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Global Medical Device Regulatory Affairs Market to reach USD 8.02 billion by 2027.

Global Medical Device Regulatory Affairs Market Size study, by Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services) Type (Diagnostic, and Therapeutic) Service Provider (Outsource, and In-house) and Regional Forecasts 2021-2027

Product Code: HLSHIT-79137335
Publish Date: 17-07-2021
Page: 200

The Global Medical Device Regulatory Affairs Market is valued approximately USD 4.5 billion in 2020 and is anticipated to grow with a healthy growth rate of more than 8.6% over the forecast period 2021-2027. The global medical device regulatory affairs market is gaining from the changing regulatory landscape and increased need for faster approval processes. The demand for the medical device regulatory affairs is being boosted by the rise of developing industries such as diagnostics and pharmaceuticals. The global market is progressing thanks to favorable government initiatives and the increasing complexity of medical equipment. Manufacturers of medical devices are adopting ways to safeguard their products in response to increased cybersecurity threats and the financial implications of data breaches. When it comes to data transfer to and from the device, the government is supporting these security enhancements to address these dangers and prevent unauthorized access. Market launch and recertification timescales are becoming more challenging due to increased regulatory issues such as medical device regulation and in vitro diagnostic device regulation, as well as regulatory cybersecurity monitoring. Due to the increased need for businesses to address regulatory challenges, the global medical device regulatory affairs market is expanding in demand. For instance, Emergo released 510(k) Builder in February 2020, a new subscription-based software tool that simplifies and streamlines the U.S. drug approval process. The FDA’s submissions for medical device manufacturers allow for quicker market access. 510(k) Builder has comprehensive integration with FDA databases, assisting users in discovering required data such as product codes and predicate devices, as well as automating documentation formatting to FDA standards. Furthermore, expected modifications in the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Devices Regulation (IVDR) from regulators will make meeting market launch and recertification timeframes much more challenging. As a result, the demand for regulatory outsourcing has grown in order to manage and improve current and ongoing regulatory requirements. As a result, the market is expected to grow.

The main regions of Asia Pacific, North America, Europe, Latin America, and the Rest of the World are included in the geographical analysis of the worldwide Medical Device Regulatory Affairs Market. Currently, the Asia Pacific region is predicted to lead the global medical device regulatory affairs market. The government’s initiatives to simplify the regulatory system for foreign investigators, fast approval for innovative products, and simplified procurement restrictions are supporting the global market’s growth. Due to the presence of two main international regulatory bodies in each area, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), North America and Europe are expected to contribute considerably to the development of the global market. More than half of all medical devices are regulated by these authorities, and the US FDA publishes various guidelines for medical device producers to help with the process.

Major market player included in this report are:
Integer Holdings
Intertek Plc
IQVIA Holdings
Promedica International

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed inRoute of Administration about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Type:
By Service:
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Other Services
By Service Provider:
By Region:
North America

Asia Pacific
South Korea
Latin America
Rest of the World

Furthermore, years considered for the study are as follows:

Historical year – 2018, 2019
Base year – 2020
Forecast period – 2021 to 2027

Target Audience of the Global Medical Device Regulatory Affairs Market in Market Study:

Key Consulting Companies & Advisors
Large, medium-sized, and small enterprises
Venture capitalists
Value-Added Resellers (VARs)
Third-party knowledge providers
Investment bankers

Chapter 1. Executive Summary
1.1. Market Snapshot
1.2. Global & Segmental Market Estimates & Forecasts, 2019-2027 (USD Billion)
1.2.1. Medical Device Regulatory Affairs Market, by Region, 2019-2027 (USD Billion)
1.2.2. Medical Device Regulatory Affairs Market, by Type, 2019-2027 (USD Billion)
1.2.3. Medical Device Regulatory Affairs Market, by Service Provider, 2019-2027 (USD Billion)
1.2.4. Medical Device Regulatory Affairs Market, by Services, 2019-2027 (USD Billion)
1.3. Key Trends
1.4. Estimation Methodology
1.5. Research Assumption
Chapter 2. Global Medical Device Regulatory Affairs Market Definition and Scope
2.1. Objective of the Study
2.2. Market Definition & Scope
2.2.1. Scope of the Study
2.2.2. Industry Evolution
2.3. Years Considered for the Study
2.4. Currency Conversion Rates
Chapter 3. Global Medical Device Regulatory Affairs Market Dynamics
3.1. Medical Device Regulatory Affairs Market Impact Analysis (2019-2027)
3.1.1. Market Drivers Changing regulations and policies. Entry of new market players
3.1.2. Market Restraints Issues with monitoring and a lack of consistency.
3.1.3. Market Opportunities New innovations and developments in the areas of property rights, monetization, and techniques.
Chapter 4. Global Medical Device Regulatory Affairs Market Industry Analysis
4.1. Porter’s 5 Force Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.1.6. Futuristic Approach to Porter’s 5 Force Model (2018-2027)
4.2. PEST Analysis
4.2.1. Political
4.2.2. Economical
4.2.3. Social
4.2.4. Technological
4.3. Investment Adoption Model
4.4. Analyst Recommendation & Conclusion
Chapter 5. Global Medical Device Regulatory Affairs Market, by Type
1.1. Market Snapshot
1.2. Global Medical Device Regulatory Affairs Market by Type, Performance – Potential Analysis
1.3. Global Medical Device Regulatory Affairs Market Estimates & Forecasts by Type 2018-2027 (USD Billion)
1.4. Medical Device Regulatory Affairs Market, Sub Segment Analysis
1.4.1. Diagnostic
1.4.2. Therapeutic
Chapter 2. Global Medical Device Regulatory Affairs Market, by Service
2.1. Market Snapshot
2.2. Global Medical Device Regulatory Affairs Market by Service Provider, Performance – Potential Analysis
2.3. Global Medical Device Regulatory Affairs Market Estimates & Forecasts by Service Provider 2018-2027 (USD Billion)
2.4. Medical Device Regulatory Affairs Market, Sub Segment Analysis
2.4.1. Regulatory Consulting
2.4.2. Legal Representation
2.4.3. Regulatory Writing & Publishing
2.4.4. Product Registration & Clinical Trial Applications
2.4.5. Other Services
Chapter 3. Global Medical Device Regulatory Affairs Market, by Service Provider
3.1. Market Snapshot
3.2. Global Medical Device Regulatory Affairs Market by Services, Performance – Potential Analysis
3.3. Global Medical Device Regulatory Affairs Market Estimates & Forecasts by Services 2018-2027 (USD Billion)
3.4. Medical Device Regulatory Affairs Market, Sub Segment Analysis
3.4.1. Outsource
3.4.2. In-house
Chapter 4. Global Medical Device Regulatory Affairs Market, Regional Analysis
4.1. Medical Device Regulatory Affairs Market, Regional Market Snapshot
4.2. North America Medical Device Regulatory Affairs Market
4.2.1. U.S. Medical Device Regulatory Affairs Market Type breakdown estimates & forecasts, 2018-2027 Service Provider breakdown estimates & forecasts, 2018-2027 Services breakdown estimates & forecasts, 2018-2027
4.2.2. Canada Medical Device Regulatory Affairs Market
4.3. Europe Medical Device Regulatory Affairs Market Snapshot
4.3.1. U.K. Medical Device Regulatory Affairs Market
4.3.2. Germany Medical Device Regulatory Affairs Market
4.3.3. France Medical Device Regulatory Affairs Market
4.3.4. Spain Medical Device Regulatory Affairs Market
4.3.5. Italy Medical Device Regulatory Affairs Market
4.3.6. Rest of Europe Medical Device Regulatory Affairs Market
4.4. Asia-Pacific Medical Device Regulatory Affairs Market Snapshot
4.4.1. China Medical Device Regulatory Affairs Market
4.4.2. India Medical Device Regulatory Affairs Market
4.4.3. Japan Medical Device Regulatory Affairs Market
4.4.4. Australia Medical Device Regulatory Affairs Market
4.4.5. South Korea Medical Device Regulatory Affairs Market
4.4.6. Rest of Asia Pacific Medical Device Regulatory Affairs Market
4.5. Latin America Medical Device Regulatory Affairs Market Snapshot
4.5.1. Brazil Medical Device Regulatory Affairs Market
4.5.2. Mexico Medical Device Regulatory Affairs Market
4.6. Rest of The World Medical Device Regulatory Affairs Market

Chapter 5. Competitive Intelligence
5.1. Top Market Strategies
5.2. Company Profiles
5.2.1. Integer Plc Key Information Overview Financial (Subject to Data Availability) Product Summary Recent Developments
5.2.2. ICON Plc
5.2.3. SGS SA
5.2.4. Emergo
5.2.5. Intertek Plc
5.2.6. Covance
5.2.7. IQVIA Holdings
5.2.8. Freyr
5.2.9. Medpace
5.2.10. Promedica International
Chapter 6. Research Process
6.1. Research Process
6.1.1. Data Mining
6.1.2. Analysis
6.1.3. Market Estimation
6.1.4. Validation
6.1.5. Publishing
6.2. Research Attributes
6.3. Research Assumption

