By 2030, it is anticipated that the global market for preclinical medical device testing services would amount to $4.9 billion
The expanding testing of medical devices
The pace of technological advancement in the healthcare industry has significantly increased recently. Modern medical gadget technology makes it simple and painless to manage sickness.
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| Additionally, animal and bench studies are used in the testing process to demonstrate the utility of the new gadget, verify electrical safety, or investigate electromagnetic interference. |
Preclinical testing is essential to the development of novel products. Most of this testing should have been conducted and reports should be accessible before starting human testing. According to ISO-10993, 510(k) notifications for Class II equipment that comes into direct contact with patients or the blood supply must contain the findings of biocompatibility testing. This demonstrates that the dangers of the new device are "essentially equivalent" to those of the predicate device. Additionally, animal and bench studies are used in the testing process to demonstrate the utility of the new gadget, verify electrical safety, or investigate electromagnetic interference.
Due to COVID-19, there is a high demand for these services. The growth was modest in the first half but increased in the second as the industry's adoption of the new standards was sped up by the epidemic. The testing and production of PPE kits have risen, and several initiatives that had been put on hold because of COVID have now been resumed. During the outbreak, there was a huge demand for many medical products, which made people forget about the need for surgical supplies. In particular, COVID-19 vaccines, ventilators, and pulse oximeters showed a rise in demand.
Highlights from the report on the market for preclinical medical device testing services
With a revenue share of 34.2% in 2021, the Microbiology & Sterility Testing category led the market. One of the key tests in pre-clinical medical device testing is this one. These tests help determine whether microbes are present in the device.
Sterility test and validation dominated the market in 2021 with a revenue share of 45.6%, according to the type of microbiology & sterility test.
The fastest CAGR of 9.0% is projected for the chemistry test segment. The test is carried out to classify, identify, and comprehend the chemicals utilised in the manufacture of medical equipment.
Due to the low cost of outsourcing medical device testing services, Asia Pacific is expected to see the quickest CAGR of 9.0% throughout the projection years and hold the top spot in the worldwide market in 2021.
Services Segment Analysis for Preclinical Medical Device Testing
- the definition and scope of the "Preclinical Medical Device Testing Services Market"
- Market Share Analysis for Preclinical Medical Device Testing Services, 2021 and 2030, Table 4.2
- Tests for biocompatibility
- Market for Biocompatibility Tests, 2018 to 2030 (USD Million)
- Chemistry Test (4.4)
- Chemistry Test Market, 2018 to 2030, section 4.4.1 (USD Million)
- 4.5. Sterility and microbiology testing
- Market for microbiology and sterility testing, 2018 to 2030 (USD Million)
- 4.5.2. Determination of Bioburden
- Market for Bioburden Determination, 2018 to 2030, 4.5.2.1 (USD Million)
- Pyrogen and endotoxin testing 4.5.3
- Market for Pyrogen and Endotoxin Testing, 2018 to 2030 (USD Million)
- Sterility Test and Validation, Section 4.5.4
- Market for Sterility Test and Validation, 2018–2030. (USD Million)
- 4.5.4.2. Sterilization with ethylene oxide (EO) gas
- Market for sterilising with ethylene oxide (EO) gas, 2018 to 2030 (USD Million)
- Gamma-irradiation (4.5.4.3)
- Gamma-irradiation Market, 2018 to 2030, Section 4.5.4.3.1 (USD Million)
- E-beam sterilisation (4.5.4.4)
- Market for e-beam sterilisation, 2018 to 2030 (USD Million)
- X-ray sterilisation (4.5.4.5)
- Market for X-ray sterilisation, 2018 to 2030 (USD Million)
- 4.5.5. Testing for antimicrobial activity
- Market for evaluating antimicrobial activity, 2018 to 2030 (USD Million)
- 4.5.6. Additional
- Market for Others, 2018 to 2030 (4.5.6.1) (USD Million)
- Packaging Validation (4.6)
- Market for Packaging Validation, 2018 to 2030 (USD Million)
Visit Research and Markets at https://www.researchandmarkets.com/r/p4hsjw for more details on this study.


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