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Key Inclusions
A detailed review of the overall landscape of medical device CROs, along with information on year of establishment, company size, location of headquarters, type of service offered by [A] clinical service providers (biostatistics, consulting, clinical operations, post marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement and training), [B] preclinical service providers (consulting, biocompatibility testing, materials characterization and analytical testing, preclinical trials support, sterility testing and microbiology testing, and training) and [C] stand-alone service providers (consulting, training, quality assurance, clinical operations, and regulatory affairs management).
An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America (the US, Canada and Mexico), Europe (France, Germany, Italy, Spain, the UK and rest of Europe), and Asia-Pacific and rest of the world (Australia, Brazil, China, India, Israel, Japan, New Zealand, Singapore, South Africa, South Korea, Taiwan, and Thailand). The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory and reimbursement scenarios in key geographies across the globe.
Elaborate profiles of key players that specialize in offering services for both clinical and preclinical stage development of medical devices. Each profile features an overview of the company, along with information on year of establishment, number of employees, location of headquarters, presence across key geographies, target therapeutic areas, financial details (if available), medical device focused service portfolio, and an informed future outlook.
An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers engaged in this domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
A competitive benchmarking, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.
A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of service portfolio), highlighting the current perceptions regarding their proprietary brands across different device classes.
A detailed geographical clinical trial analysis of ongoing and planned studies related to medical devices, along with information on number of registered trials, location of trial site, current status of trials, current phase of trial, type of sponsor, target therapeutic area(s) and number of patients enrolled.
A detailed analysis of the mergers and acquisitions that have taken place in this domain during the period 2015-2020, highlighting geographical activity. The analysis also features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.
A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract research services to medical device developers.
A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall medical device CRO industry.
An elaborate discussion on the future opportunities / trends for the medical device outsourcing market that are likely to influence the growth of this domain over the coming years.
Informed estimates of the existing market size and the future opportunity for medical device CROs, over the next decade.
The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:
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 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)
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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?
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Contact Us
Gaurav Chaudhary
+1 (415) 800 3415
gaurav.chaudhary@rootsanalysis.com
