基于(关键地区、市场参与者、规模和份额)的电子试验主文件 (eTMF) 市场 - 到 2031 年的预测

  • Report Code : TIPRE00007727
  • Category : Healthcare IT
  • Status : Published
  • No. of Pages : 145
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[研究报告]2018年医疗保健市场电子试验主档案价值93832万美元,预计到2027年将达到315564万美元;预计2019年至2027年复合年增长率为16.5%。

电子试验主文件(eTMF)系统可以定义为软件和硬件的集成共同负责临床试验数据优化管理的组件。这些解决方案有助于以易于存储的数字格式简化临床试验过程中生成的数据,这些数据可以由不同的用户检索,从而易于访问,并降低与管理和手动数据维护操作相关的成本。临床试验。电子试验主文件在医疗保健市场的增长归因于临床试验数量的增加、疾病患病率的增加以及技术进步多年来推动了市场的发展。然而,缺乏熟练的专业人员可能会对未来几年市场的增长产生负面影响。另一方面,市场参与者增加的战略举措可能会在未来几年提供增长机会。

医疗保健市场的电子试验主文件预计将见证疫情后大幅增长。由于封锁、旅行禁令和企业关闭,COVID-19 已经影响了各国的经济和行业。 COVID-19 危机使许多国家的公共卫生系统负担过重,凸显了对卫生系统可持续投资的强烈需求。随着 COVID-19 大流行的进展,医疗保健行业的增长预计将下降。由于体外诊断产品需求的增加以及全球研发活动的增加,生命科学领域蓬勃发展。然而,由于进行的手术数量减少以及设备采购推迟或延长,医疗技术和成像领域的销售额正在下降。此外,医疗保健专业人员的虚拟咨询预计将成为大流行后的主流护理服务模式。随着远程医疗改变医疗服务方式,数字医疗将在未来几年继续蓬勃发展。此外,临床试验的中断以及随后药物上市的延迟预计也将为未来的完全虚拟试验铺平道路。 mRNA 等新技术预计将出现并改变制药行业,未来几年市场预计还将出现更多的垂直整合和合资企业。

利润丰厚的地区医疗保健市场中的电子试验主文件

市场洞察

电子试验主文件在医疗保健中的不断增长的应用将推动电子试验主文件在医疗保健市场中的增长

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研究与研究开发(R&D)是公司业务的重要组成部分。制药行业的运营以研发和制造投资的形式对社会产生重大的社会经济影响。研究与开发是任何药物发现系统成功的“支柱”,电子试验主文件是基于新药物和生物技术的治疗实体的研究和开发的必备软件。制药和生物技术公司主要专注于研究和开发(R&D),为各种治疗应用提供具有最显着医疗和商业潜力的新分子。这些公司主要投资于研发,旨在向市场提供高质量和创新的产品。例如,与 2016 年相比,2017 年全球研发支出增长了 3.9%,达到 1650 亿美元。平均研发支出占处方药总销售额的比例略有上升,达到 20.9%。此外,根据 2017 年 PhRMA 成员的年度调查,制药公司报告在研发方面的支出为 714 亿美元。

制药公司在研发方面投入更多资金以提高产能他们的临床试验过程。例如,截至2019年6月30日,阿斯利康将其收入的25.63%用于研发,截至2019年3月31日,礼来公司将其收入的22.38%用于研发,截至 2019 年 6 月 30 日,罗氏控股公司也不甘落后,研发支出为 21.29%。

研发支出通常发生在发现、测试和开发新产品、预付款和里程碑、改善现有成果以及在推出前证明产品功效和法规遵从性的过程中。此外,美国制药公司的研发投资在过去 15 年中持续增长。

药物开发和发现是一个耗时且昂贵的过程。从早期检测或设计到开发再到监管部门批准的过程可能需要 10 到 15 年以上的时间。在原料药的整个开发阶段,需要各种测试服务来检查产品的质量和功效。因此,制药和生物技术公司更愿意将数据保存到电子主文件中,以节省成本和时间,这有望推动市场的增长。

临床试验是无论治疗、医疗策略或设备对人类和兽医使用是否安全有效,这是药物发现中最重要和最重要的步骤之一。临床研究有助于了解和确定某些治疗领域的最佳治疗方法。临床试验专门用于收集有关新产品和工具开发的安全性和有效性的数据。在监管机构批准药物分子和医疗器械之前,需要进行一系列的临床研究。各种传染性和非传染性疾病的日益流行增加了对开发用于治疗的新药物或医疗器械的需求。这反过来预计将增加各个治疗领域对临床试验活动的需求。

参与临床试验的生物制药和制药公司旨在从基于纸质的文档管理系统转向文件柜到电子文档管理系统,其中文档在线存储在电子档案中。通过实施全面的 eTMF 系统,组织可以自动化、捕获和管理 TMF 文档并记录不必要的风险,并且通常可以比手动纸张处理流程节省临床试验成本。

