The stringent regulatory landscape and the increasing complexity of medical devices are driving a significant surge in the Medical Device Analytical Testing Outsourcing Market. This market is projected to experience robust growth, expanding from USD 5.84 billion in 2024 to a substantial USD 10.86 billion by 2034. This represents a steady Compound Annual Growth Rate (CAGR) of 6.4% over the forecast period.
The key factors driving the market are product complexity, increased competition, an increase in the number of small-scale medical device manufacturers, and strict approval norms. The COVID-19 pandemic has highlighted the importance of developing innovative low-cost medical equipment. This crisis has caused a worldwide economic and health pandemic. As a result, several businesses have closed their factories and halted the majority of the manufacturing process.
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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.
Medical Device Analytical Testing Outsourcing Market 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.
Medical Device Analytical Testing Outsourcing Market 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 renewed 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
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 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 Future Market Insights (FMI)
Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.
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