临床试验服务市场估计价值 2024年10.9亿美元 预计将达到 到2031年达到27.5亿美元, 以复合年增长率增长 2024年至2031年占14.1%。 。 。 制药和生物技术公司的研发开支不断增加,临床试验研究的数量也不断增加,这推动了对临床试验服务的需求。

市场驱动力----越来越多地采用分散临床试验模式

涉及集中临床场所的传统临床试验模式在可扩展性和接触不同病人群体的能力方面有一定的局限性。 这一直在推动采用分散的临床试验模型,这些模型依赖虚拟环境而不是物理网站。 分散审判允许从更广泛的地理区域参与,有助于应对征聘特定病人群体所涉及的挑战。

更多的制药公司和合同研究组织正在探索混合模式,在这种模式中,某些审判程序实际上进行,而另一些程序仍然亲自进行。 例如,可通过远程医疗工具远程进行知情同意程序和例行安全评估,而实验室样本收集工作可能需要在现场进行。 这在减轻赞助者的后勤负担的同时,使病人在位置和时间安排方面更加灵活。 它还为从农村地区和开发以前难以进入的市场招募人员创造了机会。

由于诸如eConsent、eCOA、移动保健应用软件、连接设备、在家样本收集工具等技术的进步,完全实现了虚拟化。 不同治疗领域长期倾向于混合和完全分散的办法。

市场驱动器 -- -- 临床试验业务管理的重大技术进步

由于有助于各种临床跟踪管理系统(CTMS)功能的技术的迅速发展,临床试验景观正在发生重大转变。 先进的基于云的平台正在使活动从规划和预算编制到病人征聘和监测的端到端一体化。 这是精简工作流程,消除各部门和供应商之间的数据仓。 人工智能(AI)和机器学习(ML)等技术也应用于协议设计,场地可行性评估和监测等领域.

由机器人过程自动化(RPA)提供动力的自动化解决方案正在接管临床试验协调员的普通行政任务和人工文件处理。 使用块链进行透明的药物序列化和结果存档是另一个新出现的领域。 另一方面,先进的分析平台正在通过预测性监测审判进展情况,促进实时决策。 基因组学、数字生物标志和分散方法等新兴领域也正在推动专门技术解决方案的发展。

预计业务效率的提高将推动更多的临床研究和更复杂的试验设计。 这将维持对先进CTMS平台的需求,为临床试验技术提供商创造大量新机会。

市场挑战 -- -- 临床试验过程的高度资本要求

临床试验服务市场面临的主要挑战之一是与临床试验过程有关的高资本要求。 进行临床试验是一个昂贵的过程,需要在不同阶段进行大量投资。 从建立临床试验场和招募患者到监测试验以及收集和分析大量数据,临床试验过程的每一步骤都需要大量的财政资源。 这种严重的资本密集程度对预算有限的中小型制药公司构成了障碍。

临床试验的费用多年来不断上升,其原因包括试验日益复杂、严格遵守监管要求以及业务开支不断增加。 为后期试验履行沉重的财政义务甚至会对大型制药公司造成巨大的财政压力。 因此,巨大的资本需求对市场构成相当大的挑战,限制进入和限制获得资本受到限制的行业参与者的研发活动。

市场机会-临床试验中对现实世界证据的需求增加

临床试验服务市场的一个主要机会是临床试验对现实世界证据生成的需求日益增加。 越来越强调用从电子保健记录、病人登记册和索赔数据库中得出的现实世界临床证据来补充常规随机控制的试验数据。 这种转变是由一些因素驱动的,例如许多药物的治疗周期较长,需要经过广泛的批准后监测,需要在实际实践环境中评价药物表现,以及希望优化个性化医疗方法。

对现实世界证据的日益偏爱正在形成对临床试验服务的重大需求,这种服务能够利用现实世界的数据来源,并具有先进的分析能力来设计和实施更加灵活和务实的临床试验. 这为临床试验服务提供者提供了有利可图的机会,可以围绕现实世界的数据整合、分析和试验程序设计发展能力。 它还允许制药公司利用真实世界的循证试验来削减成本和缩短时限. 因此,现实世界的数据在临床发展中的重要性越来越大,为市场更多地采用相关服务提供了巨大的潜力。

Insights, By Therapeutic Areas - The Growing Threat of Cardiovascular Disease

In terms of therapeutic areas, cardiovascular disorders contribute the highest share of the market owning to the growing threat posed by conditions like heart attacks, strokes, and heart disease. Cardiovascular disorders remain the leading cause of death globally, despite advancements in treatment options. Several factors contribute to the high prevalence of these conditions.

Lifestyle changes over recent decades have led to more sedentary habits and unhealthy diets heavy in fat, salt, and sugar. Obesity, hypertension, diabetes, and other metabolic disorders associated with poor lifestyle choices significantly increase the risk of heart disease and strokes. An aging global population has also amplified this public health threat. Additionally, the development of novel cardiovascular drugs and devices undergoing clinical trials ensures a steady stream of study opportunities in this segment.

Conditions like coronary artery disease, congenital heart defects, arrhythmias and peripheral artery disease all fall under the cardiovascular disorders category. Clinical trials evaluating everything from new interventional cardiology devices and pharmaceuticals to lifestyle modification programs targeting cardiovascular risk factors are regularly recruiting. The strong relationships formed between sponsors, CROs and sites with cardiovascular expertise makes this therapeutic area particularly productive for trial recruitment. Addressing cardiovascular disease remains a top research priority given its enormous disease burden and economic toll, driving significant investment into related clinical research.

Insight, By End User - Small Players Dominate Due to Flexibility

In terms of end user, small-sized players contribute the highest share of the market due to their ability to cater to specific customer needs with a higher degree of flexibility. Small CROs and sites comprise the majority of players in the highly fragmented clinical trial industry. They appeal to smaller biotech companies and startups conducting early phase proof-of-concept studies due to lower costs and more personalized service.

With lean structures and specialist teams, small entities can often design and implement niche protocols more efficiently than their larger counterparts. Their localized footprints also allow for proximity to specific patient populations and expert investigators. Administrative burdens tend to be lighter than at large global organizations. This nimble, focused approach is well-suited to the fast timelines of early research.

Relationships between sponsor coordinators and small provider staff remain personal. Close cooperation streamlines operations as protocols evolve flexibly. Small players further capitalize on serving local sponsors who prefer dealing directly with domestic resources. While limited in their scope and capabilities compared to large multinationals, these dynamics give smaller end users and sites an edge in capturing a sizeable share of early phase work.

Insights, By Phase of Development - Phase I Studies Pioneer New Treatments

In terms of phase of development, Phase I contributes the highest share of the market owing to the critical importance of safety testing in pioneering new therapies. Phase I represents the initial moment of truth for any experimental drug, biologic or device when it first enters the human body. Safety pharmacology and dose escalation studies conducted in small healthy volunteer populations serve as the first line of defense.

Identifying maximum tolerated doses, pharmacokinetic profiles and early signs of toxicity are the key goals of Phase I trials, which typically enroll fewer than 100 subjects. However, the risk of finding serious adverse effects that halt development makes these earliest trials particularly consequential, as well as often lengthy and costly. Close monitoring in specialized Phase I units is required to rapidly identify and mitigate potential safety issues.

Given their role in de-risking candidates so later development may proceed, Phase I offerings will remain in high demand from biotech companies and pharmaceutical firms advancing early assets. Demographic testing of healthy cohorts also provides key insights to inform subsequent therapeutic investigations. With investments pouring into novel modalities like gene and cell therapies, monitoring innovative technologies safely at the initial human dose represents an area of expanding importance.

临床试验服务市场的主要参与者包括:中心点临床服务、电子临床健康、Mytras(医学数据解决方案)、科学37、Berry Consultants、通用报告格式Bracket、Cytel、Evidera、Clinerion、Medpace、西北Ehealth、TriNetX、端点临床、Greenphire、国际药物开发研究所(IDDI)和思想圈。