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醫療保健外包市場規模、佔有率和成長分析（按服務類型、行業、最終用戶和地區分類）—產業預測（2026-2033 年）

市場調查報告書

商品編碼

1898465

醫療保健外包市場規模、佔有率和成長分析（按服務類型、行業、最終用戶和地區分類）—產業預測（2026-2033 年）

Medical Affairs Outsourcing Market Size, Share, and Growth Analysis, By Service Type (Medical Writing & Publishing, Medical Monitoring), By Industry (Pharmaceuticals, Biotechnology), By End-User, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月22日 | 出版商:

SkyQuest | 英文 157 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

預計到 2024 年，醫療保健營運外包市場規模將達到 21.8 億美元，到 2025 年將達到 24.8 億美元，到 2033 年將達到 68.7 億美元，在預測期（2026-2033 年）內，複合年成長率為 13.6%。

受傳染病和非傳染病日益普遍導致的臨床試驗增加的推動，醫療營運外包市場正經歷顯著成長。臨床活動的激增帶動了對醫療設備和創新藥物的需求，進而增加了對外包服務的需求。合約研究組織 (CRO) 提供成本效益高、交付品質高的服務，並滿足嚴格的監管要求，這些優勢進一步鞏固了市場前景。疫情加速了虛擬互動，提升了科學交流的重要性，進而進一步改變了這個領域。在製藥和醫療設備產業面臨價格壓力等挑戰之際，醫療營運外包提供了策略優勢。與經驗豐富的 CRO 合作能夠幫助企業提高營運效率、增強合規性並降低風險，從而進一步推動外包趨勢的持續發展。

醫療保健外包市場促進因素

業界對真實世界證據 (RWE) 的需求日益成長，以證實醫療產品的有效性和安全性。這一趨勢提升了醫療營運外包服務提供者的重要性，他們在產生、分析和分發真實世界數據方面發揮關鍵作用。這些服務提供者利用這些資訊來增強藥品和醫療設備的價值提案，最終幫助企業做出明智的決策，並增強醫療專業人員和病患的信心。從真實世界證據中獲得的洞見對於在日常臨床環境中展現治療的實際益處和有效性至關重要。

限制醫療外包市場的因素

醫療營運外包市場在確保外包職能時品質一致性和遵守內部標準合規義務方面面臨諸多挑戰。依賴外部合作夥伴可能導致難以維持所需的監控水準和一致性。為因應這些挑戰，各機構必須建立健全的管治結構和監控體系，有效監督外包活動。這將有助於他們更好地管理相關風險，提升整體醫療營運的完整性，並確保在整個外包過程中始終符合合規性和品質標準。

醫療業務外包市場趨勢

隨著製藥和醫療設備製造商越來越重視利用真實世界數據 (RWE) 來支援其產品的安全性、有效性和整體價值，醫療營運外包市場正經歷著顯著的趨勢。隨著監管環境的不斷變化和對可靠證據需求的日益成長，外包服務提供者正成為產生和分析真實世界數據的關鍵參與者。這些合作有助於循證決策，提高監管申報的質量，並使企業能夠有效應對市場准入和相關人員溝通等複雜挑戰。這種向數據驅動策略的轉變，使外包公司成為推動創新和改善病患療效的關鍵盟友。

醫學寫作出版
- 臨床試驗報告
- 監管文件
- 學術出版品
醫療監測
- 安全監控
- 療效監測
醫療資訊
- 查詢回覆
- 醫學文獻綜述
醫藥學術專員（MSL）
- KOL互動
- 科學傳播
監管事務
- 監管文件
- 合規管理
其他
- 藥物安全檢測
- 培訓和教育

全球醫療保健外包市場規模（按產業垂直領域分類）及複合年成長率（2026-2033 年）

製藥
生物技術
醫療設備

全球醫療外包市場規模（依最終用戶分類）及複合年成長率（2026-2033 年）

中小企業
主要企業

全球醫療外包市場規模及複合年成長率（2026-2033）

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
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 其他拉丁美洲
中東和非洲
- GCC
- 南非
- 其他中東和非洲地區

