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 Markets 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 Sector Review 15
4.1 Healthcare Sector Review 15
4.2 Healthcare Expenditure 15
4.3 Healthcare Infrastructure 17
4.3.1 Healthcare Personnel Data 18
4.3.2 Healthcare Facilities Data 19
4.4 Healthcare Policy 20
5 Regulation System 21
5.1 Medical Equipment Approval Process 21
5.1.1 Classification 22
5.1.2 Conformity Assessment Process 30
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
5.1.3 Registration Fee 34
5.1.4 Registration Period 34
5.2 Post Market Surveillance (PMS) 35
6 Pricing and Reimbursement 36
6.1 Pricing and Reimbursement Policies 36
7 Distribution Structure 37
7.1 France Medical Equipment Distribution Structure 37
8 France Medical Equipment Cross Market Comparison 38
9 Nephrology and Urology Devices In France 40
9.1 Nephrology and Urology Devices Cross Country Comparison (2000-2012) 40
9.2 Nephrology and Urology Devices, France, Overall Revenues ($ mn), 2000-2012 41
9.3 Nephrology and Urology Devices, France, Category Volume (Units), 2000-2012 45
9.4 Nephrology and Urology Devices, France, Company Share (2006-2007) 46
10 Incontinence Devices In France 47
10.1 Incontinence Devices Overall Revenue (2000-2012) 47
10.2 Incontinence Devices Overall Volume (2000-2012) 49
10.3 Incontinence Devices Average Price (2000-2012) 51
10.4 Incontinence Devices Distribution Share (2006-2007) 51
10.5 Incontinence Devices, France, Company Share (2006-2007) 52
11 Lithotripters In France 53
11.1 Lithotripters Overall Revenue (2000-2012) 53
11.2 Lithotripters Overall Volume (2000-2012) 55
11.3 Lithotripters Average Price (2000-2012) 57
11.4 Lithotripters Distribution Share (2006-2007) 57
11.5 Lithotripters, France, Company SHARE (2006-2007) 58
12 Renal Dialysis Equipment In France 59
12.1 Renal Dialysis Equipment Overall Revenue (2000-2012) 59
12.1.1 Dialysis Accessories Overall Revenue (2000-2012) 61
12.2 Renal Dialysis Equipment Overall Volume (2000-2012) 63
12.2.1 Dialysis Accessories Overall Volume (2000-2012 64
12.3 Renal Dialysis Equipment Average Price (2000-2012) 66
12.4 Renal Dialysis Equipment Distribution Share (2006-2007) 67
12.5 Renal Dialysis Equipment, France, Company Share (2006-2007) 68
13 Svenska Celullosa Aktiebolaget SCA Company Profile 69
13.1 Company Overview 69
14 Fresenius Medical Care AG & Co. KGaA Company Profile 70
14.1 Company Overview 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 Marketing 71
14.2.3.1 Partnerships and Alliances 71
14.2.3.2 Licensing Agreements 72
15 Gambro AB Company Profile 73
15.1 Company Overview 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 Marketing 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 HARTMANN GROUP Company Profile 76
16.1 Company Overview 76
16.2 Value Chain Analysis 76
16.2.1 Manufacturing 77
16.2.1.1 Outsourcing 77
16.2.1.2 In House Manufacturing 77
16.2.2 Product Development 77
16.2.2.1 Regulatory Approvals 77
16.2.2.2 Research and Development 77
16.2.3 Sales and Marketing 77
16.2.3.1 Partnerships and Alliances 77
17 Coloplast A/S Company Profile 78
17.1 Company Overview 78
17.2 Value Chain Analysis 78
17.2.1 Manufacturing 79
17.2.1.1 In House Manufacturing 79
17.2.2 Product Development 79
17.2.2.1 Regulatory Approvals 79
17.2.2.2 Clinical Trials 79
17.2.2.3 Research and Development 80
17.2.3 Sales and Marketing 80
17.2.3.1 Partnerships and Alliances 80
17.2.3.2 Licensing Agreements 80
18 Baxter International Inc. Company Profile 81
18.1 Company Overview 81
18.2 Value Chain Analysis 81
18.2.1 Manufacturing 82
18.2.1.1 In House Manufacturing 82
18.2.2 Product Development 82
18.2.2.1 Research and Development 82
18.2.2.2 Regulatory Approvals 82
18.2.2.3 Clinical Trials 82
18.2.3 Sales and Marketing 83
18.2.3.1 E-distribution 83
18.2.3.2 Licensing Agreements 83
18.2.3.3 Partnerships and Alliances 83
18.3 Baxter International Inc. Pipeline Products 84
18.3.1 Baxter International Inc. Pipeline Products by Equipment Type 84
18.3.2 Baxter International Inc. Pipeline Products by Development Stage 84
18.3.3 Baxter International Inc. Pipeline Products by Therapy Area 84
18.3.4 Baxter International Inc. Pipeline Products by News Summary 84
