OPHTHALMIC DEVICES, DIAGNOSTICS AND SURGICAL EQUIPMENT: GLOBAL MARKETS. HLC083B April Melissa Elder Project Analyst ISBN:

Transcription

1 OPHTHALMIC DEVICES, DIAGNOSTICS AND SURGICAL EQUIPMENT: GLOBAL MARKETS HLC083B April 2013 Melissa Elder Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA , Custom Reports: carol.laverty@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY GOALS AND OBJECTIVES 2 REASONS FOR DOING THE STUDY 2 SCOPE AND FORMAT 2 METHODOLOGY 3 RELATED BCC REPORTS 3 ANALYST CREDENTIALS 3 BCC ON-LINE SERVICES 4 DISCLAIMER 4 CHAPTER 2 SUMMARY 6 OPHTHALMIC MARKET: MAJOR MARKETS SUMMARY 6 SUMMARY TABLE TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, THROUGH 2017 ($ SUMMARY FIGURE TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, ($ LEADING MANUFACTURERS CHAPTER 3 INDUSTRY OVERVIEW 10 OVERVIEW OF VISION 10 STRUCTURE OF THE EYE 10 PATHOLOGY OF VISION 11 TERMINOLOGY 12 TABLE 1 GLOSSARY OF TERMS USED IN OPHTHALMOLOGY 12 EYE TREATMENT SPECIALISTS 18 OPHTHALMOLOGIST 18 OPTOMETRIST 19 OPTICIAN 19 BLINDNESS: A GLOBAL PROBLEM 19 FIGURE 1 HEALTH INSURANCE AND USE OF EYE CARE SERVICES, U.S. VERSUS CANADA (%) DESCRIPTION OF OPHTHALMIC CONDITIONS AND DISEASES 20 DIABETIC RETINOPATHY 20 AGE-RELATED MACULAR DEGENERATION 21 OCULAR ALLERGIES 22 HERPES SIMPLEX VIRUS KERATITIS 22 CYTOMEGALOVIRUS RETINITIS 22 CATARACTS 23 GLAUCOMA 23 TABLE 2 GLAUCOMA TYPES AND KEY POINTS 23 UVEITIS 24 TABLE 3 KNOWN CAUSES OF UVEITIS 25 TRACHOMA 25 RETINAL DETACHMENT 26 DRY EYE SYNDROME 26 STRABISMUS 27 20

3 TABLE 4 STRABISMUS TYPES AND RELATED CATEGORIES 27 OCULAR MUSCLE SPASMS 28 U.S. EYE DISEASE AND CONDITION STATISTICS 29 TABLE 5 ESTIMATED U.S. INCIDENCE AND PREVALENCE OF SELECTED EYE CONDITIONS AND DISEASES, 2012 DATA GLAUCOMA 30 TABLE 6 PROJECTIONS FOR GLAUCOMA IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 2 PROJECTIONS FOR GLAUCOMA IN THE UNITED STATES BY RACE, (NO. OF CASES) CATARACTS 31 TABLE 7 PROJECTIONS FOR CATARACTS IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 3 PROJECTIONS FOR CATARACTS IN THE UNITED STATES BY RACE, (NO. OF CASES) AGE-RELATED MACULAR DEGENERATION 32 TABLE 8 PROJECTIONS FOR AGE-RELATED MACULAR DEGENERATION (AMD) IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 4 PROJECTIONS FOR AGE-RELATED MACULAR DEGENERATION (AMD) IN THE UNITED STATES BY RACE, (NO. OF CASES) DIABETIC RETINOPATHY 33 TABLE 9 PROJECTIONS FOR DIABETIC RETINOPATHY IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 5 PROJECTIONS FOR DIABETIC RETINOPATHY IN THE UNITED STATES BY RACE, (NO. OF CASES) OCULAR ALLERGIES 34 CYTOMEGALOVIRUS 34 HERPES SIMPLEX VIRUS KERATITIS 35 TRACHOMA 35 UVEITIS 35 NONTRAUMATIC RETINAL DETACHMENT 35 DRY EYE SYNDROME 35 STRABISMUS 36 GLOBAL EYE DISEASE AND CONDITION STATISTICS 36 TABLE 10 ESTIMATED GLOBAL PREVALENCE OF SELECTED EYE CONDITIONS AND DISEASES, ($ GLAUCOMA 37 CATARACTS 37 AGE-RELATED MACULAR DEGENERATION 37 DIABETIC RETINOPATHY 37 OTHER CONDITIONS AFFECTING THE EYE 37 REFRACTIVE ERROR: OVERVIEW AND STATISTICS CHAPTER 4 MARKET TRENDS AND ISSUES 41 GOVERNMENT REGULATION FOR MEDICAL DEVICES 41 U.S. DEVICE REGISTRATION PROCESS 41 EUROPEAN UNION (EU) DEVICE REGISTRATION PROCESS 41 JAPAN'S DEVICE REGISTRATION PROCESS 42 CANADA'S DEVICE REGISTRATION PROCESS 43

4 GOVERNMENT INTERACTION 43 CONTACT LENS REGULATION AND CONSUMER SAFETY 43 Fairness to Contact Lens Consumers Act 43 TABLE 11 GOVERNMENT BILLS/LAWS RELATED TO CONTACT LENSES AND MANUFACTURERS AFFORDABLE CARE ACT AND MEDICAL DEVICE TAX 44 THE FDA'S PRECAUTIONS INVOLVING LASIK EYE SURGERY 44 OPHTHALMIC PHARMACEUTICAL/DEVICE RECALLS AND LABEL UPDATES 45 TABLE 12 VISION PRODUCT RECALLS ADVERTISING AND MARKETING 49 TABLE 13 MARKETING AND ADVERTISING EXPENSES FOR SELECTED OPHTHALMIC MANUFACTURERS/PROVIDERS, 2012 ($ FDA WARNINGS OF IMPROPER ADVERTISING 51 REFRACTIVE SURGERY PROCEDURE VOLUMES AND PRICES 52 FIGURE 6 ESTIMATED REFRACTIVE SURGERY PROCEDURES IN THE UNITED STATES BY YEAR, (NO. OF PROCEDURES) FIGURE 7 ESTIMATED REFRACTIVE SURGERY PRICES IN THE UNITED STATES BY YEAR, ($ COST PER EYE) POPULATION DEMOGRAPHICS 53 GLOBAL DEMOGRAPHICS 53 TABLE 14 ESTIMATED GLOBAL POPULATION AND ANNUAL GROWTH BY SELECTED AGE GROUP AND SELECTED YEARS, THROUGH 2030 ( FIGURE 8 ESTIMATED GLOBAL POPULATION AND ANNUAL GROWTH BY SELECTED AGE GROUP AND SELECTED YEARS, ( TABLE 15 GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015 ( FIGURE 9 GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND PROJECTED 2015 ( Global Life Expectancy 56 TABLE 16 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980 AND 2010 (YEARS) FIGURE 10 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980 AND 2010 (YEARS) INDUSTRY ACQUISITIONS, MERGERS AND PARTNERSHIPS 57 ADVANCED MEDICAL OPTICS AND ABBOTT MEDICAL OPTICS 57 ALCON 58 BAUSCH & LOMB 58 CARL ZEISS 59 COOPER COMPANIES, INC. 59 ESCALON MEDICAL CORPORATION 59 HAAG-STREIT AG 60 HALMA PLC 60 KOWA OPTIMED, KOWA COMPANY 60 NIDEK, INC. 60 OPKO HEALTH (OPTOS PLC) 61 REICHERT TECHNOLOGIES 61 TOPCON MEDICAL SYSTEMS 61 ULTRALASE 61 ZIEMER OPHTHALMIC

5 CHAPTER 5 OPHTHALMIC DIAGNOSTICS 64 OVERVIEW 64 TYPES OF DIAGNOSTIC TESTS 64 Visual Acuity Test 64 Dilated Eye Exam 64 Manifest Refraction 65 Pupil Reflex 65 Tonometry Test 65 Ophthalmoscopy 66 Gonioscopy 66 Slit Lamp Examinations 66 Fluorescein Staining 67 Eye Muscle Tests 67 Corneal Thickness 67 Pachymetry 67 Echography 68 PRODUCT DESCRIPTION 68 IMAGING DIAGNOSTICS 68 Optic Nerve Imaging and Related Imaging Technologies 68 Glaucoma-Scope 69 Fundus Cameras 69 Aberrometer 70 Echography and Ophthalmic Ultrasound 70 Corneal Topography 71 Fluorescein Angiography 72 Slit Lamp Photography 72 TABLE 17 SELECT CONDITIONS FOUND THROUGH SLIT LAMP PHOTOGRAPHY Specular Microscopy 73 NONIMAGING DIAGNOSTICS 73 Tonometer 73 Ophthalmoscope 74 Gonioscope 74 Slit Lamps 75 Pachymeter 75 Perimeter 75 HIGHLIGHTED PRODUCTS 76 3-D OCT System from Topcon 76 Topcon's CA-200 Corneal Analyzer 76 Topcon's SL-3G Slit Lamp 76 VISX WaveScan System 77 Alcon's WaveLight Analyzer 77 Bausch & Lomb Zywave Aberrometer 77 Humphrey Field Analyzer from Carl Zeiss Meditec 77 Carl Zeiss CRS-Master II Topography Wavefront System 77 Carl Zeiss Stratus OCT 78 Carl Zeiss VISUCAM 78 72

