临床试验影像市场趋势报告| 2028 年增长与规模

  • Report Code : TIPHE100001201
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 186
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【研究报告】临床试验影像市场规模预计将从2022年的16.107亿美元增至2028年的24.8032亿美元;预计 2023 年至 2028 年复合年增长率为 7.6%。

市场洞察和分析师观点:

临床试验成像是一项与自愿参与的人一起进行的研究。该研究的主要目的是确定影像学检查对于检测、诊断、指导或监测疾病治疗的价值。一些图像解释过程可以包括使用混合在临床试验图像之间的测试图像,使得间歇性地测试读者的阅读能力和/或一致性。如果未能保持熟练程度,可能会导致用另一位经过培训且合格的读者替换该读者。多中心临床试验中影像终点的利用率快速增加,数据量和工作流程复杂性也随之增加。临床试验成像管理系统 (CTIMS) 需要全面支持临床试验中的成像流程,以遵循无缝工作流程并改善患者治疗结果。 CTIMS 的关键监管要求是通过对许多相关法规和指南进行彻底审查而提取的,包括国际协调会议 - GCP E6、FDA 21 联邦法规第 11 部分和 820 部分、良好自动化制造实践和临床数据交换标准联盟。< /span>

增长动力和挑战:

临床研究组织( 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,协助临床试验的成功实施。 CRO 已开始通过其高效且具有成本效益的运营方式成为临床试验行业的支柱,从而使试验申办者受益。例如,平均而言,CRO 进行和完成临床试验的时间比内部活动少 30%。

随着 CRO 数量的增加导致激烈的竞争,其中一些企业提供专业成像服务,从而成为成像 CRO (iCRO)。 Keosys Medical Imaging 和 Medica Group PLC 是 iCRO 的例子。自 2010 年以来,临床试验总数增加了一倍,这些试验中成像方式的使用增加了近 500%。根据 KEOSYS MEDICAL IMAGING 公司的一份报告,iCRO 将其预算的 7.5% – 10% 用于成像,这有助于他们优化工作流程,以管理从图像采集到解释的过程的每一步。这些 CRO 提供成像现场鉴定、标准化图像采集以及读取设计和标准确定等领域的关键知识见解,从而为全球临床试验成像市场的增长做出贡献。

< p>临床试验有助于确定新的治疗或预防形式(例如新药、饮食或医疗设备)是否安全有效。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,越来越多的临床试验用于开发不同的有效治疗方法,推动了临床试验成像市场的增长。

此外,临床试验正在程序日益复杂,因此对研究型组织的运作进行适当的执行和监督变得至关重要。为了避免因执行不当而出现错误,研究型组织正在外包临床试验来开发其产品。临床研究组织 (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以及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,进而推动临床试验成像市场的增长。

2021年研发投入(十亿美元)

2022年研发投资(十亿美元)

武田药品工业株式会社有限公司

4.2

4.6< /p>

辉瑞公司

10.3

11.4

Grifols SA< /span>

404.57

427.05

注意:显示货币时会考虑当前汇率。

来源:年度报告和 Insight Partners 分析

研发支出用于发现、检查和生产新产品;预付款; ; 改善现有成果;并在推出前证明产品功效和法规合规性。研发投资根据临床试验的需要和要求而有所不同。成本包括材料、使用的用品和工资,以及开发质量控制的成本。

上述公司和医院正在投资开发治疗各种疾病和疾病的产品。疾病,例如免疫系统疾病。 2021 年 6 月,武田宣布开展 ADVANCE-1,这是一项随机、安慰剂对照、双盲 3 期临床试验,评估 HYQVIA [免疫球蛋白输注 10%(人)含重组人透明质酸酶]维持慢性炎症性脱髓鞘性多发性神经根神经病的治疗( CIDP),这将达到其主要终点。因此,公司不断增加的研发投资加上先进的制药行业正在推动临床试验成像市场的增长。

对于制药和生物制药公司来说,积极参与临床研究是回报丰厚但要求很高,医学成像正在成为研究的一个组成部分。然而,临床试验和成像模式的独特技术规范和管理方面与标准护理成像有很大不同,从而给研究地点已建立的临床基础设施带来负担。不遵守此类临床要求会导致产生不可信的数据、需要重复成像以及取消患者参加试验。此外,研究地点缺乏适当的基础设施可能会阻碍 CRO 应对此类挑战的努力。临床试验成像设备寻求利益相关者的大量资源投资。例如,药物或器械研究场所必须满足临床试验要求和基础设施,保持患者护理的优势,并保证试验的完整性。此外,临床试验申办者必须承认临床试验成像的负担,为满足上述要求所需的当地基础设施的开发提供支持。北美放射学会的定量成像生物标志物联盟致力于定义标准成像协议和工作流程,确保图像检查的一致性,以产生可量化的临床试验结果。因此,高投资和标准化基础设施要求阻碍了全球临床试验成像市场的增长。

战略见解

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报告细分和范围:

“全球”临床试验影像市场》根据模式、产品、最终用户和地理位置进行细分。根据模式,临床试验成像市场分为断层扫描、超声、正电子发射断层扫描、X射线、超声心动图、磁共振成像等。根据提供的服务,临床试验成像市场分为试验设计咨询服务、读取分析服务、操作成像服务、成像软件等。根据最终用户,临床试验成像市场分为制药和临床试验成像市场。生物制药公司、合同研究组织以及学术和研究机构政府研究机构等。基于地理位置的临床试验成像市场分为北美(美国、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国、俄罗斯和欧洲其他地区)、亚太地区(澳大利亚、中国、日本) 、印度、韩国和亚太地区其他地区)、中东和非洲非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美和非洲中美洲(巴西、阿根廷以及南美洲和中美洲其他地区)。

细分分析:

全球临床试验成像市场已细分为试验设计咨询服务、读取分析服务、操作成像服务、成像软件等。运营成像服务领域在 2021 年占据最大份额,预计在预测期内将继续保持类似趋势。操作成像服务包括用于神经病学、肿瘤学、心血管疾病、胃肠病学、肌肉骨骼疾病等治疗应用的 MRI、CT、超声、PET 和 SPECT 等成像模式,以及用于进行临床试验的医疗设备。临床成像是一种非侵入性的研究方法,对于医学科学的进步,特别是临床研究,具有许多优势。因此,将新型成像技术深入临床试验的趋势日益强烈,使其成为生物技术、制药和医疗设备的基本要素。

此外,在试验中执行成像时,选择正确的读取设计至关重要。阅读设计是指用于捕捉和解释图像的阅读器的数量和类型。减少变异性会给图像捕获和分析带来重大挑战,因为试验可能包括从各种成像方式获得的图像,需要放射科医生、病理学家和心脏病学家等专家进行审查。在临床试验中解释医学图像时,所使用的读取设计类型对于减少偏差至关重要。单读、双读和带有裁决器的双读是读设计的三种主要类型。图像在单次读取中仅由一名读者解读。在双重阅读中,两个或更多读者解释它。由于工作量大,大型试验可能需要多个读者。理想情况下,一名(或两名,在双读设计的情况下)阅读器将在整个研究过程中查看同一患者的所有图像。多个读者查看同一患者的不同成像时间点可能会导致额外的变化。例如,肿瘤学试验通常涉及以下阶段:治疗前病灶选择和测量的初步筛查、每次随访成像访视时病灶的顺序选择和测量,以及每个时间点增量放射学反应的评估.

Keosys Medical Imaging 为临床试验应用提供基于网络的成像和读取软件,以限制读者的主观性;提高测量和定量精度;提高整体运营效率、数据质量和可追溯性。 Keosys 提供的阅读软件中包含先进的病变管理系统和针对不同治疗领域的专门应用程序。该读取软件已通过 FDA 510 (k) 许可并符合 ISO 13485(医疗器械)标准。

临床试验成像市场,由 Offer– 提供2021年和2028年

根据模式,临床试验成像市场分为断层扫描、超声、正电子发射断层扫描、X射线、超声心动图、磁共振成像、和别的。断层扫描细分市场在 2021 年占据最大份额,预计在预测期内将继续保持类似趋势。在断层扫描中,用于 X 射线成像的移动 X 射线管会使叠加结构的阴影变得模糊。研究和临床试验中使用的计算机断层扫描 (CT) 扫描成像结合了从不同角度拍摄的 X 射线图像,然后经过计算机处理以提供骨骼、血管和软组织的横截面图像。线性和非线性断层扫描系统的操作方式类似——管子沿一个方向移动,而胶片暗盒沿相反方向移动,在两种技术中均以支点为中心。

新成像方法的引入或现有方法的改进需要与特定疾病治疗相关的准确时机。在适当的时间安排成像对于正确解释受试者的解剖结构至关重要。在医院,它有助于有效地进行手术、放射治疗或化疗等治疗,同时监测患者的毒性和发病率。肿瘤学领域的临床研究在很大程度上依赖于成像,以一定的持续时间、强度和频率进行的扫描程序是试验方案的基础。

CT 的高级成像指标扫描广泛用于新药开发和癌症研究。它是与晚期癌症类型相关的研究中最常用的成像方式,影响颈部、胸部、腹部或骨盆。

区域分析:< /u>

根据地理位置,临床试验成像市场分为五个关键区域:北美、欧洲、亚太地区、南美和北美。中美洲、中东和非洲非洲。 2021年,北美在临床试验成像市场中占据最大份额,其次是欧洲。美国已成为领先的临床研究目的地。全球近一半的临床试验是在美国进行的。此外,由于成熟的医疗基础设施、快速的审批时间表、有利的监管框架以及全球公认的临床试验生成数据,大多数制药研究公司更愿意在美国进行临床试验。世界卫生组织 (WHO) 报告指出,2021 年美国注册的临床试验数量最多(157,618 项)。

下表列出了美国注册的临床试验数量美国的招募患者总数,以及美国在上述参数中在世界上所占的百分比。

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2023

注册临床试验研究

研究中招募的患者

美国

139,632(占全球研究的 31%)

20,680(占全球研究人数的 32%)

来源:ClinicalTrial.gov报告

创新产品公司推出的用于临床试验的应用进一步推动了美国临床试验成像市场的增长。 Medical Metrics 是一家为临床试验提供成像服务的 CRO,提供“Assessa”。该产品有助于改善药物发现和相关临床研究的决策,特别是用于神经系统疾病(例如痴呆症)的药物的发现;认知障碍;以及阿尔茨海默病、精神分裂症、帕金森病和其他与记忆相关的疾病。美国临床试验数量的不断增加有利于该国临床试验影像市场的增长。

行业发展及未来机遇:

全球临床试验成像市场主要参与者采取的各种举措如下:

  • 2022 年 12 月,塔塔咨询服务公司 (TCS)(BSE:532540,NSE:TCS)宣布,用于分散试验的 TCS ADD Connected Clinical Trials 平台已赢得印度2022 年制药奖,卓越辅助制药服务类别。
  • 2021 年 10 月,Medidata,Dassault < Systèmes 公司宣布,该公司基于云的安全临床试验成像管理平台 Rave Imaging 已达到一个重要里程碑,已支持 1,000 多项成像研究。 Rave Imaging 基于 Medidata 统一平台构建,每年处理超过 1 亿张图像。该技术可以实时查看所有 Rave Imaging 试验中所有与成像相关的试验活动,以提高研究效率。

竞争格局和主要公司:

临床试验成像市场主要由 eResearch Technology Inc、Calyx Inc、ICON PLC、VIDA Diagnostics Inc 等公司组成、WCG Clinical Inc、BioTelemetry Inc、Medical Metrics Inc、Medpace Holdings Inc、Radiant Sage LLC 和 IXICO plc。这些公司一直在实施各种有助于其增长的战略,反过来又给市场带来了各种变化。这些公司利用了有机战略(例如推出、扩张和产品批准)和无机战略(例如产品发布、伙伴关系和协作)。

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Segment Covered
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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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Frequently Asked Questions


Who are the key players in the clinical trial imaging market?

The clinical trial imaging market majorly consists of the players such eResearch Technology Inc, Calyx Inc, ICON PLC, VIDA Diagnostics Inc, WCG Clinical Inc, BioTelemetry Inc, Medical Metrics Inc, Medpace Holdings Inc, Radiant Sage LLC, and IXICO plc. .

Which are the top companies that hold the market share in clinical trial imaging market?

ICON plc and Calyx Inc are the top two companies that hold huge market shares in the clinical trial imaging market.

Which modality segment leads the clinical trial imaging market?

Tomography segment held the largest share of the market in the clinical trial imaging market and held the largest market share in 2022.

Which offering held the largest share in the clinical trial imaging market?

The operational imaging services segment dominated the clinical trial imaging market and held the largest market share in 2022.

What are the driving factors for the clinical trial imaging market across the globe?

Key factors that are driving the growth of this market are accelerated clinical trial activities in pharmaceutical and biotechnology industry and spur in number of CROs offering medical imaging services to boost the market growth for the clinical trial imaging over the years.

What is the market CAGR value of clinical trial imaging market during forecast period?

The CAGR value of the clinical trial imaging market during the forecasted period of 2023-2028 is 7.6%.

What is Clinical Trial Imaging Market?

Clinical trial imaging is a key asset in the drug development process as it offers efficacy evaluation and safety monitoring data required in clinical trials for regulatory submission. Additionally, imaging offers insights into the drug mechanism of action (MOA) and drug effects that assist researchers in making scientific decisions. For example, in late-phase trials, medical imaging can be utilized as an imaging biomarker to improve clinical trial efficacy and reduce the time to complete a given trial.

The List of Companies - Clinical Trial Imaging Market

  1. eResearch Technology Inc
  2. Calyx Inc
  3. ICON PLC
  4. VIDA Diagnostics Inc
  5. WCG Clinical Inc
  6. BioTelemetry Inc
  7. Medical Metrics Inc
  8. Medpace Holdings Inc
  9. Radiant Sage LLC
  10. IXICO 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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