BARIATRIC SURGERY: GLOBAL MARKETS FOR SERVICES AND DEVICES

Transcription

1 BARIATRIC SURGERY: GLOBAL MARKETS FOR SERVICES AND DEVICES HLC153B February 2016 Dr. Ritu Thakur Dangi Project Analyst ISBN: X 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 BARIATRIC SURGERY 2 STUDY BACKGROUND 2 STUDY GOALS AND OBJECTIVES 3 INTENDED AUDIENCE 3 SCOPE OF THE REPORT 4 METHODOLOGY AND INFORMATION SOURCES 4 ANALYST'S CREDENTIALS 5 RELATED BCC RESEARCH REPORTS 5 BCC RESEARCH WEBSITE 5 DISCLAIMER 5 CHAPTER 2 EXECUTIVE SUMMARY 7 EXECUTIVE SUMMARY 7 SUMMARY TABLE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, THROUGH 2020 ($ MILLIONS) SUMMARY FIGURE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, ($ MILLIONS) 7 7 CHAPTER 3 OVERVIEW OF OBESITY 10 DISEASE OVERVIEW 10 COMMON TOOLS TO DIAGNOSE OBESITY 10 BMI 10 TABLE 1 BMI CALCULATION 10 Waist Circumference 10 TYPES OF OBESITY 11 TABLE 2 BMI CATEGORIES BASED ON INCREASING HEALTH RISKS 11 ETIOLOGY AND PATHOPHYSIOLOGY 11 FIGURE 1 ENERGY BALANCE, RISK FACTORS 13 ECONOMIC BURDEN 14 EPIDEMIOLOGY 15 TABLE 3 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION VS. GENERAL POPULATION, THROUGH 2014 (MILLIONS) FIGURE 2 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION, 2008 AND 2014 (% OF GLOBAL GENERAL POPULATION) TABLE 4 U.S. OBESITY AND SEVERE OBESITY VS. GENERAL POPULATION, THROUGH 2014 (MILLIONS) OBESITY TREATMENT AND MANAGEMENT 18 GOALS OF WEIGHT LOSS AND MANAGEMENT 18 WEIGHT MANAGEMENT 18 DIETARY THERAPY 19 PHYSICAL ACTIVITY 19 BEHAVIORAL THERAPY 20 COMBINED THERAPY 20 PHARMACOTHERAPY

3 BARIATRIC SURGERY (WEIGHT-LOSS SURGERY) 21 CHAPTER 4 OBESITY AND TYPE 2 DIABETES 23 OBESITY AND DIABETES 23 DIABETES MELLITUS (DM) 23 GESTATIONAL DIABETES 23 LATENT AUTOIMMUNE DIABETES IN ADULTS (LADA) 23 FIGURE 3 GLOBAL DIABETES TYPES (% OF TOTAL DIABETES) 24 TYPE 2 DIABETES: ETIOLOGY AND PATHOPHYSIOLOGY 24 DISEASE SYMPTOMS AND RISK FACTORS 25 EPIDEMIOLOGY 26 TABLE 5 GLOBAL DIABETES PREVALENCE, THROUGH 2030 (BILLIONS/%/MILLIONS) 27 TREATMENT AND MANAGEMENT OPTIONS 27 LIFESTYLE CHANGES 27 ANTIOBESITY MEASURES (PHARMACOLOGIC AGENTS) 28 DIABETES MEDICATIONS AND INSULIN THERAPY 28 BARIATRIC SURGERY 29 MARKET BURDEN 29 CHAPTER 5 OVERVIEW OF BARIATRIC PROCEDURES 32 GENERAL OVERVIEW 32 CRITERIA FOR BARIATRIC SURGERY 32 LAPAROSCOPIC SURGERY VS. OPEN SURGERY 32 FIGURE 4 GLOBAL OPEN VS. LAPAROSCOPIC BARIATRIC SURGERY OCCURRENCE, 2014 (% OF TOTAL BARIATRIC PROCEDURES) BARIATRIC SURGERY PREPARATION 34 DIET MONITORING 34 DIET CONSULTATION 35 PSYCHOLOGICAL CONSULTATION 35 SCREENING BLOOD TESTS 35 INSURANCE COVERAGE 35 TYPES OF BARIATRIC SURGERIES 36 TABLE 6 TYPES OF BARIATRIC SURGERIES 36 MALABSORPTIVE 36 Biliopancreatic Diversion (BPD) 36 Advantages 37 Disadvantages 37 Biliopancreatic Diversion with a Duodenal Switch (BPD-DS) 38 Extended (Distal) Roux-en-Y Gastric Bypass (RYGBP-E) 38 Mini Gastric Bypass 38 Advantages of Malabsorptive Procedures 38 Disadvantages of Malabsorptive Procedures 39 RESTRICTIVE PROCEDURES 39 Sleeve Gastrectomy (SG) 39 Vertical Sleeve Gastrectomy (VSG) 39 Adjustable Gastric Banding (AGB) 40 Gastric Balloons 40 Advantages of Restrictive Procedures 40 34

4 Disadvantages of Restrictive Procedures 41 COMBINED RESTRICTIVE/MALABSORPTIVE 42 Gastric Bypass 42 Roux-en-Y Gastric Bypass (RYGB) 43 Advantages of Gastric Bypass 43 Disadvantages of Gastric Bypass 44 NEW BARIATRIC PROCEDURES 44 PRIMARY OBESITY SURGERY ENDOLUMINAL (POSE) PROCEDURE 44 Procedure Design 45 Clinical Trials 46 RESTORATIVE OBESITY SURGERY ENDOSCOPIC (ROSE) PROCEDURE 46 Procedure 46 Clinical Trials 47 Advantages of ROSE Procedure 47 ROSE Procedure: Procedure Cost 47 BENEFITS OF BARIATRIC SURGERY 47 RISKS AND COMPLICATIONS OF BARIATRIC SURGERY 51 PULMONARY EMBOLISM 51 GASTROINTESTINAL TRACT LEAK 51 BOWEL OBSTRUCTION (BLOCKAGES) 52 STRICTURE 52 BLEEDING 52 ULCER 53 GALLSTONES 53 INFECTIONS 53 CHRONIC NUTRITIONAL PROBLEMS 54 CONVERSION TO OPEN PROCEDURE 55 FAILURE OF WEIGHT LOSS 55 TOO MUCH WEIGHT LOSS 55 BODY IMAGE, EMOTIONAL LOSS AND DEPRESSION 56 NEUROPATHY 56 HYPOGLYCEMIA (LOW BLOOD SUGARS 56 KIDNEY FAILURE/STONES 57 COMPLICATIONS FROM ANESTHESIA 57 DEATH 57 OTHER COMPLICATIONS 57 BARIATRIC PROCEDURE HISTORIC AND CURRENT TRENDS 57 GLOBAL 57 TABLE 7 GLOBAL BARIATRIC PROCEDURES, THROUGH 2014 (NUMBER) 58 FIGURE 5 GLOBAL BARIATRIC PROCEDURE TYPES, 2014 (% OF ALL BARIATRIC PROCEDURES) FIGURE 6 GLOBAL BARIATRIC PROCEDURE BY REGION, 2014 (% OF GLOBAL PROCEDURES) NORTH AMERICA 60 TABLE 8 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH 2014 (NO. OF PROCEDURES) FIGURE 7 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2014 (% OF ALL BARIATRIC PROCEDURES)

