The global medical device testing service market size is anticipated to around USD 14.2 billion by 2026, this market is anticipated to grow with 12.2% CAGR during the forecast time period. Growing difficulty in product design paired with stringent regulatory norms is expected to boost the industry development during the forecast time frame.
Rise of drug device combination, personalized medication, artificial intelligence (AI), wearables and focus on real-time patient monitoring resulted in complex medical devices ecosystem. To match these factors, gadgets now have to undergo shear testing in augmented conditions to obtain marketing approval. Conducting these tests in-house needs a lot of time, cost, and labour; this is anticipated to increase the need for outsourcing of these services thereby increasing the market development.
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Growing need for in-vitro tests is also anticipated to boost the industry, as a lot of CROs are emerging novel methods to replace the traditional in-vivo tests that require animal testing. Development in the growth and standardization of novel in vitro test approaches; particularly for sensitization, cytotoxicity, and irritation that are the basic test required for all the medical device is also expected to support industry development.
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Also, increasing numeral of businesses in this industry is contributing to the industry growth. Structurally, global medical device industry is divided amongst few major players and a huge numeral of (SMEs) Small- and Medium-sized Enterprises.Therefore, rising need from SMEs that lack in-house capabilities, will backing the industry.
The stringent regulatory standards pertaining to operator care have also contributed to the industry. Growing need for high-quality products is also anticipated to push the need for testing services.
The global medical device testing service market is segmented into service, phrase and region.On the basis of service the global medical device testing service market is segmented biocompatibility tests, chemistry test, microbiology & sterility testing, and package validation. Microbiology & Sterility Testing is further bifurcated into bio-burden determination, pyrogen and endotoxin testing, sterility test and validation, anti-microbial activity testing, and other services. On the basis of phrasethe global medical device testing service market is segmented into preclinical and clinical. Preclinical sub segment is further bifurcated into antimicrobial wound dressings, medical coatings and others. On the basis of region the global medical device testing service market is segmented into Latin America, Europe, Asia Pacific, North America, and Middle East & Africa.
Asia Pacific captures the largest market share in the medical device testing services market due to augmented outsourcing in nations, for instance, as India and China. Contract Research Organizations (CROs) are spending heavily in emerging nations of APAC due to lower cost and easy accessibility of trained labour. North America captures the second-largest share in 2018 and is anticipated to observer important development during the forecast time frame.
This development can be credited to the fact that it is one of the top industrial hubs of complex, high-end, and reliable medical gadgets. Many CROs have a developed business in the region that delivers complete range of testing services for businesses. The Europe region is led by nations (Germany Spain, U.K., France, and Italy) EU5. Increasing demand for cost cutting and growing difficulty in product designing are anticipated to be the major industry drivers.
Market companies are concentrating on implementing new strategies for instance regional expansion, partnerships, mergers and acquisitions, new product launches, and distribution agreements to surge their revenue share. And also, growing R&D investments paired with technical advancements to commercialize highly efficient products are expected to offer huge growth opportunities for industry participants. Some of the main businesses present in the medical device testing service market are
Medical Device Testing Services, Toxikon, Inc.,American Preclinical Services LLC,SGS SA,Charles River Laboratories International, Inc.,Eurofins Scientific, LLC,Sterigenics International LLC,Intertek Group PLC,North American Science Associates, Inc.,WuXiAppTec Group, and Pace Analytical Services, LLC, Significant strategic initiatives undertaken by global businesses include partnerships, new product launch, acquisitions.
Service portfolio growth along with regional penetration is expected to be the key market strategy. There has been noteworthy consolidation in CRO space in the coming years. Such as, Sterigenics International LLC acquired the European division of Toxikon Corporation; Toxikon Europe N.V., in October 2017. The objective of the acquisition is to strengthen its preclinical service portfolio for pharmaceutical and medical device businesses.
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