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Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, and Legal Representation), and Geography (NA, EU, APAC, and RoW) – Analysis, Share, Trends, Size, & Forecast From 2014 – 2025

100 Pages | Published Date : 21 / 04 / 18  | Report Code: AV176 | Report Format: PDF

REPORT HIGHLIGHT

The regulatory affairs outsourcing market is estimated to represent a global market of USD 4.88 billion by 2017 with growth rate of 12.3%.

Market Dynamics

Outsourcing is an integral part of any pharmaceutical and biotechnology companies’ value chain during the phase of research and development. A significant rise in clinical studies conducted in emerging economies has fueled the demand for outsourcing activities in regulatory services, providing a healthy platform for this industry growth. Regions such as Asia-Pacific offers a cost-effective environment for conducting drug development studies. For instance, countries such as China and India provide lower costs for clinical trials. Cost for conducting studies in these regions are 25% to 40% lower than that of the U.S. and European countries. Due to these facts, the trend of regulatory outsourcing has taken over the pharma and biotech companies operating in developed regions. In addition, a notable change in regulatory landscape coupled with the globalization of life-science organizations plays an important role in fostering the development of this industry. However, the risk associated with data security coupled with lack of standardization is a major challenge as organizations are outsourcing their clinical activities to offshore regions like the Asia Pacific and Latin America.

Service Takeaway

In terms of services, the market is divided into Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, Legal Representation, and others. In 2017, regulatory writing and publishing segment captured the highest share, USD 1.6 billion during the same year. In addition, product registration segment is considered to show robust growth during the study period. Midsized and small-scale players are approaching clinical research organizations (CROs) for product registration and drug development needs since they do not have an established regulatory affairs department for international markets, driving this segment to great extent.

Regional Takeaway

Asia Pacific region is considered to be the fastest growing, at a 15.2% CAGR versus North America’s 10.8% from 2017 to 2025. This region is accounted for the largest share of the total market as it is well positioned to become a preferred destination for pharmaceutical studies. Attractive traits such as large patient pool, speedy recruitment, high-quality infrastructure and cost-effectiveness support the regional growth significantly. On contrary, North America captured 20.98% share of the overall market. Drug approval procedures are becoming more stringent and time-consuming in this regions. On other side, pharmaceutical industries are aimed to receive product approvals at the first attempt to gain higher shares. Thereby, companies are required to outsource their regulatory affairs in emerging regions which will pull back the growth of this industry in developed regions.

Key Vendor Takeaway

Key players such as Quintiles Transnational, ICON plc, Pharmaceutical Product Development, PAREXEL International, and Covance, Inc. are profiled extensively. Collectively, these players accounted for more than 50% share of the total market revenue. Global players have realized that timely marketing and clinical approvals from government bodies are the key parameters in drug development. Therefore, companies either strengthen their in-house regulatory department or outsource this process to the consulting firms. It has been noticed that industries are mainly focusing on their core competencies and outsourcing non-core functions to increase their productivity and operational efficiency, supporting the industry growth.

The market size and forecast for each segment and sub-segments has been considered as below:

  • Historical Year – 2014 & 2016
  • Base Year – 2017
  • Estimated Year – 2018
  • Projected Year – 2025

TARGET AUDIENCE

  • Traders, Distributors, and Suppliers
  • Manufacturers
  • Hospitals
  • Government and Regional Agencies and Research Organizations
  • Consultants
  • Distributors

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

MARKET, BY SERVICE

  • Regulatory Writing & Publishing
  • Regulatory Consulting
  • Clinical Trial & Product Registration
  • Legal Representation
  • Others

MARKET, BY REGION

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • Rest of Europe
  • Asia Pacific
    • India
    • China
    • Rest of APAC
  • Rest of the World
    • Middle East and Africa
    • Latin America

