ABLATION DEVICES: TECHNOLOGIES AND GLOBAL MARKETS HLC163A January 2014 Yojana Jeevane Project Analyst ISBN: 1-56965-682-7 BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 USA 866-285-7215 (toll-free within the USA), or (+1) 781-489-7301 www.bccresearch.com information@bccresearch.com
TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY AND OBJECTIVE 2 STUDY BACKGROUND 2 SCOPE OF THE REPORT 3 INTENDED AUDIENCE 3 SOURCE OF INFORMATION AND METHODOLOGY 3 ANALYST CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH ONLINE SERVICES 4 DISCLAIMER 5 CHAPTER 2 EXECUTIVE SUMMARY 7 SUMMARY TABLE GLOBAL MARKET FOR ABLATION DEVICES BY GEOGRAPHICAL SUMMARY FIGURE GLOBAL MARKET FOR ABLATION DEVICES BY GEOGRAPHICAL REGION, 2012-2018 ($ 8 8 CHAPTER 3 ABLATION MARKET OVERVIEW 11 ABLATION DEVICES: TECHNOLOGY TRENDS AND INNOVATIONS 11 TYPES OF CONVENTIONAL SURGICAL PROCEDURES AND DRAWBACKS 13 HEART SURGERY 13 PLASTIC SURGERY 14 BRAIN SURGERY 14 CANCER SURGERY 15 ORTHOPEDIC SURGERY 15 GOVERNMENT REGULATIONS, MEDICAL ASSOCIATIONS, FOOD AND DRUG ADMINISTRATION, AND INTERNATIONAL REGULATORY AGENCIES TABLE 1 DEVICES THAT ARE NOT YET APPROVED FOR THE TREATMENT OF ATRIAL FIBRILLATION INDUSTRY STRUCTURE AND SUPPLY CHAIN PROCESS 18 ROLE OF MANUFACTURERS 18 ROLE OF DISTRIBUTORS 19 ROLE OF RESEARCH INSTITUTES AND CONSULTANTS 19 ROLE OF GOVERNMENTS 20 ROLE OF HOSPITALS AND SURGEONS 20 DEMOGRAPHICS, INCIDENCE AND PREVALENCE RATES AND OTHER PARAMETERS INFLUENCING MARKET GROWTH INCIDENCES AND PREVALENCE RELATING TO CANCERS 21 TABLE 2 CANCER DEMOGRAPHICS IN THE U.S., 2013 (ESTIMATED) 21 FIGURE 1 DEATHS DUE TO PROSTATE CANCER IN THE U.K., 2011 (%) 22 INCIDENCES AND PREVALENCE RELATING TO CARDIOVASCULAR DISEASES 23 TABLE 3 CARDIOVASCULAR DEMOGRAPHICS IN THE U.S. BY AGE, 2010 (%) 23 TABLE 4 EUROPEAN UNION STATISTICS OF CARDIOVASCULAR DISEASES AND CIRCULATORY DISEASES, 2010 FIGURE 2 PREVALENCE OF CARDIOVASCULAR DISEASES IN ADULTS IN THE U.S. AGE GROUP 45-64 YEARS, 2000 AND 2010 (%) INCIDENCES AND PREVALENCE RELATING TO OPHTHALMOLOGY 25 16 17 21 24 24
TABLE 5 VISUAL IMPAIRMENT STATISTICS U.S., 2000 AND 2010 25 FIGURE 3 CAUSES OF VISUAL IMPAIRMENT, 2010 (%) 25 FIGURE 4 VISUAL IMPAIRMENT PER MILLION, 2010 (THOUSANDS) 26 FDA GUIDELINES FOR SELECTED PRODUCTS 27 TABLE 6 FDA GUIDELINES FOR SELECTED PRODUCTS, 2001 2013 28 REIMBURSEMENT SCENARIO 29 CODING CHANGES FOR CARDIOLOGY 30 Ablation Codes 30 TABLE 7 ABLATION CODES 30 TABLE 8 PHYSICIAN FEE SCHEDULE CODES 31 Comparison of 2012 and 2013 Codes 32 Case Study I 32 TABLE 9 ATRIAL FIBRILLATION ABLATION, PULMONARY VEIN ISOLATION 32 Case Study II 33 TABLE 10 DIAGNOSTICS OF ELECTROPHYSIOLOGY STUDY 33 MARKET DYNAMICS 34 TECHNOLOGICAL DEVELOPMENTS 34 HIGHER RISK OF CHRONIC ILLNESSES 34 FIGURE 5 WORLD PROJECTED MORTALITY TRENDS DUE TO CARDIOVASCULAR DISEASES, 2008, 2015, 2030 (%) FIGURE 6 U.S. CANCER DEMOGRAPHICS BY AGE AND GENDER, 2012 35 ABLATION THERAPY REQUIRES LESS TIME 36 LESS DAMAGE AND BLOOD LOSS 36 RESTRAINTS FOR THE GLOBAL ABLATION DEVICES MARKET 37 PRESSURE FROM REGULATORY AGENCIES 37 INSURANCE SETTLEMENT ISSUES 37 OPPORTUNITIES AND CHALLENGES FOR THE ABLATION DEVICES MARKET 38 GROWING MARKETS IN EMERGING ECONOMIES 38 NEED TO ENHANCE AWARENESS LEVELS 38 34 CHAPTER 4 ABLATION MARKET ANALYSIS BY TECHNOLOGIES 41 TABLE 11 GLOBAL MARKET FOR ABLATION DEVICES BY TECHNOLOGY, THROUGH 2018 ($ THERMAL TECHNOLOGY MARKET 41 TABLE 12 GLOBAL MARKET FOR THERMAL ABLATION DEVICES BY TECHNOLOGY, ELECTRICAL ABLATION THERAPY 42 TABLE 13 GLOBAL MARKET FOR ELECTRICAL ABLATION THERAPY BY RADIATION TECHNOLOGY 43 TABLE 14 GLOBAL MARKET FOR RADIATION ABLATION TECHNOLOGY BY Types of Radiation Ablation Techniques 45 Intensity Modulated Radiation Therapy (IMRT) 45 Image-Guided Radiation Therapy (IGRT) 45 Helical Tomography 45 Particle Therapy 46 Stereotactic Radiotherapy 46 41 42 42 44
