Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 11
1.2 List of Figures 15
2 Introduction 17
2.1 What Is This Report
About? 17
3 Definitions of Markets Covered in the Report 18
3.1 Wound
Care Management 18
3.2 Advanced Wound Management 18
3.2.1 Alginates
18
3.2.2 Collagens 18
3.2.3 Foams 18
3.2.4 Hydrocolloids 18
3.2.5 Hydrofibres 18
3.2.6 Hydrogels 18
3.2.7 Semi-Permeable Films
18
3.3 Negative Pressure Wound Therapy (NPWT) 18
3.3.1 Negative
Pressure Wound Therapy Disposables 19
3.3.2 Negative Pressure Wound
Therapy Equipment 19
3.4 Compression Therapy 19
3.4.1 Compression
Bandages 19
3.4.2 Dynamic Compression Therapy 19
3.5 Ostomy Drainage
Bags 19
3.5.1 Colostomy 19
3.5.2 Ileostomy 20
3.5.3 Urostomy
20
3.6 Pressure Relief Devices 20
3.6.1 Mattress Overlays 20
3.6.2
Mattresses 20
3.6.3 Speciality Beds 20
3.7 Traditional Wound
Management 20
3.8 Wound Closure Devices 20
3.8.1 Hemostats 20
3.8.2 Ligating Clips 20
3.8.3 Mechanical Stapling Devices 21
3.8.4
Tissue Sealants 21
3.8.5 Wound Closure Strips 21
4 Healthcare Sector
Review 22
4.1 Healthcare Expenditure 22
4.2 Healthcare Infrastructure
26
4.2.1 Healthcare Personnel Data 26
4.2.2 Healthcare Facilities Data
30
4.3 United States Healthcare Trade Statistics 32
5 Regulation
System 33
5.1 Regulation System 33
5.2 Medical Equipment Approval
Process 33
5.2.1 Pre-market Approval Process 34
5.2.2 Intended use and
Indications for use 34
5.2.3 Predicate Device 35
5.2.4 Safe and
Effective 35
5.2.5 Other Category Devices 37
5.2.6 Post-Market
Approval Process 38
5.2.7 Compliance and Enforcement 38
5.2.8
Registration Fee 39
5.2.9 Approval Time 39
6 Pricing and Reimbursement
40
6.1 Government Policies 40
6.2 Private Insurance 41
6.3
Diagnosis Related Groups (DRG) 42
7 Distribution Structure 43
7.1
Distribution Structure 43
8 Wound Care Management In United States 44
8.1 Wound Care Management, Cross Country Comparison, Revenue ($ mn), 2000-2015
44
8.2 Wound Care Management, United States, Overall Revenue ($ mn),
2000-2015 46
8.3 Wound Care Management, United States, Category Volume
(Units), 2000-2015 52
8.4 Wound Care Management, United States, Company
Share (2007-2008) 57
9 Advanced Wound Management In United States 58
9.1 Advanced Wound Management Overall Revenue (2000-2015) 58
9.2 Advanced
Wound Management Overall Volume (2000-2015) 62
9.3 Advanced Wound
Management Average Price (2000-2015) 66
9.4 Advanced Wound Management
Distribution Share (2007-2008) 67
9.5 Advanced Wound Management, United
States, Company Share (2007-2008) 68
10 Compression Therapy In United
States 70
10.1 Compression Therapy Overall Revenue (2000-2015) 70
10.1.1 Dynamic Compression Therapy Revenue (2000-2015) 72
10.2 Compression
Therapy Overall Volume (2000-2015) 74
10.2.1 Dynamic Compression Therapy
Volume (2000-2015) 75
10.3 Compression Therapy Average Price (2000-2015)
77
10.4 Compression Therapy Distribution Share (2007-2008) 78
10.5
Compression Therapy, United States, Company Share (2007-2008) 79
11
Negative Pressure Wound Therapy (NPWT) In United States 80
11.1 Negative
Pressure Wound Therapy (NPWT) Overall Revenue (2000-2015) 80
11.2 Negative
Pressure Wound Therapy (NPWT) Overall Volume (2000-2015) 82
11.3 Negative
Pressure Wound Therapy (NPWT) Average Price (2000-2015) 83
11.4 Negative
Pressure Wound Therapy (NPWT) Distribution Share (2007-2008) 84
11.5
Negative Pressure Wound Therapy (NPWT), United States, Company Share
(2007-2008) 85
12 Ostomy Drainage Bags In United States 86
12.1 Ostomy
