Oncology Clinical Trials Market Size, Share & Trends Analysis Report By Phase Type (Phase I, Phase II, Phase III, Phase IV), By Study Design (Interventional Study, Observational Study, Expanded Access Study), By Region, And Segment - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

The global oncology clinical trials market size reached USD 13.19 billion in 2023 and is projected to hit around USD 22.11 billion by 2033, expanding at a CAGR of 5.3% during the forecast period from 2024 to 2033.

Key Takeaways:

• North America dominated the market and accounted for the largest revenue share of 43% in 2023
• Asia Pacific is expected to grow at the fastest CAGR of 7.1% during the forecast period.
• Based on type, the market is segmented into phase I, phase II, phase III, and phase IV. The phase III clinical trials segment accounted for the largest revenue share of over 49% in 2023.
• The phase I segment is estimated to register the fastest CAGR of 4.8% over the forecast period.
• Based on study design, the interventional studies segment accounted for the largest revenue share of around 88.9% in 2023.
• The observational studies segment is estimated to register the fastest CAGR of 6.2% over the forecast period.

Oncology Clinical Trials Market Growth

The market is primarily driven by factors such as an increase in technological advancements, a rise in cancer incidences, and improvements in personalized medicine and cell and gene therapies, which are starting new approaches for developing new treatments for cancer-like diseases. Moreover, an increase in funding from pharmaceutical and biotech companies, non-profit organizations, and CROs for oncology clinical trials is further supporting market growth and the development of advanced products to gain substantial market share.

The global market is driven by the rising number of cancer patients. Lung cancer is predicted to emerge as the leading cause of cancer-related deaths worldwide, with an estimated 1.8 million people diagnosed each year. The number of cancer cases in the U.S. reached 1.9 million in 2022. In addition, pancreatic cancer has a terrible prognosis, with just 1 to 3 years of survival. The market is expected to be hindered by factors such as cultural and social challenges associated with clinical trial participation, recruitment barriers in the clinical trial process, lack of scientific knowledge, misuse of statistics and data, and complexity of study protocol, whereas mostly the study is funded and organized by the federal government.

The National Center for Biomedical Imaging (NCI) funds approximately 50% of all cancer clinical trials in the U.S., according to Mooney's description of the National Center for Biomedical Imaging Clinical Trials Cooperative Group Program. However, the COVID-19 pandemic slowed down clinical trials of oncology. Many clinical trials were postponed or delayed due to safety concerns and difficulties in recruiting participants during the pandemic.

Recent Investments in the Oncology Clinical Trials Market (2024) 

• A number of biotech companies, such as BioNTech and Moderna, which gained global attention for their mRNA COVID vaccines, have now expanded into personalized cancer vaccine development. Moderna, for instance, raised $50 million in early 2024 for its personalized mRNA cancer vaccine program.
  
  
• AstraZeneca’s acquisition of Orphazyme, a rare disease-focused company, for approximately $1.2 billion in 2024 is expected to bolster its oncology pipeline, with a focus on rare cancer types.
  
  
• The National Institutes of Health (NIH) continues to provide substantial funding to oncology clinical trials in the U.S., with an estimated $2.5 billion earmarked for cancer research grants in 2024.
  
  
• The Horizon Europe Program allocated €300 million ($320 million) for cancer-related clinical trials in 2024, with a focus on precision medicine, radiation oncology, and early detection technologies.

Oncology Clinical Trials Market Trends 

• The rising advancements in technology, such as advanced data analysis and enhanced diagnostic tools, play an important role in shaping the market expansion. These progressions enable real-time monitoring of treatment responses and refine the precision of patient categorization and biomarker identification.
    
• The increasing prevalence of cancer caters as a driving force behind the growth of oncology clinical trials. The imperative to invest in research and development becomes more pronounced, with a growing number of individuals grappling with various types of cancer.
    
• The increasing investments by government entities, biotechnology firms, and pharmaceutical companies are enhancing the market growth. Funding for therapeutic innovations, drug discovery, and clinical research enhances the pace of clinical research and further drives the growth of the oncology clinical trials market.

Oncology Clinical Trials Market Report Scope

Segments Insights:

Phase Type Insights

Based on type, the market is segmented into phase I, phase II, phase III, and phase IV.  The phase III clinical trials segment accounted for the largest revenue share of over 49% in 2023. The driving factors for the phase III segment include the high share of phase III trials, which is attributed to the fact that phase III trials are the most expensive but involve many subjects. Long-term safety studies are conducted for registration and post-marketing commitments in phase III trials. For instance, in Jul 2020, a phase III clinical trial of alpelisib in the mix with pertuzumab and trastuzumab was started by Novartis AG to assess the well-being and viability of use as a support therapy for patients with HER2-positive advanced breast cancer.

The phase I segment is estimated to register the fastest CAGR of 4.8% over the forecast period. The phase I clinical trial segment in the oncology clinical trials industry is driven by scientific, regulatory, financial, and patient-centric factors. In phase I of clinical trials, a small group of individuals (20 to 100 healthy volunteers) undergoes testing with an experimental drug or treatment.

Study Design Insights

Based on study design, the interventional studies segment accounted for the largest revenue share of around 88.9% in 2023. The driving factors for interventional study design in the oncology clinical trials sector primarily revolve around these conditions' unique challenges. Given the limited patient populations, studies must be meticulously designed to maximize the chances of detecting meaningful treatment effects.

The observational studies segment is estimated to register the fastest CAGR of 6.2% over the forecast period. Due to several driving factors, observational trial study designs play a crucial role in the oncology clinical trials industry. The scarcity of patients with oncology makes traditional randomized controlled trials challenging, making observational studies a more feasible option for assessing treatment efficacy and safety.

Regional Insights

North America dominated the market and accounted for the largest revenue share of 43% in 2023 and is expected to maintain its dominance during the forecast period due to various favorable reimbursement policies and the presence of major market players in the region, leading to investment and the development of innovative products. Also, the U.S. FDA has a fast-track approval process for drugs that treat cancer. For instance, according to the U.S. Government Accountability Office, the National Institutes of Health (NIH), an agency under the Department of Health and Human Services (HHS), stands as the foremost public financier of biomedical research and development (R&D).

During the fiscal years 2018 to 2022, NIH allocated a staggering USD 99 billion for fundamental research and USD 30 billion for clinical trials and associated endeavors. Whereas, Asia Pacific is expected to grow at the fastest CAGR of 7.1% during the forecast period. This is due to the availability of a significant number of Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA), and European Medicines Agency (EMA)-approved facilities in the region. Moreover, the large patient pool and low cost of conducting clinical trials in the region further support the regional market.

Oncology Clinical Trials Market Recent Developments

• In June 2022, Novartis reported positive outcomes from the Phase III RATIONALE 306 trial, revealing that tislelizumab in combination with chemotherapy significantly enhanced overall survival (OS) as a primary treatment for adult patients dealing with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC), irrespective of their PD-L1 status.
• In March 2021, Merck Sharp & Dohme Corp. initiated a phase II clinical study to assess the safety and efficacy of the fixed-dose co-formulated pembrolizumab/quavonlimab (MK-1308A) in conjunction with lenvatinib for patients with hepatocellular carcinoma (HCC).

Some of the prominent players in the Oncology Clinical Trials Market include:

• 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

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the 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

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)