北美临床试验成像市场 – 行业趋势和 2029 年预测

北美临床试验成像市场分析与洞察

成像技术的需求不断增加，老年人口增加导致慢性病患病率上升，以及市场参与者采取的产品发布、进步、收购和协议等战略举措，都是预计推动市场增长的因素。

然而，成像设备的不适当和不利的报销情形以及临床试验成像仪器缺乏明确的标准预计会抑制市场的增长。

用于诊断和治疗慢性疾病的临床试验成像技术不断进步，预计将推动市场增长。Data Bridge Market Research 分析称，在 2022 年至 2029 年的预测期内，北美临床试验成像市场将以 8.3% 的复合年增长率增长。

市场定义

Clinical trial is a process of developing new drugs. It is designed for potential treatment and its effects on humans. Before the commercialization of new drugs, extensive clinical testing is done to identify promising compounds, and safety tests are conducted to determine the possible risks.

In clinical trials, medical imaging plays a significant role in more accurate and effective results. Different imaging technologies may be used to elucidate and demonstrate the mechanistic actions of drugs. Clinical trial imaging is the process of clinical analysis and medical intervention by creating image representations of inner parts of the body. It has several different technologies which are used to view the human body to monitor, treat, and diagnose medical conditions.

In the coming future, important decisions related to clinical trial imaging on drug discovery will be made by individuals who not only understand the biopsy but can also use the clinical trial imaging tools and the knowledge they release to develop hypotheses and identify quality targets.

North America Clinical Trial Imaging Market Dynamics

Drivers

• Rising R&D Expenditure

Imaging and pharma companies are continuously investing in R&D to offer innovative services for clinical trial imaging to customers and enhance their market presence. Medical imaging plays a dynamic role in clinical development. While the medical imaging industry is in a constant state of fluctuation due to implementation of new technologies in the market, the pharmaceutical and imaging industries continue to increase. This is attributed to enhanced investment in medical imaging companies along with mergers and acquisitions as well as the adoption of innovation in imaging technologies to support clinical trials for medical devices. Increasing R&D expenditure in pharmaceutical and biotechnological companies is fueling market growth.

This has encouraged the development of new products and high research-oriented programs organized in biopharmaceutical industries and a high preference for the studies of human genome. Rising expenditure on R&D activities also develops new drugs and therapies to treat chronic diseases that boost market growth. This helps the pharmaceutical and biotechnological companies in the development of new technologies in the category of imaging clinical trials therefore, rising R&D expenditure is expected to drive the market growth.

• Increasing Number of Contract Research Organizations (CROs)

Contract Research Organization (CRO) is an organization that gives support for clinical trials and other research services to imaging and pharmaceutical industries in the form of outsourced pharmaceutical research services in terms of both drugs and medical devices. CRO helps imaging and pharmaceutical industries with the drug development process to reduce the cost and initiate the process of bringing clinical trials to develop the drug for a particular disease segment by using clinical trial imaging and other processes to overcome capacity gaps of the in-house research team for pharmaceutical and clinical research.

CRO is the backbone of the clinical trial industry. CROs manage all aspects of a clinical trial. In the clinical trial services, CRO offers various drug development services, such as:

A huge number of CROs are engaged in monitoring the drug development process such as PAREXEL (U.S.), PRA Health Sciences (U.S.), Labcorp (U.S.), PPD (U.S.), Syneos Health (U.S.), ICON plc (Ireland), Envigo (U.K.), Charles River (U.S.), and SGS (Switzerland) among others. These are some CROs that are engaged to give support for clinical trials and other research services to the imaging and pharmaceutical industries. The increasing number of CROs is expected to drive market growth.

Opportunities

• Rise in Healthcare Expenditure

Healthcare expenditure has increased across the world as people's disposable income in various countries is increasing. Moreover, to accomplish the population requirements, government bodies and healthcare organizations are taking the initiative by virtue of accelerating healthcare expenditure.

Growing healthcare expenditure is also beneficial for further growth in economic and healthcare sector, and it is primarily fruitful as it significantly affects the development of better and advanced medical products in the market. Therefore, the surge in healthcare expenditure is expected to create a greater opportunity for the market.

• Strategic Initiatives by Market Players

The demand for clinical trial imaging is increasing in the market owing to the increased levels of R&D along with the growth of clinical trial imaging market aided by the desire for innovative medications. Thus, the top market players have implemented a new strategy by developing new products and collaborating with other market players to improve business operations and profitability.

For instance,

• In June 2022, Parexel, a leading global CRO, announced the launch of its Community Alliance Network, a novel program further integrating clinical research into the community healthcare setting to better serve patients and in turn create further opportunities for increased diversity in clinical trials. CVS Health, the leading health care solutions company, and Javara, the leading Integrated Research Organization, have joined the network as inaugural members, opening the door to community-based research sites and increasing access to new patient populations to support trial delivery for Parexel’s biopharmaceutical customers.
• In February 2020, ICON plc acquired MedPass International, a European medical devices CRO, reimbursement, and regulatory consultancy. This acquisition has reportedly helped in the expansion of the medical device and diagnostic research services of ICON in Europe.

These strategic initiatives by the market players, including acquisition, conferences, and focused segment product launches, are helping them grow and improve the company's product portfolio, ultimately leading to more revenue generation. Hence, these strategic initiatives by the market players may act as an opportunity for market growth.

