BIOPSY DEVICES: TECHNOLOGY AND GLOBAL MARKETS

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1 BIOPSY DEVICES: TECHNOLOGY AND GLOBAL MARKETS HLC171B March 2016 Yojana Jeevane Project Analyst ISBN: BCC Research 49 Walnut Park, Building 2 Wellesley, MA USA (toll-free within the USA), or (+1) information@bccresearch.com

2 TABLE OF CONTENTS CHAPTER 1 INTRODUCTION 2 STUDY OBJECTIVES 2 STUDY BACKGROUND 2 SCOPE OF THE REPORT 2 INTENDED AUDIENCE 3 METHODOLOGY AND INFORMATION SOURCES 3 ANALYST'S CREDENTIALS 3 RELATED BCC RESEARCH REPORTS 3 BCC RESEARCH WEBSITE 4 DISCLAIMER 4 CHAPTER 2 EXECUTIVE SUMMARY 6 SUMMARY TABLE GLOBAL MARKET FOR BIOPSY DEVICES BY REGION, THROUGH SUMMARY FIGURE GLOBAL MARKET FOR BIOPSY DEVICES BY REGION, ($ 7 7 CHAPTER 3 OVERVIEW OF BIOPSY DEVICE MARKET 10 VACUUM-ASSISTED BREAST BIOPSY 10 ADVANTAGES OF VAB TECHNIQUE 10 DISADVANTAGES OF VAB TECHNIQUE 11 LIVER BIOPSY TRENDS 11 LIVER DISEASE FACTS 11 PERCUTANEOUS LIVER BIOPSY 12 LAPAROSCOPIC SURGERY 12 PROSTATE BIOPSY TRENDS 13 IMAGE-GUIDED PROSTATE BIOPSY 13 RISKS OF BIOPSY OF THE PROSTATE 14 CANCER DIAGNOSTICS AND IMAGING 15 MAMMOGRAPHY 15 COLONOSCOPY 16 ENDOSCOPY 17 REGULATION OF BIOPSY DEVICES 18 U.S. REGULATION OF BIOPSY DEVICES 18 EU REGULATION OF BIOPSY DEVICES 20 Breast Cancer 20 TABLE 1 IMPLEMENTATION OF BREAST CANCER SCREENING PROGRAMS BY COUNTRY Gastroenterology and Urology 21 REIMBURSEMENT POLICIES 21 U.S. REIMBURSEMENT FOR BREAST CANCER SCREENING 22 U.S. REIMBURSEMENT FOR BREAST RECONSTRUCTION OR PROSTHESIS 23 U.S. REIMBURSEMENT UNDER THE WHCRA 23 U.S. REIMBURSEMENT UNDER THE AFFORDABLE CARE ACT 23 MARKET DYNAMICS 24 DRIVERS 24 20

