医療機器検査市場 : 2028年までの世界予測

出版:MarketsandMarkets(マーケッツアンドマーケッツ) 出版年月:2023年10月

Medical Device Testing Market – Global Forecast 2028

医療機器検査市場 : サービス (試験、検査、認証)、調達 (社内、外部委託)、技術 (アクティブインプラント、アクティブ、非アクティブ、IVD、眼科、整形外科&歯科、血管)、クラス (I、II、III) – 2028年までの世界予測
Medical Device Testing Market by Service (Testing, Inspection, Certification), Sourcing (In-house, Outsourced), Technology (Active Implant, Active, Non-active, IVD, Ophthalmic, Orthopedic & Dental, Vascular), Class (I, II, III) – Global Forecast to 2028

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Report Overview

The market for medical device testing globally is expected to be valued at USD 10.6 billion in 2023 and is anticipated to reach at value of USD 13.5 billion by 2028. Furthermore, the market is expected to grow at a CAGR of 4.9% during 2023 to 2028. Global healthcare industry expansion represents a substantial potential for numerous stakeholders in the medical device testing market. As healthcare access increases globally, particularly in emerging nations, there is an increase in demand for innovative medical equipment. An increasing population, increased disposable incomes, and a greater awareness of healthcare and wellbeing are driving this need. As a result, robust testing services are required to assure the safety, efficacy, and compliance of these devices with stringent regulatory criteria. Testing facilities and services play an important role in assisting the global expansion of the healthcare business by giving manufacturers, healthcare providers, and patients with the essential assurance, thereby contributing to the overall growth and credibility of the medical device sector.

医療機器検査市場 : 2028年までの世界予測

“Outsourcing segment to account for the largest CAGR for medical device testing market”
Outsourcing in the medical device testing market refers to delegating testing responsibilities to specialized service providers on behalf of medical device manufacturers. This approach proves beneficial, particularly for smaller companies or those lacking the necessary resources or expertise for thorough testing. It provides adaptability, expandability, and wider access to diverse testing capacities, expediting product development, ensuring compliance with regulations, and offering cost-efficiency to manufacturers. The growing inclination towards outsourcing medical device testing is a significant driver for market growth.


“Certification services to account for highest CAGR of medical device testing market.”
The certification services is holds for the highest CAGR within the medical device testing market. The certification services is holds for the highest CAGR within the medical device testing market. Certification services are a fundamental aspect of the medical device testing market, ensuring that medical devices conform to industry-specific standards and regulations. These services involve a comprehensive evaluation of design, manufacturing, labeling, and intended use to determine compliance with established criteria. Obtaining certification is vital for medical device manufacturers as it demonstrates their commitment to quality and safety, helping gain market access and customer trust. Certification offers assurance to healthcare professionals and end-users that the medical devices meet rigorous quality and safety standards.


“North America to have the highest market share for medical device testing market.”
North America ranks as the second-largest market share holder in the medical device testing market, encompassing the US, Canada, and Mexico. The region stands out for its advanced healthcare infrastructure, strict regulatory frameworks, and a committed focus on ensuring the safety and effectiveness of medical devices. The US, in particular, commands a dominant market position owing to its strong research and development efforts, a considerable presence of medical device manufacturers, and substantial investments in the healthcare sector. The market growth is propelled by factors like regulatory compliance, continuous technological advancements, and a growing demand for innovative medical devices. Additionally, prominent trends such as personalized medicine and the integration of digital health technologies are significantly influencing the market landscape.

医療機器検査市場 : 2028年までの世界予測 - region


The study contains insights from various industry experts, ranging from component suppliers to Tier 1 companies and OEMs. The break-up of the primaries is as follows:
• By Company Type: Tier 1 – 38%, Tier 2 – 28%, and Tier 3 – 34%
• By Designation: C-level Executives – 40%, Directors – 30%, and Others – 30%
• By Region: North America – 35%, Europe – 20%, Asia Pacific – 35%, RoW – 10%

The key players operating in the medical device testing market are Eurofins Scientific (Luxembourg), Intertek Group plc (UK), SGS Société Générale de Surveillance SA. (Switzerland), Bureau Veritas (France), TÜV SÜD (Germany).

医療機器検査市場 : 2028年までの世界予測 - ecosystem


Research Coverage:
The research reports the Medical Device Testing Market, By Service Type (Testing Services, Inspection Services, Certification Services and Others), Sourcing Type (In-house and Outsourced), By Device Class (Class I, Class II, and Class III), By Technology (Active Implant Medical Devices, Active Medical Devices, Non-active Medical Devices, IVD Medical Devices, Ophthalmic Medical Devices, Orthopedic Medical Devices, Vascular Medical Devices and Others) and Region (North America, Europe, Asia Pacific, and RoW). The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the medical device testing market. A detailed analysis of the key industry players has been done to provide insights into their business overviews, products, key strategies, Contracts, partnerships, and agreements. New product & service launches, mergers and acquisitions, and recent developments associated with the medical device testing market. Competitive analysis of upcoming startups in the medical device testing market ecosystem is covered in this report.


