Regulatory Affairs Outsourcing Market, By Service (Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, Clinical Trial Applications and Product Registrations, and Other Regulatory Affairs) and By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) - Trends, Analysis and Forecast till 2032

Report Code: PMI111419 | Publish Date: April 2023 | No. of Pages: 168

Regulatory Affairs Outsourcing Market Overview

Introduction:

Regulatory Affairs Outsourcing Market is becoming one of the common practice in the biotech and pharmaceutical sector along with the area of 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. Regulatory affairs means the profession which is developed from desire of government  for protection of public health by controlling safety & efficacy of products in areas like veterinary medicines, pharmaceuticals,  pesticides, agrochemicals, medical devices, cosmetics & complementary medicines. Outsourcing in pharmaceutical industries is a practice used by different companies for reducing costs by transferring portions of work to suppliers from outside. Outsourced activities are in various fields like manufacturing of products and drug discovery. Outsourcing is important in pharmaceutical companies as it has become cost-effective way to bring drugs in market without sacrificing quality of packaging. The Federal Trade Commission (FTC) regulates outsourcing by enforcing various consumer protection laws applied to activities which are carried out in connection with outsourcing agreements that includes Fair Credit Reporting Act and section 5 of Federal Trade Commission Act. Regulatory compliance is an organization aware of an aligned with all laws & regulations which is relevant to industries and business. These regulations are set at state, local, federal and international levels. Importance and benefits of regulatory affairs has given push to the target market growth.

Attributes

Details

Regulatory Affairs Outsourcing Market  Value (2022)

US$ 6.8Bn

Regulatory Affairs Outsourcing Market Projected Value (2032)

US$ 8.9Bn

Regulatory Affairs Outsourcing Market CAGR (2022 – 2032)

9.8%

Regulatory Affairs Outsourcing Market Dynamics

                        Rise in research & development activities, and clinical trials

Rise in research & development (R&D) activities and clinical trials has become the major factor in regulatory affairs outsourcing market. Regulatory affairs outsourcing market is expected to have 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 regulatory affairs outsourcing market. Many biopharmaceutical and healthcare organizations are grouping up with several outsourcing companies to get their devices and drugs approved in the global market. As the medical sector is experiencing a high rate of product innovations from several companies willing to create a mark in this highly competitive market, thus 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. However, rise in research & development activities and clinical trials has enhanced the regulatory affairs outsourcing market growth.

Restrains:

However, service delivery, management difficulties, lack of flexibility, lack of consistency, confidentiality risk and data security are some disadvantages that may restrain the regulatory affairs outsourcing market growth.

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Regulatory Affairs Outsourcing Market Segmentation

Regulatory Affairs Outsourcing Market is segmented based on, service and region.

Service Insight

On the basis of Service Regulatory Affairs Outsourcing Market is segmented into Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, Clinical Trial Applications and Product Registrations, and other Regulatory Affairs. Clinical Trial Applications and Product Registrations has dominated the target market due to rise in R&D activities and clinical trials because of increase in prevalence of chronic diseases and rising population.

Regional Insights:

Disclaimer: This data is only a representation. Actual data may vary and will be available in the report.

On region the Regulatory Affairs Outsourcing Market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The Asia Pacific market is estimated to witness a significantly high revenue share over the forecast period, owing to growing population, especially in countries such as Europe and Asia Pacific, and technological advancements. Moreover, rising prevalence of chronic disease, increase in R&D activities and clinical trials, and rising presence of medical devices and pharmaceutical manufacturers is anticipated to increase demand for Regulatory Affairs Outsourcing in the region.

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Report Scope:

Attribute

Details

Base year for estimation

2022

Forecast period

2022 – 2032

Market representation

Revenue in USD Billion & CAGR from 2022 to 2032

Market Segmentation

By Service - Regulatory Consulting and Legal Representation, Regulatory Submissions, Regulatory Writing and Publishing, Clinical Trial Applications and Product Registrations, and other Regulatory Affairs.

Regional scope

North America - U.S., Canada

Europe - UK, Germany, Spain, France, Italy, Russia, Rest of Europe

Asia Pacific - Japan, India, China, South Korea, Australia, Rest of Asia-Pacific

Latin America - Brazil, Mexico, Argentina, Rest of Latin America

Middle East & Africa - South Africa, Saudi Arabia, UAE, Rest of Middle East & Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

Segments Covered in the Report:

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2022 to 2032. For the purpose of this study, has segmented the Regulatory Affairs Outsourcing Market report based on service and region:

Regulatory Affairs Outsourcing Market, By Service:

  • Regulatory Consulting and Legal Representation
  • Regulatory Submissions
  • Regulatory Writing and Publishing
  • Clinical Trial Applications and Product Registrations
  • Other Regulatory Affairs

Regulatory Affairs Outsourcing Market, By Region:

      • North America
          • U.S.
          • Canada
      • Europe
          • Germany
          • UK
          • France
          • Russia
          • Italy
          • Rest of Europe
      • Asia Pacific
          • China
          • India
          • Japan
          • South Korea
          • Rest of Asia Pacific
      • Latin America
          • Brazil
          • Mexico
          • Rest of Latin America
      • Middle East & Africa
          • GCC
          • Israel
          • South Africa
          • Rest of Middle East & Africa

Regulatory Affairs Outsourcing Market Key Players

The key players operating the Regulatory Affairs Outsourcing Market includes,

  1. Covance Inc.,

Covance provides clients with wide array of regulatory services for supporting development, planning, reviewing, submitting and publishing of regulatory documents to health authorities for supporting agency interactions, clinical trials, and marketing applications at global level.

  1. Accell Clinical Research LLC.

Accell Clinical Research is an International full service CRO (contract research organization) for managing Phase I-III clinical trials for more than 15 years across Eurasia and Europe. Accell is specialist in regulatory support, site selection, medical writing, clinical trial material management, safety management, outsourcing of clinical staffs, etc.

  1. Holborn Wells India Pvt. Ltd.

Holborn Wells India is a private company incorporated on 22 January 2021. Holborn Wells India is non -government company and registered at Registrar of Companies at Delhi. The company is involved in research and experimental development in field of natural sciences, agriculture, medical sciences, engineering and technology.

  1. Wuxi AppTec, Inc.

Wuxi AppTec, provides registration and regulatory consulting services, wide range of R&D and manufacturing services, clinical research services, biology discovery, cell and gene therapies, and helps in improving productivity of advancing healthcare products by providing efficient and cost-effective solutions.

  1. Genpact Ltd.

Genpact has 20 years of experience in Regulatory Affairs (RA). The team of 5000 consultants from Genpact team transforms and run regulatory operations for successful marketing authorizations, robust compliance and supply transfers.

  1. Medpace Inc.

Medpace team of global regulatory expert works with biotechnology, pharmaceutical, medical device companies, established companies and early stage companies. Medpace comprised of regulatory project managers, product development experts, regulatory operational colleagues, and regulatory writers. They also provides, unrivaled regulatory support in clinical development areas by early discovery to marketing authorization.

  1. Pharmaceutical Product Development (PPD) Inc.

Pharmaceutical Product Development (PPD) provides strategic regulatory services which includes, regulatory development, regulatory strategy input, full spectrum of activities & technical functions, licensing & lifecycle management, and full service regulatory partnerships.

  1. ICON Plc.

ICON helps in delivering operational support and sound regulatory strategies for drug and device development. ICON offers regulatory strategy and services for pharma, biotech, research, legal firms, provides clinical trial support by consulting and operational services.

  1. Charles River Laboratories International Inc.

Charles River Laboratories provides services with quality, regulatory compliance, cost-effectiveness and scientific integrity. Charles River Laboratories offers integrated portfolio of drug development products and services, scientific & regulatory advisory services, research models & services, etc.

  1. Criterium Inc.

Criterium provides clinical trial services, also offers project management & monitoring functions, regulatory affairs, clinical research management, and quality assurance. Criterium provides services which are time and cost efficient in several countries.

  1. PARAXEL International Corporation.

PARAXEL has specialized expertise which includes, 100 former regulators & HTA assessors, GxP compliance remediation & mitigation, Integration with health advances, industry luminaries with broad experience, therapeutic expert with deep technical expertise, PARAXEL also offers solutions and services in clinical development and clinical research, biotech, regulatory and access, etc.

Recent Development:

  • In September 2022, Holborn Wells India an IVD manufacturing company has launched Pharmaceutical and Medical Devices Regulatory Affairs Consulting Division for assisting local start-ups and consulting foreign companies who see to invest in India in pharmaceutical and medical device sector. Holborn Wells India is expected to see tremendous interest because of ‘Make in India’ initiative.

Regulatory Affairs Outsourcing Market Company Profile

  • Holborn Wells India Pvt. Ltd.*
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Covance Inc.
  • Accell Clinical Research LLC.
  • Wuxi AppTec, Inc.
  • Genpact Ltd.
  • Medpace Inc.
  • Pharmaceutical Product Development (PPD) Inc.
  • ICON Plc.
  • Charles River Laboratories International Inc.
  • Criterium Inc.
  • PARAXEL International Corporation.

“*” marked represents similar segmentation in other categories in the respective section

Regulatory Affairs Outsourcing Market Table of Contents

  1. Research Objective and Assumption
    • Preface
    • Research Objectives
    • Study Scope
    • Years Considered for the study
    • Assumptions
    • Abbreviations
  2. Research Methodology
    • Research data
    • Primary Data
      • Primary Interviews
      • Primary Breakdown
      • Key data from Primary Sources
      • Key Thickness Insights
    • Secondary Data
      • Major Secondary Sources
      • Secondary Sources
    • Market Estimation
    • Top-Down Approach
      • Approach for estimating Market Share by Top-Down Analysis (Supply Side)
    • Bottom-Up Approach
      • Approach for estimating market share by Bottom-up Analysis (Demand Side)
    • Market Breakdown and Data Triangulation
    • Research Assumptions
  3. Market Purview
    • Executive Summary
    • Key Findings—Global Outlook for medical carts Strategies
      • Key Questions this Study will Answer
      • Market Snippet, By Service
      • Market Snippet, By Region
    • Opportunity Map Analysis
    • Executive Summary—3 Big Predictions
  4. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restrains
      • Market Opportunities
      • Market Trends
    • DR Impact Analysis
    • PEST Analysis
    • Porter’s Five Forces Analysis
    • Opportunity Orbit
    • Market Investment Feasibility Index
    • Macroeconomic Factor Analysis
  5. Regulatory Affairs Outsourcing   Market, By Service
    • Overview
      • Market Value and Forecast (US$ Bn), and Share Analysis (%), 2022 – 2032
      • Y-o-Y Growth Analysis (%), 2022 – 2032
      • Segment Trends
    • Regulatory Consulting and Legal Representation
      • Overview
      • Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
    • Regulatory Submissions
      • Overview
      • Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
    • Regulatory Writing and Publishing
      • Overview
      • Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
    • Clinical Trial Applications and Product Registrations
      • Overview
      • Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
    • Other Regulatory Affairs
      • Overview
      • Market Size and Forecast (US$ Bn), and Y-o-Y Growth (%), 2022 – 2032
  6. Regulatory Affairs Outsourcing   Market, By Region, 2022 – 2032, (US$ Bn)
    • Overview
      • Market Value and Forecast (US$ Bn), and Share Analysis (%), 2022 – 2032
      • Y-o-Y Growth Analysis (%), 2022 – 2032
      • Regional Trends
    • North America
      • Market Size and Forecast (US$ Bn), By Service, 2022 – 2032
      • Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast (US$ Bn), By Service, 2022 – 2032
      • Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
      • Market Size and Forecast (US$ Bn), By Service, 2022 – 2032
      • Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
        • UK
        • France
        • Germany
        • Russia
        • Italy
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast (US$ Bn), By Service, 2022 – 2032
      • Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
        • India
        • Japan
        • South Korea
        • China
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast (US$ Bn), By Service, 2022 – 2032
      • Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
        • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East & Africa
      • Market Size and Forecast (US$ Bn), By Service, 2022 – 2032
      • Market Size and Forecast (US$ Bn), By Country, 2022 – 2032
        • GCC
        • Israel
        • South Africa
        • Rest of Middle East
  2. Competitive Landscape
    • Heat Map Analysis
    • Market Presence and Specificity Analysis
  3. Company Profiles
  • Covance Inc.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Accell Clinical Research LLC.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Holborn Wells India Pvt. Ltd.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Wuxi AppTec, Inc.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Genpact Ltd.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Medpace Inc.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Pharmaceutical Product Development (PPD) Inc.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • ICON Plc.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Charles River Laboratories International Inc.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • Criterium Inc.
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  • PARAXEL International Corporation
    • Company Overview
    • Product Portfolio
    • Key Highlights
    • Financial Performance
    • Business Strategies
  1. The Last Word
    • Future Impact
    • About Us
    • Contact

FAQs

The Regulatory Affairs Outsourcing Market is segmented into service and region.

Regulatory Affairs Outsourcing Market is driven by factors like rise in research & development activities and clinical trials.

By region, the Regulatory Affairs Outsourcing market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The Asia Pacific market is estimated to witness a significantly high revenue share over the forecast period, owing to growing population, especially in countries such as Europe and Asia Pacific, and technological advancements.

The key players operating the Regulatory Affairs Outsourcing Market includes, Covance Inc., Accell Clinical Research LLC., Holborn Wells India Pvt. Ltd., Wuxi AppTec, Inc., Genpact Ltd., Medpace Inc., Pharmaceutical Product Development (PPD) Inc., ICON Plc., Charles River Laboratories International Inc., Criterium Inc., and PARAXEL International Corporation.