3 Increase in Prevalence of Chronic Diseases 24 Minimally Invasive Procedures as Compared with Other Techniques 24 Increased Public Awareness of Disease Screening 25 Increasing Aging Population 25 TABLE 2 GLOBAL TRENDS IN AGING POPULATION BY REGION, (%) 26 FIGURE 1 GLOBAL TRENDS IN AGING POPULATION, (%) 26 Strong Reimbursement Policies in Developing Economies 26 Technological Advancements in Imaging Technology 27 RESTRAINTS 27 Increased Competition from Other Cancer Diagnostic Tests 27 High Price of Advanced Biopsy Devices 28 Availability of Advanced Diagnostic Services 28 OPPORTUNITIES/CHALLENGES 28 Tapping the Diagnostic Market Present in Emerging Economies 28 TABLE 3 PERCENTAGE OF THE AGING POPULATION IN DEVELOPING COUNTRIES, 2014 (%) FIGURE 2 PERCENTAGE OF THE AGING POPULATION IN DEVELOPING COUNTRIES, 2014 (%) CASE STUDIES 29 CASE STUDY 1: BREAST TOMOSYNTHESIS BIOPSY (2011) 29 Company Involved: Hologic Inc. 29 CASE STUDY 2: PET-GUIDED BREAST BIOPSY (2011) 30 Company Involved: Naviscan Inc. 30 CASE STUDY 3: BIOPSY USED TO INFILTRATE DUCTAL CARCINOMA 30 Company Involved: Toshiba CHAPTER 4 BIOPSY DEVICE MARKET BY TYPE 33 TABLE 4 GLOBAL MARKET FOR BIOPSY DEVICES BY TYPE, THROUGH 2020 ($ BREAST BIOPSY DEVICES 33 STEREOTACTIC BIOPSIES 34 ULTRASOUND-GUIDED BIOPSIES 34 SURGICAL OR OPEN BIOPSIES 34 Surgical Biopsies with Needle Localization 35 TABLE 5 GLOBAL MARKET FOR BREAST BIOPSY DEVICES BY TYPE, THROUGH 2020 ($ TABLE 6 TYPES OF BREAST BIOPSY AND MAMMOGRAPHY EQUIPMENT 35 TABLE 7 GLOBAL MARKET FOR BREAST BIOPSY DEVICES BY REGION, THROUGH VACUUM-ASSISTED BIOPSY DEVICES 36 TABLE 8 GLOBAL MARKET FOR VACUUM-ASSISTED BREAST BIOPSY DEVICES BY REGION, Breast Tissue Markers 38 Advantages of Vacuum-assisted Biopsy 38 Disadvantages of Vacuum-Assisted Biopsy 39 CAPITAL EQUIPMENT 39 IMAGE-GUIDED BREAST BIOPSIES 39 Ultrasound-Guided Breast Core Needle Biopsy 39 Stereotactic/MRI Breast Biopsy (Mammotome)

4 MAMMOGRAPHY 40 Digital Mammography 40 MAGNETIC RESONANCE IMAGING 41 Risks and Benefits of MRI 41 DISPOSABLE DEVICES 41 VAB Disposable Devices 42 Handheld Disposable Devices 42 Disposable Biopsy Punch 42 Punches with Plunger System 42 Punches without Plunger System 43 CORE NEEDLE BIOPSY 43 TABLE 9 GLOBAL MARKET FOR CORE NEEDLE BIOPSY DEVICES BY REGION, Core Needle Biopsy with Stereotactic Mammography 44 Advantages of Core Needle Biopsy 44 Disadvantages of Core Needle Biopsy 44 CNB Disposable Devices 45 Drapes 45 Table Drapes 45 Disposable Magnetic Drapes 45 Equipment Drape 45 Source Sleeve 45 Disposable Sterile Kit 46 CNB Tissue Markers 46 Advantages of CNB Tissue Markers 47 Disadvantages of CNB Markers 47 FINE NEEDLE ASPIRATION BIOPSY 47 TABLE 10 GLOBAL MARKET FOR FINE-NEEDLE ASPIRATION BIOPSY DEVICES BY REGION, GASTROINTESTINAL BIOPSY 48 TABLE 11 GLOBAL MARKET FOR GASTROINTESTINAL BIOPSY DEVICES BY REGION, COLD FORCEPS 49 HOT FORCEPS 49 SOFT TISSUE BIOPSY NEEDLES 50 TABLE 12 GLOBAL MARKET FOR SOFT TISSUE BIOPSY NEEDLES BY REGION, CORE NEEDLE BIOPSY NEEDLES 51 FINE-NEEDLE ASPIRATION NEEDLES 51 Advantages of FNA Needles 52 Disadvantages of FNA Needles 52 BRONCHIAL BIOPSY DEVICES 52 TABLE 13 GLOBAL MARKET FOR BRONCHIAL BIOPSY DEVICES BY REGION, FORCEPS 53 Disposable 53 Reusable 54 TBNA NEEDLES

