Medical Device Contract Research Organization Market Size, Share & Trends Analysis Report By Phase (Preclinical, Clinical), By Service (Regulatory/Medical Affairs, Clinical Monitoring), By Type, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global medical device contract research organization market size was valued at USD 7.21 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.8% from 2023 to 2030. The market growth can be attributed to an increase in the number of medical device-specific clinical trials, the growing demand for advanced medical devices, and a rise in the focus among medical device companies to reduce the cost associated with research. During the COVID-19 recovery period: The pipeline of medical devices witnessed a steady rise. For instance, according to Global Data, in Q2 of 2021, there were 1,103 medical devices in the pipeline, whereas in Q3, it increased by 20.0%.

The growing demand for novel technologies and the increasing need to make devices patient-friendly are expected to improve the pipeline of medical devices during the forecast period. The industry is growing at a steady pace owing to access to advanced technological resources. It saves time and is cost-efficient. Contract Research Organizations(CROs) are becoming important in the medical and healthcare sectors. CROs have deep knowledge of complex regulatory requirements and audits as they work in clinical compliance on a daily basis. This helps them address all compliance challenges. Furthermore, high demand for effective medical devices, a growing patient population, and funding & grants provided by the government for certain medical devices are also projected to drive the market.

The current trend in the medical device industry is of small & portable products that need more components & sophisticated manufacturing technologies along with automation systems. Medical products, including a variety of life-assistance devices, drug delivery systems, therapeutic devices, and patient monitors, are all becoming smaller in size, while features & performance are improving. Wearable and implantable devices that monitor, administer, treat, & track patient conditions are common requirements. To remain competitive in the market, medical device companies are trying to develop enhanced versions of their devices, which is expected to promote the demand for contract research services for medical devices in the coming years.

Phase Insights

Based on phase, the global industry has been further categorized into clinical and preclinical. The clinical phase segment dominated the global industry in 2022 and accounted for the largest share of more than 85.20% of the overall revenue. This is mainly because of the growing emphasis on decreasing the cost associated with research among medical device companies. Furthermore, a large pipeline of medical devices in the clinical phase supports segment growth.

The preclinical segment, on the other hand, is expected to register the fastest growth rate during the forecast period. Increasing product complexity and strict government restrictions are driving demand for medical device preclinical CRO services. Moreover, there is a growing demand for advanced medical devices. This is expected to improve the number of preclinical medical device clinical trials and, thus, support the demand for preclinical CRO services for medical devices in the coming years.

Service Insights

The clinical monitoring segment led the global industry in 2022 and accounted for the largest share of 21.12% of the overall revenue.  The segment is anticipated to maintain its position over the forecast period owing to a large number of clinical trials performed and, to study them, increasing demand for clinical trial monitoring.

The introduction of devices, such as smart analytics and real-time, is estimated to improve clinical monitoring data and thus further support segment growth. The regulatory/medical affairs segment is expected to grow at the fastest CAGR over the forecast period. The regulatory approval process reflects the different challenges involved in the development of medical devices. Medical device companies are outsourcing regulatory affairs to CROs, which is helping them focus on their core competencies. Outsourcing helps in reducing variable costs. Regulatory support activities include regulatory intelligence, product labeling, regulatory document submissions, liaison with regulatory authorities, and planning regulatory strategies. The strict regulation for medical devices is expected to support the segment’s growth.

Device Type Insights

The diagnostic devices segment accounted for the maximum share of 44.86% of the overall revenue in 2022. Based on device types, the industry is segmented into MedTech devices, diagnostic devices, handheld devices, and others. The growing prevalence of diseases worldwide supports the demand for CRO activities for diagnostic devices. According to the WHO, 17.9 million people lose their lives every year due to CVDs. Moreover, in the case of cancer, roughly 10 million deaths, or nearly one in six deaths, will be caused by cancer in 2020, making it the top cause of death globally. A timely diagnosis can significantly reduce global mortality rates. A significant number of people suffering from these diseases is expected to boost demand for diagnostic devices & support diagnostic device research activities by CROs.

The MedTech devices segment is expected to grow at the fastest CAGR during the forecast period. One of the primary reasons for supporting the medical device CRO market in MedTech is technological advancement. MedTech includes telehealth or telemedicine devices, robotic surgery devices, software, mHealth, and others. The growing need for increased computing power, hardware miniaturization, network connectivity, large data storage capacity, and advanced software capability are some of the major factors supporting the demand for clinical research in MedTech devices and is expected to promote the segment growth.

Regional Insight

Asia Pacific dominated the industry and accounted for the largest revenue share of more than 41.70% in 2022. The region is also expected to grow at the fastest CAGR during the forecast period due to the availability of a number of growth opportunities for the market in this region, especially in Japan, China, Australia, and India. Various other factors, such as improvements in the regulatory framework, higher cost savings, increasing complexity in devices, and a growing number of medical device research organizations in the region, are also expected to drive the market.

Moreover, the rising rate of outsourcing research services from developed economies to emerging economies, such as India and China, and the availability of a skilled workforce at a lower cost than in the U.S. and European countries are expected to accelerate the region’s growth. North America is expected to expand at a steady CAGR during the forecast period. North America is one of the major contributors to the global industry. Rapid growth in the development of medical devices to meet the increasing demand for efficient healthcare in North America is expected to be one of the key factors propelling regional growth. In addition, the growing demand for reducing costs associated with medical device development is likely to promote market growth over the forecast period.

Key Companies & Market Share Insights

Key players are undertaking various strategic initiatives, such as the launch of new product partnerships, collaborations, mergers & acquisitions, and geographic expansion, aiming to strengthen their service portfolio and provide a competitive advantage. For instance, in August 2022, Laboratory Corp. of America Holdings collaborated with medical device companies Becton, Dickinson, and Company. LabCorp developed flow cytometry-based companion diagnostic devices for patients receiving cancer treatment and other diseases as part of the collaboration. Some of the prominent players in the global medical device contract research organization market are:

• IQVIA, Inc.

• Charles River Laboratories

• ICON, plc

• Syneos Health

• Laboratory Corporation of America Holdings

• WuXi AppTec

• Medpace

• Eurofins Scientific SE

• Promedica International

• Qserve

Medical Device Contract Research Organization Market Report Scope

Global Medical Device Contract Research Organization Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global medical device contract research organization market report based on phase, service, device type, and region:

• Phase Outlook (Revenue, USD Million, 2018 - 2030)

  • Preclinical

  • Clinical

• Service Outlook (Revenue, USD Million, 2018 - 2030)

  • Project Management/Clinical Supply Management

  • Data Management

  • Regulatory/Medical Affairs

  • Medical Writing

  • Clinical Monitoring

  • Quality Management/Assurance

  • Bio-statistics

  • Investigator Payments

  • Laboratory

  • Patient & Site Recruitment

  • Technology

  • Others

• Device Type Outlook (Revenue, USD Million, 2018 - 2030)

  • MedTech Devices

  • Diagnostic Devices

  • Handheld Devices

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait