NA Medical Device Testing Market - Industry Trends and Forecast to 2029
- Published Date: 2022-12-31
- Report ID: 144094
- Pages: 225
-
Format:
Short Description
North America Medical Device Testing Market, By Service Type (Testing Services, Inspection Service and Certification Services), Testing Type (Physical Testing, Chemical/Biological Testing, Cybersecurity Testing, Microbiology and Sterility Testing, and Others), Phase (Preclinical and Clinical), Sourcing Type (In-House and Outsourced), Device Class (Class I, Class II, and Class III), Product (Active Implant Medical Device, Active Medical Device, Non-active Medical Device, In-vitro Diagnostics Medical Device, Ophthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device, and Others), Country (U.S., Canada, and Mexico) Industry Trends and Forecast to 2029
Market Definition:
Medical device testing is the process of demonstrating that the device is reliably and safely performed in use. In new product development, extensive Design Validation Testing is applied. This includes performance testing, toxicity, chemical analysis, and sometimes human factors orclinical testing. Ongoing quality assurance testing is generally more limited. This usually includes dimensional checks, some functional tests, and packaging verification. Various types of medical testing services are available there in the market, such as inspection services, certification services, and others
Market Segmentation:
North America medical device testing market is categorized into six notable segments which are based on service type, testing type, phase, sourcing type, device class, and product.
On the basis of service type, the North America medical device testing market is segmented into testing services, inspection services, and certification services
On the basis of testing type, the North America medical device testing market is segmented into physical testing, chemical/biological testing, cybersecurity testing, microbiology and sterility testing, and others
On the basis of phase, the North America medical device testing market is segmented into preclinical and clinical
On the basis of sourcing type, the North America medical device testing market is segmented into in-house and outsourced
On the basis of device class, the North America medical device testing market is segmented into class I, class II, and class III
On the basis of product, the North America medical device testing market is segmented into active implant medical device, active medical device, non-active medical device, in-vitro diagnostics medical device, opthalmic medical device, orthopedic and dental medical device, vascular medical device, and others
Market Players
The key market players in North America medical device testing market are listed below:
Intertek Group plc
SGS SA
Bureau Veritas
TUV SUD
TUV Rheinland
Pace
Charles River Laboratories
Biomedical Device Labs
UL LLC
North American Science Associates, LLC
WuXi AppTec
NSF
Labcorp
Eurofins Scientific
Nelson Laboratories, LLC- A Sotera Health company
Gateway Analytical
Element Materials Technology
Medical Engineering Technologies Ltd.
Cigniti
Q Laboratories
IMR Test Labs
TABLE OF CONTENTS
1 INTRODUCTION 28
1.1 OBJECTIVES OF THE STUDY 28
1.2 MARKET DEFINITION 28
1.3 OVERVIEW OF NORTH AMERICA MEDICAL DEVICE TESTING MARKET 28
1.4 LIMITATIONS 30
1.5 MARKETS COVERED 30
2 MARKET SEGMENTATION 33
2.1 MARKETS COVERED 33
2.2 GEOGRAPHICAL SCOPE 34
2.3 YEARS CONSIDERED FOR THE STUDY 35
2.4 CURRENCY AND PRICING 35
2.5 DBMR TRIPOD DATA VALIDATION MODEL 36
2.6 MULTIVARIATE MODELLING 39
2.7 SERVICE TYPE LIFELINE CURVE 39
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 40
2.9 DBMR MARKET POSITION GRID 41
2.10 MARKET TESTING TYPE COVERAGE GRID 42
2.11 VENDOR SHARE ANALYSIS 43
2.12 SECONDARY SOURCES 44
2.13 ASSUMPTIONS 44
3 EXECUTIVE SUMMARY 45
4 PREMIUM INSIGHTS 48
4.1 PESTEL ANALYSIS 50
4.2 PORTER'S FIVE FORCES 51
5 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: REGULATIONS 52
6 MARKET OVERVIEW 56
6.1 DRIVERS 58
6.1.1 RISING NEED FOR VERIFICATION VALIDATION OF MEDICAL DEVICES 58
6.1.2 INCREASING DEMAND FOR IN-VITRO TESTS 58
6.1.3 ESCALATION IN INNOVATION AND TECHNOLOGIES 58
6.2 RESTRAINTS 59
6.2.1 BARRIERS TO THE LOCAL DEVELOPMENT OF MEDICAL DEVICES 59
6.2.2 HIGH COST OF MEDICAL DEVICES 59
6.3 OPPORTUNITIES 59
6.3.1 RISE IN HEALTHCARE EXPENDITURE 59
6.3.2 DEVELOPMENT IN AI AND IOT IN VARIOUS MEDICAL DEVICES 60
6.3.3 STRATEGIC INITIATIVES OF KEY PLAYERS 60
6.4 CHALLENGES 61
6.4.1 HIGH COMPETITION IN MEDICAL TECHNOLOGY INDUSTRY 61
6.4.2 LONG LEAD TIME FOR OVERSEAS QUALIFICATION 62
7 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE 63
7.1 OVERVIEW 64
7.2 TESTING SERVICES 67
7.3 INSPECTION SERVICES 67
7.4 CERTIFICATION SERVICES 68
8 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE 70
8.1 OVERVIEW 71
8.2 CHEMICAL/BIOLOGICAL TESTING 74
8.3 MICROBIOLOGY AND STERILITY TESTING 74
8.3.1 STERILITY TEST & VALIDATION 76
8.3.2 BIO BURDEN DETERMINATION 76
8.3.3 ANTIMICROBIAL ACTIVITY TESTING 76
8.3.4 PYROGEN & ENDOTOXIN TESTING 76
8.3.5 OTHERS 76
8.4 PHYSICAL TESTING 76
8.4.1 ELECTRICAL SAFETY TESTING 77
8.4.2 FUNCTIONAL SAFETY TESTING 78
8.4.3 EMC TESTING 78
8.4.4 ENVIRONMENTAL TESTING 78
8.4.5 OTHERS 78
8.5 CYBERSECURITY TESTING 78
8.6 OTHERS 79
9 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PHASE 81
9.1 OVERVIEW 82
9.2 PRECLINICAL 85
9.3 CLINICAL 85
10 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE 87
10.1 OVERVIEW 88
10.2 OUTSOURCED 91
10.3 IN-HOUSE 91
11 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS 93
11.1 OVERVIEW 94
11.2 CLASS I 97
11.3 CLASS III 98
11.4 CLASS II 98
12 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PRODUCT 100
12.1 OVERVIEW 101
12.2 NON-ACTIVE MEDICAL DEVICE 103
12.3 ORTHOPEDIC AND DENTAL MEDICAL DEVICE 104
12.4 ACTIVE IMPLANT MEDICAL DEVICE 105
12.5 VASCULAR MEDICAL DEVICE 106
12.6 ACTIVE MEDICAL DEVICE 107
12.7 IN-VITRO DIAGNOSTICS MEDICAL DEVICE 107
12.8 OPTHALMIC MEDICAL DEVICE 108
12.9 OTHERS 109
13 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY GEOGRAPHY 110
13.1 NORTH AMERICA 111
13.1.1 U.S. 118
13.1.2 CANADA 121
13.1.3 MEXICO 124
14 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: COMPANY LANDSCAPE 127
14.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 127
15 SWOT ANALYSIS 128
16 COMPANY PROFILE 129
16.1 LABCORP 129
16.1.1 COMPANY SNAPSHOT 129
16.1.2 REVENUE ANALYSIS 129
16.1.3 COMPANY SHARE ANALYSIS 130
16.1.4 PRODUCT PORTFOLIO 130
16.1.5 RECENT DEVELOPMENTS 130
16.2 CHARLES RIVER LABORATORIES. 131
16.2.1 COMPANY SNAPSHOT 131
16.2.2 REVENUE ANALYSIS 131
16.2.3 COMPANY SHARE ANALYSIS 132
16.2.4 PRODUCT PORTFOLIO 132
16.2.5 RECENT DEVELOPMENTS 132
16.3 TUV SUD 133
16.3.1 COMPANY SNAPSHOT 133
16.3.2 REVENUE ANALYSIS 133
