Medical device testing market to grow at a CAGR of 4.9% from 2023-28

The medical device testing market is projected to reach USD 13.5 billion by 2038 from USD 10.6 billion in 2023; it is expected to grow at a CAGR of 4.9% from 2023 to 2028.

The global medical device testing market is experiencing significant growth fueled by several critical factors, including the expansion of the worldwide healthcare industry, a shift towards outsourcing medical testing services, and increased emphasis on validation and verification of medical devices. Additionally, technological advancements in medical device testing and harmonization of standards in the medical device industry provide lucrative opportunities for market players. Furthermore, using advanced technologies such as artificial intelligence (AI) and machine learning is revolutionizing testing procedures and boosting testing capabilities. These advancements present significant business opportunities in the medical device testing market, allowing them to expand their service offerings.

Medical device testing market for testing services segment to hold the highest market share during the forecast period
The medical device testing industry is experiencing significant growth in testing services. Increased regulatory requirements, advancements in technology, rising demand for quality assurance, and the need for comprehensive risk mitigation strategies drive this expansion. There is an increased regulatory focus on quality control for manufacturing operations and additional safety, testing, and reporting measures, which require advanced test equipment and instrumentation on-site in manufacturing facilities and laboratories. Test results’ accuracy largely depends on the accuracy of the test and measurement instruments used for a particular test process. As a result, companies offering testing services in this sector are witnessing heightened demand and expanding their operations to meet industry needs.

Medical device testing market for outsourced segment to hold the highest CAGR during the forecast period
The surge in demand for outsourced medical device testing services underscores the growing recognition of our specialized expertise and cost-effective solutions. As regulatory requirements become more stringent, companies increasingly rely on our streamlined processes to ensure compliance and quality assurance in their product development. Furthermore, outsourcing testing services can be advantageous, especially for smaller companies or those without the extensive resources or expertise required for comprehensive testing. This trend positions the outsourced segment for continued expansion and success in meeting the evolving needs of the medical device testing industry.

In vitro diagnostic (IVD) medical devices segment to dominate the medical device testing market during the forecast period
The marketplace for IVD Medical Devices witnesses rapid growth, driven by technological advancements, better diagnostics tools, improved treatment monitoring, and the increased availability of over-the-counter tests. The accuracy and reliability of IVD devices are paramount for providing accurate diagnostic information to healthcare professionals. Rigorous testing and validation procedures are crucial to ensure the precision, sensitivity, specificity, and overall performance of IVD medical devices, supporting accurate disease detection and patient care. According to the US Food and Drug Administration (FDA), IVD products are classified I, II, and III according to the level of regulatory control necessary to assure safety and effectiveness with respect to human-body contact.

The North America medical device testing market held the largest market share in 2023
The rise of medical device testing in North America has accelerated in recent years due to strict regulatory requirements imposed by agencies. This demands extensive testing to ensure compliance before market introduction. Technological improvements have resulted in increasingly complicated medical devices, requiring rigorous testing to assess safety and efficacy. The region’s prominence as a hub for clinical research and trials emphasizes the importance of standardised testing techniques that meet international regulatory standards. Additionally, heightened awareness among stakeholders about the need of testing for quality assurance and risk management has further spurred market growth. As demand for medical devices develops alongside an ageing population and the increasing frequency of chronic diseases, medical device testing has become a critical component of the healthcare business in the region. MarketsandMarkets