競爭資訊

前五大公司對比
主要企業的市場定位（2025 年）
主要市場參與者所採取的策略
近期市場趨勢
公司市佔率分析（2025 年）
主要企業公司簡介
- 公司詳情
- 產品系列分析
- 依業務板塊進行公司股票分析
- 2021-2023年營收年比比較
主要企業簡介
- ICON plc（愛爾蘭）
- IQVIA Holdings Inc.（美國）
- 醫療事務公司（TMAC）（美國）
- Syneos Health, Inc.（美國）
- 賽默飛世爾科技公司（美國）
- PAREXEL國際公司（美國）
- PPD公司（美國）
- 查爾斯河實驗室（美國）
- 科文斯公司（美國）
- Medpace Holdings, Inc.（美國）
- Pharm-Olam International（美國）
- Clinipace Worldwide（美國）
- PRA Health Sciences（美國）
- KCR SA（波蘭）
- 藥明康德（中國）
- SGS SA（瑞士）
- Premier Research（美國）

結論與建議

簡介目錄

Product Code: SQMIG35D2142

Medical Affairs Outsourcing Market size was valued at USD 2.18 Billion in 2024 and is poised to grow from USD 2.48 Billion in 2025 to USD 6.87 Billion by 2033, growing at a CAGR of 13.6% during the forecast period (2026-2033).

The medical affairs outsourcing market is witnessing significant growth, propelled by the increase in clinical trials due to the rising prevalence of both communicable and non-communicable diseases. This surge in clinical activity is driving demand for medical devices and innovative drugs, heightening the need for outsourcing services. The combination of cost-efficiency and high-quality outputs from contract research organizations, along with strict regulatory demands, enhances market prospects. The pandemic has further transformed the field by accelerating virtual interactions and elevating the importance of scientific communication. As pharmaceutical and medical device industries cope with challenges like pricing pressures, outsourcing medical affairs becomes a strategic advantage. Collaborating with experienced CROs allows companies to streamline operations, improve compliance, and mitigate risks, promoting a trend toward continued outsourcing.

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 Segments 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 demand for real-world evidence to validate the efficacy and safety of healthcare products is on the rise within the industry. This trend is driving the significance of medical affairs outsourcing providers, who are instrumental in the generation, analysis, and distribution of real-world data. By harnessing this information, these providers enhance the value proposition of pharmaceutical products and medical devices, ultimately supporting companies in making informed decisions and fostering trust among healthcare professionals and patients alike. The insights gained from real-world evidence are essential for demonstrating the tangible benefits and effectiveness of treatments in everyday clinical settings.

Restraints in the Medical Affairs Outsourcing Market

The Medical Affairs Outsourcing market faces obstacles related to ensuring uniform quality and adherence to internal standards and compliance obligations when delegating these functions. The reliance on external partners can create difficulties in maintaining the desired level of oversight and consistency. To address these challenges, organizations need to implement strong governance structures and monitoring systems that effectively oversee the outsourced activities. By doing so, they can better manage the associated risks and enhance the overall integrity of their medical affairs operations, ensuring that compliance and quality benchmarks are consistently met throughout the outsourcing process.

Market Trends of the Medical Affairs Outsourcing Market

The Medical Affairs Outsourcing market is witnessing a significant trend as pharmaceutical and medical device companies prioritize the utilization of real-world evidence to assert the safety, efficacy, and overall value of their products. As regulatory landscapes evolve and the demand for robust evidence intensifies, outsourcing providers have become essential in generating and analyzing real-world data. These partnerships facilitate evidence-based decision-making and enhance the quality of regulatory submissions, enabling companies to navigate the complexities of market access and stakeholder communication more effectively. This shift towards data-driven strategies positions outsourcing firms as pivotal allies in driving innovation and improving patient outcomes.

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, 2025
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 (2026-2033)

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 (2026-2033)

Market Overview
Pharmaceuticals
Biotechnology
Medical Devices

Global Medical Affairs Outsourcing Market Size by End-User & CAGR (2026-2033)

Market Overview
Small & Medium Enterprises (SMEs)
Large Enterprises

Global Medical Affairs Outsourcing Market Size & CAGR (2026-2033)

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, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2021-2023)

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