合約研究組織 (CRO) 市場機會、成長動力、產業趨勢分析及 2025-2034 年預測

2023 年全球合約研究組織市場規模達到 598 億美元，預計 2024 年至 2032 年期間的複合年成長率將達到 8.1%。隨著製藥和生物技術公司尋求具有成本效益的解決方案以加速藥物開發並滿足嚴格的監管要求，對外包研究服務的需求正在激增。隨著全球臨床試驗數量的不斷成長，CRO 在簡化藥物研發、降低營運成本和提高研究效率方面發揮著至關重要的作用。醫學研究的投資持續增加，進一步加強了市場的成長軌跡。

慢性病的日益普及推動了對創新治療的需求，促使製藥公司依賴專業研究公司。 CRO 提供臨床試驗、法規遵循和實驗室服務的專業知識，使其成為製藥和生物技術領域不可或缺的一部分。外包研究使公司能夠專注於創新，同時利用 CRO 的基礎設施和經驗來應對複雜的監管環境。此外，精準醫療、基因療法和生物製劑的進步正在擴大合約研究服務的範圍，為產業參與者創造新的機會。全球向個人化醫療的轉變進一步擴大了對專業研究的需求，CRO 促進了標靶治療和尖端醫療解決方案的發展。

市場按服務類型細分為早期開發、臨床研究、實驗室和監管諮詢服務。臨床研究服務引領產業發展，2023 年創造了 345 億美元的收入。隨著對創新治療和診斷的需求不斷成長，這一領域將繼續蓬勃發展。臨床研究分為四個階段，每個階段對於新療法推向市場至關重要。慢性病病例的增加加劇了臨床試驗的需求，促使製藥公司擴大研究力道。外包研究使公司能夠最佳化資源、加快藥物核准流程並提高臨床試驗的效率。

合約研究組織市場也依治療領域分類，包括腫瘤學、心臟病學、傳染病、神經病學、胃腸病學、肝病學、眼科學等。 2023 年，腫瘤學佔據市場主導地位，佔有 54.6% 的佔有率，預計到 2032 年將以 8.5% 的複合年成長率成長。癌症發生率的上升加大了開發先進療法和醫療設備的研究力度，導致臨床試驗活動激增。對突破性治療的追求正在推動對腫瘤學研究的投資，從而導致對合約研究服務的需求大幅增加。隨著新療法的出現，以腫瘤學為重點的試驗正在迅速擴大，鞏固了 CRO 在藥物開發生態系統中的作用。

2023 年北美合約研究組織市場價值為 226 億美元，預計到 2032 年將成長至 444 億美元。該地區主要製藥和生物技術公司的存在為其強大的市場佔有率做出了貢獻。隨著藥物開發變得越來越複雜，對專業知識和最先進基礎設施的需求也不斷成長。 CRO 透過提供全面的研究解決方案、監管支援和數據驅動的見解，在推動醫學研究方面發揮著重要作用，使其成為不斷發展的製藥領域的關鍵參與者。

目錄

第1章：方法論與範圍

第2章：執行摘要

第3章：行業洞察

• 產業生態系統分析
• 產業衝擊力
  • 成長動力
    • 全球研發支出不斷增加
    • 新興經濟體臨床試驗數量不斷增加
    • 研發活動外包日益增多
    • 不斷進步的技術
  • 產業陷阱與挑戰
    • 智慧財產權問題
• 成長潛力分析
• 臨床試驗分析
  • 2018 - 2023 年各地區臨床試驗數量
  • 2018 - 2023 年臨床試驗數量（依開發階段分類）
  • 2018 - 2023 年臨床試驗量（依適應症分類）
• 監管格局
  • 美國
  • 歐洲
  • 亞太地區
    • 新加坡
    • 馬來西亞
    • 印尼
    • 泰國
    • 韓國
    • 菲律賓
• 臨床試驗-亞太優勢
• 藥物發現與開發過程
• 波特的分析
• PESTEL分析

第4章：競爭格局

• 介紹
• 公司矩陣分析
• 競爭市佔率分析
• 策略儀表板
• 併購格局
  • 2018 年至 2023 年 CRO 產業的併購交易
  • 完成合約研究組織併購交易
  • 私募股權在CRO併購中的影響
  • 產業整合對整體市場的影響
  • 分析師見解