Restraints/Challenges

• High-Risk Radiation Causing Diseases

In clinical medical imaging, radiation is absorbed by the body which can harm the molecular structures inside the patient’s body. High doses of radiation can affect human cells including loss of hair, skin burns, and increased incidence of cancer. The estimated risk of developing fatal cancer is one in 2000 after going through a radiation dose of 10 mSv in a CT scan.

For instance,

• According to Radiological Society of North America (RSNA), 1% to 2% of all cancers in the U.S. are caused by CT scans and the American Cancer Society identified CT scans and X-rays as one of the reasons for breast cancer, brain cancer, and other cancers
• According to Center for Disease Control and Prevention, exposure to high levels of radiation results in acute radiation syndrome. The amount of radiation that a person's body absorbs is called the radiation dose.

The high-risk radiation that occurs, would decrease the usage and sale of clinical trial imaging devices, thereby affecting the credibility of manufacturers involved in this market. Therefore, the high-risk radiation-causing diseases are expected to restrain the market growth.

• Strict Regulatory Policies

The healthcare industry is regulated by a structure of laws, and rules & regulations that are extensive and complex.

For instance,

• In April 2018, the U.S. FDA released updated Guidance for Clinical Trial Imaging Endpoint Process Standards for the industry which includes the quality of imaging data obtained in clinical trials
• Biotechnology and pharmaceutical industries need to take first approval from the FDA for the process of drug development. They have to submit an Investigational New Drug (IND) application to the FDA before beginning clinical research.

COVID-19 对北美临床试验成像市场的影响

由于需要制定严格的感染控制和预防措施来控制传播风险并保护医护人员，诊断成像服务耗时且复杂。因此，对疑似患者或 COVID-19 阳性患者进行成像的决定取决于其对患者状况改善的影响。美国放射学会 (ACR) 不建议将计算机断层扫描 (CT) 作为 COVID-19 患者的一线诊断测试，并将计算机断层扫描的实用性限制在有特定临床指征的有症状和住院患者。

最新动态

• 2022 年 1 月，Clario 与放射性药物生产和正电子发射断层扫描 (PET) 收购公司 XingImaging 合作，在中国开展 PET 成像临床试验，以测试新型疗法。此次合作旨在共享 Clario 和 XingImaging 的联合资源和神经科学专家，以加快在中国开展临床试验和药物研发。
• 2021 年 11 月，Clario 成立。ERT 和 Bioclinica 合并成立 Clario。新公司的成立带来了临床成像软件和服务的分销以及销售额的上升。

北美临床试验成像市场范围

北美临床试验成像市场根据产品和服务、模式、应用、最终用户和分销商分为五个部分。这些部分之间的增长将帮助您分析行业中增长微弱的部分，并为用户提供有价值的市场概览和市场洞察，帮助他们做出战略决策，确定核心市场应用。

產品與服務

• 服务
• 软件

根据产品和服务，市场分为服务和软件。

情态

• 计算机断层扫描
• 磁共振成像
• 超声心动图
• 核医学
• 正电子发射断层扫描
• X 射线
• 超声波
• 光学相干断层扫描
• 其他的

根据模式，市场分为计算机断层扫描、磁共振成像、超声心动图、核医学、正电子发射断层扫描、X射线、超声波、光学相干断层扫描等。

应用

• 肿瘤学
•  神经病学
•  心脏病学
•  内分泌学
•  皮肤科
•  血液学
•  其他的

根据应用，市场分为肿瘤学、神经病学、心脏病学、内分泌学、皮肤病学、血液学和其他。

最终用户

• 合同研究组织
• 制药及生物技术公司
• 医疗器械制造商
• 学术和政府研究机构
• 其他的

根据最终用户，市场分为合同研究组织、制药和生物技术公司、医疗设备制造商、学术和政府研究机构等。

分销商

• 直销
•  招标销售

根据分销商，市场分为直销和招标销售。

北美临床试验成像市场区域分析/洞察

对北美临床试验成像市场进行了分析，并按上述地区、产品和服务、方式、应用、最终用户和分销商提供了市场规模洞察和趋势。

本市场报告涵盖的国家包括美国、加拿大和墨西哥。由于癌症发病率上升、对非侵入性医学成像的需求、临床试验成像技术创新的增长以及研发活动的增加，预计美国将占据市场主导地位。

报告的国家部分还提供了影响市场当前和未来趋势的各个市场影响因素和国内市场法规变化。新销售、替代销售、国家人口统计、疾病流行病学和进出口关税等数据点是用于预测各个国家市场情景的一些主要指标。此外，在提供国家数据的预测分析时，还考虑了北美品牌的存在和可用性以及由于来自本地和国内品牌的激烈或稀少的竞争对销售渠道的影响而面临的挑战。

竞争格局和北美临床试验成像市场份额分析

北美临床试验成像市场竞争格局提供了有关竞争对手的详细信息。详细信息包括公司概况、公司财务状况、产生的收入、市场潜力、研发投资、新市场计划、北美业务、生产基地和设施、生产能力、公司优势和劣势、产品发布、产品宽度和广度以及应用主导地位。以上提供的数据点仅与公司对北美临床试验成像市场的关注有关。

市场上的一些主要参与者包括 Navitas Life Sciences、Resonance Health Analytical Services、BioTelemetry、Philips Company、ICON plc、Quotient Sciences、WORLDCARE CLINICAL、Clario、Paraxel International Corporation、Median Technologies、Perspectum、Calyx、WIRB-Copernicus Group 和 Invicro.LLC 等。

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