5 Conventional Needles 54 EBUS-TBNA 55 GYNECOLOGICAL BIOPSY DEVICES 55 TABLE 14 GLOBAL MARKET FOR GYNECOLOGICAL BIOPSY DEVICES BY REGION, ENDOMETRIAL SAMPLERS 56 Functions of Endometrial Samplers 57 ROBOTIC GUIDANCE SYSTEMS 57 TABLE 15 GLOBAL MARKET FOR ROBOTIC GUIDANCE SYSTEMS BY REGION, NEUROMATE (RENISHAW) 59 Benefits of Neuromate 59 Safety Features of Neuromate 59 PATHFINDER (PROSURGICS) 59 INNOMOTION (INNOMEDIC) 60 OTHERS 60 TABLE 16 GLOBAL MARKET FOR OTHER BIOPSY DEVICES BY REGION, THROUGH BIOPSY BRUSHES 61 BIOPSY CURETTES 61 TABLE 17 TYPES OF BIOPSY CURETTES 62 BIOPSY PUNCHES 62 TABLE 18 TYPES OF BIOPSY PUNCHES CHAPTER 5 BIOPSY DEVICE MARKET BY THERAPEUTIC AREA 64 TABLE 19 GLOBAL MARKET FOR BIOPSY DEVICES BY THERAPEUTIC AREA, TABLE 20 GLOBAL MARKET FOR BIOPSY DEVICE BY NUMBER OF PROCEDURES, THROUGH 2020 (THOUSANDS) BREAST BIOPSY 65 FINE-NEEDLE ASPIRATION BIOPSY 66 Fine-Needle Aspiration Biopsy for Palpable Growth 66 Guided FNAB for Nonpalpable Growth 66 CORE NEEDLE BIOPSY 66 VACUUM-ASSISTED BIOPSIES 66 SURGICAL BIOPSY 67 TABLE 21 GLOBAL MARKET FOR BREAST BIOPSY DEVICES BY REGION, THROUGH GI BIOPSY 67 ENDOSCOPIC BIOPSY 68 FINE NEEDLE ASPIRATION BIOPSY 68 SURGICAL BIOPSY 68 TABLE 22 GLOBAL MARKET FOR GI BIOPSY DEVICES BY REGION, THROUGH 2020 ($ PROSTATE BIOPSY 68 LYMPH NODE BIOPSY 69 Laparoscopic Biopsy 69 Fine-Needle Aspiration Biopsy 69 Surgical Biopsy

6 TABLE 23 GLOBAL MARKET FOR PROSTATE BIOPSY DEVICES THROUGH 2020 ($ LIVER BIOPSY 70 NEEDLE BIOPSY 70 LAPAROSCOPIC BIOPSY 71 SURGICAL BIOPSY 71 TABLE 24 GLOBAL MARKET FOR LIVER BIOPSY DEVICES BY REGION, THROUGH LUNG BIOPSY 72 TABLE 25 FIVE YEAR SURVIVAL RATES FOR NON-SMALL LUNG CANCER BY STAGE, 2013 (%) FIGURE 3 FIVE-YEAR SURVIVAL RATE FOR NON-SMALL LUNG CANCER BY STAGE, 2013 (%) ADVANTAGES OF LUNG BIOPSY 73 DISADVANTAGES OF LUNG BIOPSY 74 TABLE 26 GLOBAL MARKET FOR LUNG BIOPSY DEVICES BY REGION, THROUGH KIDNEY BIOPSY 74 TABLE 27 INCIDENCE OF KIDNEY CANCER IN THE U.S. BY GENDER, 2014 (%) 74 FIGURE 4 INCIDENCE OF KIDNEY CANCER IN THE U.S. BY GENDER, 2014 (%) 74 COMPLICATIONS OF BIOPSIES TO DETECT KIDNEY DISEASE 75 ADVANTAGES OF RENAL/KIDNEY BIOPSY 76 DISADVANTAGES OF RENAL/KIDNEY BIOPSY 76 TABLE 28 GLOBAL MARKET FOR KIDNEY BIOPSY DEVICES BY REGION, THROUGH GYNECOLOGICAL BIOPSY 77 TABLE 29 DISTRIBUTION OF GYNECOLOGICAL CANCERS IN THE U.S. BY TYPE, FIGURE 5 DISTRIBUTION OF GYNECOLOGICAL CANCERS IN THE U.S. BY TYPE, COMPLICATIONS OF GYNECOLOGICAL BIOPSY 78 TABLE 30 GLOBAL MARKET FOR GYNECOLOGICAL BIOPSY DEVICES BY REGION, BIOPSY DEVICES USED TO DIAGNOSE OTHER DISEASES 79 PANCREATIC CANCER BIOPSY 79 Types of Biopsies Performed to Detect Pancreatic Cancer 79 Percutaneous Needle Biopsy 79 Endoscopic Retrograde Cholangiopancreatography 79 Endoscopic Ultrasound 80 BILE DUCT CANCER BIOPSY 80 THYROID BIOPSY 80 TABLE 31 GLOBAL MARKET FOR OTHER THERAPEUTIC BIOPSY DEVICES BY REGION, CHAPTER 6 BIOPSY DEVICE MARKET BY IMAGE GUIDING TECHNOLOGY 82 TABLE 32 GLOBAL MARKET FOR BIOPSY DEVICES BY IMAGE GUIDING TECHNOLOGY, IMAGING TECHNOLOGIES USED IN GUIDING BIOPSIES 83 MRI-GUIDED BREAST BIOPSY 83 Advantages of MRI-Guided Biopsy 84 82

