临床试验支援服务市场：依阶段、服务、赞助商和地区，2024年至2031年

临床试验支援服务市场评估-2024-2031

临床试验日益全球化，推动了对能够管理跨多个国家和地区的临床试验的临床试验支援服务的需求，刺激市场成长。开发新药的成本不断上升，对製药公司带来提高效率、降低成本的压力。估计2024年将超过6.7602亿美元，2031年估值将达到约9.7993亿美元。

除此之外，电子资料收集（EDC）系统和云端运算等技术进步提高临床试验的效率和有效性。这为临床试验支援服务提供者提供创新解决方案创造了机会，使利基市场在2024年至2031年期间的年复合成长率达到 4.75%。

临床试验支援服务市场定义/概述

临床试验支援服务是指向製药和生技公司提供的一系列服务，以协助临床试验的规划、实施和管理。这些服务包括场地选择、病患招募、资料管理、法规遵循和安全监控等活动。

临床试验支援服务对于临床试验的有效和成功进行非常重要。它有助于降低成本、提高资料品质并加速药物开发流程。临床试验支援服务由专门的合约研究组织（CRO）或製药和生物技术公司的内部团队提供。

慢性病的增加如何推动临床试验支持服务市场的成长？

由于全球慢性病的增加，製药公司倾向于在全球范围内扩大其临床试验活动。这些公司寻找高效且经济的方式针对不同人群进行试验，这一趋势推动全球临床试验支援服务市场的成长。根据世界卫生组织（WHO）的资料，2021年慢性病将占全球死亡人数的71%，凸显了新治疗方法的迫切性。例如，2024年3月15日，Parexel International宣布推出增强型分散式临床试验平台，目的是改善全球试验的患者招募和保留。

临床试验的复杂性日益增加，特别是在基因治疗和个人化医疗等新兴治疗领域，也是市场的主要驱动力。这些先进的临床试验需要专业知识和先进的技术，这导致对综合支援服务的需求增加。美国食品药物管理局在2023年批准了 55 种新药，其中许多包括复杂的试验设计。2024年 9月 1 日，IQVIA 推出了由 AI 驱动的临床试验最佳化套件，目的是简化复杂的试验方案创建和地点选择流程。

严格的监管要求以及对资料品质和完整性的需求刺激临床试验支援服务的采用。发起人越来越依赖专业服务提供者来帮助他们应对复杂的监管环境并确保跨多个司法管辖区的合规性。欧洲药品管理局报告指出，2023年临床试验申请数量将比前一年增加 12%。例如，2024年 6月 30 日，Syneos Health 宣布收购一家领先的监管事务咨询公司，以增强其在全球监管策略和临床试验提交管理方面的能力。

病患获取率和保留率的上升为何抑制临床试验支持服务市场？

全球临床试验支援服务市场在病患招募和留任方面面临重大障碍。例如，2024年 6月 12 日，IQVIA 宣布推出 One Home for Sites（TM）。这是一个新的技术平台，可作为一个站点进行的所有临床试验所需执行的关键系统和任务的单一登入和单一仪表板。多样化的主题和严格的资格标准往往会导致延误和成本增加。

遵守不同地区的法规也是一项重大挑战。不同的标准和要求意味着必须谨慎应对复杂的监管环境。欧洲药品管理局（EMA）在2022年报告指出，欧盟进行的68%的临床试验包括多个成员国，凸显了流程协调的必要性。例如，Parexel 于2024年 9月 4 日宣布增强其真实世界研究（RWR）产品，整合其科学资料组织（SDO）和真实世界证据（RWE）功能，以更满足不断成长的客户需求。

资料管理和完整性对临床试验提出了持续的挑战。确保在不同地点和系统之间收集一致、高品质的资料对于临床试验的成功非常重要。根据美国食品药物管理局（FDA）的资料，2019-2023年期间发给临床试验发起者的警告信中，79%都提到了资料完整性问题。为了因应这项挑战，Medidata 于2024年 6月 18 日宣布推出 Clinical Data Studio，利用 AI 来实现临床试验中资料体验的现代化。

目录

第1章 全球临床试验支援服务市场简介

• 市场介绍
• 研究范围
• 先决条件

第2章 执行摘要

第3章 VERIFIED MARKET RESEARCH的研究方法

• 资料探勘
• 验证
• 主要来源
• 资料来源列表

第4章 临床试验支援服务的全球市场展望

• 概述
• 市场动态
  • 促进因素
  • 抑制因素
  • 机会
• 波特五力模型
• 价值链分析

第5章 临床试验支援服务的全球市场：依阶段

• 概述
• 第一阶段
• 第二阶段
• 第三阶段
• 第四阶段

第6章 全球临床试验支援服务市场：依服务

• 概述
• 临床试验现场管理
• 病患招募管理
  • 病患招募与登记服务
  • 患者保留
  • 其他
• 资料管理
• 行政人员
• 内部审核委员会
• 其他

第7章 全球临床试验支援服务市场：依赞助商

• 概述
• 製药和生物製药
• 医疗设备
• 其他

第8章 全球临床试验支援服务市场：依地区

• 概述
• 北美洲
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 其他欧洲国家
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 其他亚太地区
• 世界其他地区
  • 拉丁美洲
  • 中东和非洲

第9章 全球临床试验支援服务市场的竞争格局

• 概述
• 各公司的市场排名
• 主要发展策略

第10章 公司简介

• IQVIA Holding Inc.
• Icon Plc
• WuXi AppTec
• LabCorp
• Syneos Health
• Eurofins Scientific
• PPD Inc.
• Parexel International Corporation
• Charles River Laboratories International
• Alcura

第11章 附录

• 相关研究

Clinical Trials Support Services Market Valuation - 2024-2031

The increasing globalization of clinical trials has led to a demand for clinical trial support services that can manage trials in multiple countries and regions, propelling the market growth. The cost of developing new drugs is rising, putting pressure on pharmaceutical companies to improve efficiency and reduce costs, and surpassing USD 676.02 Million in 2024 to reach a valuation of around USD 979.93 Million by 2031.

In addition to this, technological advancements, such as electronic data capture (EDC) systems and cloud computing, are improving the efficiency and effectiveness of clinical trials. This has created opportunities for clinical trial support service providers to offer innovative solutions, enabling the niche market grow at a CAGR of 4.75% from 2024 to 2031.

Clinical Trials Support Services Market: Definition/ Overview

Clinical trial support services refer to a range of services provided to pharmaceutical and biotechnology companies to assist in the planning, execution, and management of clinical trials. These services can include activities such as site selection, patient recruitment, data management, regulatory compliance, and safety monitoring.

Clinical trial support services are essential for ensuring the efficient and successful conduct of clinical trials. They can help to reduce costs, improve data quality, and accelerate the drug development process. Clinical trial support services can be provided by specialized contract research organizations (CROs) or by in-house teams within pharmaceutical and biotechnology companies.

How the Rising Cases of Chronic Diseases Upsurging the Growth of Clinical Trials Support Services Market?

The increasing prevalence of chronic diseases worldwide has spurred pharmaceutical companies to expand their clinical trial activities globally. This trend is driving the growth of the global Clinical Trials Support Services Market, as these companies seek efficient and cost-effective ways to conduct trials across diverse populations. According to the World Health Organization, chronic diseases were responsible for 71% of global deaths in 2021, highlighting the urgent need for new treatments. For instance, on March 15, 2024, Parexel International announced the launch of its enhanced decentralized clinical trial platform, aiming to improve patient recruitment and retention rates in global studies.

The rising complexity of clinical trials, particularly in emerging therapeutic areas like gene therapy and personalized medicine, is another key driver of the market. These advanced trials require specialized expertise and sophisticated technologies, leading to increased demand for comprehensive support services. The U.S. Food and Drug Administration approved 55 novel drugs in 2023, many of which involved complex trial designs. In a significant move on September 1, 2024, IQVIA unveiled its AI-powered clinical trial optimization suite, designed to streamline protocol development and site selection processes for intricate studies.

Stringent regulatory requirements and the need for data quality and integrity are fueling the adoption of clinical trial support services. Sponsors are increasingly relying on specialized service providers to navigate the complex regulatory landscape and ensure compliance across multiple jurisdictions. The European Medicines Agency reported a 12% increase in clinical trial applications in 2023 compared to the previous year. For instance, on June 30, 2024, Syneos Health announced its acquisition of a leading regulatory affairs consultancy, bolstering its capabilities in global regulatory strategy and submission management for clinical trials.

How the Rising Patient Recruitment and Retention Restraining the Clinical Trials Support Services Market?

