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Regulatory Affairs Outsourcing Market - Growth, Trends, and Forecast (2020 - 2025)

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  • 120 Pages
  • February 2020
  • Region: Global
  • Mordor Intelligence
  • ID: 4986952
  • The Regulatory Affairs Outsourcing market studied is anticipated to grow with a CAGR of nearly 9.2%, during the forecast period.
  • Certain factors that are driving the market growth include changing regulatory landscape and competitive pressures and growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs, among others.
  • The key factors propelling the growth of this market are increasing online collaborative forums, increasing efforts to characterize genes, and advancements in cancer biology. The fundamental concept of precision medicine is to understand the genetic makeup and difference at a population level, and further at an individual level, in order to customize a drug that targets a particular gene type. Hence, sequencing or characterizing genes is the most important method to gain information about genes and their possible mutations.
  • The functional characterization of identified genomic mutations, coupled with comprehensive clinical data available in electronic health records, has the potential to provide compelling evidence to implicate novel disease and/or drug-associated mutations in phenotypically well-characterized patients. There have been increasing efforts made by both the government and private players to establish databases that contain information of characterized genes of a large population.
  • In the recent years, several blockbuster biologic drugs of major pharmaceuticals companies, such as Remicade, Rituxan, Herceptin, Enbrel, Lantus, and others expired. In the coming decade, there would be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, Orencia, and others, which would provide an opportunity for many innovator companies as well as generic manufacturers to offer services, specially tailored toward biosimilars.

Key Market Trends

Regulatory Consulting Holds Significant Share in the Global Regulatory Affairs Outsourcing Market
  • The final stages of regulatory submissions can seem problematic, particularly when that path takes the concerned company through the requirements of multiple countries. The efficient regulatory consultants of the outsourcing companies across 110 countries share a profound understanding of intricate regulatory requirements and a sense of urgency to get important therapies to those who need them. Majority of them are former regulators from various regulatory bodies.
  • The present day regulatory consulting services empower the pharma or biotech or other companies to maintain control of their pathway and stay ahead of any compliance risks. With practical interpretation, the regulatory consulting services help understand how guidelines around the world apply to the concerned company including in expanding markets.

North America Dominates the Global Regulatory Affairs Outsourcing Market
  • In the North American region, the United States accounted for the largest market share due to the changing regulatory scenario across the country.
  • The Precision Medicine Initiative also includes ongoing efforts through the Department of Veteran’s Affairs (VA), which has enrolled over 450,000 veterans in the Million Veteran Program (MVP), a participant-driven research cohort.
  • The North American segment of the market studied is majorly driven by the presence of many large research laboratories, such as Sandoz, Amgen, Teva Pharmaceutical, and others. Several studies in the United States have reported that more than 40 biosimilars are under development, including approximately 20 biosimilars ready to be released into the market, and a significant number of biosimilars are in the pipeline.

Competitive Landscape

The global Regulatory Affairs Outsourcing market is moderately competitive and consists of a few major players. Companies like Accell Clinical Research, Charles River Laboratories International, Inc., Criterium, Inc., Genpact Ltd, Medpace, Inc., Paraxel International Corporation, Pharmaceutical Product Development (PPD), LLC, PRA Health Sciences, Inc., Promedica International, Wuxi AppTec, among others, hold the substantial market share in the market.

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Table of Contents

1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
4.1 Market Overview
4.2 Market Drivers
4.2.1 Changing Regulatory Landscape and Competitive Pressures
4.2.2 Growth in Emerging Areas such as Personalized Medicine, Biosimilars, and Orphan Drugs, among Others
4.3 Market Restraints
4.3.1 Monitoring Issues and Lack of Standardization
4.3.2 Risk associated with Data Security
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5.1 By Service
5.1.1 Regulatory Consulting
5.1.2 Legal Representation
5.1.3 Regulatory Writing and Publishing
5.1.4 Product Registration and Clinical Trial Application
5.1.5 Other Regulatory Services
5.2 By End-User
5.2.1 Large Pharmaceutical Companies
5.2.2 Mid-size Pharmaceutical Companies
5.2.3 Other End-Users
5.3 Geography
5.3.1 North America United States Canada Mexico
5.3.2 Europe Germany United Kingdom France Italy Spain Rest of Europe
5.3.3 Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
5.3.4 Middle-East and Africa GCC South Africa Rest of Middle-East and Africa
5.3.5 South America Brazil Argentina Rest of South America
6.1 Company Profiles
6.1.1 Accell Clinical Research
6.1.2 Charles River Laboratories International, Inc.
6.1.3 Criterium, Inc.
6.1.4 Genpact Ltd
6.1.5 Medpace, Inc.
6.1.6 PARAXEL International Corporation
6.1.7 Pharmaceutical Product Development (PPD), LLC
6.1.8 PRA Health Sciences, Inc.
6.1.9 Promedica International
6.1.10 Wuxi AppTec

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Accell Clinical Research
  • Charles River Laboratories International, Inc.
  • Criterium, Inc.
  • Genpact Ltd
  • Medpace, Inc.
  • PARAXEL International Corporation
  • Pharmaceutical Product Development (PPD), LLC
  • PRA Health Sciences, Inc.
  • Promedica International
  • Wuxi AppTec