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肿瘤临床试验市场规模、占有率、成长及全球产业分析：按类型、应用和地区划分的洞察，2026-2034 年

Oncology Clinical Trials Market Size, Share, Growth and Global Industry Analysis By Type & Application, Regional Insights and Forecast to 2026-2034
出版日期: | 出版商: Fortune Business Insights Pvt. Ltd. | 英文 130 Pages | 商品交期: 请询问到货日

价格

肿瘤临床试验市场成长驱动因子

由于癌症发生率上升、对精准医疗的日益重视以及临床试验流程外包的增加，全球肿瘤临床试验市场正经历显着增长。根据 Fortune Business Insights 预测，该市场规模预计将在 2025 年达到 189.7 亿美元，并在 2026 年达到 205.5 亿美元。预计到 2034 年，该市场将进一步成长至 404.9 亿美元，2026 年至 2034 年的复合年增长率 (CAGR) 为 8.85%。北美地区在 2025 年将以 42.52% 的市场占有率领先，这主要得益于该地区合约研究组织 (CRO) 的高度集中、强大的精准医疗基础设施以及製药公司积极开展临床试验外包业务。

肿瘤临床试验是评估新疗法、诊断方法和医疗器材的安全性和有效性的研究。全球癌症负担日益加重，促使製药公司进行更多试验。例如，2024 年 8 月，OncoSure Testing 推出了一项快速癌症筛检测试，旨在提高早期检测的可近性，体现了该行业对创新的重视。

市场动态

市场驱动因素

癌症发生率的上升和临床试验数量的增加是关键的成长驱动因素。根据世界卫生组织 2022 年的数据，预计全球将新增约 2,000 万例癌症病例，并有 970 万人死于癌症，凸显了开发新的诊断方法和治疗手段的紧迫性。 2024 年，约有 5306 项恶性肿瘤临床试验註册，比 2010 年增加了 16.7%，凸显了人们对研究的日益重视。

市场限制因子

严格的监管环境和资金短缺限制了市场成长。审批流程漫长，尤其是在巴西等发展中地区，由于监管复杂性和临床知识的缺乏，常常阻碍试验的及时开展，导致患者招募和试验实施的延误。

机会

製药公司和研究机构对新型疗法的兴趣日益浓厚，正在创造巨大的市场机会。例如，山东森卡迪亚医药股份有限公司于2025年4月启动了HRS-7058治疗晚期恶性肿瘤的II期临床试验，预计将于2027年10月完成。同样，拉诺瓦医药有限公司于2024年10月启动了LM-299治疗实体瘤的II期临床试验，预计将于2027年7月完成。

挑战

已开发国家的高昂成本、病患招募困难、持续性问题限制了临床试验的有效进行。肿瘤临床试验通常需要更长的週期、复杂的方案和专门的基础设施，因此成本高。潜在参与者的误解和认知不足进一步限制了入组率。

市场趋势

  • 分散式临床试验 (DCT)：远距医疗、穿戴式装置和家庭诊断的日益普及正在促进农村和医疗资源匮乏地区的病患参与。
  • 人工智慧 (AI) 和大数据：人工智慧可辅助识别患者群组、预测试验结果和监测，而大数据则支援自适应试验设计。
  • 监管加速措施：FDA 和 EMA 授予的快速通道资格、孤儿药资格和突破性疗法资格正在加速肿瘤试验的审批，并提升其投资吸引力。

细分分析

依阶段划分

  • 由于 III 期试验週期更长、试验数量更多，预计 2024 年将占主导地位。 2024 年，共有 418 项恶性肿瘤 III 期试验註册，较 2000 年成长 114.4%。
  • 受中小製药公司将试验外包给合约研究组织 (CRO) 的趋势推动，预计 II 期试验将以最高的复合年增长率成长。

按类型

  • 到 2024 年，乳癌临床试验将占最大占有率，这反映了製药业对研发的重视程度。
  • 摄护腺癌临床试验预计将以最快的速度成长，这主要得益于该疾病盛行率的不断上升以及对有效诊断和治疗方法的需求。

