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市場調査レポート
商品コード
1219644
電子データ収集システムの世界市場規模、シェア、産業動向分析レポート:コンポーネント別、エンドユーザー別、開発フェーズ別、提供形態別、地域別展望と予測、2022年~2028年Global Electronic Data Capture Systems Market Size, Share & Industry Trends Analysis Report By Component, By End User, By Development Phase, By Delivery Mode, By Regional Outlook and Forecast, 2022 - 2028 |
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電子データ収集システムの世界市場規模、シェア、産業動向分析レポート:コンポーネント別、エンドユーザー別、開発フェーズ別、提供形態別、地域別展望と予測、2022年~2028年 |
出版日: 2023年01月31日
発行: KBV Research
ページ情報: 英文 272 Pages
納期: 即納可能
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電子データ収集システムの世界市場規模は、2028年までに27億米ドルに達し、予測期間中にCAGR13.8%の市場成長率で上昇すると予測されています。
そもそも、紙ベースの方法でデータを収集するのとは対照的に、EDCソリューションを導入してデータを収集する方がはるかに効率的です。EDCシステムでは、臨床現場はどのコンピューターからでも迅速かつ簡単にデータを入力でき、データ審査担当者が即座にアクセスできるようになります。臨床現場はどのコンピューターからでもEDCシステムにアクセスすることができます。
これにより、紙の書類に記入し、送信する際の頭痛の種が解消されます。データクレンジングプロセスは、EDCテクノロジーによってより効率的になります。データ管理者は、システムに送信されたデータをすぐに確認し、矛盾が見つかった場合はそれを解決するために、サイトにクエリーを送信することができます。さらに、アクセス制限とデータのトレーサビリティを管理する高度な手法を統合することも、EDCプラットフォームが保存するデータの真正性、完全性、安全性を確保する方法の一つです。
COVID-19影響度分析
その結果、COVID-19の流行は、eClinicalソリューションの市場に予測される成長に有益な影響を与えると予測されます。さらに、COVID-19の流行は、デジタル作業手順に移行しつつある臨床試験市場において、このパターンを早め、従来の試験管理基準を長期的に修正する結果になると予想されます。これは、COVID-19が感染力の強いウイルスであることに起因しています。臨床試験の実施におけるバーチャルおよびリモートワークの実用性が証明された場合、eクリニカルソリューションのすべてのプロバイダーにとって大きな利益を実現することができるかもしれません。その結果、電子データ収集装置の市場は、COVID-19の普及によって利益を得ることができると思われます。
市場の成長要因
eクリニカルソリューションに対する需要の高まり
eクリニカル・ソリューションの市場を牽引している理由のひとつは、新薬の誕生を促す疾病負荷の増大です。eクリニカル・ソリューションはデータの可視性を向上させ、意思決定プロセスをより迅速にします。データの断片化と意思決定の難しさは、いずれも運用データの管理を効率化することで解決できる可能性のある問題です。駆動の自動化によってデータ管理の問題を解決し、eClinicalソリューションの利用によってデータ駆動のプロセスを容易にすることで、臨床試験に新たな機会をもたらし、eClinicalソリューションの拡大を推し進めるためのテクノロジーです。
ワークフローの効率化と治験の加速化
臨床試験において電子データ収集システムを利用する最大のメリットは、プロセスを合理化し、臨床試験をより早く、より効果的に完了させることにあります。病気は日々変化しているため、病気に対抗できる治療法や薬剤を見つけるために、迅速な臨床試験を実施する必要性が高まっています。また、治験の実施には法的手続きが必要であり、その手続きには長い年月を要します。そのため、医薬品やワクチンが安全かつ有効であるかどうかを判断するために、徹底的な試験や臨床研究、包括的な評価が必要になってきています。
市場抑制要因
患者のプライバシーに関する懸念
テクノロジーと人工知能の進歩により、臨床試験のスポンサーや臨床研究機関(CRO)は、試験の実施方法を変更しつつあります。これらは、研究者が膨大な量のデータを収集し、より完全かつ迅速な方法で評価することを可能にするものです。ビッグデータと人工知能には、多くの利点がありますが、欠点もあります。そのひとつが、患者さんの情報を盗み、データを改ざんしようとするハッカーによるデジタル危険性です。そのため、サイバーセキュリティには相当な重点を置く必要があります。
配信モードの展望
電子データ収集システム市場は、デリバリーモードに基づき、オンプレミス型とウェブ&クラウド型に分類されます。2021年、オンプレミス型は市場で大きな収益シェアを獲得しました。オンプレミスのソリューションは、データ保護と管理のレベルを向上させ、運用効率を改善することができます。しかし、導入には多額の費用がかかるため、この分野の発展を抑制する要因になる可能性があります。今後、企業数の拡大が市場拡大の原動力となることが予想されます。
コンポーネント別の展望
電子データキャプチャシステム市場は、コンポーネントごとにサービスとソフトウェアに分類されます。2021年の電子データキャプチャシステム市場は、サービス分野が最も大きな売上シェアを占め、市場を牽引しました。データ入力の自動化とそれが引き起こすミスの削減を通じて、EDCは時間と費用の両方を節約するのに役立つ可能性があります。さらに、リアルタイムの検証や監査証跡を提供することで、データの品質を向上させることができます。さらに、EDCはデータの収集と保存に安全で改ざんされない方法を提供することで、規制上の義務を満たすことができます。
開発段階の展望
電子データ収集システム市場は、開発フェーズに基づき、フェーズI、フェーズII、フェーズIII、フェーズIVに分類されます。2021年の電子データキャプチャシステム市場では、フェーズIIIのセグメントが最も高い収益シェアを獲得しました。これは、全体的なコストを削減し、業務の有効性を高めることを目的としたEDCソフトウェアに対する強い需要の結果です。一方、フェーズIは、これらのシステムが臨床データの分析、将来の成果、および臨床試験で成功する可能性が低い薬剤候補の排除を支援するという事実により、収益性の高いペースで拡大すると予想されます。
エンドユーザー別展望
電子データキャプチャシステム市場は、エンドユーザー別に、CRO、製薬・バイオテクノロジー企業、病院・ヘルスケアプロバイダー、医療機器企業、その他に区分されます。2021年には、病院/ヘルスケアプロバイダー部門が大きな収益シェアを示しました。これは、これらのエンドユーザーがEDCシステムおよびサービスの利用を拡大した結果です。患者に適切な治療とモニタリングを提供するためには、正確な患者データを持つことが重要です。電子データ収集システムを利用することで、データ入力の必要性をタイムリーに満たすことができます。
地域別の展望
電子データキャプチャシステム市場は、地域別に、北米、欧州、アジア太平洋、LAMEAに区分されます。2021年、北米地域は最大の収益シェアを生み出し、電子データキャプチャシステム市場を独占しました。これにより、同地域はリーダーという立場になりました。これは、高度に開発されたヘルスケアインフラ、重要な企業の存在、臨床研究のデジタル化の増加、および臨床試験の分散化に起因すると思われます。主要な市場参入企業は、市場への浸透と能力の拡大を目標に、さまざまな戦術を実践しています。
List of Figures
The Global Electronic Data Capture Systems Market size is expected to reach $2.7 billion by 2028, rising at a market growth of 13.8% CAGR during the forecast period.
An electronic data capture (EDC) system, or an electronic case report form (eCRF), is a highly essential software tool that is used in clinical trials. Both of these terms relate to the same thing. EDC solutions are used in order to gather, clean, and analyze the data that is created in clinical trials. Accurate data is essential for clinical research.
You will gain knowledge about the technical and practical elements of EDC systems, including the expenses associated with their purchase and use in clinical trials, by reading the following article. When it comes to running a clinical study, using an EDC system unquestionably offers a number of benefits that cannot be ignored.
To begin, implementing an EDC solution to gather data as opposed to collecting data via paper-based methods is much more efficient. The EDC system allows clinical sites to input data quickly and simply from any computer, making it instantly accessible to data reviewers. Clinical sites have access to the EDC system from any computer.
This eliminates the headache that comes with filling out and sending in paper forms. The process of data cleansing is made more efficient by EDC technologies. Data managers are able to readily check the data that was submitted into the system and send queries to sites in order to resolve any inconsistencies that may have been found. In addition, the integration of sophisticated methods to manage access restrictions and data traceability is another way in which an EDC platform ensures the authenticity, integrity, and safety of the data it stores.
