Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030

Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030

  • November 2019 •
  • 551 pages •
  • Report ID: 5836967 •
  • Format: PDF
INTRODUCTION
According to the World Bank, more than 50,000 different types of medical devices are currently being used on a daily basis in healthcare facilities across the globe. In 2018, the global medical devices market was estimated to have reached a net worth of approximately USD 450 billion. It is also worth noting that, since in the same year, the USFDA approved over 130 medical devices., However, a relatively large proportion of developers lack the resources and technical expertise required to handle regulatory filings and effectively manage the processes associated with procuring marketing authorizations from regional regulators. Moreover, keeping up with evolving regulatory guidelines, rising costs of legal advice and increasing effort required for preparing of technical documentation, is difficult for companies with limited finances. In addition, establishing reimbursement strategies for medium to high-risk devices is also a complicated process and innovator companies usually do not have the expertise to deal with payers and insurance providers. According to a recent report, 68% of medical device companies reports prepared and submitted by in-house players are either rejected or were reported to have multiple major gaps in their clinical evaluation report (CER) and supporting evidences by the notified bodies. In fact. in a survey published in the 2016 edition of Global Medical Device Supply Chain, regulatory requirements were highlighted among the primary areas of concern within the medical device value chain. Furthermore, 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 many medical device developers, especially the smaller players and certain established companies as well, to outsource parts of their regulatory operations to capable contract research organizations (CROs). Generally, CROs are known to offer a number of benefits, which include cost benefits, reductions in time-to-market and, in this specific case, an in-depth and up-to date regulatory support. Given that the global demand for medical devices is increasing at a substantial pace, the opportunity for CROs with expertise in regulatory affairs management is also on the rise. In the foreseen future, the growing complexity of regulatory processes across various developing and developed geographies is likely to prompt more developers to outsource various aspects of their dealings with regulatory authorities. Moreover, in order to cope up with latest changes in medical device-related regulations, several legacy CROs are re-evaluating their operational models and business strategies. Owing to the anticipated rise in demand for such services, the contract regulatory services domain is likely to witness the entry of a number of new players in the foreseen future.

SCOPE OF THE REPORT
The ‘Contract Regulatory Affairs Management Market for Medical Devices, 2019-2030’ report features a detailed study on the current landscape of contract service providers focused on regulatory affairs management for medical devices. The study features an in-depth analysis, highlighting the capabilities of the various CROs engaged in this domain, across different regions of the globe. Amongst other elements, the report includes:
• A detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a list of over 400 CROs engaged in this domain, and detailed analysis based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap analysis, technical dossier set-up, vigilance & medical device report, risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training)), region(s) of operation wherein the company is offering regulatory management services, and popular therapeutic area(s).
• A detailed discussion on the need for regulatory review / oversight across different stages of the medical devices supply chain, with emphasis on the optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).
• 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), 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 popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific). Each profile features a brief overview of the company, including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed 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.
• An elaborate discussion on the various outsourcing business models adopted for regulatory affairs management, along with an insightful Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.
• An analysis highlighting the key performance indicators used by sponsor companies to evaluate service providers that are active in the domain, based on information gathered via secondary research (for top-ten medical device players) and primary research.
• A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing regulatory affairs management services to medical device developers.

One of the key objectives of this report was to evaluate the current opportunity and the future potential of the medical device regulatory affairs outsourcing 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 2019-2030. In addition, we have provided the likely distribution of the opportunity across different [A] types of regulatory affair management service offered (legal representation, project registration and clinical trial application, regulatory writing and publishing and 6+ categories) [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the growth of the medical device regulatory affairs outsourcing 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 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 industry stakeholders (in alphabetical order of company name):
• Tania Persson, Business Development Manager, A+ Science
• Alexa Foltin-Mertgen, Business Development Manager, AtoZ-CRO
• Troy Mccall, Chief Operating Officer, CROMSOURCE
• Christian Wolflehner, Managing Director, Clinical Trial Specialist, CW Research & Management
• Antal Solyom, Director, Medical Device Unit, HungaroTrial
• Nazish Urooj, Senior manager, Medical & Clinical Operations, Metrics Research
• C Omprakash, Technical Director and Partner, Vyomus Consulting

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. 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 regulatory affairs management CROs market and its likely evolution in the short-midterm and long term.