区域展望

北美：预计到 2025 年，北美市场规模将达到 80.6 亿美元，由于主要合约研究组织 (CRO)（如 IQVIA、ICON 和 Thermo Fisher）的存在以及精准医疗检测的普及，北美市场将引领全球市场。美国仍将是主要贡献者。

欧洲：研发投资是推动成长的主要动力，阿斯特捷利康计画在2024年于英国投资8,085亿美元用于药物研发。

亚太地区：由于政府资助、癌症负担日益加重以及个人化医疗器材的发展，预计该地区将以最高的复合年增长率增长。

其他地区：拉丁美洲和中东/非洲地区由于监管要求相对简单，是开展成本效益高的临床试验的理想地点。

目录

第一章：引言

第二章：摘要整理

第三章：市场动态

  • 市场驱动因素
  • 市场限制因素
  • 市场机遇
  • 市场趋势

第四章：关键考虑因素

  • 主要国家/地区肿瘤临床试验数量（2025 年）
  • 肿瘤临床试验分布情形
  • 主要产业趋势（併购、合作及其他）

第五章：全球肿瘤临床试验市场分析、洞察与预测（2021-2034）

  • 市场分析、洞察与预测 - 按阶段划分
    • I期
    • II期
    • III期
    • IV期
  • 市场分析、洞察与预测 - 按类型划分
    • 乳癌
    • 黑色素瘤
    • 大肠直肠癌
    • 摄护腺癌
    • 肺癌
    • 其他
  • 市场分析、洞察与预测 - 按地区划分
    • 北美
    • 欧洲
    • 亚太地区
    • 其他

第六章 北美肿瘤临床试验市场分析、洞察与预测（2021-2034）

  • 依国家/地区
    • 美国
    • 加拿大

第七章：欧洲肿瘤临床试验市场分析、洞察与预测（2021-2034）

  • 依国家划分
    • 英国
    • 德国
    • 法国
    • 义大利
    • 西班牙
    • 斯堪的纳维亚
    • 欧洲其他地区

第八章：亚太地区肿瘤临床试验市场分析、洞察与预测（2021-2034）

  • 依国家划分
    • 日本
    • 中国
    • 印度
    • 澳大利亚
    • 东南亚
    • 其他地区亚太地区

第九章：其他肿瘤临床试验市场分析、洞察与预测（2021-2034）

第十章：竞争分析

  • 全球市占率分析（2025）
  • 公司简介
    • IQVIA Inc.
    • 赛默飞世尔科技公司
    • Parexel International Corporation
    • Medpace
    • ICON plc
    • 查尔斯河实验室
    • Fortrea
    • Syneos 健康
Product Code: FBI113466

Growth Factors of oncology clinical trials Market

The global oncology clinical trials market is experiencing significant growth due to the rising prevalence of cancer, increasing focus on precision medicine, and the growing outsourcing of clinical trial procedures. According to Fortune Business Insights, the market was valued at USD 18.97 billion in 2025, is projected to reach USD 20.55 billion in 2026, and is expected to expand to USD 40.49 billion by 2034, exhibiting a CAGR of 8.85% during 2026-2034. North America dominated the market in 2025 with a 42.52% share, attributed to the high concentration of contract research organizations (CROs), robust infrastructure for precision medicine, and active clinical trial outsourcing by pharmaceutical firms.

Oncology clinical trials are research studies evaluating the safety and efficacy of novel therapeutics, diagnostics, and medical devices. The growing global burden of cancer has driven pharmaceutical companies to conduct an increasing number of trials. For instance, in August 2024, OncoSure Testing launched a rapid cancer screening test to improve early detection accessibility, reflecting the industry's focus on innovation.

Market Dynamics

Market Drivers:

The rising prevalence of cancer and increasing number of clinical trials are the primary growth drivers. According to WHO 2022 data, there were approximately 20 million new cancer cases and 9.7 million cancer-related deaths, highlighting the urgent need for novel diagnostics and therapeutics. Around 5,306 clinical trials for malignant neoplasms were registered in 2024, showing a growth of 16.7% from 2010, emphasizing the increasing research focus.

