Introduction
The growing demand for domestic analysis from Small and Medium-Sized Enterprises (SMEs), rise in medical device technology for enhanced treatment, diagnosis, and patient monitoring, and incorporation of training programs in China, Chile, Indonesia, Mexico, Malaysia, Singapore, Peru, Russia, Vietnam, and the Philippines is significantly driving the medical device testing market growth.
The medical device market in the U.K. was valued at approximately USD 10.6 billion, in which around 2,500 small to medium-sized companies contributed their share. The country hosts a large number of multinational companies and their subsidiaries. In contrast, France accounts for over 1,300 medical device companies, of which about 88% produce entirely medical devices.
With the growing regulations and certification requirements in the EU for the development and commercialization of medical devices, the demand for testing is witnessing a slump. Manufacturers are seeking more information about the devices, infrastructure, and ability to support the testing.
As per the FDA in 2018, there have been above 80,000 incidents of medical device injury identified since 2008. Doctors have reported an observation of spinal-cord stimulators to help the patients that suffer from pain disorders. This has made spinal-cord stimulators one of the most rising products in the USD 400 billion industry. Such instances are also expected to propel the growth of the medical devices market during the forecast period.
Key Highlights
- In October 2019, TÜV SÜD, a leading certification, testing, auditing, inspection, and training company, signed a memorandum of understanding (MoU) with the NUS Centre for Additive Manufacturing at the National University of Singapore (NUS). The agreement aims to promote R&D activities in the area of 3D printed biomedical implants for clinical trials
- In May 2019, Intertek, a British multinational assurance, inspection, product testing, and Certification Company, announced the expansion of its pharmaceutical services laboratory in Melbourne by acquiring a 20,000 sq. ft facility to double the footprint of its existing laboratory.
Competitive Players
- SGS
- Eurofins Scientific
- Bureau Veritas
- Intertek
- Elements Material Technology
- Envigo
- Avomeen Analytical Services
- Gateway Analytical
- Medistri SA
- North American Science Associates
- Pace Analytical Services
Recent Developments
- February 2024- Bureau Veritas announced the acquisition of the Conformity Assessment company from ANCE Estándares S.C.: "ANCE S.A de C.V." (Asociación de Normalización y Certificación), Mexico's leader in testing and certification services for electrical and electronic equipment.
- March 2024- Intertek collaborated with Hicomply to provide end-to-end technology and certification information security solutions.
Segmentation
- By Service Type
- Testing Services
- Inspection Services
- Certification Services
- By Testing Type
- Physical testing
- Chemical and biological testing
- Cybersecurity testing
- Microbiology and sterility testing
- By Phase
- Preclinical
- Clinical
- By Sourcing Type
- In-house
- Outsourced
- By Technology
- Active Implant Medical Device
- Active Medical Device
- Non-Active Medical Device
- In-vitro Diagnostic Medical Device
- Ophthalmic Medical Device
- Orthopedic and Dental Medical Devices
- Vascular Medical Device