TABLE OF CONTENT

1. REGULATORY AFFAIRS OUTSOURCING MARKET OVERVIEW
1.1. Study Scope
1.2. Assumption and Methodology
2. EXECUTIVE SUMMARY
2.1. Key Market Facts
2.2. Geographical Scenario
2.3. Companies in the Market
3. REGULATORY AFFAIRS OUTSOURCING KEY MARKET TRENDS
3.1. Market Drivers
3.1.1. Impact Analysis of Market Drivers
3.2. Market Restraints
3.2.1. Impact Analysis of Market Restraints
3.3. Market Opportunities
3.4. Market Future Trends
4. REGULATORY AFFAIRS OUTSOURCING INDUSTRY STUDY
4.1. Porter’s Analysis
4.2. Market Attractiveness Analysis
4.3. Regulatory Framework Analysis
5. REGULATORY AFFAIRS OUTSOURCING MARKET LANDSCAPE
5.1. Market Share Analysis
6. REGULATORY AFFAIRS OUTSOURCING MARKET – BY SERVICE
6.1. Overview
6.2. Regulatory Writing & Publishing
6.2.1. Overview
6.2.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.3. Regulatory Consulting
6.3.1. Overview
6.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.4. Clinical Trial & Product Registration
6.4.1. Overview
6.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.5. Legal Representation
6.5.1. Overview
6.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
6.6. Others
6.6.1. Overview
6.6.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7. REGULATORY AFFAIRS OUTSOURCING MARKET– BY GEOGRAPHY
7.1. Introduction
7.2. North America
7.2.1. Overview
7.2.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.2.3. U.S.
7.2.3.1. Overview
7.2.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.2.4. Canada
7.2.4.1. Overview
7.2.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3. Europe
7.3.1. Overview
7.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3.3. France
7.3.3.1. Overview
7.3.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3.4. Germany
7.3.4.1. Overview
7.3.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.3.5. Rest of Europe
7.3.5.1. Overview
7.3.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4. Asia Pacific (APAC)
7.4.1. Overview
7.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4.3. China
7.4.3.1. Overview
7.4.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4.4. India
7.4.4.1. Overview
7.4.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.4.5. Rest of APAC
7.4.5.1. Overview
7.4.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.5. Rest of the World
7.5.1. Overview
7.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.5.3. Latin America
7.5.3.1. Overview
7.5.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
7.5.4. Middle East and Africa
7.5.4.1. Overview
7.5.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
8. KEY VENDOR ANALYSIS
8.1. Quintiles Transnational
8.1.1. Company Overview
8.1.2. SWOT Analysis
8.1.3. Key Developments
8.2. ICON plc
8.2.1. Company Overview
8.2.2. SWOT Analysis
8.2.3. Key Developments
8.3. Pharmaceutical Product Development
8.3.1. Company Overview
8.3.2. SWOT Analysis
8.3.3. Key Developments
8.4. PAREXEL International
8.4.1. Company Overview
8.4.2. SWOT Analysis
8.4.3. Key Developments
8.5. Covance, Inc.
8.5.1. Company Overview
8.5.2. SWOT Analysis
8.5.3. Key Developments
*Client can request additional company profiling as per specific requirements
9. 360 DEGREE ANALYSTVIEW
10. APPENDIX
10.1. Research Methodology
10.2. Abbreviations
10.3. Disclaimer
10.4. Contact Us

List of Tables
Table 1 List of Acronyms
Table 2 Key Market Facts, 2014 – 2025
Table 3 Market Drivers: Impact Analysis
Table 4 Market Restraint: Impact Analysis
Table 5 Market Opportunity: Impact Analysis
Table 6 PEST Analysis
Table 7 Porter’s Five Forces Analysis
Table 8 Company Market Share Analysis
Table 9 Global Regulatory Affairs Outsourcing Market Analysis, Forecast, and Y-O-Y Growth Rate, 2014 – 2025, (US$ Billion)
Table 10 Regulatory Affairs Outsourcing Market, by Service, 2014 – 2025 (USD Billion)
Table 11 Regulatory Affairs Outsourcing Market, by Geography, 2014 – 2025 (USD Billion)
Table 12 North America Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 13 U.S. Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 14 Canada Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 15 Europe Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 16 France Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 17 Germany Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 18 Asia Pacific Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 19 China Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 20 India Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 21 Latin America Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)
Table 22 MEA Regulatory Affairs Outsourcing Market, 2014 – 2025 (USD Billion)

List of Figures
Figure 1 Research Methodology
Figure 2 Research Process Flow Chart
Figure 3 Comparative Analysis, by Geography, 2016-2025 (Value %)
Figure 4 Regulatory Framework Analysis
Figure 5 Regulatory Affairs Outsourcing Market, by Service, 2014 – 2025 (USD Billion)
Figure 6 Regulatory Affairs Outsourcing Market, by Geography, 2014 – 2025 (USD Billion)

SCOPE AND OBJECTIVES
The objective of this report is to describe the market trends and revenue forecasts for the market for the upcoming years. The report focuses on defining and describing the key influencing factors for the growth of the market. It also offers an in-depth analysis of the market size (revenue), market share, major market segments, different geographic regions, key market players, and premium industry trends.
The report tracks the major market events including product launches, technological developments, mergers & acquisitions, and the innovative business strategies opted by key market players. Along with strategically analysing the key micro markets, the report also focuses on industry-specific drivers, restraints, opportunities and challenges in the market. The scope of this report covers the market by its major segments.

