監管外包市場規模、佔有率、成長分析（按服務、按規模、按類別、按適應症、按階段、按最終用戶、按地區）- 行業預測 2025-2032

2023 年全球醫藥外包市場規模為 59 億美元，預計將從 2024 年的 63.8 億美元成長到 2032 年的 118.9 億美元，預測期內（2025-2032 年）的複合年成長率為 8.1%。

隨著醫療保健公司面臨來自全球監管機構的越來越大的及時臨床核准壓力，監管外包市場預計將顯著成長。根據 Genpact 的一項調查，72% 的生命科學高管認為合規性是一項關鍵挑戰，而對新產品核准的日益成長的需求也要求高效的法律資訊服務。為了因應複雜的法規環境，企業擴大採用法律服務外包策略，以獲得更快的核准和更廣泛的市場准入。自付醫療費用的增加以及政府努力降低藥品價格等經濟因素進一步推動了外包監管職能的需求。此外，在開發早期階段採取針對特定藥物的策略性合規措施對於獲得快速核准並在不斷發展的生命科學領域保持競爭力至關重要。

目錄

介紹

• 調查目的
• 研究範圍
• 定義

調查方法

• 資訊採購
• 二次資料和一次資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分機會分析

市場動態與展望

• 市場概覽
• 市場規模
• 市場動態
  • 促進因素和機會
  • 限制與挑戰
• 波特的分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 主要投資機會
• 市場生態系統
• 市場吸引力指數（2024年）
• PESTEL分析
• 總體經濟指標
• 價值鏈分析
• 定價分析
• 監管格局
• 案例研究
• 技術分析

監理事務外包市場規模（依服務及複合年成長率） (2025-2032)

• 市場概覽
• 監理諮詢
• 法律代表
• 監管文件的撰寫和發布
• 產品註冊
• 臨床試驗申請
• 其他服務

監理事務外包市場規模及複合年成長率（2025-2032）

• 市場概覽
• 小的
• 中等的
• 大的

監理事務外包市場規模（依類別）及複合年成長率（2025-2032）

• 市場概覽
• 藥物
• 學名藥
• 創新者
• 生物製藥
• 生物技術
• ATMP
• 醫療設備
• 治療
• 診斷

醫藥事務外包市場規模（按適應症和複合年成長率）（2025-2032）

• 市場概覽
• 腫瘤學
• 神經病學
• 心臟病學
• 免疫學
• 其他

醫藥事務外包市場規模（依階段分類）及複合年成長率（2025-2032）

• 市場概覽
• 臨床前
• 臨床
• 上市後核准（PMA）

監理事務外包市場規模（依最終用戶和複合年成長率） (2025-2032)

• 市場概覽
• 醫療設備公司
• 製藥公司
• 生技公司

監理事務外包市場規模（按地區）及複合年成長率（2025-2032）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業市場定位（2024年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市場佔有率分析（2024年）
• 主要企業簡介
  • 公司詳情
  • 產品系列分析
  • 公司分部佔有率分析
  • 收益與前一年同期比較對比（2022-2024 年）

主要企業簡介

• Genpact（India）
• Freyr（India）
• IQVIA（United States）
• Parexel International（United States）
• Charles River Laboratories（United States）
• WuXi AppTec（China）
• ICON plc（Ireland）
• Labcorp Drug Development（United States）
• PharmaLex GmbH（Germany）
• NDA Group AB（Sweden）
• Pharmexon（Denmark）
• Qvigilance（United Kingdom）
• BlueReg（France）
• Cambridge Regulatory Services（United Kingdom）
• APCER Life Sciences（India）
• Real Regulatory Ltd（United Kingdom）
• Voisin Consulting Life Sciences（VCLS）（France）

結論和建議

Global Regulatory Affairs Outsourcing Market size was valued at USD 5.9 billion in 2023 and is poised to grow from USD 6.38 billion in 2024 to USD 11.89 billion by 2032, growing at a CAGR of 8.1% during the forecast period (2025-2032).

The regulatory affairs outsourcing market is poised for significant growth as healthcare companies face mounting pressure for timely clinical approvals from global regulators. A Genpact survey reveals that 72% of life sciences executives identify compliance as a critical challenge, necessitating efficient legal information services amid increasing demands for new product approvals. To navigate complex regulatory environments, companies are increasingly adopting outsourcing strategies for legal services, aiming for faster approvals and broader market access. Economic factors, including rising out-of-pocket healthcare costs and government efforts to reduce drug prices, further intensify the need for regulatory function outsourcing. Additionally, strategic drug-specific compliance measures during early development stages are essential for achieving swift approvals and maintaining competitive viability in the evolving life sciences landscape.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Regulatory Affairs Outsourcing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Regulatory Affairs Outsourcing Market Segments Analysis

