The global medical device market is governed by a broad range of national and international regulations and medical equipment certification standards, which are complex and vary between regions. Medical device testing and certification is an integral step in developing an innovative idea into an efficient and marketable product meeting regulatory standards. According to the latest research, the global medical device testing and certification market is poised to grow by USD 3.4 billion during 2023-2029, progressing at a CAGR of 5.2% during the forecast period. The growing consumption of medical devices in emerging countries, increasing need of validation and verification for medical devices, the imposition of rigorous government regulations, the growing trend of outsourcing medical device testing services and standards across medical devices are a few of the driving factors for the market. In addition, the rise in small medical device firms without in-house expertise is accelerating market expansion.The growing consumption of medical devices in emerging countries, increasing need of validation and verification for medical devices, the imposition of rigorous government regulations, the growing trend of outsourcing medical device testing services and standards across medical devices are a few of the driving factors for the market. In addition, the rise in small medical device firms without in-house expertise is accelerating market expansion.
The report covers market size and growth, segmentation, regional breakdowns, competitive landscape, trends and strategies for global medical device testing and certification market. It presents a quantitative analysis of the market to enable stakeholders to capitalize on the prevailing market opportunities. The report also identifies top segments for opportunities and strategies based on market trends and leading competitors' approaches.
This industry report offers market estimates and forecasts of the global market, followed by a detailed analysis of the service type, sourcing type, device class, technology, and region. The global market for medical device testing and certification can be segmented by service type: testing services, inspection services, certification services. The testing services segment captured the largest share of the market in 2022. Medical device testing and certification market is further segmented by sourcing type: in-house, outsourced. The in-house segment held the largest share of the global medical device testing and certification market in 2022 and is anticipated to hold its share during the forecast period. Based on device class, the medical device testing and certification market is segmented into: class I, class II, class III. In 2022, the class II segment made up the largest share of revenue generated by the medical device testing and certification market. On the basis of technology, the medical device testing and certification market also can be divided into: active implant medical device, active medical device, non-active medical device, in vitro diagnostic medical device, ophthalmic medical device, orthopedic and dental medical device, vascular medical device, others. Among these, the active medical device segment was accounted for the highest revenue generator in 2022. Medical device testing and certification market by region is categorized into: North America, Europe, Asia-Pacific, MEA (Middle East and Africa), Latin America.
The testing services market is further segmented into biocompatibility testing, material characterization and analytical testing, microbiology and sterility assurance testing, preclinical testing, stability testing. According to the research, the microbiology and sterility assurance testing segment had the largest share in the global medical device testing and certification market.
Market Segmentation
By service type: testing services, inspection services, certification services
By sourcing type: in-house, outsourced
By device class: class I, class II, class III
By technology: active implant medical device, active medical device, non-active medical device, in vitro diagnostic medical device, ophthalmic medical device, orthopedic and dental medical device, vascular medical device, others
By region: North America, Europe, Asia-Pacific, MEA (Middle East and Africa), Latin America
The global medical device testing and certification market report offers detailed information on several market vendors, including Absorption Systems LLC (Pharmaron Beijing Co., Ltd.), AptarGroup, Inc. (Gateway Analytical, LLC), Bureau Veritas S.A., Charles River Laboratories, Inc., DDL, Inc., DEKRA SE, Element Materials Technology Group Limited (Medical Device Testing Services, Inc., National Technical Systems, Inc.), Eurofins Scientific SE, Globus Medical, Inc., Innovatech Labs, LLC, Institute for Testing and Certification, Inc. (ITC), Intertek Group plc, Nemko Group AS, North American Science Associates, LLC (NAMSA), Pace Analytical Services, LLC, Pacific BioLabs, Inc., SGS S.A., Sotera Health Company, Tentamus Group GmbH, The Smithers Group Inc. , Toxikon Corporation (Labcorp), TUV Rheinland Group, UL LLC, Wickham Micro Limited, WuXi AppTec Co., Ltd., among others. In this report, key players and their strategies are thoroughly analyzed to understand the competitive outlook of the market.
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Scope of the Report
• To analyze and forecast the market size of the global medical device testing and certification market.
• To classify and forecast the global medical device testing and certification market based on service type, sourcing type, device class, technology, region.
• To identify drivers and challenges for the global medical device testing and certification market.
• To examine competitive developments such as mergers & acquisitions, agreements, collaborations and partnerships, etc., in the global medical device testing and certification market.
• To identify and analyze the profile of leading players operating in the global medical device testing and certification market.
Why Choose This Report
• Gain a reliable outlook of the global medical device testing and certification market forecasts from 2023 to 2029 across scenarios.
• Identify growth segments for investment.
• Stay ahead of competitors through company profiles and market data.
• The market estimate for ease of analysis across scenarios in Excel format.
• Strategy consulting and research support for three months.
• Print authentication provided for the single-user license.
TABLE OF CONTENTS
FIGURES AND TABLES
PART 1. INTRODUCTION
· Report description
· Objectives of the study
· Market segment
· Years considered for the report
· Currency
· Key target audience
PART 2. METHODOLOGY
PART 3. EXECUTIVE SUMMARY
PART 4. MARKET OVERVIEW
· Introduction
· Drivers
· Restraints
PART 5. MARKET BREAKDOWN BY SERVICE TYPE
· Testing services
· Inspection services
· Certification services
PART 6. MARKET BREAKDOWN BY SOURCING TYPE
· In-house
· Outsourced
PART 7. MARKET BREAKDOWN BY DEVICE CLASS
· Class I
· Class II
· Class III
PART 8. MARKET BREAKDOWN BY TECHNOLOGY
· Active implant medical device
· Active medical device
· Non-active medical device
· In vitro diagnostic medical device
· Ophthalmic medical device
· Orthopedic and dental medical device
· Vascular medical device
· Others
PART 9. MARKET BREAKDOWN BY REGION
· North America
· Europe
· Asia-Pacific
· MEA (Middle East and Africa)
· Latin America
PART 10. KEY COMPANIES
· Absorption Systems LLC (Pharmaron Beijing Co., Ltd.)
· AptarGroup, Inc. (Gateway Analytical, LLC)
· Bureau Veritas S.A.
· Charles River Laboratories, Inc.
· DDL, Inc.
· DEKRA SE
· Element Materials Technology Group Limited (Medical Device Testing Services, Inc., National Technical Systems, Inc.)
· Eurofins Scientific SE
· Globus Medical, Inc.
· Innovatech Labs, LLC
· Institute for Testing and Certification, Inc. (ITC)
· Intertek Group plc
· Nemko Group AS
· North American Science Associates, LLC (NAMSA)
· Pace Analytical Services, LLC
· Pacific BioLabs, Inc.
· SGS S.A.
· Sotera Health Company
· Tentamus Group GmbH
· The Smithers Group Inc.
· Toxikon Corporation (Labcorp)
· TUV Rheinland Group
· UL LLC
· Wickham Micro Limited
· WuXi AppTec Co., Ltd.
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DISCLAIMER
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Executive Summary
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