Europe Medical Device Testing Market - Industry Trends and Forecast to 2029
- Published Date: 2022-12-31
- Report ID: 144092
- Pages: 225
-
Format:
Short Description
Europe 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.K., Germany, Italy, France, Spain, Russia, Netherland, Switzerland, Turkey and Rest of Europe) 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, and chemical analysis, and sometimes human factors or clinical 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, such as inspection services, certification services, and others.
Market Segmentation:
Europe 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 Europe medical device testing market is segmented into testing services, inspection services, and certification services
On the basis of testing type, the Europe 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 Europe medical device testing market is segmented into preclinical and clinical
On the basis of sourcing type, the Europe medical device testing market is segmented into in-house and outsourced
On the basis of device class, the Europe medical device testing market is segmented into class I, class II, and class III
On the basis of product, the Europe 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 for Europe medical device testing market are listed below:
Intertek Group plc
SGS SA
Bureau Veritas
TUV SUD
TUV Rheinland
UL LLC
North American Science Associates, LLC
Medistri SA
WuXi AppTec
NSF
Labcorp
Eurofins Scientific
Nelson Laboratories, LLC- A Sotera Health company
ITC ZLIN
Element Materials Technology
EndoLab Mechanical Engineering GmbH
Hohenstein
Medical Engineering Technologies Ltd.
Cigniti
IMR Test Labs
TABLE OF CONTENTS
1 INTRODUCTION 29
1.1 OBJECTIVES OF THE STUDY 29
1.2 MARKET DEFINITION 29
1.3 OVERVIEW OF EUROPE MEDICAL DEVICE TESTING MARKET 29
1.4 LIMITATIONS 31
1.5 MARKETS COVERED 31
2 MARKET SEGMENTATION 34
2.1 MARKETS COVERED 34
2.2 GEOGRAPHICAL SCOPE 35
2.3 YEARS CONSIDERED FOR THE STUDY 36
2.4 CURRENCY AND PRICING 36
2.5 DBMR TRIPOD DATA VALIDATION MODEL 37
2.6 MULTIVARIATE MODELLING 40
2.7 SERVICE TYPE LIFELINE CURVE 40
2.8 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 41
2.9 DBMR MARKET POSITION GRID 42
2.10 MARKET TESTING TYPE COVERAGE GRID 43
2.11 VENDOR SHARE ANALYSIS 44
2.12 SECONDARY SOURCES 45
2.13 ASSUMPTIONS 45
3 EXECUTIVE SUMMARY 46
4 PREMIUM INSIGHTS 49
4.1 PESTEL ANALYSIS 51
4.2 PORTER'S FIVE FORCES 52
5 EUROPE MEDICAL DEVICE TESTING MARKET: REGULATIONS 53
6 MARKET OVERVIEW 57
6.1 DRIVERS 59
6.1.1 RISING NEED FOR VERIFICATION VALIDATION OF MEDICAL DEVICES 59
6.1.2 INCREASING DEMAND FOR IN-VITRO TESTS 59
6.1.3 ESCALATION IN INNOVATION AND TECHNOLOGIES 59
6.2 RESTRAINTS 60
6.2.1 BARRIERS TO THE LOCAL DEVELOPMENT OF MEDICAL DEVICES 60
6.2.2 HIGH COST OF MEDICAL DEVICES 60
6.3 OPPORTUNITIES 60
6.3.1 RISE IN HEALTHCARE EXPENDITURE 60
6.3.2 DEVELOPMENT IN AI AND IOT IN VARIOUS MEDICAL DEVICES 61
6.3.3 STRATEGIC INITIATIVES OF KEY PLAYERS 61
6.4 CHALLENGES 62
6.4.1 HIGH COMPETITION IN MEDICAL TECHNOLOGY INDUSTRY 62
6.4.2 LONG LEAD TIME FOR OVERSEAS QUALIFICATION 63
7 EUROPE MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE 64
7.1 OVERVIEW 65
7.2 TESTING SERVICES 68
7.3 INSPECTION SERVICES 68
7.4 CERTIFICATION SERVICES 69
8 EUROPE MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE 71
8.1 OVERVIEW 72
8.2 CHEMICAL/BIOLOGICAL TESTING 75
8.3 MICROBIOLOGY AND STERILITY TESTING 75
8.3.1 STERILITY TEST & VALIDATION 77
8.3.2 BIO BURDEN DETERMINATION 77
8.3.3 ANTIMICROBIAL ACTIVITY TESTING 77
8.3.4 PYROGEN & ENDOTOXIN TESTING 77
8.3.5 OTHERS 77
8.4 PHYSICAL TESTING 77
8.4.1 ELECTRICAL SAFETY TESTING 78
8.4.2 FUNCTIONAL SAFETY TESTING 79
8.4.3 EMC TESTING 79
8.4.4 ENVIRONMENTAL TESTING 79
8.4.5 OTHERS 79
8.5 CYBERSECURITY TESTING 79
8.6 OTHERS 80
9 EUROPE MEDICAL DEVICE TESTING MARKET, BY PHASE 82
9.1 OVERVIEW 83
9.2 PRECLINICAL 86
9.3 CLINICAL 86
10 EUROPE MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE 88
10.1 OVERVIEW 89
10.2 OUTSOURCED 92
10.3 IN-HOUSE 92
11 EUROPE MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS 94
11.1 OVERVIEW 95
11.2 CLASS I 98
11.3 CLASS III 99
11.4 CLASS II 99
12 EUROPE MEDICAL DEVICE TESTING MARKET, BY PRODUCT 101
12.1 OVERVIEW 102
12.2 NON-ACTIVE MEDICAL DEVICE 104
12.3 ORTHOPEDIC AND DENTAL MEDICAL DEVICE 105
12.4 ACTIVE IMPLANT MEDICAL DEVICE 106
12.5 VASCULAR MEDICAL DEVICE 107
12.6 ACTIVE MEDICAL DEVICE 108
12.7 IN-VITRO DIAGNOSTICS MEDICAL DEVICE 108
12.8 OPTHALMIC MEDICAL DEVICE 109
12.9 OTHERS 110
13 EUROPE MEDICAL DEVICE TESTING MARKET, BY GEOGRAPHY 111
13.1 EUROPE 112
13.1.1 GERMANY 119
13.1.2 U.K. 122
13.1.3 FRANCE 125
13.1.4 ITALY 128
13.1.5 SPAIN 131
13.1.6 RUSSIA 134
13.1.7 NETHERLANDS 137
13.1.8 SWITZERLAND 140
13.1.9 TURKEY 143
13.1.10 BELGIUM 146
13.1.11 REST OF EUROPE 149
14 EUROPE MEDICAL DEVICE TESTING MARKET: COMPANY LANDSCAPE 150
14.1 COMPANY SHARE ANALYSIS: EUROPE 150
15 SWOT ANALYSIS 151
16 COMPANY PROFILE 152
16.1 LABCORP 152
16.1.1 COMPANY SNAPSHOT 152
16.1.2 REVENUE ANALYSIS 152
16.1.3 COMPANY SHARE ANALYSIS 153
16.1.4 PRODUCT PORTFOLIO 153
16.1.5 RECENT DEVELOPMENTS 153
16.2 CHARLES RIVER LABORATORIES. 154
16.2.1 COMPANY SNAPSHOT 154
16.2.2 REVENUE ANALYSIS 154
16.2.3 COMPANY SHARE ANALYSIS 155
16.2.4 PRODUCT PORTFOLIO 155
16.2.5 RECENT DEVELOPMENTS 155
16.3 TUV SUD 156
16.3.1 COMPANY SNAPSHOT 156
16.3.2 REVENUE ANALYSIS 156
16.3.3 COMPANY SHARE ANALYSIS 157
16.3.4 PRODUCT PORTFOLIO 157
16.3.5 RECENT DEVELOPMENTS 158
16.4 WUXI APPTEC 159
16.4.1 COMPANY SNAPSHOT 159
16.4.2 REVENUE ANALYSIS 159
16.4.3 COMPANY SHARE ANALYSIS 160
16.4.4 PRODUCT PORTFOLIO 160
16.4.5 RECENT DEVELOPMENTS 161
16.5 SGS SA 162
16.5.1 COMPANY SNAPSHOT 162
16.5.2 REVENUE ANALYSIS 162
16.5.3 COMPANY SHARE ANALYSIS 163
16.5.4 PRODUCT PORTFOLIO 163
16.5.5 RECENT DEVELOPMENTS 164
16.6 NORTH AMERICAN SCIENCE ASSOCIATES, LLC 165
16.6.1 COMPANY SNAPSHOT 165
16.6.2 PRODUCT PORTFOLIO 165
16.6.3 RECENT DEVELOPMENTS 165
16.7 HOHENSTEIN 166
16.7.1 COMPANY SNAPSHOT 166
16.7.2 PRODUCT PORTFOLIO 166
16.7.3 RECENT DEVELOPMENTS 166
16.8 ARBRO PHARMACEUTICALS PRIVATE LIMITED & AURIGA RESEARCH PRIVATE LIMITED 167
16.8.1 COMPANY SNAPSHOT 167
16.8.2 PRODUCT PORTFOLIO 167
16.8.3 RECENT DEVELOPMENTS 167
16.9 BIOMEDICAL DEVICE LABS 168
16.9.1 COMPANY SNAPSHOT 168
16.9.2 PRODUCT PORTFOLIO 168
16.9.3 RECENT DEVELOPMENTS 168
16.10 BIONEEDS 169
16.10.1 COMPANY SNAPSHOT 169
16.10.2 PRODUCT PORTFOLIO 169
16.10.3 RECENT DEVELOPMENTS 169
16.11 BUREAU VERITAS 170
16.11.1 COMPANY SNAPSHOT 170
16.11.2 REVENUE ANALYSIS 170
16.11.3 PRODUCT PORTFOLIO 171
16.11.4 RECENT DEVELOPMENTS 171
16.12 CIGNITI 172
16.12.1 COMPANY SNAPSHOT 172
16.12.2 REVENUE ANALYSIS 172
16.12.3 PRODUCT PORTFOLIO 173
16.12.4 RECENT DEVELOPMENTS 173
16.13 ELEMENT MATERIALS TECHNOLOGY 174
16.13.1 COMPANY SNAPSHOT 174
16.13.2 PRODUCT PORTFOLIO 174
16.13.3 RECENT DEVELOPMENTS 174
16.14 ENDOLAB MECHANICAL ENGINEERING GMBH 175
16.14.1 COMPANY SNAPSHOT 175
16.14.2 PRODUCT PORTFOLIO 175
16.14.3 RECENT DEVELOPMENTS 175
16.15 EUROFINS SCIENTIFIC 176
16.15.1 COMPANY SNAPSHOT 176
16.15.2 REVENUE ANALYSIS 176
16.15.3 PRODUCT PORTFOLIO 177
16.15.4 RECENT DEVELOPMENTS 177
16.16 GATEWAY ANALYTICAL. 178
16.16.1 COMPANY SNAPSHOT 178
16.16.2 PRODUCT PORTFOLIO 178
16.16.3 RECENT DEVELOPMENTS 178
16.17 IMR TEST LABS 179
16.17.1 COMPANY SNAPSHOT 179
16.17.2 PRODUCT PORTFOLIO 179
16.17.3 RECENT DEVELOPMENTS 179
16.18 INTERTEK GROUP PLC 180
16.18.1 COMPANY SNAPSHOT 180
16.18.2 REVENUE ANALYSIS 180
16.18.3 PRODUCT PORTFOLIO 181
16.18.4 RECENT DEVELOPMENTS 181
16.19 ITC ZLIN 182
16.19.1 COMPANY SNAPSHOT 182
16.19.2 PRODUCT PORTFOLIO 182
16.19.3 RECENT DEVELOPMENTS 182
16.20 MEDICAL ENGINEERING TECHNOLOGIES LTD. 183
16.20.1 COMPANY SNAPSHOT 183
16.20.2 PRODUCT PORTFOLIO 183
16.20.3 RECENT DEVELOPMENTS 183
16.21 MEDISTRI SA 184
16.21.1 COMPANY SNAPSHOT 184
16.21.2 PRODUCT PORTFOLIO 184
16.21.3 RECENT DEVELOPMENTS 184
16.22 NELSON LABORATORIES, LLC- A SOTERA HEALTH COMPANY 185
16.22.1 COMPANY SNAPSHOT 185
16.22.2 REVENUE ANALYSIS 185
16.22.3 PRODUCT PORTFOLIO 186
16.22.4 RECENT DEVELOPMENTS 186
16.23 NSF. 187
16.23.1 COMPANY SNAPSHOT 187
16.23.2 PRODUCT PORTFOLIO 187
16.23.3 RECENT DEVELOPMENTS 187
16.24 PACE 188
16.24.1 COMPANY SNAPSHOT 188
16.24.2 PRODUCT PORTFOLIO 188
16.24.3 RECENT DEVELOPMENTS 188
16.25 Q LABORATORIES 189
16.25.1 COMPANY SNAPSHOT 189
16.25.2 PRODUCT PORTFOLIO 189
16.25.3 RECENT DEVELOPMENTS 189
16.26 TUV RHEINLAND 190
16.26.1 COMPANY SNAPSHOT 190
16.26.2 REVENUE ANALYSIS 190
16.26.3 PRODUCT PORTFOLIO 191
16.26.4 RECENT DEVELOPMENTS 191
16.27 UL LLC 192
16.27.1 COMPANY SNAPSHOT 192
16.27.2 PRODUCT PORTFOLIO 192
16.27.3 RECENT DEVELOPMENTS 193
17 QUESTIONNAIRE 194
18 RELATED REPORTS 197
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