Market Restraints:

Stringent regulatory scenarios and insufficient funding restrict market growth. Lengthy approval processes can delay patient recruitment and trial conduct, particularly in developing regions like Brazil, where regulatory complexity and limited clinical understanding impede timely trial execution.

Opportunities:

The growing focus on novel therapeutics by pharmaceutical and research institutes provides substantial market opportunities. For example, Shandong Suncadia Medicine Co., Ltd. initiated a Phase II trial of HRS-7058 in April 2025 for advanced malignant tumors, expected to complete in October 2027. Similarly, LaNova Medicines Limited launched a Phase II study in October 2024 for LM-299 in solid tumors, projected to complete in July 2027.

Challenges:

High costs in developed countries, patient recruitment difficulties, and retention issues constrain the efficient execution of trials. Oncology trials often require longer durations, complex protocols, and specialized infrastructure, making them cost-intensive. Misconceptions and lack of awareness among potential participants further limit enrollment rates.

Market Trends

  • Decentralized Clinical Trials (DCTs): Increasing use of telemedicine, wearable devices, and at-home diagnostics improves patient participation in rural and underserved areas.
  • Artificial Intelligence (AI) and Big Data: AI assists in patient cohort identification, trial outcome prediction, and monitoring, while Big Data supports adaptive trial designs.
  • Regulatory Fast-Track Initiatives: FDA and EMA fast-track, orphan drug, and breakthrough therapy designations accelerate oncology trial approvals and investment appeal.

Segmentation Analysis

By Phase:

  • Phase III dominated in 2024 due to the higher number and longer duration of trials, with 418 Phase III trials registered for malignant neoplasms in 2024, reflecting a 114.4% growth since 2000.
  • Phase II is expected to grow at the fastest CAGR, supported by small and mid-sized pharmaceutical companies outsourcing trials to CROs.

By Type:

  • Breast cancer trials held the largest share in 2024, reflecting strong pharmaceutical R&D focus.
  • Prostate cancer trials are projected to grow at the fastest rate due to increasing disease prevalence and the need for effective diagnostics and therapeutics.

Regional Outlook

North America: Market value USD 8.06 billion in 2025, leading globally due to the presence of major CROs (IQVIA, ICON, Thermo Fisher) and adoption of precision medicine trials. The U.S. remains a key contributor.

Europe: Growth is driven by R&D investments, such as AstraZeneca's USD 808.5 billion commitment in 2024 for pharmaceutical development in the U.K.

Asia Pacific: Projected to grow at the fastest CAGR, fueled by government funding, increasing cancer burden, and the development of personalized medicine and devices.

Rest of the World: Latin America and Middle East & Africa are attractive for cost-effective clinical trials, benefiting from less complex regulatory requirements.

Competitive Landscape

The global market is consolidated, with key players such as IQVIA Inc., ICON plc, Charles River Laboratories, Parexel International, Thermo Fisher Scientific, Medpace, Fortrea, and Syneos Health. Companies focus on partnerships, service expansion, and development of novel therapeutics. Notable developments include Thermo Fisher's collaboration with the NCI in July 2024 for the myeloMATCH precision medicine trial and Parexel's partnerships in Japan and China to accelerate oncology clinical research.

Conclusion

The oncology clinical trials market is projected to grow from USD 18.97 billion in 2025 to USD 40.49 billion by 2034, driven by the increasing cancer burden, outsourcing of clinical trials, rising adoption of AI and Big Data, and growing pharmaceutical focus on novel therapeutics. North America leads globally, followed by Europe and Asia Pacific. The expansion of decentralized trials, regulatory fast-track initiatives, and innovative trial designs are expected to enhance patient participation, accelerate clinical research, and strengthen oncology drug development throughout the forecast period.

Segmentation By Phase

  • Phase I
  • Phase II
  • Phase III
  • Phase IV

By Type

  • Breast Cancer
  • Melanoma
  • Colorectal Cancer
  • Prostate Cancer
  • Lung Cancer
  • Others

By Region

  • North America (By Phase, Type, and Country)
    • U.S.
    • Canada
  • Europe (By Phase, Type, and Country/Sub-region)
    • Germany
    • U.K.
    • France
    • Spain
    • Italy
    • Scandinavia
    • Rest of Europe
  • Asia Pacific (By Phase, Type, and Country/Sub-region)
    • China
    • Japan
    • India
    • Australia
    • Southeast Asia
    • Rest of Asia Pacific
  • Rest of the World (By Phase and Type)

Table of Content

1. Introduction

  • 1.1. Research Scope
  • 1.2. Market Segmentation
  • 1.3. Research Methodology

2. Executive Summary

3. Market Dynamics

  • 3.1. Market Drivers
  • 3.2. Market Restraints
  • 3.3. Market Opportunities
  • 3.4. Market Trends

4. Key Insights

  • 4.1. Number of Oncology Clinical Trials - by Key Countries, 2025
  • 4.2. Distribution of Oncology Clinical Trials
  • 4.3. Key Industry Developments (Mergers, Acquisitions, Partnerships, etc.)

5. Global Oncology Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

  • 5.1. Market Analysis, Insights and Forecast - By Phase
    • 5.1.1. Phase I
    • 5.1.2. Phase II
    • 5.1.3. Phase III
    • 5.1.4. Phase IV
  • 5.2. Market Analysis, Insights and Forecast - By Types
    • 5.2.1. Breast Cancer
    • 5.2.2. Melanoma
    • 5.2.3. Colorectal Cancer
    • 5.2.4. Prostate Cancer
    • 5.2.5. Lung Cancer
    • 5.2.6. Others
  • 5.3. Market Analysis, Insights and Forecast - By Region
    • 5.3.1. North America
    • 5.3.2. Europe
    • 5.3.3. Asia Pacific
    • 5.3.4. Rest of the World

6. North America Oncology Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

  • 6.1. Market Analysis, Insights and Forecast - By Phase
    • 6.1.1. Phase I
    • 6.1.2. Phase II
    • 6.1.3. Phase III
    • 6.1.4. Phase IV
  • 6.2. Market Analysis, Insights and Forecast - By Types
    • 6.2.1. Breast Cancer
    • 6.2.2. Melanoma
    • 6.2.3. Colorectal Cancer
    • 6.2.4. Prostate Cancer
    • 6.2.5. Lung Cancer
    • 6.2.6. Others
  • 6.3. Market Analysis, Insights and Forecast - By Country
    • 6.3.1. U.S.
    • 6.3.2. Canada

7. Europe Oncology Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

  • 7.1. Market Analysis, Insights and Forecast - By Phase
    • 7.1.1. Phase I
    • 7.1.2. Phase II
    • 7.1.3. Phase III
    • 7.1.4. Phase IV
  • 7.2. Market Analysis, Insights and Forecast - By Types
    • 7.2.1. Breast Cancer
    • 7.2.2. Melanoma
    • 7.2.3. Colorectal Cancer
    • 7.2.4. Prostate Cancer
    • 7.2.5. Lung Cancer
    • 7.2.6. Others
  • 7.3. Market Analysis, Insights and Forecast - By Country/Sub-region
    • 7.3.1. U.K.
    • 7.3.2. Germany
    • 7.3.3. France
    • 7.3.4. Italy
    • 7.3.5. Spain
    • 7.3.6. Scandinavia
    • 7.3.7. Rest of the Europe

