市场调查报告书
商品编码
1466369
临床试验设施管理组织市场:按阶段、服务、治疗领域划分 - 全球预测 2024-2030 年Clinical Trials Site Management Organizations Market by Phase (Phase I, Phase II, Phase III), Services (Onsite Monitoring, Project Management, Regulatory Compliance), Therapeutic Areas - Global Forecast 2024-2030 |
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临床试验设施管理组织市场规模预计到2023年为73.8亿美元,预计到2024年将达到80亿美元,到2030年将达到132.1亿美元,复合年增长率为8.65%。
临床试验现场管理组织负责招募病患、协调人员训练和会议以及管理临床试验各阶段的试验预算。我们也协助确保临床实验场所遵守相关法规,并确保所有临床实验参加者获得优质照护。近年来,随着感染疾病和非感染疾病的流行推动药物开发活动,临床实验中心管理组织的使用显着增加。此外,政府机构以及製药和生物製药製造商对投资和临床试验活动进行成本效益管理的需求也推动了设施管理机构的使用。另一方面,各个临床试验中心的管理和协调问题以及缺乏训练有素的人员阻碍了临床实验中心管理组织的使用。然而,临床试验管理和监测方面创新技术的采用,加上全球研究设施数量的持续增加,预计将在未来几年支持临床试验设施管理服务的采用。
主要市场统计 | |
---|---|
基准年[2023] | 73.8亿美元 |
预测年份 [2024] | 80亿美元 |
预测年份 [2030] | 132.1亿美元 |
复合年增长率(%) | 8.65% |
第三期临床试验需要严格的资料收集和参与者管理
在I期临床试验过程中,临床实验管理组织制定详细的方案,遵守整体研究计划,密切监控目标进展,在相关人员之间提供清晰的沟通,并与监管机构沟通协助调整。此外,这些组织可以监控招募工作,以确保招募适当的患者群体以进行准确的资料收集。在 II 期临床试验中,临床实验管理组织必须有足够的人员来处理与增加的样本量相关的业务,以及足够的能力来容纳增加的参与者访问次数和专注于提供适当的后续测试。准确且有效率地收集参与者的高品质资料,协助确保各项任务有组织、及时完成。在 III 期临床试验期间,临床实验管理组织努力维持严格的资料准确性和一致性标准,同时始终保护病患安全。整个过程中严格的品管措施等策略有助于确保资料并符合监管标准。在 IV 期临床试验中,临床实验管理组织的主要目标是透过持续的上市后监测活动(例如额外的患者追踪和额外的实验室测试)来改善正在测试的药物或医疗设备的长期开发。确定安全性和有效性。
治疗领域:肿瘤试验独特的复杂性、快速开发週期和广泛的多中心协调的需要
心臟病学是一个专注于诊断、理解和治疗与心臟和血管相关的疾病的领域。循环系统临床试验的范围包括研究治疗高血压、冠状动脉疾病、心臟衰竭和心律不整的预防性和新颖治疗方法,以及评估支架和心律调节器等尖端医疗设备。中枢神经系统领域涵盖多种神经和精神疾病,包括阿兹海默症、帕金森氏症、忧郁症、忧郁症和思觉失调症,使得试验特别复杂。这是由于测量结果的复杂性,通常是主观的或需要特殊仪器。临床实验管理组织在中枢神经系统试验中发挥关键作用,在严格的法规环境中发挥重要作用,并促进实施患者评估和结果测量的专门方法。内分泌系统检查主要针对内分泌系统疾病,如糖尿病、甲状腺疾病、骨质疏鬆症等。许多内分泌试验,特别是与糖尿病相关的试验,都是大规模试验,需要大量患者入组和长期随访,但根据内分泌疾病的频谱,操作要求也有很大差异。临床试验现场管理组织透过提供患者招募方面的专业知识,特别是在接触特定亚群和管理长期追踪的后勤方面,在这些试验中发挥了重要作用。肿瘤学领域是一个治疗领域,对临床实验设施管理组织有大量且持续的需求。鑑于对新癌症治疗的迫切需求,肿瘤学临床试验数量众多,包括新的治疗药物、联合治疗,并且需要密切监测患者的疗效和副作用,这通常非常复杂。临床试验现场管理组织是肿瘤学临床试验的宝贵资产,提供有效管理跨不同地区的多中心临床试验所需的基础设施和专业知识,每个中心都有自己独特的监管环境,提供知识和协调。疼痛管理的临床试验旨在评估新型止痛药和介入措施对神经病变疼痛、骨关节炎和偏头痛等慢性疼痛的有效性和安全性。在这些试验中经常观察到疼痛的主观性质和高安慰剂效应,需要复杂的方法来设计和实施试验。
区域洞察
美洲,特别是美国和加拿大,是全球临床试验的重要地点。先进的医疗基础设施、高昂的研发成本和强大的法规环境使该地区成为临床试验的首选目的地,从而增加了对临床试验现场管理组织的需求。美国是临床研究中心,其特点是拥有众多的製药公司和研究机构。 《21 世纪治疗方法》等倡议进一步简化了药物核准的监管流程,并鼓励更多临床试验。欧洲的特点是安全性和有效性高标准以及严格的监管要求。欧洲药品管理局 (EMA) 在成员国之间的监管协调方面发挥关键作用,并促进整个欧洲的多中心临床试验。欧洲处于罕见疾病和个人化医疗研究的前沿。最近的工作重点是提高病人参与并将数位技术纳入临床试验。由于政府加强医疗基础设施和研究活动的倡议,中东在临床试验领域变得越来越重要。以色列、沙乌地阿拉伯和阿拉伯联合大公国等国家正在投资生物技术和药物研究。由于需要服务大量且多样化的患者群体、实现成本效益并快速改善法规结构,亚太地区对临床试验活动和临床实验管理组织的需求正在显着增长。由于其庞大的人口和政府对生物医学研究的日益支持,中国已成为临床试验的领先国家。中国近期的医药品认证过程改革显着缩短了核准时间,使其成为临床研究的合适目的地。日本医疗体系先进,医疗费用高昂,是亚太地区临床试验的领先国家。印度因其庞大且基因多样化的人口和成本效率而成为临床试验领域的新兴领导者。
FPNV定位矩阵
FPNV 定位矩阵对于评估临床试验设施管理组织市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对临床试验现场管理组织市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。这种详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争力评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.临床试验设施管理组织市场的市场规模与预测为何?
2.临床试验设施管理组织市场预测期间需要考虑投资的产品、细分市场、应用程式和领域有哪些?
3.临床试验设施管理组织市场的技术趋势和法规结构是什么?
4.临床试验设施管理组织市场主要供应商的市场占有率?
5. 进入临床试验设施管理组织市场的适当型态和策略手段是什么?
[197 Pages Report] The Clinical Trials Site Management Organizations Market size was estimated at USD 7.38 billion in 2023 and expected to reach USD 8.00 billion in 2024, at a CAGR 8.65% to reach USD 13.21 billion by 2030.
Clinical trial site management organizations are responsible for recruiting patients, coordinating training and meetings for staff, managing study budgets, and more during various phases of clinical trials. They also help ensure that sites are compliant with relevant regulations, as well as make sure that all participants in the trial are receiving quality care. The utilization of site management organizations has surged considerably in recent years, with the prevalence of communicable and non-communicable diseases encouraging drug development activities. Moreover, investments made by government agencies and pharmaceutical and biopharmaceutical manufacturers and the need for cost-effective management of clinical trial activities also encourage the use of site management organizations. On the other hand, issues pertaining to managing and coordinating different clinical trial research sites and shortages of trained staff hinder their utilization. However, the adoption of innovative technologies in clinical trial management and monitoring, coupled with a continuous increase in the number of research sites across the globe, is expected to support the adoption of clinical trial site management services in the coming years.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 7.38 billion |
Estimated Year [2024] | USD 8.00 billion |
Forecast Year [2030] | USD 13.21 billion |
CAGR (%) | 8.65% |
Phase: Need for ensuring the rigorous data collection and participant management in Phase III trials
During the Phase I clinical trial process, clinical trial site management organizations aid in developing detailed protocols, ensuring strict adherence to the overall trial plan, closely monitoring progress against objectives, providing clear communication between all parties involved, and coordinating with regulatory agencies. Additionally, these organizations may monitor recruitment efforts to ensure that appropriate patient populations are enrolled for accurate data collection. In Phase II clinical trials, clinical trial site management organizations focus on increasing staff size where necessary to handle increased workloads associated with larger sample sizes, providing sufficient resources to support increased participant visits and follow-up examinations, collecting high-quality data from participants accurately and efficiently, and assisting in ensuring that all assignments are completed in an organized and timely manner. During Phase III clinical trials, clinical trial site management organizations strive to maintain rigorous standards for data accuracy and consistency while protecting patient safety at all times. Strategies such as rigorous quality control measures throughout the entire process can help ensure data integrity and compliance with regulatory standards. In Phase IV clinical trials, the primary goal of clinical trial site management organizations is to evaluate and determine the long-term safety and effectiveness of the drug or device being tested through continued post-marketing surveillance activities such as additional patient follow-up visits or additional laboratory testing.