第5章：市場估計與預測：按服務類型，2021 年至 2032 年

• 主要趨勢
• 早期開發服務
  • 發現階段
  • 化學、製造和控制（CMC）
  • 臨床前服務
    • 藥物動力學/藥效動力學（PK/PD）
    • 毒理學測試服務
    • 其他臨床前服務
• 臨床研究服務
  • 第一階段
  • 第二階段
  • 第三階段
  • 第四階段
• 實驗室服務
  • 生物分析測試服務
  • 分析測試服務
    • 物理特性
    • 原料檢測
    • 批次放行測試
    • 穩定性測試
    • 其他分析測試服務
• 監理諮詢服務

第6章：市場估計與預測：按治療領域，2021 年至 2032 年

• 主要趨勢
• 腫瘤學
• 臨床藥理學
• 心臟病學
• 傳染病
• 神經病學
• 胃腸病學和肝病學
• 眼科
• 其他治療領域

第7章：市場估計與預測：依最終用途，2021 年至 2032 年

• 主要趨勢
• 製藥和生物製藥公司
• 醫療器材公司
• 學術機構

第8章：市場估計與預測：按地區，2021 年至 2032 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 荷蘭
• 亞太地區
  • 中國
  • 日本
  • 印度
  • 澳洲
  • 韓國
• 拉丁美洲
  • 巴西
  • 墨西哥
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第9章：公司簡介

• Caidya
• Charles River Laboratories
• CMIC HOLDINGS
• EPS Holdings
• ICON plc
• IQVIA (Quintiles IMS)
• Iris Pharma
• Laboratory Corporation of America Holdings
• Lexitas Pharma Services
• Medpace Holdings
• Ora
• Parexel International (MA)
• Pharmaceutical Product Development (Thermo Fisher Scientific)
• Premier Research
• ProTrials Research
• Syneos Health
• TFS HealthScience
• The Emmes Company
• Trial Runners
• Veristat
• Worldwide Clinical Trials
• WuXi Clinical (WuXi AppTec)

The Global Contract Research Organization Market reached USD 59.8 billion in 2023 and is on track to expand at a CAGR of 8.1% from 2024 to 2032. The demand for outsourced research services is surging as pharmaceutical and biotechnology firms seek cost-effective solutions to accelerate drug development and meet stringent regulatory requirements. With a growing number of clinical trials worldwide, CROs are playing a crucial role in streamlining drug discovery, reducing operational costs, and enhancing research efficiency. Investments in medical research continue to rise, further strengthening the market's growth trajectory.

The increasing prevalence of chronic diseases is fueling the need for innovative treatments, driving pharmaceutical companies to rely on specialized research firms. CROs offer expertise in clinical trials, regulatory compliance, and laboratory services, making them indispensable to the pharmaceutical and biotech sectors. Outsourcing research allows companies to focus on innovation while leveraging the infrastructure and experience of CROs to navigate complex regulatory landscapes. Additionally, advancements in precision medicine, gene therapy, and biologics are expanding the scope of contract research services, creating new opportunities for industry players. The global shift toward personalized healthcare is further amplifying the demand for specialized research, with CROs facilitating the development of targeted therapies and cutting-edge medical solutions.

The market is segmented by service type into early phase development, clinical research, laboratory, and regulatory consulting services. Clinical research services led the industry, generating USD 34.5 billion in revenue in 2023. This segment continues to thrive as the demand for innovative treatments and diagnostics rises. Clinical research is structured into four phases, each essential in bringing new therapies to market. The increase in chronic disease cases is intensifying the need for clinical trials, prompting pharmaceutical firms to expand their research efforts. Outsourcing research enables companies to optimize their resources, accelerate drug approval processes, and enhance efficiency in clinical trials.

The contract research organization market is also categorized by therapeutic area, including oncology, cardiology, infectious diseases, neurology, gastroenterology, hepatology, ophthalmology, and others. Oncology dominated the market in 2023 with a commanding 54.6% share and is expected to grow at a CAGR of 8.5% through 2032. The rising incidence of cancer has intensified research efforts to develop advanced therapies and medical devices, leading to an upsurge in clinical trial activity. The push for breakthrough treatments is driving investment in oncology research, leading to a significant increase in demand for contract research services. As new therapies emerge, oncology-focused trials are expanding rapidly, solidifying the role of CROs in the drug development ecosystem.

North America contract research organization market was valued at USD 22.6 billion in 2023, with projections indicating growth to USD 44.4 billion by 2032. The presence of major pharmaceutical and biotechnology firms in the region has contributed to its strong market share. As drug development becomes increasingly complex, the need for specialized expertise and state-of-the-art infrastructure continues to grow. CROs are instrumental in advancing medical research by providing comprehensive research solutions, regulatory support, and data-driven insights, positioning them as key players in the evolving pharmaceutical landscape.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing R&D expenditure worldwide
    • 3.2.1.2 Rising number of clinical trials in emerging economies
    • 3.2.1.3 Growing outsourcing of R&D activities
    • 3.2.1.4 Rising technological advancements
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Intellectual property right issues
• 3.3 Growth potential analysis
• 3.4 Clinical trial analysis
  • 3.4.1 Clinical trial volume, by region, 2018 - 2023
  • 3.4.2 Clinical trial volume, by phase of development, 2018 - 2023
  • 3.4.3 Clinical trial volume, by indication, 2018 - 2023
• 3.5 Regulatory landscape
  • 3.5.1 U.S.
  • 3.5.2 Europe
  • 3.5.3 Asia Pacific
    • 3.5.3.1 Singapore
    • 3.5.3.2 Malaysia
    • 3.5.3.3 Indonesia
    • 3.5.3.4 Thailand
    • 3.5.3.5 South Korea
    • 3.5.3.6 Philippines
• 3.6 Clinical trials- Asia Pacific advantage
• 3.7 Drug discovery and development process
• 3.8 Porter's analysis
• 3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Competitive market share analysis
• 4.4 Strategy dashboard
• 4.5 Merger and acquisition landscape
  • 4.5.1 Merger and acquisition deals in the CRO industry, 2018 – 2023
  • 4.5.2 Completed contract research organization merger and acquisition deals, 2018 - 2023
  • 4.5.3 Influence of private equity in CRO mergers and acquisitions
  • 4.5.4 Impact of industry consolidation on the overall market
  • 4.5.5 Analyst insights

Chapter 5 Market Estimates and Forecast, By Service Type, 2021 – 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Early phase development services
  • 5.2.1 Discovery phase
  • 5.2.2 Chemistry, manufacturing and control (CMC)
  • 5.2.3 Preclinical services
    • 5.2.3.1 Pharmacokinetic/pharmacodynamic (PK/PD)
    • 5.2.3.2 Toxicology testing services
    • 5.2.3.3 Other preclinical services
• 5.3 Clinical research services
  • 5.3.1 Phase I
  • 5.3.2 Phase II
  • 5.3.3 Phase III
  • 5.3.4 Phase IV
• 5.4 Laboratory services
  • 5.4.1 Bioanalytical testing services
  • 5.4.2 Analytical testing services
    • 5.4.2.1 Physical characterization
    • 5.4.2.2 Raw material testing
    • 5.4.2.3 Batch release testing
    • 5.4.2.4 Stability testing
    • 5.4.2.5 Other analytical testing services
• 5.5 Regulatory consulting services

Chapter 6 Market Estimates and Forecast, By Therapeutic Area, 2021 – 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Clinical pharmacology
• 6.4 Cardiology
• 6.5 Infectious disease
• 6.6 Neurology
• 6.7 Gastroenterology and hepatology
• 6.8 Ophthalmology
• 6.9 Other therapeutic areas

Chapter 7 Market Estimates and Forecast, By End Use, 2021 – 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Pharmaceutical and biopharmaceutical companies
• 7.3 Medical device companies
• 7.4 Academic institutes

Chapter 8 Market Estimates and Forecast, By Region, 2021 – 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Netherlands
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE

Chapter 9 Company Profiles

• 9.1 Caidya
• 9.2 Charles River Laboratories
• 9.3 CMIC HOLDINGS
• 9.4 EPS Holdings
• 9.5 ICON plc
• 9.6 IQVIA (Quintiles IMS)
• 9.7 Iris Pharma
• 9.8 Laboratory Corporation of America Holdings
• 9.9 Lexitas Pharma Services
• 9.10 Medpace Holdings
• 9.11 Ora
• 9.12 Parexel International (MA)
• 9.13 Pharmaceutical Product Development (Thermo Fisher Scientific)
• 9.14 Premier Research
• 9.15 ProTrials Research
• 9.16 Syneos Health
• 9.17 TFS HealthScience
• 9.18 The Emmes Company
• 9.19 Trial Runners
• 9.20 Veristat
• 9.21 Worldwide Clinical Trials
• 9.22 WuXi Clinical (WuXi AppTec)