Brachytherapy 46 RADIO FREQUENCY (RFID) TECHNOLOGY 47 TABLE 15 GLOBAL MARKET FOR RADIO FREQUENCY ABLATION TECHNOLOGY BY Uses of RFA 47 The Key Applications of RFA 48 Specific Application of RFID in Therapeutic Segments 48 Treatment of Liver Cancer 48 Treatment of Kidney Cancer 48 Treatment of Lung Cancer 48 Arrhythmias 49 Arthritis Pain 49 Treatment of Varicose Veins 49 LIGHT 49 TABLE 16 GLOBAL MARKET FOR LIGHT/LASER ABLATION TECHNOLOGY BY ULTRASOUND 51 TABLE 17 GLOBAL MARKET FOR ULTRASOUND ABLATION TECHNOLOGY BY TABLE 18 HIFU STUDIES IN KIDNEY TISSUES IN SPECIFIED COUNTRIES 52 HIFU in Prostate Cancer 52 HIFU in Primary and Secondary Liver Cancers 53 HIFU in Pancreatic Cancer 53 HIFU in Bladder Cancer 53 MICROWAVE 53 TABLE 19 GLOBAL MARKET FOR MICROWAVE ABLATION TECHNOLOGY BY HYDROTHERMAL 54 TABLE 20 GLOBAL MARKET FOR HYDROTHERMAL ABLATION TECHNOLOGY BY NONTHERMAL ABLATION TECHNOLOGY 55 TABLE 21 GLOBAL MARKET FOR NONTHERMAL ABLATION TECHNOLOGY, THROUGH 2018 ($ CRYOABLATION 56 TABLE 22 GLOBAL MARKET FOR CRYOABLATION TECHNOLOGY BY GEOGRAPHICAL HYDROMECHANICAL 57 TABLE 23 GLOBAL MARKET FOR HYDROMECHANICAL TECHNOLOGY BY 47 50 51 54 54 56 57 58 CHAPTER 5 ABLATION MARKET ANALYSIS BY PRODUCTS 60 ELECTRICAL 60 TABLE 24 GLOBAL MARKET FOR ELECTRICAL ABLATOR BY GEOGRAPHICAL REGION, ELECTRICAL ABLATORS 60 TABLE 25 GLOBAL MARKET FOR ELECTRICAL ABLATOR REVENUE BY PRODUCT, Argon Plasma/Beam Coagulator 61 Irreversible Electroporation 61 60 61
ELECTRONIC BRACHYTHERAPY 62 RADIATION 62 TABLE 26 GLOBAL MARKET FOR RADIATION PRODUCTS BY REVENUE, THROUGH 2018 ($ BRACHYTHERAPY 62 TABLE 27 GLOBAL MARKET FOR BRACHYTHERAPY ABLATOR BY GEOGRAPHICAL High-Dose-Rate (HDR) Brachytherapy 63 TABLE 28 GLOBAL MARKET FOR HIGH-DOSE-RATE BRACHYTHERAPY BY Pulsed-Dose-Rate Brachytherapy 64 TABLE 29 GLOBAL MARKET FOR PULSE-DOSE-RATE BRACHYTHERAPY BY Permanent Seed Brachytherapy or Low-Dose-Rate (LDR) Brachytherapy TABLE 30 GLOBAL MARKET FOR PERMANENT SEED BRACHYTHERAPY BY STEREOTACTIC RADIOSURGERY AND STEREOTACTIC RADIOTHERAPY 65 TABLE 31 GLOBAL MARKET FOR STEREOTACTIC RADIOSURGERY (SRS) AND STEREOTACTIC RADIOTHERAPY (SRT) MARKET REVENUE BY GEOGRAPHICAL IMAGE-GUIDED RADIATION THERAPY (IGRT) 66 TABLE 32 GLOBAL MARKET FOR IMAGE-GUIDED RADIATION THERAPY (IGRT) BY INTENSITY-MODULATED RADIATION THERAPY (IMRT) 67 TABLE 33 GLOBAL MARKET FOR INTENSITY-MODULATED RADIATION THERAPY (IMRT) BY STEREOTACTIC BODY RADIATION THERAPY (SBRT) 68 TABLE 34 GLOBAL MARKET FOR STEREOTACTIC BODY RADIATION THERAPY (SBRT) BY PROTON BEAM THERAPY 68 TABLE 35 GLOBAL MARKET FOR PROTON BEAM THERAPY BY GEOGRAPHICAL RADIO FREQUENCY 69 TABLE 36 GLOBAL MARKET FOR RADIO FREQUENCY ABLATOR MARKET BY PRODUCT, TEMPERATURE-CONTROLLED RADIO FREQUENCY ABLATION DEVICES 70 TABLE 37 GLOBAL MARKET FOR TEMPERATURE-CONTROLLED RADIO FREQUENCY ABLATION DEVICES BY FLUID-COOLED RF ABLATION 70 TABLE 38 GLOBAL MARKET FOR FLUID COOLED RF ABLATION DEVICES BY THE ROBOTIC CATHETER MANIPULATION SYSTEM 71 TABLE 39 GLOBAL MARKET FOR CATHETER MANIPULATION SYSTEM DEVICES BY LIGHT/LASER 72 TABLE 40 GLOBAL MARKET FOR LIGHT/LASER BY PRODUCT, THROUGH 2018 ($ COLD LASER 72 TABLE 41 GLOBAL MARKET FOR COLD LASER DEVICES BY GEOGRAPHICAL REGION, 62 63 63 64 64 65 66 67 67 68 69 69 70 71 71 72 73
