According to a report published by Grand View Research, Inc.; the medical device testing service market is expected to reach a valuation of around USD 13.4 billion by 2025.
Strict regulatory standards related to user safety and high demand for good quality products can propel the market over the forecast period (2014 to 2025). In addition, substantial rise in preclinical expense for pharmaceutical as well as medical device is expected to support the market growth.
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Increasing complexity in product design along with strict regulatory policies is one of the crucial trends driving the market growth. Factors such as introduction of personalized medicines, artificial intelligence, drug device combinations, wearables, and real-time patient monitoring have led to complex medical device ecosystem. This has increased the need for testing services to get approvals in the market. In-house testing is not possible to many companies as it may take more time and labor costs to complete these tests. Increasing demand for in-vitro test is also expected to increase the demand for testing services due to growing development of in-vitro methods to replace traditional in-vivo methods, which need animal testing. These methods are generally improved for sensitization, irritation, and cytotoxicity.
Worldwide medical device testing services market can be segmented on the basis of service, phase, and region. Based on service, the market can be biocompatibility tests, chemistry test, microbiology and sterility testing, and packed validation.
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In 2016, the microbiology and sterility segment conquered the market. The biocompatibility test segment is expected to show significant growth during the forecast period. The cost of biocompatibility test is expected to reduce due to development of innovative in-vitro methods. The chemistry test segment is a projected to show rapid growth over the forecast period due to several advantages associated with it.
As per phase, the market can be classified into clinical and preclinical. In 2016, the preclinical segment estimated for the major share and likely to show high growth during the forecast period. This phase determines the safety, efficacy, and biocompatibility of biomaterials, prosthesis, and medical devices. The clinical segment is also projected to show significant growth over the study period. This segment involves in sterilization testing and validation, cleaning validation, shelf life and accelerated aging test, and package and shipping testing.
Geographically, the market can be divided into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa.
In 2016, Asia Pacific dominated the market in terms of revenue due to high outsourcing rate in emerging countries such as China and India. CROs are extensively making high investments in emerging economies due to presence of operating low cost and greater availability of skilled labors.
In 2016, North America stood on the second position. and is estimated to show remarkable growth during the forecast period. This region is one of the topmost manufacturing centers for complex, reliable, and high-quality medical devices. The region has several established CROs, which offers comprehensive testing services for medical device companies.
The market in the Europe is mainly driven by countries including Germany, the U.K., France, Spain, and Italy. Increasing need for cost cutting and rise in complexity in product designing are considered as key drivers that would drive the market in this region.
Prominent players operating in the market include Toxikon, Inc.; Charles River Laboratories International, Inc.; Toxikon, Inc.; Sterigenics International LLC; and Pace Analytical Services LLC.The market is currently observing significant rise in number of companies in recent years. The market is highly fragmented by few major companies and numerous small and medium enterprises (SMEs). The growth of this industry can be associated with increasing demand from small and mid-size companies, due to absence of in-house facilities for testing. The participants in the market are mainly focusing on portfolio expansion and to expand their geographical reach to gain higher market share. The market has also observed high consolidation in CRO space in recent years.
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