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Medical Device CROs Market (2nd Edition), 2020 - 2030

Medical Device CROs Market (2nd Edition), 2020 - 2030

  • April 2020
  • 405 pages
  • ID: 5915357
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
According to the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), at present, there are close to 175,000 types of medical devices available in the US. In fact, since 2019, the USFDA has approved close to 55 medical devices. Further, over 7,000 medical device focused clinical trials have been registered worldwide. In this context, our estimates suggest that total revenues from global sales of medical devices is likely to be around USD 450 billion in 2020. The medical devices market currently represents a large segment of the healthcare industry and is projected to continue to grow over the coming years. However, only a limited proportion of device developers claim to have the necessary resources and technical expertise to develop and conduct clinical research, in-house. This is mostly attributed to the high cost of acquiring the necessary infrastructure / capabilities for such research initiatives, making it difficult for companies with limited finances to undertake and manage elaborate R&D initiatives by themselves. In addition, regulations governing the review (of safety and efficacy) and approval of such devices are gradually becoming more stringent. For instance, the EU’s revised Medical Device Regulation (MDR) have rendered medical devices subject to rigorous quality assessments, necessitating a certain type of expertise and affiliated resources. Although the COVID-19 pandemic has delayed the enforcement of these guidelines to May 2021, device developers still need to establish the necessary means to address this upcoming challenge. In this regard, outsourcing has been shown to offer a number of benefits, including cost savings and expediting time to market. As a result, medical device developers are now increasingly outsourcing significant parts of their respective clinical research efforts and regulatory affairs management to contract research organizations (CROs).

The medical device CRO market is highly fragmented, featuring the presence of well-established players (which contribute to a majority share of the overall revenues), mid-sized firms and a number of new entrants, offering niche expertise. In fact, over 50 medical device focused CROs have been established since 2010. It is worth noting that, in order to cope with modern day challenges, CROs have adopted emerging technologies / operating principles, such as big data analysis, artificial intelligence (AI) and real-world evidence, and are gradually working towards improving their approach to research. For this purpose, many traditional CROs have established strategic business relations with information technology (IT) and data management solutions providers. In addition, this industry has witnessed significant merger and acquisition activity in the last ten years, with several smaller businesses being acquired in efforts to grow the service portfolios / capabilities of more established firms. According to experts, the medical device CRO industry is anticipated to witness a similar growth trajectory as that of the pharmaceutical CRO market, in the coming 5-10 years.

SCOPE OF THE REPORT
The ‘Medical Device CROs Market (2nd Edition), 2020-2030’ 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. Amongst other elements, the report includes:
• 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.

One of the key objectives of this report was to evaluate the existing market size and the future growth potential within the medical device CROs domain. We have provided informed estimates on the likely evolution of the market in the short to mid-term and long term, for the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] different phases of development (clinical and preclinical) [B] types of clinical services offered (clinical trial management, data management, regulatory affairs management, consulting and others) [C] types of preclinical services (biocompatibility testing, sterility and microbiology testing, material characterization and analytical services and others) [D] device class (class I, class II and class III), and [E] target therapeutic area (bone disorders, cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmic disorders, pain management, respiratory disorders, sleeping disorders and others), and [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. In addition, the report discusses the impact of the recent COVID-19 pandemic on the overall medical device industry, along with providing details related to the future market opportunity for medical device CROs.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following stakeholders:
• Lajos Sarosi, Chief Executive Officer and Co-founder, HungaroTrial
• Christian Wolflehner, Managing Director, Clinical Trial Specialist, CW Research & Management
• Troy Mccall, Chief Operating Officer, CROMSOURCE
• Nazish Urooj, Senior manager, Medical & Clinical Operations, Metrics Research
• Alexa Foltin-Mertgen, Business Development Manager, AtoZ-CRO
• Tania Persson, Business Development Manager, A+ Science
• C. Omprakash, Technical Director and Partner, Vyomus Consulting
• Anonymous

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 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 over the coming decade, the report also provides our independent view on various emerging trends 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 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.

Chapter 6 features detailed 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 area, financial details (if available), medical device focused service portfolio, and an informed future outlook.

Chapter 7 features an analysis on 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), as well as credible inputs from primary research.

Chapter 8 presents a competitive benchmarking 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 and providing a means for stakeholders to identify ways to gain a competitive advantage in the industry.

Chapter 9 provides an elaborative brand positioning analysis of the leading industry players (shortlisted on the basis of strength of service portfolio) highlighting the current perceptions regarding their proprietary brands across different device classes.

Chapter 10 presents 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.

Chapter 11 features a detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2015-2020, based on parameters such as year of acquisition, type of acquisition, geographical location of the acquirer and the acquired company, type of company and key value drivers. The analysis also features an ownership change matrix, providing insights on the involvement of private and public sector entities in this domain. Moreover, it presents a schematic world map representation of the geographical distribution of this activity, highlighting inter- and intracontinental deals.

Chapter 12 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, prevalent trends and associated commercial potential of this domain.

Chapter 13 presents a likely evolution of the market in the short to mid-term and long term, for the period 2020-2030. In addition, we have provided the likely distribution of the current and forecasted opportunity across [A] different phases of development (clinical and preclinical) [B] types of clinical services offered (clinical trial management, data management, regulatory affairs management, consulting and others) [C] types of preclinical services (biocompatibility testing, sterility and microbiology testing, material characterization and analytical services and others) [D] device class (class I, class II and class III), and [E] target therapeutic area (bone disorders, cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmic disorders, pain management disorders, respiratory disorders, sleeping disorders and others), and [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 14 highlights the effect of coronavirus outbreak on the global medical device industry. It includes a brief discussion on the short-term and long-term impact of COVID-19 upsurge on the supply chain and market opportunity for CROs. In addition, it includes a brief section on strategies and action plans that medical device companies are likely to adopt in order to prepare for supply chain disruptions in future.

Chapter 15 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 16 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) growth in number of connected devices, adoption of data analytics and real-time monitoring solutions, growing need for cloud-based data storage solutions and introduction of real-world evidence.

Chapter 17 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. In this chapter, we have presented the details of interviews held with Lajos Sarosi (Chief Executive Officer and Co-founder, HungaroTrial), Troy Mccall (Chief Operating Officer, CROMSOURCE), Christian Wolflehner (Managing Director, Clinical Trial Specialist, CW Research & Management), Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research), Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO), Tania Persson (Business Development Manager, A+ Science) and C. Omprakash (Technical Director and Partner, Vyomus Consulting) and Anonymous.

Chapter 18 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix that provides the list of companies and organizations mentioned in the report.

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