EXCIMER LASER 73 TABLE 42 GLOBAL MARKET FOR EXCIMER LASER DEVICES BY GEOGRAPHICAL ULTRASOUND 74 TABLE 43 GLOBAL MARKET FOR ULTRASOUND ABLATION PRODUCTS, THROUGH 2018 ($ HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) 74 TABLE 44 GLOBAL MARKET FOR HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) ABLATORS BY MAGNETIC RESONANCE-GUIDED ULTRASOUND (MRGUS) 75 TABLE 45 GLOBAL MARKET FOR MAGNETIC RESONANCE GUIDED ULTRASOUND (MRGUS) ABLATORS BY ULTRASONIC SURGICAL SYSTEMS 76 TABLE 46 GLOBAL MARKET FOR ULTRASONIC SURGICAL SYSTEMS BY EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY 77 TABLE 47 GLOBAL MARKET FOR EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY PRODUCT BY MICROWAVE ABLATION 77 TABLE 48 GLOBAL MARKET FOR MICROWAVE ABLATION PRODUCT BY HYDROTHERMAL ABLATION/ ENDOMETRIAL HYDROTHERMAL BALLOON ABLATION DEVICES TABLE 49 GLOBAL MARKET FOR HYDROTHERMAL ABLATION PRODUCT BY CRYOABLATION 79 TABLE 50 GLOBAL MARKET FOR CRYOABLATION PRODUCTS BY GEOGRAPHICAL TISSUE CONTACT PROBE 80 TISSUE SPRAY PROBE 80 EPIDERMAL AND SUBCUTANEOUS CRYOABLATION DEVICES 81 ADVANCEMENT IN ROBOTIC ABLATION TECHNIQUE 81 VARIOUS PROCEDURES THAT ARE ROBOTIC IN NATURE 82 STEERABLE CATHETERS 82 HEARTLANDER 82 ROBOTIC RADIOTHERAPY 82 ROBOTIC ABLATION FOR ARRHYTHMIA 82 LEADING ROBOTIC SYSTEMS USED IN CATHETER ABLATION 83 Niobe (Stereotaxis) 83 Sensei (Hansen Medical) 83 Amigo (Catheter Robotics) 83 Artis Zeego (Siemens) 83 TABLE 51 GLOBAL MARKET FOR ROBOTIC ABLATION BY PRODUCT, THROUGH 2018 ($ 73 74 75 76 76 77 78 78 79 80 83 CHAPTER 6 ABLATION MARKET ANALYSIS BY PROCEDURES 86 TABLE 52 GLOBAL ABLATION MARKET BY PROCEDURE, THROUGH 2018 ($ AESTHETICS-SKIN REJUVENATION AND TIGHTENING 86 86
TABLE 53 GLOBAL MARKET FOR AESTHETICS-SKIN REJUVENATION AND TIGHTENING BY LASER SKIN REJUVENATION 87 ILLUSTRATION: VICTORIAN COSMETIC INSTITUTE'S CASE STUDIES 87 RADIO FREQUENCY (RF) FOR FACIAL SKIN REJUVENATION 88 AESTHETICS-BODY SCULPTING, FAT REDUCTION AND REDUCTION IN THE APPEARANCE OF CELLULITE TABLE 54 GLOBAL MARKET FOR AESTHETICS-BODY SCULPTING, FAT REDUCTION AND REDUCTION IN THE APPEARANCE OF CELLULITE ABLATION PROCEDURE BY HIFU FOR FAT REDUCTION 89 ILLUSTRATION: ELSEVIER HEALTH JOURNAL 90 VACUUM MASSAGE FOR CELLULITE REDUCTION 90 BENIGN PROSTATIC HYPERPLASIA ABLATION 91 TABLE 55 GLOBAL MARKET FOR BENIGN PROSTATIC HYPERPLASIA ABLATION PROCEDURE BY GREENLIGHT LASER PROCEDURE FOR BENIGN PROSTATE HYPERPLASIA 91 ILLUSTRATION: EUROPEAN UROLOGY CENTER 91 THERMOTHERAPY FOR BENIGN PROSTATE HYPERPLASIA 92 TRANSURETHRAL NEEDLE ABLATION 92 TABLE 56 GLOBAL MARKET FOR TRANSURETHRAL NEEDLE ABLATION PROCEDURE BY ILLUSTRATION: DIVISION OF UROLOGY, JOHANNESBURG HOSPITAL, SOUTH AFRICA LASER- AND OTHER ENERGY-BASED THERAPIES/HOLMIUM LASER ABLATION/ENUCLEATION OF THE PROSTATE HOLMIUM LASER ENUCLEATION OF PROSTATE CANCER HLEOP 94 TABLE 57 GLOBAL MARKET FOR LASER- AND OTHER ENERGY-BASED ABLATION PROCEDURE BY ILLUSTRATION 94 ABLATION FOR ATRIAL FIBRILLATION 95 TABLE 58 GLOBAL MARKET FOR ATRIAL FIBRILLATION ABLATION PROCEDURE BY PAROXYSMAL ATRIAL FIBRILLATION 96 PERSISTENT ATRIAL FIBRILLATION 96 CANCER/TUMOR ABLATION 96 TABLE 59 GLOBAL MARKET FOR CANCER ABLATION PROCEDURE BY MENORRHAGIA/ENDOMETRIAL ABLATION 97 TABLE 60 GLOBAL MARKET FOR MENORRHAGIA/ENDOMETRIAL ABLATION PROCEDURE BY HEATED BALLOON PROCEDURE 98 SPINAL DECOMPRESSION AND DENERVATION 99 TABLE 61 GLOBAL MARKET FOR SPINAL DECOMPRESSION AND DENERVATION ABLATION PROCEDURE BY DIAGNOSTIC MEDIAL BRANCH BLOCK (MBB) 99 RADIO FREQUENCY ABLATION (RFA) FOR BACK PAIN 100 STRESS URINARY INCONTINENCE 100 TABLE 62 GLOBAL MARKET FOR STRESS URINARY INCONTINENCE ABLATION PROCEDURE BY 87 89 89 91 93 93 94 94 95 97 98 99 101
TRANSURETHRAL RADIO FREQUENCY COLLAGEN DENATURATION 101 VARICOSE VEIN ABLATION 101 TABLE 63 GLOBAL MARKET FOR VARICOSE VEIN ABLATION PROCEDURE BY RADIO FREQUENCY ABLATION (RFA) FOR VARICOSE VEINS 102 UTERINE FIBROIDS 103 TABLE 64 GLOBAL MARKET FOR UTERINE FIBROIDS ABLATION PROCEDURE BY HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) FOR UTERINE FIBROIDS 103 OTHER PROCEDURES 104 ELASA EYE SURGERY 104 102 103 CHAPTER 7 ABLATION MARKET ANALYSIS BY THERAPEUTICS 106 TABLE 65 GLOBAL MARKET FOR ABLATION THERAPEUTICS, THROUGH 2018 ($ CANCER/ONCOLOGY 106 TABLE 66 GLOBAL MARKET FOR CANCER ABLATION THERAPY BY GEOGRAPHICAL CARDIOVASCULAR 107 TABLE 67 GLOBAL MARKET FOR CARDIOVASCULAR ABLATION THERAPY BY OPHTHALMOLOGY 109 TABLE 68 GLOBAL MARKET FOR OPHTHALMOLOGY ABLATION THERAPY BY COSMETOLOGY 110 GYNECOLOGY 111 TABLE 69 GLOBAL MARKET FOR GYNECOLOGY ABLATION THERAPY BY UROLOGY 112 TABLE 70 GLOBAL MARKET FOR UROLOGY ABLATION THERAPY BY GEOGRAPHICAL CRYOABLATION FOR PROSTATE CANCER 113 ORTHOPEDICS 114 TABLE 71 GLOBAL MARKET FOR ORTHOPEDICS THERAPY BY GEOGRAPHICAL RADIO FREQUENCY ABLATION (RFA) FOR ORTHOPEDIC TREATMENT 114 PAIN MANAGEMENT 115 CRYOABLATION IN PAIN MANAGEMENT 115 OTHERS 116 TABLE 72 GLOBAL MARKET FOR OTHER THERAPY BY GEOGRAPHICAL REGION, COBLATION FOR TONSILLITIS 116 PORT-WINE STAINS 117 ABLATION OF PORT-WINE STAINS 117 106 107 108 109 112 113 114 116 CHAPTER 8 COMPETITIVE LANDSCAPE 119 FIGURE 7 KEY COMPETITIVE STRATEGIES*, 2010-2013 (%) 119 PRODUCT LAUNCH 120 FIGURE 8 PRODUCT LAUNCH BY COMPANY*, 2010 2013 (%) 121
TABLE 73 LIST OF KEY PRODUCT LAUNCHES ANNOUNCED, 2010-2013 122 MERGERS AND ACQUISITIONS STRATEGY 124 FIGURE 9 MERGERS AND ACQUISITIONS BY COMPANIES*, 2010-2013 (%) 124 TABLE 74 MERGERS AND ACQUISITIONS STRATEGIES BY COMPANIES, 2010-2013 126 PARTNERSHIP AND COLLABORATION STRATEGY 127 FIGURE 10 PARTNERSHIP AND COLLABORATION STRATEGIES BY COMPANIES*, 2010-2013 TABLE 75 PARTNERSHIP AND COLLABORATION STRATEGIES BY COMPANIES, 2010-2012 APPROVALS AND OTHER STRATEGIES 130 FIGURE 11 APPROVALS AND OTHER STRATEGIES BY COMPANIES*, 2010-2013 (%) 131 TABLE 76 LIST OF APPROVALS AND OTHER STRATEGIES ANNOUNCED, 2010 2013 132 127 129 CHAPTER 9 GEOGRAPHICAL ANALYSIS 136 NORTH AMERICA 136 TABLE 77 ABLATION MARKET ESTIMATION FOR NORTH AMERICA, THROUGH 2018 ($ EUROPE 137 TABLE 78 ABLATION MARKET ESTIMATION FOR EUROPE, THROUGH 2018 ($ ASIA PACIFIC 138 TABLE 79 ABLATION MARKET ESTIMATION FOR ASIA PACIFIC, THROUGH 2018 ($ REST OF WORLD (ROW) 139 TABLE 80 ABLATION MARKET ESTIMATION FOR ROW, 140 136 137 138 CHAPTER 10 PATENT ANALYSIS 142 FIGURE 12 PATENTS REGISTERED/APPROVED IN THE U.S., EUROPE AND JAPAN, 2008-2013 (%) THE