Table of Contents for Medical Device Coatings
Table of Contents
INTRODUCTION XX
STUDY GOAL AND OBJECTIVES XX
REASONS FOR DOING THE STUDY XXI
CONTRIBUTIONS OF THE STUDY AND FOR WHOM XXI
SCOPE AND FORMAT XXI
METHODOLOGY XXII
INFORMATION SOURCES XXII
ANALYST'S CREDENTIALS XXII
RELATED BCC WORK CREDENTIALS XXIII
BCC ONLINE SERVICES XXIII
DISCLAIMER XXIII
SUMMARY XXIV
Summary Table:
GLOBAL SIZE OF THE MEDICAL DEVICE COATING MARKET, BY REGION, THROUGH 2010 ($ BILLIONS) XXV
Summary Figure:
GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS, 2005 AND 2010 ($ BILLIONS) XXVI
INDUSTRY OVERVIEW 1
HOW COATINGS IMPROVE MEDICAL DEVICES 1
HOW COATINGS IMPROVE MEDICAL DEVICES (CONTINUED) 2
THE STRUCTURE OF THE MEDICAL DEVICE COATING INDUSTRY 3
Table 1 SIZE OF THE MEDICAL DEVICE INDUSTRTY BY REGION, THROUGH 2010 ($ BILLIONS) 4
INTERNATIONAL COOPERATION AND HARMONIZATION 4
Table 2 ISO STANDARDS PERTAINING TO MEDICAL DEVICE COATINGS 5
Table 3 ASTM COATING-RELATED STANDARDS 5
Table 3 (CONTINUED) 6
Table 4 ASTM MEDICAL DEVICE MATERIALS STANDARDS 6
Table 4 (CONTINUED) 7
Table 4 (CONTINUED) 8
Table 4 (CONTINUED) 9
Table 4 (CONTINUED) 10
NATIONALLY BASED ORGANIZATIONS 10
Nationally Based Organizations (Continued) 11
Nationally Based Organizations (Continued) 12
COATINGS BUYERS 13
Coatings Buyers (Continued) 14
Table 5 SUPPLIERS OF FIVE OR MORE FDA-LISTED MEDICAL DEVICES 15
Table 5 (CONTINUED)16
Table 5 (CONTINUED) 17
COATING PROVIDERS 17
4th State 18
Abbott Laboratories/Biocompatibles International 19
Adhesive Consultants 19
Advanced Cardiovascular Systems 20
All-Chemie 20
Allvivo Vascular 20
Affinergy 20
Angiotech Pharmaceuticals/STS Biopolymers 20
Armoloy of Connecticut 21
AST Products 21
Bacterin International 21
Biocoat 21
Biophan 22
BioSurface Engineering Technologies 22
Bristol-Myers Squibb 22
CardioTech International 22
CERAC 22
Ceragenix Pharmaceuticals 23
Devro 23
Gore/Carmeda 23
GFS CHEMICALS 24
Hemoteq 24
Hydromer 24
Implant Sciences 24
MC3 25
MIV Therapeutics 25
Nanocopoeia 25
Nerites 25
Novartis Pharma 26
Para Tech Coating 26
Polymerix 26
Reflex Analytical 26
Spire 26
Surface Solutions Labs 27
SurModics 27
Target Materials 28
Techni-Met 28
TyRx Pharma 28
CUSTOMER-SUPPLIER CONSOLIDATION CONTINUES 29
ACADEMIC RESEARCH DRIVES THE COATINGS BUSINESS MODEL 29
Academic Research Drives the Coatings…(Continued) 30
THE FDA AND THE COATING INDUSTRY 31
COATINGS PROMPT THE FDA TO CREATE A NEW PRODUCT CATEGORY 32
Coatings Prompt the FDA to Create…(Continued) 33
FDA CONTROL CLASS DESIGNATIONS DIVIDE THE COATING MARKET 34
FDA Control Class Designations…(Continued) 35
Table 6 NUMBER OF MEDICAL DEVICES, BY APPLICATION AND CONTROL CLASS BY NUMBER OF PRODUCT VARIATIONS) 36
Class I Medical Devices 36
Table 7 25 MOST WIDELY MANUFACTURED CLASS I MEDICAL DEVICES (BY NUMBER OF PRODUCT VARIATIONS) 37
Table 7 (CONTINUED) 38
Table 8 GLOBAL DEMAND FOR COATINGS FOR CLASS I MEDICAL DEVICES BY PLATFORM, THROUGH 2010 ($ BILLIONS) 38
Figure 1 GLOBAL DEMAND FOR COATINGS FOR CLASS I MEDICAL DEVICES BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 39
Class II Medical Devices 39
Table 9 25 MOST WIDELY MANUFACTURED CLASS II MEDICAL DEVICES (BY NUMBER OF PRODUCT VARIATIONS) 40
Table 10 GLOBAL DEMAND FOR COATINGS FOR CLASS II MEDICAL DEVICES BY PLATFORM, THROUGH 2010 ($ BILLIONS) 41
Figure 2 GLOBAL DEMAND FOR COATINGS FOR CLASS II MEDICAL DEVICES BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 41
Class III Medical Devices 42
Table 11 25 MOST WIDELY MANUFACTURED CLASS III MEDICAL DEVICES (BY NUMBER OF PRODUCT VARIATIONS) 43
Table 12 GLOBAL DEMAND FOR COATINGS FOR CLASS III MEDICAL DEVICES BY PLATFORM, THROUGH 2010 ($ BILLIONS) 44
Figure 3 GLOBAL DEMAND FOR COATINGS FOR CLASS III MEDICAL DEVICES BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 44
Table 13 FORECAST FOR ARTIFICIAL KNEES AND HIPS, THROUGH 2010 ($ BILLIONS) 45
FDA MEDICAL PANEL ASSIGNMENTS FURTHER SEGMENT THE MARKET 45
Table 14 FDA EXPERT PANELS AND THEIR DEVICE REVIEW AUTHORITY 46
Table 14 (CONTINUED) 47
FACTORS AFFECTING THE DEMAND FOR MEDICAL DEVICE COATINGS 47
TRENDS IN HEALTHCARE EXPENDITURES 48
Table 15 TRADITIONAL AND FDA MARKETS FOR MEDICAL DEVICES, THROUGH 2010 ($ BILLIONS) 48
Table 15 (CONTINUED) 49
PRESSURE IMPOSED BY AN AGING POPULATION 49
Table 16 GLOBAL GROWTH IN AGE 65 AND OLDER POPULATIONS, THROUGH 2010 (MILLIONS) 50
Table 17 AVERAGE LENGTH OF HOSPITAL STAY BY SEX AND AGE (DAYS) 51
Table 18 MOST COMMON INPATIENT SURGERY FOR OLDER AMERICANS, 2002 51
PRODUCT DIVERSITY AS A LEADING INDICATOR OF COATING DEMAND 52
Table 19 PRODUCT DIVERSITY AS AN INDICATOR OF DEMAND FOR COATINGS CLASS I MEDICAL DEVICES (BY NUMBER OF TYPES OF GENERIC PRODUCTS) 53
Table 19 (CONTINUED) 54
Table 20 PRODUCT DIVERSITY AS AN INDICATOR OF DEMAND FOR COATINGS CLASS II MEDICAL DEVICES 54
Table 20 (CONTINUED) 55
Table 21 PRODUCT DIVERSITY AS AN INDICATOR OF DEMAND FOR COATINGS CLASS III MEDICAL DEVICES 55
Table 21 (CONTINUED) 56
DEMAND FOR MEDICAL DEVICE COATINGS-BY REGION 57
Table 22 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY REGION, THROUGH 2010 ($ BILLIONS) 58
Figure 4 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY REGION, 2005 AND 2010 ($ BILLIONS) 58
DEMAND FOR MEDICAL DEVICE COATINGS-BY TECHNOLOGY PLATFORM 59
Table 23 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY PLATFORM, THROUGH 2010 ($ BILLIONS) 59
Figure 5 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 60
ACTIVE COATINGS 60
Active Coatings (Continued) 61
NANOTECHNOLOGY COATINGS 62
OPTICAL COATINGS 63
PROTECTIVE COATINGS 63
Protective Coatings (Continued) 64
DEMAND FOR MEDICAL DEVICE COATINGS-BY APPLICATION 65
Table 24 FACTORS INFLUENCING THE DEMAND FOR NEW COATINGS 65
Table 24 (CONTINUED) 66
Table 25 GLOBAL DEMAND FOR COATINGS IN MEDICAL APPLICATIONS, THROUGH 2010 ($ BILLIONS) 67
CARDIOVASCULAR MEDICINE 68
Table 26 10 FASTEST GROWING CARDIOVASCULAR MEDICAL DEVICES, THROUGH 2010 ($ BILLIONS) 69
Table 27 LEADING CARDIOVASCULAR IMPLANT SUPPLIERS (%) 70
Table 28 FDA REGULATED CARDIOVASCULAR MEDICAL DEVICES (NUMBER OF TYPES OF UNIQUE DEVICES) 70
Table 29 DEMAND FOR COATINGS IN CARDIOVASCULAR DEVICES ($ BILLIONS) 70
Table 30 DEMAND FOR COATINGS FOR CARDIOVASCULAR DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 71
Figure 6 DEMAND FOR COATINGS FOR CARDIOVASCULAR DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 71
Table 31 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR THE MOST WIDELY MANUFACTURED CARDIOVASCULAR DEVICES 72
Table 31 (CONTINUED) 73
Table 31 (CONTINUED) 74
DENTISTRY 74
Table 32 FDA REGULATED DENTAL DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 75
Table 33 DEMAND FOR COATINGS IN DENTAL DEVICES, THROUGH 2010 ($ BILLIONS) 75
Table 34 DEMAND FOR COATINGS FOR DENTAL DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 75
Figure 7 DEMAND FOR COATINGS FOR DENTAL DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 76
Table 35 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED DENTAL DEVICES 76
Table 35 (CONTINUED) 77
Table 35 (CONTINUED) 78
GENERAL HOSPITAL AND PERSONAL USE DEVICES 79
Table 36 FDA REGULATED GENERAL HOSPITAL AND PERSONAL USE DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 80
Table 37 DEMAND FOR COATINGS IN GENERAL HOSPITAL AND PERSONAL USE DEVICES, THROUGH 2010 ($ BILLIONS) 81
Table 38 DEMAND FOR PROTECTIVE COATINGS FOR GENERAL HOSPITAL AND PERSONAL USE DEVICES BY REGION, THROUGH 2010 ($ BILLIONS) 81
