Regulatory Affairs Outsourcing Market: Global Industry Analysis, Size, Share, Growth, Trends, and Forecasts 2016–2024

Report Code: ZMR-2882 | Report Format : | Status : Upcoming |


Global Regulatory Affairs Outsourcing Market: Overview

Outsourcing is gradually becoming an extremely common practice in the biotech and pharmaceutical sector along with the area of pharmacovigilance and regulatory affairs. Regulatory outsourcing has become a norm as several companies are looking for partners to manage any kind of operational tasks which comprises submission, publishing, and report publishing. Small and large-scale life-science companies prefer to outsource vendors to deal with tactical tasks at the same time they help in implementing best practices.

Global Regulatory Affairs Outsourcing Market: Growth Factors

The regulatory affairs outsourcing market is expected to witness significant development due to services, particularly in clinical research organizations. The growing numbers of patent expirations with increasing expenditure of R&D activities are the most important factors influencing the development of the global regulatory affairs outsourcing market. Biopharmaceutical and healthcare organizations are projected to team up with several outsourcing companies to get their devices and drugs approved in the global market. The authorization time of a device or drug is considered to be time-consuming, costly, as well as it is also a documentation-centric method. There is an increased requirement for expert service providers that mainly specialize in data handling which is related to regulatory affairs thus further increasing the requirement of reliable service givers for regulatory affairs outsourcing.

In addition, as the medical sector is experiencing a high rate of product innovations from several companies vying to create a mark in this highly competitive market, expenditure on R&D is also growing. In this regard, expenditure pressures and extreme competition are likely to push several companies to find out new ways to cut down the expenditure, hence outsourcing is gradually being more preferred over in-house data administration as it is regarded to be more cost-effective as well as resource-efficient way to manage huge amount of data generated during approvals, clinical trials, and patent approvals.

Global Regulatory Affairs Outsourcing Market: Segmentation

The global regulatory affairs outsourcing market is classified in terms of services and regions. Based on services, the global regulatory affairs outsourcing market is divided into regulatory consulting and legal representation, regulatory submissions, regulatory writing and publishing, clinical trial applications and product registrations, and other regulatory affairs. Based on the regions, the market is diversified into Asia Pacific, Latin America, North America, Europe, and the Middle East and Africa.

Global Regulatory Affairs Outsourcing Market: Regional Analysis

On the basis of the region, it is anticipated that the up-coming nations in the Asia Pacific and Latin America will turn out to be very promising global markets for regulatory affairs outsourcing. Rise in the commercialization units, product development, availability of cheap resources, and increasing number of researchers and raw materials are likely to fuel the expansion of global regulatory affairs outsourcing market in upcoming economies. Furthermore, the vast increase in patient population particularly in the Asia Pacific is likely to create a favorable environment condition for development. Several new entrants are using emerging nations for launching new ventures into the largest markets of Europe and North America.

Global Regulatory Affairs Outsourcing Market: Competitive Players

Some of the most important market players in the global regulatory affairs outsourcing market are Covance Inc., Wuxi AppTec, Genpact Ltd., Medpace Inc., Pharmaceutical Product Development (PPD) Llc., ICON Plc., Accell Clinical Research, Charles River Laboratories International Inc., Criterium Inc., and PARAXEL International Corporation, among others.

Global Regulatory Affairs Outsourcing Market: Regional Segment Analysis

  • North America
    • The U.S.
  • Europe
    • The UK
    • France
    • Germany
  • The Asia Pacific
    • China
    • Japan
    • India
  • Latin America
    • Brazil
  • The Middle East and Africa

What Reports Provides

  • Full in-depth analysis of the parent market
  • Important changes in market dynamics
  • Segmentation details of the market
  • Former, on-going, and projected market analysis in terms of volume and value
  • Assessment of niche industry developments
  • Market share analysis
  • Key strategies of major players
  • Emerging segments and regional markets
  • Testimonials to companies in order to fortify their foothold in the market.

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