U.S. PATENT ANALYSIS BY APPLICATION 142 FIGURE 13 U.S. PATENT ANALYSIS BY TECHNOLOGY, 2008-2013 (%) 143 U.S. PATENT ANALYSIS BY MARKET PARTICIPANTS 144 FIGURE 14 U.S. PATENT ANALYSIS BY MARKET PARTICIPANTS, 2008-2013 (%) 144 EUROPE PATENT ANALYSIS BY TECHNOLOGY 145 FIGURE 15 EUROPE PATENT ANALYSIS BY TECHNOLOGY, 2008-2013 (%) 145 EUROPE PATENT ANALYSIS BY MARKET PARTICIPANTS 146 FIGURE 16 EUROPE PATENT ANALYSIS BY MARKET PARTICIPANTS, 2008-2013 (%) 146 JAPAN PATENT ANALYSIS BY TECHNOLOGY 147 FIGURE 17 JAPAN PATENT ANALYSIS BY TECHNOLOGY, 2008 2013 (%) 147 JAPAN PATENT ANALYSIS BY MARKET PARTICIPANTS 148 FIGURE 18 JAPAN PATENT ANALYSIS BY MARKET PARTICIPANTS, 2008-2013 (%) 148 142 CHAPTER 11 COMPANY PROFILES 150 ACCURAY INC 150 ACCURAY PRODUCT PORTFOLIO 150 TABLE 81 ACCURAY RECENT DEVELOPMENTS, 2010-2012 151 TABLE 82 ACCURAY FINANCIALS, 2010-2012 151 ALCON LABORATORIES INC. 151 ABLATION PRODUCT PORTFOLIO 152
TABLE 83 ALCON RECENT DEVELOPMENT, 2012 152 TABLE 84 ALCON FINANCIALS, 2010 2012 152 ANGIODYNAMICS INC. 153 ABLATION PRODUCT PORTFOLIO 153 TABLE 85 ANGIODYNAMICS RECENT DEVELOPMENTS, 2010-2012 154 TABLE 86 ANGIODYNAMICS FINANCIALS, 2010-2012 154 ARTHROCARE CORPORATION 155 ABLATION PRODUCT PORTFOLIO 155 TABLE 87 ARTHROCARE RECENT DEVELOPMENTS, 2010 156 TABLE 88 ARTHROCARE CORPORATION FINANCIALS, 2010-2012 156 ATRICURE INC. 156 ABLATION PRODUCT PORTFOLIO 157 TABLE 89 ATRICURE RECENT DEVELOPMENTS, 2010-2011 157 TABLE 90 ATRICURE FINANCIALS, 2010-2012 158 BIOSENSE WEBSTER 158 ABLATION PRODUCT PORTFOLIO 158 TABLE 91 BIOSENSE WEBSTER RECENT DEVELOPMENTS, 2010-2012 159 TABLE 92 BIOSENSE WEBSTER FINANCIALS, 2010-2012 159 BOSTON SCIENTIFIC CORPORATION 160 ABLATION PRODUCT PORTFOLIO 160 TABLE 93 BOSTON SCIENTIFIC CORPORATION RECENT DEVELOPMENTS, 2010-2012 161 TABLE 94 BOSTON SCIENTIFIC CORPORATION FINANCIALS, 2010-2012 161 BSD MEDICAL CORPORATION 161 ABLATION PRODUCT PORTFOLIO 162 TABLE 95 BSD MEDICALS RECENT DEVELOPMENTS, 2010-2012 162 TABLE 96 BSD MEDICALS FINANCIALS, 2010-2012 163 C.R. BARD INC. 163 ABLATION PRODUCT PORTFOLIO 163 TABLE 97 C.R. BARD RECENT DEVELOPMENTS, 2011-2012 164 TABLE 98 C.R. BARD FINANCIALS, 2010-2012 164 CONMED CORPORATION 164 ABLATION PRODUCT PORTFOLIO 165 TABLE 99 CONMED RECENT DEVELOPMENTS, 2010 165 TABLE 100 CONMED FINANCIALS, 2010-2012 166 COVIDIEN 166 ABLATION PRODUCT PORTFOLIO 166 TABLE 101 COVIDIEN RECENT DEVELOPMENTS, 2011-2013 167 TABLE 102 COVIDIEN FINANCIALS, 2010-2012 168 ELEKTA AB 168 ABLATION PRODUCT PORTFOLIO 168 TABLE 103 ELEKTA AB RECENT DEVELOPMENTS, 2010 2013 169 TABLE 104 ELEKTA AB FINANCIALS, 2010-2012 170 ENDOSENSE SA 170 ABLATION PRODUCT PORTFOLIO 170 TABLE 105 ENDOSENSE RECENT DEVELOPMENTS (BEFORE ACQUISITION), 2010-2011 GALIL MEDICAL LTD. 171 ABLATION PRODUCT PORTFOLIO 171 171
TABLE 106 GALIL MEDICAL LTD RECENT DEVELOPMENTS, 2011-2012 172 MEDTRONIC INC 172 ABLATION PRODUCT PORTFOLIO 172 TABLE 107 MEDTRONIC RECENT DEVELOPMENTS, 2010-2013 173 TABLE 108 MEDTRONIC FINANCIALS, 2010-2012 174 MISONIX INC. 174 ABLATION PRODUCT PORTFOLIO 174 TABLE 109 MISONIX INC RECENT DEVELOPMENTS, 2010-2012 175 TABLE 110 MISONIX FINANCIALS, 2010-2012 176 OLYMPUS CORPORATION 176 ABLATION PRODUCT PORTFOLIO 176 TABLE 111 OLYMPUS RECENT DEVELOPMENTS, 2010-2012 177 TABLE 112 OLYMPUS FINANCIALS, 2010-2012 177 ST. JUDE MEDICAL INC. 177 ABLATION PRODUCT PORTFOLIO 178 TABLE 113 ST. JUDE