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市場調查報告書
商品編碼
1886951
腫瘤臨床試驗市場規模、佔有率、成長及全球產業分析:依類型、應用和地區劃分的洞察,以及2024年至2032年的預測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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隨著製藥公司、生技公司和臨床研究機構 (CRO) 專注於開發先進的癌症療法,全球腫瘤臨床試驗市場正經歷快速擴張。根據最新的產業分析,2024年全球腫瘤臨床試驗市場價值為175.2億美元。預計到2025年,該市場將成長至189.7億美元,到2032年將達到339.8億美元,2025年至2032年的複合年增長率 (CAGR) 為8.5%。癌症發病率上升、精準醫療的日益普及以及臨床研究活動外包的增加是推動這一全球市場成長的關鍵因素。
市場概覽
腫瘤臨床試驗在評估創新癌症藥物、診斷方法、醫療器材和治療方案的安全性和有效性方面發揮著至關重要的作用。隨著全球癌症負擔的持續加重,對臨床研究的需求也急劇上升。根據世界衛生組織 (WHO) 統計,2022 年全球新增癌症病例將達 2,000 萬例,造成 970 萬人死亡,過去五年累積新增癌症病例達 5,350 萬例。這一成長趨勢正促使生命科學公司針對各種癌症類型進行更多臨床試驗。
預計到 2024 年,北美將以 47.75% 的市佔率佔癌症臨床試驗市場的榜首。這主要得益於北美地區合約研究組織 (CRO) 的高度集中、強大的精準醫療基礎設施,以及美國和加拿大製藥公司廣泛開展的臨床試驗外包業務。
市場驅動因素
推動該市場發展的關鍵因素是全球癌症發生率的快速成長。隨著對創新診斷和治療的需求不斷增長,腫瘤臨床試驗的數量也相應增加。例如,根據世界衛生組織的報告,到2024年,針對惡性腫瘤的臨床試驗數量將達到5,306項,比2010年增加16.7%。癌症發生率的上升和研發活動的增加共同推動了市場的穩定成長。
製藥公司外包趨勢的日益增長也支撐著市場發展。合約研究組織(CRO)提供專業技術、成本效益和快速的研究進度,從而增加了試驗數量,尤其是在北美、歐洲和亞太地區。
市場限制因子
儘管成長潛力巨大,但嚴格的監管環境仍然是一項重大挑戰。冗長的審批流程、複雜的病患招募和高昂的營運成本都可能延誤研究進度。美國國家生物技術資訊中心 (NCBI) 2023 年的一項研究發現,巴西嚴格的審批程序是臨床試驗實施的主要障礙,導致患者招募減少和研究啟動延遲。
資金限制也限制市場成長。腫瘤臨床試驗由於其周期長、方案複雜以及對患者進行特殊監測的要求,成本最高。
市場機會
人們對新型癌症療法的日益關注帶來了豐厚的市場拓展機會。全球正在啟動大量 II 期臨床試驗。例如,山東森卡迪亞藥業股份有限公司於 2025 年 4 月啟動了 HRS-7058 治療晚期惡性腫瘤的 II 期臨床試驗,而蘭諾瓦醫藥股份有限公司於 2024 年 10 月啟動了 LM-299 治療實體瘤的 II 期臨床試驗。預計未來幾年,對創新和精準療法的投資增加將顯著提高臨床試驗的數量。
市場趨勢
影響市場的主要趨勢包括:
分散式臨床試驗 (DCT):遠距醫療、穿戴式裝置和家庭診斷工具的普及正在改善病患的就醫途徑,尤其是在農村和醫療資源匱乏的地區。
人工智慧和大數據整合:人工智慧驅動的患者配對、預測分析和自適應試驗設計正在提高試驗效率。
加速審批:FDA 和 EMA 等監管機構正在為有前景的腫瘤治療藥物提供優先審查和突破性療法認定,從而鼓勵進一步的臨床試驗投資。
2024 年,由於研究數量眾多且試驗持續時間較長,III 期臨床試驗將引領市場。根據世界衛生組織的數據,2024年註冊的III期癌症臨床試驗數量為418項,較2000年增加114.4%。由於中型製藥公司外包業務的增加,預計II期臨床試驗市場將成長最快。
依類型劃分,在研發投入的推動下,乳癌臨床試驗將在2024年佔最大佔有率。前列腺癌臨床試驗預計將在預測期內實現最高成長率,這主要得益於該疾病盛行率的上升以及對標靶治療需求的增加。
北美將持續維持領先地位,2024年市場規模將達74.9億美元。美國仍是全球癌症研究中心,這得益於IQVIA、ICON和Parexel等主要合約研究組織(CRO)的支持。歐洲緊隨其後,這主要得益於研發投入的增加,其中包括阿斯特捷利康計劃在2024年投資8,085億美元。亞太地區預計將成為成長最快的地區,這主要歸功於日益加重的癌症負擔、政府投入以及精準醫療能力的提升。拉丁美洲和中東/非洲地區作為成本效益高的臨床試驗地點,也越來越受到重視。
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