The medical device contract research organization cro market has seen considerable growth due to a variety of factors.
• The market size of the medical device contract research organization (CRO) has experienced significant growth in the past few years. Expected to increase from $9.93 billion in 2024 to $10.64 billion in 2025, the compound annual growth rate (CAGR) is projected to be 7.2%.
The historical growth trend points to factors such as the escalating need for clinical tests, tightening regulatory obligations, the growing complexity of medical gadgets, heightened costs for research and development, and a rise in chronic ailments.
The medical device contract research organization cro market is expected to maintain its strong growth trajectory in upcoming years.
• The market size of the contract research organization (CRO) in medical devices is set to experience vigorous expansion in the coming years, reaching a size of $13.84 billion by 2029, propelled by a compound annual growth rate (CAGR) of 6.8%.
This can be attributed to the escalating usage of digital health technologies, an intensified emphasis on patient safety, increasing production of biologics and biosimilars, a surge in home healthcare instruments, and heightened awareness about environmental sustainability. Some trends predicted for the forecast period include the utilization of AI-infused analytics, augmentation of personalized medicine services, the inclusion of real-world evidence in clinical trials, a move towards more patient-oriented trial layouts, and the embrace of cloud-based systems for managing data.
The expansion of clinical trials is projected to fuel the growth of the medical device contract research organization (CRO) market in the future. Clinical trials, research investigations involving human subjects designed to gauge the safety and efficacy of novel medical treatments, interventions, or diagnostic procedures, are on the rise due to an increased demand for inventive medical devices and stringent testing regulations. Medical device contract research organizations (CROs) contribute their specialized skills and resources to administer, execute, and supervise medical device clinical trials, ensuring adherence to regulations and efficient completion. According to the National Library of Medicine, for example in August 2024, the number of registered clinical trials surged from 477,227 in 2023 to 506,371 in the US and 221 other countries. It was also noted that a total of 52,731 medical device studies were registered worldwide. Consequently, the rise in clinical trials is set to catalyze the development of the medical device contract research organization (CRO) market.
The medical device contract research organization (CRO) market covered in this report is segmented –
1) By Service: Project Management Or Clinical Supply Management, Regulatory Or Medical Affairs, Medical Writing, Clinical Monitoring, Quality Management Or Assurance, Bio Statistics, Investigator Payments, Laboratory, Patient And Site Recruitment, Other Services
2) By Device Type: MedTech Devices, Diagnostic Devices, Handheld Devices, Other Device Types
3) By Phase: Preclinical, Clinical
4) By Application: Cardiology, Diagnostic Imaging, Orthopedic, In Vitro Diagnostics (IVD), Ophthalmic, General And Plastic Surgery, Drug Delivery
Subsegments:
1) By Project Management Or Clinical Supply Management: Study Planning and Coordination, Clinical Supply Chain Management, Vendor Management
2) By Regulatory or Medical Affairs: Regulatory Strategy Development, Medical Affairs Support, Regulatory Submission Preparation
3) By Medical Writing: Clinical Study Protocols, Clinical Study Reports (CSRs), Regulatory Submission Documents, Patient Information Leaflets
4) By Clinical Monitoring: Site Selection and Initiation, On-site Monitoring Visits, Remote Monitoring, Data Verification
5) By Quality Management or Assurance: Quality Assurance Audits, Standard Operating Procedure (SOP) Development, Compliance Management
6) By Biostatistics: Statistical Analysis Plan Development, Data Management And Analysis, Clinical Trial Design
7) By Investigator Payments: Payment Processing Services, Financial Disclosure Management
8) By Laboratory Services: Clinical Laboratory Testing, Bioanalytical Testing, Pathology Services
9) By Patient And Site Recruitment: Site Feasibility Assessment, Patient Recruitment Strategies, Retention And Engagement Strategies
10) By Other Services: Training And Education, Risk Management, Post- market Surveillance, Data Management Services
Key players in the medical device contract research organization (CRO) landscape are merging traditional methods with cutting-edge technology and talent acquisition strategies, such as hybrid and virtual clinical trial models. Their intent is to improve trial effectiveness, speed up participant enrollment, and simplify regulatory conformity. This is particularly relevant given the rising demand for decentralized trials, where virtual and hybrid trial capabilities cater to various study designs and participant necessities. For example, Lindus Health, a UK-centered clinical trials firm, unveiled a comprehensive CRO solution exclusively for medical device trials known as All-in-One Medical Device CRO in June 2024. It merges standard CRO services with advanced functions, including their unique Citrus eClinical technology. This solution compiles all critical trial resources into a single platform, incorporating clinical trial management systems (CTMS), electronic data capture (EDC), and eConsent. The offering enhances recruitment by leveraging its large database of over 30 million electronic health records (EHRs) and employing strategic digital marketing to encourage efficient and prompt enrollment. Moreover, Lindus Health offers comprehensive site services, managing trials in single-site, multi-site, and virtual/hybrid frameworks by maintaining solid ties with lead investigators and research staff.
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 2024 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.