電子臨床試験ソリューションまたはスイートまたはテクノロジーの市場規模、シェア、成長分析、ソリューションタイプ別、配信モード別、地域別 - 産業予測、2025～2032年

電子臨床試験ソリューションまたはスイートまたはテクノロジーの世界市場規模は、2023年に78億9,000万米ドルと評価され、2024年の89億9,000万米ドルから2032年には254億6,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは13.9％で成長する見通しです。

バイオ医薬品分野では、従来の手作業に代わって臨床試験の管理を自動化するe-Clinicalソリューションの採用が大きく伸びています。当初は臨床試験で使用されるあらゆる技術を包括していたe-Clinicalは、現在では臨床試験のライフサイクル全体を処理し、さまざまな段階や場所で膨大な量のデータを効率的に管理する包括的なシステムを指します。このような拡大は、NIHやHHSのような機関が安全性モニタリングとデータ共有を重視している米国のような先進国の厳しい規制によってもたらされています。その結果、製薬会社やバイオ医薬品会社は、臨床試験を合理化するためのソフトウェア・ソリューションをますます求めるようになっています。さらに、エンドユーザーの裾野が広がり、政府からの資金援助が強化されたことで、e-Clinicalソリューション市場は当面さらに拡大する見通しです。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次データと一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• ケーススタディ
• 技術の進歩
• 規制情勢
• パイプライン分析
• 特許分析

電子臨床試験ソリューションまたはスイートまたはテクノロジー市場規模：ソリューションタイプ別

• 市場概要
• 電子データキャプチャ（EDC）と臨床データ管理システム（CDMS）
• 臨床試験管理システム（CTMS）
• ランダム化および治験供給管理（RTSM）
• 電子臨床結果評価（eCOA）
• 臨床分析プラットフォーム
• その他

電子臨床試験ソリューションまたはスイートまたはテクノロジー市場規模：配信モード別

• 市場概要
• Webベース（オンデマンド）
• ライセンスエンタープライズ（オンプレミス）
• クラウドベース

電子臨床試験ソリューションまたはスイートまたはテクノロジー市場規模：臨床試験段階別

• 市場概要
• フェーズI
• フェーズII
• フェーズIII
• フェーズIV

電子臨床試験ソリューションまたはスイートまたはテクノロジー市場規模：エンドユーザー別

• 市場概要
• 製薬・バイオテクノロジー企業
• 契約調査機関（CRO）
• 学術調査機関
• 病院・クリニック

電子臨床試験ソリューションまたはスイートまたはテクノロジー市場規模

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 市場の最近の動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 会社概要
  • 製品ポートフォリオ分析
  • セグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• Medidata Solutions, Inc.（USA）
• Veeva Systems（USA）
• IQVIA Inc.（USA）
• ICON plc（Ireland）
• Oracle Corporation（USA）
• Parexel International Corporation（USA）
• Labcorp Drug Development（USA）
• PPD, Inc.（USA）
• Syneos Health（USA）
• Charles River Laboratories International, Inc.（USA）
• Covance Inc.（USA）
• PRA Health Sciences, Inc.（USA）
• WuXi AppTec（China）
• Celerion（USA）
• Medpace, Inc.（USA）
• KCR（USA）

結論と推奨事項

Global E-Clinical Trials Solutions or Suite or Technologies Market size was valued at USD 7.89 billion in 2023 and is poised to grow from USD 8.99 billion in 2024 to USD 25.46 billion by 2032, growing at a CAGR of 13.9% during the forecast period (2025-2032).

The biopharmaceutical sector is witnessing significant growth in the adoption of e-Clinical solutions, which automate the management of clinical trials, replacing traditional manual processes. Initially encompassing any technology used in clinical trials, e-Clinical now refers to comprehensive systems that handle the entire trial lifecycle, efficiently managing vast amounts of data across various stages and locations. This expansion is driven by strict regulations in developed nations like the U.S., where agencies like the NIH and HHS are emphasizing safety monitoring and data sharing. Consequently, pharmaceutical and biopharmaceutical companies are increasingly demanding software solutions to streamline their trials. Additionally, a broader end-user base and enhanced governmental funding are poised to further propel the e-Clinical solutions market in the foreseeable future.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global E-Clinical Trials Solutions Or Suite Or Technologies market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global E-Clinical Trials Solutions Or Suite Or Technologies Market Segmental Analysis

Global E-Clinical Trials Solutions or Suite or Technologies Market is segmented by Solution Type, Delivery Mode, Clinical Trial Phase, End-User and region. Based on Solution Type, the market is segmented into Electronic Data Capture (EDC) & Clinical Data Management Systems (CDMS), Clinical Trial Management Systems (CTMS), Randomization and Trial Supply Management (RTSM), Electronic Clinical Outcome Assessment (eCOA), Clinical Analytics Platforms and Others. Based on Delivery Mode, the market is segmented into Web-based (On-demand), Licensed Enterprise (On-premise) and Cloud-based. Based on Clinical Trial Phase, the market is segmented into Phase I, Phase II, Phase III and Phase IV. Based on End-User, the market is segmented into Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs), Academic Research Institutes and Hospitals & Clinics. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global E-Clinical Trials Solutions Or Suite Or Technologies Market

The Global E-Clinical Trials Solutions, Suite, or Technologies market is primarily driven by increasing operational costs and stringent regulatory requirements in clinical research. As personalized and gene-based disease management gains traction in medical research and drug therapy, there's a growing demand from government payers and commercial insurers for new drugs that demonstrate superior therapeutic value and efficacy compared to existing alternatives. Furthermore, these organizations are imposing price controls on innovative medications, thereby squeezing profit margins for manufacturers. In response, the eClinical solutions sector is focusing on producing and promoting software that enhances the efficiency and speed of clinical trials. Major pharmaceutical and biotech companies are adopting new business models to reduce overall research costs, further boosting the demand for advanced and sophisticated eClinical solutions.

Restraints in the Global E-Clinical Trials Solutions Or Suite Or Technologies Market

The global market for E-Clinical Trials Solutions, Suites, or Technologies faces significant restraints primarily due to high implementation costs. Researchers often rely on these integrated solutions, such as Clinical Trial Management Systems (CTMS) and Clinical Data Management Systems (CDMS), to streamline the management of clinical research data throughout the research lifecycle. However, the premium pricing associated with these advanced software solutions, which can exceed USD 2 million when accounting for installation and ongoing technical support for cloud-based systems, poses a considerable barrier. As a result, smaller and more budget-conscious end users may be deterred from adopting these crucial technologies.

Market Trends of the Global E-Clinical Trials Solutions Or Suite Or Technologies Market

The Global E-Clinical Trials Solutions market is witnessing a robust trend towards innovation, driven by the increasing demand for advanced diagnostic radiopharmaceuticals and nuclear imaging technologies. As companies respond to a growing patient population with chronic illnesses, there is a surge in the development of new products and solutions tailored to enhance clinical trial efficiencies. Strategic partnerships and collaborations among key market players are becoming commonplace, facilitating the rapid commercialization of cutting-edge diagnostic tools. This landscape not only underscores the rising significance of e-clinical solutions but also positions the market for sustained growth as stakeholders adapt to evolving healthcare needs and technological advancements.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Case Studies
• Technology Advancement
• Regulatory Landscape
• Pipeline Analysis
• Patent Analysis

Global E-Clinical Trials Solutions or Suite or Technologies Market Size by Solution Type & CAGR (2025-2032)

• Market Overview
• Electronic Data Capture (EDC) & Clinical Data Management Systems (CDMS)
• Clinical Trial Management Systems (CTMS)
• Randomization and Trial Supply Management (RTSM)
• Electronic Clinical Outcome Assessment (eCOA)
• Clinical Analytics Platforms
• Others

Global E-Clinical Trials Solutions or Suite or Technologies Market Size by Delivery Mode & CAGR (2025-2032)

• Market Overview
• Web-based (On-demand)
• Licensed Enterprise (On-premise)
• Cloud-based

Global E-Clinical Trials Solutions or Suite or Technologies Market Size by Clinical Trial Phase & CAGR (2025-2032)

• Market Overview
• Phase I
• Phase II
• Phase III
• Phase IV

Global E-Clinical Trials Solutions or Suite or Technologies Market Size by End-User & CAGR (2025-2032)

• Market Overview
• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations (CROs)
• Academic Research Institutes
• Hospitals & Clinics

Global E-Clinical Trials Solutions or Suite or Technologies Market Size & CAGR (2025-2032)

• North America (Solution Type, Delivery Mode, Clinical Trial Phase, End-User)
  • US
  • Canada
• Europe (Solution Type, Delivery Mode, Clinical Trial Phase, End-User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Solution Type, Delivery Mode, Clinical Trial Phase, End-User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Solution Type, Delivery Mode, Clinical Trial Phase, End-User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Solution Type, Delivery Mode, Clinical Trial Phase, End-User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Medidata Solutions, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Veeva Systems (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• IQVIA Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ICON plc (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Oracle Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Parexel International Corporation (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Labcorp Drug Development (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PPD, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Syneos Health (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories International, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Covance Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PRA Health Sciences, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• WuXi AppTec (China)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Celerion (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medpace, Inc. (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• KCR (USA)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations