Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 10
2 Introduction 11
2.1 What Is This Report About? 11
3 Definitions of
the Markets Covered in the Report 12
3.1 Ophthalmic Devices 12
3.2
Cataract Surgery 12
3.2.1 Phacoemulsification Equipment 12
3.2.2 Intra
Ocular Lens 12
3.3 Vision Care 12
3.3.1 Ophthalmoscopes 12
3.3.2
Contact lenses 12
3.3.3 Lens care 13
3.3.4 Ophthalmic lens 13
3.3.5 Rigid Gas Permeable Contact Lenses 13
3.4 Refractive Surgery 13
4 Healthcare Sector Review 14
4.1 Healthcare Expenditure 14
4.2
Healthcare Infrastructure 19
4.2.1 Healthcare Personnel Data 21
4.2.2
Healthcare Facilities Data 24
4.3 United States Healthcare Trade
Statistics 26
5 Regulation System 27
5.1 Regulation System 27
5.2
Medical Equipment Approval Process 27
5.2.1 Pre-market Approval Process
28
5.2.2 Intended use and Indications for use 28
5.2.3 Predicate
Device 29
5.2.4 Safe and Effective 29
5.2.5 Other Category Devices
31
5.2.6 Post-Market Approval Process 32
5.2.7 Compliance and
Enforcement 32
5.2.8 Registration Fee 33
5.2.9 Approval Time 33
6
Pricing and Reimbursement 34
6.1 Government Policies 34
6.2 Private
Insurance 35
6.3 Diagnosis Related Groups (DRG) 36
7 Distribution
Structure 37
7.1 Distribution Structure 37
8 Ophthalmic Devices In
United States 38
8.1 Ophthalmic Devices Cross Country Comparison, Revenue
($ mn), 2000-2015 38
8.2 Ophthalmic Devices, United States, Overall
Revenue ($ mn), 2000-2015 39
8.3 Ophthalmic Devices, United States,
Overall Volume (Units), 2000-2015 42
8.4 Ophthalmic Devices, United States
Company Share (2006-2007) 44
9 Cataract Surgery In United States 45
9.1 Cataract Surgery Overall Revenue (2000-2015) 45
9.2 Cataract Surgery
Overall Volume (2000-2015) 47
9.3 Cataract Surgery Average Price
(2000-2015) 48
9.4 Cataract Surgery Distribution Share (2007-2008) 49
9.5 Cataract Surgery, United States, Company Share (2006-2007) 50
10
Refractive Surgery In United States 51
10.1 Refractive Surgery Overall
Revenue (2000-2015) 51
10.2 Refractive Surgery Overall Volume (2000-2015)
53
10.3 Refractive Surgery Average Price (2000-2015) 55
10.4
Refractive Surgery Distribution Share (2007-2008) 56
10.5 Refractive
Surgery, United States, Company Share (2006-2007) 57
11 Vision Care In
United States 58
11.1 Vision Care Overall Revenue (2000-2015) 58
11.2
Vision Care Overall Volume (2000-2015) 61
11.3 Vision Care Average Price
(2000-2015) 63
11.4 Vision Care Distribution Share (2007-2008) 64
11.5
Vision Care, United States, Company Share (2006-2007) 65
12 Overview of
Key Companies in United States Ophthalmic Devices Market 66
12.1 Johnson &
Johnson Vision Care, Inc. Company Profile 66
12.1.1 Company Overview
66
12.2 Essilor International Company Profile 67
12.2.1 Company
Overview 67
12.2.2 Value Chain Analysis 67
12.3 CIBA Vision
Corporation Company Profile 69
12.3.1 Company Overview 69
12.3.2 CIBA
Vision Corporation Pipeline Products 69
12.4 Bausch & Lomb Incorporated
Company Profile 71
12.4.1 Company Overview 71
12.4.2 Value Chain
Analysis 71
12.4.3 Bausch & Lomb Incorporated Pipeline Products 74
12.5 Alcon, Inc. Company Profile 76
12.5.1 Company Overview 76
12.5.2
Value Chain Analysis 76
12.5.3 Alcon, Inc. Pipeline Products 79
12.6
Advanced Medical Optics, Inc. Company Profile 81
12.6.1 Company Overview
81
12.6.2 Value Chain Analysis 81
12.6.3 Advanced Medical Optics, Inc.
Pipeline Products 83
12.7 AcuFocus, Inc. Company Profile 85
12.7.1
Company Overview 85
12.7.2 AcuFocus, Inc. Pipeline Products 85
12.8
Advanced Refractive Technologies, Inc. Company Profile 87
12.8.1 Company
Overview 87
12.8.2 Advanced Refractive Technologies, Inc. Pipeline
Products 87
12.9 Calhoun Vision, Inc. Company Profile 89
12.9.1
Company Overview 89
12.9.2 Calhoun Vision, Inc. Pipeline Products 89
12.10 CooperVision, Inc. Company Profile 91
12.10.1 Company Overview
91
12.10.2 CooperVision, Inc. Pipeline Products 91
12.11 Medennium
Inc. Company Profile 93
12.11.1 Company Overview 93
12.11.2 Medennium
Inc. Pipeline Products 93
12.12 The Cooper Companies, Inc. Company Profile
94
12.12.1 Company Overview 94
12.12.2 Value Chain Analysis 94
12.13 VisionCare Ophthalmic Technologies, Inc. Company Profile 97
12.13.1
Company Overview 97
12.13.2 VisionCare Ophthalmic Technologies, Inc.
Pipeline Products 97
13 Financial Deals Landscape 99
13.1 Acquisition
99
13.1.1 National Vision Acquires Eyeglass World Chain from Vision Care
Holdings 99
13.1.2 Abbott Laboratories Receives US Antitrust Clearance To
Acquire Advanced Medical Optics 100
13.1.3 Unilens Vision Acquires Aero
Contact Lens 102
13.1.4 NovaMed Acquires Majority Interest In Physicians
Surgical Center 103
13.1.5 Ken Martin and Tom Olson Acquire Jims Optical
104
14 Recent Developments 105
14.1 Strategy and Business Planning
105
14.1.1 Dec 09, 2008: Unilens Acquires Aero Contact 105
14.2 Legal
and Regulatory 105
14.2.1 Jan 21, 2009: Levi & Korsinsky Files Class
Action Lawsuit Against AMO 105
14.2.2 Dec 22, 2008: Schmidt Files Class
Action Lawsuit Against AMO For Falsely Advertising Contact Lens Solution
106
14.3 Government and Public Interest 106
14.3.1 Feb 06, 2009: FDA
May Tighten Test Standards For Contact Lenses, Solution 106
14.4 Product
Approvals 107
14.4.1 Jan 16, 2009: TECNIS Multifocal Intraocular Lens
Receives FDA Approval 107
14.4.2 Dec 23, 2008: Alcon Announces FDA
Approval For Its AcrySof IQ ReSTOR +3.0 D Intraocular Lens 107
14.4.3 Oct
07, 2008: Advanced Medical Optics Receives FDA Approval For Healon D
Viscoelastic For Ophthalmic Surgery 108
15 Appendix 109
15.1 Global
Markets Direct Research Methodology 109
15.2 Coverage 110
15.3
Secondary Research 110
15.4 Primary Research 111
15.5 Models 111
15.6 Forecasts 112
15.7 Expert Panels 112
15.8 Currency Conversion
113
15.9 Contact Us 114
15.10 Disclaimer 114
1.1 List of
Tables
Table 1: United States Healthcare Expenditure, 2003-2010 15
Table 2: United States Healthcare Expenditure by Age (per person), 2000-2003
16
Table 3: United States Healthcare Expenditure by Sex (per person),
2000-2003 16
Table 4: United States Healthcare Expenditure by Race (per
person), 2000-2003 17
Table 5: United States Personal Healthcare
Expenditure by Type, 2000-2004 17
Table 6: United States Personal
Healthcare Expenditure by Source, 2000-2004 18
Table 7: Total Number of
Doctors in the United States, 2003-2010 21
Table 8: Number of Doctors by
Specialty in the United States, 2003-2010 22
Table 9: Doctors by Region
(Number per 10,000 Civilian Population), 2002-2004 23
Table 10: Doctors by
Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 24
Table
11: Total Hospitals in the United States, 2000-2004 24
Table 12: Community
Hospitals by Number of Beds in the United States, 2000-2004 25
Table 13:
Number of Hospital Beds in the United States, 2000-2004 25
Table 14:
Number of Hospital Beds by Range in the United States, 2000-2004 25
Table
15: United States Healthcare Trade Statistics, 2001-2006 26
Table 16:
Medical Equipment Registration Fee in United States, 2007 33
Table 17:
Medical Device Approval Time in United States, 2004 33
Table 18:
Ophthalmic Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 38
Table 19: Ophthalmic Devices, United States, Overall Revenue ($ mn),
2000-2015 39
Table 20: Ophthalmic Devices, United States, Overall
Revenue ($ mn), Historic, 2000-2008 40
Table 21: Ophthalmic Devices,
United States, Overall Revenue ($ mn), Forecast, 2008-2015 41
Table 22:
Ophthalmic Devices, United States, Overall Volume (Units), 2000-2015 42
Table 23: Ophthalmic Devices, United States, Overall Volume (Units),
Historic, 2000-2008 42
Table 24: Ophthalmic Devices, United States,
Overall Volume (Units), Forecast, 2008-2015 43
Table 25: Ophthalmic
Devices, United States Company Share by Revenue ($ mn), 2006-2007 44
Table
26: Cataract Surgery, United States, Revenue ($ mn) by Segment, Historic,
2000-2008 45
Table 27: Cataract Surgery, United States, Revenue ($
mn) by Segment, Forecast, 2008-2015 46
Table 28: Cataract Surgery,
United States, Volume (Units) by Segment, Historic, 2000-2008 47
Table 29:
Cataract Surgery, United States, Volume (Units) by Segment, Forecast,
2008-2015 47
Table 30: Cataract Surgery, United States, Average Price
($), Historic, 2000-2008 48
Table 31: Cataract Surgery, United
States, Average Price ($), Forecast, 2008-2015 48
Table 32: Cataract
Surgery, United States, Distribution Share by Revenue ($mn), 2007-2008 49
Table 33: Cataract Surgery, United States, Company Share by Revenue ($
mn), 2006-2007 50
Table 34: Refractive Surgery, United States,
Revenue ($ mn), Historic, 2000-2008 51
Table 35: Refractive Surgery,
United States, Revenue ($ mn), Forecast, 2008-2015 52
Table 36:
Refractive Surgery, United States, Volume (Units), Historic, 2000-2008 53
Table 37: Refractive Surgery, United States, Volume (Units), Forecast,
2008-2015 54
Table 38: Refractive Surgery, United States, Average
Price ($), Historic, 2000-2008 55
Table 39: Refractive Surgery,
United States, Average Price ($), Forecast, 2008-2015 55
Table 40:
Refractive Surgery, United States, Distribution Share by Revenue ($mn),
2007-2008 56
Table 41: Refractive Surgery, United States, Company
Share by Revenue ($ mn), 2006-2007 57
Table 42: Vision Care, United
States, Revenue ($ mn) by Segment, Historic, 2000-2008 59
Table 43:
Vision Care, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015
60
Table 44: Vision Care, United States, Volume (Units) by Segment,
Historic, 2000-2008 61
Table 45: Vision Care, United States, Volume
(Units) by Segment, Forecast, 2008-2015 62
Table 46: Vision Care,
United States, Average Price ($), Historic, 2000-2008 63
Table 47:
Vision Care, United States, Average Price ($), Forecast, 2008-2015 63
Table 48: Vision Care, United States, Distribution Share by Revenue
($mn), 2007-2008 64
Table 49: Vision Care, United States, Company
Share by Revenue ($ mn), 2006-2007 65
Table 50: CIBA Vision
Corporation Pipeline Products by Equipment Type 69
Table 51: CIBA
Vision Corporation Pipeline Products by Development Stage 69
Table 52:
CIBA Vision Corporation Pipeline Products by Therapy Area 69
Table 53:
CIBA Vision Corporation Pipeline Products by Clinical Trials 70
Table
54: Bausch & Lomb Incorporated Pipeline Products by Equipment Type 74
Table 55: Bausch & Lomb Incorporated Pipeline Products by Development
Stage 74
Table 56: Bausch & Lomb Incorporated Pipeline Products by
Therapy Area 74
Table 57: Bausch & Lomb Incorporated Pipeline
Products by Clinical Trials 75
Table 58: Bausch & Lomb Incorporated
Pipeline Products by News Summaries 75
Table 59: Alcon, Inc. Pipeline
Products by Equipment Type 79
Table 60: Alcon, Inc. Pipeline Products
by Development Stage 79
Table 61: Alcon, Inc. Pipeline Products by
Therapy Area 80
Table 62: Alcon, Inc. Pipeline Products by Clinical
Trials 80
Table 63: Alcon, Inc. Pipeline Products by News Summaries
80
Table 64: Advanced Medical Optics, Inc. Pipeline Products by
Equipment Type 83
Table 65: Advanced Medical Optics, Inc. Pipeline
Products by Development Stage 83
Table 66: Advanced Medical Optics,
Inc. Pipeline Products by Therapy Area 84
Table 67: Advanced Medical
Optics, Inc. Pipeline Products by Clinical Trials 84
Table 68:
AcuFocus, Inc. Pipeline Products by Equipment Type 85
Table 69:
AcuFocus, Inc. Pipeline Products by Development Stage 85
Table 70:
AcuFocus, Inc. Pipeline Products by Therapy Area 85
Table 71:
AcuFocus, Inc. Pipeline Products by Clinical Trials 86
Table 72:
AcuFocus, Inc. Pipeline Products by News Summaries 86
Table 73:
Advanced Refractive Technologies, Inc. Pipeline Products by Equipment Type
87
Table 74: Advanced Refractive Technologies, Inc. Pipeline Products
by Development Stage 87
Table 75: Advanced Refractive Technologies,
Inc. Pipeline Products by Therapy Area 87
Table 76: Advanced
Refractive Technologies, Inc. Pipeline Products by News Summaries 88
Table
77: Calhoun Vision, Inc. Pipeline Products by Equipment Type 89
Table
78: Calhoun Vision, Inc. Pipeline Products by Development Stage 89
Table 79: Calhoun Vision, Inc. Pipeline Products by Therapy Area 89
Table 80: Calhoun Vision, Inc. Pipeline Products by News Summaries 90
Table 81: CooperVision, Inc. Pipeline Products by Equipment Type 91
Table 82: CooperVision, Inc. Pipeline Products by Development Stage
91
Table 83: CooperVision, Inc. Pipeline Products by Therapy Area
92
Table 84: Medennium Inc. Pipeline Products by Equipment Type
93
Table 85: Medennium Inc. Pipeline Products by Development Stage
93
Table 86: Medennium Inc. Pipeline Products by Therapy Area 93
Table 87: VisionCare Ophthalmic Technologies, Inc. Pipeline Products by
Equipment Type 97
Table 88: VisionCare Ophthalmic Technologies, Inc.