Drainage Bags Overall Revenue (2000-2015) 86
12.2 Ostomy Drainage Bags
Overall Volume (2000-2015) 88
12.3 Ostomy Drainage Bags Average Price
(2000-2015) 90
12.4 Ostomy Drainage Bags Distribution Share (2007-2008)
91
12.5 Ostomy Drainage Bags, United States, Company Share (2007-2008)
92
13 Pressure Relief Devices In United States 93
13.1 Pressure Relief
Devices Overall Revenue (2000-2015) 93
13.2 Pressure Relief Devices
Overall Volume (2000-2015) 95
13.3 Pressure Relief Devices Average Price
(2000-2015) 96
13.4 Pressure Relief Devices Distribution Share (2007-2008)
97
13.5 Pressure Relief Devices, United States, Company Share (2007-2008)
98
14 Traditional Wound Management In United States 99
14.1
Traditional Wound Management Overall Revenue (2000-2015) 99
14.2
Traditional Wound Management Overall Volume (2000-2015) 101
14.3
Traditional Wound Management Average Price (2000-2015) 103
14.4
Traditional Wound Management Distribution Share (2007-2008) 104
14.5
Traditional Wound Management, United States, Company Share (2007-2008) 105
15 Wound Closure Devices In United States 106
15.1 Wound Closure Devices
Overall Revenue (2000-2015) 106
15.2 Wound Closure Devices Overall Volume
(2000-2015) 110
15.3 Wound Closure Devices Average Price (2000-2015)
112
15.4 Wound Closure Devices Distribution Share (2007-2008) 113
15.5
Wound Closure Devices, United States, Company Share (2007-2008) 114
16
Overview of Key Companies in United States Wound Care Management Market
115
16.1 Smith & Nephew Plc 115
16.1.1 Company Overview 115
16.1.2
Smith & Nephew Plc Pipeline Products 115
16.2 Kinetic Concepts, Inc.
118
16.2.1 Company Overview 118
16.2.2 Kinetic Concepts, Inc. Pipeline
Products 118
16.3 ConvaTec 120
16.3.1 Company Overview 120
16.4
Ethicon, Inc. 120
16.4.1 Company Overview 120
16.5 Covidien plc
120
16.5.1 Company Overview 120
16.5.2 Covidien Ltd./Tyco Healthcare
Pipeline Products 121
16.6 Baxter International Inc. 123
16.6.1
Company Overview 123
16.7 3M Health Care 123
16.7.1 Company Overview
123
16.8 B. Braun Melsungen AG 124
16.8.1 Company Overview 124
16.9 Molnlycke Health Care AB 125
16.9.1 Company Overview 125
16.10
Coloplast A/S 125
16.10.1 Company Overview 125
16.11 HARTMANN GROUP
126
16.11.1 Company Overview 126
16.12 BSN medical GmbH 126
16.12.1 Company Overview 126
16.13 Hollister Incorporated 127
16.13.1
Company Overview 127
16.14 Invacare Corporation 127
16.14.1 Company
Overview 127
16.15 Johnson & Johnson 128
16.15.1 Company Overview
128
16.16 Hill-Rom Holdings, Inc. 129
16.16.1 Company Overview 129
16.17 Nycomed International Management GmbH 129
16.17.1 Company Overview
129
16.18 Advanced Medical Solutions Group plc 130
16.18.1 Company
Overview 130
16.18.2 Advanced Medical Solutions Group plc Pipeline
Products 130
16.19 Talley Group Limited 131
16.19.1 Company Overview
131
16.20 DeRoyal Industries, Inc. 131
16.20.1 Company Overview
131
16.21 Lifecore Biomedical, Inc. 132
16.21.1 Company Overview
132
16.21.2 Lifecore Biomedical, Inc. Pipeline Products 132
16.22
Forticell Bioscience, Inc. 133
16.22.1 Company Overview 133
16.22.2
Forticell Bioscience, Inc. Pipeline Products 133
16.23 Celleration, Inc.
135
16.23.1 Company Overview 135
16.24 FzioMed, Inc. 135
16.24.1
Company Overview 135
16.24.2 FzioMed, Inc. Pipeline Products 135
16.25
KeraCure, Inc. 137
16.25.1 Company Overview 137
16.25.2 KeraCure, Inc.
Pipeline Products 137
17 Financial Deals Landscape 139
17.1
Acquisition 139
17.1.1 Synovis Life Technologies Completes Acquisition Of
