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 Nephrology and Urology Devices In United States 13
3.1 Nephrology and Urology Devices, Market Segmentation 13
3.2 Nephrology and Urology Devices, United States, Overall Revenue ($m), 2003-2017 14
3.3 Nephrology and Urology Devices Market, United States, Revenue Mix ($m), 2010 16
3.4 Nephrology and Urology Devices Market, United States, Category Contribution (%), 2010 17
3.5 Nephrology and Urology Devices, United States, Category Volume (Units), 2003-2017 23
3.6 Nephrology and Urology Devices, United States, Company Share (2009-2010) 28
4 Incontinence Devices In United States 30
4.1 Incontinence Devices, Market Segmentation 30
4.2 Incontinence Devices Market, United States, Revenue Mix ($m), 2010 31
4.3 Incontinence Devices Market, United States, Segment Contribution (%), 2010 32
4.4 Incontinence Devices Overall Revenue (2003-2017) 33
4.4.1 Protective Garments for Incontinence Revenue (2003-2017) 37
4.4.2 Urinary Catheters Revenue (2003-2017) 41
4.5 Incontinence Devices Overall Volume (2003-2017) 45
4.5.1 Protective Garments for Incontinence Volume (2003-2017) 49
4.5.2 Urinary Catheters Volume (2003-2017) 53
4.6 Incontinence Devices Average Price (2003-2017) 57
4.7 Incontinence Devices Distribution Share (2009-2010) 58
4.8 Incontinence Devices, United States, Company Share (2009-2010) 59
5 Lithotripters In United States 61
5.1 Lithotripters, Market Segmentation 61
5.2 Lithotripters Market, United States, Revenue Mix ($m), 2010 62
5.3 Lithotripters Market, United States, Segment Contribution (%), 2010 63
5.4 Lithotripters Overall Revenue (2003-2017) 64
5.5 Lithotripters Overall Volume (2003-2017) 68
5.6 Lithotripters Average Price (2003-2017) 71
5.7 Lithotripters Distribution Share (2009-2010) 72
5.8 Lithotripters, United States, Company Share (2009-2010) 73
6 Renal Dialysis Equipment In United States 75
6.1 Renal Dialysis Equipment, Market Segmentation 75
6.2 Renal Dialysis Equipment Market, United States, Revenue Mix ($m), 2010 76
6.3 Renal Dialysis Equipment Market, United States, Segment Contribution (%), 2010 77
6.4 Renal Dialysis Equipment Overall Revenue (2003-2017) 78
6.4.1 Dialysis Accessories Revenue (2003-2017) 82
6.4.2 Hemodialysis Machines Revenue (2003-2017) 86
6.5 Renal Dialysis Equipment Overall Volume (2003-2017) 90
6.5.1 Dialysis Accessories Volume (2003-2010) 94
6.5.2 Hemodialysis MachinesVolume (2003-2017) 98
6.6 Renal Dialysis Equipment Average Price (2003-2017) 102
6.7 Renal Dialysis Equipment Distribution Share (2009-2010) 103
6.8 Renal Dialysis Equipment, United States, Company Share (2009-2010) 104
7 Overview of Key Companies in United States Nephrology and Urology Devices Market 106
7.1 Fresenius Medical Care AG & Co. KGaA 106
7.1.1 Company Overview 106
7.1.2 Share in the United States Nephrology and Urology Devices Market 106
7.2 Kimberly-Clark Corporation 107
7.2.1 Company Overview 107
7.2.2 Share in the United States Nephrology and Urology Devices Market 107
7.3 Baxter International Inc. 108
7.3.1 Company Overview 108
7.3.2 Share in the United States Nephrology and Urology Devices Market 108
7.4 Gambro AB 109
7.4.1 Company Overview 109
7.4.2 Share in the United States Nephrology and Urology Devices Market 109
7.5 First Quality Enterprises, Inc. 110
7.5.1 Company Overview 110
7.5.2 Share in the United States Nephrology and Urology Devices Market 110
7.6 Svenska Cellulosa Aktiebolaget SCA 111
7.6.1 Company Overview 111
7.6.2 Share in the United States Nephrology and Urology Devices Market 111
7.7 Unicharm Corporation 112
7.7.1 Company Overview 112
7.8 NIPRO CORPORATION 112
7.8.1 Company Overview 112
7.9 B. Braun Melsungen AG 112
7.9.1 Company Overview 112
7.10 Teleflex Incorporated 113
7.10.1 Company Overview 113
7.11 Coloplast A/S 113
7.11.1 Company Overview 113
7.12 Covidien plc 113
7.12.1 Company Overview 113
7.13 Dornier MedTech GmbH 114
7.13.1 Company Overview 114
7.14 STORZ MEDICAL AG 114
7.14.1 Company Overview 114
7.15 EDAP TMS S.A. 114
7.15.1 Company Overview 114
7.16 Medline Industries, Inc. 115
7.16.1 Company Overview 115
7.17 Siemens Healthcare 115
7.17.1 Company Overview 115
8 Nephrology and Urology Devices Market Pipeline Products 116
8.1.1 Incontinence Devices Market Pipeline Products 117
8.1.2 Renal Dialysis Equipment Market Pipeline Products 118
8.1.3 Lithotripters Market Pipeline Products 120
9 Financial Deals Landscape 121
9.1 Acquisition 121
9.1.1 Fenner Acquires MRI Manufacturing & Research 121
9.1.2 K-Kitz Acquires Bacterin In Reverse Acquisition 122
9.1.3 Endo Pharmaceuticals Holding Completes Acquisition Of HealthTronics 123
9.2 Partnerships 125
9.2.1 Quick-Med Technologies Enters Into Co-Development Agreement With Foster 125
9.2.2 Argon Medical Devices Enters Into An Agreement With Rex Medical 126
9.2.3 Interface Biologics Signs Exclusive License Option Agreement With Fresenius Medical Care 127
9.2.4 AorTech International Enters Into Technology License Agreement 128
9.2.5 Boston Scientific Enters Into Co-Marketing Agreement With Bladder Health Network 129
10 Recent Developments 130
10.1 Strategy and Business Planning 130
10.1.1 Feb 10, 2011: C. R. Bard to Reduce Workforce By 20% 130
10.1.2 Jan 18, 2011: Eigen Completes Restructuring Plan For Urology Marketplace 130
10.1.3 Dec 13, 2010: Bard To Improve Overall Cost Structure And Enhance Operational Effectiveness 130
10.1.4 Aug 19, 2010: Boston Scientific To Invest In New Products: CEO 130
10.1.5 Aug 09, 2010: Zurex Establishes Headquarters In Madison, Wisconsin 130
10.1.6 Jun 17, 2010: Baxter Opens New Research & Development Facility In Alliance Park, Belgium 131
10.1.7 Jun 02, 2010: B. Braun Announces Construction Of New Infusion Technology Facility In Melsungen, Germany 132
10.1.8 Apr 29, 2010: Boston Scientific Launches Pelvic Floor Institute For Urology, Women Health Procedures 132
10.1.9 Mar 23, 2010: Nephros Signs Development Agreement With STERIS 133
10.2 Legal and Regulatory 133
10.2.1 Jan 11, 2011: Boston Scientific Reaches Settlement With Medinol 133
10.2.2 Sep 21, 2010: Robbins Geller Files Class Action Suit Against Baxter 133
10.2.3 Jun 21, 2010: HealthTronics Announces Agreement To Settle Shareholder Lawsuits 134
10.2.4 Jun 09, 2010: Mentor Settles ObTape Vaginal Sling Liability cases 135
10.2.5 Apr 09, 2010: Robbins Geller Files Class Action Suit Against Boston Scientific 135
10.3 Government and Public Interest 135
10.3.1 Jan 28, 2011: Baxter Receives FDA Warning Letter Regarding Violations At Two Manufacturing Plants In Puerto Rico 135
10.3.2 Jan 14, 2011: FMCNA Initiates Voluntary Recall Of CombiSet True Flow Series Hemodialysis Blood Tubing Set With Priming Set And Transducer Protectors For Use With Blood Volume Monitor 136
10.3.3 Dec 21, 2010: Boston Scientific Receives Notices Of Deficiency From IRS 136
10.3.4 Nov 22, 2010: Landmark Study In New England Journal Of Medicine Documents Significant Clinical Advantages Of More Frequent Hemodialysis: NxStage 137
10.3.5 Oct 06, 2010: FDA Issues Warning Letter To Fresenius Medical Care Over Faulty Kidney Devices 138
10.3.6 Sep 27, 2010: CytoSorbents Achieves ISO 13485 Certification 138
10.3.7 Sep 02, 2010: UCSF Unveils Model For Implantable Artificial Kidney To Replace Dialysis 139
10.3.8 Sep 02, 2010: UCSF Researchers Unveil Prototype Model Of First Implantable Artificial Kidney 140
10.3.9 Aug 11, 2010: Boston Scientific Resolves Corporate Warning Letter 141
10.3.10 Jun 29, 2010: FDA Issues Warning Letter To Baxter Over Reporting Process 141
10.3.11 Jun 07, 2010: Duplex Guided Dialysis Access Angioplasty Safe In Office Setting: Study 142
10.3.12 May 29, 2010: Mayo Clinic Research Finds Surgery Outperforms Drug Therapy In Treatment Of Benign Prostatic Hyperplasia 143
10.3.13 May 28, 2010: Urologix Presents Two Clinical Abstracts At Geriatric Urological Society During AUA 2010 Annual Meeting 144
10.3.14 May 17, 2010: Baxter Announces Voluntary Recall Of HYLENEX 144
10.3.15 Apr 20, 2010: FDA To Address Challenges Of Using Complex Medical Devices In Home 145
10.4 Product News 146
10.4.1 Apr 07, 2010: Preclinical Study Finds Cause Of Chronic Kidney Disease In Kids 146
11 Appendix 147
11.1 Definitions of Markets Covered in the Report 148
11.1.1 Nephrology and Urology Devices 148
11.2 Research Methodology 150
11.3 Secondary Research 150
11.4 Primary Research 151
11.5 Models 151
11.6 Forecasts 152
11.7 Expert Panels 152
11.8 GlobalData Consulting 152
11.9 Currency Conversion 152
11.10 Contact Us 153
11.11 Disclaimer 153
List of Tables
Table 1:Nephrology and Urology Devices, United States, Overall Revenue ($m), 2003-2017 15
Table 2: Nephrology and Urology Devices Market, United States, Category Contribution (%), 2010 17
Table 3:Nephrology and Urology Devices, United States, Cross-Category Analysis, 2003-2017 18
Table 4:Nephrology and Urology Devices, United States, Overall Revenue ($m), Historic, 2003-2010 20
Table 5:Nephrology and Urology Devices, United States, Overall Revenue ($m), Forecast, 2010-2017 22
Table 6:Nephrology and Urology Devices, United States, Category Volume (Units), 2003-2017 23
Table 7:Nephrology and Urology Devices, United States, Category Volume (Units), Historic, 2003-2010 25
Table 8:Nephrology and Urology Devices, United States, Category Volume (Units), Forecast, 2010-2017 27
Table 9:Nephrology and Urology Devices, United States, Company Share by Revenue ($m), 2009-2010 29
Table 10:Incontinence Devices Market, United States, Segment Contribution (%), 2010 32
Table 11:Incontinence Devices, United States, Revenue ($m) by Segment, Historic, 2003-2010 34
Table 12:Incontinence Devices, United States, Revenue ($m) by Segment, Forecast, 2010-2017 36
Table 13:Protective Garments for Incontinence, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 38
Table 14:Protective Garments for Incontinence, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 40
Table 15:Urinary Catheters, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 42
Table 16:Urinary Catheters, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 44
Table 17:Incontinence Devices, United States, Volume (Units) by Segment, Historic, 2003-2010 46
Table 18:Incontinence Devices, United States, Volume (Units) by Segment, Forecast, 2010-2017 48
Table 19:Protective Garments for Incontinence, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 50
Table 20:Protective Garments for Incontinence, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 52
Table 21:Urinary Catheters, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 54
Table 22:Urinary Catheters, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 56
Table 23:Incontinence Devices, United States, Average Price ($), Historic, 2003-2010 57
Table 24:Incontinence Devices, United States, Average Price ($), Forecast, 2010-2017 57
Table 25:Incontinence Devices, AAWUnited States, Distribution Share by Revenue ($m), 2009-2010 58
Table 26:Incontinence Devices, United States, Company Share by Revenue ($m), 2009-2010 60
Table 27:Lithotripters Market, United States, Segment Contribution (%), 2010 63
Table 28:Lithotripters, United States, Revenue ($m) by Segment, Historic, 2003-2010 65
Table 29:Lithotripters, United States, Revenue ($m) by Segment, Forecast, 2010-2017 67
Table 30:Lithotripters, United States, Volume (Units) by Segment, Historic, 2003-2010 69
Table 31:Lithotripters, United States, Volume (Units) by Segment, Forecast, 2010-2017 70
Table 32:Lithotripters, United States, Average Price ($), Historic, 2003-2010 71
Table 33:Lithotripters, United States, Average Price ($), Forecast, 2010-2017 71
Table 34:Lithotripters, United States, Distribution Share by Revenue ($m), 2009-2010 72
Table 35:Lithotripters, United States, Company Share by Revenue ($m), 2009-2010 74