At Bizwit Research and Consultancy, we employ a thorough and iterative research methodology with the goal of minimizing discrepancies, ensuring the provision of highly accurate estimates and predictions over the forecast period. Our approach involves a combination of bottom-up and top-down strategies to effectively segment and estimate quantitative aspects of the market, utilizing our proprietary data & AI tools. Our Proprietary Tools allow us for the creation of customized models specific to the research objectives. This enables us to develop tailored statistical models and forecasting algorithms to estimate market trends, future growth, or consumer behavior. The customization enhances the accuracy and relevance of the research findings.
We are dedicated to clearly communicating the purpose and objectives of each research project in the final deliverables. Our process begins by identifying the specific problem or challenge our client wishes to address, and from there, we establish precise research questions that need to be answered. To gain a comprehensive understanding of the subject matter and identify the most relevant trends and best practices, we conduct an extensive review of existing literature, industry reports, case studies, and pertinent academic research.
Critical elements of methodology employed for all our studies include:
Data Collection:
To determine the appropriate methods of data collection based on the research objectives, we consider both primary and secondary sources. Primary data collection involves gathering information directly from various industry experts in core and related fields, original equipment manufacturers (OEMs), vendors, suppliers, technology developers, alliances, and organizations. These sources encompass all segments of the value chain within the specific industry. Through in-depth interviews, we engage with key industry participants, subject-matter experts, C-level executives of major market players, industry consultants, and other relevant experts. This allows us to obtain and validate critical qualitative and quantitative information while evaluating market prospects. AI and Big Data are instrumental in our primary research, providing us with powerful tools to collect, analyze, and derive insights from data efficiently. These technologies contribute to the advancement of research methodologies, enabling us to make data-driven decisions and uncover valuable findings.
In addition to primary sources, we extensively utilize secondary sources to enhance our research. These include directories, databases, journals focusing on related industries, company newsletters, and information portals such as Bloomberg, D&B Hoovers, and Factiva. These secondary sources enable us to identify and gather valuable information for our comprehensive, technical, market-oriented, and commercial study of the market. Additionally, we utilize AI algorithms to automate the collection of vast amounts of data from various sources such as surveys, social media platforms, online transactions, and web scraping. And employ Big Data technologies for storage and processing of large datasets, ensuring that no valuable information is missed during the data collection process.
Data Analysis:
Our team of experts carefully examine the gathered data using suitable statistical techniques and qualitative analysis methods. For quantitative analysis, we employ descriptive statistics, regression analysis, and other advanced statistical methods, depending on the characteristics of the data. This analysis may also incorporate the utilization of AI tools and big data analysis techniques to extract meaningful insights.
To ensure the accuracy and reliability of our findings, we extensively leverage data science techniques, which help us minimize discrepancies and uncertainties in our analysis. We employ Data Science to clean and preprocess the data, ensuring its quality and reliability. This involves handling missing data, removing outliers, standardizing variables, and transforming data into suitable formats for analysis. The application of data science techniques enhances our accuracy, efficiency, and depth of analysis, enabling us to stay competitive in dynamic market environments.
Market Size Estimation:
Our proprietary data tools play a crucial role in deriving our market estimates and forecasts. Each study involves the creation of a unique and customized model. The model incorporates the gathered information on market dynamics, technology landscape, application development, and pricing trends. AI techniques, such as machine learning and deep learning, aid us to analyze patterns within the data to identify correlations, trends, and relationships. By recognizing patterns in consumer behavior, purchasing habits, or market dynamics, our AI algorithms aid us in more precise estimations of market size. These factors are simultaneously analyzed within the model, allowing for a comprehensive assessment. To quantify their impact over the forecast period, correlation, regression, and time series analysis are employed.
To estimate and validate the market size, we employ both top-down and bottom-up approaches. The preference is given to a bottom-up approach, where key regional markets are analyzed as separate entities. This data is then integrated to obtain global estimates. This approach is crucial as it provides a deep understanding of the industry and helps minimize errors.
In our forecasting process, we consider various parameters such as economic tools, technological analysis, industry experience, and domain expertise. By taking all these factors into account, we strive to produce accurate and reliable market forecasts. When forecasting, we take into consideration several parameters, which include:
Market driving trends and favorable economic conditions
Restraints and challenges that are expected to be encountered during the forecast period.
Anticipated opportunities for growth and development
Technological advancements and projected developments in the market
Consumer spending trends and dynamics
Shifts in consumer preferences and behaviors.
The current state of raw materials and trends in supply versus pricing
Regulatory landscape and expected changes or developments.
The existing capacity in the market and any expected additions or expansions up to the end of the forecast period.
To assess the market impact of these parameters, we assign weights to each one and utilize weighted average analysis. This process allows us to quantify their influence on the market and derive an expected growth rate for the forecasted period. By considering these various factors and applying a weighted analysis approach, we strive to provide accurate and reliable market forecasts.
Insight Generation & Report Presentation:
After conducting the research, our experts analyze the findings in relation to the research objectives and the specific needs of the client. They generate valuable insights and recommendations that directly address the client’s business challenges. These insights are carefully connected to the research findings to provide a comprehensive understanding.
Next, we create a well-structured research report that effectively communicates the research findings, insights, and recommendations to the client. To enhance clarity and comprehension, we utilize visual aids such as charts, graphs, and tables. These visual elements are employed to present the data in an engaging and easily understandable format, ensuring that the information is accessible and visually appealing to the client. Our aim is to deliver a clear and concise report that conveys the research findings effectively and provides actionable recommendations to meet the client’s specific needs.

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