Figure 8 DEMAND FOR PROTECTIVE COATINGS FOR GENERAL HOSPITAL AND PERSONAL USE DEVICES BY REGION, 2005 AND 2010 ($ BILLIONS) 82
Table 39 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED GENERAL HOSPITAL AND PERSONAL USE DEVICES 82
Table 39 (CONTINUED) 83
Table 39 (CONTINUED) 84
GENERAL AND PLASTIC SURGERY 84
Table 40 U.S. SURGICAL SUMMARY, 1996 85
Table 41 MOST COMMON SURGICAL COSMETIC PROCEDURES IN THE U.S., 2004 85
Table 42 TOP COSMETIC PROCEDURES FOR MEN IN 2004 86
Table 43 FDA REGULATED GENERAL AND PLASTIC SURGERY DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 86
Table 44 DEMAND FOR COATINGS IN GENERAL AND PLASTIC SURGERY DEVICES, THROUGH 2010 ($ BILLIONS) 87
Table 45 DEMAND FOR COATINGS FOR GENERAL AND PLASTIC SURGERY DEVICES BY REGION, THROUGH 2010 ($ BILLIONS) 87
Figure 9 DEMAND FOR COATINGS FOR GENERAL AND PLASTIC SURGERY DEVICES BY REGION, 2005 AND 2010 ($ BILLIONS) 87
Table 46 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED GENERAL AND PLASTIC SURGERY DEVICES 88
Table 46 (CONTINUED) 89
Table 46 (CONTINUED) 90
Table 46 (CONTINUED) 91
NEUROLOGY 91
Neurology (Continued) 92
Table 47 MOST WIDELY MANUFACTURED CLASS III NEUROLOGICAL DEVICES 93
Table 48 FDA REGULATED NEUROLOGICAL DEVICES, BY CONTROL CLASS (NUMBER OF UNIQUE DEVICES) 94
Table 49 DEMAND FOR COATINGS IN NEUROLOGICAL DEVICES, THROUGH 2010 ($ BILLIONS) 94
Table 50 DEMAND FOR COATINGS FOR NEUROLOGICAL DEVICES BY REGION, THROUGH 2010 ($ BILLIONS) 94
Figure 10 DEMAND FOR COATINGS FOR NEUROLOGICAL DEVICES BY REGION, 2005 AND 2010 ($ BILLIONS) 95
Table 51 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED NEUROLOGICAL DEVICES 95
Table 51 (CONTINUED) 96
Table 51 (CONTINUED) 97
Table 51 (CONTINUED) 98
OPHTHALMOLOGY 98
Ophthalmology (Continued) 99
Table 52 FDA REGULATED OPHTHALMIC DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 100
Table 53 DEMAND FOR COATINGS IN OPHTHALMIC DEVICES ($ BILLIONS) 100
Table 54 DEMAND FOR COATINGS FOR OPHTHALMIC DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 100
Figure 11 DEMAND FOR COATINGS FOR OPHTHALMIC DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 101
Table 55 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED OPHTHALMIC DEVICES 101
Table 55 (CONTINUED) 102
Table 55 (CONTINUED) 103
Table 55 (CONTINUED) 104
ORTHOPEDICS 104
Table 56 FDA REGULATED ORTHOPEDIC DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 105
Table 57 DEMAND FOR COATINGS IN ORTHOPEDIC DEVICES, THROUGH 2010 ($ BILLIONS) 106
Table 58 DEMAND FOR COATINGS IN ORTHOPEDIC DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 106
Figure 12 DEMAND FOR COATINGS IN ORTHOPEDIC DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 106
Table 59 LEADING BRANDS OF HIP IMPLANTS IN THE U.S. 107
Table 60 LEADING BRANDS OF KNEE IMPLANTS IN THE U.S. 108
Table 61 LEADING ORTHOPEDIC DEVICES SUPPLIERS (PERCENT OF MARKET) 108
Table 62 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED ORTHOPEDIC DEVICES 109
Table 62 (CONTINUED) 110
Table 62 (CONTINUED) 111
Table 62 (CONTINUED) 112
RADIOLOGY 112
Table 63 FDA REGULATED RADIOLOGIC DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 113
Table 64 DEMAND FOR COATINGS IN RADIOLOGIC DEVICES, THROUGH 2010 ($ BILLIONS) 113
Table 65 DEMAND FOR COATINGS IN RADIOLOGICAL DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 114
Figure 13 DEMAND FOR COATINGS IN RADIOLOGICAL DEVICES, BY REGION 2005 AND 2010 ($ BILLIONS) 114
Table 66 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED RADIOLOGICAL DEVICES 115
Table 66 (CONTINUED) 116
Table 66 (CONTINUED) 117
OTHER APPLICATIONS 118
Table 67 COMPARATIVE DEMAND FOR MEDICAL DEVICE COATING IN MAJOR AND MINOR APPLICATION AREAS, THROUGH 2010 ($ BILLIONS) 118
Table 68 APPLICATIONS REQUIRING MAJOR USE OF COATING MATERIALS, THROUGH 2010 ($ BILLIONS) 119
Table 69 APPLICATIONS REQUIRING MINOR USE OF COATING MATERIALS, THROUGH 2010 ($ BILLION) 119
Table 69 (CONTINUED) 120
Table 70 APPLICATIONS REQUIRING MAJOR USE OF COATING MATERIALS, BY REGION, THROUGH 2010 ($ BILLIONS) 120
Table 71 APPLICATIONS REQUIRING MINOR USE OF COATING MATERIALS, BY REGION, THROUGH 2010 ($ BILLIONS) 120
DEMAND FOR MEDICAL DEVICE COATINGS-BY MATERIAL 121
Table 72 CHARACTERISTICS OF COATING MATERIALS AND TECHNOLOGIES 122
Table 73 REQUIREMENT AND FORECAST CHANGE IN COATING MATERIAL BY TECHNOLOGY PLATFORM (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 123
DEMAND FOR MEDICAL DEVICE COATINGS…(CONTINUED) 124
Table 74 DEMAND FOR COATING MATERIALS AND TECHNOLOGIES, THROUGH 2010 ($ BILLIONS) 125
AGENTS AND CARRIERS USED IN COMBINATION PRODUCTS 126
Table 75 ACTIVE AGENTS AND CARRIERS USED IN COMBINATION PRODUCT COATINGS 126
Table 76 DEMAND FOR COMBINATION PRODUCTS AGENTS AND CARRIERS, THROUGH 2010 ($ BILLIONS) 127
Table 77 REQUIREMENT FOR COMBINATION PRODUCT AGENTS AND CARRIERS BY TECHNOLOGY PLATFORM (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 127
Table 78 REGIONAL DEMAND FOR COMBINATION PRODUCT AGENTS AND CARRIERS, THROUGH 2010 ($ BILLIONS) 127
ANGIOTECH PHARMACEUTICALS/STS MEDI-COAT CARRIER TECHNOLOGY 128
BONE MORPHOGENETIC PROTEIN 2 128
CERACIDE 129
COLLAGEN 129
DEXAMETHASONE 129
GORE/CARMEDA BIOACTIVE SURFACE TECHNOLOGY 130
HEPARIN 130
HYALURONAN 131
HYDROGELS 131
HYDROXYAPATITE 131
MUSSEL PROTEIN 132
NITRIC OXIDE 133
PACLITAXEL 133
PARYLENES (POLY-PARA-XYLENE) 134
PHOSPHORYLCHOLINE (PC TECHNOLOGY) 135
POLYMERDRUGS 135
POLYETHYLENE 136
SILVER OXIDE 137
SIROLIMUS, EVEROLIMUS AND ZOTAROLIMUS 138
STEM CELL COATINGS 138
ALLOY COATINGS FOR MEDICAL DEVICES 138
Table 79 METAL CONSUMPTION IN BIOCOMPATIBLE MEDICAL DEVICES, THROUGH 2010 (THOUSAND POUNDS) 139
Table 80 DEMAND FOR ALLOY COATINGS, THROUGH 2010 ($ BILLIONS) 140
Table 81 REQUIREMENT AND FORECAST CHANGE IN ALLOY COATING MATERIALS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 140
Table 82 REGIONAL DEMAND FOR ALLOY COATINGS, THROUGH 2010 ($ BILLIONS) 140
ALUMINUM 141
GOLD 141
NITINOL 141
STAINLESS STEEL 142
TITANIUM 143
ZINC OXIDE 144
CERAMIC COATINGS FOR MEDICAL DEVICES 144
Table 83 DEMAND FOR CERAMIC COATING MATERIALS, THROUGH 2010 ($ BILLIONS) 144
Table 84 REQUIREMENT AND FORECAST CHANGE IN CERAMIC COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM, 2005/2010) 145
Table 85 REGIONAL DEMAND FOR CERAMIC COATINGS, THROUGH 2010 ($ BILLIONS) 145
Table 86 APPLICATIONS FOR CERAMIC BIOMATERIALS IN MEDICAL DEVICES 145
ALUMINA 145
BIOGLASS 146
CARBON-BASED 147
ENERGY-ABSORBING COATINGS FOR MEDICAL DEVICES 148
ENERGY-ABSORBING COATINGS FOR…(CONTINUED) 149
Table 87 DEMAND FOR ENERGY-ABSORBING COATING MATERIALS, THROUGH 2010 ($ BILLIONS) 150
Table 88 REQUIREMENT AND FORECAST CHANGE IN ENERGY-ABSORBING COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 151
Table 89 REGIONAL DEMAND FOR ENERGY-ABSORBING COATINGS, THROUGH 2010 ($ BILLIONS) 151
ENERGY-EMITTING COATINGS FOR MEDICAL DEVICES 151
Table 90 DEMAND FOR ENERGY-EMITTING COATING MATERIALS, THROUGH 2010 ($BILLIONS) 152
Table 91 REQUIREMENT AND FORECAST CHANGE IN ENERGY-EMITTING COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 152
Table 92 REGIONAL DEMAND FOR ENERGY-EMITTING COATINGS, THROUGH 2010 ($ BILLIONS) 152
POLYMER COATINGS FOR MEDICAL DEVICES 153
Table 93 DEMAND FOR POLYMER COATINGS MATERIALS, THROUGH 2010 ($ BILLIONS) 154
Table 94 REQUIREMENT AND FORECAST CHANGE IN POLYMER COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM, 2005/2010) 154
Table 95 REGIONAL DEMAND FOR POLYMER COATINGS, THROUGH 2010 ($ BILLIONS) 155
