临床试验病人招聘服务市场估计价值 2024年9.4 Bn美元 预计将达到 19.1美元 到2031年时以复合年增长率增长 (CAGR)从2024年到2031年占8.2%.

由于每年在全球进行临床试验的次数增加,近年来市场出现了显著增长。 制药和生物技术公司一直在外包病人招聘服务,以优化成本,改进招聘过程,从而刺激需求。 此外,在识别合格病人方面面临挑战,难以接触大批人口,以及缺乏中央数据库,迫使临床研究组织依赖专业的病人招聘服务提供者。

市场驱动力 - 临床试验数量增加

由于许多制药和生物技术公司从事药物研发,过去十年来临床药物试验的数量显著增加。 根据估计,目前全世界有35万多例临床试验在进行。 成功征聘足够人数的参与者对于及时完成这些试验和将潜在的新疗法投入市场至关重要。 然而,诸如改进诊断、先进的筛选规程、严格的合格标准和调查药物的治疗指数狭窄等因素,提高了病人入学的难度。

临床试验赞助商和CROs认识到,仅靠传统的招聘方法可能已经不够。 他们已开始探索专业的病人征聘服务提供者,利用先进技术和数据驱动的战略,确定和录取合格的候选人。 这些服务提供商通过维护潜在参与者的广泛数据库、利用有针对性的数字广告和利用社交媒体平台来提高认识,来补充招聘过程。 它们还与病人宣传小组和医生网络建立关系,以便利转诊。 有些人甚至在其工作人员开办的招聘中心提供现场协调。 由于不断演变的治疗格局和管理监督,临床试验继续变得更加复杂,赞助者越来越多地将征聘活动外包给提供端到端解决办法而不是零敲碎打的援助的专职伙伴。 预计这将进一步增加今后几年对组织良好的病人招聘服务的需求。

市场驱动力 -- -- 患者入学过程日益复杂

随着医学研究的进展,正在不断发现新的迹象,并正在评估新的有针对性的疗法。 这导致临床研究的入学资格标准具有高度选择性。 调查药物现在被设计为狭义的患者子集,其特征是具体的生物标记,遗传特征或治疗史. 确定完全符合所有程序要求的病人已成为一项重大挑战。 此外,监管当局现在授权在审判期间进行更积极的安全监测,并扩大知情同意程序。 这些不断演变的良好临床实践准则增加了招聘参与者的业务困难。

这一行业的服务提供商通过其专门知识和专用技术平台,帮助克服这些复杂性。 一些人通过分析大量过去的病人数据,开发了先进的筛选算法. 这些由机器学习驱动的算法可以快速扫描电子健康记录和其他数据源,以预先筛选极有可能达到试验标准的个人. 服务提供者还协助填写定制同意表,临床事件跟踪解决方案和灵活的eCRF设计,以简化调查人员的数据采集任务. 其全国调查点网络和社区外联方案提高了确定参与者的效率。 随着临床规程逐年专业化,对知识丰富的招聘专家的需求日益增加。 它们的增值服务有助于更方便地导航复杂的入学环境,并及时完成复杂的临床研究。 这无疑正在推动全球对专业的病人招聘服务投入更多的资金。

市场挑战 -- -- 与征聘病人有关的高成本

临床试验患者招聘服务市场面临的主要挑战之一是与患者招聘相关的高昂成本. 为临床试验招募合适的患者是一个漫长,复杂和资源密集的过程. 制药和生物技术公司必须花费大量资金开展各种招聘活动,例如确定潜在的病人、对其进行筛查和注册、报销旅费、病人费用和其他相关费用。 维持大量潜在病人并与多个征聘地点协调也涉及大量业务费用。 此外,诸如资格标准狭窄、其他正在进行的审判的竞争和病人缺乏认识等因素进一步加剧了招聘方面的挑战。 这导致审判时限推迟,赞助方的预算超支增加。 随着研发支出的增加,高额的患者招聘费用已成为整个临床试验市场增长的一大障碍。 服务提供者和赞助者需要注重利用新技术和替代征聘战略,提高效率,降低与征聘病人有关的费用。

