PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930099
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930099
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
By Phase:
By Type:
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
By Type
By Region