-Segment, Historic, from 2000 to 2007 64
Table 36: Dialysis Accessories, Italy, Volume (Units) by Sub-Segment, Projection ,, from 2007 to 2012 65
Table 37: Renal Dialysis Equipment, Italy, Average Price ($), Historic, from 2000 to 2007 66
Table 38: Renal Dialysis Equipment, Italy, Average Price ($), Projection ,, from 2007 to 2012 66
Table 39: Renal Dialysis Equipment, Italy, Distribution Share by Revenue ($ mn), from 2006 to 2007 67
Table 40: Renal Dialysis Equipment, Italy, Firms Share by Revenue ($ mn), from 2006 to 2007 68
Table 41: Gambro AB Pipeline Products by Equipment Type 75
Table 42: Gambro AB Pipeline Products By Development Stage 75
Table 43: Gambro AB Pipeline Products By Therapy Area 75
Table 44: Baxter International Inc. Pipeline Products by Equipment Type 83
Table 45: Baxter International Inc. Pipeline Products By Development Stage 83
Table 46: Baxter International Inc. Pipeline Products By Therapy Area 83
Table 47: Baxter International Inc. Pipeline Products By News Summaries 83
Table 48: Sorin S.p.A. Pipeline Products by Equipment Type 89
Table 49: Sorin S.p.A. Pipeline Products By Development Stage 90
Table 50: Sorin S.p.A. Pipeline Products By Therapy Area 91
Table 51: Sorin S.p.A. Pipeline Products By Clinical Trials 92
Table 52: Sorin S.p.A. Pipeline Products By News Summaries 92
Table 53: Currency Conversion from US Dollar to Local Currency at 2007 Constant Rate 99
1.2
List of Figures
Figure 1: Total Healthcare Expenditure in Italy, 2000 - 2006 16
Figure 2: Healthcare Financing Framework in Italy, 2007 17
Figure 3: Flowchart for Classification of Non-invasive Devices in Italy, 2007 23
Figure 4: Flowchart for Classification of Invasive Devices in Italy, 2007 24
Figure 5: Flowchart for Classification of Invasive Devices in Italy, 2007 25
Figure 6: Flowchart for Classification of Invasive Devices in Italy, 2007 26
Figure 7: Flowchart for Classification of Invasive Devices in Italy, 2007 27
Figure 8: Flowchart for Classification of Active Devices in Italy, 2007 28
Figure 9: Flowchart for Classification of Active Devices in Italy, 2007 29
Figure 10: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in Italy, 2007 30
Figure 11: Conformity Assessment of Class-I Medical Devices in Italy, 2007 31
Figure 12: Conformity Assessment of Class-IIa Medical Devices in Italy, 2007 32
Figure 13: Conformity Assessment of Class-IIb Medical Devices in Italy, 2007 33
Figure 14: Conformity Assessment of Class-III Medical Devices in Italy, 2007 34
Figure 15: Italy, Medical Equipment March ket Comparison, 2007 38
Figure 16: Nephrology and Urology Devices Cross Country Comparison (from 2000 to 2012 ) 40
Figure 17: Nephrology and Urology Devices, Italy, Overall Revenues ($ mn), from 2000 to 2012 41
Figure 18: Nephrology and Urology Devices March ket, Italy, Portfolio Analysis 42
Figure 19: Nephrology and Urology Devices, Italy, Overall Revenues ($ mn), Historic, from 2000 to 2007 43
Figure 20: Nephrology and Urology Devices, Italy, Overall Revenues ($ mn), Projection , from 2007 to 2012 44
Figure 21: Nephrology and Urology Devices, Italy, Firms Share (%), 2007 46
Figure 22: Incontinence Devices, Italy, Revenue ($ mn) by Segment, Historic, from 2000 to 2007 47
Figure 23: Incontinence Devices, Italy, Revenue ($ mn) by Segment, Projection , from 2007 to 2012 48
Figure 24: Incontinence Devices, Italy, Overall Volume (Units), Historic, from 2000 to 2007 49
Figure 25: Incontinence Devices, Italy, Overall Volume (Units), Projection , from 2007 to 2012 50
Figure 26: Incontinence Devices, Italy, Firms Share (%), 2007 52
Figure 27: Lithotripters, Italy, Revenue ($ mn) by Segment, Historic, from 2000 to 2007 53
Figure 28: Lithotripters, Italy, Revenue ($ mn) by Segment, Projection , from 2007 to 2012 54
Figure 29: Lithotripters, Italy, Overall Volume (Units), Historic, from 2000 to 2007 55
Figure 30: Lithotripters, Italy, Overall Volume (Units), Projection , from 2007 to 2012 56
Figure 31: Lithotripters, Italy, Firms Share (%), 2007 58
Figure 32: Renal Dialysis Equipment, Italy, Revenue ($ mn) by Segment , Historic, from 2000 to 2007 59
Figure 33: Renal Dialysis Equipment, Italy, Revenue ($ mn) by Segment , Projection , from 2007 to 2012 60
Figure 34: Dialysis Accessories, Italy, Revenues ($ mn) by Sub-Segment, Historic, from 2000 to 2007 61
Figure 35: Dialysis Accessories, Italy, Revenues ($ mn) by Sub-Segment, Projection ,, from 2007 to 2012 62
Figure 36: Dialysis Accessories, Italy, Volume (Units) by Sub-Segment, Historic, from 2000 to 2007 64
Figure 37: Dialysis Accessories, Italy, Volume (Units) by Sub-Segment, Projection ,, from 2007 to 2012 65
Figure 38: Renal Dialysis Equipment, Italy, Firms Share (%), 2007 68
Figure 39: Fresenius Medical Care AG & Co. KGaA Value Chain Analysis 70
Figure 40: Gambro AB Value Chain Analysis 73
Figure 41: Coloplast A/S Value Chain Analysis 77
Figure 42: Baxter International Inc. Value Chain Analysis 80
Figure 43: Sorin S.p.A. Value Chain Analysis 86
Figure 44: Global March kets Direct Methodology 95
