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Table of Contents for Medical Device Coatings



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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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