Global Oncology Clinical Trials Market Projected to Reach US$ 25.61 Billion by 2035, Supported by Advances in Precision and Targeted Therapies Says Astute Analytica

Fuelled by precision medicine and rising global incidence, the sector combines North American revenue dominance with Asia’s expanding recruitment capacity. As advanced modalities mature, stakeholders are leveraging decentralized technologies to overcome operational bottlenecks, ensuring sustained growth in this capital-intensive landscape.

Chicago, Jan. 20, 2026 (GLOBE NEWSWIRE) — The global oncology clinical trials market is projected to hit the market valuation of USD 25.61 billion by 2035 from USD 14.95 billion in 2025 at a CAGR of 5.53% during the forecast period 2026–2035.

Global research activity has surged, driving the oncology clinical trials market to record levels of operational intensity. Data indicates that 2,162 oncology clinical trials were initiated globally in 2024. Such volume represents a resilient 12-unit increase on an index basis compared to 2019 levels. Sponsors specifically planned 82 new solid tumor trials for launch in 2024. Investigators also scheduled 65 trials for Non-Small Cell Lung Cancer (NSCLC) and 57 breast cancer trials to begin within the year. Furthermore, the sector has seen 1,700 liver cancer clinical trials initiated globally in the period leading up to mid-2024. Emerging targets also saw rapid uptake. Specifically, 44 new radiopharmaceutical trials targeting FAP (Fibroblast Activation Protein) were identified in the 2024 pipeline.

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Innovation rates in the oncology clinical trials market are accelerating alongside these volume increases. The number of oncology Novel Active Substances (NAS) launched globally in the 5-year period ending 2024 reached 132. Market data confirms that 25 distinct oncology NAS were launched globally in the single year of 2024 alone. Consequently, the average annual number of oncology launches rose to 26 for the 2020-2024 period, up significantly from 16 in the prior five years. Novel modalities, including ADCs and Cell/Gene therapies, accounted for 35% of all oncology trial starts in 2024. These metrics underscore a thriving ecosystem where expanding trial volumes directly correlate with successful commercial launches.

Key Findings

• North America accounted for over 41.58% revenue share of the oncology clinical trials market. 
• Asia-Pacific is projected to witness the fastest CAGR from 2025 to 2034. 
• By phase type, the Phase III segment represented more than 48.89% of the revenue share. 
• By study design, the interventional studies segment accounted for over 71% of the total revenue share. 

Capital Inflows and Acquisition Deals Drive Unprecedented Financial Market Expansion

Financial investments are reshaping the oncology clinical trials market landscape with massive capital injections. Global spending on cancer medicines reached a staggering USD 252 billion in 2024. That figure reflects a USD 29 billion increase from the previous year. Projections now indicate spending on cancer medicines will reach USD 441 billion by 2029. Major corporations have responded aggressively. Novartis acquired Mariana Oncology for USD 1 billion in 2024 to bolster its radioligand pipeline. Biotech funding remains robust as well. Abdera Therapeutics secured USD 142 million in Series A and B financing in 2024. Eli Lilly invested USD 60 million upfront in a partnership with Aktis Oncology in 2024.

Deal-making activity further validates the lucrative nature of the oncology clinical trials market. Ratio Therapeutics raised USD 50 million in Series B funding in 2024 to advance radiopharma trials. Similarly, Radionetics Oncology completed a USD 52.5 million fundraising round in 2024. Cost-saving measures are simultaneously creating fiscal headroom. Biosimilars in oncology generated USD 7 billion in savings for payers in 2023/2024. Cumulative savings from oncology biosimilars reached USD 19 billion since 2017. The top 10 tumor types are forecasted to see double-digit spending growth through 2029. These financial flows ensure that high-cost clinical research programs remain sustainable despite economic pressures.

Regulatory Milestones and Novel Substance Launches Accelerate Market Innovation Rates

Regulatory bodies have intensified their engagement with the oncology clinical trials market to expedite patient access. The FDA approved 17 novel oncology drugs (New Molecular Entities) in 2024. Additionally, the FDA Oncology Center of Excellence made 32 additional approval decisions regarding label expansions or populations in 2024. Advanced therapies also secured critical wins. Two new cellular therapy products, lifileucel and afamitresgene autoleucel, received FDA approval in 2024. Global parity is emerging quickly. China’s NMPA approved 84 oncology NAS in the five years ending 2024. Comparatively, the US FDA approved 85 oncology NAS in the same five-year period.

Specific designations within the oncology clinical trials market highlight a focus on precision. The FDA granted 1 Breakthrough Therapy Designation to dostarlimab-gxly for rectal cancer in late 2024. Priority channels remain active. One new taletrectinib application received priority review in December 2024. Commercial availability is expanding rapidly for successful candidates. Thirteen ADCs had received FDA approval for market use by the end of 2024. Furthermore, 20 radiopharmaceuticals are currently approved for market use globally as of 2024. Among these, 4 radiopharmaceuticals targeting PSMA have received market approval as of 2024. These approvals validate the immense R&D efforts poured into the sector.

North America Capture Nearly 42% Market Share Through Strategic Infrastructure Investments

Regional dominance remains a defining feature of the oncology clinical trials market. North America contributed more than 41.58% of revenue share in 2024. Infrastructure depth drives this financial lead. The United States hosted 157 radiopharmaceutical clinical trials over the last decade. Site expansion continues to support this volume. Two new early-phase oncology trial sites were opened by OneOncology and START in the US in May 2025. Recruitment disparities highlight regional differences. North America recorded 48,000 new liver cancer cases, creating a distinct recruitment landscape compared to Asia. Yet, revenue generation remains concentrated in the West due to higher trial costs.

Cross-border dynamics are influencing the oncology clinical trials market strategy. China recorded 84 NAS launches between 2020 and 2024, nearly equaling the US total of 85. However, 45 oncology NAS launched in China in the last 5 years have not yet launched in other markets. Recruitment needs are shifting eastward. Sixty-three percent of global Small Cell Lung Cancer (SCLC) incidence is in Asia. Despite this, the capital-intensive nature of US research sustains its top-tier market share. High-value trials, particularly in cell therapy, anchor North America’s financial supremacy.

By Study Design and Phase, Interventional Studies Command 71% Revenue Share and Phase II Capture the Largest 48.89% Market Share

Study design choices heavily dictate financial outcomes in the oncology clinical trials market. By study design, the interventional studies segment generated over 87.76% of revenue share. Such dominance stems from the complexity of active treatment protocols. By phase type, the phase III segment generated over 48.89% of revenue share. Large-scale pivotal studies drive these numbers. Currently, 17 liver cancer drugs have reached Phase III trials. Similarly, 10.2% of ongoing radiopharmaceutical trials have reached Phase III. Complex combination therapies require extensive resources. Over 50 Phase III trials currently involve ADC combination therapies.

Pipeline maturity varies across the oncology clinical trials market. Phase II trials accounted for 48% of all oncology trial starts in 2024. Early-stage safety remains a priority. Phase I trials represented 38% of starts. Meanwhile, Phase III trials comprised 14% of starts in 2024. Specific indications show robust early pipelines. Fifty-one liver cancer drugs are currently in Phase I development. Another 66 liver cancer drugs are in Phase II development. Radiopharma follows a similar trend. Sixty-six percent of completed radiopharmaceutical trials were in early phases (I/II). These figures illustrate a funnel where massive early-stage volume feeds high-value late-stage revenue.

Antibody Drug Conjugates and Advanced Modalities Redefine Therapeutic Success Rates

Targeted therapies are the fastest-growing sub-segment of the oncology clinical trials market. Over 180 Antibody-Drug Conjugates (ADCs) are currently in the clinical development pipeline as of 2024. Developers are focusing heavily on major cancer types. Eighty percent of these pipeline ADCs are targeting solid tumors. Technical confidence is surging. The probability of technical success for ADC monotherapies in Phase III is 53%, higher than the general oncology average. Such high success rates are attracting further investment. Consequently, the sector is witnessing a race to consolidate these high-value assets.

Radiopharmaceuticals complement the growth in the oncology clinical trials market. A total of 361 radiopharmaceutical clinical trials have been conducted over the last decade with active status confirmed in 2024. The pipeline is diverse and expanding. Ninety radiopharmaceuticals targeting PSMA are in development globally as of 2024. Additionally, 43 PSMA-targeting drugs are currently in active clinical stages. Other targets are gaining traction. Sixteen radiopharmaceuticals targeting CAIX are in development. Furthermore, 5 therapeutic radiopharmaceuticals targeting FAP are currently in clinical trials. Twenty-three radiopharmaceuticals targeting SSTR are also in the pipeline.

