Medical Device Testing Market Insights | Key players: SGS, Bureau Veritas, Intertek and DEKRA

The medical device testing market is expected to grow from USD 8.56 billion in 2017 to USD 12.26 billion by 2023, at a CAGR of 6.18% between 2017 and 2023. Some of the key factors driving this market are increasing need for validation and verification (V&V) for medical devices, and the imposition of rigorous government regulations and standards in medical devices.

The active implant medical device segment is projected to grow at the highest CAGR during the forecast period, owing to the implementation of stringent regulations to ensure that implantable medical devices are fit for the human body. These devices are prone to risks and are subject to rigorous regulatory controls, both pre- and post-marketing. Third-party service providers can leverage this opportunity to provide TIC services, including pre-shipment inspection, quality and quantity inspection, in the active implant medical devices segment.

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The class III devices segment is expected to grow at the highest CAGR during the forecast period. Class III medical devices are high-risk medical devices, and are subject to the highest level of regulatory control. Prior to marketing, class III devices must be pre-approved by the FDA or a regulatory body, and a scientific review of the medical device has to be conducted. Class III medical devices support or sustain human lives; therefore, malfunction is unacceptable.

The medical devices testing market for certification services is expected to grow at the highest CAGR during the forecast period. This is owing to the increasing number of specified standards by governments and international standardization institutions. Companies are more aware of their credibility than before and certifications demonstrate the compliance of their products with specific standards and improve their marketability. Non-conformity affects the credibility of companies and in turn hampers their reputation. Companies can leverage this market opportunity by investing in niche TIC services and expanding their service offerings to new regions.

The medical device testing market for outsourced services is expected to grow at the highest CAGR during the forecast period. Many large manufacturers of medical devices are increasingly outsourcing testing, inspection, and certification services, as the stringent regulations make conducting in-house tests costly, thereby helping the firms to reduce the overall cost of testing. Demand for outsourcing TIC services to third-party vendors is increasing for applications, such as consumer goods and manufacturing, owing to the capital-intensive nature of in-house testing, inspection, and certification activities. Asia Pacific (APAC) is expected to be the fastest-growing market for testing, inspection, and certification services during the forecast period. Many economically advanced countries have their manufacturing units in the emerging economies of APAC, especially China and India. These units are required to manufacture products in compliance with internationally accepted standards. The domestic markets in APAC are growing rapidly, owing to the rising per capita income among the middle class.

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A majority of market leaders in the medical device testing market are based in Europe. These companies can leverage this opportunity by expanding their services portfolio in APAC. For instance, TÜV SÜD received an accreditation from national accreditation board for certification bodies (NABCB, a part of Quality Council of India [QCI]) to grant certifications for ISO 13485, ICMED 9000, and ICMED 13485. This service expansion would enable manufacturers to complete the durability tests quickly and ensure exporters receive the information on time.