Medical Device Contract Research Organization (CRO) Market Report 2025

This Medical Device Contract Research Organization (CRO) market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The medical device contract research organization (CRO) market size has grown strongly in recent years. It will grow from $9.93 billion in 2024 to $10.64 billion in 2025 at a compound annual growth rate (CAGR) of 7.2%. The growth in the historic period can be attributed to increasing demand for clinical trials, growing regulatory requirements, rising complexity of medical devices, high research and development costs, and an and an increase in chronic diseases.

The medical device contract research organization (CRO) market size is expected to see strong growth in the next few years. It will grow to $13.84 billion in 2029 at a compound annual growth rate (CAGR) of 6.8%. The growth in the forecast period can be attributed to increasing adoption of digital health technologies, growing emphasis on patient safety, growth in biologics and biosimilars, an increase in home healthcare devices, and an and an increasing focus on environmental sustainability. Major trends in the forecast period include the adoption of AI-driven analytics, the expansion of personalized medicine services, the integration of real-world evidence in clinical trials, the shift towards patient-centric trial designs, and the and the adoption of cloud-based solutions for data management.

The rise in clinical trials is anticipated to boost the growth of the medical device contract research organization (CRO) market. Clinical trials involve research studies with human participants aimed at assessing the safety and efficacy of new medical treatments, interventions, or diagnostic procedures. The growing number of clinical trials is driven by increased demand for innovative medical devices and regulatory requirements for thorough testing. Medical device contract research organizations (CROs) offer specialized expertise and resources to manage, conduct, and oversee these trials, ensuring compliance and efficiency. For example, in August 2024, the National Library of Medicine reported an increase in registered clinical trials from 477,227 in 2023 to 506,371 across 50 states and 221 countries. Additionally, 52,731 medical device studies were registered globally. This surge in clinical trials is expected to propel the medical device CRO market.

Leading companies in the medical device CRO market are focusing on integrating traditional services with advanced technologies and recruitment strategies, such as hybrid and virtual trial models, to improve trial efficiency, speed up participant enrollment, and streamline regulatory compliance. Virtual and hybrid site capabilities are designed to meet diverse study requirements and participant needs, particularly in response to the growing demand for decentralized trials. For instance, in June 2024, Lindus Health, a UK-based clinical trials company, introduced All-in-One Medical Device CRO, a comprehensive solution tailored for medical device trials. This offering combines traditional CRO services with advanced features such as Citrus eClinical technology. It integrates all essential trial tools into a single platform, including clinical trial management systems (CTMS), electronic data capture (EDC), and eConsent. The platform enhances recruitment with access to over 30 million electronic health records (EHRs) and strategic digital marketing, ensuring efficient and timely enrollment. Lindus Health also provides robust site services, managing trials across single-site, multi-site, and virtual/hybrid models through strong relationships with principal investigators and research staff.

In October 2023, Avania, a US-based clinical research organization that specializes in medical technology development, acquired HULL ASSOCIATES LLC and Ironstone Product Development (IPD) for an undisclosed amount. This acquisition is intended to enhance Avania's global capabilities in regulatory affairs, clinical trial management, and product development services. HULL ASSOCIATES LLC is a US-based consultancy that specializes in regulatory strategies, while Ironstone Product Development (IPD) is a Canada-based company focused on medical device development and commercialization strategies.

Major companies operating in the medical device contract research organization (CRO) market are Thermo Fisher Scientific Inc., IQVIA Inc, Laboratory Corporation of America Holdings, ICON plc, Eurofins Scientific SE, WuXi AppTec, Syneos Health, Charles River Laboratories, PAREXEL International, Medpace Holdings, Inc., Hangzhou Tigermed Consulting Co Ltd, Caidya, QPS Holdings LLC, Avania B.V., Veristat, Cromsource S.R.L., Osmunda Medical Technology Service Group, MedTrials Inc, Boston Biomedical Associates, Hangzhou CIRS Technology Group Co Ltd, Clinlogix, Shanghai Haofeng Medical Technology Co Ltd, Promedica International, Qingdao Novelbeam Technology Co Ltd, CSSi LifeSciences, Lingboyihui, Medidee Services.

Asia-Pacific was the largest region in the medical device contract research organization (CRO) market in 2023 and is expected to be the fastest-growing region in the forecast period. The regions covered in the medical device contract research organization (CRO) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the medical device contract research organization (CRO) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

A medical device contract research organization (CRO) is a specialized service provider that offers outsourced research and development support to medical device manufacturers. These organizations assist companies in navigating the complex process of developing a medical device from concept to market, ensuring regulatory compliance, and achieving successful clinical outcomes. CROs play a critical role in reducing the time, cost, and risks associated with medical device development.

Key services provided by medical device CROs include project management or clinical supply management, regulatory or medical affairs, medical writing, clinical monitoring, quality management or assurance, biostatistics, investigator payments, laboratory services, patient and site recruitment, and more. Project management or clinical supply management focuses on overseeing the planning, execution, and coordination of clinical trials, ensuring that necessary supplies, including medical devices and drugs, are available at trial sites. The types of devices covered include medtech devices, diagnostic devices, handheld devices, and others. The phases include preclinical and clinical, with applications spanning cardiology, diagnostic imaging, orthopedics, in vitro diagnostics (IVD), ophthalmology, general and plastic surgery, and drug delivery.

The medical device contract research organization (CRO) market research report is one of a series of new reports that provides medical device contract research organization (CRO) market statistics, including medical device contract research organization (CRO) industry global market size, regional shares, competitors with an medical device contract research organization (CRO) market share, detailed medical device contract research organization (CRO) market segments, market trends and opportunities, and any further data you may need to thrive in the medical device contract research organization (CRO) industry. This medical device contract research organization (CRO) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The medical device contract research organization (CRO) market includes revenues earned by companies providing outsourced research and development services, such as clinical trials, regulatory affairs, and product development support, to medical device manufacturers. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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