7 TABLE 33 GLOBAL MARKET FOR MRI-GUIDED BIOPSY DEVICES BY REGION, STEREOTACTIC-GUIDED BREAST BIOPSY 85 Advantages of Stereotactic-Guided Needle Biopsy 86 Disadvantages/Limitations of Stereotactic-Guided Needle Biopsy 86 TABLE 34 GLOBAL MARKET FOR STEREOTACTIC GUIDED BREAST BIOPSY DEVICES BY REGION, ULTRASOUND-GUIDED BIOPSY 87 LIVER BIOPSY 87 THYROID BIOPSY 88 PROSTATE BIOPSY 88 BREAST BIOPSY 88 TRENDS 88 TABLE 35 GLOBAL MARKET FOR ULTRASOUND-GUIDED BREAST BIOPSY BY REGION, COMPUTED TOMOGRAPHY 89 ADVANTAGES OF CT-GUIDED NEEDLE BIOPSY 90 DISADVANTAGES OF CT-GUIDED NEEDLE BIOPSY 90 LIMITATIONS OF CT-GUIDED NEEDLE BIOPSY 90 TABLE 36 GLOBAL MARKET FOR CT-GUIDED BIOPSY DEVICES BY REGION, OTHERS 91 TABLE 37 GLOBAL MARKET FOR OTHER BIOPSY IMAGING DEVICES BY REGION, CHAPTER 7 END USER MARKETS FOR BIOPSY DEVICES 94 TABLE 38 GLOBAL MARKET FOR BIOPSY DEVICES BY END USER, THROUGH 2020 ($ DIAGNOSTIC CENTERS 94 TABLE 39 GLOBAL MARKET FOR BIOPSY DEVICES USED IN DIAGNOSTIC CENTERS BY REGION, HOSPITALS 96 TABLE 40 GLOBAL MARKET FOR BIOPSY DEVICES USED IN HOSPITALS AND SPECIALIZED CENTERS BY REGION, TABLE 41 GLOBAL MARKET FOR BIOPSY DEVICES USED BY SPECIALIZED CENTERS AND HOSPITALS, SPECIALIZED (CANCER) 97 TABLE 42 GLOBAL MARKET FOR BIOPSY DEVICES USED IN SPECIALIZED CENTERS BY REGION, HOSPITALS 98 TABLE 43 GLOBAL MARKET FOR BIOPSY DEVICES USED IN HOSPITALS BY REGION, CHAPTER 8 COMPETITIVE LANDSCAPE 100 FIGURE 6 DISTRIBUTION OF KEY COMPETITIVE STRATEGIES USED BY BIOPSY DEVICE COMPANIES, (%) PRODUCT LAUNCHES 101 FIGURE 7 DISTRIBUTION OF PRODUCT LAUNCH STRATEGY BY COMPANY, (%) TABLE 44 KEY PRODUCT LAUNCHES ANNOUNCED BETWEEN 2012 AND

