세계의 규제 업무 아웃소싱 시장 : 산업 규모, 점유율, 동향, 기회, 예측, 서비스별, 카테고리별, 기업 규모별, 적응증별, 제품 단계별, 최종 용도별, 지역별, 경쟁별(2020-2030년)

The Global Regulatory Affairs Outsourcing Market was valued at USD 6.84 billion in 2024 and is anticipated to reach USD 11.94 billion by 2030, growing at a CAGR of 9.73%. Market expansion is primarily driven by increased R&D efforts and a rising number of clinical trial applications and product registrations. Additionally, regulatory measures aimed at controlling drug costs are generating economic pressures that encourage life sciences companies to outsource regulatory functions. The COVID-19 pandemic further accelerated this trend, as the urgent development of vaccines underscored the importance of streamlined regulatory processes. As globalization continues, companies entering international markets face a complex web of regulatory standards, prompting greater reliance on external expertise to navigate compliance efficiently. This demand is especially strong in emerging markets where operational costs are lower and regulatory environments are increasingly attractive for expansion.

Key Market Drivers

Globalization of Biopharmaceutical and Medical Device Companies

The expansion of biopharmaceutical and medical device companies into international markets is a major driver behind the growth of regulatory affairs outsourcing. Each new market introduces unique compliance requirements, demanding specialized regulatory knowledge. Outsourcing helps companies manage these challenges efficiently and cost-effectively. Emerging regions such as Asia Pacific, Latin America, and the Middle East & Africa are particularly appealing due to lower development costs, skilled labor availability, and favorable regulatory climates. For instance, infrastructure investments like B. Braun's five new facilities in Malaysia and Flex Ltd.'s site in India reflect the trend of companies expanding regionally while leveraging outsourced regulatory expertise to ensure compliance.

Key Market Challenges

Data Security and Privacy Concerns

Security and privacy of sensitive regulatory information are critical challenges in this market. As outsourcing increases, so does the risk of data breaches and cyberattacks. The growing use of digital platforms-such as electronic Common Technical Document (eCTD) submissions and digital IND safety reporting-amplifies vulnerabilities. Additionally, mergers and acquisitions within the healthcare sector can expose organizations to greater cybersecurity threats due to the volume and sensitivity of exchanged data, posing a significant risk to business continuity and regulatory compliance.

Key Market Trends

Technological Advancements in Regulatory Processes

Technological progress is reshaping regulatory affairs outsourcing, introducing tools that enhance transparency, speed, and collaboration. Regulatory Information Management Systems (RIMS) are streamlining submission tracking and compliance monitoring. Cloud-based platforms enable real-time interaction between clients and service providers, improving operational efficiency. Furthermore, artificial intelligence (AI) and machine learning are being used to automate administrative tasks like data entry and document processing, allowing regulatory professionals to focus on strategic functions. These technologies are optimizing regulatory workflows, making it easier for companies to meet global compliance standards swiftly and accurately.

Key Market Players

• Accell Clinical Research, LLC.
• Genpact Ltd.
• CRITERIUM, INC.
• Promedica International.
• WuXi AppTec Co Ltd.
• Medpace Inc.
• Charles River Laboratories Inc.
• ICON plc.
• Covance, Inc.
• Parexel International Corporation.

Report Scope:

In this report, Global Regulatory Affairs Outsourcing market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Regulatory Affairs Outsourcing Market, By Service:

• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
• Product registration & clinical trial applications
• Regulatory Submissions
• Regulatory Operations
• Other services

Regulatory Affairs Outsourcing Market, By Category:

• Pharmaceutical
• Medical Device

Regulatory Affairs Outsourcing Market, By Company Size:

• Small Companies
• Medium Companies
• Large Companies

Regulatory Affairs Outsourcing Market, By Indication:

• Oncology
• Neurology
• Cardiology
• Immunology
• Other Indications

Regulatory Affairs Outsourcing Market, By Product Stage:

• Preclinical
• Clinical
• Premarket Approval

Regulatory Affairs Outsourcing Market, By End Use:

• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Regulatory Affairs Outsourcing Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • Germany
  • United Kingdom
  • Italy
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Australia
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Regulatory Affairs Outsourcing Market.

