north america medical device testing market

North America Medical Device Testing Market - Industry Trends and Forecast to 2030

  • Published Date: 2023-08-18
  • Report ID: 145646
  • Pages: 250
  • Format: prudent report format

North America medical device testing market is projected to register a CAGR of 12.0% in the forecast period of 2023 to 2030. The new market report contains data for the historic year 2021, the base year of calculation is 2022, and the forecast period is 2023 to 2030.

Market Segmentation:

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, Opthalmic Medical Device, Orthopedic and Dental Medical Device, Vascular Medical Device, and Others) Industry Trends and Forecast to 2030

Some of the major factors contributing to the growth of the North America medical device testing market are:

The rising need for verification and validation of medical devices globally
The rise in market players and the availability of advanced services.

Market Players
The key market players operating in the North America medical device testing market are:
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
Laboratory Corporation of America Holdings
Eurofins Scientific
Nelson Laboratories, LLC- A Sotera Health company
Gateway Analytical
Element Materials Technology
Hohenstein
Medical Engineering Technologies Ltd.
Cigniti
Q Laboratories
IMR Test Labs



TABLE OF CONTENTS
1 INTRODUCTION 13
1.1 OBJECTIVES OF THE STUDY 13
1.2 MARKET DEFINITION 13
1.3 OVERVIEW OF NORTH AMERICA MEDICAL DEVICE TESTING MARKET 13
1.4 LIMITATIONS 15
1.5 MARKETS COVERED 15
2 MARKET SEGMENTATION 17
2.1 MARKETS COVERED 17
2.2 GEOGRAPHICAL SCOPE 18
2.3 YEARS CONSIDERED FOR THE STUDY 18
2.4 CURRENCY AND PRICING 18
2.5 DBMR TRIPOD DATA VALIDATION MODEL 19
2.6 MULTIVARIATE MODELLING 22
2.7 SERVICE TYPE LIFELINE CURVE 22
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 23
2.9 DBMR MARKET POSITION GRID 24
2.10 MARKET TESTING TYPE COVERAGE GRID 25
2.11 VENDOR SHARE ANALYSIS 26
2.12 SECONDARY SOURCES 27
2.13 ASSUMPTIONS 27
3 EXECUTIVE SUMMARY 28
4 PREMIUM INSIGHTS 31
4.1 PESTEL ANALYSIS 32
4.2 PORTER'S FIVE FORCES 33
5 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: REGULATIONS 34
6 MARKET OVERVIEW 37
6.1 DRIVERS 39
6.1.1 RISING NEED FOR VERIFICATION VALIDATION OF MEDICAL DEVICES 39
6.1.2 INCREASING DEMAND FOR IN-VITRO TESTS 39
6.1.3 ESCALATION IN INNOVATION AND TECHNOLOGIES 39
6.2 RESTRAINTS 40
6.2.1 BARRIERS TO THE LOCAL DEVELOPMENT OF MEDICAL DEVICES 40
6.2.2 HIGH COST OF MEDICAL DEVICES 40
