醫療事務外包市場規模、佔有率、成長分析、按服務類型、按行業、按最終用戶、按地區 - 行業預測，2025-2032 年

2023年醫療事務外包市場規模為19.2億美元，從2024年的21.8億美元成長到2032年的60.5億美元，預測期（2025-2032）預計複合年成長率為13.6%。

由於傳染性疾病和非傳染性疾病盛行率的上升導致臨床試驗的增加，全球醫療事務外包市場正經歷顯著成長。臨床活動的激增推動了對醫療設備和創新藥物的需求，並增加了對醫療服務外包的需求。來自委外研發機構(CRO) 的經濟高效、高品質的解決方案和嚴格的監管要求正在推動這一市場勢頭。透過加強虛擬科學交流和優先考慮科學交流，COVID-19 大流行預計將改變醫療事務專業人員的工作流程，並重新定義醫療事務的角色。此外，由於定價、嚴格法規和專利到期等挑戰影響利潤率，外包醫療業務越來越被視為最佳化業務和降低成本的策略舉措。

目錄

介紹

• 研究目的
• 調查範圍
• 定義

調查方法

• 資訊採購
• 二手資料和主要資料方法
• 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
• 按細分市場的機會分析

市場動態及展望

• 市場概況
• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制因素和挑戰
• 波特的分析

主要市場考察

• 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）
• PESTEL分析
• 總體經濟指標
• 價值鏈分析
• 價格分析
• 監管環境
• 案例研究
• 貿易分析

按服務類型分類的醫療事務外包市場規模

• 市場概況
• 醫學寫作和出版
  • 臨床試驗報告
  • 規範文件
  • 科學出版品
• 醫療監測
  • 安全監控
  • 有效性監控
• 醫療資訊
  • 詢價回复
  • 醫學文獻綜述
• 醫藥學術專員(MSL)
  • KOL (KOL) 參與度
  • 科學傳播
• 監管業務
  • 監理意見書
  • 合規管理
• 其他
  • 藥物警戒
  • 培訓和教育

醫療事務外包市場規模：依產業分類

• 市場概況
• 藥品
• 生物技術
• 醫療設備

醫療事務外包市場規模：依最終用戶分類

• 市場概況
• 小型企業
• 主要企業

醫事外包市場規模

• 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
  • 其他拉丁美洲地區
• 中東/非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東/非洲

競爭資訊

• 前5名企業對比
• 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
  • 公司簡介
  • 產品系列分析
  • 按細分市場分類的佔有率分析
  • 收益與前一年同期比較（2022-2024）

主要企業簡介

• ICON plc（Ireland）
• IQVIA Holdings Inc.（USA）
• The Medical Affairs Company（TMAC）（USA）
• Syneos Health, Inc.（USA）
• Thermo Fisher Scientific Inc.（USA）
• PAREXEL International Corporation（USA）
• PPD, Inc.（USA）
• Charles River Laboratories（USA）
• Covance Inc.（USA）
• Medpace Holdings, Inc.（USA）
• Pharm-Olam International（USA）
• Clinipace Worldwide（USA）
• PRA Health Sciences（USA）
• KCR SA（Poland）
• WuXi AppTec（China）
• SGS SA（Switzerland）
• Premier Research（USA）

結論和建議

Medical Affairs Outsourcing Market size was valued at USD 1.92 Billion in 2023 and is poised to grow from USD 2.18 Billion in 2024 to USD 6.05 Billion by 2032, growing at a CAGR of 13.6% during the forecast period (2025-2032).

