Preclinical Medical Device Testing Services Market

Market Overview

The global preclinical medical device testing services market size 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.

The recent covid-19 outbreak has increased the demand for testing services for medical devices worldwide. However, most of the medical equipment being examined is Personal Protective Equipment due to a lack of medical equipment (PPE). PPE testing includes evaluating the reusability of personal protective equipment, such as disposable masks. Before the pandemic started, most facemasks were intended to be one-time use only items. Nevertheless, some manufacturers are creating strategies to test these masks for various applications due to their global scarcity. The test includes sterilization checks, fitment checks, and checks for compliance with the original filtration standards.

A complex medical device ecosystem has also been created due to technological advancements like wearables and artificial intelligence (AI) and a focus on real-time patient monitoring. These products must undergo thorough training in accelerated conditions to obtain marketing authorization. The demand for medical device testing services is anticipated to increase because performing these evaluations internally requires significant work, resources, and time. The government's growing influence, which has led to increased demand for medical device validation and verification, is the main factor driving the global market for testing services for medical devices.

Market Dynamics

Global Preclinical Medical Device Testing Services Market Driver

Rising need for the verification and validation of medical devices

In the healthcare sector, verification and validation techniques are widely and extensively used. In general, validation determines whether a product has been used for its intended purpose and, as a result, whether usability requirements have been met. Verification, however, determines whether a product has been developed to the specified requirements. Design, process, and software verification and validation are the most typical types of medical devices. Additionally, the size and complexity of medical devices are increasing, and they occasionally use sophisticated, engineered plastics. This increases the value of the validation and verification (V&V) process. The end results are better repeatability, fewer errors, less need for rework and redesign, quicker time to market, increased competitiveness, and lower production costs. The market for medical device testing is anticipated to grow due to rising standards and regulations about validation and verification services for medical devices.

New medical equipment from manufacturers

Diseases are becoming more common, which has created opportunities for manufacturers to create new medical equipment. The design and development of medical devices is a complex process. Preclinical medical device testing services are becoming increasingly popular due to the challenges in creating medical devices that will meet government safety standards while delivering the best results. Manufacturers are also conducting in-depth research to understand the need for testing services. Preclinical medical device testing services are thus gaining momentum in the healthcare market due to the convergence of research, technology, and requirement. The need for preclinical medical device testing services is consequently increasing.

Global Preclinical Medical Device Testing Services Market Restraint

Barriers to the local development of medical devices

While promoting standards and control of medical devices is essential, excessive regulations, especially in a domestic context, can impede the local innovation of these devices. It can impede domestic innovation by subjecting new technologies to a lengthy and costly licencing procedure, thereby increasing the time and money local manufacturers must spend and the cost of manufacturing medical equipment. Due to the perceived risks associated with their use, a few products of great value to low-income countries may be removed from the market.

Global Preclinical Medical Device Testing Services Market Opportunities

Development in AI and IoT in various medical devices

Several advancements in drug-device pairing, personalized medicine, and the increased adoption of various portable and wearable medical devices are being seen in the global market for medical device testing. The adoption of IoT and AI in various devices is one of the key technological advancements driving the global medical device testing services market. Manufacturers are heavily investing in testing their products because these devices must adhere to strict regulations. Integration of machine learning, artificial intelligence, and the Internet of Things provides real-time results and assists professionals in various ways. Technology has made results much more straightforward, transparent, and practical. This aids in gaining a more profound understanding and early error correction.

Segmental Analysis

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. Microbiology and sterility testing are the main tests in preclinical medical device testing. These examinations aid in identifying the presence of microorganisms within the apparatus. According to the FDA and other regulatory bodies, these tests are necessary for validation. Additionally, these tests are carried out as part of ongoing quality assurance. The segment is expanding due to the rising demand for medical devices on a global scale. Over the forecast period, the chemistry test segment is anticipated to grow at the fastest CAGR. Chemical testing is carried out to characterize, recognize, and understand the chemicals used in the production of medical devices. Testing with chemicals complies with ISO 10993-17 and 10993-18T rules. The complexity of designing medical devices is causing the segment to grow.

Regional Analysis

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 being driven by the rise in demand for cutting-edge medical devices and the presence of sophisticated infrastructure for developing complex, highly dependable, and high-end medical devices. Additionally, significant market participants are assisting in expanding the North American market. The Asia Pacific market is anticipated to grow fastest. One of the key factors fueling the regional market is the low cost of outsourcing medical device testing services to Asia and the Pacific. The region's rising disease burden and demand for advanced medical devices drive the regional market's expansion.

Recent Developments

• In June 2022: SGS announced the acquisition of proderm, the leading provider of advanced clinical testing solutions for cosmetics, personal care and medical products in Germany. Founded in 1994, proderm is headquartered in Hamburg, with two additional locations in Germany, and serves clients in the global consumer care and pharmaceutical industries.
• In June 2022: Labcorp (NYSE: LH), a leading global life sciences company, announced that it is enhancing its central laboratory presence and drug development capabilities in Japan through an expansion of CB Trial Laboratory, the central laboratory co-managed by Labcorp Drug Development and BML, a leading Japanese provider of clinical laboratory testing services.
• In June 2022: EAS Group announced the acquisition of Research For Hire, Inc., located near Porterville in Tulare County, California. Recognized as a leading CRO in regulatory field studies, Research for Hire joined a robust network of EAS field research centres and laboratories within the US.

Preclinical Medical Device Testing Services Market Segmentation

By Service

• Biocompatibility Tests
• Chemistry Test
  • Microbiology & Sterility Testing
  • Bioburden Determination
  • Pyrogen & Endotoxin Testing
  • Sterility Test And Validation
  • Antimicrobial Activity Testing
  • Others
• Package Validation

By Regional

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa