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Why Does North America Command Nearly 42% of Global Trial Volume Despite Asian Growth?

The United States oncology clinical trials market remains the undisputed leader in housing and funding oncology clinical research. As of 2025, North America accounts for 42% of all active oncology clinical trials globally. The U.S. National Cancer Institute (NCI) bolstered this leadership with a budget request of USD 7.22 billion for fiscal year 2025 to support foundational research. Furthermore, the region hosts 157 active radiopharmaceutical trials, the highest concentration in the world. Infrastructure density is a key differentiator; the U.S. boasts over 1,500 research-capable oncology sites, ranging from massive academic centers to community networks.

China has firmly established itself as the second-largest powerhouse in the global oncology clinical trials market, holding approximately 25% of the global oncology pipeline. The National Medical Products Administration (NMPA) facilitated this growth by approving 84 novel oncology active substances between 2020 and 2024, nearly matching the 85 approvals by the US FDA in the same period. Europe remains a critical hub, particularly Spain and France, contributing to 18% of global trial volume. However, recruitment centers are shifting. Asia-Pacific (excluding China) is witnessing a 12% year-over-year growth in trial initiation, driven by lower operational costs which can be 30% to 40% less than Western counterparts.

How Are Top Pharma Players and Emerging Biotechs Battling for the USD 95 Billion R&D Pie?

The oncology clinical trials market is fiercely competitive, characterized by aggressive consolidation and strategic partnerships. Top-tier pharmaceutical companies, including AstraZeneca, Merck & Co., Roche, and Novartis, dominate the landscape. In 2025, the top 10 players collectively control 35% of the total oncology pipeline. AstraZeneca has solidified its leadership in the Antibody-Drug Conjugate (ADC) space, capitalizing on the success of Enhertu, while Merck continues to leverage Keytruda in over 1,800 combination trials globally.

Mid-sized biotechs are disrupting the status quo. Companies like Bicycle Therapeutics and Radiopharm Theranostics are attracting significant venture capital. In 2024, venture funding for oncology-focused biotechs reached USD 8.2 billion. Mergers and acquisitions remain the primary growth strategy for big pharma. The acquisition of Seagen by Pfizer, fully integrated by 2025, created a combined portfolio with 43 active oncology programs. Contract Research Organizations (CROs) are equally vital, with IQVIA, PPD, and Icon managing operations for 65% of all industry-sponsored oncology trials.

Which High-Value Indications Are Dominating the Oncology Clinical Trials Market Clinical Pipeline?

Research efforts are heavily skewed toward solid tumors due to their prevalence and high unmet need. Non-Small Cell Lung Cancer (NSCLC) remains the top indication, with over 1,100 active interventional trials ongoing in 2025. Breast cancer follows closely, with 950 active studies, focusing heavily on HER2-low and triple-negative populations. Colorectal and prostate cancers each account for approximately 6% of the global trial volume.

Rare cancers are witnessing a surge in attention due to regulatory incentives. Orphan drug designations for oncology products reached a record 140 grants in 2024. Hematologic malignancies, while fewer in patient numbers, command high investment. Multiple Myeloma and Lymphoma trials account for 15% of the total oncology pipeline, driven by the high commercial value of CAR-T and bispecific antibody therapies.

Why Are ADCs and Radiopharmaceuticals Attracting Billions in New Capital Investment?

Two distinct technological waves are defining the current oncology clinical trials market. First, Antibody-Drug Conjugates (ADCs) have become the "gold rush" of oncology. There are currently 180+ ADCs in clinical development, with 80% targeting solid tumors. The probability of technical success for ADCs in Phase III has risen to 53%, significantly higher than the 35% industry average for standard chemotherapy.

Second, the radiopharmaceutical sector is exploding. Following the commercial success of Pluvicto, the market has seen a 50% increase in radioligand trial starts since 2022. Currently, 90 drugs targeting PSMA and 23 targeting SSTR are in the pipeline. Furthermore, global supply chains for isotopes like Lutetium-177 and Actinium-225 are expanding, with USD 1 billion invested in manufacturing infrastructure in 2024-2025 alone.

Is the Industry Equipped to Tackle Recruitment Bottlenecks Costing Millions Daily?

Despite massive funding, the oncology clinical trials market faces severe headwinds. Patient recruitment remains the single biggest constraint. Historically, less than 5% of adult cancer patients enroll in clinical trials. While 2025 data shows a slight improvement to 7.1% for interventional studies, it remains insufficient. Approximately 80% of oncology trials fail to meet their initial enrollment timelines, causing operational delays that cost sponsors USD 600,000 to USD 8 million per day in lost commercial opportunity.

Diversity is another critical hurdle in the oncology clinical trials market. FDA guidance issued in 2024 now mandates diversity action plans, yet racial and ethnic minorities remain underrepresented. For instance, while African Americans represent 13% of the US population, they make up only 5% of oncology trial participants. Site fatigue is also rising. The number of complex trial protocols has increased by 15%, placing immense strain on site staff. Consequently, the turnover rate for clinical research associates (CRAs) hovers around 25%, disrupting data continuity and quality.