6.3 OPPORTUNITIES 40
6.3.1 RISE IN HEALTHCARE EXPENDITURE 40
6.3.2 DEVELOPMENT IN AI AND IOT IN VARIOUS MEDICAL DEVICES 41
6.3.3 STRATEGIC INITIATIVES OF KEY PLAYERS 41
6.4 CHALLENGES 42
6.4.1 HIGH COMPETITION IN MEDICAL TECHNOLOGY INDUSTRY 42
6.4.2 LONG LEAD TIME FOR OVERSEAS QUALIFICATION 42
7 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE 44
7.1 OVERVIEW 45
7.2 TESTING SERVICES 48
7.3 INSPECTION SERVICES 48
7.4 CERTIFICATION SERVICES 49
8 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE 50
8.1 OVERVIEW 51
8.2 CHEMICAL/BIOLOGICAL TESTING 54
8.3 MICROBIOLOGY AND STERILITY TESTING 54
8.3.1 STERILITY TEST & VALIDATION 55
8.3.2 BIO BURDEN DETERMINATION 55
8.3.3 ANTIMICROBIAL ACTIVITY TESTING 55
8.3.4 PYROGEN & ENDOTOXIN TESTING 55
8.3.5 OTHERS 55
8.4 PHYSICAL TESTING 55
8.4.1 ELECTRICAL SAFETY TESTING 56
8.4.2 FUNCTIONAL SAFETY TESTING 56
8.4.3 EMC TESTING 56
8.4.4 ENVIRONMENTAL TESTING 57
8.4.5 OTHERS 57
8.5 CYBERSECURITY TESTING 57
8.6 OTHERS 58
9 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PHASE 59
9.1 OVERVIEW 60
9.2 PRECLINICAL 63
9.3 CLINICAL 63
10 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE 64
10.1 OVERVIEW 65
10.2 OUTSOURCED 68
10.3 IN-HOUSE 68
11 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS 69
11.1 OVERVIEW 70
11.2 CLASS I 73
11.3 CLASS III 74
11.4 CLASS II 75
12 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY PRODUCT 76
12.1 OVERVIEW 77
12.2 NON-ACTIVE MEDICAL DEVICE 80
12.3 ORTHOPEDIC AND DENTAL MEDICAL DEVICE 80
12.4 ACTIVE IMPLANT MEDICAL DEVICE 81
12.5 VASCULAR MEDICAL DEVICE 81
12.6 ACTIVE MEDICAL DEVICE 82
12.7 IN-VITRO DIAGNOSTICS MEDICAL DEVICE 82
12.8 OPTHALMIC MEDICAL DEVICE 83
12.9 OTHERS 83
13 NORTH AMERICA MEDICAL DEVICE TESTING MARKET, BY GEOGRAPHY 84
13.1 NORTH AMERICA 85
13.1.1 U.S. 90
13.1.2 CANADA 93
13.1.3 MEXICO 96
14 NORTH AMERICA MEDICAL DEVICE TESTING MARKET: COMPANY LANDSCAPE 99
14.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 99
15 SWOT ANALYSIS 100
16 COMPANY PROFILE 101
16.1 LABORATORY CORPORATION OF AMERICA HOLDINGS 101
16.1.1 COMPANY SNAPSHOT 101
16.1.2 REVENUE ANALYSIS 101
16.1.3 COMPANY SHARE ANALYSIS 102
16.1.4 PRODUCT PORTFOLIO 102
16.1.5 RECENT DEVELOPMENTS 102
16.2 CHARLES RIVER LABORATORIES. 103
16.2.1 COMPANY SNAPSHOT 103
16.2.2 REVENUE ANALYSIS 103
16.2.3 COMPANY SHARE ANALYSIS 104
16.2.4 PRODUCT PORTFOLIO 104
16.2.5 RECENT DEVELOPMENTS 104
16.3 TUV SUD 105
16.3.1 COMPANY SNAPSHOT 105
16.3.2 REVENUE ANALYSIS 105
16.3.3 COMPANY SHARE ANALYSIS 106
16.3.4 PRODUCT PORTFOLIO 106