Chapter 3 is a general overview of the various types of CROs that offer services to the medical devices industry. It provides a brief introduction to the concept of CROs, featuring a discussion on the historical evolution of contract research services market in this domain. Further, it elaborates on the need for outsourcing in this domain, along with the various partnership models that have been adopted by CROs and medical device developers. In addition, the chapter highlights key points that developer companies need to consider for selecting a suitable contract research services provider for regulatory management services. It also features a detailed list of regulatory management services offered by contemporary CROs, along with a discussion on the various challenges within the market.

Chapter 4 includes a detailed discussion on the need of regulatory review / oversight across different stages of the medical device supply chain. It also emphasizes on the various factors that are likely to impact the performance of the medical device supply chain, along with strategies that are likely to assist in improving visibility in the supply chain. Subsequently, the chapter provides information on optimization of the supply chain using upcoming tools / technologies (such as artificial intelligence, big data analytical, blockchain, internet of things and others).

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), 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 provides a detailed review of the current market landscape of the medical devices regulatory affairs outsourcing market, featuring a comprehensive list of over 400 CROs engaged in this domain. In addition, it features an in-depth analysis of the market, based on a number of relevant parameters, such as year of establishment, size of employee base, geographical location, device class (class I, class II, and class III), type and size of clientele (medical device developers, medical device manufacturers, medical device research organizations, and others), types of services offered, ([A] regulatory management services (such as legal representation, notified body selection, project registration and clinical trial application, regulatory writing and publishing, regulatory document submission, product labelling related service, gap analysis, technical dossier set-up, vigilance & medical device report risk management-related services), [B] additional services (such as biostatistics, consulting, clinical operations, post-marketing activities, quality assurance, reimbursement, training), region(s) of operation wherein the company is offering regulatory management services, and popular therapeutic area(s).

Chapter 7 features detailed profiles of popular players that specialize in offering end-to-end regulatory services for medical devices across key geographies (North America, Europe and Asia-Pacific), featuring a brief overview of the company including information on company headquarters, year of establishment, number of employees, and therapeutic area expertise, financial information (if available), detailed description of service portfolio, and an informed future outlook.

Chapter 8 presents a benchmark analysis of the various players engaged in this domain. It highlights the focus areas 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 9 features an elaborate discussion on the various outsourcing business models adopted for regulatory affairs management in this domain, along with an informative Harvey ball analysis of key considerations that need to be assessed by industry stakeholders while selecting a CRO partner.

Chapter 10 features an analysis on the key performance indicators used by sponsor companies to evaluate service providers that are active 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 11 presents a likely evolution of the market in the short to mid-term and long term (2019-2030). In addition, we have provided the likely distribution of the opportunity across different [A] types of regulatory affair management services offered (legal representation, project registration and clinical trial application, regulatory writing and publishing and 6+ categories) [B] device class (class I, class II and class III), [C] therapeutic areas (cardiovascular disorders, central nervous system (CNS) disorders, metabolic disorders, oncological disorders, orthopedic disorders, ophthalmic disorders, pain disorders, respiratory disorders, and others), and [D] geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 12 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the medical device regulatory affairs outsourcing market, based on the research and analysis described in the previous chapters.

Chapter 13 presents insights from the survey conducted for this study. We invited over 300 stakeholders that provide regulatory affairs management services to medical device developers / manufacturers. The participants, who were primarily CXO level / senior management 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 14 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with (in alphabetical order of company names) Tania Persson (Business Development Manager, A+ Science), Alexa Foltin-Mertgen (Business Development Manager, AtoZ-CRO), Troy Mccall (Chief Operating Officer, CROMSOURCE), Christian Wolflehner (Managing Director, Clinical Trial Specialist, CW Research & Management), Antal Solyom (Director, Medical Device Unit, HungaroTrial), Nazish Urooj (Senior manager, Medical & Clinical Operations, Metrics Research), and C Omprakash (Technical Director and Partner, Vyomus Consulting).
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 provides the list of companies and organizations mentioned in this report.