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Medical Device Analytical Testing Outsourcing Market – 2032

According to the latest data from Future Market Insights (FMI), the global Medical Device Analytical Testing Outsourcing Industry achieved a significant milestone in 2021, generating an impressive US$ 5.11 billion. The market is poised for a promising future, projected to expand at a robust CAGR of 7.18%, with a forecasted value of US$ 10.96 billion by 2032.

The surge in demand for outsourcing medical device analytical testing can be attributed to several key factors. The inherent complexity of medical device products, intensifying market competition, the proliferation of small-scale medical device production, and increasingly stringent regulatory clearance requirements collectively drive the industry’s exponential growth.

With a clear trajectory of expansion, the Medical Device Analytical Testing Outsourcing Market promises immense opportunities for industry stakeholders, offering comprehensive analytical solutions and facilitating compliance with rigorous regulatory standards. This growth signifies a paradigm shift in the healthcare sector, enhancing efficiency, quality, and safety in the development and production of medical devices.

FMI’s comprehensive research underscores the dynamic nature of this market and underscores its pivotal role in shaping the future of the medical device industry. Companies, researchers, and investors are encouraged to take note of this remarkable growth potential as the market charts its course towards an impressive US$ 10.96 billion valuation in 2032.

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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. 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.
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“Because of improved healthcare infrastructure and government initiatives, Asia Pacific has the largest share 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 are:

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