Table 36: Renal Dialysis Equipment Market, United States, Segment Contribution (%), 2010 77
Table 37:Renal Dialysis Equipment, United States, Revenue ($m) by Segment, Historic, 2003-2010 79
Table 38:Renal Dialysis Equipment, United States, Revenue ($m) by Segment, Forecast, 2010-2017 81
Table 39:Dialysis Accessories, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 83
Table 40:Dialysis Accessories, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 85
Table 41:Hemodialysis Machines, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 87
Table 42:Hemodialysis Machines, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 89
Table 43:Renal Dialysis Equipment, United States, Volume (Units) by Segment, Historic, 2003-2010 91
Table 44:Renal Dialysis Equipment, United States, Volume (Units) by Segment, Forecast, 2010-2017 93
Table 45:Dialysis Accessories, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 95
Table 46:Dialysis Accessories, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 97
Table 47:Hemodialysis Machines, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 99
Table 48:Hemodialysis Machines, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 101
Table 49:Renal Dialysis Equipment, United States, Average Price ($), Historic, 2003-2010 102
Table 50:Renal Dialysis Equipment, United States, Average Price ($), Forecast, 2010-2017 102
Table 51:Renal Dialysis Equipment, United States, Distribution Share by Revenue ($m), 2009-2010 103
Table 52:Renal Dialysis Equipment, United States, Company Share by Revenue ($m), 2009-2010 105
Table 53:Nephrology and Urology Devices Market Pipeline Products 116
Table 54:Incontinence Devices Market Pipeline Products 117
Table 55:Renal Dialysis Equipment Market Pipeline Products 118
Table 56:Lithotripters Market Pipeline Products 120
Table 57:Fenner Acquires MRI Manufacturing & Research 121
Table 58:K-Kitz Acquires Bacterin In Reverse Acquisition 122
Table 59:Endo Pharmaceuticals Holding Completes Acquisition Of HealthTronics 123
Table 60:Quick-Med Technologies Enters Into Co-Development Agreement With Foster 125
Table 61:Argon Medical Devices Enters Into An Agreement With Rex Medical 126
Table 62:Interface Biologics Signs Exclusive License Option Agreement With Fresenius Medical Care 127
Table 63:AorTech International Enters Into Technology License Agreement 128
Table 64:Boston Scientific Enters Into Co-Marketing Agreement With Bladder Health Network 129
Table 65:USD to Local Currency, United States, Average Actual Rate 2003-2010 152
List of Figures
Figure 1:Nephrology and Urology Devices, Market Segmentation 13
Figure 2:Nephrology and Urology Devices, United States, Overall Revenue ($m), 2003-2017 14
Figure 3:Nephrology and Urology Devices Market, United States, Revenue Mix ($m), 2010 16
Figure 4:Nephrology and Urology Devices Market, United States, Category Contribution (%), 2010 17
Figure 5:Nephrology and Urology Devices, United States, Cross-Category Analysis, 2003-2017 18
Figure 6:Nephrology and Urology Devices, United States, Overall Revenue ($m), Historic, 2003-2010 19
Figure 7:Nephrology and Urology Devices, United States, Overall Revenue ($m), Forecast, 2010-2017 21
Figure 8:Nephrology and Urology Devices, United States, Category Volume (Units), 2003-2017 23
Figure 9:Nephrology and Urology Devices, United States, Category Volume (Units), Historic, 2003-2010 24
Figure 10:Nephrology and Urology Devices, United States, Category Volume (Units), Forecast, 2010-2017 26
Figure 11:Nephrology and Urology Devices, United States, Company Share (%), 2010 28
Figure 12:Incontinence Devices, Market Segmentation 30
Figure 13:Incontinence Devices Market, United States, Revenue Mix ($m), 2010 31
Figure 14:Incontinence Devices Market, United States, Segment Contribution (%), 2010 32
Figure 15:Incontinence Devices, United States, Revenue ($m) by Segment, Historic, 2003-2010 33
