市场调查报告书
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1466401
临床试验设备和辅助解决方案市场:按产品类型、阶段、最终用途、适应症分类 - 全球预测 2024-2030Clinical Trial Equipment & Ancillary Solutions Market by Product (Equipment, Services, Systems), Type (Biologic Drugs, Medical Devices, Small Molecules), Phase, End-Use, Indication - Global Forecast 2024-2030 |
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预计2023年临床试验设备和辅助解决方案市场规模为42.1亿美元,2024年达45.8亿美元,预计2030年将达到76.2亿美元,复合年增长率为8.81%。
临床试验设备和辅助解决方案是临床试验过程中使用的专业医疗设备和服务,用于准确有效地评估治疗方法、药物和设备。该设备包括患者监护仪、成像系统、实验室设备、自动资料收集系统等。它还包括临床试验管理和监管支援等辅助服务。临床试验设备和支援解决方案是成功临床试验的重要组成部分,提供确保参与者安全和试验结果准确性所需的工具和资源。临床试验设备辅助解决方案包括用于支援完成临床试验的任何工具、服务和产品。增加对临床试验设备和辅助解决方案的研发活动的投资将促进创新,提高资料质量,扩大产品范围,确保合规性,并透过吸引新的市场参与企业来满足不断变化的临床试验需求。外包临床试验业务可提高成本效率、获得专业知识、扩大影响范围、简化业务、遵守法律规章、扩充性,并进一步增加临床试验设备和辅助解决方案的使用。与云端基础的临床试验解决方案相关的资料安全风险,例如未授权存取和资料洩露,引起了人们对保密、法规遵循、资料完整性和网路安全的担忧,阻碍了临床试验设备和辅助解决方案市场的成长。此外,越来越多的临床试验设备监管核准和政府支持正在推动测试活动的活性化、先进技术的采用、技术创新和监管流程的简化,从而在预测期内创造市场机会。
主要市场统计 | |
---|---|
基准年[2023] | 42.1亿美元 |
预测年份 [2024] | 45.8亿美元 |
预测年份 [2030] | 76.2亿美元 |
复合年增长率(%) | 8.81% |
扩大在产品设备租赁和租赁服务中使用辅助采购服务
在临床试验中,辅助设备是指临床试验过程、操作和系统所需的专用工具、装置和设备。辅助器具允许医务人员在测试过程中准确测量资料点,从而为临床试验提供重要的好处。临床试验中使用的实验室设备包括用于精确样本分析的离心机、高压釜、培养箱、低温冷冻和光强度。诊断影像设备包括X光设备、超音波设备、MRI扫描仪、CT扫描仪、肺计量计、临床实验室分析仪等。临床试验中所使用的诊断设备是指在试验过程中用于诊断、评估和监测受试者健康状况的设备和装置。
辅助采购服务包括设备租赁和租赁服务、采购、供应和物流。供应和物流是由临床试验设备和辅助解决方案供应商提供的服务,专注于识别、评估和采购支援成功临床试验所需的材料。供应与物流的辅助采购服务提供市场研究和分析支持,帮助临床试验申办者为其临床试验确定最佳辅助解决方案。临床试验资料管理和分析服务系统性地收集、储存和分析与临床试验相关的资料。临床试验中的维护和校准服务对于确保所获得结果的安全性和准确性至关重要,并涉及设备的定期测试、维护和校准。临床试验监管和合规服务是帮助确保遵守管理机构制定的规则、法规和标准的服务和解决方案。临床实验试验中心监测和支援服务是在整个临床实验过程中从临床实验临床试验赞助者到临床试验中心提供持续支援、监测和监督的服务。我们的临床试验培训和咨询服务为研究人员和临床实验提供有关最佳实践、安全程序和法规遵循的教育。此外,临床试验管理系统对于有效规划、管理和追踪您的临床试验组合至关重要。电子资料撷取 (EDC) 系统是一种软体应用程序,可简化临床试验资料的收集、储存和保护。
扩大临床试验设备在型生物製药生产过程中的使用
