Medical Device CROs Market

NEW YORK, Dec. 5, 2018 /PRNewswire/ -- INTRODUCTION

According to the World Bank, more than 50,000 different types of medical devices are currently being used every day in health care facilities worldwide. In 2018, the global medical devices market is estimated to reach a net worth of approximately USD 450 billion. Further, another study estimated that the number of medical device related trials increased by 63% in the period between 2012 and 2016. However, a relatively larger proportion of device developers lack the required internal resources and technical expertise to conduct in-house clinical trials. Moreover, the costs associated with acquiring the necessary infrastructure / capabilities for such elaborate research initiatives are high; therefore, it is difficult for companies with limited finances to initiate and manage clinical studies by themselves. In addition, the implementation of highly stringent regulatory guidelines, specifically for devices posing medium to high risk to consumers, render them subject to rigorous quality assessments. The aforementioned challenges have led several players in the industry to outsource a significant part of their clinical stage research efforts to capable contract research organizations (CROs).

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In the foreseen future, the growing complexity of clinical trials and demand for reliable evidence on therapeutic benefits offered by various medical devices are likely to prompt more developer companies to outsource various aspects of their operations. The evolving practices have led a number of new players to enter the contract services domain. Moreover, in order to cope up with emerging technologies and the latest research trends, several legacy CROs are also re-evaluating their operational models and business strategies. In addition, the demand for integrated data platforms to manage and analyze vast amount of data, coupled with challenges associated with unstructured datasets and data privacy, has resulted in several collaboration and acquisition agreements between CROs and data management solutions providers. It is also worth highlighting that the industry has witnessed some consolidation in the last five years as smaller players have been acquired in an effort to widen the parent company's geographical reach.

SCOPE OF THE REPORT

The 'Medical Device CROs Market, 2018-2030' report features a comprehensive study on the current landscape of contract research service providers focused on medical devices. The study features an in-depth analysis, highlighting the capabilities of the various stakeholders engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:
• An overview of the current market landscape, featuring a comprehensive list of CROs, and detailed analysis of the research service providers 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.
• An elaborate discussion on the various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful multi-dimensional, heat map analysis, featuring a comparison of the contemporary regulatory scenario in key geographies across the globe.
• 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 future outlook.
• A benchmark 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, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.
• A comprehensive geographical clinical trial analysis of ongoing and planned studies related to medical devices. It provides details related to medical devices being investigated across various geographies, based on the number of registered trials, current status of trials, therapeutic area(s) and disease indication(s), and number of patients enrolled.
• A detailed analysis of the mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2012-2018, along with the geographical distribution of this 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 CRO services to medical device developers.
• 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.
• 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.

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device CROs market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the opportunity across different [A] therapeutic areas (bone disorders, cardiological disorders, dental disorders, metabolic disorders, neurological disorders, ophthalmic disorders, respiratory disorders, wound management 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) and [E] type of services offered (clinical trial management, data management, regulatory affairs management, consulting and others). To account for the uncertainties associated with the growth of the medical device CRO market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary sources. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain.

All actual figures have been sourced and analyzed from publicly available information forums and inputs from primary research. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts' views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the 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 is a general overview of the various types of CROs in the pharmaceutical / medical device market. It provides a brief introduction to the concept of CROs, featuring a discussion on the historical evolution of contract research services market in the medical devices industry. Further, it elaborates on the need for outsourcing in this domain, along with the various partnership models that have been adopted by CROs and sponsors in the medical device industry, highlighting key points that developer companies need to consider for selecting a suitable contract research services provider. The chapter also features an exhaustive list of services offered by contemporary CROs, along with a discussion on the various challenges associated with this market.

Chapter 4 provides a comprehensive overview of the global landscape of medical device CROs. It includes information related to over 300 companies that are actively involved in the medical devices industry. It features an in-depth market review, including regional distribution, analysis by company size, year of establishment, scale of operation, types of services offered by clinical, preclinical and stand-alone service providers, and prominent therapeutic areas.

Chapter 5 features a detailed discussion on various guidelines established by major regulatory bodies for medical device approval, across different countries. The report also features an insightful heat map analysis, featuring a comparison of the contemporary regulatory scenario in key geographies, across the globe.

Chapter 6 features detailed 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 future outlook.

