Roots Analysis is pleased to announce the publication of its recent study, titled, “Medical Device CRO Market, 2021-2030”.
The report features an extensive study of the current market landscape and future opportunities of contract research service providers focused on medical devices. The study also features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe. In addition to other elements, the study includes:
- A detailed review of the overall landscape of medical device CROs.
- An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval across North America, Europe, and Asia-Pacific and rest of the world.
- Elaborate profiles of key players that specialize in offering services for both clinical and preclinical stage development of medical devices.
- An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers engaged in this domain
- 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.
- A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of service portfolio).
- A detailed geographical clinical trial analysis of ongoing and planned studies related to medical devices.
- A detailed analysis of the mergers and acquisitions that have taken place in this domain during the period 2015-2020.
- 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.
- 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.
A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)
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Phase of Development
Types of Preclinical Services Offered
- Biocompatibility testing
- Sterility and microbiology testing
- Material characterization and analytical services
Types of Clinical Services Offered
- Clinical trial management
- Data management
- Regulatory affairs management
- 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
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Key Geographical Regions
- North America
- Rest of the World
Transcripts of interviews held with the following senior level representatives of stakeholder companies
- 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)
Key companies covered in the report
- Avania (formerly known as Factory CRO)
- Charles River Laboratories
- CSSi LifeSciences™
- Eurofins Medical Device Testing
- IMARC Research
- Qserve Group
- Regulatory and Clinical Research Institute (now a part of Covance)
- WuXi AppTec
Chapter 2 provides an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the medical device CROs market and its likely evolution in the short-mid term and long term.
Chapter 3 provides a brief introduction to medical devices, highlighting key historical and development milestones, and classification of such devices. It also provides a general overview of the concept of CROs, featuring a discussion on the historical evolution of contract research services market in the medical device domain. Further, the chapter presents details related to the various types of CROs that operate within the medical device market and the different types of services they usually offer. It further lists the advantages as well as challenges associated with outsourcing medical device research and clinical operations to contract service providers, along with the key parameters that need to be considered while selecting a CRO partner.
Chapter 4 provides 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).
Chapter 5 features a discussion on the various guidelines established by major regulatory bodies for medical device approvals 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.