Shifali Gupta, the principal analyst, stated, "Given the complex R&D protocols and the increasing demand for clinical evidence of therapeutic benefit, the opportunity for contract research providers in the medical devices domain is on the rise. Since 2000, close to 130 new CROs have been established, offering a variety of cost-efficient services and solutions to medical device developers."
The report presents opinions on several key aspects of the market. Among other elements, it includes:
- An overview of the current market landscape, featuring a comprehensive list of over 300 active medical device CROs with detailed analysis based on a number of parameters, such as geographical location, year of establishment, company size, scale of operation (clinical and preclinical), types of services provided by [A] clinical service providers (biostatistics, consulting, clinical operations, post marketing surveillance / studies, quality assurance, regulatory affairs management, reimbursement, resourcing 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 (biostatistics, consulting, data management, pharmacovigilance, quality assurance, and regulatory affairs management), and popular therapeutic areas. Most contemporary CROs (82%) are based in North America and Europe. However, a relatively growing proportion of such players are situated in the Asia Pacific region, catering to the needs of emerging economies, such as China and India.
- A benchmarking analysis, highlighting the key focus areas of small-sized, mid-sized and large companies, comparing their existing capabilities within and beyond their respective peer groups, thereby, providing a means for stakeholders to identify ways to gain a competitive edge in the industry. It is worth mentioning that the market landscape is highly fragmented, featuring a mix of small-sized (<50 employees, 58%), mid-sized (50-200 employees, 23%), large (200-1,000 employees, 14%) and very large companies (>1,000 employees, 5%). Examples of established players (having more than 1,000 employees) include Charles River Laboratories, Chiltern, CMIC Group, Eurofins Scientific, FMD K&L, ICON, Medpace, NAMSA, Novella Clinical, Pharmaceutical Product Development (PPD), and WuXi AppTec.
- A comprehensive analysis of ongoing and planned clinical studies related to medical devices across various geographies, based on parameters such as number of registered trials, current status of trials, key therapeutic area(s) and disease indication(s), and number of patients enrolled. Presently, there are close to 7,000 registered (ongoing / planned) clinical studies of medical devices, with combined enrolled patient population of more than 3 million. It is worth mentioning that, amongst others, cardiovascular disorders (12%) and oncological disorders (9%) emerged as prominent therapeutic areas being targeted by medical device developers.
- An analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2012 and 2018, across different geographies. It includes an ownership change matrix that provides a summary of the involvement of private and public sector entities in this domain. Recent examples of companies that have been acquired include (in chronological order) Hilbert Paradox (March 2018), MPI Research (April 2018), Fiver Corners (June 2018), Cobridge (September 2018) and DZS Clinical Services (September 2018).
- An insightful survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract research services to medical device developers.
- A review of the various guidelines established by major regulatory bodies for medical device approval, across different countries. It includes an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe.
- A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall medical device CRO industry.
- Comprehensive profiles of popular players that specialize in providing services for both clinical and preclinical stage medical device development. Each profile features an overview of the company, its financial performance (if available), service portfolio details, and a comprehensive future outlook.
- Detailed market forecast highlighting the likely distribution of the current and future opportunity for medical device CROs market across the following segments:
- [A] therapeutic areas (bone disorders, cardiological disorders, dental disorders, metabolic disorders, neurological disorders, bone disorders, ophthalmic disorders, respiratory disorders, wound management, metabolic disorders, respiratory disorders, dental disorders, neurological disorders and others)
- [B] geographical regions (covering North America, Europe, Asia-Pacific and rest of the world)
- [C] type of device (class I, class II and class III)
- [D] phase of development (clinical and preclinical)
- [E] type of services offered (clinical trial management, data management, regulatory affairs management, consulting and others).
It is worth mentioning that contract services for clinical operations management currently captures a relatively higher (73%) share (in terms of revenues generated) in the medical device CROs market. This trend is unlikely to change in the foreseen future. The remaining share is distributed across data management (16%), regulatory (6%) and other types of services, including consulting, quality assurance, reimbursement and post-market surveillance.
- It includes a discussion on the various future opportunities, and prevalent and upcoming trends related to the contract services market for medical devices, which are likely to influence the growth of this domain over the coming years
The report features inputs from a number of eminent industry stakeholders. Gupta remarked, "In recent years, there has been an evident increase in the number of clinical trials being conducted for medical devices, which has led to a greater need for outsourcing clinical stage operations. This provides opportunity for contract service providers to step in and leverage their expertise to help expedite approval timelines." The report also includes detailed transcripts of discussions held with the following experts:
- Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial)
- Alexa Foltin-Mertgen (Business Development Manager, AtoZ- CRO)
- Christian Wolflehner (Managing Director and Clinical Trial Specialist, CW Research & Management)
- Tania Persson (Business Development Manager, A+ Science)
- Troy McCall (Chief Operating Officer, CROMSOURCE)
The research covers detailed profiles and assesses service portfolios of several companies, including (illustrative list, no selection criteria):
- CSSi Lifesciences
- Factory CRO
- IMARC Research
- PAREXEL International
- Promedica International
- Syneos Health
- Regulatory and Clinical Research Institute (RCRI)
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