HEXYL-PVP 155
PDMS POLY(DIMETHYL SILOXANE) 155
POLYURETHANE 156
PTFE POLYTETRAFLUOROETHYLENE TEFLON 156
PVC POLYVINYL CHLORIDE 156
SURFACE TREATMENT TECHNOLOGIES FOR MEDICAL DEVICES 157
Table 96 DEMAND FOR SURFACE TREATMENT TECHNOLOGIES, THROUGH 2010 ($ BILLIONS) 158
Table 97 REQUIREMENT AND FORECAST CHANGE IN SURFACE TREATMENT TECHNOLOGIES (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM, 2005/2010) 158
Table 98 REGIONAL DEMAND FOR SURFACE TREATMENT TECHNOLOGIES, THROUGH 2010 ($ BILLIONS) 158
DIP AND SPRAY COATING REACH A TECHNOLOGICAL LIMIT 158
PLASMA TECHNIQUES 159
ION IMPLANTATION TECHNIQUES 160
LASER ACTIVATION 160
TEXTURING 161
PATENT ANALYSIS 162
Table 99 STENT-RELATED COATING PATENTS 162
Table 99 (CONTINUED) 163
Table 99 (CONTINUED) 164
Table 100 HEPARIN-RELATED COATING PATENTS 164
Table 101 DRUG-RELATED COATING PATENTS 165
Table 102 MEDICAL DEVICE COATING PATENTS ISSUED SINCE 1976 165
Table 102 (CONTINUED) 166
Table 102 (CONTINUED) 167
Table 102 (CONTINUED) 168
Table 102 (CONTINUED) 169
Table 102 (CONTINUED) 170
Table 102 (CONTINUED) 171
APPENDIX 172
EXEMPT CLASS I AND CLASS II MEDICAL DEVICES 172
Table 103 EXEMPT CLASS I AND CLASS II MEDICAL DEVICES 172
Table 103 (CONTINUED) 173
Table 103 (CONTINUED) 174
Table 103 (CONTINUED) 175
Table 103 (CONTINUED) 176
Table 103 (CONTINUED) 177
Table 103 (CONTINUED) 178
Table 103 (CONTINUED) 179
Table 103 (CONTINUED) 180
Table 103 (CONTINUED) 181
Table 103 (CONTINUED) 182
Table 103 (CONTINUED) 183
Table 103 (CONTINUED) 184
Table 103 (CONTINUED) 185
Table 103 (CONTINUED) 186
Table 103 (CONTINUED) 187
Table 103 (CONTINUED) 188
Table 103 (CONTINUED) 189
Table 103 (CONTINUED) 190
Table 103 (CONTINUED) 191
Table 103 (CONTINUED) 192
KEY COATING MATERIALS PATENTS 192
KEY COATING MATERIALS PATENTS (CONTINUED) 193
KEY COATING MATERIALS PATENTS (CONTINUED) 194
KEY COATING MATERIALS PATENTS (CONTINUED) 195
KEY COATING MATERIALS PATENTS (CONTINUED) 196
KEY COATING MATERIALS PATENTS (CONTINUED) 197
KEY COATING MATERIALS PATENTS (CONTINUED) 198
KEY COATING MATERIALS PATENTS (CONTINUED) 199
KEY COATING MATERIALS PATENTS (CONTINUED) 200
KEY COATING MATERIALS PATENTS (CONTINUED) 201
KEY COATING MATERIALS PATENTS (CONTINUED) 202
KEY COATING MATERIALS PATENTS (CONTINUED) 203
KEY COATING MATERIALS PATENTS (CONTINUED) 204
KEY COATING MATERIALS PATENTS (CONTINUED) 205
KEY COATING MATERIALS PATENTS (CONTINUED) 206
KEY COATING MATERIALS PATENTS (CONTINUED) 207
KEY COATING MATERIALS PATENTS (CONTINUED) 208
KEY COATING MATERIALS PATENTS (CONTINUED) 209
KEY COATING MATERIALS PATENTS (CONTINUED) 210
KEY COATING MATERIALS PATENTS (CONTINUED) 211
KEY COATING MATERIALS PATENTS (CONTINUED) 212
KEY COATING MATERIALS PATENTS (CONTINUED) 213
KEY COATING MATERIALS PATENTS (CONTINUED) 214
KEY COATING MATERIALS PATENTS (CONTINUED) 215
KEY COATING MATERIALS PATENTS (CONTINUED) 216
KEY COATING APPLICATIONS PATENTS 217
KEY COATING APPLICATIONS PATENTS (CONTINUED) 218
KEY COATING APPLICATIONS PATENTS (CONTINUED) 219
KEY COATING APPLICATIONS PATENTS (CONTINUED) 220
KEY COATING APPLICATIONS PATENTS (CONTINUED) 221
KEY COATING APPLICATIONS PATENTS (CONTINUED) 222
KEY COATING APPLICATIONS PATENTS (CONTINUED) 223
KEY COATING APPLICATIONS PATENTS (CONTINUED) 224
KEY COATING APPLICATIONS PATENTS (CONTINUED) 225
KEY COATING APPLICATIONS PATENTS (CONTINUED) 226
KEY COATING APPLICATIONS PATENTS (CONTINUED) 227
KEY COATING APPLICATIONS PATENTS (CONTINUED) 228
KEY COATING APPLICATIONS PATENTS (CONTINUED) 229
KEY COATING APPLICATIONS PATENTS (CONTINUED) 230
KEY COATING APPLICATIONS PATENTS (CONTINUED) 231
KEY COATING APPLICATIONS PATENTS (CONTINUED) 232
KEY COATING APPLICATIONS PATENTS (CONTINUED) 233
KEY COATING APPLICATIONS PATENTS (CONTINUED) 234
KEY COATING APPLICATIONS PATENTS (CONTINUED) 235
KEY COATING APPLICATIONS PATENTS (CONTINUED) 236
KEY COATING APPLICATIONS PATENTS (CONTINUED) 237
KEY COATING APPLICATIONS PATENTS (CONTINUED) 238
KEY COATING APPLICATIONS PATENTS (CONTINUED) 239
LIST OF TABLES
GLOBAL SIZE OF THE MEDICAL DEVICE COATING MARKET, BY REGION, THROUGH 2010 ($ BILLIONS) XXV
Table 1 SIZE OF THE MEDICAL DEVICE INDUSTRTY BY REGION, THROUGH 2010 ($ BILLIONS) 4
Table 2 ISO STANDARDS PERTAINING TO MEDICAL DEVICE COATINGS 5
Table 3 ASTM COATING-RELATED STANDARDS 5
Table 4 ASTM MEDICAL DEVICE MATERIALS STANDARDS 6
Table 5 SUPPLIERS OF FIVE OR MORE FDA-LISTED MEDICAL DEVICES 15
Table 6 NUMBER OF MEDICAL DEVICES, BY APPLICATION AND CONTROL CLASS BY NUMBER OF PRODUCT VARIATIONS) 36
Table 7 25 MOST WIDELY MANUFACTURED CLASS I MEDICAL DEVICES (BY NUMBER OF PRODUCT VARIATIONS) 37
Table 8 GLOBAL DEMAND FOR COATINGS FOR CLASS I MEDICAL DEVICES BY PLATFORM, THROUGH 2010 ($ BILLIONS) 38
Table 9 25 MOST WIDELY MANUFACTURED CLASS II MEDICAL DEVICES (BY NUMBER OF PRODUCT VARIATIONS) 40
Table 10 GLOBAL DEMAND FOR COATINGS FOR CLASS II MEDICAL DEVICES BY PLATFORM, THROUGH 2010 ($ BILLIONS) 41
Table 11 25 MOST WIDELY MANUFACTURED CLASS III MEDICAL DEVICES (BY NUMBER OF PRODUCT VARIATIONS) 43
Table 12 GLOBAL DEMAND FOR COATINGS FOR CLASS III MEDICAL DEVICES BY PLATFORM, THROUGH 2010 ($ BILLIONS) 44
Table 13 FORECAST FOR ARTIFICIAL KNEES AND HIPS, THROUGH 2010 ($ BILLIONS) 45
Table 14 FDA EXPERT PANELS AND THEIR DEVICE REVIEW AUTHORITY 46
Table 15 TRADITIONAL AND FDA MARKETS FOR MEDICAL DEVICES, THROUGH 2010 ($ BILLIONS) 48
Table 16 GLOBAL GROWTH IN AGE 65 AND OLDER POPULATIONS, THROUGH 2010 (MILLIONS) 50
Table 17 AVERAGE LENGTH OF HOSPITAL STAY BY SEX AND AGE (DAYS) 51
Table 18 MOST COMMON INPATIENT SURGERY FOR OLDER AMERICANS, 2002 51
Table 19 PRODUCT DIVERSITY AS AN INDICATOR OF DEMAND FOR COATINGS CLASS I MEDICAL DEVICES (BY NUMBER OF TYPES OF GENERIC PRODUCTS) 53
Table 20 PRODUCT DIVERSITY AS AN INDICATOR OF DEMAND FOR COATINGS CLASS II MEDICAL DEVICES 54
Table 21 PRODUCT DIVERSITY AS AN INDICATOR OF DEMAND FOR COATINGS CLASS III MEDICAL DEVICES 55
Table 22 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY REGION, THROUGH 2010 ($ BILLIONS) 58
Table 23 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY PLATFORM, THROUGH 2010 ($ BILLIONS) 59
Table 24 FACTORS INFLUENCING THE DEMAND FOR NEW COATINGS 65
Table 25 GLOBAL DEMAND FOR COATINGS IN MEDICAL APPLICATIONS, THROUGH 2010 ($ BILLIONS) 67
Table 26 10 FASTEST GROWING CARDIOVASCULAR MEDICAL DEVICES, THROUGH 2010 ($ BILLIONS) 69
Table 27 LEADING CARDIOVASCULAR IMPLANT SUPPLIERS (%) 70
Table 28 FDA REGULATED CARDIOVASCULAR MEDICAL DEVICES (NUMBER OF TYPES OF UNIQUE DEVICES) 70
Table 29 DEMAND FOR COATINGS IN CARDIOVASCULAR DEVICES ($ BILLIONS) 70
Table 30 DEMAND FOR COATINGS FOR CARDIOVASCULAR DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 71
Table 31 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR THE MOST WIDELY MANUFACTURED CARDIOVASCULAR DEVICES 72
Table 32 FDA REGULATED DENTAL DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 75
Table 33 DEMAND FOR COATINGS IN DENTAL DEVICES, THROUGH 2010 ($ BILLIONS) 75
Table 34 DEMAND FOR COATINGS FOR DENTAL DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 75
Table 35 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED DENTAL DEVICES 76
Table 36 FDA REGULATED GENERAL HOSPITAL AND PERSONAL USE DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 80
Table 37 DEMAND FOR COATINGS IN GENERAL HOSPITAL AND PERSONAL USE DEVICES, THROUGH 2010 ($ BILLIONS) 81
Table 38 DEMAND FOR PROTECTIVE COATINGS FOR GENERAL HOSPITAL AND PERSONAL USE DEVICES BY REGION, THROUGH 2010 ($ BILLIONS) 81
