首頁 > 市場調查報告書 > 製藥

臨床實驗

市場調查報告書

商品編碼

1626577

臨床試驗支援服務市場：依階段、服務、贊助商和地區，2024年至2031年

Clinical Trials Support Services Market By Phase (Phase I, Phase II), Service (Clinical Trial Site Management, Patient Recruitment), Sponsor (Pharmaceutical Companies, Medical Device Companies), & Region for 2024-2031

出版日期: 2024年10月29日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

價格

簡介目錄

臨床試驗支援服務市場評估-2024-2031

臨床試驗日益全球化，推動了對能夠管理跨多個國家和地區的臨床試驗的臨床試驗支援服務的需求，刺激市場成長。開發新藥的成本不斷上升，對製藥公司帶來提高效率、降低成本的壓力。估計2024年將超過6.7602億美元，2031年估值將達到約9.7993億美元。

除此之外，電子資料收集（EDC）系統和雲端運算等技術進步提高臨床試驗的效率和有效性。這為臨床試驗支援服務提供者提供創新解決方案創造了機會，使利基市場在2024年至2031年期間的年複合成長率達到 4.75%。

臨床試驗支援服務市場定義/概述

臨床試驗支援服務是指向製藥和生技公司提供的一系列服務，以協助臨床試驗的規劃、實施和管理。這些服務包括場地選擇、病患招募、資料管理、法規遵循和安全監控等活動。

臨床試驗支援服務對於臨床試驗的有效和成功進行非常重要。它有助於降低成本、提高資料品質並加速藥物開發流程。臨床試驗支援服務由專門的合約研究組織（CRO）或製藥和生物技術公司的內部團隊提供。

慢性病的增加如何推動臨床試驗支持服務市場的成長？

由於全球慢性病的增加，製藥公司傾向於在全球範圍內擴大其臨床試驗活動。這些公司尋找高效且經濟的方式針對不同人群進行試驗，這一趨勢推動全球臨床試驗支援服務市場的成長。根據世界衛生組織（WHO）的資料，2021年慢性病將佔全球死亡人數的71%，凸顯了新治療方法的迫切性。例如，2024年3月15日，Parexel International宣布推出增強型分散式臨床試驗平台，目的是改善全球試驗的患者招募和保留。

臨床試驗的複雜性日益增加，特別是在基因治療和個人化醫療等新興治療領域，也是市場的主要驅動力。這些先進的臨床試驗需要專業知識和先進的技術，這導致對綜合支援服務的需求增加。美國食品藥物管理局在2023年批准了 55 種新藥，其中許多包括複雜的試驗設計。2024年 9月 1 日，IQVIA 推出了由 AI 驅動的臨床試驗最佳化套件，目的是簡化複雜的試驗方案創建和地點選擇流程。

嚴格的監管要求以及對資料品質和完整性的需求刺激臨床試驗支援服務的採用。發起人越來越依賴專業服務提供者來幫助他們應對複雜的監管環境並確保跨多個司法管轄區的合規性。歐洲藥品管理局報告指出，2023年臨床試驗申請數量將比前一年增加 12%。例如，2024年 6月 30 日，Syneos Health 宣布收購一家領先的監管事務諮詢公司，以增強其在全球監管策略和臨床試驗提交管理方面的能力。

病患獲取率和保留率的上升為何抑制臨床試驗支持服務市場？

全球臨床試驗支援服務市場在病患招募和留任方面面臨重大障礙。例如，2024年 6月 12 日，IQVIA 宣布推出 One Home for Sites（TM）。這是一個新的技術平台，可作為一個站點進行的所有臨床試驗所需執行的關鍵系統和任務的單一登入和單一儀表板。多樣化的主題和嚴格的資格標準往往會導致延誤和成本增加。

遵守不同地區的法規也是一項重大挑戰。不同的標準和要求意味著必須謹慎應對複雜的監管環境。歐洲藥品管理局（EMA）在2022年報告指出，歐盟進行的68%的臨床試驗包括多個成員國，凸顯了流程協調的必要性。例如，Parexel 於2024年 9月 4 日宣布增強其真實世界研究（RWR）產品，整合其科學資料組織（SDO）和真實世界證據（RWE）功能，以更滿足不斷成長的客戶需求。

資料管理和完整性對臨床試驗提出了持續的挑戰。確保在不同地點和系統之間收集一致、高品質的資料對於臨床試驗的成功非常重要。根據美國食品藥物管理局（FDA）的資料，2019-2023年期間發給臨床試驗發起者的警告信中，79%都提到了資料完整性問題。為了因應這項挑戰，Medidata 於2024年 6月 18 日宣布推出 Clinical Data Studio，利用 AI 來實現臨床試驗中資料體驗的現代化。

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.

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