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臨床試験管理システム市場レポート：コンポーネント、展開モード、エンドユーザー、地域別、2024年～2032年

Clinical Trial Management Systems Market Report by Component, Deployment Mode, End User, and Region 2024-2032

出版日
発行
IMARC
ページ情報
英文 144 Pages
納期
2～3営業日
カスタマイズ可能
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=143.57円
臨床試験管理システム市場レポート：コンポーネント、展開モード、エンドユーザー、地域別、2024年～2032年
出版日: 2024年07月01日
発行: IMARC
ページ情報: 英文 144 Pages
納期: 2～3営業日
GIIご利用のメリット
  • 全表示
  • 概要
  • 図表
  • 目次
概要

臨床試験管理システムの世界市場規模は2023年に11億4,680万米ドルに達しました。今後、IMARC Groupは、2024年から2032年にかけての成長率（CAGR）は9.7％を示し、2032年には26億8,200万米ドルに達すると予測しています。臨床試験管理システム（CTMS）市場は、臨床試験の複雑化、遠隔コラボレーションを目的としたクラウドベースのCTMSソリューションの採用増加、規制要件の厳格化、効率性とデータ品質の向上を目的とした患者中心の臨床試験の重視の高まりなどの要因によって推進されています。

臨床試験管理システム市場分析：

主な市場促進要因：臨床試験管理システム市場の成長を後押しするのは、多施設臨床試験の複雑化とクラウド技術の段階的な採用です。臨床試験管理モジュールに対する要件の強化を考慮すると、市場規模は相当程度拡大する可能性があります。

主要市場動向：臨床試験管理システムの展望では、分散型臨床試験の利用増加、仮想臨床試験プラットフォーム、リスクベースのモニタリング手法などの動向が示されています。さらに、既存の臨床試験システムやソフトウェアプラットフォームとの相互接続や統合が重視されるようになっています。

地理的動向：北米は先進的なヘルスケアインフラを整備し、多くの研究開発活動を実施しているため、CTMS市場で主導的な地位を占めています。しかし、医療ツーリズムやインフラ整備により市場が急成長しているアジア太平洋地域やラテンアメリカ地域も、臨床試験のアウトソーシングサービスを提供しています。

競合情勢：臨床試験管理システム業界の主な市場参入企業には、Advarra Inc.、ArisGlobal LLC、BioClinica Inc.、DataTrak International Inc.、DZS Clinical Services Inc.（WDB Holdings Co. Ltd.）、International Business Machines Corporation、Medidata Solutions Inc.（Dassault Systemes SE）、MedNet Solutions Inc.、Oracle Corporation、Parexel International Corporation、RealTime Software Solutions LLC、Veeva Systems Inc.などがあります。

課題と機会：この市場は、データ保護の問題、相互運用性の問題、規制上の課題などの課題に直面しています。このような機会は、高度なアナリティクス、リアルワールドエビデンスの統合、分散型トライアルモデルの実装から判断することができます。

臨床試験管理システム市場動向：

臨床試験の複雑化

プレシジョン・メディシンとパーソナライズド・メディシンの進化により、臨床試験の複雑性が増し、高度な管理ソリューションが求められています。CTMSプラットフォームは、試験計画、プロトコールデザイン、患者登録、データ管理のための包括的なソリューションを提供することで、このような複雑な臨床試験を管理する上で極めて重要な役割を果たしています。CTMSプラットフォームは、プロセスを合理化し、利害関係者間のコラボレーションを促進することで、組織が現代の複雑な臨床研究を効果的に進め、厳格なプロトコルの遵守を保証し、革新的な治療法の開発を加速するのに役立ちます。これらのプラットフォームは、人工知能や機械学習などの先進技術を活用して臨床試験のデザインと実施を最適化し、効率を高めて臨床試験管理システムの収益を生み出しています。

厳しい規制要件

規制機関は、患者の安全性とデータの完全性を維持するために厳格なガイドラインを課しており、CTMSプラットフォームが提供する強固なコンプライアンス管理が必要です。CTMSソリューションは、組織がこれらの規制上の義務を満たすのを支援する堅牢なツールと機能を提供します。CTMSプラットフォームは、プロトコルの遵守や文書管理から、監査準備や規制当局への報告まで、組織が複雑な規制状況を自信を持ってナビゲートし、コンプライアンス・リスクを低減し、規制基準を確実に遵守できるよう支援します。さらに、CTMSプラットフォームには、自動コンプライアンス監視やリアルタイムのリスク評価などの機能が組み込まれており、規制上の問題をプロアクティブに特定して対処することで、コンプライアンス全体の効率と効果を高めることができます。例えば、米国における臨床試験の規制は、2022年食品医薬品オムニバス改革法（FDORA）、1974年プライバシー法、プライバシーと機密性に関するNIHポリシーマニュアルなどの厳しいガイドラインによって管理されています。

患者中心の臨床試験の重視

患者中心主義へのシフトに伴い、CTMSプラットフォームは患者募集ポータルや遠隔モニタリングなどの機能を優先し、患者のエンゲージメントと試験の成功を高めています。臨床研究における患者中心主義の重要性が認識されつつあり、患者のエンゲージメント、経験、リテンションの向上に焦点が当てられています。CTMSプラットフォームは、患者募集ポータル、遠隔モニタリング機能、電子患者報告アウトカム（ePRO）などの機能を組み込むことで、このパラダイムシフトをサポートします。患者に積極的な参加とコミュニケーションのためのツールを提供することで、CTMSプラットフォームは患者のコンプライアンスを改善し、データの質を高め、最終的には患者中心の臨床試験の成功に貢献します。これにより、ポジティブな臨床試験管理システム市場の概観が出来上がりつつあります。

本レポートで扱う主な質問

  • 2023年の世界の臨床試験管理システム市場の規模は？
  • 2024-2032年の世界の臨床試験管理システム市場の予想成長率は？
  • COVID-19が世界の臨床試験管理システムに与えた影響は？19は世界の臨床試験管理システム市場にどのような影響を与えたか
  • 世界の臨床試験管理システム市場を牽引する主要因は何か
  • 世界の臨床試験管理システム市場のコンポーネント別区分は何か
  • 世界の臨床試験管理システム市場の展開モード別区分は何か世界の臨床試験管理システム市場の展開モード別区分は何か
  • 世界の臨床試験管理システム市場のエンドユーザー別の区分は？
  • 世界の臨床試験管理システム市場の主要地域は？
  • 世界の臨床試験管理システム市場の主要プレイヤー/企業は？

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査の目的
  • ステークホルダー
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

  • 概要
  • 主要業界動向

第5章 世界の臨床試験管理システム市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場予測

第6章 市場内訳：コンポーネント別

  • ソフトウェア
    • 市場動向
    • 市場予測
  • サービス
    • 市場動向
    • 市場予測

第7章 市場内訳：展開モード別

  • ウェブベースのCTMS
    • 市場動向
    • 市場予測
  • オンプレミス
    • 市場動向
    • 市場予測
  • クラウドベースのCTMS
    • 市場動向
    • 市場予測

第8章 市場内訳：エンドユーザー別

  • 製薬・バイオテクノロジー企業
    • 市場動向
    • 市場予測
  • 契約調査機関
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第9章 市場内訳：地域別

  • 北米
    • 米国
    • カナダ
  • アジア太平洋地域
    • 中国
    • 日本
    • インド
    • 韓国
    • オーストラリア
    • インドネシア
    • その他
  • 欧州
    • ドイツ
    • フランス
    • 英国
    • イタリア
    • スペイン
    • ロシア
    • その他
  • ラテンアメリカ
    • ブラジル
    • メキシコ
    • その他
  • 中東・アフリカ
    • 市場動向
    • 市場内訳：国別
    • 市場予測

第10章 SWOT分析

  • 概要
  • 強み
  • 弱み
  • 機会
  • 脅威

第11章 バリューチェーン分析

第12章 ポーターのファイブフォース分析

  • 概要
  • 買い手の交渉力
  • 供給企業の交渉力
  • 競合の程度
  • 新規参入業者の脅威
  • 代替品の脅威

第13章 価格分析

第14章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Advarra Inc.
    • ArisGlobal LLC
    • BioClinica Inc.
    • DataTrak International Inc.
    • DZS Clinical Services Inc.（WDB Holdings Co. Ltd.）
    • International Business Machines Corporation
    • Medidata Solutions Inc.（Dassault Systemes SE）
    • MedNet Solutions Inc.
    • Oracle Corporation
    • Parexel International Corporation
    • RealTime Software Solutions LLC
    • Veeva Systems Inc.
図表

List of Figures

  • Figure 1: Global: Clinical Trial Management Systems Market: Major Drivers and Challenges
  • Figure 2: Global: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018-2023
  • Figure 3: Global: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 4: Global: Clinical Trial Management Systems Market: Breakup by Component (in %), 2023
  • Figure 5: Global: Clinical Trial Management Systems Market: Breakup by Deployment Mode (in %), 2023
  • Figure 6: Global: Clinical Trial Management Systems Market: Breakup by End User (in %), 2023
  • Figure 7: Global: Clinical Trial Management Systems Market: Breakup by Region (in %), 2023
  • Figure 8: Global: Clinical Trial Management Systems (Software) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 9: Global: Clinical Trial Management Systems (Software) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 10: Global: Clinical Trial Management Systems (Services) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 11: Global: Clinical Trial Management Systems (Services) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 12: Global: Clinical Trial Management Systems (Web-based CTMS) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 13: Global: Clinical Trial Management Systems (Web-based CTMS) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 14: Global: Clinical Trial Management Systems (On-premise) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 15: Global: Clinical Trial Management Systems (On-premise) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 16: Global: Clinical Trial Management Systems (Cloud-based CTMS) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 17: Global: Clinical Trial Management Systems (Cloud-based CTMS) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 18: Global: Clinical Trial Management Systems (Pharmaceutical and Biotechnology Firms) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 19: Global: Clinical Trial Management Systems (Pharmaceutical and Biotechnology Firms) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 20: Global: Clinical Trial Management Systems (Contract Research Organizations) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 21: Global: Clinical Trial Management Systems (Contract Research Organizations) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 22: Global: Clinical Trial Management Systems (Other End Users) Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 23: Global: Clinical Trial Management Systems (Other End Users) Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 24: North America: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 25: North America: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 26: United States: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 27: United States: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 28: Canada: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 29: Canada: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 30: Asia-Pacific: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 31: Asia-Pacific: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 32: China: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 33: China: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 34: Japan: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 35: Japan: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 36: India: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 37: India: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 38: South Korea: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 39: South Korea: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 40: Australia: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 41: Australia: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 42: Indonesia: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 43: Indonesia: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 44: Others: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 45: Others: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 46: Europe: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 47: Europe: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 48: Germany: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 49: Germany: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 50: France: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 51: France: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 52: United Kingdom: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 53: United Kingdom: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 54: Italy: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 55: Italy: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 56: Spain: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 57: Spain: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: Russia: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 59: Russia: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: Others: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 61: Others: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: Latin America: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 63: Latin America: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: Brazil: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 65: Brazil: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: Mexico: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 67: Mexico: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Others: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 69: Others: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: Middle East and Africa: Clinical Trial Management Systems Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 71: Middle East and Africa: Clinical Trial Management Systems Market: Breakup by Country (in %), 2023
  • Figure 72: Middle East and Africa: Clinical Trial Management Systems Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 73: Global: Clinical Trial Management Systems Industry: SWOT Analysis
  • Figure 74: Global: Clinical Trial Management Systems Industry: Value Chain Analysis
  • Figure 75: Global: Clinical Trial Management Systems Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Clinical Trial Management Systems Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Clinical Trial Management Systems Market Forecast: Breakup by Component (in Million US$), 2024-2032
  • Table 3: Global: Clinical Trial Management Systems Market Forecast: Breakup by Deployment Mode (in Million US$), 2024-2032
  • Table 4: Global: Clinical Trial Management Systems Market Forecast: Breakup by End User (in Million US$), 2024-2032
  • Table 5: Global: Clinical Trial Management Systems Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 6: Global: Clinical Trial Management Systems Market: Competitive Structure
  • Table 7: Global: Clinical Trial Management Systems Market: Key Players
目次
Product Code: SR112024A4984

The global clinical trial management systems market size reached US$ 1,146.8 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 2,682.0 Million by 2032, exhibiting a growth rate (CAGR) of 9.7% during 2024-2032. The clinical trial management systems (CTMS) market is propelled by factors such as increasing clinical trial complexity, rising adoption of cloud-based CTMS solutions for remote collaboration, stringent regulatory requirements, and the growing emphasis on patient-centric trials for improved efficiency and data quality.

