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市場調査レポート
商品コード
1520617
eClinicalソリューションの世界市場の評価:製品別、提供方式別、臨床試験フェーズ別、エンドユーザー別、地域別、機会、予測(2017年~2031年)eClinical Solutions Market Assessment, By Product, By Mode of Delivery, By Clinical Trial Phase, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
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カスタマイズ可能
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eClinicalソリューションの世界市場の評価:製品別、提供方式別、臨床試験フェーズ別、エンドユーザー別、地域別、機会、予測(2017年~2031年) |
出版日: 2024年07月25日
発行: Market Xcel - Markets and Data
ページ情報: 英文 219 Pages
納期: 3~5営業日
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世界のeClinicalソリューションの市場規模は、2023年の100億1,000万米ドルから2031年に268億1,000万米ドルに達すると予測され、予測期間の2024年~2031年にCAGRで13.11%の成長が見込まれます。市場は複数の要因により、予測期間に成長が見込まれます。
eClinicalソリューションという用語は、臨床データを整理および評価するための臨床研究における技術の利用を表しています。これらの方法は、臨床試験手続きの合理化を支援し、その速度、有効性、正確性を向上させます。これらのシステムの中には、電子患者報告アウトカム(ePRO)、無作為化・治験薬供給管理(RTSM)、電子データ収集(EDC)、臨床試験管理システム(CTMS)などがあります。市場が拡大している主な理由は、技術的に洗練された臨床試験管理システムに対するニーズの高まりです。したがって、EDCおよび臨床データ管理システム(CDMSシステム)の迅速な普及、遠隔医療と遠隔患者モニタリングへのニーズの拡大が、市場にプラスの影響を与えています。さらに、臨床試験の増加や迅速な治療に対する需要の高まりも市場を刺激しています。これとは別に、正確で信頼できるデータに対するニーズの高まりや、臨床試験データの発展に対する規制当局の精査が市場を牽引しています。さらに、紙ベースの手続きを回避し、人的なデータ入力の必要性を減らすことで、eClinicalソリューションは臨床試験管理に関連する経費を削減することができます。これにより、市場の拡大がさらに加速すると予測されます。さらに、この業界は、患者中心の研究の重要性の高まりと、クラウドベースソリューションの急速な採用から恩恵を受けています。さらに、データのパターンや傾向を発見し、意思決定を強化するためのAIや機械学習(ML)アルゴリズムの統合が進むことで、業界は強化されています。市場のその他の促進要因としては、バイオ医薬品産業の顕著な拡大、慢性疾患の有病率の上昇、高齢化、スマート医療機器の使用の増加、医療システムにおける継続的なインフラの改善などがあります。例えば、Obvio Health USA, Inc.は2023年12月、最先端の電子臨床アウトカム評価(eCOA)ソリューションを発表しました。このソリューションは、臨床および科学的サービスと、信頼性の高い試験結果を生み出す最先端の試験デザイン技術を組み合わせたものです。eCOAの促進には技術が大きな役割を果たします。その支援により、試験スケジュールを迅速化し、アウトカムの捕捉を単純化することができます。しかし、技術は効果的なeCOA計画の一要素に過ぎません。スマートで科学的な試験デザインと思いやりのある患者支援が組み合わされて初めて、真に患者中心主義を達成し、よりよいエビデンスを提示することができます。
臨床試験の複雑化が市場拡大につながる
eClinicalソリューション市場は大幅な成長を見せていますが、その主な理由は臨床試験の複雑化にあります。最新の臨床試験では、複雑な手続き、異種患者群、多次元的な規制要件に対応するため、精巧なデータ管理・分析技術が必要とされます。このようなニーズを満たすのが、電子患者報告アウトカム(ePRO)、臨床試験管理システム(CTMS)、電子データ収集(EDC)などを含むeClinicalソリューションです。これらのソリューションは、データの正確性を向上させ、データ収集を合理化し、規制コンプライアンスを強化します。eClinicalソリューションは、リアルタイムのモニタリングとシームレスなデータ統合を可能にする統合システムを提供し、より効果的な臨床試験管理と迅速な意思決定を実現します。
このような効率化は、最終的にはコスト削減と患者の転帰向上につながるため、新しい治療法の上市までの期間短縮を望む製薬企業にとって不可欠です。
さらに、最新の臨床試験は世界中で実施されているため、多くの規制環境や地理的な場所で機能するソリューションを見つけることが不可欠です。eClinicalソリューションは、国際的な臨床試験を監督するために必要な規模と適応性を提供し、すべての臨床試験場所で規制コンプライアンスと統一されたデータ標準を保証します。
当レポートでは、世界のeClinicalソリューション市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。
Global eClinical solutions market is projected to witness a CAGR of 13.11% during the forecast period 2024-2031, growing from USD 10.01 billion in 2023 to USD 26.81 billion in 2031. The market is expected to grow in the forecast period due to several underlying factors.
The term "eClinical solutions" describes the use of technology in clinical research to organize and evaluate clinical data. These methods aid in streamlining the clinical trial procedure, increasing its speed, effectiveness, and accuracy. Among these systems are electronic patient-reported outcomes (ePRO), randomization and trial supply management (RTSM), electronic data capture (EDC), and clinical trial management systems (CTMS). The market is expanding mostly due to the growing need for technologically sophisticated clinical trial management systems. Accordingly, the market is being positively impacted by the quick uptake of EDC and clinical data management system CDMS systems, as well as the expanding need for telemedicine and remote patient monitoring. In addition, the market is being stimulated by an increasing number of clinical trials and a growing demand for fast medical treatment. Apart from this, the market is being driven by the increasing need for precise and dependable data and the regulatory scrutiny over developing clinical trial data. Moreover, by avoiding paper-based procedures and reducing the need for human data entry, eClinical solutions can lower the expenses related to clinical trial management. It is anticipated that this will further fuel the market's expansion. In addition, the industry is benefiting from the growing significance of patient-centric studies and the fast adoption of cloud-based solutions. Furthermore, the industry is being strengthened by the increasing integration of artificial intelligence (AI) and machine learning (ML) algorithms to find patterns and trends in data and enhance decision-making. Additional factors propelling the market include the biopharmaceutical industries' notable expansion, the rise in chronic disease prevalence, the aging population, the growing use of smart medical devices, and ongoing infrastructure improvements in the healthcare system. For instance, Obvio Health USA, Inc. unveiled a cutting-edge electronic clinical outcome assessment (eCOA) solution in December 2023 that combines clinical and scientific services with cutting-edge study design technology to produce reliable trial results. Technology plays a major role in facilitating eCOA. Study schedules can be expedited, and outcomes capture can be simplified with its assistance. However, technology is only one element of an effective eCOA plan. One can only truly attain patient centricity and present better evidence when combined with smart, scientific study design and compassionate patient assistance.
Increasing Complexity of Clinical Trials Leading to Market Expansion
The market for eClinical solutions is growing at a substantial rate, mostly due to the increasing complexity of clinical trials. Sophisticated data management and analysis technologies are required for the complex procedures, heterogeneous patient groups, and multidimensional regulatory requirements of modern clinical trials. These needs are met by eClinical solutions, which include electronic patient-reported outcomes (ePRO), clinical trial management systems (CTMS), and electronic data capture (EDC). These solutions improve data accuracy, streamline data collection, and increase regulatory compliance. Managing massive volumes of data from several sources, such as wearables, electronic health records (EHR), and genomic data, gets harder as clinical trials get more complicated. eClinical solutions provide integrated systems that enable real-time monitoring and seamless data integration, leading to more effective trial management and quicker decision-making.
This efficiency is essential for pharmaceutical companies hoping to shorten the time it takes to bring new treatments to market since it will eventually save money and enhance patient outcomes..
Furthermore, because modern clinical trials are conducted worldwide, it is imperative to find solutions that can function in many regulatory environments and geographical locations. eClinical solutions offer the scale and adaptability required to oversee international trials, guaranteeing regulatory compliance and uniform data standards at every trial location. Further increasing demand for eClinical solutions is owed to the COVID-19 pandemic, which has led to the rising adoption of remote and decentralized trial methodologies. By providing digital data collection, telemedicine consultations, and remote patient monitoring, these technologies facilitate virtual trial designs and ensure trial continuity even times of disruptions. In summary, the escalating complexity of clinical trials is propelling the growth of the eClinical solutions market by demanding more advanced, integrated, and flexible data management and analysis tools, which in turn enhance trial efficiency, compliance, and overall success.
For instance, the most recent version of ICON plc's Digital Platform, which facilitates the smooth integration of sponsor, site, and patient services with harmonized data delivery, was unveiled in June 2023. The platform is adaptable for a range of therapeutic areas and study designs, offering end-to-end solutions for patient services in clinical trials. Features include an easy-to-use mobile app, direct data capture for in-home services, eCOA, telehealth visits, eConsent, and digital health technology management.
Growth in Market Due to Adoption of Web-based eClinical Solutions
The eClinical solutions market is growing at a substantial rate due to the use of web-based eClinical solutions. These technologies provide several advantages over conventional techniques, such as using the Internet to facilitate and streamline clinical trials. One of the most important benefits is improved data management. Real-time data access and capture are made possible by web-based eClinical solutions, which increase data handling efficiency and accuracy. Additionally, its real-time capabilities speed up decision-making, allowing faster trial modifications and results. Web-based platforms also provide better flexibility and scalability. They can be easily expanded and updated to meet the needs of both big international trials and small-scale investigations, regardless of the size and complexity of the trials. This flexibility is essential as clinical studies get bigger and more complex. Another driving force is cost-effectiveness; web-based solutions save operating costs by avoiding the need for manual processes and physical infrastructure. Due to their low cost, more organizations, including academic institutions and smaller biotech firms, can afford to use modern eClinical tools, expanding the industry. Furthermore, these solutions improve stakeholder collaborations as well. Trial operations are more unified and well-coordinated when sponsors, investigators, and regulatory agencies can exchange information and interact with ease. This cooperative setting encourages creativity and speeds up the creation of novel treatments. Web-based eClinical solutions are becoming increasingly popular as a result of the increased focus on patient-centric approaches in clinical research. These solutions provide virtual trials and remote monitoring, which improve patient convenience and boost recruitment and retention rates. Overall, the integration of web-based eClinical solutions into the clinical trial process is driving market growth by offering efficiency, scalability, cost savings, and improved collaboration, thereby transforming the landscape of clinical research. The extension of eClinical Solutions LLC.'s ML and AI capabilities within the elluminate IQ platform was announced in May 2023. These state-of-the-art ML/AL capabilities allow data management teams to conduct more scalable and efficient data reviews.
