The global Medical Device Regulatory Affairs market size is expected to be worth around US$ 11.6 billion by 2030, according to a new report by Vision Research Reports.
The global Medical Device Regulatory Affairs market size was valued at US$ 5.5 billion in 2020 and is anticipated to grow at a CAGR of 10.6% during forecast period 2021 to 2030.
Technological advancements in medical devices such as AI/Machine learning, increasing trends of portable and smaller devices, and government regulations are driving the market.
Medical equipment regulation is a vast and rapidly changing field that is often complicated by legal challenges. Even within one regulatory framework, legal terms and their definitions are not always consistent. As technology expands, software, machine learning, and algorithms become an essential component of an increasing number of digital health resources. This presents new challenges as an increasing number of instruments fall under the regulatory framework.
Also, due to COVID-19, the global regulatory landscape is changing for all medical device companies. Exemptions have been granted by countries ranging from China to Australia and beyond. China has intensified the registration of medical protective clothing. Respirators, protective gear, thermometers, and surgical masks are exempt from registration requirements in Singapore.
The regulatory writing and publishing segment dominated the market for medical device regulatory affairs with 36.10% of revenue share in 2020. This is largely attributed to the fact that these services are provided from the early stages of product development to premarket approval, as high-quality documentation is essential for regulatory affairs in order to escape delays in the approval process.
The segment of product registration and clinical trial services is anticipated to witness the fastest growth rate of 30.1% over the forecast period. The clinical trial for a medical device and regulations to manage the studies are very different.
The outsourcing segment dominated the market for medical device regulatory affairs with the largest revenue share of 61.0% in 2020. This is largely attributed to the lack of an in-house regulatory team. Besides, the advantages such as cost and time saving associated with the outsourcing of these services are contributing to the market growth.
Besides, new regulatory challenges, such as medical device regulation and in vitro diagnostic device regulation in Europe, as well as regulatory cybersecurity scrutiny, make market launch and recertification timelines difficult. It is incredibly challenging for businesses to manage regulatory hurdles with unskilled personnel which drives the demand of outsourcing these services.
The therapeutics segment led the market for medical device regulatory affairs and accounted for the largest revenue share of more than 56.0% in 2020. The segment is also projected to witness the fastest CAGR of 9.10% during the forecast period. This may be attributed to the increasing prevalence of various chronic diseases such as cancer, diabetes, cardiovascular diseases, and respiratory disorders that create demand for advanced therapeutic products.
Asia Pacific dominated the medical device regulatory affairs market and accounted for the largest revenue share of 47.1% in 2020. The region is also expected to grow at a significant rate during the forecast period. This is due to the highly evolved regulatory systems in countries like Australia and Japan.Regional regulatory initiatives in Africa, Asia, and the Americas are evolving to promote the harmonization of regulatory requirements across countries, lowering market entry barriers for manufacturers that can lead to lower product prices, encourage manufacturers to register their products in more countries, and contribute to a more sustainable total market for health products.
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Service Provider Outlook
Middle East & Africa
The Medical Device Regulatory Affairs market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.
The report provides size (in terms of volume and value) of Medical Device Regulatory Affairs market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.
This report focuses on the global Medical Device Regulatory Affairs market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Medical Device Regulatory Affairs market development in United States, Europe and China.
It is pertinent to consider that in a volatile global economy, we haven’t just conducted Medical Device Regulatory Affairs market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.
In terms of production side, this report researches the Medical Device Regulatory Affairs capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.
In terms of consumption side, this report focuses on the consumption of Medical Device Regulatory Affairs by regions (countries) and application.
Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Medical Device Regulatory Affairs market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.
With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Medical Device Regulatory Affairs market companies.
Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Medical Device Regulatory Affairs market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.
The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.
Overall, this is an in-depth research report specifically for the Medical Device Regulatory Affairs industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.
Medical Device Regulatory Affairs market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Medical Device Regulatory Affairs market.
Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Medical Device Regulatory Affairs market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.
Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Medical Device Regulatory Affairs market. These factors have benefited the growth of the global market for Medical Device Regulatory Affairs. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.
New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Medical Device Regulatory Affairs. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).
In this study, the years considered to estimate the market size of Medical Device Regulatory Affairs are as follows:
Reasons to Purchase this Report:
- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Market Size Estimation
Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).
The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.
Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.
All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.
Market Breakdown and Data Triangulation
After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.
Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.
The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
The study objectives of this report are:
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