5 AVERAGE PROCEDURE COST OF BARIATRIC SURGERY 61 TABLE 9 AVERAGE COST OF BARIATRIC SURGERY BY PROCEDURE TYPE ($) 61 FACTORS AFFECTING BARIATRIC SURGERY COST 61 BARIATRIC SURGERY: COMPARATIVE ANALYSIS 62 TABLE 10 COMPARATIVE ANALYSIS OF BARIATRIC SURGERY 63 HISTORY OF BARIATRIC SURGERY 64 JAW WIRING 64 JEJUNOILEAL BYPASS 64 GASTRIC PARTITIONING 65 VERTICAL BAND GASTROPLASTY (VBG) 65 GASTRIC BALLOONS 65 CHAPTER 6 OVERVIEW OF BARIATRIC SURGERY DEVICES 67 BARIATRIC SURGERY DEVICES 67 GASTRIC BYPASS 67 GASTRIC REMOVAL DEVICES 67 IMPLANTED GASTRIC DEVICES 67 Gastric Bands 67 Intragastric Balloons (IGB) 67 TABLE 11 PRINCIPAL TYPES OF BARIATRIC SURGERY DEVICES 67 REGULATORY STATUS OF BARIATRIC SURGERY DEVICES 69 UNITED STATES 69 EUROPEAN UNION (EU) 71 JAPAN 73 OTHER ASIA 74 China 74 Hong Kong 74 Taiwan 74 India 75 END-USER SEGMENTS 75 CHAPTER 7 UNMET NEED FOR OBESITY AND DIABETES TYPE 2 77 CHAPTER 8 BARIATRIC SURGERY MARKET ASSESSMENT 80 BARIATRIC PROCEDURES AND SERVICES MARKET 80 GLOBAL 80 TABLE 12 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPE, THROUGH 2020 (NUMBER) FIGURE 8 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) TABLE 13 BARIATRIC PROCEDURE OCCURRENCE BY REGION, THROUGH 2020 (NUMBER) FIGURE 9 BARIATRIC PROCEDURE OCCURRENCE BY REGION, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) NORTH AMERICA 83 TABLE 14 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH 2020 (NUMBER) FIGURE 10 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY)

6 EUROPE 85 TABLE 15 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, THROUGH 2020 (NUMBER) FIGURE 11 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) ASIA 86 TABLE 16 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, THROUGH 2020 (NUMBER) FIGURE 12 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) PROJECTED TRENDS IN BARIATRIC SURGERY 88 BARIATRIC SURGERY DEVICES MARKET 88 GLOBAL BARIATRIC SURGERY DEVICE MARKET BY REGION 88 TABLE 17 GLOBAL BARIATRIC SURGERY DEVICE MARKET BY REGION, THROUGH 2020 ($ MILLIONS) FIGURE 13 GLOBAL BARIATRIC SURGERY DEVICE MARKET BY REGION, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) GLOBAL BARIATRIC SURGERY DEVICES MARKET BY TYPE OF DEVICE 90 North America 90 TABLE 18 NORTH AMERICAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, THROUGH 2020 ($ MILLIONS) FIGURE 14 NORTH AMERICAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) Asia 91 TABLE 19 ASIAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, THROUGH 2020 ($ MILLIONS) FIGURE 15 ASIAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) Europe 93 TABLE 20 EUROPEAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, THROUGH 2020 ($ MILLIONS) FIGURE 16 EUROPEAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) GLOBAL IMPLANTED BARIATRIC SURGERY DEVICES MARKET 95 TABLE 21 GLOBAL MARKET FOR IMPLANTED DEVICES, THROUGH 2020 ($ MILLIONS) 95 MARKET GROWTH DRIVERS AND RESTRAINTS 95 GROWTH DRIVERS 95 Global Obesity Epidemic 95 Diabetes Prevalence 96 Less Invasive/Noninvasive Procedures 96 Western Food Habits and Sedentary Lifestyles 96 Reimbursement 96 Increasing Awareness in Developed Nations 96 Medical Tourism 97 GROWTH RESTRAINTS 97 Lack of Awareness, Availability and Affordability in Developing Nations High Cost of Bariatric Surgery 97 Long Wait Time 97 Short-Term and Long-Term Complications

7 CHAPTER 9 COMPETITION AND MARKET SHARES 99 TABLE 22 GLOBAL BARIATRIC SURGERY MARKET SHARES BY COMPANY, 2014 ($ MILLIONS/%) FIGURE 17 GLOBAL BARIATRIC SURGERY MARKET SHARES BY COMPANY, 2014 (% OF TOTAL MARKET) CHAPTER 10 MARKETED, ABANDONED AND PIPELINE PRODUCTS 102 MARKETED PRODUCTS 102 TABLE 23 KEY MARKETED PRODUCTS OF BARIATRIC SURGERY DEVICES 102 VBLOC THERAPY/MAESTRO RC SYSTEM 104 General Description 104 Clinical Trials 104 Procedure 104 RESHAPE INTEGRATED DUAL BALLOON SYSTEM 105 ORBERA INTRAGASTRIC BALLOON 105 GASTRISAIL GASTRIC POSITIONING SYSTEM 105 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 106 REALIZE ADJUSTABLE GASTRIC BAND 106 ENSEAL 106 PERI-STRIPS DRY WITH VERITAS 107 ENDOPATH XCEL TROCAR 107 ECHELON FLEX POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTERS 108 HARMONIC ACE SHEARS + ADAPTIVE TISSUE TECHNOLOGY 108 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 109 Endo GIA Reload 109 ENDO STITCH ENDOSCOPIC SUTURING DEVICE 109 ENDOGASTRIC SOLUTIONS STOMAPHYX DELIVERY DEVICE, FASTENERS AND ACCESSORIES HELIOSPHERE BAG 111 HELIOGAST 111 Heliogast HAGE 111 Heliogast HAGA 111 ENDOCINCH 111 ENDOSURGICAL OPERATING SYSTEM (EOS) 112 ABANDONED PRODUCTS 112 GARREN-EDWARDS GASTRIC BUBBLE (GEGB) 112 TABLE 24 KEY ABANDONED/ DISCONTINUED PRODUCTS OF BARIATRIC SURGERY DEVICES EASYBAND 113 PIPELINE PRODUCTS 113 ENDOBARRIER 113 General Description 113 Procedure 114 Clinical Trials 114 TABLE 25 ENDOBARRIER CLINICAL TRIALS 114 Advantages 116 Disadvantages

8 EndoBarrier: Procedure Cost 117 TABLE 26 KEY PIPELINE PRODUCTS OF BARIATRIC SURGERY DEVICES 117 VALENTX 119 General Description 119 Clinical Trials 120 TABLE 27 VALENTX CLINICAL TRIALS 120 Advantages 121 ASPIREASSIST 121 General Description 121 Clinical Trials 121 TABLE 28 ASPIREASSIST CLINICAL TRIAL 122 Procedure 122 TANTALUS SYSTEM 122 General Description 122 Clinical Trials 123 TABLE 29 TANTALUS SYSTEM CLINICAL TRIAL 124 Procedure 125 DEEP BRAIN STIMULATION SYSTEM/TRIGEMINAL NERVE STIMULATION (TNS)-OBESITY General Description 125 Clinical Trials 126 TABLE 30 TRIGEMINAL NERVE STIMULATION (TNS) CLINICAL TRIAL 127 ELIPSE 127 General Description 127 Procedure 127 FULL SENSE DEVICE 127 General Description 127 Procedure 128 Clinical Trials 128 SAMSEN MAGNETS 128 General Description 128 Procedure 128 GASTRIC VEST SYSTEM 129 General Description 129 Procedure 129 OBALON BALLOON 129 General Description 129 Procedure 129 Clinical Trials 130 SMART DEVICE 130 General Description 130 Procedure 130 INTRAGASTRIC BALLOON 131 General Description 131 Procedure 131 DIGESTIBLE BALLOON 131 General Description 131 Clinical Trials