6 Carl Zeiss Cirrus HD-OCT 78 Canon CF, CR and CX Digital Retinal Cameras 79 Spectralis HRA+OCT by Heidelberg Engineering 80 Tomey TMS-4 Corneal Topographer 80 Tomey TMS-5 Scheimpflug Topographer 80 Tomey RT-7000 Auto Ref-Keratometer/Topographer 81 Tomey OA-1000 Optical Biometer 81 Nidek Orion Auto-Retinal Imaging Device 81 Nidek AFC-210 Fundus Camera 81 Nidek AFC-330 Automated Fundus Camera 81 Nidek OPD-Scan III 81 Optos P200MA 82 Optos OCT/SLO 82 Kowa Nonmydriatic Fundus Cameras with VK-2 Digital Imaging Software - Kowa Nonmyd 7 Kowa's VX-20 Retinal Camera 83 Hoya Surgical Optics itrace Surgical Workstation 83 MARKET SIZE AND GROWTH 83 TABLE 18 TOTAL GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY MARKET SEGMENT, THROUGH 2017 ($ FIGURE 11 TOTAL GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY MARKET SEGMENT, ($ MARKETS BY PRODUCT TYPE 85 Imaging/Digital Equipment 85 TABLE 19 GLOBAL MARKET FOR OPHTHALMIC IMAGING EQUIPMENT BY PRODUCT TYPE, THROUGH 2017 ($ FIGURE 12 GLOBAL MARKET FOR OPHTHALMIC IMAGING EQUIPMENT BY PRODUCT TYPE, ($ Nonimaging/Routine Exam Equipment 87 TABLE 20 GLOBAL MARKET FOR OPHTHALMIC NONIMAGING DIAGNOSTICS/EQUIPMENT BY PRODUCT TYPE, THROUGH 2017 ($ FIGURE 13 GLOBAL MARKET FOR OPHTHALMIC NONIMAGING DIAGNOSTICS/EQUIPMENT BY PRODUCT TYPE, ($ MARKETS BY WORLD REGION 88 TABLE 21 GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY GEOGRAPHIC REGION, THROUGH 2017 ($ FIGURE 14 GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY GEOGRAPHIC REGION, 2012 AND 2017 ($ COMPETITIVE STRUCTURE AND MARKET SHARE 90 TABLE 22 COMPETITIVE MARKET SHARE FOR OPHTHALMIC DIAGNOSTICS BY MANUFACTURERS' REVENUES, 2012 (%/$ FIGURE 15 COMPETITIVE MARKET SHARE FOR OPHTHALMIC DIAGNOSTICS BY MANUFACTURERS' REVENUES, 2012 ($ CHAPTER 6 VISION CORRECTION AND VISION PRESERVATION DEVICES 94 OVERVIEW 94 PRODUCT DESCRIPTION 94 Contact Lens Products 94 Soft (Disposable) Lenses 94 Alcon 94

7 Bausch & Lomb 95 CooperVision 96 Johnson & Johnson Vision Care and Vistakon 97 Gas Permeable Lenses 97 Bausch & Lomb 97 Cosmetic Lenses 98 Alcon 98 CooperVision 98 Vistakon 98 Shaping Lenses 98 Bausch & Lomb 99 Paragon Vision Sciences 99 Hybrid Lenses 99 RESEARCH AND DEVELOPMENT 99 MARKET SIZE AND GROWTH 100 TABLE 23 TOTAL GLOBAL MARKET FOR CONTACT LENSES BY MARKET SEGMENT, THROUGH 2017 ($ FIGURE 16 TOTAL GLOBAL MARKET FOR CONTACT LENSES BY MARKET SEGMENT, ($ SOFT CONTACT LENS MARKET BY PRODUCT TYPE 102 TABLE 24 GLOBAL MARKET FOR SOFT CONTACT LENSES BY PRODUCT TYPE, THROUGH 2017 ($ FIGURE 17 GLOBAL MARKET FOR SOFT CONTACT LENSES BY PRODUCT TYPE, ($ MARKETS BY WORLD REGION 103 TABLE 25 GLOBAL MARKET FOR CONTACT LENSES BY GEOGRAPHIC REGION, THROUGH 2017 ($ FIGURE 18 GLOBAL MARKET FOR CONTACT LENSES BY GEOGRAPHIC REGION, 2012 AND 2017 ($ COMPETITIVE STRUCTURE AND MARKET SHARE 105 TABLE 26 COMPETITIVE MARKET SHARE FOR CONTACT LENSES BY MANUFACTURERS' REVENUES, 2012 (%/$ FIGURE 19 COMPRETITIVE MARKET SHARE FO CONTACT LENSES BY MANUFACTURERS' REVENUES, 2012 ($ CHAPTER 7 SURGICAL EQUIPMENT 109 OVERVIEW 109 TYPES OF SURGICAL PROCEDURES 109 Corneal Procedures 109 Intracorneal Rings 109 Cornea Transplants (Penetrating Keratoplasty) 109 Deep Anterior Lamellar Corneal Transplant (DLEK) 110 Descemet's Stripping with Endothelial Keratoplasty (DSEK) 110 Radial Keratotomy 110 Limbal Relaxing Incisions (LRI) 111 Lens Procedures 111 Lens Replacements 111 Verisyse Lens Implant 111 Refractive Procedures 111