19 Laboratoires NEPHROTEK Company Profile 85
19.1 Company Overview 85
20 TMS S.A. Company Profile 86
20.1 Company Overview 86
21 Financial Deals Landscape 87
21.1 Debt Offerings 87
21.1.1 EDAP TMS Completes Private Placement Of $20 Million 87
21.2 Partnership 88
21.2.1 EDAP TMS To Distribute Stonebreaker System Of LMA Urology 88
21.2.2 Terumo And Guerbet Enter Into Distribution Agreement 90
21.3 Asset Transactions 91
21.3.1 Covidien Sells Its European Incontinence Business 91
22 Recent Developments 93
22.1 Product News 93
22.1.1 Apr 29, 2008: CeraShield Coated Urinary Catheters Provide Superior Protection Against Bacterial Colonization Compared To Leading Brands In Preclinical Testing 93
22.1.2 Apr 23, 2008: Ceragenix To Present Urinary Catheter Data At European Conference 93
23 APPENDIX 95
23.1 Global Markets Direct Research Methodology 95
23.2 Coverage 96
23.3 Secondary Research 96
23.4 Primary Research 97
23.5 Models 97
23.6 Forecasts 98
23.7 Expert Panels 98
23.8 Currency Conversion 99
23.9 Contact Us 100
23.10 Disclaimer 100
1.1 List of Tables
Table 1: Number of Doctors by Specialty in France, 2003-2007 18
Table 2: Number of Hospital Wards by Specialty in France, 2003-2007 19
Table 3: France, Medical Equipment Market Comparison 39
Table 4: Nephrology and Urology Devices Cross Country Comparison (2000-2012) 40
Table 5: Nephrology and Urology Devices, France, Overall Revenues ($ mn), 2000-2012 41
Table 6: Nephrology and Urology Devices Market, France, Portfolio Analysis 42
Table 7: Nephrology and Urology Devices, France, Overall Revenues ($ mn), Historic, 2000-2007 43
Table 8: Nephrology and Urology Devices, France, Overall Revenues ($ mn), Forecast, 2007-2012 44
Table 9: Nephrology and Urology Devices, France, Category Volume (Units), 2000-2012 45
Table 10: Nephrology and Urology Devices, France, Category Volume (Units), Historic, 2000-2007 45
Table 11: Nephrology and Urology Devices, France, Category Volume (Units), Forecast, 2007-2012 45
Table 12: Nephrology and Urology Devices, France, Company Share by Revenue ($ mn), 2006-2007 46
Table 13: Incontinence Devices, France, Revenue ($ mn) by Segment, Historic, 2000-2007 47
Table 14: Incontinence Devices, France, Revenue ($ mn) by Segment, Forecast, 2007-2012 48
Table 15: Incontinence Devices, France, Overall Volume (Units), Historic, 2000-2007 49
Table 16: Incontinence Devices, France, Overall Volume (Units), Forecast, 2007-2012 50
Table 17: Incontinence Devices, France, Average Price ($), Historic, 2000-2007 51
Table 18: Incontinence Devices, France, Average Price ($), Forecast, 2007-2012 51
Table 19: Incontinence Devices, France, Distribution Share by Revenue ($ mn), 2006-2007 51
Table 20: Incontinence Devices, France, Company Share by Revenue ($ mn), 2006-2007 52
Table 21: Lithotripters, France, Revenue ($ mn) by Segment, Historic, 2000-2007 53
Table 22: Lithotripters, France, Revenue ($ mn) by Segment, Forecast, 2007-2012 54
Table 23: Lithotripters, France, Overall Volume (Units), Historic, 2000-2007 55
Table 24: Lithotripters, France, Overall Volume (Units), Forecast, 2007-2012 56
Table 25: Lithotripters, France, Average Price ($), Historic, 2000-2007 57
Table 26: Lithotripters, France, Average Price ($), Forecast, 2007-2012 57
Table 27: Lithotripters, France, Distribution Share by Revenue ($ mn), 2006-2007 57
Table 28: Lithotripters, France, Company Share by Revenue ($ mn), 2006-2007 58
Table 29: Renal Dialysis Equipment, France, Revenue ($ mn) by Segment , Historic, 2000-2007 59
Table 30: Renal Dialysis Equipment, France, Revenue ($ mn) by Segment , Forecast, 2007-2012 60
Table 31: Dialysis Accessories, France, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 61
Table 32: Dialysis Accessories, France, Revenues ($ mn) by Sub-Segment, Forecast,, 2007-2012 62
Table 33: Renal Dialysis Equipment, France, Overall Volume (Units), Historic, 2000-2007 63
Table 34: Renal Dialysis Equipment, France, Overall Volume (Units), Forecast, 2007-2012 63
Table 35: Dialysis Accessories, France, Volume (Units) by Sub-Segment, Historic, 2000-2007 64
Table 36: Dialysis Accessories, France, Volume (Units) by Sub-Segment, Forecast,, 2007-2012 65