Strategic Patient Enrollment Initiatives Address Critical Global Recruitment Disparities

Recruitment metrics are a vital performance indicator for the oncology clinical trials market. The ratio of patient enrollment in industry-sponsored vs. federally-sponsored trials reached 8.1 to 1 in 2024. For adult trials specifically, this ratio hit 9.6 to 1 in the 2024 analysis period. Pediatric research shows similar industry dominance. Enrollment ratios for pediatric trials shifted to 2.3 to 1 (Industry vs. Federal) in the 2024 analysis. Participation rates are gradually improving. Across the board, 21.9% of cancer patients participated in some form of clinical research in 2024.

However, specific intervention rates in the oncology clinical trials market remain low. Only 7.1% of cancer patients enrolled specifically in interventional treatment trials. Institutional differences play a major role. NCI-designated cancer centers achieved a 21.6% enrollment rate for treatment trials. In contrast, community oncology programs averaged a 4.1% enrollment rate for treatment trials. Alternative participation methods are growing. Approximately 12.9% of cancer patients participated in biorepository studies in 2024. Geography drives volume significantly. China recorded 360,000 new liver cancer cases, offering a massive pool for enrollment compared to Western markets.

Emerging Markets and Decentralized Methods Reshape Future Competitive Landscapes

Innovation in trial execution is modernizing the oncology clinical trials market. Seven percent of trials in 2024 incorporated a Decentralized Clinical Trial (DCT) component. Oncology is adopting these methods selectively. Specifically, 7.2% of those DCT trials were in oncology. Advancements in treatment are yielding tangible results. A 160% increase in pancreatic cancer survival rates was reported in 2024 due to clinical trial advancements. Successes like these drive further demand for research. Rare diseases are becoming a primary focus. Seventy-four percent of 2024 oncology trial starts focused on rare cancers.

Historical data confirms the long-term trajectory of the oncology clinical trials market. A total of 282 oncology NAS have launched globally over the past 20 years. The sheer volume of new agents requires constant testing. Manufacturers have launched 132 of those NAS in just the last five years. Competitors are racing to fill unmet needs. The push for rare cancer treatments and decentralized access is expanding the addressable patient population. Stakeholders are leveraging these shifts to maintain competitive advantages. Future growth depends on balancing high-tech decentralization with complex interventional protocols.

Radiopharmaceutical Pipeline Maturation Signals Shift Toward Targeted Precision Therapies

Specialized segments are becoming critical revenue drivers in the oncology clinical trials market. Active development in radioligand therapy is expanding beyond established targets. Five therapeutic radiopharmaceuticals targeting FAP are currently in clinical trials, signaling a move toward stromal targets. The breadth of the pipeline is impressive. Twenty distinct radiopharmaceuticals are currently approved for market use globally as of 2024. This commercial success encourages further early-stage activity. Sixty-six percent of completed radiopharmaceutical trials were in early phases, ensuring a steady stream of future candidates.

Investment in the oncology clinical trials market is validating these specific modalities. The presence of 90 PSMA-targeting drugs in development illustrates the intensity of competition. Only 10.2% of ongoing radiopharmaceutical trials have reached Phase III. Such a bottleneck presents a massive opportunity for CROs and investors to facilitate late-stage transitions. Success here translates to high-value commercial assets. With 43 PSMA drugs in active clinical stages, the next few years will see a wave of pivotal data readouts. These advancements confirm that precision radiopharmaceuticals are central to the market’s future.

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Oncology Clinics Trials Market Major Players:

• 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

Key Market Segmentation:

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
• Middle East and Africa
• South America

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About Astute Analytica

Astute Analytica is a global market research and advisory firm providing data-driven insights across industries such as technology, healthcare, chemicals, semiconductors, FMCG, and more. We publish multiple reports daily, equipping businesses with the intelligence they need to navigate market trends, emerging opportunities, competitive landscapes, and technological advancements.

With a team of experienced business analysts, economists, and industry experts, we deliver accurate, in-depth, and actionable research tailored to meet the strategic needs of our clients. At Astute Analytica, our clients come first, and we are committed to delivering cost-effective, high-value research solutions that drive success in an evolving marketplace.

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Website: https://www.astuteanalytica.com/ 

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