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eクリニカルソリューション市場の2030年までの予測: 製品別、提供形態別、臨床試験フェーズ別、ユーザーデバイス別、エンドユーザー別、地域別の世界分析eClinical Solutions Market Forecasts to 2030 - Global Analysis By Product, Delivery Mode, Clinical Trial Phase, User Device, End User and By Geography |
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eクリニカルソリューション市場の2030年までの予測: 製品別、提供形態別、臨床試験フェーズ別、ユーザーデバイス別、エンドユーザー別、地域別の世界分析 |
出版日: 2024年03月03日
発行: Stratistics Market Research Consulting
ページ情報: 英文 200+ Pages
納期: 2~3営業日
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Stratistics MRCによると、世界のeクリニカルソリューション市場は2023年に95億米ドルを占め、予測期間中のCAGRは15.2%で成長し、2030年には256億米ドルに達すると予測されています。
臨床研究は、eクリニカルソリューションによって革命を起こすことが意図されています。患者をより迅速に治療するため、臨床管理組織は臨床研究データの有効性、効率性、アクセシビリティの向上に取り組んでいます。eクリニカルソリューションの開発目標は、臨床研究データの問題点を特定し、革新的な解決策を提供し、臨床試験データに簡単にアクセスできるようにし、価値を高めることです。また、臨床研究分野の標準化、報告、機能を合理化することも目的としていました。
ClinicalTrials.govによると、2023年3月現在、221カ国で443,933件の研究が登録されており、そのうち342,633件が介入研究、99,578件が観察研究でした。米国国立衛生研究所が2023年3月に更新したデータによると、2022年の米国における臨床試験および支援活動のための研究費の推定額は66億米ドルであり、2023年には68億米ドルに増加すると予測されています。
電子カルテの採用拡大
EHRは患者の健康情報を一元的に管理し、臨床研究の目的に活用できる貴重なデータを提供します。EHRシステムとシームレスに統合するeクリニカルソリューションは、臨床試験のライフサイクル全体を通じて効率的なデータ収集、患者募集、モニタリングを可能にします。臨床治療と研究のギャップを埋めることで、これらの統合ソリューションは、患者集団へのアクセスを容易にし、研究開始スケジュールを早め、臨床試験データの正確性と完全性を向上させます。さらに、EHRから構造化データを抽出できるため、データの質が向上し、手作業によるデータ入力ミスが減少します。
高い導入コスト
eクリニカルソリューションの導入には、ソフトウェアライセンス、ハードウェアインフラ、カスタマイズ、スタッフトレーニングなど、多額の先行投資が必要となります。これらのコストは、限られた予算で運営されている組織にとっては法外であり、eClinicalテクノロジーの導入を躊躇させる。継続的なメンテナンス、サポート、およびサブスクリプション料金は、総所有コストにさらに貢献し、長期的な財務負担を悪化させる。しかし、eクリニカルソリューションの複雑さや、実装やカスタマイズに専門的な知識が必要なことも、コスト上昇の一因となっています。
臨床試験の世界化の進展
臨床試験の世界化の進展は、eクリニカルソリューション市場の大きな促進要因となっています。臨床試験が世界中の幅広い患者集団やヘルスケア環境を網羅するように拡大する中、eクリニカルソリューションはデータ収集、管理、分析のための一元化されたプラットフォームを提供し、世界な臨床試験実施施設や利害関係者間のシームレスなコラボレーションを促進します。さらに、これらのソリューションは試験データへのリアルタイムアクセスを可能にし、国際的なチーム間のコミュニケーションと意思決定プロセスを合理化します。
複雑な規制状況
臨床試験には、米国のFDA(食品医薬品局)や欧州のEMA(欧州医薬品庁)など、さまざまな規制機関による厳しい規制が適用されます。データプライバシー、セキュリティ、報告基準などを含むこれらの規制を乗りこなすには、多大なリソース、専門知識、時間が必要です。進化する規制要件へのコンプライアンスは、eクリニカルソリューションの実装と運用に複雑さをもたらします。
臨床試験がロックダウンや対面での対話の制限による中断に直面する中、eClinicalプラットフォームが提供する遠隔モニタリング、仮想試験、デジタルデータキャプチャソリューションに対する需要が高まった。パンデミックは、リアルタイムのデータアクセスと分析の重要性を浮き彫りにし、より迅速な意思決定と規制遵守のためのeクリニカルソリューションの採用を促進しました。このような混乱には、製造の遅れや中断による必要なハードウェアやソフトウェア部品の調達の遅れが含まれます。さらに、COVID-19の流行はサプライチェーンの脆弱性を浮き彫りにし、企業に調達戦略の見直しと多様化を促しています。
予測期間中、臨床データ統合プラットフォーム分野が最大となる見込み
生成される臨床データの複雑さと量の増加に伴い、異種データセットを効率的に統合・調和できる合理的なソリューションに対する需要が高まっています。臨床データ統合プラットフォーム分野は、eクリニカル・ソリューション市場で予測期間中最大のシェアを占めると予測されます。臨床データ統合プラットフォームは、シームレスなデータ相互運用性を促進するだけでなく、高度な分析、リアルタイムの洞察、臨床研究とヘルスケア提供における意思決定の改善を可能にします。さらに、人工知能(AI)や機械学習(ML)技術をこれらのプラットフォームに統合することで、予測分析、個別化医療、臨床試験の最適化などの機能が強化されます。
予測期間中のCAGRは、スマートフォン・セグメントが最も高くなると予想されます。
スマートフォン分野は、ヘルスケアデータへのアクセス、収集、送信のためのユビキタスプラットフォームを提供し、eクリニカルソリューションの採用を促進するのに役立つことから、予測期間中に最も高いCAGRが見込まれます。専用のモバイル・アプリケーションを通じて、患者は遠隔地での臨床試験への参加、症状の報告、投薬スケジュールの遵守、ヘルスケア・プロバイダーとのコミュニケーションをリアルタイムで便利に行うことができます。さらに、センサーや周辺機器を搭載したスマートフォンは、心拍数、活動レベル、睡眠パターンなどの継続的な健康データの収集を可能にし、臨床研究データの豊富さと粒度を向上させる。このようにスマートフォンがeクリニカルソリューションに統合されることで、患者エンゲージメントとデータの質が向上するだけでなく、臨床試験の効率性と拡張性も高まる。
中国、インド、日本などの国々では、急速な都市化と医療インフラの拡大が進んでおり、人口の急増する医療ニーズをサポートするために高度な臨床研究テクノロジーへの需要が高まっています。同地域では慢性疾患や感染症が増加しており、医薬品開発やドラッグデリバリーのための効率的な臨床試験やデータ管理ソリューションの重要性が高まっています。さらに、臨床研究とイノベーションの促進を目的とした政府の積極的な取り組みや規制が、製薬会社、医薬品開発業務受託機関(CRO)、ヘルスケアプロバイダーの間でeクリニカルソリューションの採用を後押ししています。
欧州地域は予測期間を通じて収益性の高い成長を維持する見込みです。欧州の強固なインフラと確立された規制の枠組みは、製薬企業や臨床研究機関(CRO)が最先端のラボを設置する際の魅力的な目的地となっています。こうした高度な施設は、膨大な臨床データの収集、分析、管理など、臨床試験の効率的な実施を可能にします。さらに、ハイスループット・スクリーニング、次世代シーケンシング、バイオマーカー解析などのラボ技術の進歩により、臨床研究や医薬品開発において、より正確で個別化されたアプローチが容易になっています。
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
According to Stratistics MRC, the Global eClinical Solutions Market is accounted for $9.5 billion in 2023 and is expected to reach $25.6 billion by 2030 growing at a CAGR of 15.2% during the forecast period. Clinical research is intended to be revolutionized by e-clinical solutions. In order to treat patients more promptly, the clinical management organization is working to enhance the clinical research data's efficacy, efficiency, and accessibility. The goal of developing e-clinical solutions was to identify the issues with clinical research data, provide innovative fixes, and make clinical trial data easily accessible and valuable. It also aimed to streamline the standardization, reporting, and functioning of the clinical research area.