8 PARTNERSHIPS AND COLLABORATIONS 105 FIGURE 8 DISTRIBUTION OF THE PARTNERSHIP AND COLLABORATION STRATEGY BY COMPANY, (%) TABLE 45 PARTNERSHIP AND COLLABORATION STRATEGY BY COMPANY, ACQUISITIONS 108 FIGURE 9 DISTRIBUTION OF THE ACQUISITION STRATEGY BY COMPANY, (%) TABLE 46 COMPANY ACQUISITIONS, EXPANSIONS 110 TABLE 47 COMPANY EXPANSIONS, CHAPTER 9 BIOPSY DEVICE MARKET BY REGION 112 NORTH AMERICA 112 TABLE 48 NORTH AMERICAN MARKET FOR BIOPSY DEVICES, THROUGH 2020 ($ EUROPE 113 TABLE 49 EUROPEAN MARKET FOR BIOPSY DEVICES, 114 ASIA-PACIFIC 114 TABLE 50 ASIA-PACIFIC MARKET FOR BIOPSY DEVICES, THROUGH 2020 ($ ROW 116 TABLE 51 ROW MARKET FOR BIOPSY DEVICES, CHAPTER 10 PATENT ANALYSIS 118 FIGURE 10 U.S., EUROPEAN AND JAPANESE SHARES OF PATENTS ON BIOPSY DEVICES, (%) U.S. PATENT ANALYSIS BY MARKET PARTICIPANT 118 FIGURE 11 U.S. PATENT SHARES BY MARKET PARTICIPANT, (%) 119 EUROPEAN PATENT ANALYSIS BY MARKET PARTICIPANT 119 FIGURE 12 EUROPEAN PATENT SHARES BY MARKET PARTICIPANT, 2015 (%) 119 JAPANESE PATENT ANALYSIS BY MARKET PARTICIPANT 120 FIGURE 13 JAPANESE PATENT SHARES BY MARKET PARTICIPANT, (%) CHAPTER 11 COMPANY PROFILES 123 ARGON MEDICAL DEVICES INC. 123 BIOPSY PRODUCT PORTFOLIO 123 TABLE 52 ARGON MEDICAL DEVICES: RECENT DEVELOPMENTS 124 BECTON DICKINSON AND CO. (CAREFUSION CORP.) 124 BIOPSY PRODUCT PORTFOLIO 124 TABLE 53 BECTON DICKINSON (CAREFUSION): RECENT DEVELOPMENTS 125 TABLE 54 BECTON DICKINSON FINANCIALS ($ 125 BOSTON SCIENTIFIC CORP. 125 BIOPSY PRODUCT PORTFOLIO 126 TABLE 55 BOSTON SCIENTIFIC: RECENT DEVELOPMENTS 126 TABLE 56 BOSTON SCIENTIFIC FINANCIALS ($ 127 C. R. BARD INC. 127 BIOPSY PRODUCT PORTFOLIO 127 TABLE 57 C. R. BARD FINANCIALS ($ 128

9 CARDINAL HEALTH INC. 128 BIOPSY PRODUCT PORTFOLIO 128 TABLE 58 CARDINAL HEALTH: RECENT DEVELOPMENTS 129 TABLE 59 CARDINAL HEALTH FINANCIALS ($ 129 COOK MEDICAL INC. 129 BIOPSY PRODUCT PORTFOLIO 130 TABLE 60 COOK MEDICAL: RECENT DEVELOPMENTS 130 DTR MEDICAL LTD. 131 BIOPSY PRODUCT PORTFOLIO 131 TABLE 61 DTR MEDICAL: RECENT DEVELOPMENTS 132 ETHICON ENDO-SURGERY INC. 132 BIOPSY PRODUCT PORTFOLIO 132 TABLE 62 ETHICON ENDO-SURGERY: RECENT DEVELOPMENTS 133 TABLE 63 ETHICON ENDO-SURGERY (JOHNSON & JOHNSON) FINANCIALS ($ BILLIONS) FUJIFILM HOLDINGS CORP. 133 BIOPSY PRODUCT PORTFOLIO 134 TABLE 64 FUJIFILM HOLDINGS: RECENT DEVELOPMENTS 134 TABLE 65 FUJIFILM HOLDINGS FINANCIALS ($ 134 HOLOGIC INC. 134 BIOPSY PRODUCT PORTFOLIO 135 TABLE 66 HOLOGIC: RECENT DEVELOPMENTS 135 TABLE 67 HOLOGIC FINANCIALS ($ 136 INRAD INC. 136 BIOPSY PRODUCT PORTFOLIO 136 INTACT MEDICAL CORP. 137 BIOPSY PRODUCT PORTFOLIO 137 TABLE 68 INTACT MEDICAL: RECENT DEVELOPMENTS 137 LEICA BIOSYSTEMS (DEVICOR MEDICAL PRODUCTS) 137 BIOPSY PRODUCT PORTFOLIO 138 TABLE 69 LEICA BIOSYSTEMS (DEVICOR MEDICAL): RECENT DEVELOPMENTS 138 MAUNA KEA TECHNOLOGIES 139 BIOPSY PRODUCT PORTFOLIO 139 TABLE 70 MAUNA KEA TECHNOLOGIES: RECENT DEVELOPMENTS 140 TABLE 71 MAUNA KEA TECHNOLOGIES FINANCIALS ($ 140 MDNA LIFE SCIENCES INC. (MITOMICS INC.) 140 BIOPSY PRODUCT PORTFOLIO 141 TABLE 72 MDNA LIFE SCIENCES (MITOMICS): RECENT DEVELOPMENTS 141 MDXHEALTH INC. 142 BIOPSY PRODUCT PORTFOLIO 142 TABLE 73 MDXHEALTH: RECENT DEVELOPMENTS 143 MEDTRONIC 143 BIOPSY PRODUCT PORTFOLIO 144 TABLE 74 MEDTRONIC: RECENT DEVELOPMENTS 144 TABLE 75 MEDTRONIC FINANCIALS ($ 145 SANARUS TECHNOLOGIES LLC 145 BIOPSY PRODUCT PORTFOLIO 145 TABLE 76 SANARUS TECHNOLOGIES LLC: RECENT DEVELOPMENTS