Key Benefits of Buying the Report

• Analysis of key drivers (Global expansion of healthcare industry, increasing need for stringent standards, increasing need for validation and verification of medical devices, rising shift towards outsourcing of medical device testing, emergence of COVID 19 pandemic), restraints (lenthy and expensive licensing procedures, quality conscenrs and product recalls), opportunities (Connectivity of mobile devices, harmonization of standards, technological advancements, IoT and AI technologies), and challenges (Intricate nature of supply chains, lead time challenges) influencing the growth of the medical device testing market.

• Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product/service launches in the medical device testing market

• Market Development: Comprehensive information about lucrative markets – the report analyses the medical device testing market across varied regions.

• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the medical device testing market

• Competitive Assessment: In-depth assessment of market shares, growth strategies, and service offerings of leading players like Eurofins Scientific (Luxembourg), Intertek Group plc (UK), SGS Société Générale de Surveillance SA. (Switzerland), Bureau Veritas (France), TÜV SÜD (Germany) among others in the medical device testing market.

Table of Contents

1            INTRODUCTION            28

1.1         STUDY OBJECTIVES      28

1.2         MARKET DEFINITION   28

1.2.1      INCLUSIONS AND EXCLUSIONS 29

1.3         STUDY SCOPE  30

FIGURE 1           MEDICAL DEVICE TESTING MARKET: MARKET SEGMENTATION           30

1.3.1      REGIONAL SCOPE         30

1.3.2      YEARS CONSIDERED     31

1.4         CURRENCY CONSIDERED          31

1.5         LIMITATIONS   31

1.6         STAKEHOLDERS            32

1.7         SUMMARY OF CHANGES            32

1.8         IMPACT OF RECESSION 32

2            RESEARCH METHODOLOGY     33

2.1         RESEARCH DATA           33

FIGURE 2           MEDICAL DEVICE TESTING MARKET: RESEARCH DESIGN              33

2.1.1      SECONDARY AND PRIMARY RESEARCH 35

2.1.2      SECONDARY DATA       35

2.1.2.1   Major secondary sources    36

2.1.2.2   Secondary sources             36

2.1.3      PRIMARY DATA 36

2.1.4      BREAKDOWN OF PRIMARIES     37

2.1.4.1   Key data from primary sources         37

2.2         MARKET SIZE ESTIMATION       38

FIGURE 3           PROCESS FLOW OF MARKET SIZE ESTIMATION 38

2.2.1      BOTTOM-UP APPROACH           39

2.2.1.1   Approach to estimate market share by bottom-up analysis

(demand side)     39

FIGURE 4           MARKET SIZE ESTIMATION: BOTTOM-UP APPROACH  39

2.2.2      TOP-DOWN APPROACH             39

2.2.2.1   Approach to estimate market share by top-down analysis

(supply side)        40

FIGURE 5           MARKET SIZE ESTIMATION: TOP-DOWN APPROACH    40

FIGURE 6           MARKET SIZE ESTIMATION: TOP-DOWN APPROACH (SUPPLY SIDE)—REVENUE GENERATED FROM MEDICAL DEVICE TESTING SERVICES              40

2.2.2.2   Key industry insights          41

2.3         DATA TRIANGULATION             42

FIGURE 7           DATA TRIANGULATION             42

2.4         RESEARCH ASSUMPTIONS         43

FIGURE 8           ASSUMPTIONS FOR RESEARCH STUDY 43

2.5         RISK ASSESSMENT         43

2.6         PARAMETERS CONSIDERED TO ANALYZE IMPACT OF RECESSION ON MEDICAL DEVICE TESTING MARKET    44

2.7         RESEARCH LIMITATIONS           44

FIGURE 9           LIMITATIONS FOR RESEARCH STUDY   44

3            EXECUTIVE SUMMARY 45

FIGURE 10         IVD MEDICAL DEVICES SEGMENT TO CAPTURE LARGEST SHARE OF MEDICAL DEVICE TESTING MARKET IN 2028 46

FIGURE 11         TESTING SERVICES TO COMMAND LARGEST SHARE OF MEDICAL DEVICE TESTING MARKET IN 2028     46

FIGURE 12         IN-HOUSE SEGMENT TO ACCOUNT FOR LARGER SHARE OF MEDICAL DEVICE TESTING MARKET FROM 2023 TO 2028           47

