臨床試験支援サービス市場：フェーズ、サービス、スポンサー、地域別、2024～2031年

臨床試験支援サービス市場の評価 - 2024～2031年

臨床試験の世界化の進展により、複数の国や地域での臨床試験を管理できる臨床試験支援サービスへの需要が高まり、市場成長を促進しています。新薬の開発コストは上昇しており、製薬会社は効率改善とコスト削減を迫られています。2024年には6億7,602万米ドルを超え、2031年には約9億7,993万米ドルの評価額に達します。

これに加えて、電子データ収集（EDC）システムやクラウドコンピューティングなどの技術的進歩により、臨床試験の効率性と有効性が向上しています。これにより、臨床試験支援サービスプロバイダーが革新的なソリューションを提供する機会が生まれ、ニッチ市場は2024年から2031年にかけてCAGR 4.75％で成長することが可能になりました。

臨床試験支援サービス市場定義/概要

臨床試験支援サービスとは、臨床試験の計画、実施、管理を支援するために製薬企業やバイオテクノロジー企業に提供される一連のサービスを指します。これらのサービスには、施設選定、患者募集、データ管理、規制遵守、安全性モニタリングなどの活動が含まれます。

臨床試験支援サービスは、臨床試験を効率的かつ成功裏に実施するために不可欠です。コスト削減、データの質の向上、医薬品開発プロセスの加速に役立ちます。臨床試験支援サービスは、専門の調査受託機関（CRO）または製薬会社やバイオテクノロジー企業の社内チームによって提供されます。

慢性疾患の増加が臨床試験支援サービス市場の成長をどのように加速しているか？

慢性疾患の世界の増加により、製薬企業は臨床試験活動を世界に拡大する傾向にあります。これらの企業は多様な集団にわたって試験を実施するための効率的かつ費用対効果の高い方法を模索しており、この傾向は世界的な臨床試験サポートサービス市場の成長を促進しています。世界保健機関（WHO）によると、2021年の世界の死亡原因の71％は慢性疾患であり、新たな治療法の緊急性が浮き彫りになっています。例えば、2024年3月15日、Parexel Internationalは、世界の試験における患者の募集と維持率の向上を目指し、強化された分散型臨床試験プラットフォームの立ち上げを発表しました。

特に遺伝子治療や個別化医療などの新興治療領域で臨床試験の複雑性が高まっていることも、市場の主要な促進要因です。こうした高度な臨床試験には専門的な知識と高度な技術が必要とされるため、包括的なサポートサービスへの需要が高まっています。米国食品医薬品局は2023年に55の新薬を承認しましたが、その多くは複雑な試験デザインを伴うものでした。IQVIAは2024年9月1日、AIを活用した臨床試験最適化スイートを発表し、複雑な試験のプロトコール作成と施設選定プロセスを合理化するよう設計しました。

厳しい規制要件とデータの品質と完全性の必要性が、臨床試験支援サービスの採用に拍車をかけています。スポンサーは、複雑な規制状況をナビゲートし、複数の法域におけるコンプライアンスを確保するために、専門のサービスプロバイダーへの依存を強めています。欧州医薬品庁は、2023年の臨床試験申請件数が前年比で12％増加したと報告しています。例えば、2024年6月30日、Syneos Healthは大手薬事コンサルタント会社の買収を発表し、臨床試験の世界薬事戦略と申請管理の能力を強化しました。

臨床試験支援サービス市場を抑制する患者確保・維持率の上昇とは？

世界の臨床試験支援サービス市場は、患者の募集と維持において大きな障害に直面しています。例えば、2024年6月12日、IQVIAはOne Home for Sites（TM）の発売を発表しました。これは、治験実施施設が実施するすべての臨床試験において実行する必要がある主要なシステムやタスクのシングルサインオンおよびシングルダッシュボードとして機能する新しいテクノロジープラットフォームです。多様な被験者と厳しい適格性基準は、しばしば遅延とコスト増につながります。

異なる地域間での規制遵守も大きな課題です。基準や要件が異なるため、複雑な規制状況を注意深くナビゲートする必要があります。欧州医薬品庁（EMA）は2022年、EUで実施された臨床試験の68％が複数の加盟国に関与していると報告し、プロセスの調和の必要性を強調しました。例えば、Parexelは2024年9月4日、リアルワールド調査（RWR）サービスの強化を発表し、同社の科学的データ組織（SDO）とリアルワールドエビデンス（RWE）機能を統合して、拡大する顧客ニーズへの対応を強化しました。

臨床試験において、データ管理と完全性は継続的な困難をもたらします。臨床試験を成功させるためには、多様な施設やシステムで一貫した高品質のデータ収集を確保することが極めて重要です。米国食品医薬品局（FDA）によると、2019年から2023年の間に臨床試験スポンサーに出された警告状の79％でデータインテグリティの問題が挙げられています。この課題に対処するため、メディデータは2024年6月18日、AIを活用して臨床試験のデータ体験を近代化するclinical data studioを発表しました。

目次

第1章 世界の臨床試験支援サービス市場のイントロダクション

• 市場イントロダクション
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 臨床試験支援サービスの世界市場展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル
• バリューチェーン分析

第5章 臨床試験支援サービスの世界市場：フェーズ別

• 概要
• フェーズi
• フェーズII
• フェーズIII
• フェーズIV

第6章 臨床試験支援サービスの世界市場：サービス別

• 概要
• 治験施設管理
• 患者募集管理
  • 患者募集・登録サービス
  • 患者維持
  • その他
• データ管理
• 管理スタッフ
• IRB
• その他

第7章 臨床試験支援サービスの世界市場：スポンサー別

• 概要
• 製薬・バイオ医薬品
• 医療機器
• その他

第8章 臨床試験支援サービスの世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • ラテンアメリカ
  • 中東・アフリカ

第9章 世界の臨床試験支援サービス市場の競合情勢

• 概要
• 各社の市場ランキング
• 主な発展戦略

第10章 企業プロファイル

• 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 付録

• 関連調査

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