MICROELECTRONIC MEDICAL IMPLANTS: PRODUCTS, TECHNOLOGIES & OPPORTUNITIES

Transcription

1 MICROELECTRONIC MEDICAL IMPLANTS: PRODUCTS, TECHNOLOGIES & OPPORTUNITIES HLC016E May 2016 Andrew McWilliams 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 MICROELECTRONIC MEDICAL IMPLANTS 2 STUDY BACKGROUND 2 STUDY GOALS AND OBJECTIVES 2 INTENDED AUDIENCE 3 SCOPE OF THE STUDY 3 METHODOLOGY AND INFORMATION SOURCES 4 ANALYST'S CREDENTIALS 4 RELATED BCC RESEARCH REPORTS 4 BCC RESEARCH WEBSITE 5 DISCLAIMER 5 CHAPTER 2 SUMMARY 7 SUMMARY TABLE GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS, BY APPLICATION, THROUGH 2021 ($ SUMMARY FIGURE GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS, BY APPLICATION, ($ 7 7 CHAPTER 3 OVERVIEW 10 GENERAL DESCRIPTION 10 DEFINITION 10 HISTORY OF MICROELECTRONIC IMPLANTS 10 Early Origins 10 Early Pacemakers 11 Advances in Pacemaker Technology 11 First Implantable Defibrillator 12 Neurostimulators 12 First Implantable Drug Pump 13 Cardiac Assist/Replacement Devices 13 Ear Implants 14 Eye Implants 14 TECHNOLOGIES 14 MINIATURIZATION 15 MATERIALS 15 SENSORS 17 POWER SUPPLIES 17 RF TECHNOLOGY 18 APPLICATIONS 19 CARDIOVASCULAR DISEASE 19 TABLE 1 HOSPITALIZATIONS, PHYSICIAN OFFICE VISITS AND DEATHS DUE TO HEART DISEASE IN THE U.S., 2009 Brachycardia 20 Hypertrophic Cardiomyopathy 20 Tachyarrythmia 21 Syncope 22 Heart Failure 22 19

3 NEUROLOGICAL DISEASES/CONDITIONS 23 Chronic Pain 23 Spinal Cord Injuries 24 Parkinson's Disease 25 Epilepsy 26 Depression 27 Muscle Spasticity 27 Urge Incontinence 28 Other Conditions 28 Alzheimer's Disease 28 BONE DAMAGE 29 DIABETES 30 CANCER 30 FIGURE 1 TRENDS IN U.S. CANCER DEATHS, (NO. OF DEATHS) 31 IMPAIRED HEARING 32 BLINDNESS 33 PRODUCT TYPES 33 CARDIAC IMPLANT 33 Pacemakers 34 Description 34 Applications 34 Technology 34 Manufacturers 35 TABLE 2 HEART PACEMAKER MANUFACTURERS 35 FIGURE 2 NUMBER OF U.S. PACEMAKER-RELATED PATENTS ISSUED, MARCH 15, 2016 (%) Implantable Cardioverter Defibrillators 36 Description 36 Applications 37 Technology 37 Manufacturers 38 TABLE 3 IMPLANTABLE DEFIBRILLATOR MANUFACTURERS 38 Patent Analysis 38 FIGURE 3 NUMBER OF U.S. ICD-RELATED PATENTS ISSUED, MARCH 15, 2016 (%) 39 Cardiac Resynchronization Therapy Device 39 Description 39 Applications 40 Technology 40 Manufacturers 40 TABLE 4 CARDIAC RESYNCHRONIZATION DEVICE MANUFACTURERS 40 Patent Analysis 40 FIGURE 4 NUMBER OF U.S. CARDIAC RESYNCHRONIZATION DEVICE PATENTS ISSUED, MARCH 15, 2016 (%) Implantable Loop Recorders 41 Description 41 Applications 41 Technology 42 Manufacturers

