Home / Healthcare-IT / Medical Device Analytical Testing Services Market By Service Type (Material Characterization, Extractable & Leachable Testing, Physical Testing, Sterility Testing, Bioburden Testing ) - Growth, Share, Opportunities & Competitive Analysis, 2017 - 2025

Medical Device Analytical Testing Services Market By Service Type (Material Characterization, Extractable & Leachable Testing, Physical Testing, Sterility Testing, Bioburden Testing ) - Growth, Share, Opportunities & Competitive Analysis, 2017 - 2025

Published: Jul 2017 | Report Code: 58589-07-17

Medical devices are subject to stringent regulations and control specifications. Development, introduction and use of standard complying medical devices ensure efficacy and safety of such devices. Several regulatory authorities and organizations frequently collaborate to set standards for medical devices. Such establishment of standards include establishing performance characteristics, testing methods, manufacturing practices, product characters and standards, use protocols, ingredient specifications, labeling and other such criteria.

The purpose of this research study titled ‘Medical Device Analytical Testing Services Market - Growth, Future Prospects, and Competitive Analysis, 2017 – 2025’ is to provide investors, developers, company executives and industry participants with in-depth analysis to allow them to take strategic initiatives and decisions related to the prospects in the global medical device analytical testing services market. This report presents and analyzes the major trends prevalent in the global medical device analytical testing services market and the market size and forecast.

This report categorizes the global medical device analytical testing services market in terms of service type and geographical distribution. Based on service type, the global medical device analytical testing services market is categorized into material characterization, extractable & leachable testing, physical testing, sterility testing, bioburden testing, and others. Market size and forecast for each mentioned segment for the period 2015-2025 is presented in the report along with respective CAGRs for the forecast duration 2017-2025.

Geographically, the global medical device analytical testing services market is best understood by segmenting the market into five major regions and chief region level markets as follows:

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Spain
    • Italy
    • Rest of Europe
  • Asia Pacific
    • Japan
    • China
    • India
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East and Africa
    • GCC
    • Rest of Middle East and Africa

The market size and forecast of each considered geographical market is presented for the period 2015-2025 along with CAGRs for the forecast period 2017-2025 in this study and are further cross-sectional presented in terms of service type, and constituent region/country level markets.

This report also includes qualitative assessment factors such as market dynamics (drivers, restraints and opportunities) to have a good understanding of the current and anticipated trends in the global medical device analytical testing services market. Competition assessment tools such as, major agreements, partnerships and collaborations, market attractiveness assessment and competitive landscape analysis by key players are also demonstrated in the study. Furthermore, this report concludes with profiling of key market players currently enjoying prominent position in the medical device analytical testing services market. The key players profiled in this report are Avomeen Analytical Services, Charles River Laboratories International, Inc., EAG Inc., Envigo, Eurofins Scientific, Intertek Group plc, IMR Test Labs, Medical Device Testing Services, North American Science Associates, Inc., NSF International, Pace Analytical Services LLC., SGS SA, Toxikon, Inc., and Wuxi AppTec.

Chapter 1. Preface
1.1. Report Scope and Description
1.2. Research Methodology
1.2.1. Phase I-Secondary Research
1.2.2. Phase II-Primary Research
1.2.3. Phase II-Expert Panel Review
1.2.4. Assumptions
1.2.5. Approach Adopted

Chapter 2. Executive Summary
2.1. Global Medical Device Analytical Testing Services Market Portraiture
2.1.1. Global Medical Device Analytical Testing Services Market, by Service Type, 2016
2.1.2. Global Medical Device Analytical Testing Services Market, by Geography, 2016

Chapter 3. Medical Device Analytical Testing Services Market: Market Dynamics and Future Outlook
3.1. Market Overview
3.2. Drivers
3.3. Challenges
3.4. Opportunities
3.5. Attractive Investment Proposition, by Geography
3.6. Major Agreements, Partnerships and Collaborations
3.7. Competitive Landscape
3.7.1. Competitive Landscape, by Key Players, 2016

