Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 11
2 Introduction 12
2.1 What Is This Report About? 12
3 Definitions of
the Markets Covered in the Report 13
3.1 Ophthalmic Devices 13
3.2
Cataract Surgery 13
3.2.1 Phacoemulsification Equipment 13
3.2.2 Intra
Ocular Lens 13
3.3 Vision Care 13
3.3.1 Ophthalmoscopes 13
3.3.2
Contact lenses 13
3.3.3 Ophthalmic lens 14
3.3.4 Rigid Gas Permeable
Contact Lenses 14
3.4 Refractive Surgery 14
4 Healthcare Sector Review
15
4.1 Healthcare Expenditure 15
4.2 Healthcare Infrastructure 20
4.2.1 Healthcare Personnel Data 22
4.2.2 Healthcare Facilities Data 25
4.3 United States Healthcare Trade Statistics 27
5 Regulation System
28
5.1 Regulation System 28
5.2 Medical Equipment Approval Process
28
5.2.1 Pre-market Approval Process 29
5.2.2 Intended use and
Indications for use 29
5.2.3 Predicate Device 30
5.2.4 Safe and
Effective 30
5.2.5 Other Category Devices 32
5.2.6 Post-Market
Approval Process 33
5.2.7 Compliance and Enforcement 33
5.2.8
Registration Fee 34
5.2.9 Approval Time 34
6 Pricing and Reimbursement
35
6.1 Government Policies 35
6.2 Private Insurance 36
6.3
Diagnosis Related Groups (DRG) 37
7 Distribution Structure 38
7.1
Distribution Structure 38
8 Ophthalmic Devices In United States 39
8.1
Ophthalmic Devices Cross Segment Comparison, Revenue ($ m), 2000-2015 39
8.2 Ophthalmic Devices, United States Company Share (2006-2007) 43
9
Cataract Surgery In United States 44
9.1 Cataract Surgery Overall Revenue
(2000-2015) 44
9.2 Cataract Surgery Overall Volume (2000-2015) 46
9.3
Cataract Surgery Average Price (2000-2015) 47
9.4 Cataract Surgery Market
Trend Analysis 47
9.4.1 Market Drivers 47
9.4.2 Market Restraints
48
9.5 Cataract Surgery Distribution Share (2007-2008) 48
9.6 Cataract
Surgery, United States, Company Share (2006-2007) 49
10 Refractive Surgery
In United States 50
10.1 Refractive Surgery Overall Revenue (2000-2015)
50
10.2 Refractive Surgery Overall Volume (2000-2015) 52
10.3
Refractive Surgery Average Price (2000-2015) 54
10.4 Refractive Surgery
Market Trend Analysis 54
10.4.1 Market Drivers 54
10.4.2 Market
Restraints 55
10.5 Refractive Surgery Distribution Share (2007-2008)
55
10.6 Refractive Surgery, United States, Company Share (2006-2007)
56
11 Vision Care In United States 57
11.1 Vision Care Overall Revenue
(2000-2015) 57
11.2 Vision Care Overall Volume (2000-2015) 61
11.3
Vision Care Average Price (2000-2015) 64
11.4 Vision Care Market Trend
Analysis 65
11.4.1 Market Drivers 65
11.4.2 Market Restraints 65
11.5 Vision Care Distribution Share (2007-2008) 65
11.6 Vision Care,
United States, Company Share (2006-2007) 66
12 Overview of Key Companies
in United States Ophthalmic Devices Market 67
12.1 Johnson & Johnson
Vision Care, Inc. Company Profile 67
12.1.1 Company Overview 67
12.2
Essilor International Company Profile 68
12.2.1 Company Overview 68
12.2.2 Value Chain Analysis 68
12.3 CIBA Vision Corporation Company
Profile 70
12.3.1 Company Overview 70
12.3.2 CIBA Vision Corporation
Pipeline Products 70
12.4 Bausch & Lomb Incorporated Company Profile
72
12.4.1 Company Overview 72
12.4.2 Value Chain Analysis 72
12.4.3 Bausch & Lomb Incorporated Pipeline Products 75
12.5 Alcon, Inc.
Company Profile 77
12.5.1 Company Overview 77
12.5.2 Value Chain
Analysis 77
12.5.3 Alcon, Inc. Pipeline Products 80
12.6 Advanced
Medical Optics, Inc. Company Profile 82
12.6.1 Company Overview 82
12.6.2 Value Chain Analysis 82
12.6.3 Advanced Medical Optics, Inc.
Pipeline Products 84
12.7 AcuFocus, Inc. Company Profile 86
12.7.1
Company Overview 86
12.7.2 AcuFocus, Inc. Pipeline Products 86
12.8
Advanced Refractive Technologies, Inc. Company Profile 88
12.8.1 Company
Overview 88
12.8.2 Advanced Refractive Technologies, Inc. Pipeline
Products 88
12.9 Calhoun Vision, Inc. Company Profile 90
12.9.1
Company Overview 90
12.9.2 Calhoun Vision, Inc. Pipeline Products 90
12.10 CooperVision, Inc. Company Profile 92
12.10.1 Company Overview
92
12.10.2 CooperVision, Inc. Pipeline Products 92
12.11 Medennium
Inc. Company Profile 94
12.11.1 Company Overview 94
12.11.2 Medennium
Inc. Pipeline Products 94
12.12 The Cooper Companies, Inc. Company Profile
95
12.12.1 Company Overview 95
12.12.2 Value Chain Analysis 95
12.13 VisionCare Ophthalmic Technologies, Inc. Company Profile 98
12.13.1
Company Overview 98
12.13.2 VisionCare Ophthalmic Technologies, Inc.
Pipeline Products 98
13 Financial Deals Landscape 100
13.1 Acquisition
100
13.1.1 National Vision Acquires Eyeglass World Chain from Vision Care
Holdings 100
13.1.2 Abbott Laboratories Receives US Antitrust Clearance To
Acquire Advanced Medical Optics 101
13.1.3 Unilens Vision Acquires Aero
Contact Lens 103
13.1.4 NovaMed Acquires Majority Interest In Physicians
Surgical Center 104
13.1.5 Ken Martin and Tom Olson Acquire Jims Optical
105
14 Recent Developments 106
14.1 Strategy and Business Planning
106
14.1.1 Dec 09, 2008: Unilens Acquires Aero Contact 106
14.2 Legal
and Regulatory 106
14.2.1 Jan 21, 2009: Levi & Korsinsky Files Class
Action Lawsuit Against AMO 106
14.2.2 Dec 22, 2008: Schmidt Files Class
Action Lawsuit Against AMO For Falsely Advertising Contact Lens Solution
107
14.3 Government and Public Interest 107
14.3.1 Feb 06, 2009: FDA
May Tighten Test Standards For Contact Lenses, Solution 107
14.4 Product
Approvals 108
14.4.1 Jan 16, 2009: TECNIS Multifocal Intraocular Lens
Receives FDA Approval 108
14.4.2 Dec 23, 2008: Alcon Announces FDA
Approval For Its AcrySof IQ ReSTOR +3.0 D Intraocular Lens 109
14.4.3 Oct
07, 2008: Advanced Medical Optics Receives FDA Approval For Healon D
Viscoelastic For Ophthalmic Surgery 109
15 Appendix 110
15.1
GlobalData Research Methodology 110
15.2 Coverage 111
15.3 Secondary
Research 111
15.4 Primary Research 112
15.5 Models 112
15.6
Forecasts 113
15.7 Expert Panel 113
15.8 Currency Conversion 114
15.9 Contact Us 115
15.10 Disclaimer 115
1 Table of Contents
2
1.1 List of Tables 8
1.2 List of Figures 11
2 Introduction
12
2.1 What Is This Report About? 12
3 Definitions of the Markets
Covered in the Report 13
3.1 Ophthalmic Devices 13
3.2 Cataract
Surgery 13
3.2.1 Phacoemulsification Equipment 13
3.2.2 Intra Ocular
Lens 13
3.3 Vision Care 13
3.3.1 Ophthalmoscopes 13
3.3.2 Contact
lenses 13
3.3.3 Ophthalmic lens 14
3.3.4 Rigid Gas Permeable Contact
Lenses 14
3.4 Refractive Surgery 14
4 Healthcare Sector Review 15
4.1 Healthcare Expenditure 15
4.2 Healthcare Infrastructure 20
4.2.1
Healthcare Personnel Data 22
4.2.2 Healthcare Facilities Data 25
4.3
United States Healthcare Trade Statistics 27
5 Regulation System 28
5.1 Regulation System 28
5.2 Medical Equipment Approval Process 28
5.2.1 Pre-market Approval Process 29
5.2.2 Intended use and Indications
for use 29
5.2.3 Predicate Device 30
5.2.4 Safe and Effective 30
5.2.5 Other Category Devices 32
5.2.6 Post-Market Approval Process 33
5.2.7 Compliance and Enforcement 33
5.2.8 Registration Fee 34
5.2.9
Approval Time 34
6 Pricing and Reimbursement 35
6.1 Government
Policies 35
6.2 Private Insurance 36
6.3 Diagnosis Related Groups
(DRG) 37
7 Distribution Structure 38
7.1 Distribution Structure 38
8 Ophthalmic Devices In United States 39
8.1 Ophthalmic Devices Cross
Segment Comparison, Revenue ($ m), 2000-2015 39
8.2 Ophthalmic Devices,
United States Company Share (2006-2007) 43
9 Cataract Surgery In United
States 44
9.1 Cataract Surgery Overall Revenue (2000-2015) 44
9.2
Cataract Surgery Overall Volume (2000-2015) 46
9.3 Cataract Surgery
Average Price (2000-2015) 47
9.4 Cataract Surgery Market Trend Analysis
47
9.4.1 Market Drivers 47
9.4.2 Market Restraints 48
9.5 Cataract
Surgery Distribution Share (2007-2008) 48
9.6 Cataract Surgery, United
States, Company Share (2006-2007) 49
10 Refractive Surgery In United
States 50
10.1 Refractive Surgery Overall Revenue (2000-2015) 50
10.2
Refractive Surgery Overall Volume (2000-2015) 52
10.3 Refractive Surgery
Average Price (2000-2015) 54
10.4 Refractive Surgery Market Trend Analysis
54
10.4.1 Market Drivers 54
10.4.2 Market Restraints 55
10.5
Refractive Surgery Distribution Share (2007-2008) 55
10.6 Refractive
Surgery, United States, Company Share (2006-2007) 56
11 Vision Care In
United States 57
11.1 Vision Care Overall Revenue (2000-2015) 57
11.2
Vision Care Overall Volume (2000-2015) 61
11.3 Vision Care Average Price
(2000-2015) 64
11.4 Vision Care Market Trend Analysis 65
11.4.1 Market
Drivers 65
11.4.2 Market Restraints 65
11.5 Vision Care Distribution
Share (2007-2008) 65
11.6 Vision Care, United States, Company Share
(2006-2007) 66
12 Overview of Key Companies in United States Ophthalmic
Devices Market 67
12.1 Johnson & Johnson Vision Care, Inc. Company Profile
67
12.1.1 Company Overview 67
12.2 Essilor International Company
Profile 68
12.2.1 Company Overview 68
12.2.2 Value Chain Analysis
68
12.3 CIBA Vision Corporation Company Profile 70
12.3.1 Company
Overview 70
12.3.2 CIBA Vision Corporation Pipeline Products 70
12.4
Bausch & Lomb Incorporated Company Profile 72
12.4.1 Company Overview
72
12.4.2 Value Chain Analysis 72
12.4.3 Bausch & Lomb Incorporated
Pipeline Products 75
12.5 Alcon, Inc. Company Profile 77
12.5.1
Company Overview 77
12.5.2 Value Chain Analysis 77
12.5.3 Alcon, Inc.
Pipeline Products 80
12.6 Advanced Medical Optics, Inc. Company Profile
82
12.6.1 Company Overview 82
12.6.2 Value Chain Analysis 82
12.6.3 Advanced Medical Optics, Inc. Pipeline Products 84
12.7 AcuFocus,
Inc. Company Profile 86
12.7.1 Company Overview 86
12.7.2 AcuFocus,
Inc. Pipeline Products 86
12.8 Advanced Refractive Technologies, Inc.
Company Profile 88
12.8.1 Company Overview 88
12.8.2 Advanced
Refractive Technologies, Inc. Pipeline Products 88
12.9 Calhoun Vision,
Inc. Company Profile 90
12.9.1 Company Overview 90
12.9.2 Calhoun
Vision, Inc. Pipeline Products 90
12.10 CooperVision, Inc. Company Profile
92
12.10.1 Company Overview 92
12.10.2 CooperVision, Inc. Pipeline
Products 92
12.11 Medennium Inc. Company Profile 94
12.11.1 Company
Overview 94
12.11.2 Medennium Inc. Pipeline Products 94
12.12 The
Cooper Companies, Inc. Company Profile 95
12.12.1 Company Overview 95
12.12.2 Value Chain Analysis 95
12.13 VisionCare Ophthalmic Technologies,
Inc. Company Profile 98
12.13.1 Company Overview 98
12.13.2 VisionCare
Ophthalmic Technologies, Inc. Pipeline Products 98
13 Financial Deals
Landscape 100
13.1 Acquisition 100
13.1.1 National Vision Acquires
Eyeglass World Chain from Vision Care Holdings 100
13.1.2 Abbott
Laboratories Receives US Antitrust Clearance To Acquire Advanced Medical
Optics 101
13.1.3 Unilens Vision Acquires Aero Contact Lens 103
