メディカル・アフェアーズ・アウトソーシング市場規模、シェア、成長分析、サービスタイプ別、産業別、エンドユーザー別、地域別 - 産業予測、2025～2032年

メディカル・アフェアーズ・アウトソーシング市場規模は2023年に19億2,000万米ドルと評価され、2024年の21億8,000万米ドルから2032年には60億5,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは13.6%で成長する見通しです。

世界のメディカル・アフェアーズ・アウトソーシング市場は、伝染病と非伝染病の両方の有病率の上昇に起因する臨床試験の増加によって、大きな成長を経験しています。このような臨床活動の急増は、医療機器や革新的な医薬品に対する需要を押し上げ、医療サービスのアウトソーシングに対するニーズを高めています。医薬品開発業務受託機関（CRO）による費用対効果に優れた高品質のソリューションと厳格な規制要件が、この市場の勢いに拍車をかけています。COVID-19の流行はメディカルアフェアーズ専門家のワークフローを一変させ、バーチャルな科学的交流を強化し、科学的コミュニケーションを優先させることで、メディカルアフェアーズの役割を再定義することが期待されています。さらに、価格設定や厳しい規制、特許切れといった課題が利益率に影響を及ぼす中、メディカル・アフェアーズ業務のアウトソーシングは、業務の最適化とコスト削減のための戦略的な一手と見なされるようになっています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• 規制情勢
• ケーススタディ
• 貿易分析

メディカル・アフェアーズ・アウトソーシング市場規模：サービスタイプ別

• 市場概要
• 医学的執筆と出版
  • 臨床試験レポート
  • 規制文書
  • 科学出版物
• 医療モニタリング
  • 安全監視
  • 有効性モニタリング
• 医療情報
  • お問い合わせ対応
  • 医学文献レビュー
• メディカルサイエンスリエゾン（MSL）
  • KOL（KOL）エンゲージメント
  • 科学コミュニケーション
• 規制関連業務
  • 規制当局への提出
  • コンプライアンス管理
• その他
  • 医薬品安全性監視
  • トレーニングと教育

メディカル・アフェアーズ・アウトソーシング市場規模：産業別

• 市場概要
• 医薬品
• バイオテクノロジー
• 医療機器

メディカル・アフェアーズ・アウトソーシング市場規模：エンドユーザー別

• 市場概要
• 中小企業
• 大企業

メディカル・アフェアーズ・アウトソーシング市場規模

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 市場の最近の動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• 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 S.A.（Poland）
• WuXi AppTec（China）
• SGS S.A.（Switzerland）
• Premier Research（USA）

結論と推奨事項

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