8 Mechanical Microkeratome 111 Blade-free Microkeratome 112 LASEK, LASIK AND PRK 112 TABLE 27 LIST OF FDA APPROVED LASERS FOR LASIK, Retinal Procedures 114 Vitreoretinal Surgery 114 Surgical Procedures for Cataracts 114 Phacoemulsification Cataract Surgery 114 Endocapsular Tension Ring 114 TABLE 28 ENDOSCAPULAR TENSION RINGS AVAILABLE BY MANUFACTURER 115 Surgical Procedures for Glaucoma 115 Glaucoma Implant 115 TABLE 29 GLAUCOMA IMPLANTS AVAILABLE BY MANUFACTURER 116 Neodymium:YAG Laser Cyclophotocoagulation (YAG CP) 116 Diode Laser Transscleral Cyclophotocoagulation (Diode CYC) 116 Selective Laser Trabeculoplasty (SLT) 116 Argon Laser Trabeculoplasty (ALT) 116 Laser Peripheral Iridotomy (LPI) 117 Filtering Microsurgery 117 Procedures for Age-Related Macular Degeneration (AMD) 117 Focal Laser Treatment and PDT 117 PRODUCT DESCRIPTION 118 OPHTHALMIC LASERS 118 Blade-free Femtosecond Microkeratome 118 TABLE 30 MICROKERATOME/FEMTOSECOND SYSTEMS BY MANUFACTURER 119 Abbott Medical Optics 119 Alcon Laboratories 120 Bausch & Lomb/Technolas Perfect Vision 120 Carl Zeiss 121 LensAR, Inc. 121 OptiMedica Corp. 121 Technolas Perfect Vision 121 Ziemer Ophthalmic Systems 121 Excimer Laser 122 TABLE 31 EXCIMER LASER SYSTEMS BY MANUFACTURER 122 Abbott Medical Optics 123 Alcon Laboratories 123 Carl Zeiss 123 Nidek Co. 124 Schwind Eye-tech-Solutions 124 Technolas Perfect Vision 124 Nd:YAG Lasers 124 TABLE 32 SELECT YAG LASER SYSTEMS BY MANUFACTURER 125 Other Laser Systems 126 Product Examples 126 PHACOEMULSIFICATION SYSTEMS 127 Alcon 127

9 Abbott Medical Optics 128 Bausch & Lomb 128 Carl Zeiss 129 LightMed Corporation 129 Optikon 2000 SpA 129 STAAR Surgical 129 INTRAOCULAR LENSES AND OTHER LENS IMPLANTS 129 Alcon, Inc. 130 Abbott Medical Optics 130 Bausch & Lomb 130 Carl Zeiss 131 Hoya Surgical Optics 131 Nidek Co. 132 Ophtec BV 132 STAAR Surgical 132 OTHER EQUIPMENT AND DEVICES 133 Shunts and Drainage Devices 133 Abbott Medical Optics 134 Alcon Laboratories 134 New World Medical 134 SOLX, Inc. 134 STAAR Surgical 134 Telescoping Implantable Device 135 Conductive Keratoplasty (CK) Device 135 Intacs - Intracorneal Rings 135 Artificial Cornea 136 Surgical Microscopes 136 Viscoelastic Materials/Devices 136 Abbott Medical Optics 136 Alcon Laboratories 136 Ophtec BV 137 STAAR Surgical 137 Retinal Surgical Oils 137 Intravitreal Drug Implants 137 Vitreoretinal Instruments 138 KEY PRODUCTS 138 LASERS AND SURGICAL INSTRUMENTS 138 Bausch & Lomb's Hansatome Microkeratome 138 Abbott Medical Optics' IntraLase FS Laser 138 VISX Star S4 Laser System 138 Technolas 217z Laser 138 Bausch & Lomb's Orbscan IIz 139 Alcon's WaveLight Allegretto Wave Excimer 139 Carl Zeiss MEL 80 Laser System 139 Nidek EC-5000CX 139 LENSES 139 Alcon 139

10 Abbott Medical Optics 140 STAAR Surgical 140 RESEARCH AND DEVELOPMENT 141 MARKET SIZE AND GROWTH 143 TABLE 33 TOTAL GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES BY MARKET SEGMENT, THROUGH 2017 ($ FIGURE 20 TOTAL GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES BY MARKET SEGMENT, ($ MARKETS BY PRODUCT TYPE 144 Cataract, Vitreoretinal and Other Eye Conditions 144 TABLE 34 GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES FOR CATARACT, VITREORETINAL AND OTHER EYE CONDITIONS BY PRODUCT TYPE, THROUGH 2017 ($ FIGURE 21 GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES FOR CATARACT, VITREORETINAL AND OTHER EYE CONDITIONS BY PRODUCT TYPE, ($ Refractive 146 TABLE 35 GLOBAL MARKET FOR OPHTHALMIC REFRACTIVE SURGERY EQUIPMENT/PRODUCTS BY PRODUCT TYPE, THROUGH 2017 ($ FIGURE 22 GLOBAL MARKET FOR OPHTHALMIC REFRACTIVE SURGERY EQUIPMENT/PRODUCTS BY PRODUCT TYPE, THROUGH 2017 ($ MARKETS BY WORLD REGION 148 TABLE 36 GLOBAL MARKET FOR OPHTHALMIC SURGERY EQUIPMENT AND DEVICES BY GEOGRAPHIC REGION, THROUGH 2017 ($ FIGURE 23 GLOBAL MARKET FOR OPHTHALMIC SURGERY EQUIPMENT AND DEVICES BY GEOGRAPHIC REGION, 2012 AND 2017 ($ COMPETITIVE STRUCTURE AND MARKET SHARE 149 TABLE 37 COMPETITIVE MARKET SHARE FOR SURGICAL EQUIPMENT AND DEVICE BY MANUFACTURERS' REVENUES, 2012 (%/$ FIGURE 24 COMPETITIVE MARKET SHARE FOR SURGICAL EQUIPMENT AND DEVICES BY MANUFACTURERS' REVENUES, 2012 ($ CHAPTER 8 MARKET SUMMARY 153 TOTAL OPHTHALMIC MARKET 153 TABLE 38 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET, THROUGH 2017 ($ FIGURE 25 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET, ($ TOTAL MARKET DISTRIBUTION BY MARKET SEGMENT 154 TABLE 39 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, THROUGH 2017 ($ FIGURE 26 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, ($ TOTAL MARKET DISTRIBUTION BY GEOGRAPHICAL REGION 155 TABLE 40 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY GEOGRAPHICAL REGION, THROUGH 2017 ($ FIGURE 27 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET, BY GEOGRAPHICAL REGION, 2012 AND 2017 ($

11 INDUSTRY PARTICIPANTS 157 TABLE 41 INDUSTRY PARTICIPANTS BY PRODUCT TYPE 157 COMPETITIVE ANALYSIS 159 TABLE 42 COMPETITIVE ANALYSIS FOR THE OPHTHALMIC MARKET BY TOP PROVIDERS AND REVENUES, 2012 ($ FIGURE 28 COMPETITIVE ANALYSIS FOR THE OPHTHALMIC MARKET, BY TOP PROVIDERS AND REVENUES, 2012 ($ CHAPTER 9 TECHNOLOGY 163 CURRENT USES OF TECHNOLOGY 163 ABBOTT MEDICAL OPTIC'S WAVESCAN/CUSTOMVUE TECHNOLOGY 163 CRYSTALENS BY EYEONICS, INC. 163 HYBRID LENSES BY SYNERGEYES, INC. 163 SILICONE HYDROGEL 163 TABLE 43 EXTENDED WEAR GAS PERMEABLE SOFT LENSES BY BRAND 164 SENOFILCON A LENS 164 HIGHLY PERMEABLE LENS TECHNOLOGY 164 IMPLANTABLE CONTACT LENSES 165 RETISERT IMPLANT BY BAUSCH & LOMB 165 ORTHOKERATOLOGY 166 NIKE MAXSIGHT 166 TORSIONAL PHACOEMULSIFICATION 167 ILASIK PROCEDURE 167 PARADIGM MEDICAL/LACE ELETTRONICA 167 HOYA CORPORATION LENS SIMULATION CENTER 168 WELCH ALLYN'S IPHONE OPHTHALMOSCOPE 168 BIOSENSOR TECHNOLOGY AND GLUCOSE MEASUREMENTS 168 PATENT EVALUATION 168 OVERVIEW 168 PATENT INFORMATION FOR OPHTHALMIC DEVICES 169 TABLE 44 U.S. OPHTHALMIC DEVICE PATENTS BY FILING DATE 169 PATENT INFORMATION FOR OPHTHALMIC LASERS 173 TABLE 45 U.S. OPHTHALMIC LASER PATENTS BY FILING DATE 173 EVALUATION OF PATENTS BY DATE 174 Devices 174 TABLE 46 U.S. OPHTHALMIC DEVICE PATENTS BY YEAR ISSUED, FIGURE 29 U.S. OPHTHALMIC DEVICE PATENTS BY YEAR ISSUED 174 Lasers 175 TABLE 47 U.S. OPHTHALMIC LASER PATENTS BY YEAR ISSUED 176 FIGURE 30 U.S. OPHTHALMIC LASER PATENTS BY YEAR ISSUED 176 CHAPTER 10 COMPANY PROFILES 178 IN-DEPTH COMPANY PROFILES 178 ABBOTT MEDICAL OPTICS 178 COMPANY OVERVIEW 178 MARKET PERFORMANCE 179 TABLE 48 ADVANCED MEDICAL OPTICS REVENUE PERFORMANCE, ($ 179

