市場調查報告書
商品編碼
1453953
到 2030 年的電子臨床解決方案市場預測:按產品、交付型態、臨床試驗階段、用戶設備、最終用戶和地區進行的全球分析eClinical Solutions Market Forecasts to 2030 - Global Analysis By Product, Delivery Mode, Clinical Trial Phase, User Device, End User and By Geography |
根據 Stratistics MRC 的數據,2023 年全球電子臨床解決方案市場規模將達到 95 億美元,預計到 2030 年將達到 256 億美元,預測期內年複合成長率為 15.2%。
電子臨床解決方案旨在徹底改變臨床研究。為了更快地治療患者,臨床管理組織正在努力提高臨床研究資料的有效性、效率和可近性。開發電子臨床解決方案的目標是識別臨床研究資料中的痛點,提供創新的解決方案,讓臨床試驗資料更容易取得、更有價值。它還旨在簡化臨床研究領域的標準化、報告和功能。
根據 ClinicalTrials.gov 統計,截至 2023 年 3 月,已有 221 個國家註冊了 443,933 項研究,其中 342,633 項為干涉研究,99,578 項為觀察性研究。根據美國衛生研究院2023年3月更新的資料,2022年美國用於臨床試驗和推廣的研究支出預計為66億美元,2023年將增加至68億美元,預計還會增加。
擴大電子健康記錄的採用
EHR 集中患者健康資訊並提供可用於臨床研究目的的有價值的資料。與 EHR 系統無縫整合的 eClinical 解決方案可在整個臨床試驗生命週期中實現高效的資料收集、患者招募和監控。透過彌合臨床護理和研究之間的差距,這些整合解決方案有助於接觸患者群體,加快研究啟動時間,並提高臨床試驗資料的準確性和完整性。此外,還可以從 EHR 中提取結構化資料,從而提高資料品質並減少手動資料輸入錯誤。
實施成本高
實施電子臨床解決方案需要大量的前期投資,包括軟體許可證、硬體基礎設施、客製化和員工培訓。對於預算有限的組織來說,這些成本過高,阻礙了他們實施電子臨床技術。持續的維護、支援和訂閱費用進一步增加了總擁有成本,加劇了長期的財務負擔。然而,電子臨床解決方案的複雜性以及實施和客製化它們所需的專業知識也導致成本上升。
臨床試驗全球化進展
臨床試驗的日益全球化是電子臨床解決方案市場的主要促進因素。隨著臨床試驗擴大到涵蓋世界各地的廣泛患者群體和醫療保健環境,電子臨床解決方案提供了一個統一的資料收集、管理和分析平台,可供世界各地的臨床試驗場所和場所使用,促進無縫相關人員。此外,這些解決方案還可以即時存取試驗資料,並簡化國際團隊之間的溝通和決策流程。
複雜的監管環境
臨床試驗受到各監管機構的嚴格監管,例如美國FDA(食品藥物管理局)和歐洲EMA(歐洲藥品管理局)。遵守這些法規,包括資料隱私、安全、報告標準等,需要大量的資源、專業知識和時間。遵守不斷變化的監管要求為電子臨床解決方案的實施和操作帶來了複雜性。
由於臨床試驗因面對面互動的封鎖和限制而面臨中斷,對 eClinical 平台提供的遠端監控、虛擬測試和數位數位資料擷取解決方案的需求增加。此次疫情凸顯了即時資料存取和分析的重要性,推動了電子臨床解決方案的採用,以加快決策和監管合規性。此類中斷包括由於製造延遲或中斷而導致必要的硬體和軟體組件的採購延遲。此外,COVID-19 的爆發凸顯了供應鏈的脆弱性,促使企業重新思考其籌資策略並使其多元化。
臨床資料整合平台細分市場預計將成為預測期內最大的細分市場
所產生的臨床資料的複雜性和數量不斷增加,增加了對能夠有效整合和協調不同資料集的簡化解決方案的需求。預計在預測期內,臨床資料整合平台部分將佔據電子臨床解決方案市場的最大佔有率。臨床資料整合平台不僅促進無縫資料互通性,而且還支援臨床研究和醫療保健服務中的高階分析、即時洞察和改進決策。此外,將人工智慧 (AI) 和機器學習 (ML) 技術整合到這些平台中將增強預測分析、個人化醫療和臨床試驗最佳化等功能。
智慧型手機領域預計在預測期內年複合成長率最高。
智慧型手機產業預計在預測期內將出現最高的年複合成長率,因為它提供了一個無處不在的平台來存取、收集和傳輸醫療資料,並有助於推動電子臨床解決方案的採用。透過專用的行動應用程式,患者可以輕鬆地遠端參與臨床試驗、報告症狀、遵守用藥時間表並與醫療保健提供者即時溝通。此外,配備感測器和周邊設備的智慧型手機可以收集連續的健康資料,例如心率、活動水平和睡眠模式,從而增加了臨床研究資料的豐富性和粒度。將智慧型手機整合到電子臨床解決方案中不僅提高了病人參與和資料質量,還提高了臨床試驗的效率和擴充性。
中國、印度和日本等國家正在經歷快速的都市化和醫療基礎設施的擴張,增加了對先進臨床研究技術的需求,以滿足其迅速成長的人口的醫療需求。該地區的慢性病和感染疾病呈上升趨勢,提高了藥物開發和交付的高效臨床試驗和資料管理解決方案的重要性。此外,旨在促進臨床研究和創新的積極政府舉措和法規正在推動製藥公司、委外研發機構(CRO) 和醫療保健提供者採用電子臨床解決方案。
預計歐洲地區在整個預測期內將保持盈利成長。歐洲強大的基礎設施和完善的法律規範使其成為製藥公司和臨床研究組織 (CRO) 建立最先進實驗室的有吸引力的目的地。這些先進的設施使得臨床試驗能夠有效率地進行,包括大量臨床資料的收集、分析和管理。此外,高通量篩檢、次世代定序和生物標記分析等實驗室技術的進步正在促進臨床研究和藥物開發更精確和個人化的方法。
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.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.