市场机会----向新兴市场扩展

临床试验病人招聘服务市场参与者的一个有希望的机会是向新兴市场扩展。 随着保健基础设施的改善以及对临床研究的投资的增加,一些新兴国家现在提供了大量尚未开发的潜在病人。 诸如中国、印度、巴西和东欧某些国家为临床试验病人的招聘提供了有利可图的前景。 与发达市场相比,他们的人口多样性、治疗幼稚人口和不太严格的条例使招募病人更容易。 此外,在新兴市场,进行临床试验的费用要低得多。 这使得赞助商和CRO可以招募更多的病人,并在较短的时间内以较低的成本完成试验. 为了利用这一机会,服务提供者正注重通过伙伴关系、采购和设立地方办事处来加强他们在高增长的新兴市场的存在。 这一扩大将使这些地区的病人有更多机会接触,并在今后几年为参与者带来更多的收入。

Insights, By Patient Recruitment Step: Increased focus on patient screening

In terms of patient recruitment step, pre-screening sub-segment contributes the highest share of 51.3% in the market owing to increased focus on patient screening.

The clinical trial patient recruitment services market segment for pre-screening contributes the highest share due to increased focus of sponsors and CROs on ensuring right patients are selected for clinical trials. Pre-screening involves evaluating patients' medical history and determining their eligibility as per the trial protocol at an initial phase, before they are formally screened. This helps avoid the costs involved in screening those patients who are unlikely to be suitable as per eligibility criteria.

With rising costs of clinical trials, sponsors and CROs are more focused on eliminating potentially ineligible patients as early as possible to improve screening efficiency. Pre-screening allows them to filter out patients who have no probability of enrolling for a particular study based on pre-defined parameters. This saves significant time and resources during the later screening stage. Moreover, pre-screening data collected from patients can be utilized to select the most suitable sites for actual patient recruitment.

Advanced technologies including AI and machine learning are also being leveraged more during pre-screening. Tools enabling virtual pre-screening of electronic health records allow automating the initial screening process and prioritizing suitable patients. This is further expediting the pre-screening stage. The use of real-world data for pre-screening purposes is also on the rise. Overall factors like the focus on efficiency, advanced tools, and real-world data are propelling the pre-screening segment in the clinical trial patient recruitment services market.

Insights, By Trial Phase: Higher patient screening requirements

The phase I sub-segment holds the highest share of 27.9% among trial phase segmentation due to the significantly higher number of patients required to be screened during this initial testing stage. Phase I trials are mostly first-in-human studies involving small groups of healthy volunteers or patients.

The primary aim of phase I is to evaluate a compound's safety, tolerability, pharmacokinetics and pharmacodynamics. To achieve this safely, sponsors need to screen extensively to identify suitable healthy subjects or patients based on stringent eligibility criteria and exclusion factors. Sometimes hundreds of individuals need to be assessed to enroll less than a hundred patients across low dose escalation cohorts in phase I.

Moreover, given the exploratory nature of phase I studies, eligibility parameters may change depending on early dose-response and toxicity results. This necessitates rescreening of additional patients. The higher number of screening cycles makes patient recruitment more challenging compared to later phases. CROs play a critical role in sourcing, pre-screening and formally screening large pools of potential candidates to identify and enroll the correct patients.

As phase I forms the platform for subsequent clinical development, sponsors dedicate significant resources to its recruitment planning and place greater reliance on CRO expertise. This drives significant demand for patient recruitment services specializing in the critical phase I segment.

临床试验病人招聘服务市场的主要参与者包括IQVIA,Synes Health,Parexel,PPD,PRA Health Sciences,Medpace,ICON,Labcorp Drug Development,环球临床试验和查尔斯河实验室.