10 VERAN MEDICAL TECHNOLOGIES 146 BIOPSY PRODUCT PORTFOLIO 146 TABLE 77 VERAN MEDICAL TECHNOLOGIES: RECENT DEVELOPMENTS 147 CHAPTER 12 APPENDIX 149 TABLE 78 LIST OF NORTH AMERICAN PATENTS ON BIOPSY DEVICES, TABLE 79 LIST OF EUROPEAN PATENTS ON BIOPSY DEVICES, TABLE 80 LIST OF JAPANESE PATENTS ON BIOPSY DEVICES,

11 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR BIOPSY DEVICES BY REGION, THROUGH TABLE 1 IMPLEMENTATION OF BREAST CANCER SCREENING PROGRAMS BY COUNTRY TABLE 2 GLOBAL TRENDS IN AGING POPULATION BY REGION, (%) 26 TABLE 3 PERCENTAGE OF THE AGING POPULATION IN DEVELOPING COUNTRIES, 2014 (%) TABLE 4 GLOBAL MARKET FOR BIOPSY DEVICES BY TYPE, THROUGH 2020 ($ TABLE 5 GLOBAL MARKET FOR BREAST BIOPSY DEVICES BY TYPE, THROUGH 2020 ($ TABLE 6 TYPES OF BREAST BIOPSY AND MAMMOGRAPHY EQUIPMENT 35 TABLE 7 GLOBAL MARKET FOR BREAST BIOPSY DEVICES BY REGION, THROUGH TABLE 8 GLOBAL MARKET FOR VACUUM-ASSISTED BREAST BIOPSY DEVICES BY REGION, TABLE 9 GLOBAL MARKET FOR CORE NEEDLE BIOPSY DEVICES BY REGION, TABLE 10 GLOBAL MARKET FOR FINE-NEEDLE ASPIRATION BIOPSY DEVICES BY REGION, TABLE 11 GLOBAL MARKET FOR GASTROINTESTINAL BIOPSY DEVICES BY REGION, TABLE 12 GLOBAL MARKET FOR SOFT TISSUE BIOPSY NEEDLES BY REGION, TABLE 13 GLOBAL MARKET FOR BRONCHIAL BIOPSY DEVICES BY REGION, THROUGH TABLE 14 GLOBAL MARKET FOR GYNECOLOGICAL BIOPSY DEVICES BY REGION, TABLE 15 GLOBAL MARKET FOR ROBOTIC GUIDANCE SYSTEMS BY REGION, TABLE 16 GLOBAL MARKET FOR OTHER BIOPSY DEVICES BY REGION, THROUGH TABLE 17 TYPES OF BIOPSY CURETTES 62 TABLE 18 TYPES OF BIOPSY PUNCHES 62 TABLE 19 GLOBAL MARKET FOR BIOPSY DEVICES BY THERAPEUTIC AREA, THROUGH TABLE 20 GLOBAL MARKET FOR BIOPSY DEVICE BY NUMBER OF PROCEDURES, THROUGH 2020 (THOUSANDS) TABLE 21 GLOBAL MARKET FOR BREAST BIOPSY DEVICES BY REGION, THROUGH TABLE 22 GLOBAL MARKET FOR GI BIOPSY DEVICES BY REGION, THROUGH 2020 ($ TABLE 23 GLOBAL MARKET FOR PROSTATE BIOPSY DEVICES THROUGH 2020 ($ TABLE 24 GLOBAL MARKET FOR LIVER BIOPSY DEVICES BY REGION, THROUGH 2020 ($ TABLE 25 FIVE YEAR SURVIVAL RATES FOR NON-SMALL LUNG CANCER BY STAGE, 2013 (%) TABLE 26 GLOBAL MARKET FOR LUNG BIOPSY DEVICES BY REGION, THROUGH 2020 ($ TABLE 27 INCIDENCE OF KIDNEY CANCER IN THE U.S. BY GENDER, 2014 (%)