Figure 16:Incontinence Devices, United States, Revenue ($m) by Segment, Forecast, 2010-2017 35
Figure 17:Protective Garments for Incontinence, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 37
Figure 18:Protective Garments for Incontinence, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 39
Figure 19:Urinary Catheters, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 41
Figure 20:Urinary Catheters, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 43
Figure 21:Incontinence Devices, United States, Volume (Units) by Segment, Historic, 2003-2010 45
Figure 22:Incontinence Devices, United States, Volume (Units) by Segment, Forecast, 2010-2017 47
Figure 23:Protective Garments for Incontinence, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 49
Figure 24:Protective Garments for Incontinence, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 51
Figure 25:Urinary Catheters, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 53
Figure 26:Urinary Catheters, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 55
Figure 27:Incontinence Devices, United States, Company Share (%), 2010 59
Figure 28:Lithotripters, Market Segmentation 61
Figure 29:Lithotripters Market, United States, Revenue Mix ($m), 2010 62
Figure 30:Lithotripters Market, United States, Segment Contribution (%), 2010 63
Figure 31:Lithotripters, United States, Revenue ($m) by Segment, Historic, 2003-2010 64
Figure 32:Lithotripters, United States, Revenue ($m) by Segment, Forecast, 2010-2017 66
Figure 33:Lithotripters, United States, Volume (Units) by Segment, Historic, 2003-2010 68
Figure 34:Lithotripters, United States, Volume (Units) by Segment, Forecast, 2010-2017 70
Figure 35:Lithotripters, United States, Company Share (%), 2010 73
Figure 36:Renal Dialysis Equipment, Market Segmentation 75
Figure 37:Renal Dialysis Equipment Market, United States, Revenue Mix ($m), 2010 76
Figure 38:Renal Dialysis Equipment Market, United States, Segment Contribution (%), 2010 77
Figure 39:Renal Dialysis Equipment, United States, Revenue ($m) by Segment, Historic, 2003-2010 78
Figure 40:Renal Dialysis Equipment, United States, Revenue ($m) by Segment, Forecast, 2010-2017 80
Figure 41:Dialysis Accessories, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 82
Figure 42:Dialysis Accessories, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 84
Figure 43:Hemodialysis Machines, United States, Revenue ($m) by Sub-Segment, Historic, 2003-2010 86
Figure 44:Hemodialysis Machines, United States, Revenue ($m) by Sub-Segment, Forecast, 2010-2017 88
Figure 45:Renal Dialysis Equipment, United States, Volume (Units) by Segment, Historic, 2003-2010 90
Figure 46:Renal Dialysis Equipment, United States, Volume (Units) by Segment, Forecast, 2010-2017 92
Figure 47:Dialysis Accessories, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 94
Figure 48:Dialysis Accessories, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 96
Figure 49:Hemodialysis Machines, United States, Volume (Units) by Sub-Segment, Historic, 2003-2010 98
Figure 50:Hemodialysis Machines, United States, Volume (Units) by Sub-Segment, Forecast, 2010-2017 100
Figure 51:Renal Dialysis Equipment, United States, Company Share (%), 2010 104
Figure 52:Fresenius Medical Care AG & Co. KGaA, Company Share (%),United States Nephrology and Urology Devices Market, 2010 106
Figure 53:Kimberly-Clark Corporation, Company Share (%),United States Nephrology and Urology Devices Market, 2010 107
Figure 54:Baxter International Inc., Company Share (%),United States Nephrology and Urology Devices Market, 2010 108
Figure 55:Gambro AB, Company Share (%),United States Nephrology and Urology Devices Market, 2010 109
Figure 56:First Quality Enterprises, Inc., Company Share (%),United States Nephrology and Urology Devices Market, 2010 110
Figure 57:Svenska Cellulosa Aktiebolaget SCA, Company Share (%),United States Nephrology and Urology Devices Market, 2010 111