9 SPATZ3 ADJUSTABLE BALLOON SYSTEM 132 General Description 132 Procedure 132 Clinical Trials 132 ENDORETICS DEVICE 132 General Description 132 Procedure 132 ATTIVA 133 NOBESE DEVICE 133 General Description 133 Procedure 133 SATISPHERE 134 General Description 134 Clinical Trials 134 Procedure 134 SILIMED GASTRIC BALLOON 135 General Description 135 Procedure 135 Clinical Trial 135 TABLE 31 SILIMED GASTRIC BALLOON CLINICAL TRIAL 135 TRANSPYLORIC SHUTTLE 135 General Description 135 Clinical Trials 136 TABLE 32 TRANSPYLORIC SHUTTLE DEVICE CLINICAL TRIAL 136 Procedure 136 TOGA SYSTEM 136 General Description 136 Clinical Trials 137 TABLE 33 TOGA SYSTEM CLINICAL TRIALS 137 Procedure 137 SENSATE ANCHORED GASTRIC DEVICE 137 General Description 137 Procedure 138 Clinical Trial 138 TABLE 34 SENSATE ANCHORED GASTRIC DEVICE CLINICAL TRIAL 138 ABILITI 138 General Description 138 Clinical Trials 139 TABLE 35 ABILITI SYSTEM CLINICAL TRIALS 139 CHAPTER 11 REIMBURSEMENT 141 GENERAL REIMBURSEMENT CRITERIA 141 UNITED STATES 141 ICD-9-CM 142 TABLE 36 BARIATRIC SURGERY, INTERNATIONAL CLASSIFICATION OF DISEASES, NINTH REVISION (ICD-9) CODES TABLE 37 COVERED INPATIENT FACILITY ICD-9-CM PROCEDURE CODES 142 ICD

10 EUROPE 144 JAPAN 144 OTHER ASIA 145 CHAPTER 12 CONCLUSIONS: THE OUTLOOK FOR BARIATRIC SURGERY DEVICES 147 MAJOR DEVELOPMENTS THAT WILL INFLUENCE THE BARIATRIC SURGERY MARKET TECHNOLOGICAL DEVELOPMENTS 147 Adaptation of Minimally Invasive Techniques to New Types of Surgical Procedures Endoluminal Procedures 148 Gastric Stimulators 148 New Designs of Gastric Balloons 149 DEMOGRAPHIC AND ECONOMIC TRENDS 149 Growing Obesity Populations Worldwide 149 TABLE 38 TRENDS IN OBESITY COMPOSITION OF THE WORLD'S POPULATION, THROUGH 2020 (MILLIONS) TABLE 39 U.S. OBESITY AND SEVERE OBESITY VS GENERAL POPULATION, THROUGH 2020 (MILLIONS) Income Growth in Developing Markets 151 TABLE 40 TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION, (ANNUAL AVERAGE PERCENTAGE CHANGE) CHANGING STRUCTURE OF THE HEALTH CARE INDUSTRY 151 Hospital Consolidation 151 Medical Tourism 152 Health Insurance Developments 152 LONG-TERM OUTLOOK FOR BARIATRIC SURGERY DEVICES AND SERVICES CHAPTER 13 APPENDIX A: ABBREVIATIONS 155 CHAPTER 14 COMPANY PROFILES 158 ALLURION TECHNOLOGIES 158 A.M.I. (AGENCY FOR MEDICAL INNOVATIONS) 158 APOLLO ENDOSURGERY 158 APPLIED MEDICAL 159 ASPIRE BARIATRICS 159 BARONOVA 160 BAROSENSE (SUBSIDIARY OF BOSTON SCIENTIFIC) 160 BAXTER 161 BETA-STIM 161 BFKW 161 COOK GROUP 162 C.R. BARD 162 CROSPON 163 ENDOGASTRIC SOLUTIONS 163 ENDORETICS 163 ENDOBETIX 164 ENDOSPHERE 164

11 ENTEROMEDICS 164 ETHICON ENDO-SURGERY (SUBSIDIARY OF JOHNSON & JOHNSON) 165 GELESIS 165 GI DYNAMICS 166 GI WINDOWS 167 HELIOSCOPIE 167 INTRAPACE INC. 167 MEDTRONIC 168 METACURE 169 OBALON THERAPEUTICS 169 ONCIOMED 169 PLENSAT 170 RESHAPE MEDICAL 170 SARL COUSIN BIOTECH 170 SATIETY 171 SCIENTIFIC INTAKE 171 SENSATE 171 SILHOUETTE MEDICAL 172 SKLAR 172 SLIMEDICS 172 SPATZ FGIA 173 TRANSENTERIX 173 TULIP MEDICAL 173 USGI MEDICAL 174 VALENTX 174 W. L. GORE 175 CHAPTER 15 APPENDIX C: INDUSTRY AND PROFESSIONAL ORGANIZATIONS 177 THE AMERICAN SOCIETY FOR METABOLIC AND BARIATRIC SURGERY (ASMBS) 177 EUROPEAN ASSOCIATION FOR ENDOSCOPIC SURGERY (EAES) 177 INTERNATIONAL ASSOCIATION FOR THE STUDY OF OBESITY 177 INTERNATIONAL DIABETES FEDERATION (IDF) 178 INTERNATIONAL FEDERATION FOR THE SURGERY OF OBESITY AND METABOLIC DISORDERS INTERNATIONAL OBESITY TASK FORCE (IOTF) 178 OBESITY IN AMERICA 179 THE OBESITY SOCIETY 179 SOCIETY OF AMERICAN GASTROINTESTINAL ENDOSCOPIC SURGEONS (SAGES) 179 SOCIETY OF LAPAROENDOSCOPIC SURGEONS (SLS)

12 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, THROUGH 2020 ($ MILLIONS) TABLE 1 BMI CALCULATION 10 TABLE 2 BMI CATEGORIES BASED ON INCREASING HEALTH RISKS 11 TABLE 3 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION VS. GENERAL POPULATION, THROUGH 2014 (MILLIONS) TABLE 4 U.S. OBESITY AND SEVERE OBESITY VS. GENERAL POPULATION, THROUGH 2014 (MILLIONS) TABLE 5 GLOBAL DIABETES PREVALENCE, THROUGH 2030 (BILLIONS/%/MILLIONS) 27 TABLE 6 TYPES OF BARIATRIC SURGERIES 36 TABLE 7 GLOBAL BARIATRIC PROCEDURES, THROUGH 2014 (NUMBER) 58 TABLE 8 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH 2014 (NO. OF PROCEDURES) TABLE 9 AVERAGE COST OF BARIATRIC SURGERY BY PROCEDURE TYPE ($) 61 TABLE 10 COMPARATIVE ANALYSIS OF BARIATRIC SURGERY 63 TABLE 11 PRINCIPAL TYPES OF BARIATRIC SURGERY DEVICES 67 TABLE 12 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPE, THROUGH 2020 (NUMBER) TABLE 13 BARIATRIC PROCEDURE OCCURRENCE BY REGION, THROUGH 2020 (NUMBER) TABLE 14 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, THROUGH 2020 (NUMBER) TABLE 15 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, THROUGH 2020 (NUMBER) TABLE 16 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, THROUGH 2020 (NUMBER) 87 TABLE 17 GLOBAL BARIATRIC SURGERY DEVICE MARKET BY REGION, THROUGH 2020 ($ MILLIONS) TABLE 18 NORTH AMERICAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, THROUGH 2020 ($ MILLIONS) TABLE 19 ASIAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, THROUGH 2020 ($ MILLIONS) TABLE 20 EUROPEAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, THROUGH 2020 ($ MILLIONS) TABLE 21 GLOBAL MARKET FOR IMPLANTED DEVICES, THROUGH 2020 ($ MILLIONS) 95 TABLE 22 GLOBAL BARIATRIC SURGERY MARKET SHARES BY COMPANY, 2014 ($ MILLIONS/%) TABLE 23 KEY MARKETED PRODUCTS OF BARIATRIC SURGERY DEVICES 102 TABLE 24 KEY ABANDONED/ DISCONTINUED PRODUCTS OF BARIATRIC SURGERY DEVICES TABLE 25 ENDOBARRIER CLINICAL TRIALS 114 TABLE 26 KEY PIPELINE PRODUCTS OF BARIATRIC SURGERY DEVICES 117 TABLE 27 VALENTX CLINICAL TRIALS 120 TABLE 28 ASPIREASSIST CLINICAL TRIAL 122 TABLE 29 TANTALUS SYSTEM CLINICAL TRIAL 124 TABLE 30 TRIGEMINAL NERVE STIMULATION (TNS) CLINICAL TRIAL 127 TABLE 31 SILIMED GASTRIC BALLOON CLINICAL TRIAL 135 TABLE 32 TRANSPYLORIC SHUTTLE DEVICE CLINICAL TRIAL 136 TABLE 33 TOGA SYSTEM CLINICAL TRIALS 137 TABLE 34 SENSATE ANCHORED GASTRIC DEVICE CLINICAL TRIAL