12 TABLE HEADING TABLE 28 GLOBAL MARKET FOR KIDNEY BIOPSY DEVICES BY REGION, THROUGH TABLE 29 DISTRIBUTION OF GYNECOLOGICAL CANCERS IN THE U.S. BY TYPE, TABLE 30 GLOBAL MARKET FOR GYNECOLOGICAL BIOPSY DEVICES BY REGION, TABLE 31 GLOBAL MARKET FOR OTHER THERAPEUTIC BIOPSY DEVICES BY REGION, TABLE 32 GLOBAL MARKET FOR BIOPSY DEVICES BY IMAGE GUIDING TECHNOLOGY, TABLE 33 GLOBAL MARKET FOR MRI-GUIDED BIOPSY DEVICES BY REGION, TABLE 34 GLOBAL MARKET FOR STEREOTACTIC GUIDED BREAST BIOPSY DEVICES BY REGION, TABLE 35 GLOBAL MARKET FOR ULTRASOUND-GUIDED BREAST BIOPSY BY REGION, TABLE 36 GLOBAL MARKET FOR CT-GUIDED BIOPSY DEVICES BY REGION, THROUGH TABLE 37 GLOBAL MARKET FOR OTHER BIOPSY IMAGING DEVICES BY REGION, TABLE 38 GLOBAL MARKET FOR BIOPSY DEVICES BY END USER, THROUGH 2020 ($ TABLE 39 GLOBAL MARKET FOR BIOPSY DEVICES USED IN DIAGNOSTIC CENTERS BY REGION, TABLE 40 GLOBAL MARKET FOR BIOPSY DEVICES USED IN HOSPITALS AND SPECIALIZED CENTERS BY REGION, TABLE 41 GLOBAL MARKET FOR BIOPSY DEVICES USED BY SPECIALIZED CENTERS AND HOSPITALS, TABLE 42 GLOBAL MARKET FOR BIOPSY DEVICES USED IN SPECIALIZED CENTERS BY REGION, TABLE 43 GLOBAL MARKET FOR BIOPSY DEVICES USED IN HOSPITALS BY REGION, TABLE 44 KEY PRODUCT LAUNCHES ANNOUNCED BETWEEN 2012 AND TABLE 45 PARTNERSHIP AND COLLABORATION STRATEGY BY COMPANY, TABLE 46 COMPANY ACQUISITIONS, TABLE 47 COMPANY EXPANSIONS, TABLE 48 NORTH AMERICAN MARKET FOR BIOPSY DEVICES, THROUGH 2020 ($ TABLE 49 EUROPEAN MARKET FOR BIOPSY DEVICES, 114 TABLE 50 ASIA-PACIFIC MARKET FOR BIOPSY DEVICES, 115 TABLE 51 ROW MARKET FOR BIOPSY DEVICES, 116 TABLE 52 ARGON MEDICAL DEVICES: RECENT DEVELOPMENTS 124 TABLE 53 BECTON DICKINSON (CAREFUSION): RECENT DEVELOPMENTS 125 TABLE 54 BECTON DICKINSON FINANCIALS ($ 125 TABLE 55 BOSTON SCIENTIFIC: RECENT DEVELOPMENTS 126 TABLE 56 BOSTON SCIENTIFIC FINANCIALS ($ 127 TABLE 57 C. R. BARD FINANCIALS ($ 128 TABLE 58 CARDINAL HEALTH: RECENT DEVELOPMENTS 129 TABLE 59 CARDINAL HEALTH FINANCIALS ($ 129 TABLE 60 COOK MEDICAL: RECENT DEVELOPMENTS 130 TABLE 61 DTR MEDICAL: RECENT DEVELOPMENTS

