Intensifying Competition and Regulatory Demands Fuel Growth: Global Medical Device Analytical Testing Outsourcing Market Poised to Reach $10.57 Billion by 2030 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Medical Device Analytical Testing Outsourcing Market Size, Share & Trends Analysis Report By Service (Sterility Testing, Physical Testing), By Therapeutic Areas, By Device Type, By End-use, By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

The global medical device analytical testing outsourcing market size is expected to reach USD 10.57 billion by 2030. The market is expected to grow at a CAGR of 8.2% from 2023 to 2030.

Several medical device companies outsource analytical testing operations to decrease business risks, accelerate product market entrance, and lower expenses. As a result of this considerable rise in spending levels, medical device original equipment manufacturers (OEMs) quickly shift to outsourcing as a cost-cutting technique. The testing requirements of medical device manufacturers (MDMs) reflected variations in the medical/healthcare market as it recovered from the COVID-19 slowdown.

In 2021, the need for European Medical Device Regulation (MDR) remediation standards, as well as the ever-increasing regulatory demands in the leachables & extractables (E&L) arena, accounted for a significant portion of the testing effort. However, due to delays and a lack of external resources and labor, labs' ability to expand capacity has been limited. Regulatory authorities are focusing on testing technique validation, especially data quality, including repeatability and reproducibility. There is also a trend of more deterministic testing methods.

This enables companies to acquire more statistically reliable data to determine if their products meet the criteria. For example, the medical device sector and testing labs confront considerable hurdles in adopting ISO 10993-18:2020 E&L testing regulations while still meeting FDA expectations.

The FDA had requested the use of conservative techniques to reduce areas of ambiguity or potential inaccuracy in E&L testing throughout 2021.

Furthermore, intensifying competition in the medical device industry is expected to create growth opportunities for the market. In such an intensely competitive environment, companies must reduce the time to market. Considering that the approval processes for medical devices are not simple, companies need a better understanding of updated regulatory norms and protocols. Not all companies have such expertise; hence, outsourcing these functions to a specialized firm is a better option for medical device companies. Recent studies have shown significant opportunities for both suppliers and buyers in the medical device industry.

For smaller companies, outsourcing manufacturing, and development functions is an effective alternative to cut costs. For larger companies, outsourcing activities enable them to focus on core business activities and drive future growth. Based on end-uses, the hospital segment accounted for the largest revenue share in 2022 due to high patient volume and increased hospital management budget allocation for these surgeries.

The reprocessed devices segment is projected to witness the fastest CAGR during the forecast period due to the low prices of these devices. They cost about 30 to 40% less than new devices; thus, the demand for such products is significant in price-sensitive low- and medium-income countries.

Medical Device Analytical Testing Outsourcing Market Report Highlights

• The material characterization services segment accounted for the largest share of the global revenue in 2022. Material characterization is crucial for maintaining quality, mitigating risks, ensuring regulatory compliance, and optimizing cost and time efficiency.
• The cardiology therapeutic area segment held the largest revenue share in 2022 due to the high demand for cardiovascular devices as a result of the increased prevalence of related conditions.
• Asia Pacific led the global market in 2022 and is projected to witness the fastest CAGR during the forecast period. This is owing to the region's large population base, low per capita income, and demand for accessible treatment solutions.
• North America is also anticipated to witness considerable growth during the forecast period. This can be attributed to the presence of various multinational players, such as Charles River Laboratories, WuXi AppTec, and SGS SA.
• Moreover, the increased need for scrutiny pertaining to the quality of devices and reorganizing of classes is a key factor expected to impose additional testing requirements on manufacturers. These requirements can be met by partnering with laboratories that perform tests at an affordable price rather than installing in-house analytical tools.

Market Dynamics

Drivers

• Intensifying Competition
• Increasing Number Of Small-Size Medical Device Manufacturers Lacking In-House Testing Infrastructure
• Strict Approval Norms

Restraint

• Regulatory And Legal Compliance

Companies Mentioned

• SGS SA
• Toxikon, Inc
• Eurofins Scientific
• Pace Analytical Services LLC.
• Intertek Group plc
• Wuxi AppTec
• NORTH AMERICAN SCIENCE ASSOCIATES, INC.
• Envigo
• Charles River Laboratories International, Inc
• Medical Device Testing Services

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