临床试验管理系统市场规模报告| 2023-2031

  • Report Code : TIPHC00002241
  • Category : Healthcare IT
  • Status : Upcoming
  • No. of Pages : 150
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[研究报告]临床试验管理系统市场规模预计将从2022年的141098万美元增长到2030年的206186万美元;预计 2022 年至 2030 年市场复合年增长率为 12.56%。

分析师的观点

临床试验管理系统市场分析需要市场驱动因素,例如新型慢性病和药物开发活动数量的增加,从而导致临床试验数量的增加。临床试验数量的增加反过来又推动了对临床试验管理系统的需求。然而,预算限制预计将阻碍预测期内市场的增长。根据类型,市场分为企业市场和现场市场;软件部分在 2022 年占据最大的市场份额。此外,CTMS 与现有软件的集成正在 2023 年至 2030 年的临床试验管理系统市场创造机会。根据类型,临床试验管理系统市场分为企业和现场。企业细分市场在 2022 年占据最大的市场份额,预计将以最高的复合年增长率增长。

临床试验是为确保新疗法的安全性和有效性而进行的实验。制药、生物技术或医疗器械公司赞助这些试验,以寻求 FDA 或国际监管机构对其药物或器械的批准。临床试验管理系统 (CTMS) 旨在跟踪直观、逻辑性的结构信息,使生命科学团队能够监控和报告临床试验进展,做出更明智的决策,并提供最优质的数据,同时确保患者安全。

战略洞察

市场洞察

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临床试验数量的增加推动市场增长

临床试验是循证医学的重要组成部分,因为它们有助于确定新的医疗方法、诊断方法或疫苗的效果。他们经常涉及大量人员,以确保新的干预措施安全有效。试验主要在药物开发过程中进行。根据美国国家医学图书馆 (NLM) 提供的数据,2020 年在 NLM (ClinicalTrials.gov) 注册了约 52,000 项新研究,到 2023 年增加到约 58,000 项。2023 年 1 月,NLM 报告了 38,837 项正在进行的临床试验在美国和全球范围内进行了 105,172 项活跃试验。据欧洲药品管理局统计,欧盟(EU)每年授权约4,000项临床试验,其中约60%的临床试验与制药行业相关。由于全球慢性病患病率不断上升,越来越多的用于开发不同有效治疗方法的临床试验正在推动临床试验市场的增长。随着更大的样本量、多样化的患者人口统计数据和多个研究地点,临床试验变得越来越复杂。 CTMS 系统有助于简化试验操作、改进数据管理并改善利益相关者的合作。此外,临床研究会产生大量数据,必须仔细收集、处理和分析。 CTMS 平台包括数据集成、实时报告和数据可视化功能,使研究人员和申办者能够做出明智的决策并提高试验效率。此外,遵守监管要求对于受到严格监管的制药行业至关重要。 CTMS 系统通过提供管理监管文档、保证协议遵守和维护数据完整性的工具来增强合规活动。

此外,市场参与者推出的先进创新正在推动增长2022-2030 年市场规模。例如,2023 年,著名科技公司 Oracle Corporation 推出了最新的 CTMS 解决方案,称为 Oracle Health Sciences Clinical One CTMS。这一新解决方案拥有实时数据分析、集中数据管理和改进的合规能力等先进功能,旨在简化临床试验流程并提高整体效率。

机遇

CTMS 与现有系统的集成正在为 CTMS 市场创造机遇

与 EHR 系统无缝集成的 CTMS 系统可以更好地管理整个临床试验中的患者数据。在引入取代纸张的电子数据采集(EDC)技术之后,将电子病历(EMR)软件与临床试验软件集成被视为数据处理的合理下一步。这种集成将使临床试验数据收集更加准确和高效,特别是在多站点试验中。据BMC 2023年4月发表的文章称,开展了开发一体化临床试验管理系统的研究,通过系统开发方法、标准化协议、与外部业务系统的高效集成、数据安全等优化临床试验的管理流程。和隐私保护。通过使用提取-转换-加载、消息队列和远程过程调用服务,实现了高效的数据集成,将CTMS与医院信息系统(HIS)、实验室信息系统(LIS)、电子医疗等外部系统连接起来。记录 (EMR) 和临床数据存储库 (CDR)。

2022 年 10 月,RealTime Software Solutions, LLC 与 Aspen Insights 合作,整合了世界一流的 EMR/EHR 患者识别功能技术融入 RealTime 世界一流的临床试验管理系统 (CTMS)。该公司的整合使临床研究机构能够挖掘结构化和非结构化 EMR/EHR 数据,以进行研究可行性分析、实践人群资格分析、医生评估以及将预审合格的参与者直接传送到 RealTime-CTMS。

报告细分和范围

基于类型的见解

根据类型,临床试验管理系统市场分为企业 CTMS 和现场 CTMS。 2022年,企业细分市场占据最大市场份额;预计 2022 年至 2030 年复合年增长率最高。企业CTMS是一个完整的临床研究管理系统,适用于要求较高的大中型组织。由于医疗保健领域的技术进步以及 CTMS 市场领先市场参与者不断推出的产品,该细分市场正在不断增长。