Increasing Dominance of Clinical Data Management Segment Leading to Market Growth
A crucial stage in clinical research is clinical data management (CDM), which produces high-quality, dependable, and statistically sound data from clinical trials. This contributes to a significant reduction in the time taken between drug development and marketing. The integration of the CDM with supply management, trial, clinical randomization, and patient recruiting systems is a key trend propelling this market. Additionally, businesses are improving their current eClinical technologies to increase their functionality and make conducting clinical trials an easy process. Furthermore, considering the complexity of data management procedures in clinical trials for diabetes and the pervasive use of information technologies, a study published in the Journal of Healthcare Engineering in February 2022 states that the use of clinical data management systems in these trials appears inevitable. Software that helps with data management during clinical trials and reduces the chances of errors that might happen when data is manipulated manually. Over the course of the projection period, it is expected that the advantages of clinical data management in clinical trials will propel segment expansion. Furthermore, significant market players' developments are fostering segment growth.
For instance, Veeva Systems Inc. stated in February 2022 that Idorsia Pharmaceuticals Ltd. had added Veeva Vault CDM for electronic data capture (EDC) and coding to its list of applications using Veeva Vault Clinical Suite.
Asia-Pacific to Dominate the eClinical Solutions Market
Due to significant unmet medical requirements and the increased prevalence of chronic diseases like cancer, cardiovascular problems, and infectious diseases, Asia-Pacific is expected to achieve promising growth throughout the projection period. Owing to their vast patient populations and low costs, China, India, Korea, and Japan are seeing an increase in the number of studies that are outsourced to them. Government funding for drug development and research is a major factor driving the growth of the Asia-Pacific market, which is expected to continue to rise over the projected period despite being an emerging economy.
The Ministry of Health and Family Welfare (MoHFW) in India received an allocation of USD 10.5 billion (INR 86,201 crore) for 2022-2023; of which, the Department of Health Research in India received USD 391 million (INR 3,201 crore) for research purposes in 2022, according to data published by the Policy Research Studied (PRS) Legislative Research. As a result, an increase in government financing for medical development and research is driving up market growth overall. The advancements made by different industry participants are also contributing to the expansion of the market. One of the top Japanese clinical trial companies, 3H Medi Solution Inc., announced in February 2023 that it had chosen THREAD research to increase decentralized research capacity and enhance patient access to clinical research in Japan. THREAD's tested technology platform and advisory services, along with 3H Medi Solution Inc.'s extensive recruitment, home visit assistance, and general clinical research delivery skills, provide clients with improved options. Such technological advancements in the region lead to growth and fuel market expansion.
Future Market Scenario (2024-2031F)
The global eClinical solutions market, which is growing in significance as the healthcare industry undergoes a digital transformation, is influencing the direction of clinical research and patient care in the future. eClinical technologies, which combine state-of-the-art data analytics, cloud computing, and innovative software platforms, are revolutionizing clinical trials, increasing data accuracy, and speeding up the drug development process. The main factors contributing to the anticipated growth of the eClinical solutions market are the increasing complexity of clinical trials and the rising problems associated with data management. Not only this, but the rising adoption of cloud-based and web-based solutions is a significant factor contributing to the growth of this market in the forecast period. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. In January 2023, oral dosage form-focused contract development and manufacturing organization (CDMO) Adare Pharma Solutions selected Veeva Systems Inc.'s Veeva Vault Quality Suite to standardize quality systems throughout the entire enterprise.
Key Players Landscape and Outlook
Several companies, such as Oracle Corporation, Dassault Systemes, Parexel International Corporation, Clario, ICON plc, Signant Health, MaxisIT Inc., 4G Clinical, Veeva Systems Inc., eClinical Solutions LLC, etc., are expanding their businesses by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launches of newly developed eClinical solutions to help researchers and strengthen their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve the same.
For instance, Syneos Health and uMotif Limited partnered in June 2023, utilizing a cutting-edge digital platform with strong electronic clinical outcome assessment (eCOA) and electronic patient-reported outcomes (ePRO) functionalities. Through this collaboration, clinical trials will become quicker, leading to more effective patient delivery of innovative drugs.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.