How Will Decentralization and AI Reshape the Next Decade of Oncology Research?

The path forward relies on integrating technology to solve these human bottlenecks. Decentralized Clinical Trial (DCT) elements are now present in 28% of oncology studies, utilizing home health nursing and remote monitoring to reduce patient burden. Artificial Intelligence (AI) is also reshaping feasibility. AI-driven patient matching algorithms have demonstrated the ability to reduce screening time by 34% in pilot programs.

Ultimately, the oncology clinical trials market in 2025 is a sector of immense contrast—characterized by record-breaking financial figures and revolutionary science, yet tethered by persistent operational inefficiencies. With 2,162 new trials initiated in the last year alone and an R&D spend approaching USD 100 billion, the momentum is undeniable. Stakeholders who can navigate the complexities of recruitment and leverage novel modalities like ADCs will define the future of cancer care.

 Segmental Analysis 

Phase III Trials Command Revenue Through Massive Scale and Regulatory Demands

Phase III oncology trials command a dominant 48.89% revenue share of the oncology clinical trials market, a figure driven by scale rather than volume. While ClinicalTrials.gov trends reveal that Phase II studies are more numerous—accounting for 51.3% of over 4,000 radiation oncology trials—Phase III studies are significantly more capital-intensive. On average, a Phase III trial costs $52.84 million and enrolls 479 patients across hundreds of sites, dwarfing the typical Phase II cost of $18.49 million for 143 enrollees.

This cost disparity is largely dictated by FDA-mandated endpoints required for regulatory approval in the oncology clinical trials market. Complex studies, such as those for active ADC combinations and Lu-177 PSMA (e.g., the VISION trial, reporting rPFS of 11.60 months), necessitate thousands of patients, advanced imaging, and long-term monitoring. Similarly, the PSMAfore trial, which demonstrated a 59% risk reduction versus standard ARPI, exemplifies the massive spending required to justify new mCRPC therapies. Furthermore, the NIH’s translational push via the NCTN integrates pilot data into late-phase designs, amplifying costs to address resistance mechanisms in ADCs and CAR-T. Ultimately, high interventional demands—seen in the ADC MATCH trial (NCT06311214)—highlight the high-stakes pivot to FDA clearance, sustaining Phase III's revenue lead despite fewer trial starts.

Interventional Studies Secure Monopoly via Complex IP Logistics and Safety Monitoring

Interventional oncology trials monopolize the oncology clinical trials market with an 87% revenue share, a dominance driven by the complex logistics of investigational product (IP) dosing compared to low-cost observational designs. By 2024, ClinicalTrials.gov recorded 4,253 radiation oncology trials, heavily emphasizing digestive, CNS, and head-and-neck cancers (49.7%). This sector relies on substantial infrastructure, with U.S.-led sites managing nuclear agents across 793 specialized locations.

The high cost of these interventional studies is exemplified by therapies such as Lu-177 PSMA-617. Following its post-VISION FDA approval, the expenses associated with 6–8.5 GBq dosage cycles, global randomized controlled trials, and rigorous safety tracking far exceed observational baselines. Similarly, Antibody-Drug Conjugate (ADC) pipelines—like ADCT-301 (NCT03621982) for solid tumors—significantly inflate budgets due to requirements for cold-chain biologics and adverse event management. CAR-T therapies further illustrate this capital intensity, with Medicare data citing costs of $414,000 to $498,000 per case, driven by personalized manufacturing needs that are absent in non-interventional setups.

Recent regulatory milestones in the oncology clinical trials market, including 2024 FDA approvals for neoadjuvant nivolumab in NSCLC, underscore this focus on interventional treatments. However, with only 6% of radiation trials funded by industry, there is a heavy reliance on public funding for these high-value operations. This structural dynamic is set to persist, as 28% of the 1,460 radiopharma trials remain active, prioritizing solid-tumor ADCs (which make up 80% of the pipeline) over passive monitoring.

Regional Analysis 

North America Solidifies Revenue Supremacy with Advanced Infrastructure and Funding Power

North America led global oncology clinical trials market with over 58% of radiation oncology studies originating there as of early 2024, reflecting its dominance in high-revenue segments like radiopharmaceuticals and advanced therapies. ClinicalTrials.gov data shows explosive growth, with total registered studies surging from 477,200 in 2023 to 520,874 by late 2024, and oncology interventions comprising a major portion at 68,453 trials. 