Pegasus Biologics 139
17.1.2 SpongeTech Delivery Systems Acquires Dicon
Technologies 140
17.1.3 United EcoEnergy Completes Acquisition Of Epic
Wound Care 141
17.1.4 The Dow Chemical Company Acquires Rohm and Haas
142
17.1.5 Applied Nanoscience Terminates Acquisition Of Emergency
Filtration Products 144
17.1.6 Moog Acquires Ethox International 145
17.1.7 Bio Med Sciences Terminates Its Acquisition By ULURU 146
17.2
Partnerships 147
17.2.1 Integra LifeSciences Holdings Signs Licensing
Agreement With Organogenesis 147
17.2.2 ELMARCO Enters Into An Agreement
With HemCon Medical Technologies 148
17.2.3 ConvaTec Enters Into An
Agreement With HemCon Medical Technologies 149
17.2.4 ACell Signs An
Agreement With Medline Industries 150
17.2.5 HyperBranch Medical
Technology Enters Into An Agreement With BD 151
18 Recent Developments
152
18.1 Strategy and Business Planning 152
18.1.1 Jun 02, 2009: BSN
Medical To Expand Facility In Conover, North Carolina 152
18.1.2 Apr 24,
2009: Covalon Technologies, Amsino International Announce Strategic Alliance
152
18.1.3 Apr 13, 2009: AHRQ Wants More Studies On Wound Therapy 152
18.1.4 Mar 30, 2009: KCI Announces Cost Reduction Initiatives 153
18.1.5
Feb 02, 2009: ConvaTec Plans To Expand In Greensboro 154
18.2 Legal and
Regulatory 154
18.2.1 Jul 29, 2009: Kendall Law Group Files Class Action
Suit Against Genzyme 154
18.2.2 Mar 30, 2009: Smith & Nephew Orthopaedics
Announces End Of DPA And Dismissal Of Complaint By USAO 154
18.2.3 Feb 02,
2009: KCI Says Court Again Affirms Patents As Valid 155
18.3 Government
and Public Interest 155
18.3.1 Mar 23, 2009: CMS Considers HHS
Recommendations On Payments For NPWT Pumps 155
18.4 Product News 155
18.4.1 Jul 29, 2009: Smith & Nephew Launches ACTICOAT Flex 3 And ACTICOAT Flex
7 In The US 155
18.4.2 Jul 07, 2009: Wound Care Innovations To Showcase
CellerateRx At NCVH 156
18.4.3 Jun 19, 2009: Oculus Innovative Sciences
Announces Clinical Results Of Microcyn Technology Based Hydrogel To Address
The Treatment Of Acne 157
18.4.4 Jun 17, 2009: Premier Healthcare Alliance
Selects HemCon Patch 157
18.4.5 May 28, 2009: ConvaTec’s Moldable
Skin Barrier Shows High Levels Of Satisfaction In A Prospective Evaluation
158
18.4.6 May 14, 2009: ConvaTec Introduces New AQUACEL Ag Dressing With
Strengthening Fiber 159
18.4.7 May 05, 2009: US FDA Warns Baxter Regarding
The Promotion Of Tisseel Surgical Sealant 159
18.4.8 Apr 27, 2009: Integra
LifeSciences Will Showcase INTEGRA Meshed Bilayer Wound Matrix At The Annual
Symposium On Advanced Wound Care And Wound Healing Society Meeting 160
18.4.9 Apr 23, 2009: ULURU To Report Clinical Evidence And Advanced Research
On Altrazeal At The Society For Advance Wound Care Conference 160
18.4.10
Apr 23, 2009: Wound Management Technologies To Present Evidence Based Clinical
Studies At The Symposium On Advanced Wound Care Conference 161
18.4.11 Apr
14, 2009: US FDA Grants Approval To American Biotech' s New Wound Care Gel
Product 161
18.4.12 Apr 13, 2009: Wright Medical Announces Peer-Reviewed
Level-1 Study Data Of GRAFTJACKET Regenerative Matrix 161
18.4.13 Apr 09,
2009: Quick-Med Technologies To Present NIMBUS Trial Data At Advanced Wound
Care And Wound Healing Society Meeting 162
18.4.14 Apr 01, 2009: Altrazeal
To Present Clinical Evidence At The APWCA National Clinical Conference 2009
163
18.4.15 Mar 31, 2009: Innocoll Announces Submission Of 510 (k)
Application For CollaRx Lidocaine Sponge 163
18.4.16 Mar 17, 2009:
HyperBranch Medical Technology Announces The Licensing Of OcuSeal Liquid
Ocular Bandage To BD 164
18.4.17 Mar 09, 2009: KCI Debuts New V.A.C.
GranuFoam Bridge Dressing 164
18.4.18 Mar 03, 2009: Quick-Med Receives
Additional Patent For NIMBUS 164
18.4.19 Feb 26, 2009: Quick-Med
Technologies Receives FDA Clearance For NIMBUS 165
18.4.20 Feb 24, 2009:
HemCon Medical Unveils Flexible Hemostatic Dressing For Clinical Settings
165
18.4.21 Feb 13, 2009: In Case Studies MEDIHONEY Dressings Proves To Be
Effective For Non-Healing Venous Leg Ulcers 166
18.4.22 Feb 10, 2009: To
Provide Medical Manufacturing And Supply Chain Support For Game Ready Injury
Treatment System, CoolSystems Selects PRIDE Industries 166
18.4.23 Feb 03,
2009: Stratatech Genetically Modifies StrataGraft To Fight Against Potent
Bacterial Infections 166
18.4.24 Jan 22, 2009: ConvaTec Receives Expanded
Indications For AQUACEL And AQUACEL Ag Dressings 167
18.4.25 Jan 07, 2009:
Adhezion Biomedical Announces 510(K) Clearance For SurgiSeal 167
19
Appendix 168
19.1 Global Markets Direct Research Methodology 168
19.2
Secondary Research 169
19.3 Primary Research 169
19.4 Models 170
19.5 Forecasts 170
19.6 Expert Panel Validation 170
19.7 Currency
Conversion 171
19.8 Contact Us 172
19.9 Disclaimer 172
1.1
List of Tables
Table 1: United States Healthcare Expenditure, 2000-2007
23
Table 2: United States Personal Healthcare Expenditure by Type, $
Billions, 2000-2007 24
Table 3: United States Personal Healthcare
Expenditure by Source, $ Billions, 2000-2007 25
Table 4: Total Number of
Doctors in the United States, 2003-2010 26
Table 5: Number of Doctors by
Specialty in the United States, 2003-2010 27
Table 6: Doctors by Region
(Number per 10,000 Civilian Population), 2002-2004 28
Table 7: Doctors by
Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 29
Table
8: Total Hospitals in the United States, 2000-2004 30
Table 9: Community
Hospitals by Number of Beds in the United States, 2000-2004 30
Table 10:
Number of Hospital Beds in the United States, 2000-2004 30
Table 11:
Number of Hospital Beds by Range in the United States, 2000-2004 31
Table
12: United States Healthcare Trade Statistics, 2001-2006 32
Table 13:
Medical Equipment Registration Fee in United States, 2007 39
Table 14:
Medical Device Approval Time in United States, 2007 39
Table 15:
Wound Care Management, Cross Country Comparison, Revenue ($ mn), 2000-2015
45
Table 16: Wound Care Management, United States, Overall Revenue ($
mn), 2000-2015 46
Table 17: Wound Care Management, United States,
Cross-Category Analysis, 2000-2015 47
Table 18: Wound Care
Management, United States, Overall Revenue ($ mn), Historic, 2000-2008 49
Table 19: Wound Care Management, United States, Overall Revenue ($ mn),
Forecast, 2008-2015 51
Table 20: Wound Care Management, United
States, Category Volume (Units), 2000-2015 52
Table 21: Wound Care
Management, United States, Category Volume (Units), Historic, 2000-2008 54
Table 22: Wound Care Management, United States, Category Volume (Units),
Forecast, 2008-2015 56
Table 23: Wound Care Management, United
States, Company Share by Revenue ($ mn), 2007-2008 57
Table 24:
Advanced Wound Management, United States, Revenue ($ mn) by Segment, Historic,
2000-2008 59
Table 25: Advanced Wound Management, United States,
Revenue ($ mn) by Segment, Forecast, 2008-2015 61
Table 26: Advanced
Wound Management, United States, Volume (Units) by Segment, Historic,
2000-2008 63
Table 27: Advanced Wound Management, United States,
Volume (Units) by Segment, Forecast, 2008-2015 65
Table 28: Advanced
Wound Management, United States, Average Price ($), Historic, 2000-2008 66
Table 29: Advanced Wound Management, United States, Average Price ($),
Forecast, 2008-2015 66
Table 30: Advanced Wound Management, United
States, Distribution Share by Revenue ($mn), 2007-2008 67
Table 31:
Advanced Wound Management, United States, Company Share by Revenue ($ mn),
2007-2008 69
Table 32: Compression Therapy, United States, Revenue ($
mn) by Segment, Historic, 2000-2008 70
Table 33: Compression Therapy,
United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 71
Table 34:
Dynamic Compression Therapy, United States, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 72
Table 35: Dynamic Compression
Therapy, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
73
Table 36: Compression Therapy, United States, Volume (Units) by
Segment, Historic, 2000-2008 74
Table 37: Compression Therapy, United
States, Volume (Units) by Segment, Forecast, 2008-2015 74
Table 38:
Dynamic Compression Therapy, United States, Volume (Units) by Sub-Segment,
Historic, 2000-2008 75
Table 39: Dynamic Compression Therapy, United
States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 76
Table 40:
Compression Therapy, United States, Average Price ($), Historic, 2000-2008
77
Table 41: Compression Therapy, United States, Average Price ($),
Forecast, 2008-2015 77
Table 42: Compression Therapy, United States,
Distribution Share by Revenue ($mn), 2007-2008 78
Table 43:
Compression Therapy, United States, Company Share by Revenue ($ mn), 2007-2008
79
Table 44: Negative Pressure Wound Therapy (NPWT), United States,
Revenue ($ mn) by Segment, Historic, 2000-2008 80
Table 45: Negative
Pressure Wound Therapy (NPWT), United States, Revenue ($ mn) by Segment,
Forecast, 2008-2015 81
Table 46: Negative Pressure Wound Therapy
(NPWT), United States, Volume (Units) by Segment, Historic, 2000-2008 82
Table 47: Negative Pressure Wound Therapy (NPWT), United States, Volume
(Units) by Segment, Forecast, 2008-2015 82
Table 48: Negative
Pressure Wound Therapy (NPWT), United States, Average Price ($), Historic,
2000-2008 83
Table 49: Negative Pressure Wound Therapy (NPWT), United
States, Average Price ($), Forecast, 2008-2015 83
Table 50: Negative
Pressure Wound Therapy (NPWT), United States, Distribution Share by Revenue
($mn), 2007-2008 84
Table 51: Negative Pressure Wound Therapy (NPWT),
United States, Company Share by Revenue ($ mn), 2007-2008 85
Table 52:
Ostomy Drainage Bags, United States, Revenue ($ mn) by Segment, Historic,
2000-2008 86
Table 53: Ostomy Drainage Bags, United States, Revenue
($ mn) by Segment, Forecast, 2008-2015 87
Table 54: Ostomy Drainage
Bags, United States, Volume (Units) by Segment, Historic, 2000-2008 88
Table 55: Ostomy Drainage Bags, United States, Volume (Units) by Segment,
Forecast, 2008-2015 89
Table 56: Ostomy Drainage Bags, United States,
Average Price ($), Historic, 2000-2008 90
Table 57: Ostomy Drainage
Bags, United States, Average Price ($), Forecast, 2008-2015 90
Table 58:
Ostomy Drainage Bags, United States, Distribution Share by Revenue ($mn),
2007-2008 91
Table 59: Ostomy Drainage Bags, United States, Company
Share by Revenue ($ mn), 2007-2008 92
Table 60: Pressure Relief
Devices, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 93
Table 61: Pressure Relief Devices, United States, Revenue ($ mn) by
Segment, Forecast, 2008-2015 94