医疗设备临床试验是为了评估用于治疗、预防和诊断人类疾病的医疗设备的安全性和性能而进行的测试。在医疗设备临床试验中,患者监护仪、影像系统、诊断工具、资料管理系统和设备校准设备等设备和辅助解决方案有助于确保准确的评估和成功的测试。生物製药製造过程中使用的临床试验设备具有许多好处,包括提高效率和精确度。在生物製药中,临床试验设备可以实现更高品质的资料收集和分析,从而提高药物製造的整体效率和准确性。小分子临床试验中常用的设备包括高效液相层析(HPLC)、超高效液相层析(UHPLC)、气相层析法(GC)、溶出度测试设备、自动移液系统、离心机等。临床试验领域使用的辅助解决方案包括样本处理、收集、储存、资料分析系统、用于患者记录监控和追踪的软体解决方案以及样本安全性和合规性。
适应症在消化器官系统疾病分析中越来越偏好临床试验仪器
临床试验仪器透过提供电脑化和高度专业化的血液分析仪来分析血液样本中的红血球、白血球、血红蛋白和血小板,从而增强了血液疾病临床研究的工作流程。代谢和消化器官系统疾病临床试验中优选使用显微镜、胃镜、十二指肠镜等临床试验仪器进行分析,以改善临床研究过程中的临床结果。仪器和辅助解决方案可用于急性骨髓性白血病、贫血性癌症和慢性骨髓性白血病病症的肿瘤学临床试验。在心血管疾病、中枢神经系统和精神疾病、感染疾病、代谢性疾病的临床试验中,根据适应症采用医学影像设备和智慧穿戴设备,有效进行临床试验。
扩大临床试验设备和辅助解决方案在第二期临床试验的使用,以评估第二期药物的疗效
一期临床试验主要着重于评估新药和治疗方法的安全性和剂量。 I 期临床试验中使用的设备和辅助解决方案包括剂量管理、病患监测和安全评估工具。在开发过程的第一阶段,将在最多 100 人的研究小组中进行药物动力学和耐受性评估,包括初始单剂量研究、剂量递增研究和健康志愿者的重复剂量研究。 II 期试验评估药物或治疗方法在 100 至 500 名患者的较大人群中的有效性。该试验旨在发现该产品的初步功效和副作用。 III 期试验涉及约 3,000 人的更多患者群体,并将新药或治疗方法与现有护理标准进行比较。 III期试验需要很长时间来研究药物。
最终用途:扩大临床试验设备在生物技术和製药公司的使用
临床试验仪器和辅助解决方案用于在药物开发、委外研发机构(CRO)、製药公司和生物技术公司进行的临床试验期间监测患者的进展。临床试验设备和辅助解决方案可提高方案合规性并确保符合医疗设备公司的监管标准。学术和研究机构为参与者和工作人员提供教育支持,以实现临床试验的最佳表现。
区域洞察
由于政府对药物发现和开发的支持投资和倡议,以及该地区临床试验活动的显着增长,美洲临床试验设备和辅助解决方案市场高度发展。亚太地区因其庞大且多样化的患者群体以及低成本因素而成为临床试验设备和辅助解决方案不断增长的市场,这是开展临床试验的主要优势。此外,在欧洲、中东和非洲地区,为确保临床试验设备和辅助解决方案的安全性和有效性而製定的严格政府法规正在推动市场竞争和标准化。包括欧洲药品管理局 (EMA)、临床试验法规 536/2014 (EU-CTR) 和区域框架在内的各种政府框架负责监控和规范该地区临床试验设备和辅助解决方案的使用。
FPNV定位矩阵
FPNV定位矩阵对于评估临床试验设备和辅助解决方案市场至关重要。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,可以对临床试验设备和辅助解决方案市场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.竞争评估及资讯: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、製造能力等进行综合评估。
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.临床试验设备及辅助解决方案市场的市场规模与预测为何?
2.临床试验设备和辅助解决方案市场预测期间需要考虑投资的产品、细分市场、应用和领域有哪些?
3.临床试验设备和辅助解决方案市场的技术趋势和法规结构是什么?
4.临床试验设备及辅助解决方案市场主要厂商的市场占有率如何?
5. 进入临床试验设备及辅助解决方案市场的合适型态和策略手段是什么?
[189 Pages Report] The Clinical Trial Equipment & Ancillary Solutions Market size was estimated at USD 4.21 billion in 2023 and expected to reach USD 4.58 billion in 2024, at a CAGR 8.81% to reach USD 7.62 billion by 2030.
Clinical trial equipment & ancillary solutions are specialized medical equipment and services used during clinical trials to accurately and effectively evaluate treatments, drugs, and devices. This equipment includes patient monitors, imaging systems, laboratory instruments, and automated data collection systems. It also includes ancillary services such as clinical trial management and regulatory support. Clinical trial equipment & ancillary solutions are essential components of any successful clinical trial as they provide the necessary tools and resources to ensure participants' safety and the trial results' accuracy. An ancillary solution for clinical trial equipment includes any tools, services, or products used to assist in completing a clinical trial. Rising investment in R&D activities for clinical trial equipment and ancillary solutions drives market growth by fueling innovation, improving data quality, expanding product offerings, ensuring regulatory compliance, addressing evolving trial needs, and attracting new market participants. Outsourcing clinical trial activities provides cost-effectiveness, access to expertise, expanded reach, streamlined operations, regulatory compliance, and scalability, further increasing the use of clinical trial equipment & ancillary solutions. Data security risks associated with cloud-based clinical trial solutions, such as unauthorized access and data breaches, create concerns about confidentiality, regulatory compliance, data integrity, and cybersecurity, hampering the clinical trial equipment & ancillary solutions market growth. Moreover, rising regulatory approvals for clinical trial equipment and government support, which increased trial activity, adoption of advanced technologies, innovation, and streamlined regulatory processes, have created market opportunities in the forecasted period.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 4.21 billion |
Estimated Year [2024] | USD 4.58 billion |
Forecast Year [2030] | USD 7.62 billion |
CAGR (%) | 8.81% |
Product: Growing utilization of ancillary sourcing services for equipment leasing & rental services
In clinical trials, ancillary supplies equipment refers to the specialized tools, devices, and instruments necessary for the clinical trials processes, operations, or system. Ancillary supplies provide essential advantages to clinical trials by enabling medical staff to accurately measure data points during a test. Laboratory equipment used in clinical trials includes centrifuges, autoclaves, incubators, cryogenic freezers, and spectrophotometers used to ensure accurate sample analysis. Imaging & diagnostics equipment includes X-ray machines, sonography machines, MRI scanners, CT scanners, spirometers, and laboratory analyzers. Diagnostic equipment used in clinical trials refers to the instruments and devices employed to diagnose, assess, and monitor participants' health status during the test.
Ancillary sourcing services include equipment leasing & rental services, procurement, and supply & logistics, a service provided by clinical trial equipment and ancillary solutions providers that focuses on identifying, evaluating, and procuring the materials needed to support the success of a clinical trial. Supply & logistics ancillary sourcing services provide market research and analytical support to help clinical trial sponsors identify the optimal ancillary solutions for their trials. Data management & analysis services in clinical trials offer an organized way to collect, store, and analyze data related to the trial. Maintenance & calibration services in clinical trials are vital in ensuring the safety and accuracy of results achieved, which involve regular inspections, maintenance, and equipment calibration. Regulatory & compliance services in clinical trials are services and solutions that help ensure organizations comply with the rules, regulations, and standards established by a governing body. Site monitoring & support services in clinical trials involve providing ongoing support, monitoring, and oversight for research sites from the trial sponsor throughout the clinical trial process. Training & consulting services in clinical trials educate research staff and investigators on matters concerning best practices, safety procedures, and regulatory compliance. Moreover, a clinical trial management system is essential to effectively plan, manage, and track clinical study portfolios. An electronic data capture (EDC) system is a software application that helps streamline collecting, storing, and securing data from clinical studies.
Type: Increasing application of clinical trial equipment in the manufacturing process of biological drugs
Medical device clinical trials are examinations undertaken to assess a medical device's safety or performance in terms of its use in treating, preventing, or diagnosing diseases in human subjects. In medical device clinical trials, equipment and ancillary solutions such as patient monitors, imaging systems, diagnostic tools, data management systems, and device calibration equipment ensure accurate evaluation and successful trial outcomes. Clinical trial equipment used in the manufacturing process of biological drugs offers numerous benefits, including increased efficiency and accuracy. In biological drugs, clinical trial equipment results in higher-quality data collection and analysis, which can increase overall efficiency and accuracy in drug production. The commonly used equipment in small molecule clinical trials include high-performance liquid chromatography (HPLC), ultra-high performance liquid chromatography (UHPLC), gas chromatography (GC), dissolution testing apparatus, automated dispensing systems, and centrifuges. Ancillary solutions utilized in the clinical trials space include sample handling, collection, storage, data analysis systems, software solutions for monitoring and tracking patient records, and sample safety and compliance.