12 ALCON LABORATORIES, INC. 179 COMPANY OVERVIEW 179 MARKET PERFORMANCE 180 TABLE 49 ALCON REVENUE PERFORMANCE, 2011 AND 2012 ($ 180 BAUSCH & LOMB 181 COMPANY OVERVIEW 181 MARKET PERFORMANCE 181 CARL ZEISS AG 182 COMPANY OVERVIEW 182 MARKET PERFORMANCE 182 COOPERVISION 183 COMPANY OVERVIEW 183 MARKET PERFORMANCE 183 TABLE 50 COOPER COMPANIES REVENUE PERFORMANCE, ($ HOYA SURGICAL OPTICS, INC. 184 COMPANY OVERVIEW 184 MARKET PERFORMANCE 184 TABLE 51 HOYA CORPORATION REVENUE PERFORMANCE, ($ JOHNSON & JOHNSON VISION CARE 185 COMPANY OVERVIEW 185 MARKET PERFORMANCE 185 TABLE 52 JOHNSON & JOHNSON VISION CARE REVENUE PERFORMANCE, ($ LUMENIS LTD. 186 COMPANY OVERVIEW 186 MARKET PERFORMANCE 187 TABLE 53 LUMENIS REVENUE PERFORMANCE, ($ 187 NIDEK CO., LTD. 187 COMPANY OVERVIEW 187 MARKET PERFORMANCE 188 TABLE 54 ESTIMATED NIDEK REVENUE PERFORMANCE, ($ OPTOS PLC 189 COMPANY OVERVIEW 189 MARKET PERFORMANCE 189 TABLE 55 OPTOS REVENUE PERFORMANCE, 2011 AND 2012 ($ 189 STAAR SURGICAL COMPANY 190 COMPANY OVERVIEW 190 MARKET PERFORMANCE 190 TABLE 56 STAAR SURGICAL COMPANY REVENUE PERFORMANCE, ($ TOPCON CORPORATION 191 COMPANY OVERVIEW 191 MARKET PERFORMANCE 192 TABLE 57 TOPCON REVENUE PERFORMANCE, ($ 192 MINI PROFILES

13 ACCUTOME, INC. 193 CANON, INC. 193 ESCALON MEDICAL CORPORATION 194 HAAG-STREIT AG 195 HEIDELBERG ENGINEERING GMBH 196 IRIDEX CORPORATION 196 KOWA COMPANY LTD. 197 MARCO OPHTHALMIC, INC. 198 OPHTEC BV 198 TOMEY CORPORATION 199 ZIEMER OPHTHALMIC SYSTEMS AG 199 CHAPTER 11 APPENDICES 202 APPENDIX I: OPHTHALMIC PRODUCT MANUFACTURERS 202 APPENDIX II: ORGANIZATIONS 213

14 LIST OF TABLES TABLE HEADING SUMMARY TABLE TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, THROUGH 2017 ($ TABLE 1 GLOSSARY OF TERMS USED IN OPHTHALMOLOGY 12 TABLE 2 GLAUCOMA TYPES AND KEY POINTS 23 TABLE 3 KNOWN CAUSES OF UVEITIS 25 TABLE 4 STRABISMUS TYPES AND RELATED CATEGORIES 27 TABLE 5 ESTIMATED U.S. INCIDENCE AND PREVALENCE OF SELECTED EYE CONDITIONS AND DISEASES, 2012 DATA TABLE 6 PROJECTIONS FOR GLAUCOMA IN THE UNITED STATES BY RACE, (NO. OF CASES) TABLE 7 PROJECTIONS FOR CATARACTS IN THE UNITED STATES BY RACE, (NO. OF CASES) TABLE 8 PROJECTIONS FOR AGE-RELATED MACULAR DEGENERATION (AMD) IN THE UNITED STATES BY RACE, (NO. OF CASES) TABLE 9 PROJECTIONS FOR DIABETIC RETINOPATHY IN THE UNITED STATES BY RACE, (NO. OF CASES) TABLE 10 ESTIMATED GLOBAL PREVALENCE OF SELECTED EYE CONDITIONS AND DISEASES, ($ TABLE 11 GOVERNMENT BILLS/LAWS RELATED TO CONTACT LENSES AND MANUFACTURERS TABLE 12 VISION PRODUCT RECALLS TABLE 13 MARKETING AND ADVERTISING EXPENSES FOR SELECTED OPHTHALMIC MANUFACTURERS/PROVIDERS, 2012 ($ TABLE 14 ESTIMATED GLOBAL POPULATION AND ANNUAL GROWTH BY SELECTED AGE GROUP AND SELECTED YEARS, THROUGH 2030 ( TABLE 15 GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015 ( TABLE 16 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980 AND 2010 (YEARS) TABLE 17 SELECT CONDITIONS FOUND THROUGH SLIT LAMP PHOTOGRAPHY 72 TABLE 18 TOTAL GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY MARKET SEGMENT, THROUGH 2017 ($ TABLE 19 GLOBAL MARKET FOR OPHTHALMIC IMAGING EQUIPMENT BY PRODUCT TYPE, THROUGH 2017 ($ TABLE 20 GLOBAL MARKET FOR OPHTHALMIC NONIMAGING DIAGNOSTICS/EQUIPMENT BY PRODUCT TYPE, THROUGH 2017 ($ TABLE 21 GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY GEOGRAPHIC REGION, THROUGH 2017 ($ TABLE 22 COMPETITIVE MARKET SHARE FOR OPHTHALMIC DIAGNOSTICS BY MANUFACTURERS' REVENUES, 2012 (%/$ TABLE 23 TOTAL GLOBAL MARKET FOR CONTACT LENSES BY MARKET SEGMENT, THROUGH 2017 ($ TABLE 24 GLOBAL MARKET FOR SOFT CONTACT LENSES BY PRODUCT TYPE, THROUGH 2017 ($ TABLE 25 GLOBAL MARKET FOR CONTACT LENSES BY GEOGRAPHIC REGION, THROUGH 2017 ($ TABLE 26 COMPETITIVE MARKET SHARE FOR CONTACT LENSES BY MANUFACTURERS' REVENUES, 2012 (%/$ TABLE 27 LIST OF FDA APPROVED LASERS FOR LASIK, TABLE 28 ENDOSCAPULAR TENSION RINGS AVAILABLE BY MANUFACTURER

15 TABLE HEADING TABLE 29 GLAUCOMA IMPLANTS AVAILABLE BY MANUFACTURER 116 TABLE 30 MICROKERATOME/FEMTOSECOND SYSTEMS BY MANUFACTURER 119 TABLE 31 EXCIMER LASER SYSTEMS BY MANUFACTURER 122 TABLE 32 SELECT YAG LASER SYSTEMS BY MANUFACTURER 125 TABLE 33 TOTAL GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES BY MARKET SEGMENT, THROUGH 2017 ($ TABLE 34 GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES FOR CATARACT, VITREORETINAL AND OTHER EYE CONDITIONS BY PRODUCT TYPE, THROUGH 2017 ($ TABLE 35 GLOBAL MARKET FOR OPHTHALMIC REFRACTIVE SURGERY EQUIPMENT/PRODUCTS BY PRODUCT TYPE, THROUGH 2017 ($ TABLE 36 GLOBAL MARKET FOR OPHTHALMIC SURGERY EQUIPMENT AND DEVICES BY GEOGRAPHIC REGION, THROUGH 2017 ($ TABLE 37 COMPETITIVE MARKET SHARE FOR SURGICAL EQUIPMENT AND DEVICE BY MANUFACTURERS' REVENUES, 2012 (%/$ TABLE 38 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET, THROUGH 2017 ($ TABLE 39 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, THROUGH 2017 ($ TABLE 40 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY GEOGRAPHICAL REGION, THROUGH 2017 ($ TABLE 41 INDUSTRY PARTICIPANTS BY PRODUCT TYPE 157 TABLE 42 COMPETITIVE ANALYSIS FOR THE OPHTHALMIC MARKET BY TOP PROVIDERS AND REVENUES, 2012 ($ TABLE 43 EXTENDED WEAR GAS PERMEABLE SOFT LENSES BY BRAND 164 TABLE 44 U.S. OPHTHALMIC DEVICE PATENTS BY FILING DATE 169 TABLE 45 U.S. OPHTHALMIC LASER PATENTS BY FILING DATE 173 TABLE 46 U.S. OPHTHALMIC DEVICE PATENTS BY YEAR ISSUED, TABLE 47 U.S. OPHTHALMIC LASER PATENTS BY YEAR ISSUED 176 TABLE 48 ADVANCED MEDICAL OPTICS REVENUE PERFORMANCE, ($ TABLE 49 ALCON REVENUE PERFORMANCE, 2011 AND 2012 ($ 180 TABLE 50 COOPER COMPANIES REVENUE PERFORMANCE, ($ TABLE 51 HOYA CORPORATION REVENUE PERFORMANCE, ($ TABLE 52 JOHNSON & JOHNSON VISION CARE REVENUE PERFORMANCE, ($ TABLE 53 LUMENIS REVENUE PERFORMANCE, ($ 187 TABLE 54 ESTIMATED NIDEK REVENUE PERFORMANCE, ($ TABLE 55 OPTOS REVENUE PERFORMANCE, 2011 AND 2012 ($ 189 TABLE 56 STAAR SURGICAL COMPANY REVENUE PERFORMANCE, ($ TABLE 57 TOPCON REVENUE PERFORMANCE, ($