MEDICAL RECENT DEVELOPMENTS, 2010 2013 178 TABLE 114 ST. JUDE MEDICAL FINANCIALS, 2010-2012 179 UROLOGIX INC. 179 ABLATION PRODUCT PORTFOLIO 179 TABLE 115 UROLOGIX RECENT DEVELOPMENTS, 2011-2012 180 TABLE 116 UROLOGIX FINANCIALS, 2010-2012 180 VARIAN MEDICAL SYSTEMS INC. 180 ABLATION PRODUCT PORTFOLIO 181 TABLE 117 VARIAN MEDICAL SYSTEMS RECENT DEVELOPMENTS, 2010-2012 181 TABLE 118 VARIAN MEDICAL SYSTEMS INC, 2010-2012 182 CHAPTER 12 APPENDIX 184 LIST OF U.S. PATENTS 184 TABLE 119 LIST OF PATENTS: UNITED STATES, 2008-2013 184 LIST OF PATENTS: EUROPE 188 TABLE 120 LIST OF PATENTS: EUROPE, 2008-2013 188 LIST OF PATENTS: JAPAN 194 TABLE 121 LIST OF PATENTS: JAPAN, 2008-2013 194
LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR ABLATION DEVICES BY GEOGRAPHICAL TABLE 1 DEVICES THAT ARE NOT YET APPROVED FOR THE TREATMENT OF ATRIAL FIBRILLATION TABLE 2 CANCER DEMOGRAPHICS IN THE U.S., 2013 (ESTIMATED) 21 TABLE 3 CARDIOVASCULAR DEMOGRAPHICS IN THE U.S. BY AGE, 2010 (%) 23 TABLE 4 EUROPEAN UNION STATISTICS OF CARDIOVASCULAR DISEASES AND CIRCULATORY DISEASES, 2010 TABLE 5 VISUAL IMPAIRMENT STATISTICS U.S., 2000 AND 2010 25 TABLE 6 FDA GUIDELINES FOR SELECTED PRODUCTS, 2001 2013 28 TABLE 7 ABLATION CODES 30 TABLE 8 PHYSICIAN FEE SCHEDULE CODES 31 TABLE 9 ATRIAL FIBRILLATION ABLATION, PULMONARY VEIN ISOLATION 32 TABLE 10 DIAGNOSTICS OF ELECTROPHYSIOLOGY STUDY 33 TABLE 11 GLOBAL MARKET FOR ABLATION DEVICES BY TECHNOLOGY, THROUGH 2018 ($ TABLE 12 GLOBAL MARKET FOR THERMAL ABLATION DEVICES BY TECHNOLOGY, TABLE 13 GLOBAL MARKET FOR ELECTRICAL ABLATION THERAPY BY GEOGRAPHICAL TABLE 14 GLOBAL MARKET FOR RADIATION ABLATION TECHNOLOGY BY TABLE 15 GLOBAL MARKET FOR RADIO FREQUENCY ABLATION TECHNOLOGY BY TABLE 16 GLOBAL MARKET FOR LIGHT/LASER ABLATION TECHNOLOGY BY TABLE 17 GLOBAL MARKET FOR ULTRASOUND ABLATION TECHNOLOGY BY TABLE 18 HIFU STUDIES IN KIDNEY TISSUES IN SPECIFIED COUNTRIES 52 TABLE 19 GLOBAL MARKET FOR MICROWAVE ABLATION TECHNOLOGY BY TABLE 20 GLOBAL MARKET FOR HYDROTHERMAL ABLATION TECHNOLOGY BY TABLE 21 GLOBAL MARKET FOR NONTHERMAL ABLATION TECHNOLOGY, THROUGH 2018 ($ TABLE 22 GLOBAL MARKET FOR CRYOABLATION TECHNOLOGY BY GEOGRAPHICAL TABLE 23 GLOBAL MARKET FOR HYDROMECHANICAL TECHNOLOGY BY TABLE 24 GLOBAL MARKET FOR ELECTRICAL ABLATOR BY GEOGRAPHICAL REGION, TABLE 25 GLOBAL MARKET FOR ELECTRICAL ABLATOR REVENUE BY PRODUCT, TABLE 26 GLOBAL MARKET FOR RADIATION PRODUCTS BY REVENUE, THROUGH 2018 ($ TABLE 27 GLOBAL MARKET FOR BRACHYTHERAPY ABLATOR BY GEOGRAPHICAL TABLE 28 GLOBAL MARKET FOR HIGH-DOSE-RATE BRACHYTHERAPY BY 8 17 24 41 42 42 44 47 50 51 54 54 56 57 58 60 61 62 63 63
TABLE HEADING TABLE 29 GLOBAL MARKET FOR PULSE-DOSE-RATE BRACHYTHERAPY BY TABLE 30 GLOBAL MARKET FOR PERMANENT SEED BRACHYTHERAPY BY TABLE 31 GLOBAL MARKET FOR STEREOTACTIC RADIOSURGERY (SRS) AND STEREOTACTIC RADIOTHERAPY (SRT) MARKET REVENUE BY GEOGRAPHICAL REGION, TABLE 32 GLOBAL MARKET FOR IMAGE-GUIDED RADIATION THERAPY (IGRT) BY TABLE 33 GLOBAL MARKET FOR INTENSITY-MODULATED RADIATION THERAPY (IMRT) BY TABLE 34 GLOBAL MARKET FOR STEREOTACTIC BODY RADIATION THERAPY (SBRT) BY TABLE 35 GLOBAL MARKET FOR PROTON BEAM THERAPY BY GEOGRAPHICAL TABLE 36 GLOBAL MARKET FOR RADIO FREQUENCY ABLATOR MARKET BY PRODUCT, TABLE 37 GLOBAL MARKET FOR TEMPERATURE-CONTROLLED RADIO FREQUENCY ABLATION DEVICES BY TABLE 38 GLOBAL MARKET FOR FLUID COOLED RF ABLATION DEVICES BY TABLE 39 GLOBAL MARKET FOR CATHETER MANIPULATION SYSTEM DEVICES BY TABLE 40 GLOBAL MARKET FOR LIGHT/LASER BY PRODUCT, THROUGH 2018 ($ TABLE 41 GLOBAL MARKET FOR COLD LASER DEVICES BY GEOGRAPHICAL REGION, TABLE 42 GLOBAL MARKET FOR EXCIMER LASER DEVICES BY GEOGRAPHICAL TABLE 43 GLOBAL MARKET FOR ULTRASOUND ABLATION PRODUCTS, THROUGH 2018 ($ TABLE 44 GLOBAL MARKET FOR HIGH-INTENSITY FOCUSED ULTRASOUND (HIFU) ABLATORS BY TABLE 45 GLOBAL MARKET FOR MAGNETIC RESONANCE GUIDED ULTRASOUND (MRGUS) ABLATORS BY TABLE 46 GLOBAL MARKET FOR ULTRASONIC SURGICAL SYSTEMS BY TABLE 47 GLOBAL MARKET FOR EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY PRODUCT BY TABLE 48 GLOBAL MARKET FOR MICROWAVE ABLATION PRODUCT BY TABLE 49 GLOBAL MARKET FOR HYDROTHERMAL ABLATION PRODUCT BY TABLE 50 GLOBAL MARKET FOR CRYOABLATION PRODUCTS BY GEOGRAPHICAL TABLE 51 GLOBAL MARKET FOR ROBOTIC ABLATION BY PRODUCT, THROUGH 2018 ($ TABLE 52 GLOBAL ABLATION MARKET BY PROCEDURE, 86 TABLE 53 GLOBAL MARKET FOR AESTHETICS-SKIN REJUVENATION AND TIGHTENING BY 64 65 66 67 67 68 69 69 70 71 71 72 73 73 74 75 76 76 77 78 79 80 83 87
TABLE HEADING TABLE 54 GLOBAL MARKET FOR AESTHETICS-BODY SCULPTING, FAT REDUCTION AND REDUCTION IN THE APPEARANCE OF CELLULITE ABLATION PROCEDURE BY TABLE 55 GLOBAL MARKET FOR BENIGN PROSTATIC HYPERPLASIA ABLATION PROCEDURE BY TABLE 56 GLOBAL MARKET FOR TRANSURETHRAL NEEDLE ABLATION PROCEDURE BY TABLE 57 GLOBAL MARKET FOR LASER- AND OTHER ENERGY-BASED ABLATION PROCEDURE BY TABLE 58 GLOBAL MARKET FOR ATRIAL FIBRILLATION ABLATION PROCEDURE BY TABLE 59 GLOBAL MARKET FOR CANCER ABLATION PROCEDURE BY GEOGRAPHICAL TABLE 60 GLOBAL MARKET FOR MENORRHAGIA/ENDOMETRIAL ABLATION PROCEDURE BY TABLE 61 GLOBAL MARKET FOR SPINAL DECOMPRESSION AND DENERVATION ABLATION PROCEDURE BY TABLE 62 GLOBAL MARKET FOR STRESS URINARY INCONTINENCE ABLATION PROCEDURE BY TABLE 63 GLOBAL MARKET FOR VARICOSE VEIN ABLATION PROCEDURE BY TABLE 64 GLOBAL MARKET FOR UTERINE FIBROIDS ABLATION PROCEDURE BY TABLE 65 GLOBAL MARKET FOR ABLATION THERAPEUTICS, THROUGH 2018 ($ TABLE 66 GLOBAL MARKET FOR CANCER ABLATION THERAPY BY GEOGRAPHICAL TABLE 67 GLOBAL MARKET FOR CARDIOVASCULAR ABLATION THERAPY BY TABLE 68 GLOBAL MARKET FOR OPHTHALMOLOGY ABLATION THERAPY BY TABLE 69 GLOBAL MARKET FOR GYNECOLOGY ABLATION THERAPY BY TABLE 70 GLOBAL MARKET FOR UROLOGY ABLATION THERAPY BY GEOGRAPHICAL TABLE 71 GLOBAL MARKET FOR ORTHOPEDICS THERAPY BY GEOGRAPHICAL TABLE 72 GLOBAL MARKET FOR OTHER THERAPY BY GEOGRAPHICAL REGION, TABLE 73 LIST OF KEY PRODUCT LAUNCHES ANNOUNCED, 2010-2013 122 TABLE 74 MERGERS AND ACQUISITIONS STRATEGIES BY COMPANIES, 2010-2013 126 TABLE 75 PARTNERSHIP AND COLLABORATION STRATEGIES BY COMPANIES, 2010-2012 TABLE 76 LIST OF APPROVALS AND OTHER STRATEGIES ANNOUNCED, 2010 2013 132 TABLE 77 ABLATION MARKET ESTIMATION FOR NORTH AMERICA, THROUGH 2018 ($ TABLE 78 ABLATION MARKET ESTIMATION FOR EUROPE, THROUGH 2018 ($ TABLE 79 ABLATION MARKET ESTIMATION FOR ASIA PACIFIC, THROUGH 2018 ($ TABLE 80 ABLATION MARKET ESTIMATION FOR ROW, 140 TABLE 81 ACCURAY RECENT DEVELOPMENTS, 2010-2012 151 89 91 93 94 95 97 98 99 101 102 103 106 107 108 109 112 113 114 116 129 136 137 138
TABLE HEADING TABLE 82 ACCURAY FINANCIALS, 2010-2012 151 TABLE 83 ALCON RECENT DEVELOPMENT, 2012 152 TABLE 84 ALCON FINANCIALS, 2010 2012 152 TABLE 85 ANGIODYNAMICS RECENT DEVELOPMENTS, 2010-2012 154 TABLE 86 ANGIODYNAMICS FINANCIALS, 2010-2012 154 TABLE 87 ARTHROCARE RECENT DEVELOPMENTS, 2010 156 TABLE 88 ARTHROCARE CORPORATION FINANCIALS, 2010-2012 156 TABLE 89 ATRICURE RECENT DEVELOPMENTS, 2010-2011 157 TABLE 90 ATRICURE FINANCIALS, 2010-2012 158 TABLE 91 BIOSENSE WEBSTER RECENT DEVELOPMENTS, 2010-2012 159 TABLE 92 BIOSENSE WEBSTER FINANCIALS, 2010-2012 159 TABLE 93 BOSTON SCIENTIFIC CORPORATION RECENT DEVELOPMENTS, 2010-2012 161 TABLE 94 BOSTON SCIENTIFIC CORPORATION FINANCIALS, 2010-2012 161 TABLE 95 BSD MEDICALS RECENT DEVELOPMENTS, 2010-2012 162 TABLE 96 BSD MEDICALS FINANCIALS, 2010-2012 163 TABLE 97 C.R. BARD RECENT DEVELOPMENTS, 2011-2012 164 TABLE 98 C.R. BARD FINANCIALS, 2010-2012 164 TABLE 99 CONMED RECENT DEVELOPMENTS, 2010 165 TABLE 100 CONMED FINANCIALS, 2010-2012 166 TABLE 101 COVIDIEN RECENT DEVELOPMENTS, 2011-2013 167 TABLE 102 COVIDIEN FINANCIALS, 2010-2012 168 TABLE 103 ELEKTA AB RECENT DEVELOPMENTS, 2010 2013 169 TABLE 104 ELEKTA AB FINANCIALS, 2010-2012 170 TABLE 105 ENDOSENSE RECENT DEVELOPMENTS (BEFORE ACQUISITION), 2010-2011 TABLE 106 GALIL MEDICAL LTD RECENT DEVELOPMENTS, 2011-2012 172 TABLE 107 MEDTRONIC RECENT DEVELOPMENTS, 2010-2013 173 TABLE 108 MEDTRONIC FINANCIALS, 2010-2012 174 TABLE 109 MISONIX INC RECENT DEVELOPMENTS, 2010-2012 175 TABLE 110 MISONIX FINANCIALS, 2010-2012 176 TABLE 111 OLYMPUS RECENT DEVELOPMENTS, 2010-2012 177 TABLE 112 OLYMPUS FINANCIALS, 2010-2012 177 TABLE 113 ST. JUDE MEDICAL RECENT DEVELOPMENTS, 2010 2013 178 TABLE 114 ST. JUDE MEDICAL FINANCIALS, 2010-2012 179 TABLE 115 UROLOGIX RECENT DEVELOPMENTS, 2011-2012 180 TABLE 116 UROLOGIX FINANCIALS, 2010-2012 180 TABLE 117 VARIAN MEDICAL SYSTEMS RECENT DEVELOPMENTS, 2010-2012 181 TABLE 118 VARIAN MEDICAL SYSTEMS INC, 2010-2012 182 TABLE 119 LIST OF PATENTS: UNITED STATES, 2008-2013 184 TABLE 120 LIST OF PATENTS: EUROPE, 2008-2013 188 TABLE 121 LIST OF PATENTS: JAPAN, 2008-2013 194 171
LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR ABLATION DEVICES BY GEOGRAPHICAL REGION, 2012-2018 ($ FIGURE 1 DEATHS DUE TO PROSTATE CANCER IN THE U.K., 2011 (%) 22 FIGURE 2 PREVALENCE OF CARDIOVASCULAR DISEASES IN ADULTS IN THE U.S. AGE GROUP 45-64 YEARS, 2000 AND 2010 (%) FIGURE 3 CAUSES OF VISUAL IMPAIRMENT, 2010 (%) 25 FIGURE 4 VISUAL IMPAIRMENT PER MILLION, 2010 (THOUSANDS) 26 FIGURE 5 WORLD PROJECTED MORTALITY TRENDS DUE TO CARDIOVASCULAR DISEASES, 2008, 2015, 2030 (%) FIGURE 6 U.S. CANCER DEMOGRAPHICS BY AGE AND GENDER, 2012 35 FIGURE 7 KEY COMPETITIVE STRATEGIES*, 2010-2013 (%) 119 FIGURE 8 PRODUCT LAUNCH BY COMPANY*, 2010 2013 (%) 121 FIGURE 9 MERGERS AND ACQUISITIONS BY COMPANIES*, 2010-2013 (%) 124 FIGURE 10 PARTNERSHIP AND COLLABORATION STRATEGIES BY COMPANIES*, 2010-2013 FIGURE 11 APPROVALS AND OTHER STRATEGIES BY COMPANIES*, 2010-2013 (%) 131 FIGURE 12 PATENTS REGISTERED/APPROVED IN THE U.S., EUROPE AND JAPAN, 2008-2013 (%) FIGURE 13 U.S. PATENT ANALYSIS BY TECHNOLOGY, 2008-2013 (%) 143 FIGURE 14 U.S. PATENT ANALYSIS BY MARKET PARTICIPANTS, 2008-2013 (%) 144 FIGURE 15 EUROPE PATENT ANALYSIS BY TECHNOLOGY, 2008-2013 (%) 145 FIGURE 16 EUROPE PATENT ANALYSIS BY MARKET PARTICIPANTS, 2008-2013 (%) 146 FIGURE 17 JAPAN PATENT ANALYSIS BY TECHNOLOGY, 2008 2013 (%) 147 FIGURE 18 JAPAN PATENT ANALYSIS BY MARKET PARTICIPANTS, 2008-2013 (%) 148 8 24 34 127 142