到 2031 年临床数据管理系统 (CDMS) 市场规模

Publication Month : Feb 2024

  • Report Code : TIPRE00030098
  • Category : Healthcare IT
  • Status : Upcoming
  • No. of Pages : 150
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【研究报告】临床数据管理系统市场规模预计将从2022年的212289万美元增长到2030年的549007万美元;预计 2022 年至 2030 年市场复合年增长率将达到 12.6%。

市场洞察和分析师观点:

收集、记录和数据存储过程对于临床试验或程序以及生物技术公司和制药制造商非常重要,称为临床数据管理。临床试验数据管理系统广泛用于新医学治疗和诊断测试的开发。临床数据管理工具用于临床研究中来管理临床试验的数据。临床数据管理是临床研究的初始阶段,可生成高质量、可靠且统计全面的数据,以缩短从药物开发到上市的时间。临床数据管理的主要目标是确保数据支持从研究中得出的推论,以保护公众健康和对上市疗法的信任。

临床研究数据管理系统市场是由于该行业初创企业数量的增加,预计该行业将出现增长。 Merative Clinical Development、Clinion 和 Bioclinica ICL 是一些初创公司。

医疗保健行业开展的大量临床试验帮助市场在此期间取得了可观的增长。政府积极支持各种研究试验,将现代药物引入市场,并取得更高的成功率,这有助于市场随着时间的推移获得可观的收入。

患病率多种慢性病在人群中的流行推动了对主要市场领导者进行临床试验和研究项目的需求,这些项目在临床试验管理系统的帮助下进行管理。政府为研究项目提供的资金帮助市场开展高质量的研究项目和临床试验,这也促进了管理系统的市场。老年人口的快速增长也成为市场的重要增长因素。

增长动力:

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临床试验数量不断增加

研究和开发正在制药公司的重要组成部分,包括药物开发和产品开发。在所有行业中,制药行业用于研发的收入最多。全球许多公司活跃于药物研发领域。基于网络的数据收集工具的几个优点,例如最大限度地减少数据输入的时间和简便性、格式的灵活性、低成本以及捕获额外的响应集信息的能力,推动了临床数据管理系统市场的发展。此外,临床数据管理系统提供的高水平生产力和效率预计将重新定义公司的传统数据管理流程,从而促进临床数据管理市场的增长。此外,临床研究和生命科学行业研发支出的增加,加上临床试验数量的增加,有助于临床数据管理系统市场的增长。

细分分析:

根据交付模式,临床数据管理系统市场分为许可企业解决方案、云-基于云的解决方案、网络托管解决方案。基于云的解决方案细分市场在 2022 年占据了更大的市场份额,预计该细分市场在 2022 年至 2030 年期间将实现更高的复合年增长率。这一增长归因于医疗保健行业的技术发展以及基于云的解决方案的日益采用。基于云的模型具有多种优势,例如灵活性、可扩展性和协作。与基于云的模型相关的这些好处预计将推动市场发展。此外,基于云的模型还消除了购买、维护和部署本地服务的要求,从而最大限度地降低了安装和维护成本,并有助于整体扩展。

由于这些优势,大多数企业都在使用基于云的安全解决方案。组织正在逐步实施基于云的解决方案,以满足客户需求和业务目标。对这些组织产生的大量数据的高效云存储、访问和管理的需求不断增长,这是一个关键的增长促进因素。

临床数据管理系统市场,按交付模式划分 – 2022 年和 2030 年

基于最终用户的临床数据管理系统市场分为 CRO、医疗器械公司、制药/生物技术公司。 CRO 细分市场在 2022 年占据了更大的市场份额。预计 2022 年至 2030 年复合年增长率将更高。全球范围内不断扩张的合同研究组织(CRO)预计将增加市场收入。将临床试验外包给 CRO 的趋势不断增长,这降低了药物开发的总体成本,预计也将进一步推动市场需求。此外,一些 CRO 选择使用临床数据管理系统 (CDMS) 和电子数据采集 (EDC) 作为两种最流行的数字解决方案来处理不断增长的数据量。因此,在各种临床研究计划中使用 CDMS 将对来年的市场增长产生积极影响。

此外,与跨国公司或当地 CRO 的合作简化了这一过程。例如,Clario 为所有试验模型提供解决方案,例如基于现场的、分散的和混合临床试验。它通过北美、欧洲和亚太地区 9 个国家的 30 个设施生成多样化且可靠的证据。 2022 年 10 月,Veeva Systems 与近 40 家 CRO 合作部署其临床试验管理工具套件,包括 Veeva Vault CTMS。此外,由于虚拟或混合临床试验变得必要,该公司在 COVID-19 大流行期间实现了快速增长。

区域分析:

根据地理位置,全球临床数据管理系统市场分为五个关键区域:北美、欧洲、亚太地区、 中东及非洲、南部非洲中美洲。 2022年,北美在全球临床数据管理系统市场规模中贡献最大份额。预计亚太地区在 2022 年至 2030 年期间复合年增长率最高。

北美在临床数据管理系统市场中占有最大份额。该地区的市场分为美国、加拿大和墨西哥。该地区市场的增长归因于关键参与者的存在以及研发技术的不断采用等因素。有利的监管政策和制药公司不断增加的投资也有利于区域增长。 2021 年 11 月,临床终点技术领导者 ERT 与 Bioclinica 合并,成立 Clario。此次合并帮助该公司提供基于技术的治疗领域解决方案,以满足临床试验目标。

美国是北美临床数据管理系统市场的最大贡献者,世界。根据 ClinicalTrials.gov 的数据,截至 2023 年 6 月,北美正在进行 1,95,130 项临床试验。其中 163,336 起发生在美国。临床试验和研究数量的增加,加上临床研究资金的增加,可能会推动市场的增长。

制药公司的研发预算也增加了该地区近几年有所增加。例如,美国国立卫生研究院 (NIH) 大力资助临床研究,到 2022 年,其在美国的资助金额为 450 亿美元。因此,凭借对研发活动的大力投资和正在开发的治疗药物管道,市场预计将大幅增长。此外,Suvoda 于 2023 年 2 月推出了一个专用软件平台,为临床试验管理带来了经过验证的技术创新。它提供了下一代临床试验应用程序,旨在轻松处理复杂性并降低整个试验的总体风险。

因此,由于增加研发投资和不断增长的药物开发需求。

竞争格局和主要公司:

Oracle Corporation、Veeva Systems、Axion Real-Time Metrics、IBM Watson Health、CIMS Global、eClinical Solutions LLC、MMS Holdings、Calyx、Fortress Medical 和 Ennov 是著名的临床数据管理公司系统市场公司。这些公司专注于新技术、现有产品的开发。进步和地域扩张,以满足全球不断增长的消费者需求。

行业发展和未来机遇:

临床数据管理系统市场领先企业采取的各种举措如下:

  1. 2023 年 3 月, Assentia 推出了支持临床试验领域支付的技术平台。该公司发布了两款基于 SaaS 的应用程序 GrantPay 和 GrantPact,提供临床试验合同谈判和支付服务。
  2. 2023 年 2 月,Vial 与 Egnyte 合作。通过集成 Egnyte 的 eTMF,Vial 将为客户提供 eTMF 管理、合规性和审计准备方面的黄金标准,并提高临床试验技术的门槛。
  3. 2022 年 6 月,Medidata 宣布了技术增强解决关键的临床试验管理和监督问题。 Medidata Detect 和 Rave 临床试验管理系统的增强功能将以两种有意义的方式改善申办者和 CRO 的数据监督和报告,帮助他们全面监控试验数据并可视化这些数据以更快地做出决策。
  4. 2021 年 4 月,埃森哲收购了临床试验管理系统 (CTMS) 提供商 Zafgen。该交易扩展了埃森哲在临床试验管理和分析方面的能力。
  5. 2021 年 3 月,为新兴中型企业提供服务的 CRO Peachtree BioResearch Solutions, Inc. 采用了 Oracle Health Sciences Cloud Services和 Siebel 临床试验管理系统 (CTMS),以简化临床试验的启动和监控。
  6. 2021 年 2 月,eClinical Solutions LLC 为生命科学公司推出了 elluminate CTMS,以支持药物开发。 elluminate CTMS 平台具有增强运营监督和控制、提高试验性能以及优化资源等优势。
  7. 2020 年 11 月,Oracle 公司宣布收购 CTMS 服务提供商 ICON。该交易扩大了 Oracle 在生命科学行业的全球影响力,并帮助组织加速新疗法和疗法的开发。
  8. 2019 年 5 月,IQVIA Technologies 宣布收购提供商 Medidata Solutions基于云的 CTMS 解决方案。该交易扩大了 IQVIA 在临床试验管理市场的影响力。
  9. 2019 年 3 月,Oracle 公司宣布收购基于云的临床试验管理解决方案提供商 Comprehend Systems。该交易扩展了 Oracle 在医疗保健和生命科学行业的能力。
  10. 2018 年 12 月,Veeva Systems 宣布收购 CloudNine,这是一家基于云的临床试验管理解决方案提供商。该交易增强了 Oracle 的实力。 Veeva 的临床试验管理解决方案组合。
Report Coverage
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Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

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

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  • Oracle Corporation
  • Veeva Systems
  • Axion Real-Time Metrics
  • IBM Watson Health
  • CIMS Global
  • eClinical Solutions LLC
  • MMS Holdings
  • Calyx
  • Fortress Medical
  • Ennov

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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