Global Regulatory Affairs Outsourcing Market is segmented by Service, Size, Category, Indication, Stage, End-User and region. Based on Service, the market is segmented into Regulatory Consulting, Legal Representation, Regulatory Writing and Publishing, Product Registration, Clinical Trial Applications and Other Services. Based on Size, the market is segmented into Small, Medium and Large. Based on Category, the market is segmented into Drugs, Generics, Innovators, Biologics, Biotech, ATMPs, Medical Devices, Therapeutic and Diagnostic. Based on Indication, the market is segmented into Oncology, Neurology, Cardiology, Immunology and Others. Based on Stage, the market is segmented into Preclinical, Clinical and Post Market Authorization (PMA). Based on End-User, the market is segmented into Medical Device Companies, Pharmaceutical Companies and Biotechnology Companies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Regulatory Affairs Outsourcing Market

The Global Regulatory Affairs Outsourcing market is being propelled by the increasingly intricate regulatory framework across various sectors, especially in the pharmaceutical, biotechnology, and medical device industries. Regulatory bodies such as the FDA in the United States and the EMA in Europe consistently revise their regulations, guidelines, and compliance standards, making it challenging for companies to adapt. Outsourcing regulatory affairs allows organizations to tap into the expertise of specialized firms that possess in-depth knowledge of both local and global regulatory requirements, ensuring compliance and facilitating navigation through these dynamic landscapes. This demand for specialized knowledge and adaptability is a key driver of growth in the market.

Restraints in the Global Regulatory Affairs Outsourcing Market

A significant challenge facing the global regulatory affairs outsourcing market is the apprehension surrounding data security and privacy. Outsourcing essential regulatory functions often necessitates sharing sensitive information, including clinical trial results, proprietary business methods, and intellectual property, which raises the risk of potential data breaches and complicates compliance with regulations like the GDPR. Many companies hesitate to depend fully on external service providers due to these privacy concerns, especially in heavily regulated sectors such as pharmaceuticals and biotechnology, where safeguarding data is crucial. Such apprehensions could hinder the adoption of outsourcing solutions and impede the growth of the market.

Market Trends of the Global Regulatory Affairs Outsourcing Market

The Global Regulatory Affairs Outsourcing market is witnessing a robust trend towards the integration of digital solutions, significantly transforming how regulatory processes are managed. Companies are increasingly adopting Regulatory Technology (RegTech) solutions that streamline compliance and automate workflows, including shipments and regulatory approvals. Legal outsourcing firms are leveraging advanced cloud-based platforms, artificial intelligence, and automation technologies to enhance productivity and minimize human error, while ensuring real-time updates on regulatory changes. This shift not only fosters transparency and scalability in outsourced regulatory functions but also offers cost-effective, quick, and accurate solutions, thereby setting a new benchmark for efficiency in the regulatory landscape.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Regulatory Landscape
• Case Studies
• Technology Analysis

Global Regulatory Affairs Outsourcing Market Size by Service & CAGR (2025-2032)

• Market Overview
• Regulatory Consulting
• Legal Representation
• Regulatory Writing and Publishing
• Product Registration
• Clinical Trial Applications
• Other Services

Global Regulatory Affairs Outsourcing Market Size by Size & CAGR (2025-2032)

• Market Overview
• Small
• Medium
• Large

Global Regulatory Affairs Outsourcing Market Size by Category & CAGR (2025-2032)

• Market Overview
• Drugs
• Generics
• Innovators
• Biologics
• Biotech
• ATMPs
• Medical Devices
• Therapeutic
• Diagnostic

Global Regulatory Affairs Outsourcing Market Size by Indication & CAGR (2025-2032)

• Market Overview
• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Global Regulatory Affairs Outsourcing Market Size by Stage & CAGR (2025-2032)

• Market Overview
• Preclinical
• Clinical
• Post Market Authorization (PMA)

Global Regulatory Affairs Outsourcing Market Size by End-User & CAGR (2025-2032)

• Market Overview
• Medical Device Companies
• Pharmaceutical Companies
• Biotechnology Companies

Global Regulatory Affairs Outsourcing Market Size & CAGR (2025-2032)

• North America (Service, Size, Category, Indication, Stage, End-User)
  • US
  • Canada
• Europe (Service, Size, Category, Indication, Stage, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Service, Size, Category, Indication, Stage, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Service, Size, Category, Indication, Stage, End-User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Service, Size, Category, Indication, Stage, End-User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Genpact (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Freyr (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IQVIA (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Parexel International (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ICON plc (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Labcorp Drug Development (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PharmaLex GmbH (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• NDA Group AB (Sweden)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pharmexon (Denmark)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Qvigilance (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BlueReg (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cambridge Regulatory Services (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• APCER Life Sciences (India)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Real Regulatory Ltd (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Voisin Consulting Life Sciences (VCLS) (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations