Medical Device Analytical Testing Outsourcing Market Segmented On The Basis Of Services, Device Type, End-Use, Therapeutic Areas, Region And Forecast 2030: Grand View Research Inc.

San Francisco, 9 Dec 2022: The Report Medical Device Analytical Testing Outsourcing Market Size, Share & Trends Analysis Report By Services, By Therapeutic Areas ,By Device Type ,By End-use, By Region And Segment Forecasts, 2022 – 2030

The global medical device analytical testing outsourcing market size is expected to reach USD 10.6 billion by 2030, registering a CAGR of 8.1% over the forecast period, according to a new report by Grand View Research, Inc. 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. Medical device testing remained consistent in 2021. 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 toward 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.

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Medical Device Analytical Testing Outsourcing Market Report Highlights

• The material characterization services segment accounted for the largest share of the global revenue in 2021
• The cardiology therapeutic area segment held the largest revenue share in 2021 due to the high demand for cardiovascular devices as a result of the increased prevalence of related conditions
• Reprocessed devices are 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
• Based on end-use, the hospital segment accounted for the largest revenue share in 2021 due to high patient volume and increased hospital management budget allocation for these surgeries
• Asia Pacific led the global market in 2021 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

List of Key Players in Medical Device Analytical Testing Outsourcing Market

• SGS
• 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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Medical Device Analytical Testing Outsourcing Market Size Is Poised To Reach USD 9.7 Billion By 2028: Grand View Research Inc.

San Francisco, 3 March 2021: The Report Medical Device Analytical Testing Outsourcing Market Size, Share & Trends Analysis Report By Services, By Therapeutic Area (Cardiology, Diagnostic Imaging, Orthopedic), By End-use, By Device Type, By Region, And Segment Forecasts, 2021 – 2028

The global medical device analytical testing outsourcing market size is expected to reach USD 9.7 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 7.6% from 2021 to 2028. Numerous medical device companies outsource analytical testing operations to minimize business risks, hasten product market entry, and reduce costs. These procedures lead to a significant rise in expenditure levels and, therefore, original equipment manufacturers of medical instruments rapidly switch to outsourcing as one of the effective cost curbing tools.

Implantable Medical Devices (IMDs) are being used increasingly in order to improve patients’ health outcomes. Designers of IMDs have to balance complexity, reliability, power consumption, and costs. Consequently, companies are shifting their focus to innovation rather than non-core activities and, therefore, outsourcing these activities to launch efficient instruments. All these factors are expected to drive the market over the forecast period.

In this complex ecosystem, it is necessary for the equipment to provide accurate results, to have durability, and easy operation. To match these parameters, devices now have to undergo shear checking in accelerated conditions to obtain marketing approval and have a competitive advantage. Conducting this in-house is a matter of time, labor, and cost; outsourcing these tests helps overcome these limitations. For instance, the ISO 10993 has revised the Analytical Evaluation Threshold (AET) for better toxicological safety assessment. Lack of awareness with regards to these tests among the manufacturers of medical instruments may lead to reworking, which is usually avoided when outsourced to third-parties. Hence it is very important to be aware of AET as regulators will review the analytical report to check whether the AET was followed or not. Also, it is the duty of the medical device manufacturer to ensure that AET is applied to the checking process.

Various companies globally have increased the manufacturing of medical devices such as personal protective equipment (PPE) kits, ventilators, and N-95 masks. This has created opportunities for the players in the Testing, Inspection, and Certification (TIC) Market to test and certify these instruments. Many companies such as TÜV SÜD and Eurofins have started checking these medical instruments, thus increasing the demand for analytical testing services from the healthcare industry. Also with increasing cases of COVID-19 globally, the demand for analytical testing services will surge in the coming months.

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Medical Device Analytical Testing Outsourcing Market Report Highlights

• The material characterization segment dominated the market in 2020 and is likely to grow at a lucrative rate during the forecast period
• Other tests that are inclusive of cleaning, reprocessing, method development and validation, accelerated stability testing, biocompatibility, validation checking for packaging materials (container closure permeation), and transport stability are anticipated to witness the fastest growth over the forecast period
• North America accounted for significant market share owing to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical instruments, with the presence of abundant service providers

List of Key Players of Medical Device Analytical Testing Outsourcing Market

• 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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Medical Device Analytical Testing Outsourcing Market Dominate The Industry Size With USD 8.3 Billion By 2025 : Grand View Research Inc.

San Francisco, 26 August 2019: The Report Medical Device Analytical Testing Outsourcing Market Analysis By Services (Extractable and leachable, Material characterization, Physical testing, Bioburden testing, Sterility testing), By Region, And Segment Forecasts, 2018 – 2025

The global medical device analytical testing outsourcing market is expected to reach USD 8.3 billion by 2025, according to a new report by Grand View Research, Inc. A large number of medical device companies outsource analytical testing operations to minimize business risks, hasten product market entry, and reduce costs. These lead to significant rise in expenditure levels and, therefore, medical device original equipment manufacturers rapidly switch to outsourcing as one of the effective cost curbing tool.

Implantable Medical Devices (IMDs) are being used increasingly in order to improve patients’ health outcome. Designers of IMDs have to balance complexity, reliability, power consumption, and costs. Consequently, companies are shifting their focus to innovation rather than noncore activities and, therefore, outsourcing these activities to launch efficient devices. All these factors are expected to increase the medical device outsourcing market over the forecast period.

In this complex ecosystem, it is necessary for equipment to provide accurate results, to have durability, and easy operation. To match these parameters, devices now have to undergo shear testing in accelerated conditions to obtain marketing approval and have competitive advantage. Conducting these in-house is matter of time, labor, and cost; outsourcing these tests helps overcome these limitations.

Access Research Report of Medical Device Analytical Testing Outsourcing Market @ www.grandviewresearch.com/industry-analysis/medical-device-analytical-testing-outsourcing-market

Further key findings from the study suggest:

• Material characterization dominated the market in 2015 and is likely to grow at a lucrative rate during the forecast period
• Other tests that are inclusive of cleaning, reprocessing, method development & validation, accelerated stability testing, biocompatibility, validation testing for packaging materials (container closure permeation), and transport stability are also anticipated to witness rewarding growth.
• North America is likely to witness lucrative growth which is attributed to the fact that it is one of the top manufacturing hubs of highly reliable, complex, and high-end medical devices.
• Some of the key players operating in this space are 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.; and Medical Device Testing Services

Browse more reports of this category by Grand View Research at: www.grandviewresearch.com/industry/medical-devices

Grand View Research has segmented the global medical device analytical testing outsourcing market on the basis of services and region:

Medical Device Analytical Testing Outsourcing Services Outlook (Revenue, USD Million, 2014 – 2025)

• Extractable & Leachable
• Material Characterization
• Physical Testing
• Bioburden Testing
• Others

Medical Device Analytical Testing Outsourcing Regional Outlook (Revenue, USD Million, 2014 – 2025)

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)

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About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.

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