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市场调查报告书
商品编码
1886951
肿瘤临床试验市场规模、占有率、成长及全球产业分析:依类型、应用和地区划分的洞察,以及2024年至2032年的预测Oncology Clinical Trials Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032 |
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随着製药公司、生技公司和临床研究机构 (CRO) 专注于开发先进的癌症疗法,全球肿瘤临床试验市场正经历快速扩张。根据最新的产业分析,2024年全球肿瘤临床试验市场价值为175.2亿美元。预计到2025年,该市场将成长至189.7亿美元,到2032年将达到339.8亿美元,2025年至2032年的复合年增长率 (CAGR) 为8.5%。癌症发病率上升、精准医疗的日益普及以及临床研究活动外包的增加是推动这一全球市场成长的关键因素。
市场概览
肿瘤临床试验在评估创新癌症药物、诊断方法、医疗器材和治疗方案的安全性和有效性方面发挥着至关重要的作用。随着全球癌症负担的持续加重,对临床研究的需求也急剧上升。根据世界卫生组织 (WHO) 统计,2022 年全球新增癌症病例将达 2,000 万例,造成 970 万人死亡,过去五年累积新增癌症病例达 5,350 万例。这一成长趋势正促使生命科学公司针对各种癌症类型进行更多临床试验。
预计到 2024 年,北美将以 47.75% 的市占率占癌症临床试验市场的榜首。这主要得益于北美地区合约研究组织 (CRO) 的高度集中、强大的精准医疗基础设施,以及美国和加拿大製药公司广泛开展的临床试验外包业务。
市场驱动因素
推动该市场发展的关键因素是全球癌症发生率的快速成长。随着对创新诊断和治疗的需求不断增长,肿瘤临床试验的数量也相应增加。例如,根据世界卫生组织的报告,到2024年,针对恶性肿瘤的临床试验数量将达到5,306项,比2010年增加16.7%。癌症发生率的上升和研发活动的增加共同推动了市场的稳定成长。
製药公司外包趋势的日益增长也支撑着市场发展。合约研究组织(CRO)提供专业技术、成本效益和快速的研究进度,从而增加了试验数量,尤其是在北美、欧洲和亚太地区。
市场限制因子
儘管成长潜力巨大,但严格的监管环境仍然是一项重大挑战。冗长的审批流程、复杂的病患招募和高昂的营运成本都可能延误研究进度。美国国家生物技术资讯中心 (NCBI) 2023 年的一项研究发现,巴西严格的审批程序是临床试验实施的主要障碍,导致患者招募减少和研究启动延迟。
资金限制也限制市场成长。肿瘤临床试验由于其周期长、方案复杂以及对患者进行特殊监测的要求,成本最高。
市场机会
人们对新型癌症疗法的日益关注带来了丰厚的市场拓展机会。全球正在启动大量 II 期临床试验。例如,山东森卡迪亚药业股份有限公司于 2025 年 4 月启动了 HRS-7058 治疗晚期恶性肿瘤的 II 期临床试验,而兰诺瓦医药股份有限公司于 2024 年 10 月启动了 LM-299 治疗实体瘤的 II 期临床试验。预计未来几年,对创新和精准疗法的投资增加将显着提高临床试验的数量。
市场趋势
影响市场的主要趋势包括:
分散式临床试验 (DCT):远距医疗、穿戴式装置和家庭诊断工具的普及正在改善病患的就医途径,尤其是在农村和医疗资源匮乏的地区。
人工智慧和大数据整合:人工智慧驱动的患者配对、预测分析和自适应试验设计正在提高试验效率。
加速审批:FDA 和 EMA 等监管机构正在为有前景的肿瘤治疗药物提供优先审查和突破性疗法认定,从而鼓励进一步的临床试验投资。
2024 年,由于研究数量众多且试验持续时间较长,III 期临床试验将引领市场。根据世界卫生组织的数据,2024年註册的III期癌症临床试验数量为418项,较2000年增加114.4%。由于中型製药公司外包业务的增加,预计II期临床试验市场将成长最快。
依类型划分,在研发投入的推动下,乳癌临床试验将在2024年占最大占有率。前列腺癌临床试验预计将在预测期内实现最高成长率,这主要得益于该疾病盛行率的上升以及对标靶治疗需求的增加。
北美将持续维持领先地位,2024年市场规模将达74.9亿美元。美国仍是全球癌症研究中心,这得益于IQVIA、ICON和Parexel等主要合约研究组织(CRO)的支持。欧洲紧随其后,这主要得益于研发投入的增加,其中包括阿斯特捷利康计划在2024年投资8,085亿美元。亚太地区预计将成为成长最快的地区,这主要归功于日益加重的癌症负担、政府投入以及精准医疗能力的提升。拉丁美洲和中东/非洲地区作为成本效益高的临床试验地点,也越来越受到重视。
The global oncology clinical trials market is undergoing rapid expansion as pharmaceutical companies, biotechnology firms, and clinical research organizations (CROs) intensify efforts to develop advanced cancer therapies. According to the latest industry analysis, the global oncology clinical trials market size was valued at USD 17.52 billion in 2024. The market is projected to increase to USD 18.97 billion in 2025, and by 2032, it is forecast to reach USD 33.98 billion, exhibiting a CAGR of 8.5% between 2025 and 2032. Rising cancer incidence, growing adoption of precision medicine, and increasing outsourcing of clinical research activities are among the primary factors fueling this global market acceleration.
Market Overview
Oncology clinical trials play a vital role in evaluating the safety and efficacy of innovative cancer therapeutics, diagnostics, medical devices, and treatment procedures. As the global burden of cancer continues to increase, demand for clinical studies has surged. According to the World Health Organization (WHO), there were 20 million new cancer cases in 2022, with 9.7 million deaths and 53.5 million people living with cancer over the previous five years. This rising prevalence is encouraging life science companies to launch more trial activities across various cancer types.
In 2024, North America dominated the oncology clinical trials market with a 47.75% share, supported by a high concentration of CROs, strong precision medicine infrastructure, and extensive outsourcing of clinical studies by U.S. and Canadian pharmaceutical companies.
Market Drivers
The primary driver of the market is the rapidly growing incidence of cancer globally. As the demand for innovative diagnostics and treatments rises, the number of oncology clinical trials is expanding accordingly. For instance, WHO reported 5,306 clinical trials for malignant neoplasms in 2024, reflecting a 16.7% increase from 2010. The rise in cancer prevalence, combined with increased R&D activity, is fueling steady market growth.
The expanding outsourcing trend among pharmaceutical companies also supports the market. CROs offer specialized expertise, cost efficiencies, and faster study timelines, resulting in higher trial volumes, especially in North America, Europe, and Asia Pacific.
Market Restraints
Despite substantial growth prospects, stringent regulatory environments remain a notable challenge. Lengthy approval processes, complex patient recruitment, and high operational costs can delay study timelines. A 2023 NCBI study identified Brazil's stringent licensing procedures as a major barrier to conducting trials, leading to reduced patient recruitment and delayed study initiation.
Funding limitations also restrain market growth. Oncology trials are among the most expensive due to longer duration, complex protocols, and specialized patient monitoring requirements.
Market Opportunities
The rising focus on novel cancer therapeutics presents lucrative expansion opportunities. Numerous phase II studies are being initiated globally. For example, Shandong Suncadia Medicine Co. Ltd. launched a phase II trial in April 2025 evaluating HRS-7058 for advanced malignant tumors, whereas LaNova Medicines Limited initiated a phase II trial in October 2024 for LM-299 targeting solid tumors. The increasing investment in innovative precision therapies is expected to significantly boost trial volume in the years ahead.
Market Trends
Key trends shaping the market include:
Decentralized Clinical Trials (DCTs): The adoption of telemedicine, wearable devices, and at-home diagnostic tools is improving patient accessibility, particularly across rural and underserved regions.
AI and Big Data Integration: AI-driven patient matching, predictive analytics, and adaptive trial designs are accelerating trial efficiency.
Fast-Track Approvals: Agencies like the FDA and EMA are offering priority review and breakthrough therapy status for promising oncology therapies, encouraging further trial investments.
In 2024, Phase III clinical trials dominated the market, driven by the high number of studies and long trial durations. WHO noted that 418 Phase III oncology trials were registered in 2024, representing a 114.4% increase since 2000. The Phase II segment is expected to grow fastest due to increasing outsourcing by mid-sized pharmaceutical organizations.
By type, breast cancer trials held the largest share in 2024, supported by intensive R&D investments. Prostate cancer trials are expected to grow at the highest rate over the forecast period, supported by rising disease prevalence and demand for targeted therapies.
North America led the market in 2024 with USD 7.49 billion in value. The U.S. remains a global hub for oncology research, supported by major CROs such as IQVIA, ICON, and Parexel. Europe follows, driven by increased R&D spending-such as AstraZeneca's USD 808.5 billion investment in 2024. Asia Pacific is projected to grow fastest due to rising cancer burden, government funding, and expanding precision medicine capabilities. Latin America, the Middle East, and Africa are gaining traction as cost-effective trial destinations.
Conclusion
With the global market expected to rise from USD 17.52 billion in 2024 to USD 33.98 billion by 2032, the oncology clinical trials sector is positioned for strong, sustained growth. Increasing patient needs, advancing trial methodologies, and rising cross-industry collaborations will continue driving the global expansion of oncology research.
Segmentation By Phase
By Type
By Region