The U.S. oncology clinical trials market alone hosted 793 radiopharmaceutical trial sites, far outpacing China's 160, underscoring unmatched infrastructure for complex logistics like nuclear supply chains. NIH's FY2024 budget reached $48.6 billion overall, including a $120 million boost for the National Cancer Institute, fueling premium contracts amid CAR-T therapies averaging $498,723 per Medicare inpatient case. FDA approvals reinforced this, with 15 oncology nods in Q4 2024 alone, including novel agents like revumenib for leukemia, concentrating revenue as Phase III pivotal trials demand global-scale execution. While Asia grows in volume (25.2% of radiation trials), North America's regulatory rigor and pharma hubs like those driving 361 RDC trials ensure dollar-value supremacy, with per-patient oncology costs hitting $124,800 in Phase III.​

Asia Pacific is Transforming from Outsourcing Hub to Global Innovation Powerhouse in the Oncology Clinical Trials Market

Asia Pacific (APAC) is transforming from a low-cost outsourcing hub into a global oncology innovation powerhouse, driven by cost efficiencies and vast patient pools that address recruitment bottlenecks. Operational costs in APAC are 30-40% lower than Western markets due to cheaper procedures, visits, and full-time equivalents, enabling sponsors to stretch R&D budgets further. China leads with liver cancer incidence at ~197,000-365,000 new cases annually—far surpassing North America's ~42,000—facilitating rapid enrollment for prevalent indications like liver, gastric, and lung cancers that Western sites struggle to match. South Korea and Australia bolster this shift with regulatory reforms and incentives, fueling ~12% year-over-year growth in trial initiations across APAC (excluding China).​

APAC's volume leadership positions it as indispensable for 2025 trials, complementing North America's infrastructure despite lower revenue per trial. 

Europe Transforming into a Premier Oncology Trials Hub

Europe is solidifying its role as a vital oncology clinical trials market, contributing around 18% of global volume through established infrastructure and regulatory advancements like the Clinical Trials Regulation (CTIS), which enables single submissions for multi-country studies starting January 2025, cutting administrative burdens by up to 50%. Spain and France lead as key powerhouses: Spain climbs fastest with cost-efficient enrollment and strong patient networks, while France hosts 3,312 active trials (41% oncology), bolstered by renowned centers like Gustave Roussy and IUCT Oncopole for early-phase studies. Oncology dominates at 36% of Europe's trials, fueled by immunotherapy pipelines and EMA approvals of over 30 novel molecular-targeted drugs from 2020-2023.​

Treatment costs offer advantages over the US, with median monthly cancer expenses at $6,950-$8,300 in Switzerland/Germany versus $11,755 stateside, aiding budget efficiency amid high disease burden. Eastern Europe (Poland, Hungary) provides 15-20% savings versus Western peers, though site quality varies for oncology sponsors. Despite some global share loss to Asia/US, collaborations via academic-industry clusters in Italy and Germany ensure Europe's enduring strength in precision medicine and decentralized models. 

Recent Developments in Oncology Clinical Trials Market

1. Cardiff Oncology's Positive Phase 2 Data (July 28, 2025): Cardiff Oncology announced encouraging results from its ongoing randomized Phase 2 trial of onvansertib in first-line RAS-mutated metastatic colorectal cancer, showing improved efficacy signals when combined with standard care, presented at key conferences.​
2. Roche's Phase 3 lidERA Success (December 10, 2025): Roche reported that giredestrant significantly reduced invasive disease risk in ER-positive early breast cancer in the Phase 3 lidERA study, positioning it as a potential new endocrine standard with superior survival data.​
3. Cardiff Oncology's CMML Trial Data (December 8, 2025): Cardiff Oncology revealed clinical data from an investigator-sponsored trial of onvansertib in chronic myelomonocytic leukemia at the ASH 2025 meeting, highlighting PLK1 inhibition's promise against treatment-resistant cancers.​
4. TREOS Bio's Phase 1b Publication (November 5, 2025): TREOS Bio published Phase 1b results for PolyPEPI1018 plus atezolizumab in biomarker-selected metastatic colorectal cancer patients, demonstrating immune response stimulation without tumor biopsy needs.​
5. Bristol Myers Squibb's FDA Priority Review (2025): BMS secured FDA Priority Review for a therapy in oncology (target action April 2026), advancing late-stage development based on strong clinical evidence in hematologic malignancies.

Top Companies in the Oncology Clinics Trials Market

• AbbVie Inc.
• AstraZeneca PLC
• BeiGene Ltd.
• Bristol Myers Squibb
• Charles River Laboratories
• Clovis Oncology
• Eli Lilly and Company
• F. Hoffmann-La Roche Ltd
• IQVIA
• ICON plc
• Johnson & Johnson
• Labcorp Drug Development
• Medpace Holdings
• Merck & Co., Inc.
• Novartis AG
• Parexel International
• Pfizer Inc.
• Syneos Health
• Takeda Pharmaceutical
• Thermo Fisher Scientific
• Wuxi Clinical CRO
• Other Prominent Players

Market Segmentation Overview

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
  • The US
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia and New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America