Chapter 4. Global Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
4.1. Overview
4.2. Top 3 Country Markets
4.3. Attractive Investment Proposition: Global Medical Device Analytical Testing Services Market, by Service Type
4.4. Material Characterization
4.5. Extractable & Leachable Testing
4.6. Physical Testing
4.7. Sterility Testing
4.8. Bioburden Testing
4.9. Others

Chapter 5. Global Medical Device Analytical Testing Services Market, by Geography, 2015 – 2025 (US$ Mn)
5.1. Overview
5.2. North America Medical Device Analytical Testing Services Market Analysis, 2015 – 2025
5.2.1. North America Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.2.2. North America Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
5.2.2.1. U.S.
5.2.2.1.1. U.S. Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.2.2.2. Canada
5.2.2.2.1. Canada Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.3. Europe Medical Device Analytical Testing Services Market Analysis, 2015 – 2025
5.3.1. Europe Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.3.2. Europe Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
5.3.2.1. U.K.
5.3.2.1.1. U.K. Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.3.2.2. Germany
5.3.2.2.1. Germany Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.3.2.3. France
5.3.2.3.1. France Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.3.2.4. Spain
5.3.2.4.1. Spain Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.3.2.5. Italy
5.3.2.5.1. Italy Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.3.2.6. Rest of Europe
5.3.2.6.1. Rest of Europe Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.4. Asia Pacific Medical Device Analytical Testing Services Market Analysis, 2015 – 2025
5.4.1. Asia Pacific Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.4.2. Asia Pacific Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
5.4.2.1. Japan
5.4.2.1.1. Japan Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.4.2.2. China
5.4.2.2.1. China Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.4.2.3. India
5.4.2.3.1. India Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.4.2.4. Rest of Asia Pacific
5.4.2.4.1. Rest of Asia Pacific Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.5. Latin America Medical Device Analytical Testing Services Market Analysis, 2015 – 2025
5.5.1. Latin America Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.5.2. Latin America Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
5.5.2.1. Brazil
5.5.2.1.1. Brazil Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.5.2.2. Mexico
5.5.2.2.1. Mexico Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.5.2.3. Rest of Latin America
5.5.2.3.1. Rest of Latin America Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.6. Middle East & Africa (MEA) Medical Device Analytical Testing Services Market Analysis, 2015 – 2025
5.6.1. MEA Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.6.2. MEA Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
5.6.2.1. GCC
5.6.2.1.1. GCC Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
5.6.2.2. Rest of MEA
5.6.2.2.1. Rest of MEA Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)

Chapter 6. Company Profiles
6.1. Avomeen Analytical Services
6.1.1. Business Description
6.1.2. Financial Information (Subject to data availability)
6.1.3. Service Portfolio
6.1.4. Key Developments
6.2. Charles River Laboratories International, Inc
6.3. EAG Inc.
6.4. Envigo
6.5. Eurofins Scientific
6.6. Intertek Group plc
6.7. IMR Test Labs
6.8. Medical Device Testing Services
6.9. NORTH AMERICAN SCIENCE ASSOCIATES, INC.
6.10. NSF International
6.11. Pace Analytical Services LLC.
6.12. SGS SA
6.13. Toxikon, Inc
6.14. Wuxi AppTec
6.15. Other Notable Players

List Of Table :

TABLE 1 Global Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 2 Global Medical Device Analytical Testing Services Market, by Geography, 2015 – 2025 (US$ Mn)
TABLE 3 North America Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 4 North America Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 5 U.S. Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 6 Canada Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 7 Europe Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 8 Europe Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 9 U.K. Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 10 Germany Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 11 France Medical Device Analytical Testing Services Market, by Service Type, 2015-2025 (US$ Mn)
TABLE 12 Spain Medical Device Analytical Testing Services Market, by Service Type, 2015-2025 (US$ Mn)
TABLE 13 Italy Medical Device Analytical Testing Services Market, by Service Type, 2015-2025 (US$ Mn)
TABLE 14 Rest of Europe Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 15 Asia Pacific Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 16 Asia Pacific Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 17 Japan Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 18 China Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 19 India Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 20 Rest of Asia Pacific Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 21 Latin America Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 22 Latin America Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 23 Brazil Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 24 Mexico Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 25 Rest of Latin America Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 26 Middle East and Africa Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 27 Middle East and Africa Medical Device Analytical Testing Services Market, by Country, 2015 – 2025 (US$ Mn)
TABLE 28 GCC Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 29 Rest of Middle East and Africa Medical Device Analytical Testing Services Market, by Service Type, 2015 – 2025 (US$ Mn)
TABLE 30 Avomeen Analytical Services: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 31 Charles River Laboratories International, Inc.: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 32 EAG, Inc.: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 33 Envigo: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 34 Eurofins Scientific: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 35 Intertek Group plc: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 36 IMR Test Labs: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 37 Medical Device Testing Services: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 38 North American Science Associates, Inc.: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 39 NSF International: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 40 Pace Analytical Services LLC.: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 41 SGS SA: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 42 Toxikon, Inc.: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)
TABLE 43 Wuxi AppTec: Company Snapshot (Business Description; Financial Information; Service Portfolio; News Coverage)