Pipeline Products by Development Stage 97
Table 89: VisionCare
Ophthalmic Technologies, Inc. Pipeline Products by Therapy Area 97
Table
90: VisionCare Ophthalmic Technologies, Inc. Pipeline Products by
Clinical Trials 98
Table 91: VisionCare Ophthalmic Technologies, Inc.
Pipeline Products by News Summaries 98
Table 92: National Vision
Acquires Eyeglass World Chain From Vision Care Holdings 99
Table 93:
Abbott Laboratories Receives US Antitrust Clearance To Acquire Advanced
Medical Optics 100
Table 94: Unilens Vision Acquires Aero Contact
Lens 102
Table 95: NovaMed Acquires Majority Interest In Physicians
Surgical Center 103
Table 96: Ken Martin And Tom Olson Acquire Jims
Optical 104
Table 97: Currency Conversion from USD to Local Currency at
2008 Constant Rate 113
1.2 List of Figures
Figure 1: United
States, Healthcare Expenditure by Source, 2003 15
Figure 2: United States,
Healthcare Infrastructure, Top Level View, 2007 20
Figure 3: Healthcare
Expenses Segmentation by End User, 2003 21
Figure 4: Medical Equipment
Approval Process in the United States, 2007 28
Figure 5: PMA Approval
Process in the United States, 2007 30
Figure 6: The 510(k) Approval
Process for Medical Devices in the United States, 2007 31
Figure 7:
Reimbursement Structure in the United States, 2007 36
Figure 8:
Distribution Structure of Medical Equipment in the United States, 2006 37
Figure 9: Ophthalmic Devices Cross Country Comparison, Revenue ($ mn),
2000-2015 38
Figure 10: Ophthalmic Devices, United States, Overall
Revenue ($ mn), 2000-2015 39
Figure 11: Ophthalmic Devices, United
States, Overall Revenue ($ mn), Historic, 2000-2008 40
Figure 12:
Ophthalmic Devices, United States, Overall Revenue ($ mn), Forecast, 2008-2015
41
Figure 13: Ophthalmic Devices, United States Company Share (%),
2007 44
Figure 14: Cataract Surgery, United States, Revenue ($ mn) by
Segment, Historic, 2000-2008 45
Figure 15: Cataract Surgery, United
States, Revenue ($ mn) by Segment, Forecast, 2008-2015 46
Figure 16:
Cataract Surgery, United States, Company Share (%), 2007 50
Figure 17:
Refractive Surgery, United States, Revenue ($ mn), Historic, 2000-2008 51
Figure 18: Refractive Surgery, United States, Revenue ($ mn), Forecast,
2008-2015 52
Figure 19: Refractive Surgery, United States, Volume
(Units), Historic, 2000-2008 53
Figure 20: Refractive Surgery, United
States, Volume (Units), Forecast, 2008-2015 54
Figure 21: Refractive
Surgery, United States, Company Share (%), 2007 57
Figure 22: Vision
Care, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 58
Figure 23: Vision Care, United States, Revenue ($ mn) by Segment,
Forecast, 2008-2015 60
Figure 24: Vision Care, United States, Volume
(Units) by Segment, Historic, 2000-2008 61
Figure 25: Vision Care,
United States, Volume (Units) by Segment, Forecast, 2008-2015 62
Figure
26: Vision Care, United States, Company Share (%), 2007 65
Figure 27:
Essilor International Value Chain Analysis 67
Figure 28: Bausch
& Lomb Incorporated Value Chain Analysis 71
Figure 29: Alcon, Inc.
Value Chain Analysis 76
Figure 30: Advanced Medical Optics, Inc.
Value Chain Analysis 81
Figure 31: The Cooper Companies, Inc. Value
Chain Analysis 94
Figure 32: Global Markets Direct Methodology 109
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