According to ClinicalTrials.gov, as of March 2023, 443,933 studies were listed in 221 countries, out of which 342,633 were interventional studies and 99,578 observational studies. According to the data updated by the National Institute of Health in March 2023, the estimated research funding for clinical trials and supportive activities in the United States in 2022 was USD 6.6 billion, and it is expected to rise to USD 6.8 billion in 2023.
Growing adoption of electronic health records
EHRs provide a centralized repository of patient health information, offering valuable data that can be leveraged for clinical research purposes. eClinical solutions that integrate seamlessly with EHR systems enable efficient data collection, patient recruitment, and monitoring throughout the clinical trial lifecycle. By bridging the gap between clinical care and research, these integrated solutions facilitate access to patient populations, accelerate study start-up timelines, and improve the accuracy and completeness of clinical trial data. Moreover, the ability to extract structured data from EHRs enhances data quality and reduces manual data entry errors, ultimately leading to more efficient and cost-effective clinical trials.
High implementation costs
Implementing eClinical solutions entails substantial upfront investments in software licenses, hardware infrastructure, customization, and staff training. These costs can be prohibitive for organizations operating on constrained budgets, deterring them from embracing eClinical technologies. Ongoing maintenance, support, and subscription fees further contribute to the total cost of ownership, exacerbating financial burdens over time. However, the complexity of eClinical solutions and the need for specialized expertise for implementation and customization also contribute to higher costs.
Increasing globalization of clinical trials
The increasing globalization of clinical trials serves as a significant driver for the eClinical solutions market, as it necessitates efficient data management and collaboration tools across diverse geographic regions. With clinical trials expanding to encompass a broader range of patient populations and healthcare settings worldwide, eClinical solutions provide centralized platforms for data collection, management, and analysis, facilitating seamless collaboration among global trial sites and stakeholders. Additionally, these solutions enable real-time access to study data, streamlining communication and decision-making processes across international teams.
Complex regulatory landscape
Clinical trials are subject to stringent regulations imposed by various regulatory bodies such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. Navigating these regulations, which encompass data privacy, security, and reporting standards, requires significant resources, expertise, and time. Compliance with evolving regulatory requirements adds complexity to the implementation and operation of eClinical solutions, as organizations must ensure that their systems meet the latest standards.
As clinical trials faced disruptions due to lockdowns and restrictions on in-person interactions, there was a heightened demand for remote monitoring, virtual trials, and digital data capture solutions offered by eClinical platforms. The pandemic underscored the importance of real-time data access and analysis, driving the adoption of eClinical solutions for faster decision-making and regulatory compliance. These disruptions can include delays in the procurement of necessary hardware and software components due to manufacturing slowdowns or interruptions. Moreover, the COVID-19 pandemic has highlighted vulnerabilities in supply chains, prompting companies to reassess and diversify their sourcing strategies.
The clinical data integration platforms segment is expected to be the largest during the forecast period
With the increasing complexity and volume of clinical data generated, there is a growing demand for streamlined solutions that can efficiently consolidate and harmonize disparate datasets. Clinical Data Integration Platforms segment is projected to witness largest share in the eClinical Solutions Market throughout the domination period. Clinical Data Integration Platforms not only facilitate seamless data interoperability but also enable advanced analytics, real-time insights, and improved decision-making in clinical research and healthcare delivery. Furthermore, the integration of artificial intelligence (AI) and machine learning (ML) technologies into these platforms enhances their capabilities for predictive analytics, personalized medicine, and clinical trial optimization.
The smart phone segment is expected to have the highest CAGR during the forecast period
Smart Phone segment is expected to have the highest CAGR during the forecast period as it offers a ubiquitous platform for accessing, collecting, and transmitting healthcare data, making them instrumental in driving the adoption of eClinical solutions. Through dedicated mobile applications, patients can conveniently participate in remote clinical trials, report symptoms, adhere to medication schedules, and communicate with healthcare providers in real-time. Moreover, smartphones equipped with sensors and peripherals enable the collection of continuous health data, such as heart rate, activity levels, and sleep patterns, enhancing the richness and granularity of clinical research data. This integration of smartphones into eClinical solutions not only improves patient engagement and data quality but also enhances the efficiency and scalability of clinical trials.