13 TABLE HEADING TABLE 35 ABILITI SYSTEM CLINICAL TRIALS 139 TABLE 36 BARIATRIC SURGERY, INTERNATIONAL CLASSIFICATION OF DISEASES, NINTH REVISION (ICD-9) CODES TABLE 37 COVERED INPATIENT FACILITY ICD-9-CM PROCEDURE CODES 142 TABLE 38 TRENDS IN OBESITY COMPOSITION OF THE WORLD'S POPULATION, THROUGH 2020 (MILLIONS) TABLE 39 U.S. OBESITY AND SEVERE OBESITY VS GENERAL POPULATION, THROUGH 2020 (MILLIONS) TABLE 40 TRENDS IN PER CAPITA REAL GDP GROWTH BY REGION, (ANNUAL AVERAGE PERCENTAGE CHANGE)

14 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR BARIATRIC SURGERY BY REGION, ($ MILLIONS) FIGURE 1 ENERGY BALANCE, FIGURE 2 GLOBAL OBESE POPULATION AND SEVERE OBESE POPULATION, 2008 AND 2014 (% OF GLOBAL GENERAL POPULATION) FIGURE 3 GLOBAL DIABETES TYPES (% OF TOTAL DIABETES) 24 FIGURE 4 GLOBAL OPEN VS. LAPAROSCOPIC BARIATRIC SURGERY OCCURRENCE, 2014 (% OF TOTAL BARIATRIC PROCEDURES) FIGURE 5 GLOBAL BARIATRIC PROCEDURE TYPES, 2014 (% OF ALL BARIATRIC PROCEDURES) FIGURE 6 GLOBAL BARIATRIC PROCEDURE BY REGION, 2014 (% OF GLOBAL PROCEDURES) FIGURE 7 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2014 (% OF ALL BARIATRIC PROCEDURES) FIGURE 8 GLOBAL BARIATRIC PROCEDURE OCCURRENCE BY TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 9 BARIATRIC PROCEDURE OCCURRENCE BY REGION, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 10 BARIATRIC PROCEDURE OCCURRENCE IN NORTH AMERICA, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 11 BARIATRIC PROCEDURE OCCURRENCE IN EUROPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 12 BARIATRIC PROCEDURE OCCURRENCE IN ASIA, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 13 GLOBAL BARIATRIC SURGERY DEVICE MARKET BY REGION, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 14 NORTH AMERICAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 15 ASIAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 16 EUROPEAN BARIATRIC SURGERY MARKET BY DEVICE TYPE, 2014 AND 2020 (% OF TOTAL BARIATRIC SURGERY) FIGURE 17 GLOBAL BARIATRIC SURGERY MARKET SHARES BY COMPANY, 2014 (% OF TOTAL MARKET)