16 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, ($ FIGURE 1 HEALTH INSURANCE AND USE OF EYE CARE SERVICES, U.S. VERSUS CANADA (%) FIGURE 2 PROJECTIONS FOR GLAUCOMA IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 3 PROJECTIONS FOR CATARACTS IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 4 PROJECTIONS FOR AGE-RELATED MACULAR DEGENERATION (AMD) IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 5 PROJECTIONS FOR DIABETIC RETINOPATHY IN THE UNITED STATES BY RACE, (NO. OF CASES) FIGURE 6 ESTIMATED REFRACTIVE SURGERY PROCEDURES IN THE UNITED STATES BY YEAR, (NO. OF PROCEDURES) FIGURE 7 ESTIMATED REFRACTIVE SURGERY PRICES IN THE UNITED STATES BY YEAR, ($ COST PER EYE) FIGURE 8 ESTIMATED GLOBAL POPULATION AND ANNUAL GROWTH BY SELECTED AGE GROUP AND SELECTED YEARS, ( FIGURE 9 GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND PROJECTED 2015 ( FIGURE 10 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980 AND 2010 (YEARS) FIGURE 11 TOTAL GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY MARKET SEGMENT, ($ FIGURE 12 GLOBAL MARKET FOR OPHTHALMIC IMAGING EQUIPMENT BY PRODUCT TYPE, ($ FIGURE 13 GLOBAL MARKET FOR OPHTHALMIC NONIMAGING DIAGNOSTICS/EQUIPMENT BY PRODUCT TYPE, ($ FIGURE 14 GLOBAL MARKET FOR OPHTHALMIC DIAGNOSTIC EQUIPMENT BY GEOGRAPHIC REGION, 2012 AND 2017 ($ FIGURE 15 COMPETITIVE MARKET SHARE FOR OPHTHALMIC DIAGNOSTICS BY MANUFACTURERS' REVENUES, 2012 ($ FIGURE 16 TOTAL GLOBAL MARKET FOR CONTACT LENSES BY MARKET SEGMENT, ($ FIGURE 17 GLOBAL MARKET FOR SOFT CONTACT LENSES BY PRODUCT TYPE, ($ FIGURE 18 GLOBAL MARKET FOR CONTACT LENSES BY GEOGRAPHIC REGION, 2012 AND 2017 ($ FIGURE 19 COMPRETITIVE MARKET SHARE FO CONTACT LENSES BY MANUFACTURERS' REVENUES, 2012 ($ FIGURE 20 TOTAL GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES BY MARKET SEGMENT, ($ FIGURE 21 GLOBAL MARKET FOR OPHTHALMIC SURGICAL EQUIPMENT AND DEVICES FOR CATARACT, VITREORETINAL AND OTHER EYE CONDITIONS BY PRODUCT TYPE, ($ FIGURE 22 GLOBAL MARKET FOR OPHTHALMIC REFRACTIVE SURGERY EQUIPMENT/PRODUCTS BY PRODUCT TYPE, THROUGH 2017 ($ FIGURE 23 GLOBAL MARKET FOR OPHTHALMIC SURGERY EQUIPMENT AND DEVICES BY GEOGRAPHIC REGION, 2012 AND 2017 ($ FIGURE 24 COMPETITIVE MARKET SHARE FOR SURGICAL EQUIPMENT AND DEVICES BY MANUFACTURERS' REVENUES, 2012 ($

17 FIGURE TITLE FIGURE 25 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET, ($ FIGURE 26 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET BY SEGMENT, ($ FIGURE 27 TOTAL GLOBAL OPHTHALMIC DIAGNOSTIC, DEVICE AND SURGICAL MARKET, BY GEOGRAPHICAL REGION, 2012 AND 2017 ($ FIGURE 28 COMPETITIVE ANALYSIS FOR THE OPHTHALMIC MARKET, BY TOP PROVIDERS AND REVENUES, 2012 ($ FIGURE 29 U.S. OPHTHALMIC DEVICE PATENTS BY YEAR ISSUED 174 FIGURE 30 U.S. OPHTHALMIC LASER PATENTS BY YEAR ISSUED