Chapter 7 presents a benchmark analysis of the various players engaged in this domain. It highlights the capabilities of small-sized, mid-sized and large companies in terms of their expertise in medical device services. The analysis allows companies to compare their existing capabilities within and beyond their respective peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.

Chapter 8 presents a comprehensive geographical clinical trial analysis of ongoing and planned studies related to medical devices. For the purpose of this analysis, we looked at the clinical studies that have been initiated since 2013 and analyzed them on the basis of various parameters, such as year of registration, regional distribution, current status of trials, therapeutic area(s) and disease indication(s), and number of patients enrolled across different geographies.

Chapter 9 features a detailed analysis of the mergers and acquisitions that have taken place in this space, highlighting the trend in the number of companies acquired from 2012-2018. The analysis also features an ownership change matrix, providing a summary of the involvement of private and public sector entities in this domain.

Chapter 10 presents insights from the survey conducted for this study. We invited over 200 stakeholders that provide CRO services to medical device developers. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.

Chapter 11 presents a likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the opportunity across different [A] type of therapeutic areas (bone disorders, cardiological disorders, dental disorders, metabolic disorders, neurological disorders, ophthalmic disorders, respiratory disorders, wound management and others), [B] geographical regions (covering North America, Europe, Asia-Pacific and rest of the world), [C] type of device class (class I, class II and class III), [D] phase of development (clinical and preclinical) and [E] type of services offered (clinical trial management, data management, regulatory affairs management, consulting and others).

Chapter 12 provides 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 devices CRO industry.

Chapter 13 presents a discussion on 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. These include (but not limited to) increase in number of connected devices, advancement of data analytics and real-time monitoring solutions, growing need for cloud-based data storage solutions and introduction of real world evidence.

Chapter 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market.

Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 16 is an appendix, which contains a list of companies and organizations mentioned in this report.

EXAMPLE HIGHLIGHTS

1. With more than 300 CROs focused on the development of medical devices, the market landscape is highly fragmented, featuring a mix of small-sized (<50 employees, 58%), mid-sized (50-200 employees, 23%), large-sized (200-1,000 employees, 14%) and very large-sized companies (>1,000 employees, 5%). Examples of established players (more than 1,000 employees, no selection criteria) include Charles River Laboratories, Chiltern, CMIC Group, Eurofins Scientific, FMD K&L, ICON, Medpace, NAMSA, Novella Clinical, PAREXEL International, Pharmaceutical Product Development (PPD), Promedica International, Syneos Health and WuXi AppTec.
2. Most of the aforementioned 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. Examples of companies that have recently (since 2015) entered the domain include (in alphabetical order, no selection criteria) 1MED, AccuLab Life Sciences, Axcent Advanced Analytics, Azelix, BioAgile Therapeutics, CarthoPharma, CTServ, dMed, dn8 collaborate, Dove Quality Solutions, Firma Clinical Research, MedQ Consultants, NOVO Consulting Group, Pepgra, Proxima Research, Remo CRO, RMF Clinical and Scope International.
3. Close to 7,000 clinical studies for medical devices, having enrolled more than three million patients, were registered (ongoing / planned) across different geographies in the last five years alone. It is worth mentioning that, amongst others, cardiovascular disorders (12%) and oncological disorders (9%) have emerged as prominent therapeutic areas being targeted by medical device developers. Within cardiovascular disorders, indications, such as stroke and coronary artery disease, have emerged as prominent conditions, whereas in the case of oncology, breast cancer and lung cancer are presently the most commonly targeted indications.
4. Over 35 mergers and acquisitions have taken place among stakeholders in this domain, during the period 2012-2018. Companies that were recently acquired include (in the chronological order of their acquisition) Hilbert Paradox (March 2018), MPI Research (April 2018), Fiver Corners (June 2018), Cobridge (September 2018) and DZS Clinical Services (September 2018).
5. Driven by the growing technical and regulatory complexities related to medical device development, the demand for contract services providers is anticipated to increase in the coming years. Overall, we expect the market to grow at an annualized rate of 6.3% between 2018 and 2030. Contract services for clinical operations management currently captures a relatively higher (73%) share in the medical device CROs market. This trend is unlikely to change in the foreseen future. The rest of the market is distributed across data management (16%), regulatory (6%) and other types of services, including consulting, quality assurance, reimbursement and post-market surveillance.

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