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Presently, several medical devices are being investigated in clinical trials for variety of indications across the globe that are likely to get market approval in near future. In order to facilitate the approval in different geographies, there seems to be enhanced business opportunities for companies offering required services in this domain.
-- Business Development Manager, a Hungary based Mid-sized company
The regulatory affairs management for medical devices market is estimated to be worth $326 million in 2019 and is expected to grow at CAGR of 6.92% during the forecast period. 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.
Examples of key companies engaged in regulatory affairs management for medical devices market (which have also been profiled in this market report; the complete list of companies is available in the full report) include CTI Clinical Trial and Consulting (CTI), Medpace, NAMSA, PAREXEL, Premier Research, Underwriters Laboratory (UL), CROMSOURCE, ICON, Intertek, PharmaLex, SteriPack and MIC Medical. This market report includes an easily searchable excel database of all the companies providing regulatory affairs management for medical devices, worldwide.
The ‘Regulatory Affairs Management for Medical Devices Market, 2019-2030’ market report features a detailed study on the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the regulatory affairs management for medical devices market. The market research report features an in-depth analysis, highlighting the capabilities of the various CROs engaged in regulatory affairs management for medical devices market, across different regions of the globe.
Amongst other elements, the market research report includes:
The key objective of regulatory affairs management for medical devices market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for regulatory affairs management for medical devices market during the forecast period. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the forecast 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 market forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.
The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcripts of interviews held with the following industry stakeholders (in alphabetical order of company name):
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market research report are in USD, unless otherwise specified.