Clinical Trial Management Systems Market Analysis:

Major Market Drivers: The clinical trial management systems market growth is fueled by the growing complexity of multisite clinical trials and the gradual adoption of cloud technology. The market size will potentially grow to a considerable extent considering enhanced requirement for trial management modules.

Key Market Trends: The clinical trial management system outlook showcases trends such as the rise in utilization of decentralized clinical trials, the virtual trial platforms, and risk-based monitoring methods. Moreover, there is an increasing emphasis on interconnectivity and integration with existing trial systems and software platforms.

Geographical Trends: North America owns the leading position in CTMS market as it has developed advanced healthcare infrastructure and is conducting numerous research and development activities. However, the Asia-Pacific and Latin America regions, which are undergoing rapid market growth because of medical tourism and improving infrastructure, are also offering clinical trial outsourcing services.

Competitive Landscape: Some of the major market players in the clinical trial management systems industry include Advarra Inc., ArisGlobal LLC, BioClinica Inc., DataTrak International Inc., DZS Clinical Services Inc. (WDB Holdings Co. Ltd.), International Business Machines Corporation, Medidata Solutions Inc. (Dassault Systemes SE), MedNet Solutions Inc., Oracle Corporation, Parexel International Corporation, RealTime Software Solutions LLC, Veeva Systems Inc., among many others.

Challenges and Opportunities: The market faces challenges such as data protection issues, interoperability issues and regulatory challenges. It also offers opportunities, such opportunities can be determined from implementation of the advanced analytics, real-world evidence integration, and decentralized trial models.

Clinical Trial Management Systems Market Trends:

Increasing Clinical Trial Complexity

The evolution of precision and personalized medicine has intensified the intricacies of clinical trials, demanding sophisticated management solutions. CTMS platforms play a pivotal role in managing these intricate trials by providing comprehensive solutions for study planning, protocol design, patient enrollment, and data management. By streamlining processes and facilitating collaboration among stakeholders, CTMS platforms help organizations effectively navigate the complexities of modern clinical research, ensuring adherence to rigorous protocols and accelerating the development of innovative therapies. These platforms leverage advanced technologies such as artificial intelligence and machine learning to optimize trial design and execution, enhancing efficiency and generating clinical trial management systems revenue.

Stringent Regulatory Requirements

Regulatory bodies impose rigorous guidelines to uphold patient safety and data integrity, necessitating robust compliance management offered by CTMS platforms. CTMS solutions offer robust tools and functionalities to assist organizations in meeting these regulatory obligations. From ensuring protocol adherence and documentation management to facilitating audit readiness and regulatory reporting, CTMS platforms help organizations navigate the complex regulatory landscape with confidence, reducing compliance risks and ensuring adherence to regulatory standards. Additionally, CTMS platforms incorporate features such as automated compliance monitoring and real-time risk assessment to proactively identify and address regulatory issues, enhancing overall compliance efficiency and effectiveness. For instance, the regulations for clinical trials in the United States are governed by stringent guidelines such as the Food and Drug Omnibus Reform Act of 2022 (FDORA), Privacy Act of 1974, and the NIH Policy Manual on Privacy and Confidentiality.

Emphasis on Patient-Centric Trials

With a shift toward patient-centricity, CTMS platforms prioritize features like patient recruitment portals and remote monitoring to enhance patient engagement and trial success. There is a growing recognition of the importance of patient-centricity in clinical research, with a focus on enhancing patient engagement, experience, and retention. CTMS platforms support this paradigm shift by incorporating features such as patient recruitment portals, remote monitoring capabilities, and electronic patient-reported outcomes (ePRO). By empowering patients with tools for active participation and communication, CTMS platforms improve patient compliance, enhance data quality, and ultimately contribute to the success of patient-centric trials. This is creating a positive clinical trial management systems market overview.

Clinical Trial Management Systems Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on component, deployment mode, and end user.

Breakup by Component:

Software

Services

Software accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the component. This includes software, and services. According to the report, software represented the largest segment.

The expanding penetration of software in the CTMS market is mainly induced by the potential for added flexibility, scalability, and customization. Software offerings provide bespoke functions for trial design, subject recruitment, data management, and regulatory conformity as clinical trial ecosystem has different stakeholders. Apart from this, SaaS models facilitate in having cost-effective deployment and easy accessibility, especially for the small and mid-sized organizations. The growing sophistication of the clinical trials and implicit need for advanced analytics and real-time insights has placed software at the heart of trial workflow management, process improvement, and drug development speedup. For instance, the U.S. Federal Government, through the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH), has proposed policy changes to improve clinical trial transparency by expanding trial registration requirements and data sharing to enhance research transparency.

Breakup by Deployment Mode:

Web-based CTMS

On-premise

Cloud-based CTMS

Web-based CTMS holds the largest share of the industry

A detailed breakup and analysis of the market based on the deployment mode have also been provided in the report. This includes web-based CTMS, on-premise, and cloud-based CTMS. According to the report, web-based CTMS accounted for the largest market share.

The web-based CTMS as a deployment mode dominates the CTMS market as web-based methods provide more availability and convenience as users can access the system from any location worldwide where there is internet connection. This makes it possible for a stakeholder team to work remotely and have ready data access, ensuring the smooth running of trials. Moreover, online CTMS systems typically have lower initial costs and fewer IT infrastructure investments than on-site installations making them to be terrific options to small and mid-sized organization looking for an economical and scalable trials management solutions. For instance, Sitero recently acquired the Clario eClinical suite including, Mentor CTMS, a web-based CTMS solution offer benefits, such as easy and affordable third-party eTMF integration, unrestricted access, a familiar Microsoft Office-based interface, rapid implementation, and mobility-enabled features, catering to the demand for efficient and user-friendly CTMS platforms.

Breakup by End User:

Pharmaceutical and Biotechnology Firms

Contract Research Organizations

Others

Pharmaceutical and biotechnology firms represent the leading market segment

The report has provided a detailed breakup and analysis of the market based on the end user. This includes pharmaceutical and biotechnology firms, contract research organizations, and others. according to the report, pharmaceutical and biotechnology firms represented the largest market share.

Clinical trials are becoming more complex and highly scrutinized making it necessary for pharmaceuticals and biotechnology companies to incorporate CTMS solutions on a daily basis as the end users. CTMS platforms furnish with all-encompassing features that are meant to be customized for the use of the pharmaceutical and biotech companies, and hence trials operations can be seamlessly carried out. The collaboration of different stakeholders is enhanced and, besides, regulatory compliance is maintained, and therapies developed much faster. Furthermore, CTMS systems are useful to these entities in reducing resources utilization, controlling the clinical trial costs and improving the overall organization productivity, thus improving the clinical trial management systems market statistics.

Breakup by Regional:

North America

United States

Canada

Asia-Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

North America leads the market, accounting for the largest clinical trial management systems market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America holds the leading position in the market for clinical trial management systems.

North America drives the CTMS market due to its robust healthcare infrastructure, extensive clinical research activities, and stringent regulatory standards. The region hosts numerous pharmaceutical, biotechnology, and medical device companies conducting clinical trials, creating a significant demand for CTMS solutions. Additionally, the prevalence of chronic diseases and the need for innovative therapies further fuel the adoption of advanced trial management tools. Moreover, North America's substantial investments in research and development, coupled with its technological advancements and focus on precision medicine, contributing to the the CTMS market growth.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the clinical trial management systems industry include Advarra Inc., ArisGlobal LLC, BioClinica Inc., DataTrak International Inc., DZS Clinical Services Inc. (WDB Holdings Co. Ltd.), International Business Machines Corporation, Medidata Solutions Inc. (Dassault Systemes SE), MedNet Solutions Inc., Oracle Corporation, Parexel International Corporation, RealTime Software Solutions LLC and Veeva Systems Inc.

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Key players in the CTMS market are focusing on innovation and strategic partnerships to enhance their offerings and expand their market presence. They are investing in advanced technologies such as artificial intelligence and machine learning to improve trial efficiency and data analytics capabilities, thereby providing the global clinical trial management systems market opportunities. Additionally, these companies are collaborating with pharmaceutical firms, contract research organizations, and academic institutions to develop integrated solutions that address the evolving needs of clinical research. Moreover, they are expanding their global footprint through acquisitions and regional expansions to tap into emerging markets and capitalize on the growing demand for CTMS solutions worldwide. For instance, On 27 September 2023, Emmes, known for its clinical research services and technology solutions, is now utilizing telehealth features of its advantage eClinical platform. Emmes' move of combining these productivity and operating tools under a single strategic plan confirms its commitment to delivering more integrated services and meeting the requirements of the continuously shifting terrain in clinical research.

Clinical Trial Management Systems Market Recent Developments:

October 17, 2022: Veeva Systems Inc., the high-tech company supplying cloud- based software solutions for the life sciences sector, signed a strategic agreement with over 40 Contract Research Organizations (CROs). The collaboration sought to deploy a complete trial solutions technology, which is the award-winning Veeva Vault CTMS (Clinical Trial Management System) among others. Through leveraging the experience and operational capabilities of a broad spectrum of CROs with a common goal, Veeva aimed at the increased usage of its state-of-the-art CTMS platform.

June 27, 2022: Medidata Solutions Inc. (Dassault Systemes SE), world-renowned vendor of life sciences based in the cloud, has recently introduced clinical operation technologies. These novel products are invented to cope with major needs of these players in clinical trials management and monitoring. Harnessing advanced technologies, such as artificial intelligence and predictive analytics, Medidata strives for better trial performance, improved data quality, and enhanced patient safety. The introduction of these novel technologies underlines Medidate's dedication to innovation in clinical research as well as equipping companies with tools to address the intricacies of drug development of the current time with assuredness.

Key Questions Answered in This Report

  • 1. What was the size of the global clinical trial management systems market in 2023?
  • 2. What is the expected growth rate of the global clinical trial management systems market during 2024-2032?
  • 3. What has been the impact of COVID-19 on the global clinical trial management systems market?
  • 4. What are the key factors driving the global clinical trial management systems market?
  • 5. What is the breakup of the global clinical trial management systems market based on the component?
  • 6. What is the breakup of the global clinical trial management systems market based on the deployment mode?
  • 7. What is the breakup of the global clinical trial management systems market based on the end user?
  • 8. What are the key regions in the global clinical trial management systems market?
  • 9. Who are the key players/companies in the global clinical trial management systems market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Clinical Trial Management Systems Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Component

  • 6.1 Software
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Services
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast

7 Market Breakup by Deployment Mode

  • 7.1 Web-based CTMS
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 On-premise
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Cloud-based CTMS
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast

8 Market Breakup by End User

  • 8.1 Pharmaceutical and Biotechnology Firms
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Contract Research Organizations
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Others
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast

9 Market Breakup by Region

  • 9.1 North America
    • 9.1.1 United States
      • 9.1.1.1 Market Trends
      • 9.1.1.2 Market Forecast
    • 9.1.2 Canada
      • 9.1.2.1 Market Trends
      • 9.1.2.2 Market Forecast
  • 9.2 Asia-Pacific
    • 9.2.1 China
      • 9.2.1.1 Market Trends
      • 9.2.1.2 Market Forecast
    • 9.2.2 Japan
      • 9.2.2.1 Market Trends
      • 9.2.2.2 Market Forecast
    • 9.2.3 India
      • 9.2.3.1 Market Trends
      • 9.2.3.2 Market Forecast
    • 9.2.4 South Korea
      • 9.2.4.1 Market Trends
      • 9.2.4.2 Market Forecast
    • 9.2.5 Australia
      • 9.2.5.1 Market Trends
      • 9.2.5.2 Market Forecast
    • 9.2.6 Indonesia
      • 9.2.6.1 Market Trends
      • 9.2.6.2 Market Forecast
    • 9.2.7 Others
      • 9.2.7.1 Market Trends
      • 9.2.7.2 Market Forecast
  • 9.3 Europe
    • 9.3.1 Germany
      • 9.3.1.1 Market Trends
      • 9.3.1.2 Market Forecast
    • 9.3.2 France
      • 9.3.2.1 Market Trends
      • 9.3.2.2 Market Forecast
    • 9.3.3 United Kingdom
      • 9.3.3.1 Market Trends
      • 9.3.3.2 Market Forecast
    • 9.3.4 Italy
      • 9.3.4.1 Market Trends
      • 9.3.4.2 Market Forecast
    • 9.3.5 Spain
      • 9.3.5.1 Market Trends
      • 9.3.5.2 Market Forecast
    • 9.3.6 Russia
      • 9.3.6.1 Market Trends
      • 9.3.6.2 Market Forecast
    • 9.3.7 Others
      • 9.3.7.1 Market Trends
      • 9.3.7.2 Market Forecast
  • 9.4 Latin America
    • 9.4.1 Brazil
      • 9.4.1.1 Market Trends
      • 9.4.1.2 Market Forecast
    • 9.4.2 Mexico
      • 9.4.2.1 Market Trends
      • 9.4.2.2 Market Forecast
    • 9.4.3 Others
      • 9.4.3.1 Market Trends
      • 9.4.3.2 Market Forecast
  • 9.5 Middle East and Africa
    • 9.5.1 Market Trends
    • 9.5.2 Market Breakup by Country
    • 9.5.3 Market Forecast

10 SWOT Analysis

  • 10.1 Overview
  • 10.2 Strengths
  • 10.3 Weaknesses
  • 10.4 Opportunities
  • 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

  • 12.1 Overview
  • 12.2 Bargaining Power of Buyers
  • 12.3 Bargaining Power of Suppliers
  • 12.4 Degree of Competition
  • 12.5 Threat of New Entrants
  • 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

  • 14.1 Market Structure
  • 14.2 Key Players
  • 14.3 Profiles of Key Players
    • 14.3.1 Advarra Inc.
      • 14.3.1.1 Company Overview
      • 14.3.1.2 Product Portfolio
    • 14.3.2 ArisGlobal LLC
      • 14.3.2.1 Company Overview
      • 14.3.2.2 Product Portfolio
    • 14.3.3 BioClinica Inc.
      • 14.3.3.1 Company Overview
      • 14.3.3.2 Product Portfolio
      • 14.3.3.3 SWOT Analysis
    • 14.3.4 DataTrak International Inc.
      • 14.3.4.1 Company Overview
      • 14.3.4.2 Product Portfolio
    • 14.3.5 DZS Clinical Services Inc. (WDB Holdings Co. Ltd.)
      • 14.3.5.1 Company Overview
      • 14.3.5.2 Product Portfolio
    • 14.3.6 International Business Machines Corporation
      • 14.3.6.1 Company Overview
      • 14.3.6.2 Product Portfolio
      • 14.3.6.3 Financials
      • 14.3.6.4 SWOT Analysis
    • 14.3.7 Medidata Solutions Inc. (Dassault Systemes SE)
      • 14.3.7.1 Company Overview
      • 14.3.7.2 Product Portfolio
      • 14.3.7.3 SWOT Analysis
    • 14.3.8 MedNet Solutions Inc.
      • 14.3.8.1 Company Overview
      • 14.3.8.2 Product Portfolio
    • 14.3.9 Oracle Corporation
      • 14.3.9.1 Company Overview
      • 14.3.9.2 Product Portfolio
      • 14.3.9.3 Financials
      • 14.3.9.4 SWOT Analysis
    • 14.3.10 Parexel International Corporation
      • 14.3.10.1 Company Overview
      • 14.3.10.2 Product Portfolio
      • 14.3.10.3 SWOT Analysis
    • 14.3.11 RealTime Software Solutions LLC
      • 14.3.11.1 Company Overview
      • 14.3.11.2 Product Portfolio
    • 14.3.12 Veeva Systems Inc.
      • 14.3.12.1 Company Overview
      • 14.3.12.2 Product Portfolio
      • 14.3.12.3 Financials
      • 14.3.12.4 SWOT Analysis