List Of Figures :

FIG. 1 Medical Device Analytical Testing Services: Market Segmentation
FIG. 2 Global Medical Device Analytical Testing Services Market Share, by Service Type, 2016 (Value %)
FIG. 3 Global Medical Device Analytical Testing Services Market, by Geography, 2016 (Value %)
FIG. 4 Attractive Investment Proposition, by Geography
FIG. 5 Market Competition Landscape, by Key Players, 2016
FIG. 6 Global Material Characterization Services Market, 2015 – 2025 (US$ Mn)
FIG. 7 Global Extractable & Leachable Testing Services Market, 2015 – 2025 (US$ Mn)
FIG. 8 Global Physical Testing Services Market, 2015 – 2025 (US$ Mn)
FIG. 9 Global Sterility Testing Services Market, 2015 – 2025 (US$ Mn)
FIG. 10 Global Bioburden Testing Services Market, 2015 – 2025 (US$ Mn)
FIG. 11 Global Plastic Medical Device Analytical Testing Services Market, 2015 – 2025 (US$ Mn)
FIG. 12 Global Other Medical Device Analytical Testing Services Market, 2015 – 2025 (US$ Mn)

Based on the type of services, the global medical device analytical testing services market is segmented as follows:

  • Material Characterization
  • Extractable & Leachable Testing
  • Physical Testing
  • Sterility Testing
  • Bioburden Testing
  • Others

Medical Device Analytical Testing Services Market

Among the considered service types, material characterization holds the largest revenue share in the overall medical device analytical testing services market. Through material characterization services, the services providers support medical device manufacturers in establishing biocompatibility by identification and quantification of chemicals in materials. Material characterization is performed to determine material toxicity and usually follows ISO 10993-18 methods. Some common types of material characterization testing are polymer molecular weight testing. Surface cleanliness, vendor changes testing and analyte-specific cleaning verification. Additionally, tests for elemental metals, bioburden, sterility, packaging material, particulate matter, residual ethylene oxide, microbial identification, etc. are also anticipated to witness significant demand during the forecast period, owing to growing regulatory concerns and mandates raised by approving authorities.

Geographically, the global medical device analytical testing services market is cumulative to North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.

Medical Device Analytical Testing Services Market

North America, and Western Europe together occupy the largest revenue share in the global medical device analytical testing services market. Domicile of multitude of medical device market leaders in the region, along with presence of the most evolved regulatory scenario majorly contribute to the dominance of North America and Europe. The regions deliver some of the most sophisticated, complex and novel medical devices to the global market. The original equipment manufacturers in North America and Europe have an additional concern of containing overall business expenditure while simultaneously focusing on core competency of development of novel medical devices. This has led the medical device manufacturers in these regions to increasingly outsource their non-core processes to third-party service providers. Additionally, as the healthcare infrastructure in Asia Pacific is correspondingly growing to the ever growing patient pool, the Asia Pacific market is presenting lucrative market penetration opportunities to the multinational giants.

The detailed regional classification of the global medical device analytical testing services market is as follows:

  • North America (U.S. & Canada)
  • Europe (Germany, U.K., France, Spain, Italy and Rest of Europe)
  • Asia Pacific (China, India, Japan and Rest of Asia Pacific)
  • Latin America (Brazil, Mexico, and Rest of Latin America)
  • Middle East and Africa (GCC and Rest of Middle East and Africa)
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