Medical Device and Diagnostics Contract Research Organization Market Size, Trends and Growth Analysis by 2027

The global market for medical device and diagnostics contract research organizations (CROs) is projected to grow significantly, reaching approximately US$ 20,336.08 million by 2028, up from US$ 12,314.65 million in 2021. This growth represents a compound annual growth rate (CAGR) of 7.4% from 2021 to 2028.

Several key factors are propelling this market forward, including the increasing number of clinical trials being conducted globally, a growing trend towards outsourcing research and development (R&D) activities, and rising expenditures in R&D. Despite these positive trends, the market faces challenges, particularly due to intense competition within the CRO services sector, which can impede growth.

Pharmaceutical, medical device, and biotechnology firms are increasingly focusing on R&D strategies to innovate and develop advanced medical devices and diagnostic kits aimed at various treatment, diagnostic, and monitoring applications that hold significant medical and commercial promise. These companies allocate substantial resources to R&D to ensure the delivery of high-quality and innovative products to the market. However, limitations in internal resources and the potential failure of clinical trials often lead these companies to outsource their research and clinical trial processes to gain regulatory approval for medical devices across different countries.

Medical device contract research organizations play a crucial role in assisting original equipment manufacturers (OEMs) by facilitating the development of new technologies, conducting clinical trials, navigating regulatory affairs, securing reimbursement for therapeutic devices, and managing documentation?all at comparatively lower costs. This trend has prompted small and mid-sized companies to increasingly rely on contract-based organizations for the development of new medical devices, enabling them to maintain their competitive edge in a rapidly evolving industry. This shift is expected to further stimulate market growth in the coming years.

In 2021, the medical devices segment represented the largest share of the global medical device and diagnostics CRO market, categorized by type. The expansion of the medical devices segment can be attributed to the rising number of clinical trials focused on medical devices, increased investment in R&D, and the growing prevalence of chronic diseases. Conversely, the diagnostics segment is anticipated to experience the highest CAGR during the forecast period, driven by the swift approval and launch of new products. For example, in May 2019, Roche Diagnostics introduced the Cobas MTB-RIF/INH test, which identifies antibiotic resistance in tuberculosis DNA. Such technological innovations are expected to bolster the growth of this segment.

The COVID-19 pandemic, which was first identified in December 2019 in Wuhan, China, has had a profound impact on the global landscape, affecting over 100 countries and prompting the World Health Organization (WHO) to declare it a public health emergency. The pandemic severely disrupted contract-based research and manufacturing activities for non-essential medical devices due to stringent shutdown measures. As industries navigate the aftermath of COVID-19, there is a pressing need for long-term, sustainable solutions to the challenges that have emerged. Overall, the pandemic has negatively influenced the growth trajectory of the medical devices and diagnostics CRO market.

In preparing the report on the medical device and diagnostics CRO market, various secondary sources were consulted, including the National Registry for Health Research (NRHR), the European Union (EU), the Organization for Economic Co-operation and Development (OECD), the Saudi Arabian Monetary Agency (SAMA), the Centers for Disease Control and Prevention (CDC), the International Trade Administration (ITA), and the Scientific Institutes for Research, Hospitalization, and Care (IRCCS).