Available Customizations:

Global Regulatory Affairs Outsourcing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Regulatory Affairs Outsourcing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
  • 5.2.2. By Category (Pharmaceutical, Medical Device)
  • 5.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
  • 5.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
  • 5.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
  • 5.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
  • 5.2.7. By Region (North America, Europe, Asia Pacific, South America, Middle East & Africa)
  • 5.2.8. By Company (2024)
• 5.3. Market Map
• 5.3.1 By Service
• 5.3.2 By Category
• 5.3.3 By Company Size
• 5.3.4 By Indication
• 5.3.5 By Product Stage
• 5.3.6 By End Use

6. North America Regulatory Affairs Outsourcing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
  • 6.2.2. By Category (Pharmaceutical, Medical Device)
  • 6.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
  • 6.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
  • 6.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
  • 6.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
  • 6.2.7. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Regulatory Affairs Outsourcing Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Service
      • 6.3.1.2.2. By Category
      • 6.3.1.2.3. By Company Size
      • 6.3.1.2.4. By Indication
      • 6.3.1.2.5. By Product Stage
      • 6.3.1.2.6. By End Use
  • 6.3.2. Canada Regulatory Affairs Outsourcing Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Service
      • 6.3.2.2.2. By Category
      • 6.3.2.2.3. By Company Size
      • 6.3.2.2.4. By Indication
      • 6.3.2.2.5. By Product Stage
      • 6.3.2.2.6. By End Use
  • 6.3.3. Mexico Regulatory Affairs Outsourcing Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Service
      • 6.3.3.2.2. By Category
      • 6.3.3.2.3. By Company Size
      • 6.3.3.2.4. By Indication
      • 6.3.3.2.5. By Product Stage
      • 6.3.3.2.6. By End Use

7. Europe Regulatory Affairs Outsourcing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
  • 7.2.2. By Category (Pharmaceutical, Medical Device)
  • 7.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
  • 7.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
  • 7.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
  • 7.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
  • 7.2.7. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Regulatory Affairs Outsourcing Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Service
      • 7.3.1.2.2. By Category
      • 7.3.1.2.3. By Company Size
      • 7.3.1.2.4. By Indication
      • 7.3.1.2.5. By Product Stage
      • 7.3.1.2.6. By End Use
  • 7.3.2. Germany Regulatory Affairs Outsourcing Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Service
      • 7.3.2.2.2. By Category
      • 7.3.2.2.3. By Company Size
      • 7.3.2.2.4. By Indication
      • 7.3.2.2.5. By Product Stage
      • 7.3.2.2.6. By End Use
  • 7.3.3. United Kingdom Regulatory Affairs Outsourcing Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Service
      • 7.3.3.2.2. By Category
      • 7.3.3.2.3. By Company Size
      • 7.3.3.2.4. By Indication
      • 7.3.3.2.5. By Product Stage
      • 7.3.3.2.6. By End Use
  • 7.3.4. Italy Regulatory Affairs Outsourcing Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Service
      • 7.3.4.2.2. By Category
      • 7.3.4.2.3. By Company Size
      • 7.3.4.2.4. By Indication
      • 7.3.4.2.5. By Product Stage
      • 7.3.4.2.6. By End Use
  • 7.3.5. Spain Regulatory Affairs Outsourcing Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Service
      • 7.3.5.2.2. By Category
      • 7.3.5.2.3. By Company Size
      • 7.3.5.2.4. By Indication
      • 7.3.5.2.5. By Product Stage
      • 7.3.5.2.6. By End Use

8. Asia-Pacific Regulatory Affairs Outsourcing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
  • 8.2.2. By Category (Pharmaceutical, Medical Device)
  • 8.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
  • 8.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
  • 8.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
  • 8.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
  • 8.2.7. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Regulatory Affairs Outsourcing Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Service
      • 8.3.1.2.2. By Category
      • 8.3.1.2.3. By Company Size
      • 8.3.1.2.4. By Indication
      • 8.3.1.2.5. By Product Stage
      • 8.3.1.2.6. By End Use
  • 8.3.2. India Regulatory Affairs Outsourcing Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Service
      • 8.3.2.2.2. By Category
      • 8.3.2.2.3. By Company Size
      • 8.3.2.2.4. By Indication
      • 8.3.2.2.5. By Product Stage
      • 8.3.2.2.6. By End Use
  • 8.3.3. Japan Regulatory Affairs Outsourcing Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Service
      • 8.3.3.2.2. By Category
      • 8.3.3.2.3. By Company Size
      • 8.3.3.2.4. By Indication
      • 8.3.3.2.5. By Product Stage
      • 8.3.3.2.6. By End Use
  • 8.3.4. South Korea Regulatory Affairs Outsourcing Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Service
      • 8.3.4.2.2. By Category
      • 8.3.4.2.3. By Company Size
      • 8.3.4.2.4. By Indication
      • 8.3.4.2.5. By Product Stage
      • 8.3.4.2.6. By End Use
  • 8.3.5. Australia Regulatory Affairs Outsourcing Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Service
      • 8.3.5.2.2. By Category
      • 8.3.5.2.3. By Company Size
      • 8.3.5.2.4. By Indication
      • 8.3.5.2.5. By Product Stage
      • 8.3.5.2.6. By End Use

9. South America Regulatory Affairs Outsourcing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
  • 9.2.2. By Category (Pharmaceutical, Medical Device)
  • 9.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
  • 9.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
  • 9.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
  • 9.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
  • 9.2.7. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Regulatory Affairs Outsourcing Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Service
      • 9.3.1.2.2. By Category
      • 9.3.1.2.3. By Company Size
      • 9.3.1.2.4. By Indication
      • 9.3.1.2.5. By Product Stage
      • 9.3.1.2.6. By End Use
  • 9.3.2. Argentina Regulatory Affairs Outsourcing Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Service
      • 9.3.2.2.2. By Category
      • 9.3.2.2.3. By Company Size
      • 9.3.2.2.4. By Indication
      • 9.3.2.2.5. By Product Stage
      • 9.3.2.2.6. By End Use
  • 9.3.3. Colombia Regulatory Affairs Outsourcing Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Service
      • 9.3.3.2.2. By Category
      • 9.3.3.2.3. By Company Size
      • 9.3.3.2.4. By Indication
      • 9.3.3.2.5. By Product Stage
      • 9.3.3.2.6. By End Use

10. Middle East and Africa Regulatory Affairs Outsourcing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services)
  • 10.2.2. By Category (Pharmaceutical, Medical Device)
  • 10.2.3. By Company Size (Small Companies, Medium Companies, Large Companies)
  • 10.2.4. By Indication (Oncology, Neurology, Cardiology, Immunology, Other Indications)
  • 10.2.5. By Product Stage (Preclinical, Clinical, Premarket Approval)
  • 10.2.6. By End Use (Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies)
  • 10.2.7. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Regulatory Affairs Outsourcing Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Service
      • 10.3.1.2.2. By Category
      • 10.3.1.2.3. By Company Size
      • 10.3.1.2.4. By Indication
      • 10.3.1.2.5. By Product Stage
      • 10.3.1.2.6. By End Use
  • 10.3.2. Saudi Arabia Regulatory Affairs Outsourcing Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Service
      • 10.3.2.2.2. By Category
      • 10.3.2.2.3. By Company Size
      • 10.3.2.2.4. By Indication
      • 10.3.2.2.5. By Product Stage
      • 10.3.2.2.6. By End Use
  • 10.3.3. UAE Regulatory Affairs Outsourcing Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Service
      • 10.3.3.2.2. By Category
      • 10.3.3.2.3. By Company Size
      • 10.3.3.2.4. By Indication
      • 10.3.3.2.5. By Product Stage
      • 10.3.3.2.6. By End Use

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Development
• 12.2. Mergers & Acquisitions
• 12.3. Product Launches

13. Global Regulatory Affairs Outsourcing Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Accell Clinical Research, LLC.
  • 15.1.1. Business Overview
  • 15.1.2. Company Snapshot
  • 15.1.3. Products & Services
  • 15.1.4. Financials (As Reported)
  • 15.1.5. Recent Developments
  • 15.1.6. Key Personnel Details
  • 15.1.7. SWOT Analysis
• 15.2. Genpact Ltd.
• 15.3. CRITERIUM, INC.
• 15.4. Promedica International.
• 15.5. WuXi AppTec Co Ltd.
• 15.6. Medpace Inc.
• 15.7. Charles River Laboratories Inc.
• 15.8. ICON plc.
• 15.9. Covance, Inc.
• 15.10. Parexel International Corporation.

16. Strategic Recommendations

17. About Us & Disclaimer