电子审判主文件 (eTMF) 市场策略、顶级参与者、增长机会、2027 年分析和预测

  • Report Code : TIPRE00007727
  • Category : Technology, Media and Telecommunications
  • Status : Published
  • No. of Pages : 145
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[研究报告] 2018 年医疗保健市场中的电子试验主文件价值为 9.3832 亿美元,预计到 2027 年将达到 31.5564 亿美元;预计 2019 年至 2027 年的复合年增长率为 16.5%。

电子试验主文件 (eTMF) 系统可定义为软件和硬件组件的集成,它们共同负责临床试验数据的最佳管理。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,不同用户可以检索这些数据,这有助于轻松访问并降低与临床试验中的管理和手动数据维护操作相关的成本。医疗保健市场中电子试验主文件的增长归因于临床试验数量的增加、疾病患病率的上升和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的市场增长产生负面影响。另一方面,市场参与者不断增加的战略举措可能会在未来几年提供增长机会。

预计医疗保健市场的电子试验主文件在疫情后出现大幅增长。由于封锁、旅行禁令和企业停业,COVID-19 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不堪重负,凸显了对卫生系统进行可持续投资的强烈需求。随着 COVID-19 疫情的进展,预计医疗保健行业的增长将出现下降。由于对体外诊断产品的需求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,由于手术数量减少以及设备采购延迟或延长,医疗技术和成像领域的销售额正在下降。此外,预计医疗保健专业人员的虚拟咨询将成为疫情后主流的医疗服务模式。随着远程医疗改变医疗服务,数字医疗将在未来几年继续蓬勃发展。此外,临床试验中断以及随后的药物上市延迟也有望为未来的完全虚拟试验铺平道路。 mRNA 等新技术预计将会出现并改变制药行业,未来几年市场也有望见证更多的垂直整合和合资企业。

 

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电子审判主文件 (eTMF) 市场:

Electronic Trial Master File (eTMF) Market
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市场洞察

 

 

电子试验主文件在医疗保健领域的应用日益广泛,推动了电子试验主文件在医疗保健市场的增长

 

研发 (R&D) 是公司业务中重要且必不可少的一部分。制药行业的运营以研发和制造投资的形式对社会产生了重大的社会经济影响。研发是任何药物发现系统取得成功的“支柱”,电子试验主文件是研发新药和生物技术治疗实体的必备软件。制药和生物技术公司主要专注于研发 (R&D),以开发具有最大医疗和商业潜力的各种治疗应用的新分子。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小幅增长至 20.9%。此外,根据 2017 年对美国药物研究和制造商协会 (PhRMA) 成员的年度调查,制药公司报告称在研发上的支出为 714 亿美元。

制药公司加大了对研发的投入,以加快临床试验进程。例如,截至 2019 年 6 月 30 日,阿斯利康以 25.63% 的收入用于研发,引领行业发展;截至 2019 年 3 月 31 日,礼来公司保持强劲,其 22.38% 的收入用于研发;截至 2019 年 6 月 30 日,罗氏控股公司紧随其后,其 21.29% 的收入用于研发。

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、改进现有成果以及在上市前证明产品功效和法规合规性的过程中。此外,美国制药公司的研发投入在过去 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。在药物的整个开发阶段,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。

无论治疗、医疗策略或设备对人类和兽医是否安全有效,临床试验都是药物发现中最重要和最有意义的步骤之一。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,会进行一系列临床研究。各种传染性和非传染性疾病的日益流行,增加了对开发新药或医疗器械的需求。这反过来又会增加对各种治疗领域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文件柜中的纸质文档管理系统转向电子文档管理系统,将文档存储在在线电子档案中。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,并且通常可以节省临床试验成本,而不必依赖手动纸质处理流程。

临床过程中采用电子试验主文件系统的增加可能会推动市场的发展。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中的临床合作。它是制药行业的内容管理系统,为可能需要遵守政府监管机构的临床药物试验提供了一种正式的组织和存储文件、照片和其他数字内容的方法。在临床试验中,EMA 完全支持使用 eTMF 系统进行电子存储以替代纸张。该机构在警告声明中指出,由于纸质内容和不一致(例如缺页、标签不合适或文件不完整)导致 TMF 和 eTMF 存在质量问题。由于 eTMF 具有创新功能,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)以及多种添加文档的方法,eTMF 对于业务效率、成本节约和缩短 BioPharma 产品生产时间以实施电子文档管理流程变得非常重要。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发展,合同研究组织和制药及生物技术公司正在采用 eTMF 来更好地管理临床数据和临床试验管理流程。上述原因和因素推动了电子试验主文件市场的增长。