COVID-19 Impact Analysis
As a result, it is projected that the COVID-19 pandemic will have a beneficial effect on the growth that is anticipated for the market for eClinical solutions. Additionally, it is anticipated that the COVID-19 outbreak will both hasten this pattern and result in long-term modifications to traditional trial management standards in the clinical trials market, which is moving toward digital work procedures. This is due to the fact that COVID-19 is a highly contagious virus. When the practicality of virtual and remote working arrangements for the conduct of trials is proved, it may be to the advantage of all providers of eClinical solutions to realize significant gains. As a consequence of this, the market for electronic data capture devices would profit from the widespread distribution of COVID-19.
Market Growth Factors
Rising demand for eclinical solutions
One of the reasons that are driving the market for eClinical solutions is the growth in the sickness load that is prompting the creation of new medications. eClinical solutions improve the visibility of the data, which in turn makes the decision-making process go more quickly. The fragmentation of data and the difficulty in making decisions are both problems that may be solved by streamlining operational data management. Technology is designed to bring up new opportunities in clinical trials and to push the expansion of eClinical solutions by solving issues with data management via the automation of drive and by making the process of data driving easier through the use of eClinical solutions.
Workflow streamlining and accelerated clinical trials
Streamlining processes, which leads to clinical tests that are completed more quickly and with more effectiveness, is one of the primary advantages of using electronic data-capturing systems in clinical trials. Because illnesses change on a daily basis, there is a growing need for the conduct of rapid clinical trials in order to find treatments and medications that may combat these diseases. The legal process can take many years. As a result, there is an increased need for exhaustive testing, clinical studies, and comprehensive assessments to determine whether or not medications and vaccines are safe and effective.
Market Restraining Factors
Concerns regarding patient privacy
Because of advancements in technology and artificial intelligence, clinical trial sponsors and clinical research organizations (CROs) are modifying the ways in which they conduct their tests. They make it possible for researchers to collect an enormous amount of data and assess it in a more complete and expedient manner. Big data and artificial intelligence both offer a lot of potential benefits, but there are also some potential drawbacks. One sort of digital danger consists of hackers with the intention of stealing patient information and corrupting data. As a result, there needs to be a considerable amount of emphasis placed on cybersecurity.
Delivery Mode Outlook
Based on delivery mode, the electronic data capture systems market is classified into on-premise and, web & cloud-based. In 2021, the on-premise segment garnered the significant revenue share in the market. On-premises solutions provide increased levels of data protection and management, in addition to improved operational efficiencies. However, they entail substantial costs of implementation, which could be a factor in restraining the development of the category. It is anticipated that an expanding number of businesses will drive the expansion of the market.
Component Outlook
Based on Component, the electronic Data Capture Systems Market is divided into Services and Software. The service segment led the electronic data capture system market in 2021, with the biggest revenue share. Through the automation of data input and the reduction of mistakes that it causes, EDC may help you save both time and money. In addition to this, it may assist you in enhancing the quality of your data by offering real-time validation and audit trails. In addition to this, EDC can assist you in meeting regulatory obligations by providing a safe and tamper-proof method for the collection and storage of data.
Development Phase Outlook
Based on development phase, the electronic data capture systems market is segregated into phase I, phase II, phase III, and phase IV. In the electronic data capture systems market in 2021, the Phase III segment generated the highest revenue share. This comes as a result of the strong demand for EDC software, which is intended to reduce overall costs and enhance the effectiveness of operations. On the other hand, Phase I is anticipated to expand at a profitable pace due to the fact that these systems assist in the analysis of clinical data, future outcomes, and the elimination of drug candidates that have a low likelihood of succeeding in clinical trials.
End-user Outlook
On the basis of End-user, the electronic data capture systems market is segmented into CROs, Pharmaceutical & Biotechnology Firms, Hospitals/Healthcare providers, Medical Device Firms, and Others. In 2021, the Hospitals/ Healthcare providers segment showcased the significant revenue share. This is a result of these end-users increased usage of EDC systems and services. It is critical to have accurate patient data in order to provide appropriate treatment and monitoring for patients. All of your data entry requirements may be met in a timely way with the assistance of a specialized electronic data capture system.
