Preclinical Medical Device Testing Services Market Extends at a Healthy CAGR of 15.10% by 2030

Introduction

The recent COVID-19 outbreak has increased the global demand for medical device testing services. Due to a lack of medical equipment, most examined medical equipment is Personal Protective Equipment (PPE). The reusability of personal protective equipment, such as disposable masks, is evaluated during PPE testing. Before the pandemic, most facemasks were intended to be single-use items. Due to their global scarcity, some manufacturers are developing methods to test these masks for various applications. The test includes checks for sterilization, fit, and compliance with the original filtration standards.

Due to technological advancements such as wearables and artificial intelligence (AI) and a focus on real-time patient monitoring, a complex medical device ecosystem has emerged. These items must undergo intensive training under accelerated conditions to obtain marketing authorization. It is anticipated that the demand for medical device testing services will increase, as conducting these evaluations internally requires significant effort, resources, and time. Growing government influence and increasing demand for medical device validation and verification is the primary factor driving the global medical device testing services market.

Market Dynamics

The increasing need for the verification and validation of medical devices is driving the market.

In the healthcare industry, verification and validation procedures are used extensively. Validation determines, in general, whether a product has been utilized for its intended purpose and, consequently, whether usability requirements have been met. Verification, however, determines whether a product was developed following the specified requirements. Verification and validation of design, process, and software are the most common types of medical devices. In addition, the size and complexity of medical devices are growing, and they occasionally employ engineered plastics with advanced properties. This enhances the validation and verification (V&V) process. The final results are better repeatability, fewer errors, less need for rework and redesign, faster time to market, increased competitiveness, and lower production costs. The market for medical device testing is anticipated to expand due to increasing regulations and standards for medical device validation and verification services.

Innovative medical equipment from manufacturers

As diseases become more prevalent, opportunities have arisen for manufacturers to create new medical equipment. Medical device design and development is a complex process. Preclinical medical device testing services are gaining popularity due to the difficulties associated with developing medical devices that meet government safety standards and deliver optimal results. In addition, manufacturers are conducting extensive research to determine the need for testing services. As a result of the convergence of research, technology, and demand, preclinical medical device testing services are gaining momentum in the healthcare market. Consequently, the demand for preclinical medical device testing services is growing.

Integrating AI and IoT in various medical devices is an opportunity for the market.

In the global market for medical device testing, several developments in drug-device pairing, personalized medicine, and the increased adoption of various portable and wearable medical devices can be observed. Adopting IoT and AI in various devices is one of the critical technological developments propelling the global medical device testing services market. Because these devices must adhere to stringent regulations, manufacturers invest significantly in product testing. Integrating machine learning, artificial intelligence, and the Internet of Things yields real-time results and provides numerous benefits to professionals. Technology has rendered outcomes considerably more straightforward, transparent, and applicable. This facilitates a more profound comprehension and early error correction.

Regional analysis of the Global Preclinical Medical Device Testing Services Market

According to the region, the market is segmented into North America, Europe; Asia Pacific; Latin America and Middle East & Africa. North America accounted for a sizeable portion of revenue. The region's preclinical medical device testing services market is driven by the demand for cutting-edge medical devices and sophisticated infrastructure for developing complex, highly dependable, and high-end medical devices. The Asia Pacific market is expected to grow fastest. One of the critical factors growing the regional market is the low cost of outsourcing medical device testing services to Asia and the Pacific.

Key Highlights

• The Global Preclinical Medical Device Testing Services Market was valued at USD 5.38 billion in 2021 and is projected to reach USD 15.10 billion by 2030, registering a CAGR of 12.15% from 2022 to 2030.
• Service and region segment the Global Preclinical Medical Device Testing Services Market. Based on Service, the market is categorized into Biocompatibility Tests, Chemistry tests, Microbiology & Sterility Testing and Package Validation. The segment that contributed the most significant percentage of revenue was microbiology and sterility testing.
• According to the region, the market is segmented into North America, Europe; Asia Pacific; Latin America and Middle East & Africa. North America accounted for a sizeable portion of revenue.

Competitive Players

1. SGS SA
2. Toxikon Inc.
3. Eurofins Scientific
4. Pace Analytical Services LLC
5. Intertek Group Plc
6. WUXI APPTEC
7. TÜV SÜD AG
8. Sterigenics International LLC
9. Nelson Labs
10. North American Science Associates, Inc.
11. American Preclinical Services
12. Charles River Laboratories International, Inc.
13. Pacific Biolabs
14. WuXi AppTec
15. Avomeen Analytical Services

Recent Developments

• January 2024- T3 Labs, a preclinical laboratory located in Atlanta, has been acquired by Veranex, an end-to-end medtech manufacturing partner.
• January 2024- iuvo BioScience, a specialized Partner Research Organization (PRO) that offers services for preclinical and clinical research, laboratory services, and scientific consultation, has obtained Promedica International (PMI), a California Corporation specializing in ophthalmology-focused clinical Contract Research Organization (CRO).

Segmentation

1. By Services
   1. Biocompatibility tests
   2. Microbiology & sterility testing
   3. Chemistry test
   4. Bioburden determination
   5. Pyrogen & endotoxin testing
   6. Sterility test and validation
   7. Antimicrobial activity testing
   8. Others
2. By Phase
   1. Preclinical
   2. Clinical