13.1.4
NovaMed Acquires Majority Interest In Physicians Surgical Center 104
13.1.5 Ken Martin and Tom Olson Acquire Jims Optical 105
14 Recent
Developments 106
14.1 Strategy and Business Planning 106
14.1.1 Dec
09, 2008: Unilens Acquires Aero Contact 106
14.2 Legal and Regulatory
106
14.2.1 Jan 21, 2009: Levi & Korsinsky Files Class Action Lawsuit
Against AMO 106
14.2.2 Dec 22, 2008: Schmidt Files Class Action Lawsuit
Against AMO For Falsely Advertising Contact Lens Solution 107
14.3
Government and Public Interest 107
14.3.1 Feb 06, 2009: FDA May Tighten
Test Standards For Contact Lenses, Solution 107
14.4 Product Approvals
108
14.4.1 Jan 16, 2009: TECNIS Multifocal Intraocular Lens Receives FDA
Approval 108
14.4.2 Dec 23, 2008: Alcon Announces FDA Approval For Its
AcrySof IQ ReSTOR +3.0 D Intraocular Lens 109
14.4.3 Oct 07, 2008:
Advanced Medical Optics Receives FDA Approval For Healon D Viscoelastic For
Ophthalmic Surgery 109
15 Appendix 110
15.1 GlobalData Research
Methodology 110
15.2 Coverage 111
15.3 Secondary Research 111
15.4
Primary Research 112
15.5 Models 112
15.6 Forecasts 113
15.7
Expert Panel 113
15.8 Currency Conversion 114
15.9 Contact Us 115
15.10 Disclaimer 115
1.2 List of Figures
Figure 1: United States,
Healthcare Expenditure by Source, 2003 16
Figure 2: United States,
Healthcare Infrastructure, Top Level View, 2007 21
Figure 3: Healthcare
Expenses Segmentation by End User, 2003 22
Figure 4: Medical Equipment
Approval Process in the United States, 2007 29
Figure 5: PMA Approval
Process in the United States, 2007 31
Figure 6: The 510(k) Approval
Process for Medical Devices in the United States, 2007 32
Figure 7:
Reimbursement Structure in the United States, 2007 37
Figure 8:
Distribution Structure of Medical Equipment in the United States, 2006 38
Figure 9: Ophthalmic Devices, United States, Overall Revenue ($ mn),
Historic, 2000-2008 39
Figure 10: Ophthalmic Devices, United States,
Overall Revenue ($ mn), Forecast, 2008-2015 41
Figure 11: Ophthalmic
Devices, United States Company Share (%), 2007 43
Figure 12: Cataract
Surgery, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 44
Figure 13: Cataract Surgery, United States, Revenue ($ mn) by Segment,
Forecast, 2008-2015 45
Figure 14: Cataract Surgery, United States,
Company Share (%), 2007 49
Figure 15: Refractive Surgery, United
States, Revenue ($ mn), Historic, 2000-2008 50
Figure 16: Refractive
Surgery, United States, Revenue ($ mn), Forecast, 2008-2015 51
Figure 17:
Refractive Surgery, United States, Volume (Units), Historic, 2000-2008
52
Figure 18: Refractive Surgery, United States, Volume (Units),
Forecast, 2008-2015 53
Figure 19: Refractive Surgery, United States,
Company Share (%), 2007 56
Figure 20: Vision Care, United States,
Revenue ($ mn) by Segment, Historic, 2000-2008 57
Figure 21: Vision
Care, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 59
Figure 22: Vision Care, United States, Volume (Units) by Segment,
Historic, 2000-2008 61
Figure 23: Vision Care, United States, Volume
(Units) by Segment, Forecast, 2008-2015 63
Figure 24: Vision Care,
United States, Company Share (%), 2007 66
Figure 25: Essilor
International Value Chain Analysis 68
Figure 26: Bausch & Lomb
Incorporated Value Chain Analysis 72
Figure 27: Alcon, Inc. Value
Chain Analysis 77
Figure 28: Advanced Medical Optics, Inc. Value
Chain Analysis 82
Figure 29: The Cooper Companies, Inc. Value Chain
Analysis 95
Figure 30: GlobalData Methodology 110
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