KEY BENEFITS OF THE REPORT
• In-depth analysis of the key market dynamics
• Granular analysis of the current market scenario and expected factors to affect the market
• Detailed analysis of the geographic region, regional and county wise analysis
• Highlight on the strategies that are being adopted by the key players in this market to stay competitive
• Extensive analysis of the key players dominating the market

RESEARCH METHODOLOGY

Research methodology is developed on a combination of specialist industry analyst knowledge and in-country research experience. We employ data interrogation methodologies to generate new and meaningful analyses and insights. The research study includes extensive use of secondary sources, paid databases (such as Bloomberg, Dun & Bradstreet, and BusinessWeek) and directories, to identify and collect information, useful to understand technical, commercial and market-oriented aspects. Market data and information are also collected (but not limited to) from the secondary sources such as:

  • Official company’s website, financial and annual reporting
  • Government statistical data
  • Online publishing articles
  • Industry player’s investor presentations
  • Economic news articles
  • National and international trade associations
  • The financial, business, and mainstream press
  • Industry study groups and semiofficial sources
  • Informative channels related to the market topics

* Gathering data through secondary sources is only the first step. The ability to cross-refer market data through available secondary            information often conflicting across multiple sources is a key aspect of the added value we provide

In order to verify and validate secondary market data, we engage with the Key Opinion Leaders (KoL’s), operating in the respective markets, through phone calls, emails, and web-based survey responses. This platform help us validate our data in terms of accuracy and gain insight into the current market and future expectations. Furthermore, the obtained information guide us to understand several facets of the market with respect to manufacturers and buyers’ perspectives.

In addition, to assign weights to all the relevant market dynamics and parameters and quantify their market impact for generating projected market growth rate, we used advanced machine learning algorithms in order to collate essential market data. The machine learning method utilizes algorithms such as regression, correlation, and decision tree, among others, to derive the desired output. This tool help us in deriving highly detailed forecasts, profound knowledge of product demand, and others.

These collected data points are carefully filtered, analyzed, compared, and presented in an easy way to develop accurate research study. Furthermore, all collected data is subjected to undergo exhaustive review process at country level, regional level, and global level.

Market Forecast

Market forecast is primarily based on the year-on-year (YOY) growth rate. Data projection and future performance of each segment is analyzed based on the key aspects extracted from primary and secondary research results. Thus, data projection exhibits the assumption on how the market performs under microeconomic and macroeconomic parameters. Our market forecasting technique represents strategic conclusions which can play a crucial role for our client’s in making strategic marketing plans.

For forecasting, the following parameters were considered:

  • Market drivers and restraints along with their current and expected impacts
  • Technological scenario and expected developments
  • Trends in the consumer behaviors
  • End-user industry trends

We have assigned weights to above-mentioned parameters and quantified their market impacts using the weighted average analysis, to derive an expected market growth rate.

Market Analysis

Once the information is collected, and the forecasts are determined, we provide a clear written analysis of the market conditions. This includes detailed information on market segments regarding market drivers, market restraints, and market opportunities. These offer insights on different channel dynamics, brand preference, incidence/prevalence data, consumption trend, and technology upgradations.

We also include supporting data from relevant awareness campaigns, new introductions, regulatory norms, government initiatives, and an industry player’s expansion in specific product segments. From a research perspective, this information explains and substantiates estimated data finding and forecast which helps us to improve the accuracy of the final report. This helps our clients to make better business decisions as they possess all the market information they require.

Assumptions

  • The report provides the market in terms of USD million/billion at regional as well as country level
  • We have implemented a mixture of top-down and bottom-up approach to estimate the total market and market for an individual segment
  • We reviewed various publications from government and non-government organizations, analyst perspectives for different regions from the paid databases available to us
  • This data helped us extract historical data and market scenario for various countries
  • The total population of respective countries, end users, product demand, local presence of key players, and cost are considered to analyze market revenue
  • Fundamental industry dynamics, demand-supply ratio, and upcoming technological trends are considered for the forecast period.
  • Growth rates are estimated using correlation, regression, and time-series analysis
  • All market estimates and forecasts have been validated through exhaustive primary research with key industry participants and analyst perspectives

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