Medical Device Testing Market by Services, Sourcing, Class, Technology - Global Forecast to 2023

  • ID: 4435929
  • Report
  • Region: Global
  • 188 Pages
  • Markets and Markets
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The Medical Device Testing Market is Estimated to be USD 8.56 Billion in 2017 and is Expected to Reach USD 12.26 Billion by 2023

FEATURED COMPANIES

  • ASTM
  • Bureau Veritas
  • Eurofins Scientific
  • Intertek
  • Pace Analytical Services
  • Surpass
  • MORE

'Medical Device Testing Market by Services (Testing, Inspection, Certification), Sourcing (In-house, Outsourced), Class (Class I, Class II, Class III), Technology (Active Implant, IVD, Orthopedic & Dental, Ophthalmic, Vascular) - Global Forecast to 2023'

“Medical device testing market is projected to grow at a CAGR of 6.18% between 2017 and 2023”

The medical device testing market is estimated to be USD 8.56 billion in 2017 and is expected to reach USD 12.26 billion by 2023, growing at a CAGR of 6.18% between 2017 and 2023. Some of the market drivers are an increasing need of validation and verification (V&V) for medical device, and imposition of rigorous government regulations and standards across medical devices. The main restrain for the market growth is barrier to local development of medical device manufacturers.

“Medical device testing market for certification services expected to grow at the highest CAGR during the forecast period”

There has been an increasing demand for certification services, owing to the increasing number of specified standards by governments and international standardization institutions. Companies are more aware about their credibility than before and certifications demonstrate the compliance of their medical device with specific standards and improve its marketability.

“Medical device testing market for in-house sourcing type accounted for the largest share in 2016”

Manufacturers and organizations had to adhere to limited standards and regulations in the past; hence, it was possible for companies to build their in-house testing and inspection capabilities. In the recent years, the standards pertaining to human/user safety have increased and become mandatory for medical devices. However, this trend is shifting to the increase in outsourcing TIC services to specialized third-party service providers as they help reduce manufacturers’ operational expenditure.

“Medical device testing market for active implant medical device to grow at the highest CAGR during the forecast period”

Implementation of stringent regulations to ensure that the implantable medical devices are fit for the human body is increasing. These devices are prone to risks. Hence, they are subjected to rigorous regulatory controls, both pre- and post-marketing.

“APAC is expected to be the fastest-growing market for medical device testing, inspection, and certification services during the forecast period”

Many economically advanced countries have their manufacturing units in the developing economies of APAC, especially China and India. These units are required to manufacture products in compliance with internationally accepted standards. The markets in APAC are growing rapidly, owing to the rising per capita income among the middle class.

Breakdown of profile of primary participants:

  • By Company: Tier 1 - 52 %, Tier 2 - 14%, and Tier 3 - 34%
  • By Designation: C-Level Executives - 49%, Directors = 28%, and Others = 23%
  • By Region: North America - 42%, Europe - 32%, APAC - 21%, and RoW - 5%

The major players profiled in this report include:

  • SGS (Switzerland)
  • Bureau Veritas (France)
  • Intertek (UK)
  • DEKRA (Germany)
  • TÜV SÜD (Germany)
  • Eurofins Scientific (Luxembourg)
  • TÜV Rheinland (Germany)
  • BSI (UK)
  • UL (US)
  • ASTM (US)

Research Coverage:

The study segments the medical device testing market report into service type (testing services, inspection services, certification services, and others) and sourcing type (in-house and outsourced). The study also covers device class (class I, class II, class III), technologies (active implant, active, non-active, IVD, ophthalmic, orthopedic and dental, vascular, and others), and provides the geographic forecast of the market size for various segments with regard to 4 main regions-North America, Europe, Asia Pacific (APAC), and Rest of the World (RoW).

