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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, )
§
Christopher Rupp (Vice President of Global Marketing and
Commercial Operations, )
§
Christian Wolflehner (General Manager, )
§
Troy Mccall (Chief Operating Officer, )
§
Nazish Urooj (Senior manager, Medical & Clinical
Operations, )
§
C. Omprakash (Technical Director and Partner, )
§
Tania Persson (Director of Business Development, )
§
Alexa Foltin-Mertgen (Business Development Manager, )
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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
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