Table 39 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED GENERAL HOSPITAL AND PERSONAL USE DEVICES 82
Table 40 U.S. SURGICAL SUMMARY, 1996 85
Table 41 MOST COMMON SURGICAL COSMETIC PROCEDURES IN THE U.S., 2004 85
Table 42 TOP COSMETIC PROCEDURES FOR MEN IN 2004 86
Table 43 FDA REGULATED GENERAL AND PLASTIC SURGERY DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 86
Table 44 DEMAND FOR COATINGS IN GENERAL AND PLASTIC SURGERY DEVICES, THROUGH 2010 ($ BILLIONS) 87
Table 45 DEMAND FOR COATINGS FOR GENERAL AND PLASTIC SURGERY DEVICES BY REGION, THROUGH 2010 ($ BILLIONS) 87
Table 46 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED GENERAL AND PLASTIC SURGERY DEVICES 88
Table 47 MOST WIDELY MANUFACTURED CLASS III NEUROLOGICAL DEVICES 93
Table 48 FDA REGULATED NEUROLOGICAL DEVICES, BY CONTROL CLASS (NUMBER OF UNIQUE DEVICES) 94
Table 49 DEMAND FOR COATINGS IN NEUROLOGICAL DEVICES, THROUGH 2010 ($ BILLIONS) 94
Table 50 DEMAND FOR COATINGS FOR NEUROLOGICAL DEVICES BY REGION, THROUGH 2010 ($ BILLIONS) 94
Table 51 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED NEUROLOGICAL DEVICES 95
Table 52 FDA REGULATED OPHTHALMIC DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 100
Table 53 DEMAND FOR COATINGS IN OPHTHALMIC DEVICES ($ BILLIONS) 100
Table 54 DEMAND FOR COATINGS FOR OPHTHALMIC DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 100
Table 55 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED OPHTHALMIC DEVICES 101
Table 56 FDA REGULATED ORTHOPEDIC DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 105
Table 57 DEMAND FOR COATINGS IN ORTHOPEDIC DEVICES, THROUGH 2010 ($ BILLIONS) 106
Table 58 DEMAND FOR COATINGS IN ORTHOPEDIC DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 106
Table 59 LEADING BRANDS OF HIP IMPLANTS IN THE U.S. 107
Table 60 LEADING BRANDS OF KNEE IMPLANTS IN THE U.S. 108
Table 61 LEADING ORTHOPEDIC DEVICES SUPPLIERS (PERCENT OF MARKET) 108
Table 62 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED ORTHOPEDIC DEVICES 109
Table 63 FDA REGULATED RADIOLOGIC DEVICES, BY CONTROL CLASS (NUMBER OF TYPES OF UNIQUE DEVICES) 113
Table 64 DEMAND FOR COATINGS IN RADIOLOGIC DEVICES, THROUGH 2010 ($ BILLIONS) 113
Table 65 DEMAND FOR COATINGS IN RADIOLOGICAL DEVICES, BY REGION, THROUGH 2010 ($ BILLIONS) 114
Table 66 FORECAST CHANGES IN THE DEMAND FOR COATINGS FOR MOST WIDELY MANUFACTURED RADIOLOGICAL DEVICES 115
Table 67 COMPARATIVE DEMAND FOR MEDICAL DEVICE COATING IN MAJOR AND MINOR APPLICATION AREAS, THROUGH 2010 ($ BILLIONS) 118
Table 68 APPLICATIONS REQUIRING MAJOR USE OF COATING MATERIALS, THROUGH 2010 ($ BILLIONS) 119
Table 69 APPLICATIONS REQUIRING MINOR USE OF COATING MATERIALS, THROUGH 2010 ($ BILLION) 119
Table 70 APPLICATIONS REQUIRING MAJOR USE OF COATING MATERIALS, BY REGION, THROUGH 2010 ($ BILLIONS) 120
Table 71 APPLICATIONS REQUIRING MINOR USE OF COATING MATERIALS, BY REGION, THROUGH 2010 ($ BILLIONS) 120
Table 72 CHARACTERISTICS OF COATING MATERIALS AND TECHNOLOGIES 122
Table 73 REQUIREMENT AND FORECAST CHANGE IN COATING MATERIAL BY TECHNOLOGY PLATFORM (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 123
Table 74 DEMAND FOR COATING MATERIALS AND TECHNOLOGIES, THROUGH 2010 ($ BILLIONS) 125
Table 75 ACTIVE AGENTS AND CARRIERS USED IN COMBINATION PRODUCT COATINGS 126
Table 76 DEMAND FOR COMBINATION PRODUCTS AGENTS AND CARRIERS, THROUGH 2010 ($ BILLIONS) 127
Table 77 REQUIREMENT FOR COMBINATION PRODUCT AGENTS AND CARRIERS BY TECHNOLOGY PLATFORM (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY LATFORM FROM 2005/2010) 127
Table 78 REGIONAL DEMAND FOR COMBINATION PRODUCT AGENTS AND CARRIERS, THROUGH 2010 ($ BILLIONS) 127
