U.S. Oncology Clinical Trials Market Size to Surpass USD 12,416 Mn by 2034

According to Statifacts, the U.S. oncology clinical trials market size is calculated at 8,283 million in 2025 and is projected to surpass USD 12,416 million by 2034 with a remarkable CAGR of 4.6% from 2025 to 2034.

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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.

The market is expanding due to the increasing number of lung cancer cases. Technological advancements in cancer detection, customized treatment options, and clinical gene therapy trials further augment the market.

The U.S. oncology market is expanding owing to the increasing rate of lung cancer patients in the United States. The major reasons behind increasing cases of lung cancer include smoking excessively, continuous exposure to certain toxic elements in the air, and genetic reasons. According to the data published by the American Cancer Society in 2024, both type of lung cancers – small cell and non-small cell is the second most common cancer found in people of every age group and gender. Hence, increasing lung cancer cases is expected to foster the market's growth. In 2024, nearly 234,580 people were diagnosed with lung cancer. On the other hand, according to the data published by ClinicalTrial.gov, nearly 12,190 clinical trials were registered in June 2024, with lung cancer at various stages. The positive results of this report impacted the market growth in the U.S.

Moreover, the launch of clinical trials to detect developing lung cancer is anticipated to expand the market during the upcoming period. For instance, in December 2023, Moderna Inc. and Merck introduced the pivotal Phase III clinical trial of the novel personalized neoantigen therapy in collaboration with Keytruda. These factors are positively impacting market growth.

Artificial Intelligence in oncology clinical trials has been demonstrated to support clinician-driven cancer. AI is also more promising in diagnosis accuracy than human intervention, minimizes timescales required for targeted drug discovery, and can customize drug regimen design. For instance, in February 2025, according to the data published in the Lancet Digital Health, the study of mammography screening with AI detected that the use of AI in breast cancer screening minimized the workload of screen reading without chances of increasing false positives.

Why Are Clinical Trials Important?

The dramatic progress that has been made in treating cancer over the past three decades has predominantly come from scientific research, including the testing of new medications and procedures. These clinical trials are designed to identify new, more effective therapies. The patients who participate in these investigative studies gain access to the very latest changes in cancer care developed by the nation's foremost cancer specialists.

Clinical trials provide a way to explore the most effective means to prevent, diagnose and treat cancer.

Benefits of clinical trials include the following:

•  They show the effectiveness of new cancer treatments.

•  They provide options for people with cancer, while allowing physicians to improve the way they prevent, diagnose and treat cancer.

•  These trials also give those participating access to the latest advances available in the nation.

•  Clinical trials can help benefit future generations.

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U.S.  Oncology Clinical Trials Market Report Scope

U.S. Oncology Clinical Trials Market Trends

• Increasing funding for clinical trials: The significant market trend fueling the market further is increasing funding for clinical trials by pharmaceuticals, biotech companies, and non-profit organizations and from CROs to support the development of advanced products, which helps to gain significant market share. Cancer is detected as the leading reason behind the cancer-related mortality rate. It is estimated that nearly 1.8 million people are diagnosed each year. In 2022, the U.S. witnessed 1.9 million cancer cases, which is a huge number, highlighting the urgency to resolve this. Among these, pancreatic cancer registered severe damage and life expectancy only up to 1 to 3 years after confirmed diagnosis. According to the sources, the National Center for Biomedical Imaging funds nearly 50% of all cancer clinical trials in the U.S.

• Increasing research and development to treat various cancers: Another driving factor for the market is increasing research and development spending on cancer clinical trials by acknowledging the need for cancer treatment to reduce mortality rates. For instance, in August 2022, Griffith University announced the launch of a new cancer research center with a whopping investment of USD 4.6 million granted by the Australian Cancer Research Foundation. Such strategic investment by leading institutes helps to boost market growth.

• Escalating incidences of cancer: The major driving factors for the U.S. oncology clinical trials market include different types of cancer detection among individuals, which is increasing and shifting towards clinical trials. The notable inclination towards personalized medicine, which is majorly focused on molecularly targeted and leads to immunotherapeutic, escalates the market demand for oncology trials, which helps targeted groups of patients. Additionally, integrating advanced technologies like next-generation sequencing and real-world evidence facilitates the dynamic growth of the U.S. oncology clinical trials market.

• Decentralized clinical trials platform: The increasing inclination towards decentralized clinical trials and virtual platforms showcases lucrative market expansion opportunities. This can be achieved by leveraging digital health technologies, remote monitoring, and telemedicine. This approach can be fruitful for clinical trials, as they can be done without the conventional setting required for clinical trials. It can be done virtually, enhancing patients' involvement and active participation and reducing patients' compulsion to travel to leverage treatment benefits, making it convenient for both patients and professionals.

U.S. Oncology Clinical Trials Market Segment Insights

By Phase Type

By phase type, the phase III clinical trial segment accounted for the largest market share and thus dominated the U.S. oncology clinical trials market. The growth of this segment is attributed to factors like the increasing number of cancer cases and the need for precise medication required to tackle it at its early stage to save people. According to the data published in 2024 by cancer facts and figures, nearly 2.0 million cancer cases were diagnosed in 2024, which was 1.93 million in the year 2023. For instance, in February 2023, Pfizer observed positive results from the phase III TALAPRO-2 study of talazoparib. It showcases statically prominent and clinically significant improvement in radiographic progression-free survival.

The phase I segment is expected to witness the fastest growth rate by phase type during the forecast period. This growth is related to the high share of phase III trials. Although highly expensive, they cover many subjects, making them fruitful trials. The intent behind long-term safety studies includes post-marketing commitments and registration. For instance, in April 2024, BioNtech SE released three years of follow-up data from the phase 1 trial, based on a personalized neoantigen-specific immunotherapy called iNeST.

By Study Design

By study design, the interventional studies segment accounted for the highest market share and thus dominated the market. Interventional study design majorly depends upon conditions and unique challenges. Based on the patient population, studies must be designed precisely to increase the chances of detecting fruitful treatment effects.

On the other hand, by study design, the observational studies segment is expected to witness the fastest growth rate in the upcoming period. Along with several factors, observational trial study designs play a vital role in the oncology clinical trials sector. Less availability of patients suffering from oncology further complicates the conventional way of randomized control trials, which is difficult to perform. Hence, observational studies seem to be a more feasible alternative for assessing safety and treatment efficacy.

U.S. Oncology Clinical Trials Market Recent Developments:

•  In January 2024, Ipsen introduced a cabometyx combined with immunotherapy presented at the American Society of Clinical Oncology Genitourinary symposium in the United States.

•  In January 2024, NEC Corp and Transgene collaborated and signed an agreement to continue the clinical evaluation of the personalized neoantigen cancer vaccine TG4050.

•  In March 2023, a multi-layer deal was signed between two leading players, Microsoft and Syneos Health, aiming to develop a platform that adopts machine learning. With this platform's help, biopharma firms' commercial performance can accelerate their clinical

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U.S. Oncology Clinical Trials Market Top Key Companies:

•  Astrazeneca

•  Merck & Co., Inc

•  IQVIA Inc

•  Gilead Sciences, Inc.

•  F. Hoffmann-La Roche Ltd

•  PAREXEL International Corporation

•  PRA Health Sciences

•  Syneos Health

•  Medpace

•  Novotech

•  Pivotal

U.S. Oncology Clinical Trials Market Report Segmentation

This report forecasts revenue growth at regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. Oncology Clinical Trials Market

By Phase Type

•  Phase I

•  Phase II

•  Phase III

•  Phase IV

By Study Design

•  Interventional Studies

•  Observational Studies

•  Expanded Access Studies

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