The global medical affairs outsourcing market is experiencing significant growth, driven by an increase in clinical trials attributed to the rising prevalence of both communicable and non-communicable diseases. This surge in clinical activity boosts demand for medical devices and innovative drugs, enhancing the need for outsourced medical services. Cost-effective, high-quality solutions from contract research organizations (CROs) and rigorous regulatory requirements add to this market's momentum. The COVID-19 pandemic has transformed medical affairs professionals' workflows, enhancing virtual scientific interactions and prioritizing scientific communication, which is expected to redefine medical affairs roles. Additionally, with pressures such as pricing challenges, strict regulations, and patent expirations affecting profit margins, outsourcing medical affairs functions is increasingly viewed as a strategic move to optimize operations and reduce costs.

Top-down and bottom-up approaches were used to estimate and validate the size of the Medical 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.

Medical Affairs Outsourcing Market Segmental Analysis

Global Medical Affairs Outsourcing Market is segmented by service type, industry, end-user and region. Based on service type, the market is segmented into medical writing & publishing, medical monitoring, medical information, medical science liaisons (MSLS), regulatory affairs and others. Based on industry, the market is segmented into pharmaceuticals, biotechnology and medical devices. Based on end-user, the market is segmented into small & medium enterprises (SMEs) and large enterprises. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Medical Affairs Outsourcing Market

The Medical Affairs Outsourcing market is significantly driven by the escalating demand for real-world evidence in the healthcare sector, which is essential for validating product efficacy and safety. As pharmaceutical and medical device companies prioritize their core functions-research, development, manufacturing, and marketing-outsourcing medical affairs has become a strategic move. By collaborating with specialized providers, these companies can effectively generate, analyze, and communicate real-world data, thereby reinforcing the value propositions of their products. This approach not only allows them to utilize expert knowledge but also optimizes resource allocation and improves overall operational efficiency in an increasingly competitive landscape.

Restraints in the Medical Affairs Outsourcing Market

The Medical Affairs Outsourcing market faces several constraints, notably regarding quality control and compliance risks. Entrusting medical affairs functions to external vendors can pose challenges in maintaining consistent quality and complying with established internal standards. To effectively address these concerns, companies must implement strong governance and monitoring systems. Additionally, outsourcing can foster a dependency on outside providers for essential services, potentially diminishing a company's control over critical processes and timelines. This reliance may hinder operational efficiency and increase the risk of non-compliance, ultimately affecting the overall effectiveness of the medical affairs functions being outsourced.

Market Trends of the Medical Affairs Outsourcing Market

The Medical Affairs Outsourcing market is witnessing a significant upward trend as pharmaceutical and medical device companies leverage real-world evidence to substantiate the safety, efficacy, and value of their products. This shift towards evidence-based strategies is driving demand for specialized outsourcing providers adept at generating, analyzing, and interpreting real-world data. These providers are crucial in enhancing regulatory submissions and informing strategic decision-making, leading to a burgeoning market for outsourcing services in medical affairs. Companies are increasingly prioritizing partnerships that facilitate robust evidence generation, positioning medical affairs outsourcing as a vital component of their overall research and development efforts.

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
• Trade Analysis

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

• Market Overview
• Medical Writing & Publishing
  • Clinical Trial Reports
  • Regulatory Documents
  • Scientific Publications
• Medical Monitoring
  • Safety Monitoring
  • Efficacy Monitoring
• Medical Information
  • Inquiry Handling
  • Medical Literature Review
• Medical Science Liaisons (MSLs)
  • Key Opinion Leader (KOL) Engagement
  • Scientific Communication
• Regulatory Affairs
  • Regulatory Submissions
  • Compliance Management
• Others
  • Pharmacovigilance
  • Training & Education

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

• Market Overview
• Pharmaceuticals
• Biotechnology
• Medical Devices

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

• Market Overview
• Small & Medium Enterprises (SMEs)
• Large Enterprises

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

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

• ICON plc (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IQVIA Holdings Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• The Medical Affairs Company (TMAC) (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Syneos Health, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PAREXEL International Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PPD, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Covance Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medpace Holdings, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pharm-Olam International (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Clinipace Worldwide (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PRA Health Sciences (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• KCR S.A. (Poland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• SGS S.A. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Premier Research (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations