监管外包市场规模、份额、成长分析（按服务、按规模、按类别、按适应症、按阶段、按最终用户、按地区）- 行业预测 2025-2032

2023 年全球医药外包市场规模为 59 亿美元，预计将从 2024 年的 63.8 亿美元成长到 2032 年的 118.9 亿美元，预测期内（2025-2032 年）的复合年增长率为 8.1%。

随着医疗保健公司面临来自全球监管机构的越来越大的及时临床核准压力，监管外包市场预计将显着成长。根据 Genpact 的一项调查，72% 的生命科学高管认为合规性是一项关键挑战，而对新产品核准的日益增长的需求也要求高效的法律资讯服务。为了因应复杂的法规环境，企业越来越多地采用法律服务外包策略，以获得更快的核准和更广泛的市场准入。自付医疗费用的增加以及政府努力降低药品价格等经济因素进一步推动了外包监管职能的需求。此外，在开发早期阶段采取针对特定药物的策略性合规措施对于获得快速核准并在不断发展的生命科学领域保持竞争力至关重要。

目录

介绍

• 调查目的
• 研究范围
• 定义

调查方法

• 资讯采购
• 二次资料和一次资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分机会分析

市场动态与展望

• 市场概览
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特的分析

关键市场考察

• 关键成功因素
• 竞争程度
• 主要投资机会
• 市场生态系统
• 市场吸引力指数（2024年）
• PESTEL分析
• 总体经济指标
• 价值链分析
• 定价分析
• 监管格局
• 案例研究
• 技术分析

监理事务外包市场规模（依服务及复合年增长率） (2025-2032)

• 市场概览
• 监理咨询
• 法律代表
• 监管文件的撰写和发布
• 产品註册
• 临床试验申请
• 其他服务

监理事务外包市场规模及复合年增长率（2025-2032）

• 市场概览
• 小的
• 中等的
• 大的

监理事务外包市场规模（依类别）及复合年增长率（2025-2032）

• 市场概览
• 药物
• 学名药
• 创新者
• 生物製药
• 生物技术
• ATMP
• 医疗设备
• 治疗
• 诊断

医药事务外包市场规模（按适应症和复合年增长率）（2025-2032）

• 市场概览
• 肿瘤学
• 神经病学
• 心臟病学
• 免疫学
• 其他的

医药事务外包市场规模（依阶段划分）及复合年增长率（2025-2032）

• 市场概览
• 临床前
• 临床
• 上市后核准（PMA）

监理事务外包市场规模（依最终用户和复合年增长率） (2025-2032)

• 市场概览
• 医疗设备公司
• 製药公司
• 生技公司

监理事务外包市场规模（按地区）及复合年增长率（2025-2032）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲国家地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业市场定位（2024年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市场占有率分析（2024年）
• 主要企业简介
  • 公司详情
  • 产品系列分析
  • 公司分部份额分析
  • 收益与前一年同期比较对比（2022-2024 年）

主要企业简介

• 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）

结论和建议

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