Indication: Rising preferences for clinical trial equipment to analyze digestive disorders
Clinical trial equipment enhances the workflow of clinical investigation of blood disorders by providing computerized, highly specialized hematology analyzers for analyzing red and white blood cells, hemoglobin, and blood platelets in a blood sample. Clinical trial equipment such as the microscope, gastroscope, and duodenoscope is preferred in analyzing metabolic disorders and digestive disorders clinical trials to enhance the clinical outcomes during clinical investigation. Equipment and ancillary solutions are available for acute myelogenous leukemia, anemic cancer, and chronic myeloid leukemia disease conditions for oncology clinical studies. Medical imaging equipment and smart wearable devices are employed in the clinical trials of cardiovascular diseases, central nervous system (CNS) & mental disorders, infectious diseases, and metabolic disorders depending upon the indication to organize clinical trials effectively.
Phase: Growing usage of clinical trial equipments & ancillary solutions in phase II to assess effectiveness of drug
Phase I clinical trials primarily focus on assessing the security and dosage of a new drug or treatment. Equipment and ancillary solutions used in phase I trials include tools for dose administration, patient monitoring, and safety assessments. During phase I of the development process, pharmacokinetics and tolerance evaluations occur in a trial group comprising 100 people or less, including initial single-dose studies, dose-escalation, and repeated-dose studies in healthy volunteers. Phase II trials assess the effectiveness of a drug or therapy in a larger group of patients, between 100 and 500. The trial aims to discover the product's preliminary efficacy and side effect profile. Phase III trials involve a larger patient population, around 3,000, and compare the new drug or treatment against existing standard therapies. Phase III trial takes an extended period to study the drug.
End-Use: Expanding application of clinical trial equipment in biotechnology & pharmaceutical companies
Clinical trial equipment and ancillary solutions are utilized in drug development, monitoring patient progress during a clinical trial executed by contract research organizations (CROs), pharmaceutical companies, and biotechnology companies. Clinical trial equipment and ancillary solutions improve protocol adherence and ensure compliance with medical device companies' regulatory standards. Academic & research institutes provide educational support to participants and staff for optimum performance in clinical trials.
Regional Insights
The clinical trials equipment & ancillary solutions market in the Americas is highly developing due to supportive governmental investments and initiatives for drug discovery and development and significant growth of clinical trial activities in the region. The Asia-Pacific region is an evolving market for clinical trial equipment & ancillary solutions owing to factors such as a large and diverse patient base and low costs that provide significant advantages for conducting clinical trials. Moreover, the stringent government norms in the EMEA region for ensuring the safety and efficacy of clinical trial equipment & ancillary solutions are making the market more competitive and standardized. The various government frameworks, including the European Medicines Agency (EMA), Clinical Trial Regulation 536/2014 (EU-CTR), and regional frameworks, monitor and regulate the use of clinical trial equipment & ancillary solutions in the region.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Clinical Trial Equipment & Ancillary Solutions 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 Trial Equipment & Ancillary Solutions 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 Trial Equipment & Ancillary Solutions Market, highlighting leading vendors and their innovative profiles. These include Almac Group Limited, Ancillare, LP, Avantor, Inc., Axelerist, B. Braun SE, Bio-Rad Laboratories, Inc., Charles River Laboratories International, Inc., Dassault Systemes SE, Emsere B.V., Eppendorf SE, Eurofins Scientific SE, Global Vision Technologies, Inc., Hitachi, Ltd., IQVIA Holdings Inc., Lonza Group Ltd., MedNet Solutions, Inc., Myonex, Inc., Navitas Inc., Oracle Corporation, Parexel International Corporation, Quanticate International Limited, Quipment SAS, Royal Philips, Thermo Fisher Scientific, Inc., United Parcel Service, Inc., Veeva Systems Inc., Yokogawa Electric Corporation, and Zifo Technologies Private Limited.
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 Trial Equipment & Ancillary Solutions Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Clinical Trial Equipment & Ancillary Solutions Market?
3. What are the technology trends and regulatory frameworks in the Clinical Trial Equipment & Ancillary Solutions Market?
4. What is the market share of the leading vendors in the Clinical Trial Equipment & Ancillary Solutions Market?
5. Which modes and strategic moves are suitable for entering the Clinical Trial Equipment & Ancillary Solutions Market?