Reasons to buy the report

The report would help the market leaders/new entrants in this market in the following ways:

  • This report segments the medical device testing market comprehensively and provides the closest approximations of the overall market size and those of the subsegments across different applications and regions.
  • The report provides the detailed analysis of the medical device testing, inspection, and certification market with the help of competitive leadership mapping, and value chain analysis including key companies in the market and their relations in the ecosystem.
  • The report helps stakeholders to understand the pulse of the market and provides them information on the key market drivers, restraints, challenges, and opportunities.
  • This report would help stakeholders to understand their competitors better and gain insights to enhance their position in the market. The competitive landscape section includes the competitor ecosystem, standards and certification developments, expansion and service expansion, partnerships, and mergers and acquisitions in the medical device testing market.
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FEATURED COMPANIES

  • ASTM
  • Bureau Veritas
  • Eurofins Scientific
  • Intertek
  • Pace Analytical Services
  • Surpass
  • MORE

1 Introduction
1.1 Objectives of the Study
1.2 Market Definition
1.3 Scope of the Study
1.3.1 Markets Covered
1.3.2 Years Considered for the Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders

2 Research Methodology
2.1 Research Data
2.1.1 Secondary Data
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Data
2.1.2.1 Key Data From Primary Sources
2.1.2.2 Key Industry Insights
2.1.2.3 Breakdown of Primaries
2.2 Market Size Estimation
2.2.1 Bottom-Up Approach
2.2.2 Top-Down Approach
2.3 Market Breakdown and Data Triangulation
2.4 Research Assumptions

3 Executive Summary

4 Premium Insights
4.1 Lucrative Opportunities in the Medical Device Testing Market
4.2 Medical Device Testing Market, By Technology
4.3 Medical Device Testing Market, By Device Class and Technology
4.4 Medical Device Testing Market, By Device Class and Service Type
4.5 Medical Device Testing Market, By Technology and Sourcing Type
4.6 Medical Device Testing Market in Asia Pacific, By Country and Technology
4.7 Medical Device Testing Market, By Geography

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 The Race of Market vs More Regulatory Compliance
5.2.1.2 Increasing Need of Validation and Verification (V&V) for Medical Devices
5.2.1.3 Imposition of Rigorous Government Regulations and Standards in Medical Devices
5.2.2 Restraints
5.2.2.1 Barriers to Local Development of Medical Device Manufacturers
5.2.3 Opportunities
5.2.3.1 Integration of Mobile and Medical Devices
5.2.3.2 Consolidation of Fragmented Market
5.2.3.3 Inclination Toward Outsourcing Tic Services
5.2.4 Challenges
5.2.4.1 Complex Nature of Global Supply Chains
5.2.4.2 Long Lead Time for Overseas Qualification Tests
5.3 Value Chain Analysis
5.4 Core Industry Segments for the Overall Medical Device Testing Market
5.4.1.1 Tic Standards and Regulatory Bodies
5.4.1.2 Companies Offering Tic Services
5.4.1.3 Technology for End-User Applications
5.5 Key Trends

6 Medical Device Testing Market, By Service Type
6.1 Introduction
6.2 Testing Services
6.3 Inspection Services
6.4 Certification Services
6.5 Others

7 Medical Device Testing Market, By Sourcing Type
7.1 Introduction
7.2 In-House
7.3 Outsourced

8 Medical Device Testing Market, By Device Class
8.1 Introduction
8.2 Regional Class Differentiation
8.2.1 Us
8.2.1.1 Class I: General Controls
8.2.1.2 Class II: General Controls With Special Controls
8.2.1.3 Class III: General Controls, Special Controls, and Premarket Approval
8.2.2 European Union and European Free Trade Association
8.2.3 Canada
8.2.4 Australia
8.3 Class Differentiation Considered in This Study
8.4 Class I
8.5 Class II
8.6 Class III

9 Medical Device Testing Market, By Technology
9.1 Introduction
9.2 Active Implant Medical Device
9.3 Active Medical Device
9.4 Non-Active Medical Device
9.5 In-Vitro Diagnostic Medical Device
9.6 Ophthalmic Medical Device
9.7 Orthopedic and Dental Medical Device
9.8 Vascular Medical Device
9.9 Other Medical Device Technologies
9.9.1 Mobile Devices
9.9.2 Medical Devices With Ancillary Medicinal Substances
9.9.3 Medical Devices Utilizing Animal Origin

10 Geographic Analysis
10.1 Introduction
10.2 North America
10.2.1 US
10.2.2 Canada
10.2.3 Mexico
10.3 Europe
10.3.1 UK
10.3.2 Germany
10.3.3 France
10.3.4 Italy
10.3.5 Spain
10.3.6 Rest of Europe
10.4 APAC
10.4.1 China
10.4.2 Japan
10.4.3 India
10.4.4 South Korea
10.4.5 Australia
10.4.6 Rest of APAC
10.5 RoW
10.5.1 South America
10.5.2 Middle East and Africa

11 Competitive Landscape
11.1 Overview
11.2 Key Players in the Medical Device Testing Market
11.3 Competitive Situations and Trends
11.4 Developments
11.4.1 New Standards and Certification Developments
11.4.2 Expansions and Service Expansions
11.4.3 Mergers and Acquisitions

12 Company Profiles
(Overview, Services Offered, Strength of Service Offering, Business Strategy Excellence, Recent Developments, Key Relationships)*
12.1 Key Players
12.1.1 SGS
12.1.2 Bureau Veritas
12.1.3 Intertek
12.1.4 TUV SUD
12.1.5 Dekra
12.1.6 BSI
12.1.7 TUV Rheinland
12.1.8 UL
12.1.9 Eurofins Scientific
12.1.10 ASTM
12.2 Start-Up Ecosystem
12.2.1 Element Material Technology (Exova)
12.2.2 Envigo
12.2.3 Avomeen Analytical Services
12.2.4 Gateway Analytical
12.2.5 Medistri SA
12.3 Other Key Players
12.3.1 North American Science Associates (NAMSA)
12.3.2 Pace Analytical Services
12.3.3 Wuxi Apptec
12.3.4 Toxikon
12.3.5 Charles River Laboratories
12.3.6 Medical Device Testing Services
12.3.7 Source Bioscience
12.3.8 NSF International
12.3.9 BDC Laboratories
12.3.10 Surpass

*Details on Overview, Services Offered, Strength of Service Offering, Business Strategy Excellence, Recent Developments, Key Relationships Might Not Be Captured in Case of Unlisted Companies.

13 Appendix
13.1 Insights of Industry Experts
13.2 Discussion Guide
13.3 Knowledge Store
13.4 Introducing RT: Real-Time Market Intelligence
13.5 Available Customizations
13.6 Related Reports
13.7 Author Details