FIGURE 13         NORTH AMERICA ACCOUNTED FOR LARGEST SHARE OF MEDICAL DEVICE TESTING MARKET IN 2022     47

4            PREMIUM INSIGHTS      49

4.1         ATTRACTIVE OPPORTUNITIES FOR PLAYERS IN MEDICAL DEVICE TESTING MARKET         49

FIGURE 14         STRINGENT REGULATORY STANDARDS PERTAINING TO MEDICAL DEVICES TO BOOST MARKET GROWTH         49

4.2         MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE             49

FIGURE 15         TESTING SERVICES SEGMENT TO COMMAND LARGEST SHARE OF MEDICAL DEVICE TESTING MARKET IN 2028             49

4.3         MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY            50

FIGURE 16         ACTIVE IMPLANT MEDICAL DEVICES SEGMENT TO REGISTER HIGHEST CAGR FROM 2023 TO 2028       50

4.4         MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE         50

FIGURE 17         IN-HOUSE SEGMENT TO ACCOUNT FOR LARGER SHARE OF MEDICAL DEVICE TESTING MARKET FROM 2023 TO 2028           50

4.5         MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS             51

FIGURE 18         CLASS III SEGMENT TO REGISTER HIGHEST CAGR IN MEDICAL DEVICE TESTING MARKET FROM 2023 TO 2028 51

4.6         NORTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY AND COUNTRY 51

FIGURE 19         IVD MEDICAL DEVICES AND US HELD LARGEST SHARE OF MARKET IN NORTH AMERICA IN 2022   51

4.7         REGIONAL SNAPSHOT OF MEDICAL DEVICE TESTING MARKET              52

FIGURE 20         MEDICAL DEVICE TESTING MARKET IN INDIA TO GROW AT FASTEST RATE DURING FORECAST PERIOD      52

5            MARKET OVERVIEW     53

5.1         INTRODUCTION            53

5.2         MARKET DYNAMICS     54

FIGURE 21         DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES: MEDICAL DEVICE TESTING MARKET    54

5.2.1      DRIVERS            55

FIGURE 22         ANALYSIS OF IMPACT OF DRIVERS ON MEDICAL DEVICE TESTING MARKET         55

5.2.1.1   Expansion of global healthcare industry         55

5.2.1.2   Need to meet stringent industry regulations with advancements in medical devices              56

5.2.1.3   Increasing emphasis on validation and verification of medical devices      56

5.2.1.4   Enforcement of stringent regulations by governments worldwide             56

TABLE 1             COMMON FRAMEWORK FOR MEDICAL DEVICE REGULARIZATION        57

5.2.1.5   Shift toward outsourcing of medical device testing services        57

5.2.1.6   Increased focus on testing of medical devices post emergence of COVID-19 pandemic             58

5.2.1.7   Integration of advanced technologies with medical equipment   58

TABLE 2             LIST OF STANDARDS RELATED TO WIRELESS MEDICAL DEVICES            59

5.2.2      RESTRAINT       60

FIGURE 23         ANALYSIS OF IMPACT OF RESTRAINT ON MEDICAL DEVICE TESTING MARKET         60

5.2.2.1   Lengthy and expensive licensing procedures hindering development of medical devices   60

5.2.3      OPPORTUNITIES           61

FIGURE 24         ANALYSIS OF IMPACT OF OPPORTUNITIES ON MEDICAL DEVICE TESTING MARKET        61

5.2.3.1   Harmonization of standards in medical device industry 61

5.2.3.2   Technological advancements in medical device testing 61

5.2.4      CHALLENGES   62

FIGURE 25         ANALYSIS OF IMPACT OF CHALLENGES ON MEDICAL DEVICE TESTING MARKET         62

5.2.4.1   Complexities of managing global supply chains in medical device testing  62

5.2.4.2   Long lead times required for overseas qualification tests for medical devices              63

5.3         VALUE CHAIN ANALYSIS            64

FIGURE 26         MEDICAL DEVICE TESTING MARKET: VALUE CHAIN ANALYSIS              64

5.4         MEDICAL DEVICE TESTING MARKET: ECOSYSTEM MAPPING    65

5.4.1      TIC STANDARDS AND REGULATORY BODIES    65

5.4.2      TIC SERVICE PROVIDERS           65

FIGURE 27         MEDICAL DEVICE TESTING MARKET: KEY PLAYERS IN ECOSYSTEM     66

5.5         TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESS       66

FIGURE 28         TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESS              66

5.6         TECHNOLOGY TRENDS             67

5.6.1      3D PRINTING AND PROTOTYPING        67

5.6.2      INTERNET OF THINGS (IOT) AND CONNECTIVITY        67

5.6.3      AUGMENTED REALITY (AR) AND VIRTUAL REALITY (VR)          67

5.6.4      ARTIFICIAL INTELLIGENCE (AI)             67

5.6.5      MACHINE LEARNING (ML)        67

6            MEDICAL DEVICE TESTING MARKET, BY TESTING TYPE            68

6.1         INTRODUCTION            68

6.2         ELECTROMAGNETIC COMPATIBILITY  68

6.2.1      PROLIFERATION OF WIRELESS TECHNOLOGIES TO NECESSITATE ELECTROMAGNETIC COMPATIBILITY TESTING OF MEDICAL DEVICES 68

TABLE 3             COMMON STANDARDS FOR MEDICAL DEVICE REGULARIZATION IN EUROPEAN NATIONS       69

6.3         ELECTRICAL SAFETY    69

6.3.1      STRINGENT SAFETY MEASURES TO DRIVE DEMAND FOR ELECTRICAL SAFETY TESTS  69

6.4         WIRELESS CONNECTIVITY        70

6.4.1      INTEGRATION OF CONNECTED HEALTH TECHNOLOGIES IN MEDICAL DEVICES TO FUEL DEMAND FOR WIRELESS CONNECTIVITY TESTING           70

6.5         ENVIRONMENTAL TESTING      71

6.5.1      INCREASING COMPLEXITY OF MEDICAL DEVICES TO NECESSITATE ENVIRONMENTAL TESTING      71

6.6         MECHANICAL TESTING 71

6.6.1      GROWING SOPHISTICATION OF MEDICAL DEVICES TO CONTRIBUTE TO DEMAND FOR MECHANICAL TESTING SERVICES     71

6.7         CHEMICAL, PHYSICAL, AND BIOCOMPATIBILITY TESTING        72

6.7.1      STRINGENT REGULATIONS ON MEDICAL DEVICES FOR PATIENT SAFETY TO FOSTER MARKET GROWTH 72

6.8         CYBERSECURITY TESTING        72

6.8.1      RISING CYBER ATTACKS ON MEDICAL DEVICES TO NECESSITATE CYBERSECURITY TESTING        72

TABLE 4             MEMORANDA OF UNDERSTANDING ON CYBERSECURITY IN MEDICAL DEVICES        73

7            MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE             74

7.1         INTRODUCTION            75

FIGURE 29         CERTIFICATION SERVICES SEGMENT TO EXHIBIT HIGHEST CAGR IN MEDICAL DEVICE TESTING MARKET DURING FORECAST PERIOD              75

TABLE 5             MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)     76

TABLE 6             MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)     76

7.2         TESTING SERVICES       76

7.2.1      RISING FOCUS ON ENSURING COMPLIANCE WITH REGULATORY STANDARDS TO DRIVE DEMAND FOR TESTING SERVICES         76

7.3         INSPECTION SERVICES 77

7.3.1      INCREASING EMPHASIS ON IMPROVING QUALITY OF MEDICAL DEVICES TO BOOST DEMAND FOR INSPECTION SERVICES        77

7.4         CERTIFICATION SERVICES        77

7.4.1      GROWING STRINGENCY OF NORMS AND REGULATIONS PERTAINING TO MEDICAL DEVICES TO BOOST DEMAND FOR CERTIFICATION SERVICES              77

7.5         OTHERS             78

8            MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE         79

8.1         INTRODUCTION            80

FIGURE 30         OUTSOURCED SEGMENT TO REGISTER HIGHEST CAGR IN MEDICAL DEVICE TESTING MARKET DURING FORECAST PERIOD         80

TABLE 7             MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)          81

TABLE 8             MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)          81

8.2         IN-HOUSE         81

8.2.1      CAPABILITY TO MEET CUSTOMIZED TESTING REQUIREMENTS FOR SPECIFIC DEVICES TO BOOST DEMAND FOR IN-HOUSE TESTING          81

8.3         OUTSOURCED 82

8.3.1      INCREASING FOCUS ON EXPEDITING PRODUCT DEVELOPMENT TO LEAD TO OUTSOURCING OF MEDICAL DEVICE TESTING           82

9            MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS             83

9.1         INTRODUCTION            84

9.2         REGIONAL CLASS DIFFERENTIATION   84

9.2.1      US         84

9.2.1.1   Class I: General controls    84

9.2.1.2   Class II: General controls with special controls             84

9.2.1.3   Class III: General controls, special controls, and pre-market approval      85

9.2.2      EUROPEAN UNION AND EUROPEAN FREE TRADE ASSOCIATION              85

9.2.3      CANADA            85

9.2.4      AUSTRALIA       85

FIGURE 31         CLASS III SEGMENT TO DOMINATE MEDICAL TESTING MARKET DURING FORECAST PERIOD   86

TABLE 9             MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS, 2019–2022 (USD MILLION)     86

TABLE 10           MEDICAL DEVICE TESTING MARKET, BY DEVICE CLASS, 2023–2028 (USD MILLION)     86

9.3         CLASS I 87

9.3.1      RAPID INCREASE IN DEMAND FOR ESSENTIAL HEALTHCARE PRODUCTS TO DRIVE MARKET 87

9.4         CLASS II             87

9.4.1      GROWING DEMAND FOR MONITORING AND DIAGNOSTIC DEVICES IN HEALTHCARE TO DRIVE CLASS II MEDICAL DEVICE TESTING   87

9.5         CLASS III            87

9.5.1      ADVANCEMENTS IN IMPLANTABLE TECHNOLOGIES TO INDUCE DEMAND FOR TESTING OF CLASS III DEVICES  87

10          MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY            88

10.1       INTRODUCTION            89

FIGURE 32         IVD MEDICAL DEVICES SEGMENT TO DOMINATE MEDICAL DEVICE TESTING MARKET DURING FORECAST PERIOD             89

TABLE 11           MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)     90

TABLE 12           MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)     90

10.2       ACTIVE IMPLANT MEDICAL DEVICES   91

10.2.1    INCREASING PREVALENCE OF CHRONIC DISEASES TO NECESSITATE USE OF MEDICAL IMPLANTS     91

TABLE 13           ACTIVE IMPLANT MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)         92

TABLE 14           ACTIVE IMPLANT MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)         92

TABLE 15           ACTIVE IMPLANT MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)            92

TABLE 16           ACTIVE IMPLANT MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)            93

10.3       ACTIVE MEDICAL DEVICES       93

10.3.1    NEED FOR CONTINUOUS MONITORING OF PATIENTS WITH CHRONIC DISEASES TO DRIVE SEGMENT 93

TABLE 17           ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)            94

TABLE 18           ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)            94

TABLE 19           ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION) 94

TABLE 20           ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION) 95

10.4       NON-ACTIVE MEDICAL DEVICES           95

10.4.1    INCREASING NUMBER OF SURGICAL PROCEDURES TO FUEL DEMAND FOR TESTING OF NON-ACTIVE MEDICAL DEVICES        95

TABLE 21           NON-ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)            96

TABLE 22           NON-ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)            96

TABLE 23           NON-ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION) 96

TABLE 24           NON-ACTIVE MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION) 97

10.5       IN VITRO DIAGNOSTIC (IVD) MEDICAL DEVICES           97

10.5.1    NEED TO ENSURE ACCURACY OF DIAGNOSTIC INFORMATION TO CREATE DEMAND FOR TESTING OF IVD MEDICAL DEVICES      97

TABLE 25           IVD MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)  98

TABLE 26           IVD MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)  98

TABLE 27           IVD MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)     98

TABLE 28           IVD MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)     99

10.6       OPHTHALMIC MEDICAL DEVICES         99

10.6.1    INCREASING PREVALENCE OF EYE DISEASES TO INDUCE DEMAND FOR TESTING OF OPHTHALMIC MEDICAL DEVICES      99

TABLE 29           OPHTHALMIC MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)            100

TABLE 30           OPHTHALMIC MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)            100

TABLE 31           OPHTHALMIC MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION) 100

TABLE 32           OPHTHALMIC MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION) 101

10.7       ORTHOPEDIC & DENTAL DEVICES        101

10.7.1    NEED TO VALIDATE DURABILITY AND PROPER FUNCTIONING OF ORTHOPEDIC DEVICES TO FUEL DEMAND FOR TESTING SERVICES      101

TABLE 33           ORTHOPEDIC & DENTAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)         102

TABLE 34           ORTHOPEDIC & DENTAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)         102

TABLE 35           ORTHOPEDIC & DENTAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)            102

TABLE 36           ORTHOPEDIC & DENTAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)            103

10.8       VASCULAR MEDICAL DEVICES 103

10.8.1    RISING INCIDENCE OF CARDIOVASCULAR DISEASES TO PROPEL NEED FOR TESTING OF VASCULAR MEDICAL DEVICES            103

TABLE 37           VASCULAR MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)            104

TABLE 38           VASCULAR MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)            104

TABLE 39           VASCULAR MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION) 104

TABLE 40           VASCULAR MEDICAL DEVICES: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION) 105

10.9       OTHERS             105

TABLE 41           OTHERS: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)          106

TABLE 42           OTHERS: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)          106

TABLE 43           OTHERS: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2019–2022 (USD MILLION)             106

