Regulatory Affairs Outsourcing Market Revenue & Trend Forecasts Report, 2019-2026

Regulatory Affairs Outsourcing Market by Services (Legal representation, Regulatory writing and publishing, Clinical trial application, Regulatory submission, and Product registrations), By Region (North America, Europe, APAC and Rest of the World)
 

  • Report ID : MD1126
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  • Pages : 198
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  • Tables : 96
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  • Formats :

Regulatory Affairs Outsourcing market revenue shall reach a value of $ 8,213.3 Million in 2026, growing with a CAGR of 9.7% during the forecast period of 2018 to 2026. In terms of volume sales, the market is anticipated to reach XX Units.

The changing environmental conditions contribute to the growth of the market as outsourcing of the regulatory affairs if beneficial to them. Major factors supplementing the market shares are: raising demands of regulatory data management, literature searches, and others. Further, there is a rise in the demand for this technology in the commercial sector as it reduces the operational time, which is responsible for driving the regulatory affairs outsourcing market shares. This service finds wide application in pharmaceutical industries and the increase in the number of various diseases in the Asia Pacific regions are leading to a requirement to adopt this technology. 

Rapid development in the trade of orphan drugs and biosimilar is anticipated to increase the regulatory affairs outsourcing market size during the forecast period. Moreover, strict government rules and regulations to adopt this technology in developing countries are expected to accelerate market growth. FDA has introduced few digital programs for the digital health pre-certification program, and policies for the multi-functional medical devices. The main aim of such programs is to reduce healthcare costs and patient risks which in turn could affect the market for Regulatory Affairs Outsourcing positively.

REGIONAL ANALYSIS

North America and Europe regions are the dominant regions in contributing to the market growth in 2018. The Middle East, Africa and Latin America are anticipated to witness a tremendous increase in its market shares over the forecast period owing to the rising awareness among the consumers. Further, the rising adoption of this technology in the developing countries is responsible for significant growth in the market shares in the coming few years. Owing to the easy availability of workers at low cost in the Asia Pacific region as compared to US, this region is anticipated to generate significant market revenue.

SEGMENT ANALYSIS

Based on services, the regulatory affairs outsourcing market report provides a detailed analysis of legal representation, regulatory writing and publishing, clinical trial application, regulatory submission, and product registrations. Out of which the regulatory writing segment has dominated the overall revenue in 2018. Further, the legal representation and the regulatory consulting segment has contributed significantly to the growth of the market shares owing to the rising demand for consultation.  

Due to the growing demand of legal representatives in Europe, the legal representative section is expected to contribute to a remarkable increase in overall revenue during the forecast period. Introduction to clinical trials in countries like the Asia Pacific and Latin America is expected to boost demand for product registration and diagnostic testing application services, which results in the development of the regulatory affairs outsourcing industry. The pharmaceutical sector is also responsible for market growth.

INDUSTRY PLAYER ANALYSIS

Major industry players have been analyzed with coverage on their operating areas, revenues, and other strategic aspects. These industry players include PAREXEL International Corporation, WuXi AppTec, Clinilabs Incorporated, Criterium Incorporated, IQVIA Holdings Incorporated, Accell Clinical Research LLC, Pharmaceutical Product Development, (PPD) LLC, ICON plc., BlueReg Group, Promedica International, Charles River Laboratories International Incorporated, Covance Incorporated, and Dr. Regenold GmbH, among others.

COVERAGE HIGHLIGHTS

•    Revenue Estimation and Forecast (2018 – 2026)
•    Production Estimation and Forecast (2018 – 2026)
•    Sales/Consumption Volume Estimation and Forecast (2018 – 2026)
•    Breakdown of Revenue by Segments (2018 – 2026)
•    Breakdown of Production by Segments (2018 – 2026)
•    Breakdown of Sales Volume by Segments (2018 – 2026)
•    Gross Margin and Profitability Analysis of Companies
•    Business Trend and Expansion Analysis
•    Import and Export Analysis
•    Regional Analysis and Data Breakdown

SEGMENTAL ANALYSIS

By Services Outlook ($Revenue, 2018-2026)

•    Regulatory writing and publishing
•    Legal representation
•    Clinical trial application
•    Regulatory submission
•    Product registrations

By Regional Outlook ($Revenue and Unit Sales, 2018-2026)

•    North America
•    Canada
•    U.S
•    Mexico
•    Europe
•    Germany
•    U.K
•    France
•    Netherlands
•    Austria
•    Rest of Europe 
•    Asia-Pacific
•    China
•    India
•    Japan
•    South Korea
•    Australia
•    Rest of Asia Pacific
•    The Middle East and Africa
•    Saudi Arabia
•    United Arab Emirates
•    Rest of Middle East
•    Africa
•    South America
•    Brazil
•    Argentina
•    Rest of South America

INDUSTRY PLAYERS ANALYSIS 

·    PAREXEL International Corporation
·    WuXi AppTec
·    Clinilabs Incorporated
·    Criterium Incorporated
·    IQVIA Holdings Incorporated
·    Accell Clinical Research LLC
·    Pharmaceutical Product Development
·    (PPD) LLC
·    ICON plc.
·    BlueReg Group
·    Promedica International
·    Charles River Laboratories International Incorporated
·    Covance Incorporated
·    Dr. Regenold GmbH
·    ProductLife Group S.A
·    Intertek Group plc
·    FMD K&L
·    Genpact Limited
·    Kinapse Ltd
·    Medpace Incorporated
·    PRA Health Sciences Incorporated 
·    Navitas Life Sciences
·    PharmaLex GmbH

CHAPTER 1. INTRODUCTION
           1.1. RESEARCH METHODOLOGY
                        1.1.1. Data Collection
                        1.1.2. Data Modeling
                        1.1.3. Historical Revenue and Sales Estimation
                        1.1.4. Data Triangulation

           1.2. RESEARCH PROCESS
                        1.2.1. Primary Research
                        1.2.2. Secondary Research
                        1.2.3. Survey Data
                        1.2.4. Validation by In-House Expert
           1.3. REGULATORY AFFAIRS OUTSOURCING MARKET OVERVIEW
                        1.3.1. Research Scope and Market Definition
                        1.3.2. Executive Summary
 

CHAPTER 2. GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET DEMAND SIDE ANALYSIS
           2.1. REGULATORY AFFAIRS OUTSOURCING MARKET CONSUMPTION VOLUME (MILLION UNITS), 2018 – 2025
           2.2. MARKET CONSUMPTION VOLUME SPLIT BY REGION (MILLION UNITS), 2018 – 2025
           2.3. MARKET CONSUMPTION VOLUME SPLIT BY COUNTRIES (MILLION UNITS), 2018 – 2025
           2.4. MARKET REVENUE (MILLION USD), 2018-2025
           2.5. MARKET REVENUE SPLIT BY REGION (MILLION UNITS), 2018 – 2025
           2.6. REGULATORY AFFAIRS OUTSOURCING MARKET REVENUE SPLIT BY COUNTRIES (MILLION UNITS), 2018 – 2025

CHAPTER 3. GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET SUPPLY SIDE ANALYSIS
           3.1. REGULATORY AFFAIRS OUTSOURCING MARKET PRODUCTION VOLUME (MILLION UNITS), 2018 – 2025
           3.2. MARKET PRODUCTION VOLUME SPLIT BY REGION (MILLION UNITS), 2018-2025
           3.3. MARKET PRODUCTION VOLUME SPLIT/RANKING BY COUNTRIES (MILLION UNITS), 2018 – 2025

CHAPTER 4. GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET COMPETITIVE SCENARIO & BUSINESS OPPORTUNITY ANALYSIS
          4.1. COMPETITIVE STRENGTH RANKING BY MAJOR COUNTRIES, 2018 
          4.2. MARKET ATTRACTIVENESS RANKING BY MAJOR COUNTRIES, 2018 - 2025
          4.3. EMERGING BUSINESS OPPORTUNITIES AND GROWTH PROSPECTS
                        4.3.1. Growth Drivers 
                        4.3.2. Market Restraints 
                        4.3.2. Opportunities 

CHAPTER 5. GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET ENTRY STRATEGIES
         5.1. ENTRY STRATEGIES IN DEVELOPING MARKETS
         5.2. ENTRY STRATEGIES IN DEVELOPED MARKETS

CHAPTER 6. GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICES
         6.1. SEGMENT OUTLINE 
         6.2. REVENUE SHARE BY SERVICES, $MILLION, 2018 – 2025
         6.2. CONSUMPTION SHARE BY SERVICES, MILLION UNITS, 2018 - 2025
         6.3. PRODUCTION SHARE BY SERVICES, MILLION UNITS, 2018 – 2025
         6.4. REGULATORY WRITING AND PUBLISHING
                        6.4.1. Market determinants and trend analysis
                        6.4.2. Market revenue, sales and production volume, 2018 – 2025
         6.5. LEGAL REPRESENTATION
                        6.5.1. Market determinants and trend analysis
                        6.5.2. Market revenue, sales and production volume, 2018 – 2025
         6.6. CLINICAL TRIAL APPLICATION
                        6.6.1. Market determinants and trend analysis
                        6.6.2. Market revenue, sales and production volume, 2018 – 2025
         6.7. REGULATORY SUBMISSION
                        6.7.1. Market determinants and trend analysis
                        6.7.2. Market revenue, sales and production volume, 2018 – 2025
         6.8. PRODUCT REGISTRATIONS
                        6.8.1. Market determinants and trend analysis
                        6.8.2. Market revenue, sales and production volume, 2018 – 2025

CHAPTER 7. GLOBAL REGULATORY AFFAIRS OUTSOURCING MARKET BY REGIONS
          7.1. REGIONAL OUTLOOK 
          7.2. MARKET PRODUCTION, CONSUMPTION & REVENUE BY REGION, 2018-2025
          7.3. NORTH AMERICA
                        7.3.1. Current Trends and Future Prospects  
                        7.3.2. North America market revenue, sales and production volume, 2018 – 2025
                        7.3.3.
U.S.
                                 7.3.3.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.3.3.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.3.3.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.3.4. Canada
                                 7.3.4.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.3.4.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.3.4.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.3.5. Mexico
                                 7.3.5.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.3.5.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.3.5.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
          7.4. EUROPE
                        7.4.1. Current Trends and Future Prospects  
                        7.4.2. Europe market revenue, sales and production volume, 2018 – 2025
                        7.4.3. U.K
                                 7.4.3.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.4.3.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.4.3.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.4.4. Germany 
                                 7.4.4.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.4.4.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.4.4.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.4.5. France 
                                 7.4.5.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.4.5.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.4.5.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.4.6. Italy 
                                 7.4.6.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.4.6.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.4.6.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.4.7. Rest of Europe 
                                 7.4.7.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.4.7.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.4.7.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
          7.5. ASIA PACIFIC 
                        7.5.1. Current Trends and Future Prospects  
                        7.5.2. Europe market revenue, sales and production volume, 2018 – 2025
                        7.5.3. India
                                 7.5.3.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.5.3.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.5.3.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.5.4. Japan
                                 7.5.4.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.5.4.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.5.4.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.5.5. China
                                 7.5.5.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.5.5.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.5.5.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.5.6. South Korea  
                                 7.5.6.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.5.6.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.5.6.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.5.7. Rest of APAC 
                                 7.5.7.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.5.7.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.5.7.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
          7.6. REST OF THE WORLD  
                        7.6.1. Current Trends and Future Prospects  
                        7.6.2. Europe market revenue, sales and production volume, 2018 – 2025
                        7.6.3. Latin America  
                                 7.6.3.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.6.3.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.6.3.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.6.4. Middle East  
                                 7.6.4.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.6.4.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.6.4.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)
                        7.6.5. Africa  
                                 7.6.5.1. Regulatory Affairs Outsourcing Market Revenue $Million (2018 – 2025) 
                                 7.6.5.2. Regulatory Affairs Outsourcing Market Consumption Million Units (2018 – 2025)
                                 7.6.5.3. Regulatory Affairs Outsourcing Market Production Million Units (2018 – 2025)

CHAPTER 8.  KEY VENDOR PROFILES
        8.1. PAREXEL International Corporation
                      8.1.1. Company overview
                      8.1.2. Portfolio Analysis 
                      8.1.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.1.4. Regional & business segment Revenue Analysis 
        8.2. WuXi AppTec
                      8.2.1. Company overview
                      8.2.2. Portfolio Analysis 
                      8.2.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.2.4. Regional & business segment Revenue Analysis 
        8.3. Clinilabs Incorporated
                      8.3.1. Company overview
                      8.3.2. Portfolio Analysis 
                      8.3.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.3.4. Regional & business segment Revenue Analysis 
        8.4. Criterium Incorporated
                      8.4.1. Company overview
                      8.4.2. Portfolio Analysis 
                      8.4.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.4.4. Regional & business segment Revenue Analysis 
        8.5. IQVIA Holdings Incorporated
                      8.5.1. Company overview
                      8.5.2. Portfolio Analysis 
                      8.5.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.5.4. Regional & business segment Revenue Analysis 
        8.6. Accell Clinical Research LLC
                      8.6.1. Company overview
                      8.6.2. Portfolio Analysis 
                      8.6.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.6.4. Regional & business segment Revenue Analysis 
        8.7. Pharmaceutical Product Development
                      8.7.1. Company overview
                      8.7.2. Portfolio Analysis 
                      8.7.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.7.4. Regional & business segment Revenue Analysis 
        8.7. (PPD) LLC
                      8.7.1. Company overview
                      8.7.2. Portfolio Analysis 
                      8.7.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.7.4. Regional & business segment Revenue Analysis 
        8.9. ICON plc.
                      8.9.1. Company overview
                      8.9.2. Portfolio Analysis 
                      8.9.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.9.4. Regional & business segment Revenue Analysis 
        8.10. BlueReg Group
                      8.10.1. Company overview
                      8.10.2. Portfolio Analysis 
                      8.10.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.10.4. Regional & business segment Revenue Analysis 
        8.11. Promedica International
                      8.11.1. Company overview
                      8.11.2. Portfolio Analysis 
                      8.11.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.11.4. Regional & business segment Revenue Analysis
        8.12. Charles River Laboratories International Incorporated
                      8.12.1. Company overview
                      8.12.2. Portfolio Analysis 
                      8.12.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.12.4. Regional & business segment Revenue Analysis
        8.13. Covance Incorporated
                      8.13.1. Company overview
                      8.13.2. Portfolio Analysis 
                      8.13.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.13.4. Regional & business segment Revenue Analysis
        8.14. Dr. Regenold GmbH
                      8.14.1. Company overview
                      8.14.2. Portfolio Analysis 
                      8.14.3. Estimated revenue from regulatory affairs outsourcing business and market share
                      8.14.4. Regional & business segment Revenue Analysis

 

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