2022 年 10 月,Veeva Vault CTMS 推出, Veeva Systems 被 40 家合同研究组织 (CRO) 选择,其中包括全球六大 CRO 中的四家,以确保更快、更高效的临床试验。 Vault CTMS 是一款企业试验管理系统,已被超过 120 家申办者选择,其中包括排名前 20 的制药公司中的 9 家。

基于交付的见解

根据交付情况,临床试验管理系统市场分为网络托管、基于云和本地部署。网络托管细分市场因其优势而在 2022 年占据最大的市场份额,包括提高临床试验质量和效率、更好的时间管理以及易于访问。由于领先的市场参与者推出了各种产品,预计基于云的细分市场将在 2022 年至 2030 年实现最高的复合年增长率。 2021 年 12 月,云原生 eClinical 应用程序的领先提供商 SureClinical 宣布推出新的临床生态系统 (ECO) 应用程序和平台捆绑包。 ECO 捆绑包专为满足临床研究组织的独特需求而设计。它将人员、计划、项目和流程全面连接起来,以实现临床数据的无缝视图。 ECO Bundle 集中了跨多个应用程序、数据点和系统的临床情报和报告,从而使分布式临床研究团队能够在单一、现代且易于使用的应用程序体验中进行协作。

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基于最终用户的见解

就最终而言 -用户中,临床试验管理系统市场分为制药和生物技术公司、医疗器械公司、CRO 等。制药和生物技术公司细分市场在 2022 年占据最大市场份额,由于生命科学行业积极参与,临床试验研究转向 CRO,预计 CRO 细分市场在 2022 年至 2030 年复合年增长率最高将药物开发和临床试验研究外包给 CRO。 CRO 通过使用高质量设施和深厚的主题专业知识提供的服务,协助成功实施临床试验。 CRO 已开始通过其高效且具有成本效益的运营使试验申办者受益,成为临床试验行业的支柱。根据赛默飞世尔科技发布的博客,到 2022 年,约四分之三的临床试验由 CRO 进行,以确保药物开发商的临床计划,提供丰富的专业知识,提高时间和成本效率,并提供定制的、高质量的数据。因此,开发具有成本效益的解决方案并减少药物开发过程中 CRO 的错误正在推动临床试验市场的增长。

临床试验管理系统,由类型 – 2022年和2030年

区域分析

北美临床试验管理系统市场分为美国、加拿大和墨西哥。市场增长归因于正在进行的药物开发研究导致临床试验数量的增加。美国已成为领先的临床研究目的地。近一半的临床试验是在美国进行的。此外,大多数制药研究公司更愿意在美国进行临床试验,因为美国拥有完善的医疗基础设施、快速的审批时间表、有利的监管框架以及全球接受的临床试验生成的数据。世界卫生组织 (WHO) 报告指出,美国在 2021 年登记的临床试验数量最多(157,618 项)。此外,预计亚太地区在 2022-2030 年期间将以最高的复合年增长率增长。

该报告介绍了全球临床试验管理系统市场的领先参与者。其中包括 Advarra Inc.、Clario、Deloitte Touche Tohmatsu Limited、IBM Corporation、Medideta Solution Inc.、Mednet Solution Inc.、Oracle Corporation、PAREXEL International Corporation、Thermo Fisher Scientific, Inc. 和 Veeva System Inc.。这些参与者专注于扩展业务实现市场布局多元化并获得新的客户群,挖掘临床试验管理系统市场的现有商机。

临床试验最新发展的一些例子管理系统市场的情况如下:

  • 2023 年 9 月,Zelta 与 BSI Life Sciences 合作,这是为 CRO 和申办者创造无缝体验的重要一步。在整个临床试验过程中访问和整合他们的数据。 CTMS 和 eTMF 功能为临床试验的各个方面(从研究设置到收尾)提供全面的功能。这些功能包括管理和监控研究中心和研究人员、完全集成的试验主文件 (eTMF) 以及试验供应管理,使其易于访问并适合全球范围内的临床试验。
  • 2022 年 4 月,布里斯托尔Myers Squibb 在全球范围内实施了 Veeva Vault CTMS,取代了传统的 Celgene CTMS 和传统的 Bristol Myers Squibb CTMS。 Veeva Vault CTMS 现已与 Veeva 的 eTMF 和 Study Startup 应用程序紧密集成。通过在全公司范围内实施 Veeva 业界领先的试验管理和监控解决方案,百时美施贵宝旨在简化试验流程,使临床试验更快、更高效。这种统一、敏捷的解决方案预计将推动端到端试验管理。
  • 2021 年 2 月,基于云的企业软件和软件驱动的临床数据的全球提供商 eClinical Solutions LLC 成立推出 Elluminate 临床试验管理系统 (CTMS)。 Elluminate 平台加速数字化并缩短临床数据审查周期时间。 Elluminate CTMS 的引入促进了更快、更明智的决策。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
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to country scope.

The List of Companies

1. Oracle
2. Medidata Solutions Inc.
3. PAREXEL International Corporation.
4. MedNet Solutions, Inc.
5. Bioclinica
6. BioOptronics, Inc.
7. DATATRAK Int.
8. ERT Clinical
9. FORTE
10. ICON plc

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.

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