As per newly released data by Future Market Insights (FMI), The global Medical Device Analytical Testing Outsourcing Market generated US$ 5.11 billion in 2021 and is predicted to grow at a credible CAGR of 7.18% to reach US$ 10.96 billion in 2032.

The global market for outsourcing medical device analytical testing generated US$ 5.11 billion in 2021 and is predicted to grow at a credible CAGR of 7.18% to reach US$ 10.96 billion in 2032. The complexity of the product, increased competition, an increase in the production of small-scale medical devices, and strict clearance requirements are all contributing factors.

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The growing global prevalence of chronic diseases is driving up demand for medical device analytical testing outsourcing. The government’s increasingly stringent quality certificate rules are propelling the global medical device analytical testing outsourcing market forward. Class II devices require premarket approvals and 510 (k) clearance; however, obtaining such clearance is a time-consuming process; thus, such emerging scenarios have fuelled the growth of the global medical device analytical testing outsourcing market. Medical device manufacturers are hiring consultants to help them understand the documentation and regulations required for pre-market approvals.

The development of advanced devices such as surgical microscopes, surgical robots, neurosurgery devices, ophthalmic surgical devices, and many others has reduced the direct contact of humans in the surgical procedure, making quality certificates for medical devices mandatory. The growing demand for minimally invasive surgeries is driving the global medical device analytical testing outsourcing market forward. However, manufacturers are turning to medical device analytical testing outsourcing to ensure accuracy, precision, quality control, and periodic maintenance.

Key Takeaways

  • The global Medical Device Analytical Testing Outsourcing market is estimated at US$ 10.96 Billion during the forecast period.
  • The global Medical Device Analytical Testing Outsourcing market is estimated at US$ 5.11 Billion in 2021.
  • The U.S is projected to lead the market while procuring US$ 1.5 Billion while expanding at a CAGR of 7% during the forecast period.
  • China is anticipated to grow at 5.5% CAGR
  • The hospitals segment is predicted to lead the market with a CAGR of 6.15% during the assessment period.

 “Because of improved healthcare infrastructure and government initiatives, Asia Pacific has the largest share of the global medical device analytical testing outsourcing market. Furthermore, rapid economic development in countries such as China and India are expected to significantly boost regional market growth over the forecast period.” Says an analyst at FMI.

Competitive Landscape

The global medical device analytical testing outsourcing market is highly fragmented. Mergers, acquisitions, and partnerships, among other strategies, were used by industry participants to maintain market share. The key market players are:

  • 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

Some of the recent developments in the global medical device analytical testing outsourcing market are:

  • In May 2022, Intertek renews its contract with the Philippines Bureau of Customs for its Bulk and Break Bulk Cargo Clearance Enhancement Programme.
  • InMay 2022, Intertek announced the launch of ‘Intertek Hydrogen’ which assists the hydrogen industry in commercializing ground-breaking technology securely into the future.

Medical Device Analytical Testing Outsourcing Industry Report Segmentation:

By Service:

  • Extractable and Leachable
  • Material Characterization
  • Physical Testing
  • Bioburden Testing
  • Sterility Testing
  • Other Tests

By Device Type:

  • Reprocessed Devices
  • Others Medical

By End Use:

  • Hospitals
  • Others

By Therapeutic Areas:

  • Cardiology
  • Diagnostic Imaging
  • Orthopedic
  • IVD
  • Ophthalmic
  • General & Plastic Surgery
  • Drug Delivery
  • Endoscopy
  • Dental
  • Diabetes Care
  • Others

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