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Global Regulatory Affairs Market to reach USD 20.75 Billion by 2027.

Global Regulatory Affairs Market Size study, by Service (Regulatory consulting, Legal representation, Regulatory writing & publishing, Product registration & clinical trial applications, Other services), by Category (Drugs, Biologics, Medical Devices), by Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications), by product stage (Preclinical, Clinical, PMA), by end use (Medical Device Companies, Biotechnology Companies, Pharmaceutical Companies), by company size(Small, Medium and Large) and Regional Forecasts 2021-2027

Product Code: HLSMDE-46932825
Publish Date: 12-10-2021
Page: 200

Global Regulatory Affairs Market is valued approximately at USD 11.8 Billion in 2020 and is anticipated to grow with a healthy growth rate of more than 8.4% over the forecast period 2021-2027. Regulatory Affairs (RA) is also known as Government Affairs, it is a profession within regulation industries, such as pharmaceuticals, energy, medical devices, and banking. The global Regulatory Affairs market is being driven by demand for faster approval process for breakthrough drugs and devices, growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs. Furthermore, life science companies focusing on their core competencies and economic and competitive pressures, will provide new opportunities for the global Regulatory Affairs industry. For instance, according to Steve Gens Report published 2018, nearly around 58% of pharma companies covered under survey had planned to enhance the Regulatory Intelligence (RI) capability of their companies, while another study states that about 20 out of 22 participating companies had considered AI for RI data as a leveraging processing activities. As a result, increased in adoption of AI and RI by the companies, will serve as a catalyst for the Regulatory Affairs industry in the future. However, risk associated with data security and monitoring issues and lack of standardization, may impede market growth over the forecast period of 2021-2027.

Asia Pacific, North America, Europe, Latin America, and Rest of the World are the key region considered for the regional analysis of global regulatory affairs. Low cost for outsourcing, presence of skilled workforce along with technical expertise, tax benefits, and the expansion of healthcare companies makes the Asia Pacific the leading region across the world in terms of market share. Whereas Asia Pacific is also anticipated to exhibit the highest growth rate over the forecast period 2021-2027, due to supportive regulatory landscape.
Major market player included in this report are:

Accell Clinical Research, LLC.
GenPact Ltd.
Criterium, Inc.
PRA Health Sciences
Promedica International
WuXi AppTec, Inc.
Charles River Laboratories International, Inc.

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to 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 information 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 Service:
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Other services
By Category:
Medical Devices
By Indication:
Other Indications
By product stage:
by end use
Medical Device Companies
Biotechnology Companies
Pharmaceutical Companies
by company size:

