Global Medical Device Testing Market Revenue to Surpass $15.84 Billion by 2030, Recording an 8.20% CAGR, with North America Leading the Market Due to Stringent Government Regulations, Estimates Kings Research

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

• In-house
• Outsourced

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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