The medical device CRO market is projected to reach USD 15.7 billion by 2030, growing at an annualized rate of 6.4%, claims Roots Analysis

The medical device CRO market is projected to reach USD 15.7 billion by 2030, growing at an annualized rate of 6.4%, claims Roots Analysis

The medical device CRO market is highly fragmented, featuring the presence of well-established players, mid-sized firms and a number of new entrants, offering niche expertise. In fact, over 50 medical device focused CROs have been established since 2010. It is worth noting that, in order to cope with modern day challenges, CROs have adopted emerging technologies / operating principles, such as big data analysis, artificial intelligence (AI) and real-world evidence
Owing to the numerous complexities associated with clinical research, medical device developers rely on contract service providers in order to reduce the risk of device recalls and expedite the time to market

Roots Analysis has announced the addition of the “Medical Device CRO Market (2nd Edition), 2020-2030” report to its list of offerings.


Given the complex R&D protocols and the increasing demand for clinical evidence of therapeutic benefit, there seems to be a lucrative opportunity for contract research providers engaged in the medical devices’ domain. In fact, since 2000, 150 new CROs have been established that offer a variety of cost-efficient services and solutions to medical device developers.


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Key Market Insights


Over 300 CROs presently offer a wide range of preclinical and clinical research-related services to medical device developers

It worth noting that more than 85% CROs offer clinical development services to sponsor companies. Further, the market is currently dominated by the presence of very small and small companies (less than 51 employees), that represent over 50% of the total players.


Close to 50% CROs claim to have elaborate clinical service portfolio, offering end-to-end solutions

Majority of such players offer assistance in clinical trial monitoring (83%) and clinical data management (83%); other popular services include (in terms of number of companies offering them) those provided for initiating clinical studies (79%), medical writing (78%), devising a clinical strategy (75%), and clinical project management (70%).


More than 70% of medical device CROs are based in North America and Europe

Within North America, majority of the service providers are headquartered in the US, in fact, over 50% of preclinical service providers are US-based; whereas, in Europe, most of the CROs are distributed across France, Germany, Switzerland, Spain, Italy and Sweden. Further, a significant number of such players (30%) are headquartered in Asia-Pacific and other developing countries of the world.


7,500+ medical device focused clinical trials have been registered worldwide

Of these, close to 70% trials are actively recruiting participants. So far, close to 2.9 million patients have been enrolled in ongoing / planned trials of medical devices. Interestingly, maximum number of patients were enrolled in studies being conducted in Asia-Pacific, during the period 2015-2020.


M&A activity in this domain increased at a CAGR of 47%, during 2015-2019

Key drivers behind acquisitions include geographical consolidation, geographical expansion, service portfolio consolidation and service portfolio expansion. Examples of acquisitions carried out to expand the acquirer company’s geographical reach include (in reverse chronological order) the acquisition of The Clinical Trial by Veristat (January 2020), Target Health by dMed (June 2019), Citoxlab by Charles River Laboratories (April 2019), and MedicSense by genae (January 2019).


North America and Europe are anticipated to capture over 65% of the market share by 2030

In the long term, the market in Asia-Pacific is expected to grow at a relatively faster pace. Further, in terms of device class, class III medical devices currently represent the highest share and this trend is unlikely to change in the foreseen future.


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Key Questions Answered

  • Who are the leading players that offer contract research services for medical devices? Which companies have relatively stronger brand positioning?
  • How does the market landscape vary across different regions of the world?
  • What are the key value drivers of the merger and acquisition activity in the medical device CRO industry?
  • What are the key differences in regulatory requirements for medical device approval, across various geographies?
  • What are the different payment systems and reimbursement strategies being adopted for medical devices?
  • What are the key performance indicators used by sponsors to evaluate potential service providers?
  • How is the current and future market opportunity likely to be distributed across key market segments?
  • What are the upcoming opportunities / trends of medical device contract services market that are likely to impact the future evolution of this domain over the coming years?


The USD 15.7 billion (by 2030) financial opportunity within the antibody contract manufacturing market has been analyzed across the following segments:

  • Phase of Development
    • Clinical
    • Preclinical


  • Types of Preclinical Services Offered
  • Biocompatibility testing
  • Sterility and microbiology testing
  • Material characterization and analytical services
  • Others


  • Types of Clinical Services Offered
  • Clinical trial management
  • Data management
  • Regulatory affairs management
  • Consulting
  • Others


  • Device Class
  • Class I medical devices
  • Class II medical devices
  • Class III medical devices


  • Target Therapeutic Area
    • CNS disorders
    • Cardiovascular disorders
    • Oncological disorders
    • Bone disorders
    • Respiratory disorders
    • Pain management disorders
    • Ophthalmic disorders
    • Psychological disorders
    • Metabolic disorders
    • Others


  • Key Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World


The report features inputs from eminent industry stakeholders, according to whom, the requirement of high technical expertise and experienced personnel for conducting clinical research has compelled developers to outsource various aspects of their clinical operations. Experts further suggest that, at present, most outsourced activities by sponsor companies include regulatory affairs management, clinical trial site selection, trial monitoring and project management. The report includes detailed transcripts of discussions held with the following experts:

  • Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial)
  • Christopher Rupp (Vice President of Global Marketing and Commercial Operations, NAMSA)
  • Christian Wolflehner (General Manager, CW Research & Management)
  • Troy Mccall (Chief Operating Officer, CROMSOURCE)
  • Nazish Urooj (Senior Manager, Medical & Clinical Operations, Metrics Research)
  • C. Omprakash (Technical Director and Partner, Vyomus Consulting)
  • Tania Persson (Director of Business Development, A+ Science)
  • Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO)


The research covers profiles of key players; each profile features an overview of the company, financial details (if available), medical device focused service portfolio and an informed future outlook.

  • Avania (formerly known as Factory CRO)
  • Charles River Laboratories
  • Clinlogix
  • CSSi LifeSciences™
  • Eurofins Medical Device Testing
  • genae
  • IMARC Research
  • Medpace
  • Qserve Group
  • Regulatory and Clinical Research Institute (now a part of Covance)
  • WuXi AppTec


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Gaurav Chaudhary

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