List of Tables:
Table 1 Common Framework for Medical Device Regularization
Table 2 List of Standards Related to the Wireless Medical Device
Table 3 Medical Device Testing Market, By Service Type, 2015-2023 (USD Million)
Table 4 Medical Device Testing Market for Testing Services, By Technology, 2015-2023 (USD Million)
Table 5 Medical Device Testing Market for Testing Services, By Device Class, 2015-2023 (USD Million)
Table 6 Medical Device Testing Market for Inspection Services, By Technology, 2015-2023 (USD Million)
Table 7 Medical Device Testing Market for Inspection Services, By Device Class, 2015-2023 (USD Million)
Table 8 Medical Device Testing Market for Certification Services, By Technology, 2015-2023 (USD Million)
Table 9 Medical Device Testing Market for Certification Services, By Device Class, 2015-2023 (USD Million)
Table 10 Medical Device Testing Market for Other Service Types, By Technology, 2015-2023 (USD Million)
Table 11 Medical Device Testing Market for Other Service Types, By Device Class, 2015-2023 (USD Million)
Table 12 Medical Device Testing Market, By Sourcing Type, 2015-2023 (USD Million)
Table 13 Medical Device Testing Market for In-House Sourcing Type, By Technology, 2015-2023 (USD Million)
Table 14 Medical Device Testing Market for Outsourced Sourcing Type, By Technology, 2015-2023 (USD Million)
Table 15 Medical Device Testing Market, By Device Class, 2015-2023 (USD Million)
Table 16 Medical Device Testing Market for Class I, By Technology, 2015-2023 (USD Million)
Table 17 Medical Device Testing Market for Class I, By Service Type, 2015-2023 (USD Million)
Table 18 Medical Device Testing Market for Class II, By Technology, 2015-2023 (USD Million)
Table 19 Medical Device Testing Market for Class II, By Service Type, 2015-2023 (USD Million)
Table 20 Medical Device Testing Market for Class III, By Technology, 2015-2023 (USD Million)
Table 21 Medical Device Testing Market for Class III, By Service Type, 2015-2023 (USD Million)
Table 22 Medical Device Testing Market, By Technology, 2015-2023 (USD Million)
Table 23 Medical Device Testing Market for Active Implant Medical Device, By Device Class, 2015-2023 (USD Million)
Table 24 Medical Device Testing Market for Active Implant Medical Device, By Service Type, 2015-2023 (USD Million)
Table 25 Medical Device Testing Market for Active Implant Medical Device, By Sourcing Type, 2015-2023 (USD Million)
Table 26 Medical Device Testing Market for Active Implant Medical Device, By Region, 2015-2023 (USD Million)
Table 27 Medical Device Testing Market for Active Medical Device, By Device Class, 2015-2023 (USD Million)
Table 28 Medical Device Testing Market for Active Medical Device, By Service Type, 2015-2023 (USD Million)
Table 29 Medical Device Testing Market for Active Medical Device, By Sourcing Type, 2015-2023 (USD Million)
Table 30 Medical Device Testing Market for Active Medical Device, By Region, 2015-2023 (USD Million)
Table 31 Medical Device Testing Market for Non-Active Medical Device, By Device Class, 2015-2023 (USD Million)
Table 32 Medical Device Testing Market for Non-Active Medical Device, By Service Type, 2015-2023 (USD Million)
Table 33 Medical Device Testing Market for Non-Active Medical Device, By Sourcing Type, 2015-2023 (USD Million)
Table 34 Medical Device Testing Market for Non-Active Medical Device, By Region, 2015-2023 (USD Million)
Table 35 Medical Device Testing Market for In-Vitro Diagnostic Medical Device, By Device Class, 2015-2023 (USD Million)
Table 36 Medical Device Testing Market for In-Vitro Diagnostic Medical Device, By Service Type, 2015-2023 (USD Million)
Table 37 Medical Device Testing Market for In-Vitro Diagnostic Medical Device, By Sourcing Type, 2015-2023 (USD Million)
Table 38 Medical Device Testing Market for In-Vitro Diagnostic Medical Device, By Region, 2015-2023 (USD Million)
Table 39 Medical Device Testing Market for Ophthalmic Medical Device, By Device Class, 2015-2023 (USD Million)
Table 40 Medical Device Testing Market for Ophthalmic Medical Device, By Service Type, 2015-2023 (USD Million)
Table 41 Medical Device Testing Market for Ophthalmic Medical Device, By Sourcing Type, 2015-2023 (USD Million)
Table 42 Medical Device Testing Market for Ophthalmic Medical Device, By Region, 2015-2023 (USD Million)
Table 43 Medical Device Testing Market for Orthopedic and Dental Medical Device, By Device Class, 2015-2023 (USD Million)
Table 44 Medical Device Testing Market for Orthopedic and Dental Medical Device, By Service Type, 2015-2023 (USD Million)
Table 45 Medical Device Testing Market for Orthopedic and Dental Medical Device, By Sourcing Type, 2015-2023 (USD Million)
Table 46 Medical Device Testing Market for Orthopedic and Dental Medical Device, By Region, 2015-2023 (USD Million)
Table 47 Medical Device Testing Market for Vascular Medical Device, By Device Class, 2015-2023 (USD Million)
Table 48 Medical Device Testing Market for Vascular Medical Device, By Service Type, 2015-2023 (USD Million)
Table 49 Medical Device Testing Market for Vascular Medical Device, By Sourcing Type, 2015-2023 (USD Million)
Table 50 Medical Device Testing Market for Vascular Medical Device, By Region, 2015-2023 (USD Million)
Table 51 Medical Device Testing Market for Other Medical Device Technologies, By Device Class, 2015-2023 (USD Million)
Table 52 Medical Device Testing Market for Other Medical Device Technologies, By Service Type, 2015-2023 (USD Million)
Table 53 Medical Device Testing Market for Other Medical Device Technologies, By Sourcing Type, 2015-2023 (USD Million)
Table 54 Medical Device Testing Market for Other Medical Device Technologies, By Region, 2015-2023 (USD Million)
Table 55 Medical Device Testing Market, By Region, 2015-2023 (USD Million)
Table 56 Medical Device Testing Market in North America, By Country, 2015-2023 (USD Million)
Table 57 Medical Device Testing Market in North America, By Technology, 2015-2023 (USD Million)
Table 58 Medical Device Testing Market in Europe, By Country, 2015-2023 (USD Million)
Table 59 Medical Device Testing Market in Europe, By Technology, 2015-2023 (USD Million)
Table 60 Medical Device Testing Market in APAC, By Country, 2015-2023 (USD Million)
Table 61 Medical Device Testing Market in APAC, By Technology, 2015-2023 (USD Million)
Table 62 Medical Device Testing Market in RoW, By Region, 2015-2023 (USD Million)
Table 63 Medical Device Testing Market in RoW, By Technology, 2015-2023 (USD Million)
Table 64 Top 5 Players in the Medical Device Testing Market, 2016
Table 65 New Standards and Certification Developments (2017)
Table 66 Expansions and Service Expansions (2017)
Table 67 Mergers and Acquisitions (2015-2017)

List of Figures:
Figure 1 Market Segmentation
Figure 2 Process Flow of Market Size Estimation
Figure 3 Medical Device Testing Market: Research Design
Figure 4 Data Triangulation Methodology
Figure 5 Medical Device Testing Market Snapshot, By Technology, 2017-2023 (USD Billion)
Figure 6 Testing Services Segment is Expected to Have the Largest Market Size During the Forecast Period
Figure 7 Outsourced Sourcing Type is Likely to Grow at A Higher CAGR During the Forecast Period
Figure 8 Class II Medical Device is Expected to Hold the Largest Market Size During the Forecast Period
Figure 9 North America Led the Medical Device Testing Market in 2016
Figure 10 Need of Verification and Validation Process in Medical Devices is Expected to Drive the Market Growth During the Forecast Period
Figure 11 Active Implant Medical Device is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 12 Class II Medical Device for Active Implant Medical Device Technology is Expected to Exhibit the Highest Growth Rate During the Forecast Period
Figure 13 Class III Medical Devices for Certification Services is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 14 IVD Medical Device in Outsourced Sourcing Type is Expected to Hold A Larger Market Size During the Forecast Period
Figure 15 In-Vitro Diagnostic Medical Device Held the Largest Market Share in 2016
Figure 16 Emerging Markets, Such as China and India, are Some of the Growing Countries for the Medical Device Testing Market
Figure 17 Medical Device Testing Market Dynamics
Figure 18 Value Chain Analysis of the Medical Device Testing Market,2017
Figure 19 Commercialization of IoT Technology: Leading Trends Among Key Market Players
Figure 20 Certification Services Segment is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 21 In-Vitro Diagnostic Medical Device Technology is Expected to Hold the Largest Market Size for Testing Services During the Forecast Period
Figure 22 Active Medical Device Technology is Expected to Grow at the Highest CAGR for Inspection Services During the Forecast Period
Figure 23 In-Vitro Diagnostic Medical Device Technology is Expected to Hold the Largest Market Size for Certification Services During the Forecast Period
Figure 24 Outsourced Sourcing Type is Expected to Grow at A Higher CAGR During the Forecast Period
Figure 25 Active Implant Medical Device is Expected to Have the Highest CAGR in In-House Sourcing Type During the Forecast Period
Figure 26 In-Vitro Diagnostic Medical Device Technology is Expected to Have the Largest Market Size of the Outsourced Medical Device Testing Market During the Forecast Period
Figure 27 Class II Medical Device is Expected to Hold the Largest Market Size During the Forecast Period
Figure 28 Testing Services Segment is Expected to Have the Largest Market Size in Class I Medical Device During the Forecast Period
Figure 29 In-Vitro Diagnostic Medical Device Technology is Expected to Have the Largest Market Size in Class II Medical Device Testing Market During the Forecast Period
Figure 30 Active Implant Medical Device is Expected to Have the Highest CAGR in Class III Medical Device Testing Market During the Forecast Period
Figure 31 Active Implant Medical Device is Expected to Grow at the Highest CAGR During the Forecast Period
Figure 32 In-House Sourcing Type is Expected to Grow at A Higher CAGR for Active Implant Medical Device During the Forecast Period
Figure 33 Testing Services Segment for Active Medical Device is Expected to Hold the Largest Market Size During the Forecast Period
Figure 34 Class II Medical Device is Expected to Grow at the Highest CAGR for Non-Active Medical Device During the Forecast Period
Figure 35 In-House Sourcing Type is Expected to Hold A Larger Market Size for In-Vitro Diagnostic Medical Device During the Forecast Period
Figure 36 APAC is Expected to Grow at the Highest CAGR for Ophthalmic Medical Device During the Forecast Period
Figure 37 North America is Expected to Hold the Largest Market Size for the Orthopedic and Dental Medical Device During the Forecast Period
Figure 38 Certification Services Segment is Expected to Grow at the Highest CAGR for Vascular Medical Device During the Forecast Period
Figure 39 In-House Sourcing Type is Expected to Hold A Larger Market Size for Other Medical Device Technologies During the Forecast Period
Figure 40 Geographic Snapshot: Rapidly Growing Countries Such as India, Japan, Australia, and China are Emerging as Potential New Markets
Figure 41 Medical Device Testing Market in APAC is Likely to Witness the Highest CAGR During the Forecast Period
Figure 42 Market Snapshot: North America
Figure 43 In-Vitro Diagnostic Medical Device Technology is Likely to Hold the Largest Market Size of the Medical Device Testing Market in North America During the Forecast Period
Figure 44 Market Snapshot: Europe
Figure 45 Germany is Expected to Hold the Largest Market Size in the Medical Device Testing Market in Europe During the Forecast Period
Figure 46 Market Snapshot: APAC
Figure 47 China is Estimated to Hold the Largest Market Size of the Medical Device Testing Market in APAC During the Forecast Period
Figure 48 South America is Expected to Grow at A Higher CAGR in the Medical Device Testing Market in RoW During the Forecast Period
Figure 49 Companies Adopted Product Development as the Key Growth Strategy Between 2014 and 2017
Figure 50 Market Evolution Framework: New Standard and Certification is the Major Strategy Adopted By Key Players
Figure 51 SGS: Company Snapshot
Figure 52 Bureau Veritas: Company Snapshot
Figure 53 Intertek: Company Snapshot
Figure 54 TUV SUD: Company Snapshot
Figure 55 Dekra: Company Snapshot
Figure 56 BSI: Company Snapshot
Figure 57 TUV Rheinland: Company Snapshot
Figure 58 Eurofins Scientific: Company Snapshot
Figure 59 ASTM: Company Snapshot

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  • ASTM
  • Avomeen Analytical Services
  • BDC Laboratories
  • BSI
  • Bureau Veritas
  • Charles River Laboratories
  • Dekra
  • Element Material Technology (Exova)
  • Envigo
  • Eurofins Scientific
  • Gateway Analytical
  • her Key Players
  • Intertek
  • Medical Device Testing Services
  • Medistri SA
  • North American Science Associates (NAMSA)
  • NSF International
  • Pace Analytical Services
  • SGS
  • Source Bioscience
  • Surpass
  • Toxikon
  • TUV Rheinland
  • TUV SUD
  • UL
  • Wuxi Apptec
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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