TABLE 44           OTHERS: MEDICAL DEVICE TESTING MARKET, BY SERVICE TYPE, 2023–2028 (USD MILLION)             107

11          MEDICAL DEVICE TESTING MARKET, BY REGION          108

11.1       INTRODUCTION            109

FIGURE 33         ASIA PACIFIC TO EXHIBIT HIGHEST CAGR IN MEDICAL DEVICE TESTING MARKET DURING FORECAST PERIOD 109

TABLE 45           MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION) 109

TABLE 46           MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION) 110

11.2       NORTH AMERICA          110

FIGURE 34         NORTH AMERICA: MEDICAL DEVICE TESTING MARKET SNAPSHOT        111

TABLE 47           NORTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY COUNTRY, 2019–2022 (USD MILLION)    111

TABLE 48           NORTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY COUNTRY, 2023–2028 (USD MILLION)    112

TABLE 49           NORTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)      112

TABLE 50           NORTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)      112

TABLE 51           NORTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)          113

TABLE 52           NORTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)          113

11.2.1    US         114

11.2.1.1 Robust research & development activities to drive market          114

TABLE 53           US: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)          114

TABLE 54           US: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)          115

11.2.2    CANADA            115

11.2.2.1 Increasing adoption of advanced technologies to propel market growth    115

TABLE 55           CANADA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             115

TABLE 56           CANADA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             116

11.2.3    MEXICO             116

11.2.3.1 Rising demand for healthcare services to augment market growth            116

TABLE 57           MEXICO: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             117

TABLE 58           MEXICO: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             117

11.2.4    RECESSION IMPACT ON MARKET IN NORTH AMERICA 117

11.3       EUROPE             118

FIGURE 35         EUROPE: MEDICAL DEVICE TESTING MARKET SNAPSHOT              119

TABLE 59           EUROPE: MEDICAL DEVICE TESTING MARKET, BY COUNTRY, 2019–2022 (USD MILLION)          120

TABLE 60           EUROPE: MEDICAL DEVICE TESTING MARKET, BY COUNTRY, 2023–2028 (USD MILLION)          120

TABLE 61           EUROPE: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             120

TABLE 62           EUROPE: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             121

TABLE 63           EUROPE: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)          121

TABLE 64           EUROPE: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)          122

11.3.1    GERMANY         122

11.3.1.1 Strong focus on quality of medical devices to foster market growth          122

TABLE 65           GERMANY: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)      123

TABLE 66           GERMANY: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)      123

11.3.2    UK         123

11.3.2.1 Stringent regulatory standards pertaining to medical devices to contribute to market growth     123

TABLE 67           UK: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)          124

TABLE 68           UK: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)          124

11.3.3    FRANCE             124

11.3.3.1 Consolidating trend of outsourcing testing services to fuel market growth              124

TABLE 69           FRANCE: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             125

TABLE 70           FRANCE: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             125

11.3.4    ITALY   125

11.3.4.1 Rise in demand for testing of home healthcare devices to complement market growth   125

TABLE 71           ITALY: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             126

TABLE 72           ITALY: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             126

11.3.5    SPAIN   126

11.3.5.1 Increasing burden of chronic diseases to provide growth opportunities to market players   126

TABLE 73           SPAIN: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             127

TABLE 74           SPAIN: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             127

11.3.6    REST OF EUROPE           127

TABLE 75           REST OF EUROPE: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)      127

TABLE 76           REST OF EUROPE: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)      128

11.3.7    RECESSION IMPACT ON MARKET IN EUROPE    128

11.4       ASIA PACIFIC    128

FIGURE 36         ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET SNAPSHOT              129

TABLE 77           ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY COUNTRY, 2019–2022 (USD MILLION)    130

TABLE 78           ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY COUNTRY, 2023–2028 (USD MILLION)    130

TABLE 79           ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)      130

TABLE 80           ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)      131

TABLE 81           ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)          131

TABLE 82           ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)          132

11.4.1    CHINA  132

11.4.1.1 Focus on increasing production of high-end medical devices to boost demand for testing services    132

TABLE 83           CHINA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             133

TABLE 84           CHINA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             133

11.4.2    JAPAN  133

11.4.2.1 Growing concerns regarding product safety and regulatory compliance to support market growth     133

TABLE 85           JAPAN: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             134

TABLE 86           JAPAN: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             134

11.4.3    INDIA   134

11.4.3.1 Increasing demand for medical devices to boost testing              134

TABLE 87           INDIA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             135

TABLE 88           INDIA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             135

11.4.4    SOUTH KOREA 135

11.4.4.1 Increasing emphasis on basic medical care to favor market growth           135

TABLE 89           SOUTH KOREA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)      136

TABLE 90           SOUTH KOREA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)      136

11.4.5    AUSTRALIA       136

11.4.5.1 Increasing need for robust testing procedures to foster market growth     136

TABLE 91           AUSTRALIA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)      137

TABLE 92           AUSTRALIA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)      137

11.4.6    REST OF ASIA PACIFIC  137

TABLE 93           REST OF ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION) 138

TABLE 94           REST OF ASIA PACIFIC: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION) 138

11.4.7    RECESSION IMPACT ON MARKET IN ASIA PACIFIC         138

11.5       ROW     139

TABLE 95           ROW: MEDICAL DEVICE TESTING MARKET, BY REGION, 2019–2022 (USD MILLION)     139

TABLE 96           ROW: MEDICAL DEVICE TESTING MARKET, BY REGION, 2023–2028 (USD MILLION)     139

TABLE 97           ROW: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)             139

TABLE 98           ROW: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)             140

TABLE 99           ROW: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2019–2022 (USD MILLION)          140

TABLE 100         ROW: MEDICAL DEVICE TESTING MARKET, BY TECHNOLOGY, 2023–2028 (USD MILLION)          141

11.5.1    SOUTH AMERICA           141

11.5.1.1 Development of advanced medical technologies to necessitate rigorous testing procedures           141

TABLE 101         SOUTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION)      142

TABLE 102         SOUTH AMERICA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION)      142

11.5.2    MIDDLE EAST AND AFRICA       142

11.5.2.1 Growing concerns regarding product safety to accelerate demand for testing services  142

TABLE 103         MIDDLE EAST & AFRICA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2019–2022 (USD MILLION) 143

TABLE 104         MIDDLE EAST & AFRICA: MEDICAL DEVICE TESTING MARKET, BY SOURCING TYPE, 2023–2028 (USD MILLION) 143

11.5.3    RECESSION IMPACT ON MARKET IN ROW          143

12          COMPETITIVE LANDSCAPE       144

12.1       INTRODUCTION            144

12.2       STRATEGIES ADOPTED BY KEY PLAYERS           145

TABLE 105         OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS IN MEDICAL DEVICE TESTING MARKET    145

12.2.1    PRODUCT/SERVICE PORTFOLIO           146

12.2.2    REGIONAL FOCUS         146

12.2.3    ORGANIC/INORGANIC GROWTH STRATEGIES  146

12.3       MARKET SHARE ANALYSIS, 2022             147

TABLE 106         MEDICAL DEVICE TESTING MARKET: MARKET SHARE ANALYSIS, 2022 147

12.4       REVENUE ANALYSIS OF TOP PLAYERS IN MEDICAL DEVICE TESTING MARKET            149

FIGURE 37         FIVE-YEAR REVENUE ANALYSIS OF TOP PLAYERS IN MEDICAL DEVICE TESTING MARKET        149

12.5       COMPANY EVALUATION MATRIX, 2022 150

12.5.1    STARS  150

12.5.2    PERVASIVE PLAYERS     150

12.5.3    EMERGING LEADERS    150

12.5.4    PARTICIPANTS 150

FIGURE 38         MEDICAL DEVICE TESTING MARKET (GLOBAL): COMPANY EVALUATION MATRIX, 2022      151

12.6       COMPANY FOOTPRINT 152

12.6.1    COMPANY FOOTPRINT, BY SERVICE TYPE         152

12.6.2    COMPANY FOOTPRINT, BY REGION      153

12.6.3    OVERALL COMPANY FOOTPRINT          154

12.7       COMPETITIVE SCENARIOS AND TRENDS           155

12.7.1    SERVICE LAUNCHES & DEVELOPMENTS             155

TABLE 107         MEDICAL DEVICE TESTING MARKET: SERVICE LAUNCHES/DEVELOPMENTS, 2020–2023             155

12.7.2    DEALS  156

TABLE 108         MEDICAL DEVICE TESTING MARKET: DEALS, 2020–2023 156

13          COMPANY PROFILES    159

(Business Overview, Products/Services/Solutions Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats))*

13.1       KEY PLAYERS   159

13.1.1    SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA 159

TABLE 109         SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: COMPANY OVERVIEW        159

FIGURE 39         SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: COMPANY SNAPSHOT        160

TABLE 110         SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: PRODUCTS/SERVICES/SOLUTIONS OFFERED   160

TABLE 111         SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: DEALS 162

TABLE 112         SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: OTHERS              163