Table 79 METAL CONSUMPTION IN BIOCOMPATIBLE MEDICAL DEVICES, THROUGH 2010 (THOUSAND POUNDS) 139
Table 80 DEMAND FOR ALLOY COATINGS, THROUGH 2010 ($ BILLIONS) 140
Table 81 REQUIREMENT AND FORECAST CHANGE IN ALLOY COATING MATERIALS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 140
Table 82 REGIONAL DEMAND FOR ALLOY COATINGS, THROUGH 2010 ($ BILLIONS) 140
Table 83 DEMAND FOR CERAMIC COATING MATERIALS, THROUGH 2010 ($ BILLIONS) 144
Table 84 REQUIREMENT AND FORECAST CHANGE IN CERAMIC COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM, 2005/2010) 145
Table 85 REGIONAL DEMAND FOR CERAMIC COATINGS, THROUGH 2010 ($ BILLIONS) 145
Table 86 APPLICATIONS FOR CERAMIC BIOMATERIALS IN MEDICAL DEVICES 145
Table 87 DEMAND FOR ENERGY-ABSORBING COATING MATERIALS, THROUGH 2010 ($ BILLIONS) 150
Table 88 REQUIREMENT AND FORECAST CHANGE IN ENERGY-ABSORBING COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 151
Table 89 REGIONAL DEMAND FOR ENERGY-ABSORBING COATINGS, THROUGH 2010 ($ BILLIONS) 151
Table 90 DEMAND FOR ENERGY-EMITTING COATING MATERIALS, THROUGH 2010 ($BILLIONS) 152
Table 91 REQUIREMENT AND FORECAST CHANGE IN ENERGY-EMITTING COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM FROM 2005/2010) 152
Table 92 REGIONAL DEMAND FOR ENERGY-EMITTING COATINGS, THROUGH 2010 ($ BILLIONS) 152
Table 93 DEMAND FOR POLYMER COATINGS MATERIALS, THROUGH 2010 ($ BILLIONS) 154
Table 94 REQUIREMENT AND FORECAST CHANGE IN POLYMER COATINGS (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM, 2005/2010) 154
Table 95 REGIONAL DEMAND FOR POLYMER COATINGS, THROUGH 2010 ($ BILLIONS) 155
Table 96 DEMAND FOR SURFACE TREATMENT TECHNOLOGIES, THROUGH 2010 ($ BILLIONS) 158
Table 97 REQUIREMENT AND FORECAST CHANGE IN SURFACE TREATMENT TECHNOLOGIES (RELATIVE CHANGE IN DEMAND BY TECHNOLOGY PLATFORM, 2005/2010) 158
Table 98 REGIONAL DEMAND FOR SURFACE TREATMENT TECHNOLOGIES, THROUGH 2010 ($ BILLIONS) 158
Table 99 STENT-RELATED COATING PATENTS 162
Table 100 HEPARIN-RELATED COATING PATENTS 164
Table 101 DRUG-RELATED COATING PATENTS 165
Table 102 MEDICAL DEVICE COATING PATENTS ISSUED SINCE 1976 165
Table 103 EXEMPT CLASS I AND CLASS II MEDICAL DEVICES 172
LIST OF FIGURES
GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS, 2005 AND 2010 ($ BILLIONS) XXVI
Figure 1 GLOBAL DEMAND FOR COATINGS FOR CLASS I MEDICAL DEVICES BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 39
Figure 2 GLOBAL DEMAND FOR COATINGS FOR CLASS II MEDICAL DEVICES BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 41
Figure 3 GLOBAL DEMAND FOR COATINGS FOR CLASS III MEDICAL DEVICES BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 44
Figure 4 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY REGION, 2005 AND 2010 ($ BILLIONS) 58
Figure 5 GLOBAL DEMAND FOR MEDICAL DEVICE COATINGS BY PLATFORM, 2005 AND 2010 ($ BILLIONS) 60
Figure 6 DEMAND FOR COATINGS FOR CARDIOVASCULAR DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 71
Figure 7 DEMAND FOR COATINGS FOR DENTAL DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 76
Figure 8 DEMAND FOR PROTECTIVE COATINGS FOR GENERAL HOSPITAL AND PERSONAL USE DEVICES BY REGION, 2005 AND 2010 ($ BILLIONS) 82
Figure 9 DEMAND FOR COATINGS FOR GENERAL AND PLASTIC SURGERY DEVICES BY REGION, 2005 AND 2010 ($ BILLIONS) 87
Figure 10 DEMAND FOR COATINGS FOR NEUROLOGICAL DEVICES BY REGION, 2005 AND 2010 ($ BILLIONS) 95
Figure 11 DEMAND FOR COATINGS FOR OPHTHALMIC DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 101
Figure 12 DEMAND FOR COATINGS IN ORTHOPEDIC DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 106
Figure 13 DEMAND FOR COATINGS IN RADIOLOGICAL DEVICES, BY REGION, 2005 AND 2010 ($ BILLIONS) 114
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