Therapeutic Areas: Inherent complexities of oncology studies and the need for rapid development cycles and extensive multi-site coordination
The field of cardiology focuses on diagnosing, understanding, and treating disorders related to the heart and blood vessels. Clinical trials in cardiology might encompass a broad spectrum of studies, from those investigating preventive measures and novel therapeutics for managing hypertension, coronary artery disease, heart failure, and arrhythmias to evaluating cutting-edge medical devices such as stents and pacemakers. The central nervous system realm, encompassing a range of neurological and psychiatric conditions, including Alzheimer's disease, Parkinson's disease, epilepsy, depression, and schizophrenia, is marked by a high degree of trial complexity. This is due to the intricacies of measuring outcomes that are often subjective or require special instruments. Clinical trial site management organizations play a critical role in CNS trials, facilitating the navigation through stringent regulatory environments and the implementation of specialized methodologies for patient assessment and outcome measurement. Endocrine trials focus on disorders of the endocrine system, including diabetes, thyroid disorders, and osteoporosis. Although many endocrine trials, particularly those related to diabetes, are large-scale studies requiring extensive patient enrollment and long-term follow-up, the operational demands vary widely across the spectrum of endocrine disorders. Clinical trial site management organizations are instrumental in these studies, offering expertise in patient recruitment, especially in reaching specific subpopulations and managing the logistical aspects of long-term follow-ups. Oncology is a therapeutic area with a significant and ongoing need for clinical trial site management organizations. Given the urgent need for new cancer treatments, oncology trials are numerous and often highly complex, involving novel therapeutic agents, combination therapies, and the need to closely monitor patients for both efficacy and adverse effects. Clinical trial site management organizations are valuable in oncology clinical trials, providing the essential infrastructure, expertise, and coordination to efficiently manage multicenter trials across different regions, each with its unique regulatory landscape. Clinical trials in pain management seek to evaluate the efficacy and safety of new analgesics or interventions for chronic pain conditions such as neuropathic pain, osteoarthritis, and migraines. The subjective nature of pain and the high placebo effect often observed in these trials demand a sophisticated approach to trial design and execution.
Regional Insights
The Americas, particularly the United States and Canada, represent a significant landscape for clinical trials globally. The region's advanced healthcare infrastructure, high research and development expenditure, and robust regulatory environment make it a preferred destination for clinical trials, thereby contributing to the need for clinical trial site management organizations. The U.S. is the epicenter of clinical research, characterized by the presence of a vast majority of pharmaceutical companies and research institutions. Initiatives such as the 21st Century Cures Act have further streamlined the regulatory process for drug approval, encouraging more clinical trials. Europe is characterized by its high standards for safety and efficacy alongside stringent regulatory requirements. The European Medicines Agency (EMA) plays a vital role in harmonizing regulations across member states, facilitating multicenter trials across the continent. Europe is at the forefront of research in rare diseases and personalized medicine. Recent initiatives focus on enhancing patient engagement and incorporating digital technologies in trials. The Middle East is increasingly becoming significant in the clinical trials landscape, driven by government initiatives to boost healthcare infrastructure and research activities. Countries such as Israel, Saudi Arabia, and the UAE are investing in biotechnology and pharmaceutical research. The APAC region has seen significant growth in the need for clinical trial activities and clinical trial site management organizations, primarily driven by the need to cater to the large and diverse patient population, achieve cost efficiencies, and rapidly improve regulatory frameworks. China has become a major nation for clinical trials due to its massive population and a government that is increasingly supportive of biomedical research. Recent reforms in China's drug approval processes have significantly reduced approval times, making it a suitable destination for clinical research. Japan, with its advanced healthcare system and high healthcare expenditure, is a leading country for clinical trials in the Asia Pacific. India is an emerging leader in clinical trials due to its vast, genetically diverse population and cost efficiencies.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Clinical Trials Site Management Organizations Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Clinical Trials Site Management Organizations Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Clinical Trials Site Management Organizations Market, highlighting leading vendors and their innovative profiles. These include Accel Clinical Services, Accelagen, Access Clinical Research, Altasciences, Celerion, ClinChoice, Clinical Development Solutions, CMIC HOLDINGS Co., LTD., Criterium, Inc., FIDELIS RESEARCH AD by BioIVT, FOMAT Medical Research Inc., George Clinical Pty Ltd,, Grand Pacific CRO, ICON PLC, IQVIA Inc., KV Clinical Research Services, L.E.K. Consulting LLC, MCRA, LLC, Medigence Solutions Pvt Ltd., Novotech, Parexel International Corporation, PPD Inc. by Thermo Fisher Scientific Inc., PROMETRIKA, LLC., ProTrials Research, Inc., Red Maple Trials Inc., SGS S.A., Veristat, LLC., Vial Health Technology, Inc., WIRB-Copernicus Group, Xylem Research LLP, and Zave Clinical Research Management.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Clinical Trials Site Management Organizations Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Clinical Trials Site Management Organizations Market?
3. What are the technology trends and regulatory frameworks in the Clinical Trials Site Management Organizations Market?
4. What is the market share of the leading vendors in the Clinical Trials Site Management Organizations Market?
5. Which modes and strategic moves are suitable for entering the Clinical Trials Site Management Organizations Market?