Regional Outlook
Based on region, the electronic data capture systems market is segmented into North America, Europe, Asia Pacific, and LAMEA. In 2021, the North American region dominated the electronic data capture systems market by producing the greatest revenue share. This put the region in the position of being the leader. This may be attributed to the highly developed healthcare infrastructure, the presence of significant corporations, the increasing digitization of clinical research, as well as the decentralization of clinical trials. The primary market participants put into practice a variety of tactics with the goal of expanding their market penetration and capabilities.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Oracle Corporation, IBM Corporation, Veeva Systems, Inc., IQVIA Holdings, Inc., Medidata Solutions, Inc. (Dassault Systems SE), OpenClinica, LLC, DATATRAK International, Inc., Clario, Castor EDC, and Calyx.
Recent Strategies Deployed in Electronic Data Capture Systems Market
Partnerships, Collaboration and Agreement:
Nov-2022: IQVIA teamed-up with Clalit, a health services organization based in Israel. This collaboration would enable both companies with their combined expertise to focus on the future of innovation, consisting of precision medicine and offering data-driven trials.
Oct-2022: Oracle collaborated with Obviohealth, a provider of a decentralized clinical trial app. This collaboration would help get breakthrough therapies to boost commercialization through higher efficient combination of the wide range of data sets.
Jun-2022: Clario partnered with ActiGraph, a provider of activity-sensing wearable technology. This partnership would broaden its vast evidence-generation platform and suite of decentralization technologies. Moreover, the partnership would help clinical trial sponsors and sites propel accuracy and efficiency during enhancing convenience for study participants.
May-2022: Clario announced an expanded partnership with a cognitive science company, a cognitive assessment, and training company. Under this partnership, both companies would offer data quality solutions to assist the unique demands of neuroscience assessments for therapeutic development.
Mar-2022: Medidata extended a partnership with Labcorp, a life sciences company. Under this partnership, together both companies would advance digital biomarkers and broaden the use and functionality of decentralized trials.
Mar-2022: IBM teamed up with Genomics England. The partnership was aimed to support Genomics England's objective of enabling clinicians to deliver leading treatment and diagnosis services to NHS patients and boosting scientific discovery to change care into the future.
Feb-2022: Medidata extended a partnership with Parexel, a clinical research organization focused on the delivery and advancement of the latest innovative therapies. This partnership represents a chance to transform patient experience and development timelines for the advancement of the latest vaccines and medicines.
Oct-2021: OpenClinica teamed up with CDISC, standards developing organization. Through this collaboration, both companies would enhance data collection in clinical studies organized by academic researchers and institutions to propel research forward.
Sep-2021: IQVIA collaborated with HealthCore, Inc., a real-world research firm in the United States. The collaboration is aimed to develop real-world evidence studies with enhanced efficiency and quality. Moreover, this collaboration would focus on enhancing Real World Data (RWD) breadth and depth, also research advancement.
Product Launches and Product Expansions:
Dec-2022: Medidata released the myMedidata app, a patient-centric native app created to offer trial participants another choice for a smooth platform experience and a unique login for all their isolated trial activities. The product would feature every myMedidata patient-centric solution with a focus on electronic clinical outcome assessments.
Nov-2022: Castor launched Virtual Visits, the latest telemedicine feature created to allow diverse and faster clinical trials. This launch is aimed to simplify clinical trials for everyone who participated, consisting of individuals facing daily life commitments or researcher managing various studies.
Nov-2022: Medidata introduced Rave Companion, an advanced scalable, patent-pending technology supporting clinical trial sites to decrease errors and save time in transferring EHR data to the Rave EDC system. The product meets the need of the long-standing industry challenge of duplicate data entry by allowing unstructured and structured data from any electronic health record to be utilized by Rave EDC.
Oct-2022: Veeva Systems released Veeva ePRO, the latest development in patient-centric digital trials. The product simplifies the exchange and collection of patient-reported outcomes in digital clinical trials.
Jun-2022: Medidata announced a partnership with MMS Holdings, a data-focused clinical research organization. The partnership is aimed to offer clients a comprehensive range of solutions for the decentralized clinical trial (DCT) technologies and clinical data management. The company's potential to work on Medidata's unified platform, particularly with Rave EDC and other clinical data management solutions opens the latest chances to support Sponsors.
Market Segments covered in the Report:
By Component
By End-user
By Development Phase
By Delivery Mode
By Geography
Companies Profiled
Unique Offerings from KBV Research