The global Clinical Trials Support Services Market faces significant hurdles in patient recruitment and retention. For instance, on 12 June 2024, IQVIA announced the launch of One Home for Sites(TM), a new technology platform that acts as a single sign-on and a single dashboard for the key systems and tasks a clinical research site needs to perform across all the clinical trials it is conducting. Diverse populations and stringent eligibility criteria often lead to delays and increased costs.

Regulatory compliance across different regions presents another major challenge. Varying standards and requirements necessitate careful navigation of complex regulatory landscapes. The European Medicines Agency (EMA) reported in 2022 that 68% of clinical trials conducted in the EU involved multiple member states, highlighting the need for harmonized processes. For instance, on 04 September 2024, Parexel, announced the strengthening of its Real-World Research (RWR) offering, bringing together the company's Scientific Data Organization (SDO) and Real-World Evidence (RWE) capabilities to better meet growing customer needs.

Data management and integrity pose ongoing difficulties in clinical trials. Ensuring consistent, high-quality data collection across diverse sites and systems is crucial for trial success. The U.S. Food and Drug Administration (FDA) found that data integrity issues were cited in 79% of warning letters issued to clinical trial sponsors between 2019 and 2023. To address this challenge, on 18 June 2024, Medidata launched clinical data studio, leveraging AI to modernize the data experience in clinical trials.

Category-Wise Acumens

What are the Features Bolstering the Demand of Patient Recruitment Management Segment?

Patient recruitment management has emerged as a dominant segment in the clinical trials support services market, driven by the critical need to identify, enroll, and retain suitable participants for clinical studies. This growth of this segment arises from its ability to address one of the most persistent challenges in clinical research: insufficient or slow patient enrollment. According to the National Center for Biotechnology Information (NCBI), a study published in 2022 revealed that 86% of clinical trials fail to meet recruitment timelines, underscoring the vital role of effective patient recruitment strategies.

The dominance of patient recruitment management is further reinforced by its potential to reduce costs and timelines associated with clinical trials. By employing targeted outreach, digital marketing, and data-driven approaches, service providers can significantly improve the efficiency of the recruitment process. The U.S. Department of Health and Human Services reported in 2023 that patient recruitment accounts for nearly 30% of the total time spent on clinical trials.

How will the demand for Residential Clinical Trials Support Services Impacts the Market Growth?

Pharmaceutical and biopharmaceutical companies are dominating the Clinical Trials Support Services Market due to their substantial investment in research and development, particularly for novel therapies and personalized medicines. These companies rely heavily on clinical trials to bring new drugs to market, driving demand for specialized support services. According to the U.S. National Institutes of Health (NIH), as of 2023, the pharmaceutical industry sponsored 70% of all clinical trials registered on ClinicalTrials.gov.

The complexity of modern clinical trials, especially in areas like oncology and rare diseases, has further cemented the dominance of pharmaceutical and biopharmaceutical companies in this market. These trials often require advanced technologies, specialized expertise, and global reach that many pharma companies can afford to access through support service providers. The European Medicines Agency (EMA) reported in its 2023 annual report that 62% of all clinical trial applications in the EU were submitted by pharmaceutical companies. Highlighting this trend, on 03 October 2023, IQVIA, announced a strategic collaboration with argenx to advance treatment to patients with rare autoimmune diseases through innovative and integrated technology-enabled pharmacovigilance (PV) safety services and solutions.

Country/Region-wise Acumens

How will the Developed Healthcare Infrastructure Affects the Clinical Trials Support Services Market in North America?

North America maintains a dominant position in the clinical trials support services market due to its robust healthcare infrastructure, significant R&D investments. The region's advanced technological capabilities and large pool of experienced researchers contribute to its leadership. According to the National Institutes of Health (NIH), as of 2023, the United States conducted over 40% of the world's clinical trials, highlighting its pivotal role in global drug development.

The presence of major pharmaceutical companies and contract research organizations (CROs) further solidifies North America's dominance in the market. These organizations continually invest in innovative trial designs and cutting-edge technologies to improve trial efficiency and outcomes. The U.S. Food and Drug Administration (FDA) reported that in 2022, it received 65% more Investigational New Drug (IND) applications compared to a decade ago, indicating sustained growth in clinical research activities. Addressing the increasing demand for specialized trial support, on 24 June 2021, IQVIA introduced Clinical Data Analytics Suite (CDAS), a new SaaS-based clinical data analytics platform that combines structured and unstructured data from clinical trials into a single, standardized setting for easier access and use.