 

基于组件的洞察

 

从组成部分来看,医疗保健市场的电子试验主文件分为服务和软件。服务部门在 2019 年占据了最大的市场份额。

 

基于交付模式的洞察

 

根据交付模式,医疗保健市场中的电子试验主文件分为基于云的 eTMF 和本地 eTMF。基于云的 eTMF 部分在 2019 年占据了最大的市场份额。

 

基于最终用户的洞察

 

就最终用户而言,医疗保健市场的电子试验主文件细分为制药和生物技术公司、CRO 和其他。制药和生物技术公司部门在 2019 年占据了最大的市场份额。

医疗保健电子试验主文件市场参与者正在采用产品发布和扩展策略来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保持自己的品牌名称。

 

 

电子审判主文件 (eTMF) 市场区域洞察

Insight Partners 的分析师已详细解释了预测期内影响电子审判主文件 (eTMF) 市场的区域趋势和因素。本节还讨论了北美、欧洲、亚太地区、中东和非洲以及南美和中美洲的电子审判主文件 (eTMF) 市场细分和地理位置。

Electronic Trial Master File (eTMF) Market
  • 获取电子审判主文件 (eTMF) 市场的区域特定数据

电子审判主文件 (eTMF) 市场报告范围

报告属性细节
2018 年市场规模9.3832亿美元
2027 年市场规模31.5564亿美元
全球复合年增长率(2018 - 2027)16.5%
史料2016-2017
预测期2019-2027
涵盖的领域按组件
  • 服务
  • 软件
按交付方式
  • 基于云的 eTMF
  • 本地 eTMF
按最终用户
  • 制药和生物技术公司
  • 合同研究组织
覆盖地区和国家北美
  • 我们
  • 加拿大
  • 墨西哥
欧洲
  • 英国
  • 德国
  • 法国
  • 俄罗斯
  • 意大利
  • 欧洲其他地区
亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
南美洲和中美洲
  • 巴西
  • 阿根廷
  • 南美洲和中美洲其他地区
中东和非洲
  • 南非
  • 沙特阿拉伯
  • 阿联酋
  • 中东和非洲其他地区
市场领导者和主要公司简介
  •  
  • Aurea 公司
  • 传输完美
  • Covance Inc(实验室公司)
  • 甲骨文
  • 恩诺夫
  • Mastercontrol 公司
  • 宏盟
  • 药物警戒
  • 维瓦系统

 

电子审判主文件 (eTMF) 市场参与者密度:了解其对业务动态的影响

电子审判主文件 (eTMF) 市场正在快速增长,这得益于最终用户需求的不断增长,这些需求源于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者的需求,并利用新兴趋势,从而进一步推动市场增长。

市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明在给定市场空间中,相对于其规模或总市场价值,有多少竞争对手(市场参与者)存在。

在电子审判主文件 (eTMF) 市场运营的主要公司有:

  1. Aurea 公司
  2. 传输完美
  3. Covance Inc(实验室公司)
  4. 甲骨文
  5. 恩诺夫

免责声明上面列出的公司没有按照任何特定顺序排列。


Electronic Trial Master File (eTMF) Market

 

  • 获取电子审判主文件 (eTMF) 市场顶级关键参与者概览

 

 

医疗保健市场中的电子试验主文件 – 按组件划分

  • 服务
  • 软件

 

医疗保健市场中的电子试验主文件 – 按交付方式

  • 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
  • 合同研究组织
  • 其他的

 

医疗保健市场中的电子试验主文件 – 按地区划分

  • 北美

    • 我们
    • 加拿大
    • 墨西哥
  • 欧洲

    • 法国
    • 德国
    • 意大利
    • 英国
    • 西班牙
    • 欧洲其他地区
  • 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 (MEA)

    • 南非
    • 沙特阿拉伯
    • 阿联酋
    • MEA 其他地区
  • 南美洲和中美洲(SCAM)

    • 巴西
    • 阿根廷
    • 其余的骗局

 

公司简介

  • Aurea 公司
  • 完美转运。
  • Covance Inc(实验室公司)
  • 甲骨文
  • 恩诺夫
  • Mastercontrol 公司
  • 宏盟
  • 药物警戒
  • 维瓦系统
  • 福莱克斯环球
  • Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
  • PEST and SWOT Analysis
  • Market Size Value / Volume - Global, Regional, Country
  • Industry and Competitive Landscape
  • Excel Dataset
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


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).

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.

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.

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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

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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.