8. Asia Pacific Oncology Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

  • 8.1. Market Analysis, Insights and Forecast - By Phase
    • 8.1.1. Phase I
    • 8.1.2. Phase II
    • 8.1.3. Phase III
    • 8.1.4. Phase IV
  • 8.2. Market Analysis, Insights and Forecast - By Types
    • 8.2.1. Breast Cancer
    • 8.2.2. Melanoma
    • 8.2.3. Colorectal Cancer
    • 8.2.4. Prostate Cancer
    • 8.2.5. Lung Cancer
    • 8.2.6. Others
  • 8.3. Market Analysis, Insights and Forecast - By Country/Sub-region
    • 8.3.1. Japan
    • 8.3.2. China
    • 8.3.3. India
    • 8.3.4. Australia
    • 8.3.5. Southeast Asia
    • 8.3.6. Rest of Asia Pacific

9. Rest of the World Oncology Clinical Trials Market Analysis, Insights and Forecast, 2021-2034

  • 9.1. Market Analysis, Insights and Forecast - By Phase
    • 9.1.1. Phase I
    • 9.1.2. Phase II
    • 9.1.3. Phase III
    • 9.1.4. Phase IV
  • 9.2. Market Analysis, Insights and Forecast - By Types
    • 9.2.1. Breast Cancer
    • 9.2.2. Melanoma
    • 9.2.3. Colorectal Cancer
    • 9.2.4. Prostate Cancer
    • 9.2.5. Lung Cancer
    • 9.2.6. Others

10. Competitive Analysis

  • 10.1. Global Market Share Analysis (2025)
  • 10.2. Company Profiles
    • 10.2.1. IQVIA Inc.
      • 10.2.1.1. Overview
      • 10.2.1.2. Products
      • 10.2.1.3. SWOT Analysis
      • 10.2.1.4. Recent Developments
      • 10.2.1.5. Strategies
      • 10.2.1.6. Financials (Based on Availability)
    • 10.2.2. Thermo Fisher Scientific Inc.
      • 10.2.2.1. Overview
      • 10.2.2.2. Products
      • 10.2.2.3. SWOT Analysis
      • 10.2.2.4. Recent Developments
      • 10.2.2.5. Strategies
      • 10.2.2.6. Financials (Based on Availability)
    • 10.2.3. Parexel International Corporation
      • 10.2.3.1. Overview
      • 10.2.3.2. Products
      • 10.2.3.3. SWOT Analysis
      • 10.2.3.4. Recent Developments
      • 10.2.3.5. Strategies
      • 10.2.3.6. Financials (Based on Availability)
    • 10.2.4. Medpace
      • 10.2.4.1. Overview
      • 10.2.4.2. Products
      • 10.2.4.3. SWOT Analysis
      • 10.2.4.4. Recent Developments
      • 10.2.4.5. Strategies
      • 10.2.4.6. Financials (Based on Availability)
    • 10.2.5. ICON plc
      • 10.2.5.1. Overview
      • 10.2.5.2. Products
      • 10.2.5.3. SWOT Analysis
      • 10.2.5.4. Recent Developments
      • 10.2.5.5. Strategies
      • 10.2.5.6. Financials (Based on Availability)
    • 10.2.6. Charles River Laboratories
      • 10.2.6.1. Overview
      • 10.2.6.2. Products
      • 10.2.6.3. SWOT Analysis
      • 10.2.6.4. Recent Developments
      • 10.2.6.5. Strategies
      • 10.2.6.6. Financials (Based on Availability)
    • 10.2.7. Fortrea
      • 10.2.7.1. Overview
      • 10.2.7.2. Products
      • 10.2.7.3. SWOT Analysis
      • 10.2.7.4. Recent Developments
      • 10.2.7.5. Strategies
      • 10.2.7.6. Financials (Based on Availability)
    • 10.2.8. Syneos Health
      • 10.2.8.1. Overview
      • 10.2.8.2. Products
      • 10.2.8.3. SWOT Analysis
      • 10.2.8.4. Recent Developments
      • 10.2.8.5. Strategies
      • 10.2.8.6. Financials (Based on Availability)

List of Tables

  • Table 1: Global Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Phase, 2021-2034
  • Table 2: Global Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Application, 2021-2034
  • Table 3: Global Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Region, 2021-2034
  • Table 4: North America Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Phase, 2021-2034
  • Table 5: North America Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Application, 2021-2034
  • Table 6: North America Oncology Clinical Trials Market Revenue (USD billion) Forecast, By Country, 2021-2034
  • Table 7: Europe Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Phase, 2021-2034
  • Table 8: Europe Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Application, 2021-2034
  • Table 9: Europe Oncology Clinical Trials Market Revenue (USD billion) Forecast, By Country/ Sub-region, 2021-2034
  • Table 10: Asia Pacific Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Phase, 2021-2034
  • Table 11: Asia Pacific Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Application, 2021-2034
  • Table 12: Asia Pacific Oncology Clinical Trials Market Revenue (USD billion) Forecast, By Country/ Sub-region, 2021-2034
  • Table 13: Rest of the World Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Phase, 2021-2034
  • Table 14: Rest of the World Oncology Clinical Trials Market Revenue (USD billion) Forecast, by Application, 2021-2034

List of Figures

  • Figure 1: Global Oncology Clinical Trials Market Revenue Breakdown (USD billion, %) by Region, 2025 & 2034
  • Figure 2: Global Oncology Clinical Trials Market Value Share (%), by Phase, 2025 & 2034
  • Figure 3: Global Oncology Clinical Trials Market Value Share (%), by Application, 2025 & 2034
  • Figure 4: Global Oncology Clinical Trials Market Value (USD billion), by Region, 2025 & 2034
  • Figure 5: North America Oncology Clinical Trials Market Value (USD billion), by Phase, 2025 & 2034
  • Figure 6: North America Oncology Clinical Trials Market Value Share (%), by Phase, 2025
  • Figure 7: North America Oncology Clinical Trials Market Value (USD billion), by Application, 2025 & 2034
  • Figure 8: North America Oncology Clinical Trials Market Value Share (%), by Application, 2025
  • Figure 9: North America Oncology Clinical Trials Market Value (USD billion), By Country, 2025 & 2034
  • Figure 10: North America Oncology Clinical Trials Market Value Share (%), By Country, 2025
  • Figure 11: Europe Oncology Clinical Trials Market Value (USD billion), by Phase, 2025 & 2034
  • Figure 12: Europe Oncology Clinical Trials Market Value Share (%), by Phase, 2025
  • Figure 13: Europe Oncology Clinical Trials Market Value (USD billion), by Application, 2025 & 2034
  • Figure 14: Europe Oncology Clinical Trials Market Value Share (%), by Application, 2025
  • Figure 15: Europe Oncology Clinical Trials Market Value (USD billion), By Country/ Sub-region, 2025 & 2034
  • Figure 16: Europe Oncology Clinical Trials Market Value Share (%), By Country/ Sub-region, 2025
  • Figure 17: Asia Pacific Oncology Clinical Trials Market Value (USD billion), by Phase, 2025 & 2034
  • Figure 18: Asia Pacific Oncology Clinical Trials Market Value Share (%), by Phase, 2025
  • Figure 19: Asia Pacific Oncology Clinical Trials Market Value (USD billion), by Application, 2025 & 2034
  • Figure 20: Asia Pacific Oncology Clinical Trials Market Value Share (%), by Application, 2025
  • Figure 21: Asia Pacific Oncology Clinical Trials Market Value (USD billion), By Country/ Sub-region, 2025 & 2034
  • Figure 22: Asia Pacific Oncology Clinical Trials Market Value Share (%), By Country/ Sub-region, 2025
  • Figure 23: Rest of the World Oncology Clinical Trials Market Value (USD billion), by Phase, 2025 & 2034
  • Figure 24: Rest of the World Oncology Clinical Trials Market Value Share (%), by Phase, 2025
  • Figure 25: Rest of the World Oncology Clinical Trials Market Value (USD billion), by Application, 2025 & 2034
  • Figure 26: Rest of the World Oncology Clinical Trials Market Value Share (%), by Application, 2025
  • Figure 27: Global Oncology Clinical Trials Market Share (%), By Company, 2025