Table 62: Pressure Relief Devices,
United States, Volume (Units) by Segment, Historic, 2000-2008 95
Table 63:
Pressure Relief Devices, United States, Volume (Units) by Segment,
Forecast, 2008-2015 95
Table 64: Pressure Relief Devices, United
States, Average Price ($), Historic, 2000-2008 96
Table 65: Pressure
Relief Devices, United States, Average Price ($), Forecast, 2008-2015 96
Table 66: Pressure Relief Devices, United States, Distribution Share by
Revenue ($mn), 2007-2008 97
Table 67: Pressure Relief Devices, United
States, Company Share by Revenue ($ mn), 2007-2008 98
Table 68:
Traditional Wound Management, United States, Revenue ($ mn), Historic,
2000-2008 99
Table 69: Traditional Wound Management, United States,
Revenue ($ mn), Forecast, 2008-2015 100
Table 70: Traditional Wound
Management, United States, Volume (Units), Historic, 2000-2008 101
Table
71: Traditional Wound Management, United States, Volume (Units),
Forecast, 2008-2015 102
Table 72: Traditional Wound Management,
United States, Average Price ($), Historic, 2000-2008 103
Table 73:
Traditional Wound Management, United States, Average Price ($), Forecast,
2008-2015 103
Table 74: Traditional Wound Management, United States,
Distribution Share by Revenue ($mn), 2007-2008 104
Table 75:
Traditional Wound Management, United States, Company Share by Revenue ($ mn),
2007-2008 105
Table 76: Wound Closure Devices, United States, Revenue
($ mn) by Segment, Historic, 2000-2008 107
Table 77: Wound Closure
Devices, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 109
Table 78: Wound Closure Devices, United States, Volume (Units) by
Segment, Historic, 2000-2008 110
Table 79: Wound Closure Devices,
United States, Volume (Units) by Segment, Forecast, 2008-2015 111
Table
80: Wound Closure Devices, United States, Average Price ($), Historic,
2000-2008 112
Table 81: Wound Closure Devices, United States, Average
Price ($), Forecast, 2008-2015 112
Table 82: Wound Closure Devices,
United States, Distribution Share by Revenue ($mn), 2007-2008 113
Table
83: Wound Closure Devices, United States, Company Share by Revenue ($
mn), 2007-2008 114
Table 84: Smith & Nephew Plc Pipeline Products by
Equipment Type 115
Table 85: Smith & Nephew Plc Pipeline Products By
Development Stage 116
Table 86: Smith & Nephew Plc Pipeline Products
By Therapy Area 117
Table 87: Smith & Nephew Plc Pipeline Products By
News Summary 117
Table 88: Kinetic Concepts, Inc. Pipeline Products
by Equipment Type 118
Table 89: Kinetic Concepts, Inc. Pipeline
Products By Development Stage 119
Table 90: Kinetic Concepts, Inc.
Pipeline Products By Therapy Area 119
Table 91: Kinetic Concepts,
Inc. Pipeline Products By Clinical Trials 119
Table 92: Kinetic
Concepts, Inc. Pipeline Products By News Summary 119
Table 93:
Covidien Ltd./Tyco Healthcare Pipeline Products by Equipment Type 121
Table 94: Covidien Ltd./Tyco Healthcare Pipeline Products By Development
Stage 121
Table 95: Covidien Ltd./Tyco Healthcare Pipeline Products
By Therapy Area 121
Table 96: Covidien Ltd./Tyco Healthcare Pipeline
Products By Clinical Trials 122
Table 97: Covidien Ltd./Tyco
Healthcare Pipeline Products By News Summary 122
Table 98: Advanced
Medical Solutions Group plc Pipeline Products by Equipment Type 130
Table
99: Advanced Medical Solutions Group plc Pipeline Products By Development
Stage 130
Table 100: Advanced Medical Solutions Group plc Pipeline
Products By Therapy Area 131
Table 101: Lifecore Biomedical, Inc.