4 Patent Analysis 42 Cardiac Assist/Replacement Devices 42 Description 42 Applications 42 Technology 43 TABLE 5 IMPLANTABLE HEART ASSIST DEVICES 44 Ventricle Assisted 45 Pulsatile versus Continuous-Flow Pumping 45 Percutaneous versus Transcutaneous Devices 46 Power Source 46 Other Technical Developments 47 High-Performance Materials 47 Greater Longevity 47 Miniaturization 47 Manufacturers 47 TABLE 6 CARDIAC ASSIST/REPLACEMENT DEVICE MANUFACTURERS 48 Patent Analysis 48 FIGURE 5 NUMBER OF U.S. CARDIAC ASSIST/REPLACEMENT DEVICE PATENTS ISSUED, MARCH 15, 2016 (%) NEUROSTIMULATORS 49 Spinal Nerve Stimulators 50 Description 50 Applications 50 Technologies 50 Spinal Nerve Stimulators for Chronic Pain 51 Spinal Stimulators for Spinal Cord Injury 51 Freehand 51 Vocare 51 Implantable Breathing Pacemaker 52 Recent Developments in Spinal Nerve Stimulators for SCI Spinal Nerve Stimulators for Urge Incontinence 54 Manufacturers 54 TABLE 7 SPINAL CORD STIMULATOR MANUFACTURERS 54 Recent Patents 55 Vagal Nerve Stimulator 55 Description 55 Applications 55 Technology 55 Manufacturers 56 Patent Analysis 56 Gastric Nerve Stimulation 56 Description 56 Applications 56 Technology 57 Manufacturers 57 Patents

5 FIGURE 6 NUMBER OF GASTRIC ELECTRICAL STIMULATION TECHNOLOGY PATENTS ISSUED, MARCH 15, 2016 (%) Cortical Stimulation 58 Description 58 Applications 59 Poststroke Recovery 59 Epilepsy Treatment 59 Technology 60 Manufacturers 60 Patents 60 FIGURE 7 NUMBER OF CORTICAL STIMULATION TECHNOLOGY PATENTS ISSUED MARCH 15, 2016 (%) Deep Brain Stimulation 61 Description 61 Applications 61 Technology 62 Manufacturers 62 Patent Analysis 63 FIGURE 8 NUMBER OF DEEP BRAIN STIMULATION TECHNOLOGY PATENTS ISSUED, MARCH 15, 2016 (%) SPINAL FUSION STIMULATORS 64 Description 64 Applications 64 Technology 64 Manufacturers 64 TABLE 8 SPINAL FUSION STIMULATOR MANUFACTURERS 64 Patent Analysis 65 IMPLANTABLE DRUG DIFFUSION PUMPS 65 Description 65 Applications 65 Technology 65 Microfluidics 66 Manufacturers 66 TABLE 9 IMPLANTABLE DRUG PUMP MANUFACTURERS 66 Patent Analysis 66 EAR IMPLANTS 67 Cochlear Implants 67 Description 67 Applications 67 Technology 67 Multichannel Cochlear Implants 67 Speech Coding 68 Miniaturization 68 Hybrid Cochlear Implants 68 Totally Implantable Cochlear Implants 69 Dual Microphone Directional Technology 69 Wireless Hearing Assistance Technologies 69 Manufacturers

6 TABLE 10 COCHLEAR IMPLANT MANUFACTURERS 70 Patent Analysis 70 FIGURE 9 NUMBER OF U.S. COCHLEAR IMPLANT PATENTS ISSUED, MARCH 15, 2016 (%) Middle Ear Implants 71 Description 71 Applications 71 Technologies 71 Piezoelectric Middle Ear Implants 71 Electromagnetic Middle Ear Implants 71 Other Differences 72 Manufacturers 72 TABLE 11 MIDDLE EAR IMPLANT MANUFACTURERS 72 Patent Analysis 73 FIGURE 10 NUMBER OF U.S. MIDDLE EAR IMPLANT PATENTS ISSUED, MARCH 15, 2016 (%) OCULAR IMPLANTS 73 Description 73 Applications 74 Technologies 74 Cortical Implants 74 Retinal Implants 74 Epiretinal Implants 74 Boston Retinal Implant Project 75 Second Sight Medical Products Inc. 76 Intelligent Medical Implants 76 Pixium Vision 76 Subretinal Implants 77 Optobionics Corp. 77 Retina Implant GmbH 78 Bionic Vision Australia 78 Hybrid Implants 78 Telescopic Implants 79 Optic Nerve Stimulator 79 Cortical Visual Prostheses 79 Patents 80 FIGURE 11 NUMBER OF U.S. RETINAL IMPLANT PATENTS ISSUED, MARCH 15, 2016 (%) COMPONENTS AND SUPPLIES 81 Batteries 81 Lithium/Iodine Pacemaker Cells 81 Lithium/Silver Vanadium Oxide Defibrillator Cells 81 Lithium Carbon Monofluoride Cells 81 Lithium/Silver Vanadium Oxide/Fluorinated Carbon Cells 81 Lithium Ion Rechargeable Batteries 82 Other Technologies 82 Leads and Electrodes

7 CHAPTER 4 REGULATORY AND LEGISLATIVE ISSUES 85 UNITED STATES 85 EUROPEAN UNION 87 JAPAN 89 CHAPTER 5 GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS 91 SUMMARY 91 FIGURE 12 GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS, ($ BILLIONS) DETAILED MARKET ESTIMATES AND PROJECTIONS, TABLE 12 GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS BY TYPE OF IMPLANT, THROUGH 2021 ($ FIGURE 13 MARKET SHARES OF MICROELECTRONIC MEDICAL IMPLANT APPLICATIONS, 2015 AND 2021 (%) CARDIAC IMPLANTS 94 TABLE 13 GLOBAL MARKET FOR CARDIAC IMPLANTS, THROUGH 2021 ($ 94 FIGURE 14 MARKET SHARES OF CARDIOVASCULAR IMPLANTS, 2015 AND 2021 (%) 94 Pacemakers 96 Historical Sales of Pacemakers 96 Market Dynamics 96 Projected Sales of Pacemakers 97 TABLE 14 GLOBAL MARKET FOR PACEMAKERS, THROUGH 2021 ($ 97 Implanted Cardioverter Defibrillators 97 Historical Sales 97 Market Dynamics 97 New Indications 97 TABLE 15 ICD INDICATIONS 98 Expanded Medical Insurance Coverage 98 Low Market Penetration 99 Projected Sales 99 TABLE 16 GLOBAL MARKET FOR ICD, THROUGH 2021 ($ 99 Cardiac Resynchronization Therapy Devices 99 Implantable Loop Recorders 99 Historical Sales 100 Market Dynamics 100 Number of New Syncope Cases 100 TABLE 17 U.S. POPULATION AGED 55 AND OLDER, THROUGH 2021 ( 100 Diagnostic Use of ILR 100 Projected Sales 101 TABLE 18 GLOBAL MARKET FOR ILR, THROUGH 2021 ($ 101 Cardiac Assist/Replacement Devices 101 Historical Sales 101 Market Dynamics 101 Bridge-to-Transplant Applications 102 Destination Therapy Applications 102 Health Insurance Trends 102 Constraints on Number of Qualified Surgeons 103 Projected Sales

8 TABLE 19 GLOBAL MARKET FOR CARDIAC ASSIST AND REPLACEMENT DEVICES, THROUGH 2021 ($ NEUROSTIMULATORS 104 TABLE 20 GLOBAL MARKET FOR NEUROSTIMULATORS, THROUGH 2021 ($ FIGURE 15 MARKET SHARES OF IMPLANTED NEUROSTIMULATOR, 2015 AND 2021 (%) Spinal Nerve Stimulators 105 TABLE 21 GLOBAL MARKET FOR SPINAL NERVE STIMULATORS, THROUGH 2021 ($ Spinal Nerve Stimulators for Chronic Pain Historical Sales 106 Market Dynamics 106 FIGURE 16 MARKET PENETRATION OF SPINAL NERVE STIMULATOR FOR CHRONIC PAIN MANAGEMENT, 2015 (%) 106 Projected Sales 107 TABLE 22 GLOBAL MARKET FOR SPINAL NERVE STIMULATORS USED FOR CHRONIC PAIN MANAGEMENT, THROUGH 2016 ($ Spinal Nerve Stimulators for Spinal Cord Injury Historical Sales 108 Market Dynamics 108 Projected Sales 108 TABLE 23 GLOBAL MARKET FOR SPINAL NERVE STIMULATORS USED FOR SPINAL CORD INJURY, THROUGH 2021 ($ Spinal Nerve Stimulators for Urge Incontinence Historical Sales 109 Market Dynamics 109 Projected Sales 109 TABLE 24 MARKET SALES OF SPINAL STIMULATORS FOR MANAGING URGE INCONTINENCE, THROUGH 2021 ($ Vagal Nerve Stimulators 110 Historical Sales 110 Market Dynamics Epilepsy Cases 110 FIGURE 17 MARKET PENETRATION OF VNS EPILEPSY, Depression 111 Future Sales 111 TABLE 25 MARKET SALES OF VNS STIMULATORS, THROUGH 2021 ($ 112 Deep Brain Stimulators 112 Historical Sales 112 Market Dynamics 112 FIGURE 18 MARKET PENETRATION OF DEEP BRAIN STIMULATION IMPLANTS, Projected Sales 113 TABLE 26 MARKET SALES OF DEEP BRAIN STIMULATORS, THROUGH 2021 ($ SPINAL FUSION STIMULATORS 113 Historical Sales 113 Market Dynamics 114 Projected Sales

9 TABLE 27 MARKET SALES OF SPINAL FUSION STIMULATORS, THROUGH 2016 ($ DRUG PUMPS 114 Historical Sales 115 Market Dynamics 115 FIGURE 19 GROWTH IN SALES OF IMPLANTABLE DRUG PUMPS VERSUS TRENDS IN MAJOR TARGET MARKETS, (%) Projected Sales 116 TABLE 28 MARKET SALES OF DRUG PUMPS, THROUGH 2021 ($ 116 HEARING IMPLANTS 116 TABLE 29 MARKET SALES OF HEARING IMPLANTS, THROUGH 2021 ($ 117 Cochlear Implants 117 Historical Sales 117 Market Dynamics 117 FIGURE 20 MARKET PENETRATION OF COCHLEAR IMPLANTS, 2015 (%) 117 Projected Sales 118 TABLE 30 MARKET SALES OF COCHLEAR IMPLANTS, THROUGH 2021 ($ 118 Middle Ear Implants 119 Historical Sales 119 Market Dynamics 119 Projected Sales 119 TABLE 31 MARKET SALES OF MIDDLE EAR IMPLANTS, THROUGH 2021 ($ 120 EYE IMPLANTS 120 Historical Sales 120 Market Dynamics 120 Projected Sales 121 TABLE 32 MARKET SALES OF RETINAL IMPLANTS, THROUGH 2021 ($ 121 ACCESSORIES AND SUPPLIES 122 Historical Sales 122 Market Dynamics 122 Projected Sales 122 TABLE 33 MARKET SALES OF IMPLANTABLE LEADS AND ELECTRODES, THROUGH 2021 ($ CHAPTER 6 INDUSTRY STRUCTURE AND COMPETITION 125 MARKET SHARES 125 CARDIAC RHYTHM MANAGEMENT DEVICES 125 Pacemakers 125 FIGURE 21 MARKET SHARES OF CARDIAC PACEMAKERS, 2015 (%) 125 Implantable Cardioverter Defibrillators 126 FIGURE 22 MARKET SHARES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, 2015 (%) Implantable Loop Recorders 126 Heart Assist/Replacement Devices 126 FIGURE 23 MARKET SHARES OF IMPLANTABLE HEART ASSIST/REPLACEMENT DEVICE, 2015 (%) NEUROSTIMULATORS 127 Spinal Stimulators