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 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. Regulatory Affairs Market , by Region, 2019-2027 (USD Billion)
1.2.2. Regulatory Affairs Market , by Service, 2019-2027 (USD Billion)
1.2.3. Regulatory Affairs Market , by Category , 2019-2027 (USD Billion)
1.2.4. Regulatory Affairs Market , by Indication, 2019-2027 (USD Billion)
1.2.5. Regulatory Affairs Market , by Product stage, 2019-2027 (USD Billion)
1.2.6. Regulatory Affairs Market , by End Use, 2019-2027 (USD Billion)
1.2.7. Regulatory Affairs Market , by company size, 2019-2027 (USD Billion)
1.3. Key Trends
1.4. Estimation Methodology
1.5. Research Assumption
Chapter 2. Global 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 Regulatory Affairs Market Dynamics
3.1. Regulatory Affairs Market Impact Analysis (2019-2027)
3.1.1. Market Drivers Demand for faster approval process for breakthrough drugs and devices Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
3.1.2. Market Restraint Risk associated with data security Monitoring issues and lack of standardization
3.1.3. Market Opportunities Life science companies focusing on their core competencies Economic and competitive pressures
Chapter 4. Global 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 Regulatory Affairs Market , by Service
5.1. Market Snapshot
5.2. Global Regulatory Affairs Market by Service, Performance – Potential Analysis
5.3. Global Regulatory Affairs Market Estimates & Forecasts by Service 2018-2027 (USD Billion)
5.4. Regulatory Affairs Market , Sub Segment Analysis
5.4.1. Regulatory consulting
5.4.2. Legal representation
5.4.3. Regulatory writing & publishing
5.4.4. Product registration & clinical trial applications
5.4.5. Other services
Chapter 6. Global Regulatory Affairs Market , by Category
a. Market Snapshot
6.1. Global Regulatory Affairs Market by Category, Performance – Potential Analysis
6.2. Global Regulatory Affairs Market Estimates & Forecasts by Category 2018-2027 (USD Billion)
6.3. Regulatory Affairs Market , Sub Segment Analysis
6.3.1. Drugs
6.3.2. Biologics
6.3.3. Medical Devices
Chapter 7. Global Regulatory Affairs Market , by Indication
b. Market Snapshot
7.1. Global Regulatory Affairs Market by Indication, Performance – Potential Analysis
7.2. Global Regulatory Affairs Market Estimates & Forecasts by Indication 2018-2027 (USD Billion)
7.3. Regulatory Affairs Market , Sub Segment Analysis
7.3.1. Oncology
7.3.2. Neurology
7.3.3. Cardiology
7.3.4. Immunology
7.3.5. Other Indications
Chapter 8. Global Regulatory Affairs Market , by Product stage
c. Market Snapshot
8.1. Global Regulatory Affairs Market by Product stage, Performance – Potential Analysis
8.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
8.3. Regulatory Affairs Market , Sub Segment Analysis
8.3.1. Preclinical
8.3.2. Clinical
8.3.3. PMA
Chapter 9. Global Regulatory Affairs Market , by End use
d. Market Snapshot
9.1. Global Regulatory Affairs Market by Product stage, Performance – Potential Analysis
9.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
9.3. Regulatory Affairs Market , Sub Segment Analysis
9.3.1. Medical Device Companies
9.3.2. Biotechnology Companies
9.3.3. Pharmaceutical Companies
Chapter 10. Global Regulatory Affairs Market , by Company size
e. Market Snapshot
10.1. Global Regulatory Affairs Market by Product stage, Performance – Potential Analysis
10.2. Global Regulatory Affairs Market Estimates & Forecasts by product stage 2018-2027 (USD Billion)
10.3. Regulatory Affairs Market , Sub Segment Analysis
10.3.1. Small
10.3.2. Medium
10.3.3. Large
Pharmaceutical Companies
Chapter 11. Global Regulatory Affairs Market , Regional Analysis
11.1. Regulatory Affairs Market , Regional Market Snapshot
11.2. North America Regulatory Affairs Market
11.2.1. U.S. Regulatory Affairs Market Service breakdown estimates & forecasts, 2018-2027 Category breakdown estimates & forecasts, 2018-2027 Indication breakdown estimates & forecasts, 2018-2027 Product stage breakdown estimates & forecasts, 2018-2027 (USD Billion) End Use breakdown estimates & forecasts, 2018-2027 (USD Billion) Company Size breakdown estimates & forecasts, 2018-2027 (USD Billion)
11.2.2. Canada Regulatory Affairs Market
11.3. Europe Regulatory Affairs Market Snapshot
11.3.1. U.K. Regulatory Affairs Market
11.3.2. Germany Regulatory Affairs Market
11.3.3. France Regulatory Affairs Market
11.3.4. Spain Regulatory Affairs Market
11.3.5. Italy Regulatory Affairs Market
11.3.6. Rest of Europe Regulatory Affairs Market
11.4. Asia-Pacific Regulatory Affairs Market Snapshot
11.4.1. China Regulatory Affairs Market
11.4.2. India Regulatory Affairs Market
11.4.3. Japan Regulatory Affairs Market
11.4.4. Australia Regulatory Affairs Market
11.4.5. South Korea Regulatory Affairs Market
11.4.6. Rest of Asia Pacific Regulatory Affairs Market
11.5. Latin America Regulatory Affairs Market Snapshot
11.5.1. Brazil Regulatory Affairs Market
11.5.2. Mexico Regulatory Affairs Market
11.6. Rest of The World Regulatory Affairs Market
Chapter 12. Competitive Intelligence
12.1. Top Market Strategies
12.2. Company Profiles
12.2.1. Accell Clinical Research, LLC. Key Information Overview Financial (Subject to Data Availability) Product Summary Recent Developments
12.2.2. GenPact Ltd.
12.2.3. Criterium, Inc.
12.2.4. PRA Health Sciences
12.2.5. Promedica International
12.2.6. WuXi AppTec, Inc.
12.2.7. Medpace
12.2.8. Charles River Laboratories International, Inc.
12.2.9. ICON plc
12.2.10. Covance

Chapter 13. Research Process
13.1. Research Process
13.1.1. Data Mining
13.1.2. Analysis
13.1.3. Market Estimation
13.1.4. Validation
13.1.5. Publishing
13.2. Research Attributes
13.3. Research Assumption

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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.
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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.
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