How will the Strong Regulatory Framework Support the Market Growth in the Europe?

Europe is emerging as the fastest-growing region in the clinical trials support services market due to its strong regulatory framework, and increasing investment in research and development. The European Medicines Agency (EMA) reported that in 2022, the number of clinical trial applications in the EU increased by 12% compared to the previous year, indicating a growing demand for support services. This growth is further fueled by the implementation of the EU Clinical Trials Regulation, which aims to harmonize and streamline the clinical trial process across member states.

The attractiveness for clinical trials in this region is also bolstered by its diverse patient population and high-quality medical facilities. According to the European Commission's Directorate-General for Health and Food Safety, as of 2023, 19% of global clinical trials were conducted in Europe, second only to North America. This significant market share is expected to grow further as pharmaceutical companies increasingly recognize the benefits of conducting trials in the region.

Competitive Landscape

The clinical trials support services market is a dynamic and competitive landscape, with a mix of established players and emerging challengers vying for market share. These players are actively working to strengthen their presence by implementing strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations are dedicated to continuously improving their product line to meet the needs of a wide range of customers in different regions.

Some of the key players operating in the clinical trials support services market include:

Charles River Laboratories International, Inc.

Wuxi Apptec, Inc

Syneos Health, Inc.

Eurofins Scientific

PPD, Inc. (Pharmaceutical Product Development)

Icon Plc

Laboratory Corporation of America Holdings (Labcorp)

Alcura

Parexel International Corporation

Latest Developments

In July 2024, DocMode Health Technologies implemented novel clinical research services. The company's objective is to offer comprehensive solutions that include data analysis, regulatory compliance, clinical trial management, and more. The service will assist pharmaceutical companies, healthcare providers, and researchers in the efficient and effective execution of high-quality clinical studies.

In June 2024, Labcorp Global Trial Connect, a central laboratory solution that was introduced, is designed to accelerate the pace of clinical trials. The solution is a digital and data solution that simplifies investigator site workflows, reduces data delays, and supports clinical trial efficacy.

Clinical Trials Support Services Market, By Category

• Phase:
• Phase I
• Phase II
• Phase III
• Phase IV
• Service:
• Clinical Trial Site Management
• Patient Recruitment Management
• Patient recruitment & Registry Services
• Patient retention
• Others
• Data Management
• Administrative Staff
• IRB
• Others
• Sponsor:
• Pharmaceutical & Biopharmaceutical Companies
• Medical Device Companies
• Others
• Region:
• North America
• Asia-Pacific
• Europe
• South America
• Middle East & Africa

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL CLINICAL TRIAL SUPPORT SERVICES MARKET

• 1.1 Introduction of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL CLINICAL TRIAL SUPPORT SERVICES MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL CLINICAL TRIAL SUPPORT SERVICES MARKET, BY PHASE

• 5.1 Overview
• 5.2 Phase I
• 5.3 Phase II
• 5.4 Phase III
• 5.5 Phase IV

6 GLOBAL CLINICAL TRIAL SUPPORT SERVICES MARKET, BY SERVICE

• 6.1 Overview
• 6.2 Clinical Trial Site Management
• 6.3 Patient Recruitment Management
  • 6.3.1 Patient recruitment & Registry Services
  • 6.3.2 Patient retention
  • 6.3.3 Others
• 6.4 Data Management
• 6.5 Administrative Staff
• 6.6 IRB
• 6.7 Others

7 GLOBAL CLINICAL TRIAL SUPPORT SERVICES MARKET, BY SPONSOR

• 7.1 Overview
• 7.2 Pharmaceutical & Biopharmaceutical
• 7.3 Medical Devices
• 7.4 Others

8 GLOBAL CLINICAL TRIAL SUPPORT SERVICES MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East and Africa

9 GLOBAL CLINICAL TRIAL SUPPORT SERVICES MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 IQVIA Holding Inc.
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Icon Plc
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 WuXi AppTec
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 LabCorp
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Syneos Health
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Eurofins Scientific
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 PPD Inc.
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Parexel International Corporation
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Charles River Laboratories International
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Alcura
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 Appendix

• 11.1 Related Research