Pipeline Products by Equipment Type 132
Table 102: Lifecore
Biomedical, Inc. Pipeline Products By Development Stage 132
Table 103:
Lifecore Biomedical, Inc. Pipeline Products By Therapy Area 132
Table
104: Lifecore Biomedical, Inc. Pipeline Products By News Summary 132
Table 105: Forticell Bioscience, Inc. Pipeline Products by Equipment Type
133
Table 106: Forticell Bioscience, Inc. Pipeline Products By
Development Stage 133
Table 107: Forticell Bioscience, Inc. Pipeline
Products By Therapy Area 134
Table 108: Forticell Bioscience, Inc.
Pipeline Products By Clinical Trials 134
Table 109: Forticell
Bioscience, Inc. Pipeline Products By News Summary 134
Table 110:
FzioMed, Inc. Pipeline Products by Equipment Type 135
Table 111:
FzioMed, Inc. Pipeline Products By Development Stage 135
Table 112:
FzioMed, Inc. Pipeline Products By Therapy Area 136
Table 113:
FzioMed, Inc. Pipeline Products By Clinical Trials 136
Table 114:
FzioMed, Inc. Pipeline Products By News Summary 136
Table 115:
KeraCure, Inc. Pipeline Products by Equipment Type 137
Table 116:
KeraCure, Inc. Pipeline Products By Development Stage 137
Table 117:
KeraCure, Inc. Pipeline Products By Therapy Area 137
Table 118:
KeraCure, Inc. Pipeline Products By Clinical Trials 138
Table 119:
KeraCure, Inc. Pipeline Products By News Summary 138
Table 120:
Synovis Life Technologies Completes Acquisition Of Pegasus Biologics 139
Table 121: SpongeTech Delivery Systems Acquires Dicon Technologies
140
Table 122: United EcoEnergy Completes Acquisition Of Epic Wound
Care 141
Table 123: The Dow Chemical Company Acquires Rohm and Haas
142
Table 124: Applied Nanoscience Terminates Acquisition Of
Emergency Filtration Products 144
Table 125: Moog Acquires Ethox
International 145
Table 126: Bio Med Sciences Terminates Its
Acquisition By ULURU 146
Table 127: Integra LifeSciences Holdings
Signs Licensing Agreement With Organogenesis 147
Table 128: ELMARCO
Enters Into An Agreement With HemCon Medical Technologies 148
Table 129:
ConvaTec Enters Into An Agreement With HemCon Medical Technologies 149
Table 130: ACell Signs An Agreement With Medline Industries 150
Table
131: HyperBranch Medical Technology Enters Into An Agreement With BD
151
Table 132: USD to Local Currency, Average Exchange Rate 2008 171
1.2 List of Figures
Figure 1: United States, Healthcare Expenditure
by Source, 2007 23
Figure 2: Healthcare Expenses Segmentation by End User,
2007 24
Figure 3: United States, Healthcare Infrastructure, Top Level
View, 2007 26
Figure 4: Medical Equipment Approval Process in the United
States, 2007 34
Figure 5: PMA Approval Process in the United States, 2007
36
Figure 6: The 510(k) Approval Process for Medical Devices in the United
States, 2007 37
Figure 7: Reimbursement Structure in the United States,
2007 42
Figure 8: Distribution Structure of Medical Equipment in the
United States, 2007 43
Figure 9: Wound Care Management, Cross Country
Comparison, Revenue ($ mn), 2000-2015 44
Figure 10: Wound Care
Management, United States, Overall Revenue ($ mn), 2000-2015 46
Figure 11:
Wound Care Management, United States, Cross-Category Analysis, 2000-2015
47
Figure 12: Wound Care Management, United States, Overall Revenue
($ mn), Historic, 2000-2008 48
Figure 13: Wound Care Management,
United States, Overall Revenue ($ mn), Forecast, 2008-2015 50
Figure 14:
Wound Care Management, United States, Category Volume (Units), 2000-2015
52
Figure 15: Wound Care Management, United States, Category Volume
(Units), Historic, 2000-2008 53
Figure 16: Wound Care Management,
United States, Category Volume (Units), Forecast, 2008-2015 55
Figure 17:
Wound Care Management, United States, Company Share (%), 2008 57
Figure 18: Advanced Wound Management, United States, Revenue ($ mn) by
Segment, Historic, 2000-2008 58
Figure 19: Advanced Wound Management,
United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 60
Figure
20: Advanced Wound Management, United States, Volume (Units) by Segment,
Historic, 2000-2008 62
Figure 21: Advanced Wound Management, United
States, Volume (Units) by Segment, Forecast, 2008-2015 64
Figure 22:
Advanced Wound Management, United States, Company Share (%), 2008 68
Figure 23: Compression Therapy, United States, Revenue ($ mn) by Segment,
Historic, 2000-2008 70
Figure 24: Compression Therapy, United States,
Revenue ($ mn) by Segment, Forecast, 2008-2015 71
Figure 25: Dynamic
Compression Therapy, United States, Revenue ($ mn) by Sub-Segment, Historic,
2000-2008 72
Figure 26: Dynamic Compression Therapy, United States,
Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 73
Figure 27:
Dynamic Compression Therapy, United States, Volume (Units) by Sub-Segment,
Historic, 2000-2008 75
Figure 28: Dynamic Compression Therapy, United
States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 76
Figure 29:
Compression Therapy, United States, Company Share (%), 2008 79
Figure
30: Negative Pressure Wound Therapy (NPWT), United States, Revenue ($ mn)
by Segment, Historic, 2000-2008 80
Figure 31: Negative Pressure Wound
Therapy (NPWT), United States, Revenue ($ mn) by Segment, Forecast, 2008-2015
81
Figure 32: Negative Pressure Wound Therapy (NPWT), United States,
Company Share (%), 2008 85
Figure 33: Ostomy Drainage Bags, United
States, Revenue ($ mn) by Segment, Historic, 2000-2008 86
Figure 34:
Ostomy Drainage Bags, United States, Revenue ($ mn) by Segment, Forecast,
2008-2015 87
Figure 35: Ostomy Drainage Bags, United States, Volume
(Units) by Segment, Historic, 2000-2008 88
Figure 36: Ostomy Drainage
Bags, United States, Volume (Units) by Segment, Forecast, 2008-2015 89
Figure 37: Ostomy Drainage Bags, United States, Company Share (%), 2008
92
Figure 38: Pressure Relief Devices, United States, Revenue ($ mn)
by Segment, Historic, 2000-2008 93
Figure 39: Pressure Relief
Devices, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 94
Figure 40: Pressure Relief Devices, United States, Company Share (%),
2008 98
Figure 41: Traditional Wound Management, United States,
Revenue ($ mn), Historic, 2000-2008 99
Figure 42: Traditional Wound
Management, United States, Revenue ($ mn), Forecast, 2008-2015 100
Figure
43: Traditional Wound Management, United States, Volume (Units),
Historic, 2000-2008 101
Figure 44: Traditional Wound Management,
United States, Volume (Units), Forecast, 2008-2015 102
Figure 45:
Traditional Wound Management, United States, Company Share (%), 2008 105
Figure 46: Wound Closure Devices, United States, Revenue ($ mn) by
Segment, Historic, 2000-2008 106
Figure 47: Wound Closure Devices,
United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 108
Figure
48: Wound Closure Devices, United States, Volume (Units) by Segment,
Historic, 2000-2008 110
Figure 49: Wound Closure Devices, United
States, Volume (Units) by Segment, Forecast, 2008-2015 111
Figure 50:
Wound Closure Devices, United States, Company Share (%), 2008 114
Figure
51: Global Markets Direct Methodology 168
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