The global medical device and diagnostics contract research organization market is expected to reach US$ 20,336.08 million in 2028 from US$ 12,314.65 million in 2021. The market is estimated to grow with a CAGR of 7.4% from 2021 to 2028.

Key factors driving the market such as increasing number of clinical trials worldwide and rise in adoption of outsourcing activities coupled with increasing R&D expenditures. However, the extensive competition in the CRO services market is a major factor hindering the market growth.

Pharmaceutical, medical device, and biotechnology companies adopt research and development (R&D) strategy to come up with new and high-tech medical devices and diagnostic kits for various treatment, diagnosis, and monitoring applications with the greatest medical and commercial potential. The companies invest majorly in the R&Ds to deliver high quality and innovative products to the market. However, lack of resources within the company and failure of clinical trials have led to outsourcing the research and clinical trials for approval of medical device across various countries worldwide. The medical device contract research organizations help the original equipment manufacturers (OEMs) in developing new technologies, conducting clinical trials, clearing the regulatory affairs, seeking reimbursement for therapeutic devices, and maintaining documentation at relatively lower costs. This has resulted into a shift towards approaching to contract based organizations by small and mid-sized companies for development of new medical devices to keep up their significance in the highly dynamic industry, which is likely to augment the growth of the market during the years to come.

In 2021, the medical devices segment accounted for the largest share of the global medical device and diagnostics contract research organization market, by type. The growth of the medical devices segment is attributed to the increasing number of clinical trials for medical devices, rising spending for research and development, and growing prevalence of chronic diseases. The market for diagnostics segment is estimated to grow at the highest CAGR during the forecast period owing to rapid product approvals and launches. For instance, in May 2019, Roche Diagnostics launched Cobas MTB-RIF/INH test that detects resistance to antibiotics in tuberculosis DNA. Such technological advancements are likely to favor the growth of the segment.

COVID-19 outbreak was first observed in December 2019 in Wuhan (China), and it has spread to more than 100 countries across the world, with the World Health Organization (WHO) stating it as a public health emergency. The contract-based research and manufacturing activities for all the non-essential medical devices was hampered due to strict imposition of company shut-downs in the region. Industries, however, need to adopt long-term, permanent solutions to challenges that arose due to COVID. Overall, the COVID-19 created a negative impact on the growth of medical devices and diagnostics contract research organization market.

The National Registry for Health Research (NRHR), European Union (EU), Organization for Economic Co-operation and Development, Saudi Arabian Monetary Agency (SAMA), Centers for Disease Control and Prevention (CDC), International Trade Administration (ITA), Scientific Institutes for Research, Hospitalization, and Care (IRCCS) are among the secondary sources referred to while preparing the report on the medical device and diagnostics contract research organization market.