Medical Device Testing Services Market To Hit Value $16.78 Billion By 2030 |Grand View Research, Inc

Author : Mrudula Karmarkar | Published On : 01 Feb 2024

San Francisco, 01 February 2024: The Report Medical Device Testing Services Market Size, Share & Trends Analysis Report By Service (Biocompatibility Tests, Chemistry Test, Microbiology & Sterility Testing, Package Validation), By Phase, By Region, And Segment Forecasts, 2024 - 2030

The global medical device testing services market size is expected to reach USD 16.78 billion by 2030, registering a CAGR of 9.44% from 2024 to 2030, according to a new report by Grand View Research, Inc. Increasing complexity in product design and stringent government regulations are driving demand for medical device testing services.

Significant rise in preclinical spending is a recent trend among pharmaceutical and medical device companies, which is expected to significantly contribute to market growth. According to the global health center, for pharmaceuticals, supporting preclinical research required 73 months and cost USD 7 million for biologics, it took 47 months and cost USD 6.3 million.

With modern medical devices offering a host of complex functions, the need for appropriate tests to check the compliance of the device with regulatory requirements is becoming vital. In order to meet the requirement of enhanced accuracy, ease of use, and durability, medical devices need to undergo extensive tests. This is expected to deliver competitive advantage to manufacturers.

On the other hand, an increase in the need for production efficiency and safety and rising regulatory requirements for medical devices are some of the major factors driving the market growth. Regulatory bodies such as the European Medicines Agency, U.S. Food and Drug Administration, Therapeutic Goods Administration, and other country regulatory bodies require documentation and testing to certify that medical devices meet efficacy and safety standards prior they can be sold and marketed to patients and healthcare providers.

The COVID-19 pandemic has created an unprecedented demand for medical device testing services. This is largely due to the increasing demand for COVID-10 related products such as masks, PPE, & respiratory equipments. Besides, countries such as Mexico, Spain, and France have published pertinent specifications and standards, namely the UNE 0064-1, UNE 0064-2, AFNOR-SPEC-S76 & UNE 0065, which must be met until a mask can be sold.

Complexity in product design, intensifying competition, increasing number of small-sized medical device manufacturers, and strict approval norms are key factors driving the market. In addition, the COVID-19 pandemic has accelerated the demand for testing services around the globe. Favorable government support is expected to drive the market. To obtain approvals & clearances, companies need to comply with an elaborate list of standards provided by regulatory bodies and maintain complete documentation of the same.

Request sample report of Medical Device Testing Services Market@ https://www.grandviewresearch.com/industry-analysis/medical-device-testing-services-market/request/rs1

These requirements must be met as per the stipulated formats and specifications to ensure the products are permitted for sale. The regulatory authorities also perform routine post-market surveillance by levying a fee on the manufacturer. Receipt of any complaints about drawbacks of the product can entail its withdrawal from the market, thereby proving the stringent nature of the regulations governing these procedures.

Medical Device Testing Services Market Report Highlights

• The microbiology and sterility testing was the leading segment in 2022 with a market share of 34.2% and is likely to remain dominant over the forecast period. Producing safe and effective products is a core goal of medical device manufacturers, and sterility assurance is a major component for achieving it
• Biocompatibility tests held the largest share in 2023. This is attributed to strict requirements for biocompatibility testing set by global regulatory bodies to ensure that their devices are safe to use before being made available in the market
• The clinical segment held the largest market share in 2023 and accounted for 68.8% of the market share as this stage is mostly focused on assessing safety & biocompatibility of medical devices
• On the other hand, The preclinical market accounted for the 39.74% share in 2023. The preclinical phase of medical device includes determination of efficacy, safety, and biocompatibility of prosthesis, biomaterials, and medical devices
• Raw materials, packaging, and design all have an impact on a device's safety and compatibility, and preclinical testing of all of these factors is an important step in determining a device's market potential
• Asia Pacific dominated the global medical device testing services market in 2023, holding a revenue share of 41.1%. This is due to rising demand for medical devices in developing nations such as India and china
• North America is estimated to show growth at a lucrative rate in the market over the forecast period. This can be attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical devices

Market growth stage is stable, and market growth is expected to accelerate over the estimated time period. The Medical Device Testing Services market is characterized by regulatory considerations, evolving technologies, materials innovation, and globalization & outsourcing of services.

Furthermore, outsourcing in the medical device testing services market is substantially growing due to various benefits such as cost-effectiveness, access to specialized expertise, and flexibility in resource allocation. Likewise, outsourcing mitigates risks associated with in-house testing, offering flexibility in resource allocation, scalability, and access to a broader range of testing capabilities based on project requirements, thereby influencing market demand.

In addition, the market is highly competitive, characterized by numerous established and emerging players offering a wide array of testing services. Differentiation based on expertise, technology, regulatory compliance, and service quality is crucial for market positioning. Companies leveraging advanced types of medical device testing technologies and innovative methodologies gain a competitive edge. Investment in cutting-edge equipment and the ability to offer specialized, high-value testing solutions strengthens market growth.

Medical Device Testing Services Market Report Scope

ASCA's emphasis on conformity assessment encourages advancements in testing methodologies and technology adoption. Accredited labs are encouraged to continually improve and innovate, aligning with evolving regulatory expectations. Besides, innovations in testing technologies and methodologies, such as the adoption of AI, IoT, or robotics in testing processes, can significantly influence the medical device testing services market. Businesses need to stay abreast of technological advancements to remain competitive and meet clients' evolving needs.

Some of the medical device testing companies operating in the market are SGS SA, Laboratory Corporation of America Holdings, Nelson Laboratories, LLC, TÜV SÜD, Charles River Laboratories, Element Minnetonka, North America Science Associates Inc. (NAMSA), Eurofins Scientific, Pace Analytical Services LLC, Intertek Group Plc, and WuXi AppTec among others. Several key players are acquiring various strategic initiatives to strengthen their market position offering diverse services to customers. The prominent strategies adopted by companies are service launches, mergers & acquisitions/joint ventures merger, partnership & agreements, expansions, and others to increase market presence & revenue and gain a competitive edge. These initiatives may be implemented to expand regionally or widen the global network to reach more customers.

List of Key Players in the Medical Device Testing Services Market

• SGS SA
• Laboratory Corporation of America Holdings
• Nelson Laboratories, LLC
• TÜV SÜD
• Charles River Laboratories
• Element Minnetonka
• North America Science Associates Inc. (NAMSA)
• Eurofins Scientific
• Pace Analytical Services LLC
• Intertek Group Plc
• WuXi AppTec