Global Regulatory Affairs Outsourcing Market – Insights

Regulatory affairs outsourcing refers to services used by the biotech, medical and pharmaceutical device manufacturing companies to gain speedy regulatory approvals by several organizations.

The Global Regulatory Affairs Outsourcing Market size accounted for US$ 3,683.7 mn in 2019, and is projected to witness a CAGR of 12.0% during the forecast period (2019 – 2027).

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Global Regulatory Affairs Outsourcing Market – Drivers

Rising refractive disorders prevalence is expected to drive the global regulatory affairs outsourcing market growth

Rising expenditure on R&D in healthcare sector is expected to propel the global regulatory affairs outsourcing market growth. In February 2018, as per the National Bureau of Statistics, China’s R&D expenditure surged from 10.6% in 2016 to 11.6% in 2017, valuing for US$ 280 Million.

Players that offer outsourcing services are more likely to get product approval, compared to biotechnology or pharmaceutical companies due to specialized expertise within the regulatory affairs field.  For instance, Health Consultancy Group subsidiary – ProEd Regulatory, noted that its success rate is 80% and around 8-10 drugs are required during any regulatory process for securing the approval every year.

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Global Regulatory Affairs Outsourcing Market – Restraints

The risks linked with outsourcing and data sharing are crucial factors expected to hinder growth of the global regulatory outsourcing market over the forecast period. Furthermore, several outsourcing partners possesses the access to pharmaceutical and other industries sensitive data, which is likely to impose threat to data sharing  and security to the companies.

Global Regulatory Affairs Outsourcing Market – Regional Insights

North America holds the highest share in the global regulatory affairs outsourcing market, due to rising acquisition and merger strategies accepted by players in the market. For instance, BioClinica, Inc., in 2015, acquired Synowledge, which has its headquarters in Miami, U.S., for expanding its product offering in drug safety including global regulatory business process outsourcing market. Synowledge is a specialist in information technology and regulatory affairs services for the biopharmaceutical players. Similarly, Certara, a tech-enabled drug safety and development, in 2014, announced its acquisition of Synchrogenix Information Strategies Inc., a contract research organization (CRO). Synchrogenix provides services related to regulatory writing to manufacturers of biotechnology, medical and pharmaceutical devices in the world.

Furthermore, rising expenditure of R&D is amongst the vital factors driving growth of the global regulatory outsourcing market within North America during the forecast period. For instance, in 2016, as per the Pharmaceutical Research and Manufacturers of America, the industry of biopharmaceutics has been invested around US$ 90 bn in the activities of R&D, in the U.S.

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Key Players

Key players functioning in the global regulatory affairs outsourcing market are WuXi AppTec Co., Ltd., Accell Clinical Research, Charles River Laboratories, Inc., LLC, Parexel International Corporation, PRA Health Sciences, Inc., Clinilabs Inc., IQVIA Holdings Inc., Criterium Inc., Certara, L.P. and Medpace Inc.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Service Type
      • Market Snippet, By Application
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Key Highlights
    • PEST Analysis
    • Collaborations and Agreements
  4. Global Regulatory Affairs Outsourcing Market, By Service Type, 2016 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • Regulatory Consulting and Legal Representation
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Product Registration and Clinical Trial Applications
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Regulatory Writing and Publishing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Regulatory Submission
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
  5. Global Regulatory Affairs Outsourcing Market, By Application, 2016 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, 2017 – 2027
      • Segment Trends
    • Pharma and Biotech Products
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
    • Medical Devices
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
  6. Global Regulatory Affairs Outsourcing Market, By Region, 2016 – 2027, (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2019 and 2027 (%)
      • Y-o-Y Growth Analysis, For Regions, 2017–2026
    • North America
      • Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
    • Latin America
      • Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of APAC
    • Middle East
      • Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
      • Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)
        • South Africa
        • Central Africa
        • North Africa
  7. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
    • Analyst Views
  8. Section
    • References
    • Research Methodology
    • About us and Sales Contact

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