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1930099

腫瘤臨床試驗市場規模、佔有率、成長及全球產業分析：按類型、應用和地區劃分的洞察，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: 請詢問到貨日

價格

腫瘤臨床試驗市場成長驅動因子

由於癌症發生率上升、對精準醫療的日益重視以及臨床試驗流程外包的增加，全球腫瘤臨床試驗市場正經歷顯著增長。根據 Fortune Business Insights 預測，該市場規模預計將在 2025 年達到 189.7 億美元，並在 2026 年達到 205.5 億美元。預計到 2034 年，該市場將進一步成長至 404.9 億美元，2026 年至 2034 年的複合年增長率 (CAGR) 為 8.85%。北美地區在 2025 年將以 42.52% 的市場佔有率領先，這主要得益於該地區合約研究組織 (CRO) 的高度集中、強大的精準醫療基礎設施以及製藥公司積極開展臨床試驗外包業務。

腫瘤臨床試驗是評估新療法、診斷方法和醫療器材的安全性和有效性的研究。全球癌症負擔日益加重，促使製藥公司進行更多試驗。例如，2024 年 8 月，OncoSure Testing 推出了一項快速癌症篩檢測試，旨在提高早期檢測的可近性，體現了該行業對創新的重視。

市場動態

市場驅動因素

癌症發生率的上升和臨床試驗數量的增加是關鍵的成長驅動因素。根據世界衛生組織 2022 年的數據，預計全球將新增約 2,000 萬例癌症病例，並有 970 萬人死於癌症，凸顯了開發新的診斷方法和治療手段的緊迫性。 2024 年，約有 5306 項惡性腫瘤臨床試驗註冊，比 2010 年增加了 16.7%，凸顯了人們對研究的日益重視。

市場限制因子

嚴格的監管環境和資金短缺限制了市場成長。審批流程漫長，尤其是在巴西等發展中地區，由於監管複雜性和臨床知識的缺乏，常常阻礙試驗的及時開展，導致患者招募和試驗實施的延誤。

機會

製藥公司和研究機構對新型療法的興趣日益濃厚，正在創造巨大的市場機會。例如，山東森卡迪亞醫藥股份有限公司於2025年4月啟動了HRS-7058治療晚期惡性腫瘤的II期臨床試驗，預計將於2027年10月完成。同樣，拉諾瓦醫藥有限公司於2024年10月啟動了LM-299治療實體瘤的II期臨床試驗，預計將於2027年7月完成。

挑戰

已開發國家的高昂成本、病患招募困難、持續性問題限制了臨床試驗的有效進行。腫瘤臨床試驗通常需要更長的週期、複雜的方案和專門的基礎設施，因此成本高。潛在參與者的誤解和認知不足進一步限制了入組率。

市場趨勢

  • 分散式臨床試驗 (DCT)：遠距醫療、穿戴式裝置和家庭診斷的日益普及正在促進農村和醫療資源匱乏地區的病患參與。
  • 人工智慧 (AI) 和大數據：人工智慧可輔助識別患者群組、預測試驗結果和監測，而大數據則支援自適應試驗設計。
  • 監管加速措施：FDA 和 EMA 授予的快速通道資格、孤兒藥資格和突破性療法資格正在加速腫瘤試驗的審批，並提升其投資吸引力。

細分分析

依階段劃分

  • 由於 III 期試驗週期更長、試驗數量更多，預計 2024 年將佔主導地位。 2024 年，共有 418 項惡性腫瘤 III 期試驗註冊，較 2000 年成長 114.4%。
  • 受中小製藥公司將試驗外包給合約研究組織 (CRO) 的趨勢推動，預計 II 期試驗將以最高的複合年增長率成長。

按類型

  • 到 2024 年，乳癌臨床試驗將佔最大佔有率，這反映了製藥業對研發的重視程度。
  • 攝護腺癌臨床試驗預計將以最快的速度成長，這主要得益於該疾病盛行率的不斷上升以及對有效診斷和治療方法的需求。

區域展望

北美：預計到 2025 年，北美市場規模將達到 80.6 億美元，由於主要合約研究組織 (CRO)（如 IQVIA、ICON 和 Thermo Fisher）的存在以及精準醫療檢測的普及，北美市場將引領全球市場。美國仍將是主要貢獻者。

歐洲：研發投資是推動成長的主要動力，阿斯特捷利康計畫在2024年於英國投資8,085億美元用於藥物研發。

亞太地區：由於政府資助、癌症負擔日益加重以及個人化醫療器材的發展，預計該地區將以最高的複合年增長率增長。

其他地區：拉丁美洲和中東/非洲地區由於監管要求相對簡單，是開展成本效益高的臨床試驗的理想地點。

目錄

第一章：引言

第二章：摘要整理

第三章：市場動態

  • 市場驅動因素
  • 市場限制因素
  • 市場機遇
  • 市場趨勢

第四章：關鍵考慮因素

  • 主要國家/地區腫瘤臨床試驗數量（2025 年）
  • 腫瘤臨床試驗分佈情形
  • 主要產業趨勢（併購、合作及其他）

第五章：全球腫瘤臨床試驗市場分析、洞察與預測（2021-2034）

  • 市場分析、洞察與預測 - 按階段劃分
    • I期
    • II期
    • III期
    • IV期
  • 市場分析、洞察與預測 - 按類型劃分
    • 乳癌
    • 黑色素瘤
    • 大腸直腸癌
    • 攝護腺癌
    • 肺癌
    • 其他
  • 市場分析、洞察與預測 - 按地區劃分
    • 北美
    • 歐洲
    • 亞太地區
    • 其他

第六章 北美腫瘤臨床試驗市場分析、洞察與預測（2021-2034）

  • 依國家/地區
    • 美國
    • 加拿大

第七章：歐洲腫瘤臨床試驗市場分析、洞察與預測（2021-2034）

  • 依國家劃分
    • 英國
    • 德國
    • 法國
    • 義大利
    • 西班牙
    • 斯堪的納維亞
    • 歐洲其他地區

第八章：亞太地區腫瘤臨床試驗市場分析、洞察與預測（2021-2034）

  • 依國家劃分
    • 日本
    • 中國
    • 印度
    • 澳大利亞
    • 東南亞
    • 其他地區亞太地區

第九章：其他腫瘤臨床試驗市場分析、洞察與預測（2021-2034）

第十章：競爭分析

  • 全球市佔率分析（2025）
  • 公司簡介
    • IQVIA Inc.
    • 賽默飛世爾科技公司
    • Parexel International Corporation
    • Medpace
    • ICON plc
    • 查爾斯河實驗室
    • 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