Medical Device Analytical Testing Outsourcing Market Segmentation, Analysis by Recent Trends and Development till 2030

 Medical Device Analytical Testing Outsourcing Industry Overview

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.

Medical Device Analytical Testing Outsourcing Market Segmentation

Grand View Research has segmented the global medical device analytical testing outsourcing market based on services, device type, end-use, therapeutic areas, and region:

Based on the Services Insights, the market is segmented into Extractable & Leachable, Material Characterization, Physical Testing, Bioburden Testing, Sterility Testing and Other Tests.

  • The material characterization segment dominated the market and accounted for the largest revenue share of 18.2% in 2021. Material characterization forms the basis for understanding the composition of a medical device material and its potential to cause an undesirable biological effect when used.
  • Extractable and leachable, material characterization, physical testing, bioburden testing, sterility testing, and other tests are other services covered in this report. The bioburden testing segment is expected to rise with the fastest CAGR over the forecast period.

Based on the Device Type Insights, the market is segmented into Reprocessed Devices and Others.

  • The reprocessed device segment accounted for the second-largest revenue share of the global market in 2021 and is estimated to expand further at the fastest CAGR of more than 9.5% from 2022 to 2030.

Based on the End-use Insights, the market is segmented into Hospital and Others

  • The hospitals segment dominated the global market in 2021 and accounted for the maximum share of more than 86.00% of the global revenue. This growth can be attributed to the increased patient traffic and increased budget allocation for these operations by hospital administration.

Based on the Therapeutic Areas Insights, the market is segmented into Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmin, General & Plastic Surgery, Drug Delivery, Endoscopy, Dental, Diabetes Care and Others.

  • The cardiology segment accounted for the maximum revenue share of more than 21.00% in 2021 and is projected to expand further at a significant CAGR over the forecast period. Rising demand for cardiovascular devices, as a result of the increasing prevalence of related conditions, is attributable to the expansion of these products outsourcing.
  • The availability of professional outsourcing organizations that meet regulatory criteria and increased demand for aesthetic surgeries are projected to fuel the growth of this category.

Medical Device Analytical Testing Outsourcing Regional Outlook

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

Key Companies Profile

Mergers, acquisitions, and partnerships among others were the key strategies adopted by industry participants to maintain their market share.

Some prominent players in the global Medical Device Analytical Testing Outsourcing market include

  • 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

Order a free sample PDF of the Medical Device Analytical Testing Outsourcing Market Intelligence Study, published by Grand View Research.

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