10 FIGURE 24 MARKET SHARES OF SPINAL STIMULATOR, 2015 (%) 127 SPINAL FUSION STIMULATORS 128 FIGURE 25 MARKET SHARES OF SPINAL FUSION STIMULATOR, IMPLANTABLE DRUG INFUSION PUMPS 129 EAR IMPLANTS 129 Cochlear Implants 129 FIGURE 26 MARKET SHARES OF COCHLEAR IMPLANTS, CHAPTER 7 VENDOR PROFILES 132 ABIOMED INC. 132 ADVANCED BIONICS CORP. 132 BIOMET INC. 133 BIOPHAN TECHNOLOGIES INC. 133 BIOTRONIK GMBH 133 BOSTON SCIENTIFIC 134 CLEVELAND FES CENTER 134 COCHLEAR LIMITED 134 CYBERONICS INC. 135 ENVOY MEDICAL 136 FINETECH MEDICAL LTD. 136 GREATBATCH INC. 137 HEARTWARE 137 JARVIK HEART INC. 137 MED-EL 138 MEDTRONIC INC. 138 NEUROPACE INC. 138 RETINA IMPLANT AG 139 ST. JUDE MEDICAL INC. 139 SECOND SIGHT MEDICAL PRODUCTS INC. 140

11 LIST OF TABLES TABLE HEADING SUMMARY TABLE GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS, BY APPLICATION, THROUGH 2021 ($ TABLE 1 HOSPITALIZATIONS, PHYSICIAN OFFICE VISITS AND DEATHS DUE TO HEART DISEASE IN THE U.S., 2009 TABLE 2 HEART PACEMAKER MANUFACTURERS 35 TABLE 3 IMPLANTABLE DEFIBRILLATOR MANUFACTURERS 38 TABLE 4 CARDIAC RESYNCHRONIZATION DEVICE MANUFACTURERS 40 TABLE 5 IMPLANTABLE HEART ASSIST DEVICES 44 TABLE 6 CARDIAC ASSIST/REPLACEMENT DEVICE MANUFACTURERS 48 TABLE 7 SPINAL CORD STIMULATOR MANUFACTURERS 54 TABLE 8 SPINAL FUSION STIMULATOR MANUFACTURERS 64 TABLE 9 IMPLANTABLE DRUG PUMP MANUFACTURERS 66 TABLE 10 COCHLEAR IMPLANT MANUFACTURERS 70 TABLE 11 MIDDLE EAR IMPLANT MANUFACTURERS 72 TABLE 12 GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS BY TYPE OF IMPLANT, THROUGH 2021 ($ TABLE 13 GLOBAL MARKET FOR CARDIAC IMPLANTS, THROUGH 2021 ($ 94 TABLE 14 GLOBAL MARKET FOR PACEMAKERS, THROUGH 2021 ($ 97 TABLE 15 ICD INDICATIONS 98 TABLE 16 GLOBAL MARKET FOR ICD, THROUGH 2021 ($ 99 TABLE 17 U.S. POPULATION AGED 55 AND OLDER, THROUGH 2021 ( 100 TABLE 18 GLOBAL MARKET FOR ILR, THROUGH 2021 ($ 101 TABLE 19 GLOBAL MARKET FOR CARDIAC ASSIST AND REPLACEMENT DEVICES, THROUGH 2021 ($ TABLE 20 GLOBAL MARKET FOR NEUROSTIMULATORS, THROUGH 2021 ($ 104 TABLE 21 GLOBAL MARKET FOR SPINAL NERVE STIMULATORS, THROUGH 2021 ($ TABLE 22 GLOBAL MARKET FOR SPINAL NERVE STIMULATORS USED FOR CHRONIC PAIN MANAGEMENT, THROUGH 2016 ($ TABLE 23 GLOBAL MARKET FOR SPINAL NERVE STIMULATORS USED FOR SPINAL CORD INJURY, THROUGH 2021 ($ TABLE 24 MARKET SALES OF SPINAL STIMULATORS FOR MANAGING URGE INCONTINENCE, THROUGH 2021 ($ TABLE 25 MARKET SALES OF VNS STIMULATORS, THROUGH 2021 ($ 112 TABLE 26 MARKET SALES OF DEEP BRAIN STIMULATORS, THROUGH 2021 ($ TABLE 27 MARKET SALES OF SPINAL FUSION STIMULATORS, THROUGH 2016 ($ TABLE 28 MARKET SALES OF DRUG PUMPS, THROUGH 2021 ($ 116 TABLE 29 MARKET SALES OF HEARING IMPLANTS, THROUGH 2021 ($ 117 TABLE 30 MARKET SALES OF COCHLEAR IMPLANTS, THROUGH 2021 ($ 118 TABLE 31 MARKET SALES OF MIDDLE EAR IMPLANTS, THROUGH 2021 ($ 120 TABLE 32 MARKET SALES OF RETINAL IMPLANTS, THROUGH 2021 ($ 121 TABLE 33 MARKET SALES OF IMPLANTABLE LEADS AND ELECTRODES, THROUGH 2021 ($

12 LIST OF FIGURES FIGURE TITLE SUMMARY FIGURE GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS, BY APPLICATION, ($ FIGURE 1 TRENDS IN U.S. CANCER DEATHS, (NO. OF DEATHS) 31 FIGURE 2 NUMBER OF U.S. PACEMAKER-RELATED PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 3 NUMBER OF U.S. ICD-RELATED PATENTS ISSUED, MARCH 15, 2016 (%) 39 FIGURE 4 NUMBER OF U.S. CARDIAC RESYNCHRONIZATION DEVICE PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 5 NUMBER OF U.S. CARDIAC ASSIST/REPLACEMENT DEVICE PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 6 NUMBER OF GASTRIC ELECTRICAL STIMULATION TECHNOLOGY PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 7 NUMBER OF CORTICAL STIMULATION TECHNOLOGY PATENTS ISSUED MARCH 15, 2016 (%) FIGURE 8 NUMBER OF DEEP BRAIN STIMULATION TECHNOLOGY PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 9 NUMBER OF U.S. COCHLEAR IMPLANT PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 10 NUMBER OF U.S. MIDDLE EAR IMPLANT PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 11 NUMBER OF U.S. RETINAL IMPLANT PATENTS ISSUED, MARCH 15, 2016 (%) FIGURE 12 GLOBAL MARKET FOR MICROELECTRONIC MEDICAL IMPLANTS, ($ BILLIONS) FIGURE 13 MARKET SHARES OF MICROELECTRONIC MEDICAL IMPLANT APPLICATIONS, 2015 AND 2021 (%) FIGURE 14 MARKET SHARES OF CARDIOVASCULAR IMPLANTS, 2015 AND 2021 (%) 94 FIGURE 15 MARKET SHARES OF IMPLANTED NEUROSTIMULATOR, 2015 AND 2021 (%) 105 FIGURE 16 MARKET PENETRATION OF SPINAL NERVE STIMULATOR FOR CHRONIC PAIN MANAGEMENT, 2015 (%) FIGURE 17 MARKET PENETRATION OF VNS EPILEPSY, FIGURE 18 MARKET PENETRATION OF DEEP BRAIN STIMULATION IMPLANTS, FIGURE 19 GROWTH IN SALES OF IMPLANTABLE DRUG PUMPS VERSUS TRENDS IN MAJOR TARGET MARKETS, (%) FIGURE 20 MARKET PENETRATION OF COCHLEAR IMPLANTS, 2015 (%) 117 FIGURE 21 MARKET SHARES OF CARDIAC PACEMAKERS, 2015 (%) 125 FIGURE 22 MARKET SHARES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, 2015 (%) FIGURE 23 MARKET SHARES OF IMPLANTABLE HEART ASSIST/REPLACEMENT DEVICE, 2015 (%) FIGURE 24 MARKET SHARES OF SPINAL STIMULATOR, 2015 (%) 127 FIGURE 25 MARKET SHARES OF SPINAL FUSION STIMULATOR, FIGURE 26 MARKET SHARES OF COCHLEAR IMPLANTS,