(MENAFN- PR Newswire) DUBAI, UAE, Feb. 5, 2024 /PRNewswire/ -- As per the latest report published by Kings Research, the global Medical Device Testing market size was recorded at USD 9.12 billion in 2022 and is estimated to grow to USD 15.84 billion by 2030, registering an 8.20% CAGR through the projection period of 2023-2030. The stringent regulations imposed by the government, the rise of small medical device companies lacking in-house expertise, and an increasing demand for thorough verification and validation of medical devices are some of the key factors propelling market growth.
Medical device testing involves the thorough evaluation and assessment of the safety, quality, and performance of medical devices to ensure their compliance with regulatory standards and their reliability for use by healthcare professionals and patients. This crucial testing process plays a vital role in the development and assessment of various types of medical equipment, such as diagnostic tools, therapeutic devices, monitoring equipment, and implants. Its primary objective is to ascertain the safety and efficacy of these devices before they are approved and released into the market.
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Trending Now: UL Solutions Expands Presence with Medical Device Testing Launch in Michigan
In October 2023, UL Solutions introduced a range of medical device testing services at their Rochester Hills laboratory in Michigan. These new services aim to assist the thriving medical device industry in Michigan by enhancing the safety, security, usability, and interoperability of healthcare products. UL Solutions is committed to aiding manufacturers in their pursuit of excellence in the field of medical devices.
Advancements in medical device technology have resulted in numerous advantages for patient care. In order to uphold this rapid pace of innovation and ensure the safety of medical device users, manufacturers need to carefully consider the speed at which they develop new products while also addressing potential risks such as quality, safety, and cybersecurity concerns. UL Solutions, based in Michigan, now offers a range of services including third-party verification and validation, auditing, cybersecurity assistance, usability testing, and compliance training to assist medical device manufacturers in tackling these challenges.
Competitive Landscape
Key players operating in the global medical device testing market are focusing on partnerships in order to expand their global reach. For instance, in March 2023, Nemera and Nelson Labs Europe formed a collaborative alliance with the objective of offering their clients a wide range of integrated services encompassing leachables, extractables, microbiology, biocompatibility, and chemical testing. Through this partnership, customers were to benefit from a holistic approach to various testing aspects of the companies' products.
Major participants in the global medical device testing market include:
Labcorp Nelson Laboratories, LLC (Sotera Health) The British Standards Institution Element Materials Technology Eurofins Scientific Pace Analytical Services, LLC SGS SA ITC ZLÍN DEKRA
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The global Medical Device Testing Market is segmented as:
By Service
Testing Inspection Certification Others
Growing Focus on Providing High-quality Products to Boost Demand for Medical Device Testing Services
On the basis of service, the testing segment accounted for the largest revenue share in the medical device testing market in 2022, mainly driven by the rising demand for medical devices for the testing of various conditions. This can be attributed to the industry's growing focus on delivering products that are both high in quality and compliant with regulations. These services have a significant impact on guaranteeing that medical devices adhere to the necessary regulatory standards in terms of quality, safety, and performance.
Various types of testing services are available, such as thorough analyses like testing the functionality of electro-medical devices, determining biocompatibility, conducting clinical research, as well as assessing the materials used and the overall performance of the devices. These services are primarily carried out in specialized laboratories and research facilities.
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By Sourcing
Increased Interest in Outsourcing Medical Device Testing Services to Boost Market Revenue
In terms of sourcing, the outsourced segment is expected to grow at a significant CAGR through the projected period. A number of well-known businesses are choosing to outsource their medical device testing services as a result of the escalating expenses involved in conducting these tests in-house, primarily due to stringent regulations. By engaging the services of external vendors, large companies can effectively lower the overall costs associated with testing.
The outsourcing of testing, inspection, and certification (TIC) services has become increasingly popular, especially for advanced medical devices such as active implant technologies. These devices necessitate substantial financial investment for in-house testing. By outsourcing these services, companies can allocate their resources more efficiently, allowing them to concentrate on their key strengths and ensure adherence to regulatory standards.
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Rising Need for Validation and Verification of Medical Devices to Drive Market Growth
The medical device testing market is primarily driven by the increasing requirement for the validation and verification of medical devices. Stringent regulatory standards and the focus on patient safety make it essential to thoroughly test and certify these devices. Manufacturers face pressure to meet the necessary standards as the demand for advanced and high-quality medical products rises. As a result, there is a greater reliance on testing services to validate the safety, functionality, and performance of medical devices.
Furthermore, the growing complexity of medical devices and the aim to reduce risks connected to their usage are driving the requirement for verification and validation. Consequently, the medical device testing industry is foreseen to witness notable expansion as companies pursue expert testing and certification services to adhere to regulations and showcase the quality of their products.
North America to Dominate Medical Device Testing Market Due to Presence of Strong Regulatory Organizations
North America led the global medical device testing market in 2022 due to the increasing complexities in product design and the increasing consumer inclination toward achieving cost savings. Furthermore, the market is experiencing sizable growth due to the existence of strong regulatory organizations such as the FDA that guarantee adherence to safety standards. The increasing need for quality healthcare in North America has resulted in a significant boost in the production of medical devices, further fueling market expansion. These factors collectively drive market growth, promoting innovation, improved efficiency, and enhanced accessibility in the healthcare industry throughout the region.
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Key Points from TOC:
1 Introduction of The Global Medical Device Testing Market
1.1 Market Definition
1.2 Market Segmentation
1.3 Research Timelines
1.4 Limitations
1.5 Assumptions
2 Executive Summary
3 Research Methodology
3.1 Data Collection
3.1.1 Secondary Sources
3.1.2 Primary Sources
3.1.3 Research Flow
3.2 Subject Matter Expert Advice
3.3 Quality Check
3.4 Final Review
3.5 Bottom-Up Approach
3.6 Top-down Approach
4 Global Medical Device Testing Market Outlook
4.1 Market Evolution
4.2 Overview
4.3 Market Dynamics
4.3.1 Drivers
4.3.2 Restraints
4.3.3 Opportunities
4.3.4 Challenges
4.4 Pricing Analysis
4.5 Porter's Five Forces Analysis
4.6 Value Chain Analysis
4.7 Macroeconomic Analysis
5 Impact of Russia-Ukraine War
6 Global Medical Device Testing Market, By Service
7 Global Medical Device Testing Market, By Sourcing
8 Global Medical Device Testing Market, By Device Class
9 Global Medical Device Testing Market, By Technology
10 Global Medical Device Testing Market, By Geography
11 North America
12 Europe
13 Asia Pacific
14 Middle East & Africa
15 Latin America
16 Global Medical Device Testing Market Competitive Landscape
16.1 Overview
16.2 Key Developments
16.3 Key Strategic Developments
16.4 Company Market Ranking
16.5 Regional Footprint
16.6 Industry Footprint
17 Company Profiles
17.1 SGS SA
17.1.1 Key Facts
17.1.2 Financial Overview
17.1.3 Product Benchmarking
17.1.4 Recent Developments
17.1.5 Winning Imperatives
17.1.6 Current Focus & Strategies
17.1.7 Threat from competition
17.1.8 SWOT Analysis
17.2 Labcorp
17.2.1 Key Facts
17.2.2 Financial Overview
17.2.3 Product Benchmarking
17.2.4 Recent Developments
17.2.5 Winning Imperatives
17.2.6 Current Focus & Strategies
17.2.7 Threat from competition
17.2.8 SWOT Analysis
17.3 Nelson Laboratories, LLC (Sotera Healthm)
17.3.1 Key Facts
17.3.2 Financial Overview
17.3.3 Product Benchmarking
17.3.4 Recent Developments
17.3.5 Winning Imperatives
17.3.6 Current Focus & Strategies
17.3.7 Threat from competition
17.3.8 SWOT Analysis
17.4 The British Standards Institution
17.4.1 Key Facts
17.4.2 Financial Overview
17.4.3 Product Benchmarking
17.4.4 Recent Developments
17.4.5 Winning Imperatives
17.4.6 Current Focus & Strategies
17.4.7 Threat from competition
17.4.8 SWOT Analysis
17.5 Element Materials Technology
17.5.1 Key Facts
17.5.2 Financial Overview
17.5.3 Product Benchmarking
17.5.4 Recent Developments
17.5.5 Winning Imperatives
17.5.6 Current Focus & Strategies
17.5.7 Threat from competition
17.5.8 SWOT Analysis
Continued.........
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