16.3.5 RECENT DEVELOPMENTS 106
16.4 WUXI APPTEC 107
16.4.1 COMPANY SNAPSHOT 107
16.4.2 REVENUE ANALYSIS 107
16.4.3 COMPANY SHARE ANALYSIS 108
16.4.4 PRODUCT PORTFOLIO 108
16.4.5 RECENT DEVELOPMENTS 108
16.5 SGS SA 109
16.5.1 COMPANY SNAPSHOT 109
16.5.2 REVENUE ANALYSIS 109
16.5.3 COMPANY SHARE ANALYSIS 110
16.5.4 PRODUCT PORTFOLIO 110
16.5.5 RECENT DEVELOPMENTS 110
16.6 NORTH AMERICAN SCIENCE ASSOCIATES, LLC 111
16.6.1 COMPANY SNAPSHOT 111
16.6.2 PRODUCT PORTFOLIO 111
16.6.3 RECENT DEVELOPMENTS 111
16.7 HOHENSTEIN 112
16.7.1 COMPANY SNAPSHOT 112
16.7.2 PRODUCT PORTFOLIO 112
16.7.3 RECENT DEVELOPMENTS 112
16.8 BIOMEDICAL DEVICE LABS 113
16.8.1 COMPANY SNAPSHOT 113
16.8.2 PRODUCT PORTFOLIO 113
16.8.3 RECENT DEVELOPMENTS 113
16.9 BUREAU VERITAS 114
16.9.1 COMPANY SNAPSHOT 114
16.9.2 REVENUE ANALYSIS 114
16.9.3 PRODUCT PORTFOLIO 115
16.9.4 RECENT DEVELOPMENTS 115
16.10 CIGNITI 116
16.10.1 COMPANY SNAPSHOT 116
16.10.2 REVENUE ANALYSIS 116
16.10.3 PRODUCT PORTFOLIO 117
16.10.4 RECENT DEVELOPMENTS 117
16.11 ELEMENT MATERIALS TECHNOLOGY 118
16.11.1 COMPANY SNAPSHOT 118
16.11.2 PRODUCT PORTFOLIO 118
16.11.3 RECENT DEVELOPMENTS 118
16.12 EUROFINS SCIENTIFIC 119
16.12.1 COMPANY SNAPSHOT 119
16.12.2 REVENUE ANALYSIS 119
16.12.3 PRODUCT PORTFOLIO 120
16.12.4 RECENT DEVELOPMENTS 120
16.13 GATEWAY ANALYTICAL. 121
16.13.1 COMPANY SNAPSHOT 121
16.13.2 PRODUCT PORTFOLIO 121
16.13.3 RECENT DEVELOPMENTS 121
16.14 IMR TEST LABS 122
16.14.1 COMPANY SNAPSHOT 122
16.14.2 PRODUCT PORTFOLIO 122
16.14.3 RECENT DEVELOPMENTS 122
16.15 INTERTEK GROUP PLC 123
16.15.1 COMPANY SNAPSHOT 123
16.15.2 REVENUE ANALYSIS 123
16.15.3 PRODUCT PORTFOLIO 124
16.15.4 RECENT DEVELOPMENTS 124
16.16 NELSON LABORATORIES, LLC- A SOTERA HEALTH COMPANY 125
16.16.1 COMPANY SNAPSHOT 125
16.16.2 PRODUCT PORTFOLIO 126
16.16.3 RECENT DEVELOPMENTS 126
16.17 NSF. 127
16.17.1 COMPANY SNAPSHOT 127
16.17.2 PRODUCT PORTFOLIO 127
16.17.3 RECENT DEVELOPMENTS 127
16.18 PACE 128
16.18.1 COMPANY SNAPSHOT 128
16.18.2 PRODUCT PORTFOLIO 128
16.18.3 RECENT DEVELOPMENTS 128
16.19 Q LABORATORIES 129
16.19.1 COMPANY SNAPSHOT 129
16.19.2 PRODUCT PORTFOLIO 129
16.19.3 RECENT DEVELOPMENTS 129
16.20 TUV RHEINLAND 130
16.20.1 COMPANY SNAPSHOT 130
16.20.2 REVENUE ANALYSIS 130
16.20.3 PRODUCT PORTFOLIO 131
16.20.4 RECENT DEVELOPMENTS 131
16.21 UL LLC 132
16.21.1 COMPANY SNAPSHOT 132
16.21.2 PRODUCT PORTFOLIO 132
16.21.3 RECENT DEVELOPMENTS 132
17 QUESTIONNAIRE 133
18 RELATED REPORTS 136
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