16.3.3 COMPANY SHARE ANALYSIS 134
16.3.4 PRODUCT PORTFOLIO 134
16.3.5 RECENT DEVELOPMENTS 135
16.4 WUXI APPTEC 136
16.4.1 COMPANY SNAPSHOT 136
16.4.2 REVENUE ANALYSIS 136
16.4.3 COMPANY SHARE ANALYSIS 137
16.4.4 PRODUCT PORTFOLIO 137
16.4.5 RECENT DEVELOPMENTS 138
16.5 SGS SA 139
16.5.1 COMPANY SNAPSHOT 139
16.5.2 REVENUE ANALYSIS 139
16.5.3 COMPANY SHARE ANALYSIS 140
16.5.4 PRODUCT PORTFOLIO 140
16.5.5 RECENT DEVELOPMENTS 141
16.6 NORTH AMERICAN SCIENCE ASSOCIATES, LLC 142
16.6.1 COMPANY SNAPSHOT 142
16.6.2 PRODUCT PORTFOLIO 142
16.6.3 RECENT DEVELOPMENTS 142
16.7 HOHENSTEIN 143
16.7.1 COMPANY SNAPSHOT 143
16.7.2 PRODUCT PORTFOLIO 143
16.7.3 RECENT DEVELOPMENTS 143
16.8 ARBRO PHARMACEUTICALS PRIVATE LIMITED & AURIGA RESEARCH PRIVATE LIMITED 144
16.8.1 COMPANY SNAPSHOT 144
16.8.2 PRODUCT PORTFOLIO 144
16.8.3 RECENT DEVELOPMENTS 144
16.9 BIOMEDICAL DEVICE LABS 145
16.9.1 COMPANY SNAPSHOT 145
16.9.2 PRODUCT PORTFOLIO 145
16.9.3 RECENT DEVELOPMENTS 145
16.10 BIONEEDS 146
16.10.1 COMPANY SNAPSHOT 146
16.10.2 PRODUCT PORTFOLIO 146
16.10.3 RECENT DEVELOPMENTS 146
16.11 BUREAU VERITAS 147
16.11.1 COMPANY SNAPSHOT 147
16.11.2 REVENUE ANALYSIS 147
16.11.3 PRODUCT PORTFOLIO 148
16.11.4 RECENT DEVELOPMENTS 148
16.12 CIGNITI 149
16.12.1 COMPANY SNAPSHOT 149
16.12.2 REVENUE ANALYSIS 149
16.12.3 PRODUCT PORTFOLIO 150
16.12.4 RECENT DEVELOPMENTS 150
16.13 ELEMENT MATERIALS TECHNOLOGY 151
16.13.1 COMPANY SNAPSHOT 151
16.13.2 PRODUCT PORTFOLIO 151
16.13.3 RECENT DEVELOPMENTS 151
16.14 ENDOLAB MECHANICAL ENGINEERING GMBH 152
16.14.1 COMPANY SNAPSHOT 152
16.14.2 PRODUCT PORTFOLIO 152
16.14.3 RECENT DEVELOPMENTS 152
16.15 EUROFINS SCIENTIFIC 153
16.15.1 COMPANY SNAPSHOT 153
16.15.2 REVENUE ANALYSIS 153
16.15.3 PRODUCT PORTFOLIO 154
16.15.4 RECENT DEVELOPMENTS 154
16.16 GATEWAY ANALYTICAL. 155
16.16.1 COMPANY SNAPSHOT 155
16.16.2 PRODUCT PORTFOLIO 155
16.16.3 RECENT DEVELOPMENTS 155
16.17 IMR TEST LABS 156
16.17.1 COMPANY SNAPSHOT 156
16.17.2 PRODUCT PORTFOLIO 156
16.17.3 RECENT DEVELOPMENTS 156
16.18 INTERTEK GROUP PLC 157
16.18.1 COMPANY SNAPSHOT 157
16.18.2 REVENUE ANALYSIS 157
16.18.3 PRODUCT PORTFOLIO 158
16.18.4 RECENT DEVELOPMENTS 158
16.19 ITC ZLIN 159
16.19.1 COMPANY SNAPSHOT 159
16.19.2 PRODUCT PORTFOLIO 159
16.19.3 RECENT DEVELOPMENTS 159
16.20 MEDICAL ENGINEERING TECHNOLOGIES LTD. 160
16.20.1 COMPANY SNAPSHOT 160
16.20.2 PRODUCT PORTFOLIO 160
16.20.3 RECENT DEVELOPMENTS 160
16.21 MEDISTRI SA 161
16.21.1 COMPANY SNAPSHOT 161
16.21.2 PRODUCT PORTFOLIO 161
16.21.3 RECENT DEVELOPMENTS 161
16.22 NELSON LABORATORIES, LLC- A SOTERA HEALTH COMPANY 162
16.22.1 COMPANY SNAPSHOT 162
16.22.2 REVENUE ANALYSIS 162
16.22.3 PRODUCT PORTFOLIO 163
16.22.4 RECENT DEVELOPMENTS 163
16.23 NSF. 164
16.23.1 COMPANY SNAPSHOT 164
16.23.2 PRODUCT PORTFOLIO 164
16.23.3 RECENT DEVELOPMENTS 164
16.24 PACE 165
16.24.1 COMPANY SNAPSHOT 165
16.24.2 PRODUCT PORTFOLIO 165
16.24.3 RECENT DEVELOPMENTS 165
16.25 Q LABORATORIES 166
16.25.1 COMPANY SNAPSHOT 166
16.25.2 PRODUCT PORTFOLIO 166
16.25.3 RECENT DEVELOPMENTS 166
16.26 TUV RHEINLAND 167
16.26.1 COMPANY SNAPSHOT 167
16.26.2 REVENUE ANALYSIS 167
16.26.3 PRODUCT PORTFOLIO 168
16.26.4 RECENT DEVELOPMENTS 168
16.27 UL LLC 169
16.27.1 COMPANY SNAPSHOT 169
16.27.2 PRODUCT PORTFOLIO 169
16.27.3 RECENT DEVELOPMENTS 170
17 QUESTIONNAIRE 171
18 RELATED REPORTS 174
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