在临床过程中越来越多地采用电子试验主文件系统可能会提振市场。例如,Aurea Software 的 NextDocs 是一个电子试验主文件 (eTMF) 论坛,用于临床试验记录管理方面的临床合作。它是制药行业的内容管理系统,提供了组织和存储临床药物试验的文档、照片和其他数字内容的正式方法,这些内容可能需要遵守政府监管机构的要求。在临床试验中,EMA完全支持使用eTMF系统进行电子存储作为纸张的替代品。该机构在一份警告声明中指出了 TMF 和 eTMF 的质量问题,原因是纸质内容和页面缺失、标签不合适或文档不完整等不一致。由于 eTMF 的创新功能,例如临床试验文档的集中和管理、强大的搜索功能(使用元数据)以及添加文档的多种方法,eTMF 对于提高业务效率、节省成本和缩短生物制药的生产时间变得越来越重要产品实施电子文档管理流程。引入可互操作的 eTMF 框架的秘诀是使用通用内容模型;基于词汇的标准;和基于网络的标准技术。

由于试验主文件向电子试验主文件的进步,合同研究组织和制药与制药公司生物技术公司正在采用 eTMF 来实现更好的临床数据管理和临床试验管理流程。上述原因和因素推动了电子审判主档市场的增长。

基于组件的洞察

从组件角度,医疗保健市场中的电子试验主文件分为服务和软件。 2019 年,服务领域占据了最大的市场份额。

医疗保健市场中的电子试验主文件(按组件) 2018 年和 2027 年


基于交付模式的见解

基于交付模式的电子审判主文件医疗保健市场分为基于云的 etmf 和本地 etmf。基于云的 eTMF 细分市场在 2019 年占据了最大的市场份额。

基于最终用户的见解

就最终用户而言,医疗保健市场的电子试验主文件分为制药和生物技术公司、CROS 等。制药和生物技术公司细分市场在 2019 年占据最大市场份额。


战略见解

医疗保健市场参与者正在采用产品发布和电子试验主文件扩展战略,以满足全球不断变化的客户需求,这也使他们能够在全球范围内维持其品牌名称。

医疗保健市场中的电子试验主文件 -按组件

  • 服务
  • 软件

医疗保健市场中的电子试验主文件 -按交付模式

  • 基于云的 eTMF
  • 本地 eTMF

医疗保健市场中的电子试验主文件 -按最终用户划分

  • 制药和生物技术公司
  • CRO
  • 其他

医疗保健领域的电子试验主文件市场——按地理位置

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • < li>欧洲
    • 法国
    • 德国
    • 意大利
    • 英国
    • 西班牙
    • 休息欧洲
  • 亚太地区 (APAC)
    • 中国
    • 印度
    • 韩国
    • 日本
    • 澳大利亚
    • 亚太地区其他地区
  • 中东和非洲非洲 (MEA)
    • 南非
    • 沙特阿拉伯
    • 阿联酋
    • 中东和非洲其他地区
  • 南美洲和中美洲 (SCAM)
    • 巴西
    • 阿根廷
    • 其他 SCAM
  • < /ul>

    公司简介

    • Aurea, Inc.
    • Transperfect。
    • Covance Inc ( Lab Corp)
    • Oracle
    • Ennov
    • Mastercontrol, Inc.
    • Omnicomm
    • Pharmavigilalnce
    • Veeva 系统
    • Phlexglobal
Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

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

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is electronic trial master file (eTMF)?

Electronic trial master file (eTMF) systems can be defined as an integration of software and hardware components collectively responsible for the optimal management of clinical trial data. These solutions help to streamline the data generated during the course of a clinical trial in an easy-to-store digital format, which can be retrieved by dissimilar users beneficial in easy accessibility and reduction the cost associated with the administrative and manual data maintenance operations in clinical trials.

What are the driving factors for the electronic trial master file (eTMF) market across the globe?

Increasing in number of clinical trial, increasing prevalence of diseases and technology advancement have been boosting the market over the years. However, dearth of skilled professionals is likely to have a negative impact on the growth of the market in the coming years. On the other hand, increasing strategic initiatives by market players is likely to provide growth opportunities over the coming years.

Which industries can use electronic trial master file (eTMF)?

Pharmaceutical and biotechnology companies, contract research organizations (CROs) and other users can make use of electronic trial master file (eTMF).

The List of Companies - Electronic Trial Master File (eTMF) Market

  1. Aurea, Inc.
  2. TRANSPERFECT
  3. Covance Inc (Lab Corp)
  4. Oracle
  5. Ennov
  6. Mastercontrol, Inc.
  7. Omnicomm
  8. Pharmavigilalnce
  9. Veeva Systems
  10. Phlexglobal

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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