NEWARK, Del, July 30, 2024 (GLOBE NEWSWIRE) -- The medical device analytical testing outsourcing market is forecasted to thrive to a valuation of USD 5,844 million in 2024, garnering a valuation of USD 10,867.3 million, and is likely to register a CAGR of 6.4% by the end of the projected period.
The strict regulatory environment governing medical devices is a key driver for outsourcing analytical testing. Before a medical device may be commercialized, regulatory authorities such as the Food and Drug Administration in the United States and the European Medicines Agency in Europe conduct extensive testing to assure its safety, effectiveness, and quality. Outsourcing analytical testing to qualified third-party laboratories assures adherence to the complicated rules. The laboratories are capable of conducting thorough testing, such as biocompatibility, sterility, shelf life testing, and material characterization, while adhering to regulatory norms.
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Outsourcing analytical testing provides medical device makers with considerable cost savings and time efficiency gains. Setting up and maintaining in-house testing labs can be prohibitively expensive due to the requirement for specialized equipment, qualified workers, and regulatory compliance. Outsourcing enables businesses to have access to cutting-edge facilities and knowledge without making significant initial expenditures. Outsourcing shortens the time to market by expediting testing procedures, allowing firms to launch goods more quickly and capitalize on market possibilities.
Rapid improvements in analytical technology are driving the demand for medical device outsourcing services. Third-party testing labs are constantly investing in cutting-edge technology including mass spectrometry, chromatography, and molecular diagnostics. The technologies allow for precise and thorough study of medical device materials, components, and functionality. Technological improvements improve the sensitivity, accuracy, and speed of testing, allowing for faster decision-making in product development and regulatory filings.
Attributes | Details | |
Global Medical Device Analytical Testing Outsourcing Market CAGR (2024 to 2034) | 6.4% | |
Global Medical Device Analytical Testing Outsourcing Market (2034) | USD 10.3 billion | |
Global Medical Device Analytical Testing Outsourcing Market Attraction | Product complexity, increased rivalry, an increase in the number of small-scale medical device manufacturers, and high clearance criteria are all primary drivers in the industry. |
Key Takeaways from the Medical Device Analytical Testing Outsourcing Market
- India is likely to augment at a CAGR of 8.8% throughout 2034.
- Spain is anticipated to ascend at a CAGR of 7.8% throughout 2034.
- The United States is expected to rise at a CAGR of 2.4% by 2034.
- Extractable and Leachable (E&L) Testing is projected to hold a market share of 26.15% in 2024.
- The medical device analytical testing outsourcing for hospitals segment is likely to hold a market share of 81.5% in 2024.
“Outsourcing analytical testing in the medical device industry is expected to increase significantly due to regulatory needs and technological innovations,” says Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.)
What are the Major Trends in the Global Medical Device Analytical Testing Outsourcing Market?
Medical device makers are hiring consultants to help them grasp the documents and laws required for pre-market clearance. The development of modern technologies such as surgical microscopes, surgical robots, neurosurgical devices, ophthalmic surgical devices, and many others has reduced the direct interaction of people in the surgical procedure, making quality certifications for medical devices vital.
The increased need for minimally invasive operations is driving the ubiquitous medical device analytical testing outsourcing market forward.
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What Challenges Are in Store for Medical Device Analytical Testing Outsourcing Sales?
Although, outsourcing reduces the costs of such operations, which is projected to drive market expansion. The Medical Device Analytical Testing Outsourcing Market has its fair share of drawbacks.
The primary drawback of medical device analytical testing outsourcing resides in the third-world countries which might still be price-sensitive for medical device analytical testing, which is a key impediment to the medical device analytical testing outsourcing industry.
How are key players revolutionizing the Medical Device Analytical Testing Outsourcing Market?
Key companies are transforming the medical device analytical testing outsourcing market with novel technology and complete testing solutions. The key players are investing in new analytical techniques including molecular diagnostics and high resolution imaging to improve accuracy and dependability. Collaborations with research institutes and healthcare providers are accelerating innovation and broadening service offerings.
The emphasis on regulatory compliance and quality assurance assures conformity to global standards. Using automation and digitalization simplifies operations, decreases turnaround times, and boosts efficiency. Key actors are raising the bar for medical device testing and quality assurance by harnessing cutting-edge technology and encouraging industry alliances.
Recent Developments from the Medical Device Analytical Testing Outsourcing Market:
- In March 2024, Pace Analytical Services LLC announced the acquisition of the Lebanon, New Jersey laboratory facility from Curia.
- In November 2023, SGS Hong Kong got certification for China Mobile Hong Kong (CMHK) to ISO 37001, the first worldwide anti-bribery management system standard which was one of the first central Chinese state-owned telecommunications firms to acquire the accreditation.
Key Players of Medical Device Analytical Testing Outsourcing Sector
- 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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Key Segments of the Medical Device Analytical Testing Outsourcing Market:
By Service:
In terms of services, the sector is divided into extractable and leachable medical device analytical testing outsourcing, material characterization medical device analytical testing outsourcing, physical testing medical device analytical testing outsourcing, bioburden testing medical device analytical testing outsourcing, sterility testing medical device analytical testing outsourcing, and other tests medical device analytical testing outsourcing.
By Device Type:
In terms of device type, the sector is segregated into Reprocessed Devices and Other Medical Devices.
By End Use:
By end use, the industry is divided into hospitals and others.
By Region:
Key countries of North America, Latin America, Western Europe, South Asia and Pacific, East Asia and Middle East and Africa have been covered in the report.
Author by:
Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.
Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.
Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.
About the Healthcare Domain at Future Market Insights
The healthcare team at Future Market Insights offers expert analysis, time-efficient research, and strategic recommendations with an objective of providing authentic insights and accurate results to help clients worldwide. With a repertoire of over 100+ reports and 1 Billion+ data points, the team has been analyzing the industry lucidly in 50+ countries for over a decade. The team provides a brief analysis of key trends including competitive landscape, profit margin, and research development efforts.
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