The global Medical Device Analytical Testing Outsourcing Market was valued at US$ 5.6 billion in 2022 and it is anticipated to grow up to US$ 12.8 billion by 2032, at a CAGR of 7.9% during the forecast period.
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Outsourcing analytical testing for medical devices aids in monitoring and maintaining the performance, accuracy, and precision of the equipment. As part of the quality control process, a medical device manufacturer outsources medical device testing. This testing comprises a thorough examination, inspection, and evaluation of the item to ensure that it functions effectively and is appropriate for practical use. Physical testing, bioburden testing, extractable & leachable testing, and other types of analytical testing for medical devices are utilized for cardiovascular devices, orthopedic devices, and many other types of equipment.
Market Drivers and Trends
The increased use of acquisition methods by various important companies across the world to develop their businesses is expected to favorably impact market growth. Pace Analytical Services, a branch of Pace Science and Technology Company, for example, approved the acquisition of Specified Testing Laboratories, LLC in March 2022. Pace clients in New York and nearby states now have more options for analytical and environmental testing services as a result of this transaction.
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Additionally, the need for medical device analytical testing outsourcing is not only seen in developed nations, but also in developing countries such as China, Brazil, and India, which fuels the market’s growth. The accessibility of professional outsourcing organizations that satisfy regulatory standards, as well as the rise in demand for cosmetic operations, which necessitate the use of medical devices, are the drivers driving market expansion.. These drivers are likely to propel market expansion.
Market Restraints and Challenges
However, outsourcing lowers the costs of such procedures, which is expected to boost market growth. The Medical Device Analytical Testing Outsourcing Market has its downsides. The main disadvantage of medical device analytical testing outsourcing is that it takes place in third-world nations, which may still be price-sensitive for medical device analytical testing, resulting in a major hindrance to the medical device analytical testing outsourcing sector.
Major Players in the Global Medical Device Analytical Testing Outsourcing Market
The key players studied in the global Medical Device Analytical Testing Outsourcing Market are Eurofins Scientific (Luxembourg), Nelson Laboratories (United States), Toxikon Corporation (United States), SGS SA (Switzerland), WuXi AppTec (China), Charles River Laboratories (United States), Intertek Group (United Kingdom), Pace Analytical Services (United States), Avomeen Analytical Services (United States), and North American Science Associates, Inc. (NAMSA) (United States).
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COVID-19 Impact
The pandemic had a substantial effect on medical device testing. Because of the Covid-19-induced lockdown and social distancing norms, the clinics had to temporarily halt operations. However, once the pandemic situation improved, demand for medical device analytical testing and services revived. The majority of procedures have been halted because of COVID-19, a ban on the use of medical equipment. This crisis has caused a delay in many aesthetic treatments, the bulk of which are cosmetic surgeries such as liposuction, breast implantation, and elective dentistry procedures, resulting in a fall in demand for medical equipment, which has hampered market growth. Several elective treatments, particularly those deemed non-essential or non-urgent, have been postponed or canceled in order to create a place for patients getting viral therapy. Despite the fact that the epidemic had a primarily negative impact in many locations. During the crisis, for example, the MedTech industry saw difficulties. Medical gadget producers are not immune to the impacts of the epidemic. Medical device manufacturers, like pharmaceutical firms, rely heavily on healthcare organizations to collect data from clinical studies, which needs extra time for clearance owing to the pandemic, limiting the growth of the medical device analytical testing outsourcing market. As the COVID-19 outbreak continues, medical device companies are finding it difficult to make decisions about their products, supply networks, and regulatory responsibilities.
Market Segments
By Type of Medical Device
- Class I Devices
- Class II Devices
- Class III Devices
By Service Providers
- Contract Research Organizations (CROs)
- Testing Laboratories
- Academic and Research Institutions
By End Users
- Medical Device Manufacturers
- Biotechnology Companies
- Pharmaceutical Companies
- Government Regulatory Agencies
- Others (e.g., Hospitals and Clinics)
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