Table 37: Renal Dialysis Equipment, France, Average Price ($), Historic, 2000-2007 66
Table 38: Renal Dialysis Equipment, France, Average Price ($), Forecast,, 2007-2012 66
Table 39: Renal Dialysis Equipment, France, Distribution Share by Revenue ($ mn), 2006-2007 67
Table 40: Renal Dialysis Equipment, France, Company Share by Revenue ($ mn), 2006-2007 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 84
Table 45: Baxter International Inc. Pipeline Products By Development Stage 84
Table 46: Baxter International Inc. Pipeline Products By Therapy Area 84
Table 47: Baxter International Inc. Pipeline Products By News Summaries 84
Table 48: Currency Conversion from USD to Local Currency at 2007 Constant Rate 99
1.2
List of Figures
Figure 1: Total Healthcare Expenditure in France, 2000 – 2006 16
Figure 2: Flowchart for Classification of Non-invasive Devices in France, 2007 23
Figure 3: Flowchart for Classification of Invasive Devices in France, 2007 24
Figure 4: Flowchart for Classification of Invasive Devices in France, 2007 25
Figure 5: Flowchart for Classification of Invasive Devices in France, 2007 26
Figure 6: Flowchart for Classification of Invasive Devices in France, 2007 27
Figure 7: Flowchart for Classification of Active Devices in France, 2007 28
Figure 8: Flowchart for Classification of Active Devices in France, 2007 29
Figure 9: Flowchart for Classification of Devices except Non-invasive, Invasive and Active Devices in France, 2007 30
Figure 10: Conformity Assessment of Class-I Medical Devices in France, 2007 31
Figure 11: Conformity Assessment of Class-IIa Medical Devices in France, 2007 32
Figure 12: Conformity Assessment of Class-IIb Medical Devices in France, 2007 33
Figure 13: Conformity Assessment of Class-III Medical Devices in France, 2007 34
Figure 14: Medical Equipment Distribution Structure in France, 2007 37
Figure 15: France, Medical Equipment Market Comparison,2007 38
Figure 16: Nephrology and Urology Devices Cross Country Comparison (2000-2012) 40
Figure 17: Nephrology and Urology Devices, France, Overall Revenues ($ mn), 2000-2012 41
Figure 18: Nephrology and Urology Devices Market, France, Portfolio Analysis 42
Figure 19: Nephrology and Urology Devices, France, Overall Revenues ($ mn), Historic, 2000-2007 43
Figure 20: Nephrology and Urology Devices, France, Overall Revenues ($ mn), Forecast, 2007-2012 44
Figure 21: Nephrology and Urology Devices, France, Company Share (%), 2007 46
Figure 22: Incontinence Devices, France, Revenue ($ mn) by Segment, Historic, 2000-2007 47
Figure 23: Incontinence Devices, France, Revenue ($ mn) by Segment, Forecast, 2007-2012 48
Figure 24: Incontinence Devices, France, Overall Volume (Units), Historic, 2000-2007 49
Figure 25: Incontinence Devices, France, Overall Volume (Units), Forecast, 2007-2012 50
Figure 26: Incontinence Devices, France, Company Share (%), 2007 52
Figure 27: Lithotripters, France, Revenue ($ mn) by Segment, Historic, 2000-2007 53
Figure 28: Lithotripters, France, Revenue ($ mn) by Segment, Forecast, 2007-2012 54
Figure 29: Lithotripters, France, Overall Volume (Units), Historic, 2000-2007 55
Figure 30: Lithotripters, France, Overall Volume (Units), Forecast, 2007-2012 56
Figure 31: Lithotripters, France, Company Share (%), 2007 58
Figure 32: Renal Dialysis Equipment, France, Revenue ($ mn) by Segment , Historic, 2000-2007 59
Figure 33: Renal Dialysis Equipment, France, Revenue ($ mn) by Segment , Forecast, 2007-2012 60
Figure 34: Dialysis Accessories, France, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 61
Figure 35: Dialysis Accessories, France, Revenues ($ mn) by Sub-Segment, Forecast,, 2007-2012 62
Figure 36: Dialysis Accessories, France, Volume (Units) by Sub-Segment, Historic, 2000-2007 64
Figure 37: Dialysis Accessories, France, Volume (Units) by Sub-Segment, Forecast,, 2007-2012 65
Figure 38: Renal Dialysis Equipment, France, Company 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: Hartmann Group Value Chain Analysis 76
Figure 42: Coloplast A/S Value Chain Analysis 78
Figure 43: Baxter International Inc. Value Chain Analysis 81
Figure 44: Global Markets Direct Methodology 95