세계의 헬스케어 RA(Regulatory Affairs) 아웃소싱 시장 규모 : 서비스별, 적응증별, 제품 단계별, 최종 용도별 예측(2024-2032년)

Healthcare Regulatory Affairs Outsourcing Market size is expected to grow at 8.4% CAGR from 2024-2032, driven by rising adoption of outsourcing solutions, escalating cost pressures and resource constraints, and the strong need for timely product approvals.

In an era characterized by the increasing regulatory complexities and stringent compliance requirements, pharmaceutical, biotechnology, and medical device companies are turning to outsourcing solutions to navigate through these challenges effectively. As per Radixweb in 2024, approximately a quarter of small businesses outsource to boost efficiency, while around 70% of companies view outsourcing as a cost-effective solution, primarily due to its ability to lower the expenses associated with hiring in-house staff. By leveraging the expertise of specialized regulatory affairs service providers, companies can streamline their operations, enhance efficiency, and ensure compliance with evolving regulatory standards. Moreover, outsourcing regulatory affairs tasks also allows organizations to focus on their core competencies while benefiting from the specialized knowledge and experience of outsourcing partners.

The healthcare regulatory affairs outsourcing market is divided into service, indication, product stage, end-use and region.

The industry size from the post market approval (PMA) services product stage segment is poised to grow at 8.5% CAGR up to 2032. These services encompass a comprehensive range of regulatory activities aimed at securing approval from regulatory authorities for the commercialization of medical devices and diagnostics. With the increasing complexity of regulatory requirements and the growing scrutiny from regulatory agencies, companies are turning to outsourcing partners to navigate the PMA process efficiently. This enables companies to leverage the expertise of regulatory professionals who possess extensive experience in preparing and submitting PMA applications, conducting regulatory assessments, and liaising with regulatory authorities.

By end-use, the healthcare regulatory affairs outsourcing industry size from the biotechnology companies segment is expected to expand at 8.3% CAGR up to 2032. Biotechnology companies often lack the in-house expertise and resources required to navigate the intricate regulatory pathways. As a result, they rely on outsourcing partners to assist them in obtaining regulatory approvals and ensuring product safety and efficacy. To that end, regulatory affairs outsourcing offers biotechnology companies access to regulatory experts who possess in-depth knowledge of regional and global regulatory requirements.

Asia Pacific healthcare regulatory affairs outsourcing market size is anticipated to record 9.5% CAGR from 2024 to 2032. This is driven by the burgeoning pharmaceutical and biotechnology industries coupled with favorable regulatory reforms and increasing investments in healthcare infrastructure. Moreover, the presence of a skilled workforce, cost-effective labor pool, and supportive government policies will further bolster the attractiveness of the region as a key outsourcing destination for regulatory affairs services.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definition
• 1.2 Base estimates & calculations
• 1.3 Data collection
• 1.4 Forecast parameters
• 1.5 Data validation
• 1.6 Data sources
  • 1.6.1 Primary
  • 1.6.2 Secondary
    • 1.6.2.1 Paid sources
    • 1.6.2.2 Public sources

Chapter 2 Executive Summary

• 2.1 Industry 360-degree synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Growing need to comply with regulatory requirements
    • 3.2.1.2 Surging demand for faster approval process for breakthrough drugs and devices
    • 3.2.1.3 Rising number of clinical trials
    • 3.2.1.4 Increasing regulatory complexity
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Data security and privacy concerns
    • 3.2.2.2 Lack of standardization
• 3.3 Growth potential analysis
• 3.4 Porter's analysis
  • 3.4.1 Supplier power
  • 3.4.2 Buyer power
  • 3.4.3 Threat of new entrants
  • 3.4.4 Threat of substitutes
  • 3.4.5 Industry rivalry
• 3.5 PESTEL analysis
• 3.6 Service price analysis
• 3.7 Regulatory landscape
• 3.8 Technological landscape
• 3.9 Future market trends

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive positioning matrix
• 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Services, 2018 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Product registration & clinical trial application
• 5.3 Regulatory consulting/strategic services
• 5.4 Submission management
• 5.5 Legal representation
• 5.6 Regulatory writing & publishing
• 5.7 Other services

Chapter 6 Market Estimates and Forecast, By Indication, 2018 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Neurology
• 6.4 Cardiology
• 6.5 Immunology
• 6.6 Other indications

Chapter 7 Market Estimates and Forecast, By Product Stage, 2018 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Preclinical
• 7.3 Clinical
• 7.4 Post market authorization (PMA)

Chapter 8 Market Estimates and Forecast, By End-Use, 2018 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 Pharmaceutical companies
• 8.3 Biotechnology companies
• 8.4 Medical device companies

Chapter 9 Market Estimates and Forecast, By Region, 2018 - 2032 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
  • 9.4.6 Rest of Asia Pacific
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
  • 9.5.4 Rest of Latin America
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE
  • 9.6.4 Rest of Middle East and Africa

Chapter 10 Company Profiles

• 10.1 Accell Clinical Research, LLC
• 10.2 Charles River Laboratories
• 10.3 Clinilabs, Inc.
• 10.4 Freyr
• 10.5 Genpact
• 10.6 ICON plc
• 10.7 Labcorp Drug Development
• 10.8 PAREXEL International Corporation
• 10.9 ProPharma Group
• 10.10 Proventa International
• 10.11 Thermo Fisher Scientific Inc.