U.S. Oncology Clinical Trials - Industry Report, 2034

The U.S. oncology clinical trials market size is calculated at USD 7,919 million in 2024 and is predicted to reach around USD 12,416 million by 2034, expanding at a CAGR of 4.6% from 2024 to 2034.

U.S. Oncology Clinical Trials Market Report Highlights

• The Based on type, the market is segmented into phase I, phase II, phase III, and phase IV. The phase I clinical trials segment accounted for the largest revenue share of over 28.9% in 2024. 
• The phase III segment is estimated to register the fastest CAGR of 5.7% over the forecast period.
• Based on study design, the interventional studies segment accounted for the largest revenue share of around 80.6% in 2024. 
• The observational studies segment is estimated to register the fastest CAGR of 6% over the forecast period.

Oncology trials refer to clinical research practices implemented for studying, researching and developing potential therapies and treatments for curing cancer. With cancer being the leading cause of deaths across the U.S., the rising demand for developing potential cures while mitigating the adverse side effects associated with cancer are driving the conduction of oncological clinical trials in the U.S. healthcare industry.
 
In the U.S., the most common cancers estimated through new cases in 2024 are breast cancer, prostate cancer, lung and bronchus cancer, colon and rectum cancer, melanoma of the skin, bladder cancer, kidney and renal pelvis cancer, non-Hodgkin lymphoma, endometrial cancer, pancreatic cancer, leukaemia, thyroid cancer and liver cancer. 

The technological advancements in applying novel diagnostics tools and data analysis software for improving patient categorization and identification of biomarkers, personalized treatment approaches, prevalence of cancer driving the need for R&D, support from regulatory authorities, rising investments by biopharmaceutical companies and government bodies and increased research collaborations are boosting the growth of the U.S. oncology clinical trials market. Furthermore, the increased demand for 

Even after being the home to major market players and the presence of advanced healthcare infrastructure, the U.S. oncology clinical trials market faces certain challenges which restrain the market growth. The recruitment of qualified volunteers and participants while maintaining the sociodemographic diversity can be quite challenging. Also, the consideration of the efficacy endpoints and trial design limitations while adhering to the changing regulatory requirements impacts the clinical trial design process. Furthermore, the travel burden, expensive treatment costs and limitations in data reporting can hamper the development process and productivity outputs in clinical trials.

The U.S. government has been continuously supporting the development of oncology clinical trials. The National Cancer Institute (NCI) is the federal government’s principal agency for cancer research and training. The NCI receives funds from Congress which streamlines the cancer across various health institutes and research organizations in the U.S. and abroad. The investments have significantly reduced the cancer related deaths and emergence of new cases. The NCI is engaged in supporting 2,500 clinical trial sites involved in all phases within the U.S. and is also the largest funder leading cancer research in the world through its National Cancer Program. Additionally, in the fiscal year 2023, Congress issued $7.104 billion to NCI. 

According to an estimate provided by the NCI, about 2,001,140 new cases of cancer will be diagnosed and 611,720 people will die of cancer in 2024 in the United States. Moreover, approximately 14,910 children and adolescents aging 0 to 19 will be diagnosed with cancer and 1,590 will die of the disease in 2024. 

Integration of artificial intelligence (AI) in the U.S. oncology trials has potentially increased the efficacy, accuracy and drug development cycles while enhancing the approach to personalized treatments. AI algorithms are applied for analysing electronic health records (EHRs) for quick patient recruitment and screening with minimized delays. By inspecting large genomic datasets AI can potentially identify biomarkers for predicting patient response to specific therapies, leading to targeted treatment strategies. Furthermore, AI can optimize the clinical trial design process through simulations and examination of historical data.

With the rising prevalence of cancer and recent developments in creating novel therapies in oncology clinical trials with access to state-of-the art technologies for cancer treatments, advancements in medical research, streamlining of patient recruitment processes through strategies, increased employment in clinical trial designs, study coordination and rising participation of pharmaceutical industries as well as academic institutes and research organizations are significantly impacting the growth and creating opportunities for the U.S. oncology clinical trials market in the upcoming years.