13.1.2    EUROFINS SCIENTIFIC  164

TABLE 113         EUROFINS SCIENTIFIC: COMPANY OVERVIEW  164

FIGURE 40         EUROFINS SCIENTIFIC: COMPANY SNAPSHOT  165

TABLE 114         EUROFINS SCIENTIFIC: PRODUCTS/SERVICES/SOLUTIONS OFFERED          165

TABLE 115         EUROFINS SCIENTIFIC: DEALS  166

13.1.3    BUREAU VERITAS          168

TABLE 116         BUREAU VERITAS: COMPANY OVERVIEW           168

FIGURE 41         BUREAU VERITAS: COMPANY SNAPSHOT          169

TABLE 117         BUREAU VERITAS: PRODUCTS/SERVICES/SOLUTIONS OFFERED          169

TABLE 118         BUREAU VERITAS: DEALS          170

13.1.4    TÜV RHEINLAND           171

TABLE 119         TÜV RHEINLAND: COMPANY OVERVIEW           171

FIGURE 42         TÜV RHEINLAND: COMPANY SNAPSHOT           172

TABLE 120         TÜV RHEINLAND: PRODUCTS/SERVICES/SOLUTIONS OFFERED          172

TABLE 121         TÜV RHEINLAND: DEALS           173

TABLE 122         TÜV RHEINLAND: OTHERS        174

13.1.5    TÜV SÜD           175

TABLE 123         TÜV SÜD: COMPANY OVERVIEW            175

FIGURE 43         TÜV SÜD: COMPANY SNAPSHOT           176

TABLE 124         TÜV SÜD: PRODUCTS/SERVICES/SOLUTIONS OFFERED              176

TABLE 125         TÜV SÜD: OTHERS        177

13.1.6    DEKRA 179

TABLE 126         DEKRA: COMPANY OVERVIEW  179

FIGURE 44         DEKRA: COMPANY SNAPSHOT 180

TABLE 127         DEKRA: PRODUCTS/SERVICES/SOLUTIONS OFFERED   180

TABLE 128         DEKRA: OTHERS            181

13.1.7    UL LLC 183

TABLE 129         UL LLC: COMPANY OVERVIEW 183

TABLE 130         UL LLC: PRODUCTS/SERVICES/SOLUTIONS OFFERED  183

TABLE 131         UL LLC: DEALS 184

13.1.8    ASTM   185

TABLE 132         ASTM: COMPANY OVERVIEW    185

TABLE 133         ASTM: PRODUCTS/SERVICES/SOLUTIONS OFFERED     185

TABLE 134         ASTM: PRODUCT/SERVICE LAUNCHES 186

13.1.9    INTERTEK GROUP PLC 187

TABLE 135         INTERTEK GROUP PLC: COMPANY OVERVIEW 187

FIGURE 45         INTERTEK GROUP PLC: COMPANY SNAPSHOT 188

TABLE 136         INTERTEK GROUP PLC: PRODUCTS/SERVICES/SOLUTIONS OFFERED          188

TABLE 137         INTERTEK GROUP PLC: PRODUCT/SERVICE LAUNCHES              189

13.1.10  SOTERA HEALTH           190

TABLE 138         SOTERA HEALTH: COMPANY OVERVIEW           190

FIGURE 46         SOTERA HEALTH: COMPANY SNAPSHOT           191

TABLE 139         SOTERA HEALTH: PRODUCTS/SERVICES/SOLUTIONS OFFERED          191

TABLE 140         SOTERA HEALTH: PRODUCT/SERVICE LAUNCHES        192

TABLE 141         SOTERA HEALTH: DEALS           192

TABLE 142         SOTERA HEALTH: OTHERS        194

13.2       OTHER PLAYERS           195

13.2.1    ELEMENT MATERIALS TECHNOLOGY   195

13.2.2    INOTIV 196

13.2.3    GATEWAY ANALYTICAL             197

13.2.4    MEDISTRI SA     198

13.2.5    NORTH AMERICAN SCIENCE ASSOCIATES, LLC (NAMSA)            199

13.2.6    PACE    200

13.2.7    WUXI APPTEC  201

13.2.8    LABORATORY CORPORATION OF AMERICA      202

13.2.9    CHARLES RIVER LABORATORIES            203

13.2.10  SOURCE BIOSCIENCE    204

13.2.11  NSF       205

13.2.12  BIOMEDICAL DEVICE LABS       206

13.2.13  SURPASS, INC.   207

13.2.14  THE BRITISH STANDARDS INSTITUTION           207

13.2.15  MEASUR OY      208

*Details on Business Overview, Products/Services/Solutions Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats) might not be captured in case of unlisted companies.

14          APPENDIX         209

14.1       DISCUSSION GUIDE      209

14.2       KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL             212

14.3       CUSTOMIZATION OPTIONS      214

14.4       RELATED REPORTS       214

14.5       AUTHOR DETAILS         215