13 TABLE HEADING TABLE 62 ETHICON ENDO-SURGERY: RECENT DEVELOPMENTS 133 TABLE 63 ETHICON ENDO-SURGERY (JOHNSON & JOHNSON) FINANCIALS ($ BILLIONS) 133 TABLE 64 FUJIFILM HOLDINGS: RECENT DEVELOPMENTS 134 TABLE 65 FUJIFILM HOLDINGS FINANCIALS ($ 134 TABLE 66 HOLOGIC: RECENT DEVELOPMENTS 135 TABLE 67 HOLOGIC FINANCIALS ($ 136 TABLE 68 INTACT MEDICAL: RECENT DEVELOPMENTS 137 TABLE 69 LEICA BIOSYSTEMS (DEVICOR MEDICAL): RECENT DEVELOPMENTS 138 TABLE 70 MAUNA KEA TECHNOLOGIES: RECENT DEVELOPMENTS 140 TABLE 71 MAUNA KEA TECHNOLOGIES FINANCIALS ($ 140 TABLE 72 MDNA LIFE SCIENCES (MITOMICS): RECENT DEVELOPMENTS 141 TABLE 73 MDXHEALTH: RECENT DEVELOPMENTS 143 TABLE 74 MEDTRONIC: RECENT DEVELOPMENTS 144 TABLE 75 MEDTRONIC FINANCIALS ($ 145 TABLE 76 SANARUS TECHNOLOGIES LLC: RECENT DEVELOPMENTS 146 TABLE 77 VERAN MEDICAL TECHNOLOGIES: RECENT DEVELOPMENTS 147 TABLE 78 LIST OF NORTH AMERICAN PATENTS ON BIOPSY DEVICES, TABLE 79 LIST OF EUROPEAN PATENTS ON BIOPSY DEVICES, TABLE 80 LIST OF JAPANESE PATENTS ON BIOPSY DEVICES,

14 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR BIOPSY DEVICES BY REGION, ($ FIGURE 1 GLOBAL TRENDS IN AGING POPULATION, (%) 26 FIGURE 2 PERCENTAGE OF THE AGING POPULATION IN DEVELOPING COUNTRIES, 2014 (%) FIGURE 3 FIVE-YEAR SURVIVAL RATE FOR NON-SMALL LUNG CANCER BY STAGE, 2013 (%) FIGURE 4 INCIDENCE OF KIDNEY CANCER IN THE U.S. BY GENDER, 2014 (%) 74 FIGURE 5 DISTRIBUTION OF GYNECOLOGICAL CANCERS IN THE U.S. BY TYPE, FIGURE 6 DISTRIBUTION OF KEY COMPETITIVE STRATEGIES USED BY BIOPSY DEVICE COMPANIES, (%) FIGURE 7 DISTRIBUTION OF PRODUCT LAUNCH STRATEGY BY COMPANY, (%) FIGURE 8 DISTRIBUTION OF THE PARTNERSHIP AND COLLABORATION STRATEGY BY COMPANY, (%) FIGURE 9 DISTRIBUTION OF THE ACQUISITION STRATEGY BY COMPANY, (%) FIGURE 10 U.S., EUROPEAN AND JAPANESE SHARES OF PATENTS ON BIOPSY DEVICES, (%) FIGURE 11 U.S. PATENT SHARES BY MARKET PARTICIPANT, (%) 119 FIGURE 12 EUROPEAN PATENT SHARES BY MARKET PARTICIPANT, 2015 (%) 119 FIGURE 13 JAPANESE PATENT SHARES BY MARKET PARTICIPANT, (%)

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