Due to the rapid urbanization and expanding healthcare infrastructure across countries like China, India, and Japan are fueling demand for advanced clinical research technologies to support the burgeoning healthcare needs of their populations, Asia Pacific region commanded the largest share of the market over the extrapolated period. The increasing prevalence of chronic diseases and infectious ailments in the region has heightened the importance of efficient clinical trials and data management solutions for drug development and healthcare delivery. Additionally, favorable government initiatives and regulations aimed at promoting clinical research and innovation are encouraging the adoption of eClinical solutions among pharmaceutical companies, contract research organizations (CROs), and healthcare providers.
Europe region is poised to hold profitable growth throughout the forecast period. Europe's robust infrastructure and well-established regulatory framework make it an attractive destination for pharmaceutical companies and clinical research organizations (CROs) to set up state-of-the-art laboratories. These advanced facilities enable efficient conduct of clinical trials, including the collection, analysis, and management of vast amounts of clinical data. Moreover, advancements in laboratory technologies, such as high-throughput screening, next-generation sequencing, and biomarker analysis, are facilitating more precise and personalized approaches to clinical research and drug development.
Key players in the market
Some of the key players in eClinical Solutions market include Medidata Solution, OmniComm Systems, Oracle Corp, ERT Clinical, CRF Health, PAREXEL International, IBM Watson Health, Dassault Systems, Saama Technologies, INC and Veeva Systems.
In December 2023, ObvioHealth launched an innovative eCOA solution, integrating scientific and clinical services with advanced study design technology for robust trial outcomes.
In October 2023, a major provider of life science solutions announced the collaboration with the full-service CRO "Atherion Bioresearch". The strategic partnership aims to enhance the opportunities for organizations to increase and streamline processes, grow, and improve data integrity.
In October 2023, Almac Clinical Technologies announced the partnership with Exostar aiming to assist the risk associated with the intellectual property. According to the collaboration, the organizations will come to provide Federated Authentication Access and Single Sign-On (SSO) to eClinical applications for supporting clinical trials which also includes Interactive Response Technology (IRT).
In October 2023, a healthcare technology organization "Madnet" launched the latest software release having (eConsent) electronic consent capabilities in the iMednet eClinical platform. The launch was designed to generate a cost-effective, simple, and general method to collect and store participants' consent for fulfilling the virtual, hybrid, and decentralized clinical trials.
In June 2023, ICON plc announced the latest release of its Digital Platform, supporting seamless integration of site, sponsor, and patient services with harmonized data delivery. The platform is customizable for various therapeutic areas and study designs, offering end-to-end solutions for patient services in clinical trials, including a user-friendly mobile app, direct data capture for in-home services, eCOA, telehealth visits, eConsent, and digital health technology management.
In June 2023, Syneos Health collaborated with uMotif Limited, leveraging an advanced digital platform that incorporates robust Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-reported Outcomes (ePRO) capabilities. This partnership aims to accelerate the pace of clinical trials, expediting the delivery of groundbreaking medications to patients more efficiently.
In May 2023, eClinical Solutions LLC. announced the expansion of its machine learning (ML) and artificial intelligence (AI) capabilities within the elluminate IQ offering. Data management teams can take advantage of these cutting-edge ML/AL capabilities to conduct data review more efficiently and scalable.
In April 2023, the Medidata subsidiary of Dassault Systemes announced Lambda Therapeutics is deploying Medidata's cloud-based clinical products, Rave EDC, Rave RTSM, and Rave Imaging, according to a statement from Dassault Systemes subsidiary Medidata. Automating and optimizing data management operations and securely delivering higher-quality data for quicker insights will further improve clinical trial productivity. This has aided the business in promoting its offerings across the globe.
In March 2023, Clario has launched a cloud-based Image Viewer tool that helps the Sponsors and CROs to see the images of their clinical trials. Previously, several organizations had to participate in the image transfer procedure to see photos for a clinical trial.