Medical Device Coatings

  • September 2014
  • -
  • BCC Research
  • -
  • 389 pages

This BCC Research report examines the medical device coating and surface modification treatment industry and describes the eight coating and surface treatment technologies that add value to medical devices used in 19 healthcare areas. Forecasts for each healthcare area are provided for the period 2014 through 2019.

Use this report to:
- Examine the medical device coating and surface modification treatment industry.
- Receive forecasts for healthcare area project demands from 2014 through 2019, for the United States, the European Union, other developed nations as well as the rest of the
world.
- Receive information about how the FDA impacts the structure the global market.
- Learn about the FDA’s major regulatory pathways.

Highlights
- The global medical device coating market reached about $6.1 billion in 2013. This market is expected to grow to $6.3 billion in 2014 and $9 billion in 2019, a compound annual growth rate (CAGR) of 7.3% from 2014 to 2019.
- The United States market reached nearly $3 billion in 2013. This market is expected to grow to $3.1 billion in 2014 and $4.8 billion in 2019, a CAGR of 8.9% from 2014 to 2019.
l The European Union market reached $1.5 billion in 2013. This market is expected to grow to $1.6 billion in 2014 and $2.3 billion in 2019, a CAGR of 7.6% from 2014 to 2019.

Table Of Contents

TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
STUDY GOAL AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
INTENDED AUDIENCE 2
SCOPE AND FORMAT 2
TECHNOLOGIES 3
HEALTHCARE AREAS 3
COUNTRIES AND REGIONS 4
TABLE A EUROPEAN UNION 4
TABLE B OTHER DEVELOPED NATIONS 5
TABLE C REST OF THE WORLD 5
METHODOLOGY 6
INFORMATION SOURCES 6
ANALYST'S CREDENTIALS 7
RELATED BCC WORK CREDENTIALS 7
BCC RESEARCH WEBSITE 7
DISCLAIMER 7
CHAPTER 2 SUMMARY 10
SUMMARY TABLE GLOBAL MEDICAL DEVICE COATING MARKET BY REGION,
THROUGH 2019 ($ MILLIONS) 11
SUMMARY FIGURE GLOBAL REQUIREMENT FOR MEDICAL DEVICE COATINGS BY
REGION, 2012-2019 ($ MILLIONS) 11
CHAPTER 3 INDUSTRY OVERVIEW 13
TABLE 1 THE 25 COMPANIES THAT DRIVE THE MEDICAL DEVICE BUSINESS, BY
REVENUE, 2014 ($ BILLIONS) 13
HOW HEALTH DRIVES DEMAND FOR MEDICAL DEVICE COATINGS 14
TABLE 2 HOW ILLNESS AND ACCIDENT RATES CHANGE WITH AGE (NUMBER OF U.S.
FATALITIES) 14
TABLE 3 MOST COMMON PATIENT SURGICAL PROCEDURES FOR OLDER
AMERICANS 15
HOW COATINGS IMPROVE MEDICAL DEVICES 15
TABLE 4 LIFE-SUSTAINING MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA) 16
TABLE 5 IMPLANTED MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA) 16
TABLE 6 MEDICAL DEVICES NOTING COATINGS IN THEIR PROPRIETARY NAMES
(BASED ON FDA DATA AS OF JULY 2014) 19
INDUSTRY-DRIVEN STANDARDIZATION 56
TABLE 7 FREQUENTLY CITED ISO MEDICAL DEVICE AND COATING RELATED
STANDARDS 57
TABLE 8 FREQUENTLY CITED JOINT ANSI/AAMI/ISO MEDICAL DEVICE AND COATING
RELATED STANDARDS 58
TABLE 9 AMERICAN SOCIETY FOR TESTING AND MATERIALS MEDICAL DEVICE AND
COATING RELATED STANDARDS 59
GLOBAL HARMONIZATION 62
TABLE 10 MAJOR U.S. MEDICAL DEVICE MANUFACTURING FACILITIES (BASED ON
FDA DATA AS OF JULY 2014) 63
TABLE 11 MAJOR MEDICAL DEVICE MANUFACTURING FACILITIES OUTSIDE OF THE
U.S. (BASED ON FDA OWNER OPERATOR RECORDS AS OF JULY 2014) 69
STRATEGICALLY IMPORTANT TECHNICAL DEVELOPMENTS 70
SELF-POWERING MEDICAL DEVICES 70
MID-FIELD WIRELESS POWER TRANSMISSION 71
3D-PRINTING 71
TRANSLATIONAL MEDICINE AND THE FUTURE RandD AGENDA 72
CORPORATE INVERSIONS 73
CHAPTER 4 HOW THE FDA STRUCTURES THE GLOBAL MARKET 75
CONTROL CLASS IS THE CRITICAL REVIEW PARAMETER 77
TABLE 12 FDA REGULATORY CONTROLS 78
CLASS I MEDICAL DEVICES 78
CLASS II MEDICAL DEVICES 79
CLASS III MEDICAL DEVICES 79
REGULATORY PATHWAYS TO THE MARKETPLACE 80
FIGURE 1 510(K) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS 81
FIGURE 2 TRENDS IN SUBSTANTIAL EQUIVALENT DECISIONS 81
FIGURE 3 TREND IN PMA APPROVALS 82
MEDICAL DEVICE AND COATING SUPPLIERS 83
CONTRACT MANUFACTURERS 83
CONTRACT STERILIZERS 83
DEVICE MANUFACTURERS 83
FOREIGN EXPORTERS 83
INITIAL DISTRIBUTORS OR IMPORTERS 84
RELABELERS 84
REMANUFACTURERS 84
REPACKAGERS 84
REPROCESSORS OF SINGLE-USE DEVICES 84
SPECIFICATIONS DEVELOPERS 84
CHAPTER 5 COATINGS AND SURFACE TREATMENT TECHNOLOGIES 86
TABLE 13 DEMAND FOR ALL COATINGS AND TREATMENTS BY REGION, THROUGH
2019 ($ MILLIONS) 86
ALLOY COATINGS 87
TYPES OF ALLOY COATINGS 88
Aluminum 88
Copper 88
Gold 89
Nitinol 89
Silver Compounds 89
Stainless Steel 90
Titanium 91
Zinc Oxide 92
CERAMIC COATINGS DESCRIPTIONS AND FORECAST 92
TYPES OF CERAMIC COATINGS 92
Alumina 92
Bioglass 93
Carbon-Based 94
COMBINATION COATINGS DESCRIPTIONS AND FORECAST 94
TYPES OF COMBINATION COATINGS 96
Bone Morphogenetic Protein 2 96
Cationic Steroid Antimicrobials 96
Collagen 96
Dexamethasone 97
Gore/Carmeda BioActive Surface Technology 97
Heparin 97
Hyaluronan 98
Hydrogels 98
Hydroxyapatite 99
Medi-Coat Carrier Technology 100
Nitric Oxide 100
Paclitaxel 100
Parylenes 101
Phosphorylcholine (PC Technology) 102
Polymer Drugs 102
Polyethylene 102
Sirolimus, Everolimus and Zotarolimus 104
Stem Cell Coatings 104
ENERGY-ABSORBING COATINGS: DESCRIPTIONS 104
TYPES OF ENERGY-ABSORBING COATINGS 105
ENERGY-EMITTING COATINGS: DESCRIPTIONS 107
TYPES OF ENERGY-EMITTING COATINGS 107
Bioactive 107
Conductive 107
TABLE 14 CONDUCTIVE COATINGS FOR MEDICAL DEVICES 108
Galvanic 108
Radioactive 108
NANO-COATINGS 109
MICRO- AND NANO-MATERIALS 111
PROTECTIVE POLYMER COATINGS: DESCRIPTIONS 112
TABLE 15 LUBRICIOUS MEDICAL DEVICE COATINGS 113
TYPES OF PROTECTIVE POLYMER COATINGS 115
Hexyl-PVP 115
PDMS poly(dimethyl siloxane) 115
Polyurethane 115
Polytetrafluoroethylene Teflon 115
Polyvinyl Chloride 116
SURFACE TREATMENT DESCRIPTIONS 116
TYPES OF SURFACE TREATMENTS 117
Direct Deposition Techniques 117
Plasma Techniques 117
Ion Implantation Techniques 118
Laser Activation 118
Texturing 119
COATING FORECASTS 119
TABLE 16 U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH
2019 ($ MILLIONS) 120
TABLE 17 EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY
MATERIAL, THROUGH 2019 ($ MILLIONS) 120
TABLE 18 OTHER DEVELOPED NATIONS DEMAND FOR MEDICAL DEVICE COATINGS
BY MATERIAL, THROUGH 2019 ($ MILLIONS) 121
TABLE 19 REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY
MATERIAL, THROUGH 2019 ($ MILLIONS) 121
MEDICAL DEVICE COATINGS PATENT ANALYSIS 121
TABLE 20 THE 25 MOST RECENTLY ISSUED PATENTS REFERENCING MEDICAL
DEVICES AND COATINGS, AS OF MARCH 3, 2012 122
REGIONAL DEMAND BY MATERIAL 122
TABLE 21 U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA
AND MATERIAL, THROUGH 2019 ($ MILLIONS) 123
TABLE 22 EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY
HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS) 127
TABLE 23 OTHER DEVELOPED NATIONS' DEMAND FOR MEDICAL DEVICE COATINGS
BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS) 131
TABLE 24 REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY
HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS) 135
CHAPTER 6 COATING DEMAND BY HEALTHCARE AREA 141
TABLE 25 MEDICAL DEVICE REVIEW PANELS 141
ANESTHESIOLOGY FORECAST AND DEVICES 142
TABLE 26 COATING FORECAST FOR ANESTHESIOLOGY DEVICES, THROUGH 2019
($MILLIONS) 142
TABLE 27 ANESTHESIOLOGY DEVICES 143
CARDIOVASCULAR FORECAST AND DEVICES 150
TABLE 28 COATING FORECAST FOR CARDIOVASCULAR DEVICES, THROUGH 2019
($ MILLIONS) 151
TABLE 29 CARDIOVASCULAR DEVICES 152
CLINICAL CHEMISTRY FORECAST AND DEVICES 162
TABLE 30 COATING FORECAST FOR CHEMISTRY DEVICES, THROUGH 2019 ($
MILLIONS) 162
TABLE 31 CHEMISTRY DEVICES 163
DENTAL DEVICES AND FORECAST 174
TABLE 32 COATING FORECAST FOR DENTAL DEVICES, THROUGH 2019 ($ MILLIONS) 175
TABLE 33 DENTAL DEVICES 176
EAR, NOSE AND THROAT FORECAST AND DEVICES 184
TABLE 34 COATING FORECAST FOR EAR, NOSE AND THROAT DEVICES, THROUGH
2019 ($ MILLIONS) 184
TABLE 35 EAR, NOSE AND THROAT DEVICES 185
GASTROENTEROLOGY AND UROLOGY DEVICES AND FORECAST 191
TABLE 36 COATING FORECAST FOR GASTROENTEROLOGY AND UROLOGY DEVICES,
THROUGH 2019 ($ MILLIONS) 192
TABLE 37 GASTROENTEROLOGY AND UROLOGY DEVICES 193
GENERAL AND PLASTIC SURGERY FORECAST AND DEVICES 207
TABLE 38 COATING FORECAST FOR GENERAL AND PLASTIC SURGERY DEVICES,
THROUGH 2019 ($MILLIONS) 208
TABLE 39 GENERAL AND PLASTIC SURGERY DEVICES 209
GENERAL HOSPITAL USE FORECAST AND DEVICES 216
TABLE 40 AVERAGE LENGTH OF HOSPITAL STAY BY SEX AND AGE (DAYS) 217
TABLE 41 COATING FORECAST FOR GENERAL HOSPITAL USE DEVICES, THROUGH
2019 ($MILLIONS) 217
TABLE 42 GENERAL HOSPITAL USE DEVICES 218
HEMATOLOGY FORECAST AND DEVICES 225
TABLE 43 COATING FORECAST FOR HEMATOLOGY DEVICES, THROUGH 2019
($MILLIONS) 225
TABLE 44 HEMATOLOGY DEVICES 227
IMMUNOLOGY FORECAST AND DEVICES 233
TABLE 45 COATING FORECAST FOR IMMUNOLOGY DEVICES, THROUGH 2019
($MILLIONS) 233
TABLE 46 IMMUNOLOGY DEVICES 235
MICROBIOLOGY FORECAST AND DEVICES 244
TABLE 47 COATING FORECAST FOR MICROBIOLOGY DEVICES, THROUGH 2019 ($
MILLIONS) 245
TABLE 48 MICROBIOLOGY DEVICES 246
NEUROLOGY DEVICES AND FORECAST 260
TABLE 49 COATING FORECAST FOR NEUROLOGY DEVICES, THROUGH 2019 ($
MILLIONS) 261
TABLE 50 NEUROLOGY DEVICES 262
OBSTETRICS AND GYNECOLOGY FORECAST AND DEVICES 268
TABLE 51 COATING FORECAST FOR OBSTETRICS AND GYNECOLOGY DEVICES,
THROUGH 2019 ($MILLIONS) 268
TABLE 52 OBSTETRICS AND GYNECOLOGY DEVICES 269
OPHTHALMOLOGY FORECAST AND DEVICES 276
TABLE 53 COATING FORECAST FOR OPHTHALMOLOGY DEVICES, THROUGH 2019 ($
MILLIONS) 276
TABLE 54 OPHTHALMOLOGY DEVICES 278
ORTHOPEDIC DEVICE AND FORECAST 286
TABLE 55 COATING FORECAST FOR ORTHOPEDIC DEVICES, THROUGH 2019
($MILLIONS) 286
TABLE 56 ORTHOPEDIC DEVICES 287
PATHOLOGY FORECAST 297
TABLE 57 COATING FORECAST FOR PATHOLOGY DEVICES, THROUGH 2019
($MILLIONS) 297
TABLE 58 PATHOLOGY DEVICES 298
PHYSICAL MEDICINE FORECAST AND DEVICES 304
TABLE 59 COATING FORECAST FOR PHYSICAL MEDICINE DEVICES, THROUGH 2019
($MILLIONS) 304
TABLE 60 PHYSICAL MEDICINE DEVICES 306
RADIOLOGY DEVICES AND FORECAST 311
TABLE 61 COATING FORECAST FOR RADIOLOGY DEVICES, THROUGH 2019
($MILLIONS) 312
TABLE 62 RADIOLOGY DEVICES 313
TOXICOLOGY FORECAST AND DEVICES 317
TABLE 63 COATING FORECAST FOR TOXICOLOGY DEVICES, THROUGH 2019
($MILLIONS) 317
TABLE 64 TOXICOLOGY DEVICES 319
CHAPTER 7 APPENDIX 333
SIGNIFICANT COATING PATENTS 333

LIST OF TABLES

TABLE A EUROPEAN UNION 4
TABLE B OTHER DEVELOPED NATIONS 5
TABLE C REST OF THE WORLD 5
SUMMARY TABLE GLOBAL MEDICAL DEVICE COATING MARKET BY REGION,
THROUGH 2019 ($ MILLIONS) 11
TABLE 1 THE 25 COMPANIES THAT DRIVE THE MEDICAL DEVICE BUSINESS, BY
REVENUE, 2014 ($ BILLIONS) 13
TABLE 2 HOW ILLNESS AND ACCIDENT RATES CHANGE WITH AGE (NUMBER OF U.S.
FATALITIES) 14
TABLE 3 MOST COMMON PATIENT SURGICAL PROCEDURES FOR OLDER AMERICANS 15
TABLE 4 LIFE-SUSTAINING MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA) 16
TABLE 5 IMPLANTED MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA) 16
TABLE 6 MEDICAL DEVICES NOTING COATINGS IN THEIR PROPRIETARY NAMES
(BASED ON FDA DATA AS OF JULY 2014) 19
TABLE 7 FREQUENTLY CITED ISO MEDICAL DEVICE AND COATING RELATED
STANDARDS 57
TABLE 8 FREQUENTLY CITED JOINT ANSI/AAMI/ISO MEDICAL DEVICE AND COATING
RELATED STANDARDS 58
TABLE 9 AMERICAN SOCIETY FOR TESTING AND MATERIALS MEDICAL DEVICE AND
COATING RELATED STANDARDS 59
TABLE 10 MAJOR U.S. MEDICAL DEVICE MANUFACTURING FACILITIES (BASED ON
FDA DATA AS OF JULY 2014) 63
TABLE 11 MAJOR MEDICAL DEVICE MANUFACTURING FACILITIES OUTSIDE OF THE
U.S. (BASED ON FDA OWNER OPERATOR RECORDS AS OF JULY 2014) 69
TABLE 12 FDA REGULATORY CONTROLS 78
TABLE 13 DEMAND FOR ALL COATINGS AND TREATMENTS BY REGION, THROUGH
2019 ($ MILLIONS) 86
TABLE 14 CONDUCTIVE COATINGS FOR MEDICAL DEVICES 108
TABLE 15 LUBRICIOUS MEDICAL DEVICE COATINGS 113
TABLE 16 U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH
2019 ($ MILLIONS) 120
TABLE 17 EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY
MATERIAL, THROUGH 2019 ($ MILLIONS) 120
TABLE 18 OTHER DEVELOPED NATIONS DEMAND FOR MEDICAL DEVICE COATINGS
BY MATERIAL, THROUGH 2019 ($ MILLIONS) 121
TABLE 19 REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY
MATERIAL, THROUGH 2019 ($ MILLIONS) 121
TABLE 20 THE 25 MOST RECENTLY ISSUED PATENTS REFERENCING MEDICAL
DEVICES AND COATINGS, AS OF MARCH 3, 2012 122
TABLE 21 U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA
AND MATERIAL, THROUGH 2019 ($ MILLIONS) 123
TABLE 22 EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY
HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS) 127
TABLE 23 OTHER DEVELOPED NATIONS' DEMAND FOR MEDICAL DEVICE COATINGS
BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS) 131
TABLE 24 REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY
HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS) 135
TABLE 25 MEDICAL DEVICE REVIEW PANELS 141
TABLE 26 COATING FORECAST FOR ANESTHESIOLOGY DEVICES, THROUGH 2019
($MILLIONS) 142
TABLE 27 ANESTHESIOLOGY DEVICES 143
TABLE 28 COATING FORECAST FOR CARDIOVASCULAR DEVICES, THROUGH 2019 ($
MILLIONS) 151
TABLE 29 CARDIOVASCULAR DEVICES 152
TABLE 30 COATING FORECAST FOR CHEMISTRY DEVICES, THROUGH 2019 ($
MILLIONS) 162
TABLE 31 CHEMISTRY DEVICES 163
TABLE 32 COATING FORECAST FOR DENTAL DEVICES, THROUGH 2019 ($ MILLIONS) 175
TABLE 33 DENTAL DEVICES 176
TABLE 34 COATING FORECAST FOR EAR, NOSE AND THROAT DEVICES, THROUGH
2019 ($ MILLIONS) 184
TABLE 35 EAR, NOSE AND THROAT DEVICES 185
TABLE 36 COATING FORECAST FOR GASTROENTEROLOGY AND UROLOGY DEVICES,
THROUGH 2019 ($ MILLIONS) 192
TABLE 37 GASTROENTEROLOGY AND UROLOGY DEVICES 193
TABLE 38 COATING FORECAST FOR GENERAL AND PLASTIC SURGERY DEVICES,
THROUGH 2019 ($MILLIONS) 208
TABLE 39 GENERAL AND PLASTIC SURGERY DEVICES 209
TABLE 40 AVERAGE LENGTH OF HOSPITAL STAY BY SEX AND AGE (DAYS) 217
TABLE 41 COATING FORECAST FOR GENERAL HOSPITAL USE DEVICES, THROUGH
2019 ($MILLIONS) 217
TABLE 42 GENERAL HOSPITAL USE DEVICES 218
TABLE 43 COATING FORECAST FOR HEMATOLOGY DEVICES, THROUGH 2019
($MILLIONS) 225
TABLE 44 HEMATOLOGY DEVICES 227
TABLE 45 COATING FORECAST FOR IMMUNOLOGY DEVICES, THROUGH 2019
($MILLIONS) 233
TABLE 46 IMMUNOLOGY DEVICES 235
TABLE 47 COATING FORECAST FOR MICROBIOLOGY DEVICES, THROUGH 2019 ($
MILLIONS) 245
TABLE 48 MICROBIOLOGY DEVICES 246
TABLE 49 COATING FORECAST FOR NEUROLOGY DEVICES, THROUGH 2019 ($
MILLIONS) 261
TABLE 50 NEUROLOGY DEVICES 262
TABLE 51 COATING FORECAST FOR OBSTETRICS AND GYNECOLOGY DEVICES,
THROUGH 2019 ($MILLIONS) 268
TABLE 52 OBSTETRICS AND GYNECOLOGY DEVICES 269
TABLE 53 COATING FORECAST FOR OPHTHALMOLOGY DEVICES, THROUGH 2019 ($
MILLIONS) 276
TABLE 54 OPHTHALMOLOGY DEVICES 278
TABLE 55 COATING FORECAST FOR ORTHOPEDIC DEVICES, THROUGH 2019
($MILLIONS) 286
TABLE 56 ORTHOPEDIC DEVICES 287
TABLE 57 COATING FORECAST FOR PATHOLOGY DEVICES, THROUGH 2019
($MILLIONS) 297
TABLE 58 PATHOLOGY DEVICES 298
TABLE 59 COATING FORECAST FOR PHYSICAL MEDICINE DEVICES, THROUGH 2019
($MILLIONS) 304
TABLE 60 PHYSICAL MEDICINE DEVICES 306
TABLE 61 COATING FORECAST FOR RADIOLOGY DEVICES, THROUGH 2019
($MILLIONS) 312
TABLE 62 RADIOLOGY DEVICES 313
TABLE 63 COATING FORECAST FOR TOXICOLOGY DEVICES, THROUGH 2019
($MILLIONS) 317
TABLE 64 TOXICOLOGY DEVICES 319

LIST OF FIGURES

SUMMARY FIGURE GLOBAL REQUIREMENT FOR MEDICAL DEVICE COATINGS BY
REGION, 2012-2019 ($ MILLIONS) 11
FIGURE 1 510(K) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS 81
FIGURE 2 TRENDS IN SUBSTANTIAL EQUIVALENT DECISIONS 81
FIGURE 3 TREND IN PMA APPROVALS 82

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Brod-Dugan Co.

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Sherwin-Williams Co.

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