United States Oncology Clinical Trials Market 2031 | Growth Drivers, Key Players & Investment Opportunities

Market Size and Growth

The global Oncology Clinical Trials market is growing at a high CAGR during the forecast period (2024-2031).

December 2025 The landscape of oncology clinical trials is rapidly evolving as AI-driven technologies and global collaborations reshape cancer drug development.

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Key developments this month highlight the pace of innovation:

> Global Licensing Partnership: Kelun-Biotech (China) has partnered with Crescent Biopharma (USA) to license two experimental cancer therapies SKB105, an antibody-drug conjugate for solid tumors, and CR‐001, a PD‐1 × VEGF bispecific antibody. Clinical trials are scheduled to begin in Q1 2026, marking a significant step in expanding global oncology trial capacity.

> AI-Powered Precision Oncology: BostonGene will present seven new studies at the San Antonio Breast Cancer Symposium (SABCS 2025), showcasing its AI-powered multi-omic and immunoprofiling platform. The platform identifies novel biomarkers, tumor-microenvironment signatures, and patient stratification strategies, enabling more personalized and effective breast cancer trials.

> Streamlining Trial Recruitment: Innovative tools such as TrialMatchAI are transforming patient-to-trial matching. By leveraging AI to screen patient records and match eligibility criteria, these platforms significantly reduce recruitment bottlenecks and enhance access to clinical trials across diverse populations.

> Enhanced Treatment Personalization: Advanced AI and machine learning platforms are now integrating genomics, transcriptomics, and immune profiling to predict immunotherapy response. These models support smarter trial design and better targeting of therapies for individual patients.

> Implications for the Oncology Ecosystem:
These advances indicate a paradigm shift in oncology clinical trials combining AI, precision medicine, and global collaboration to accelerate drug development, improve patient outcomes, and expand trial accessibility. Pharma, biotech, CROs, and healthcare technology providers are encouraged to explore partnerships and technology adoption to stay at the forefront of this transformation.

About Kelun-Biotech:
Kelun-Biotech is a leading Chinese biopharmaceutical company focused on oncology therapeutics and global partnerships to bring innovative treatments to patients worldwide.

About BostonGene:
BostonGene is a precision oncology company leveraging AI and multi-omic analysis to enable personalized cancer therapies and accelerate clinical research.

About TrialMatchAI:
TrialMatchAI provides AI-powered patient-to-trial matching solutions, optimizing recruitment and eligibility screening to enhance clinical trial efficiency and access.

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Key developments:

United States: Recent Oncology Regulatory Developments

✅ In November 2025, Sevabertinib (Hyrnuo) received accelerated approval for adults with locally advanced or metastatic non‐squamous non‐small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine‐kinase domain activating mutations and who had received prior systemic therapy.

✅ In November 2025, Ziftomenib (Komzifti), a menin inhibitor, was approved for adults with relapsed or refractory acute myeloid leukemia (AML) harboring NPM1 mutation and lacking satisfactory alternative therapies.

✅ In November 2025, Epcoritamab‐bysp (Epkinly) plus lenalidomide and rituximab got FDA approval for relapsed or refractory follicular lymphoma (FL), providing a new bispecific‐antibody-based treatment option.

✅ In November 2025, Darzalex Faspro (daratumumab + hyaluronidase‐fihj) was approved for adults with high‐risk smoldering multiple myeloma.

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Japan: Recent Oncology Regulatory Developments

✅ In October 2025, the Fam‐trastuzumab deruxtecan‐nxki (T‐DXd; Enhertu) + Pertuzumab (Perjeta) combo was submitted as a supplemental NDA to MHLW for first‐line treatment of HER2‐positive unresectable or recurrent breast cancer based on data from a Phase 3 trial.

✅ In September 2025, the companion diagnostic test for ROS1‐positive NSCLC was approved in parallel with Taletrectinib (IBTROZI), enabling identification of eligible patients for treatment.

✅ In September 2025, Taletrectinib (IBTROZI) was approved by the Ministry of Health, Labour and Welfare (MHLW) for adult patients with ROS1‐positive unresectable, advanced and/or recurrent non‐small cell lung cancer (NSCLC), offering a targeted therapy for ROS1‐fusion NSCLC in Japan.

✅ In August 2025, Taiho Pharmaceutical (alongside partners) announced plans to develop cancer vaccines using whole‐genome information, signaling a move toward next‐generation immuno‐oncology strategies in Japan.

Key Players:

=> AstraZeneca, Merck & Co., Inc, Gilead Sciences, Inc, F. Hoffmann-La Roche Ltd, Syneos Health, Daiichi Sankyo Company, Eli Lilly and Company, PharmaMar, Novocure, Pfizer Inc among others.

Key Segments:

➥ By Phase Type: Phase I, Phase II, Phase III

➥ By Study Design: Interventional Studies, Observational Studies, Expanded Access Trials

➥ By Cancer Type: Lung Cancer, Breast Cancer, Prostate Cancer, Skin Cancer, Others

➥ By End User: Biopharmaceutical Companies, Academic and Research Institutes, Others

➥ By Region

North America - 45% Share
North America leads due to strong biopharma infrastructure, advanced regulatory frameworks, and high clinical trial activity in oncology.

Europe - 25% Share
Europe contributes 25%, supported by government-backed research programs, large academic centers, and collaborative clinical networks.

Asia Pacific - 15% Share
Asia Pacific holds 15%, with increasing investment in oncology R&D and expanding clinical trial sites in China, India, Japan, and South Korea.

Latin America - 8% Share
Latin America represents 8%, driven by emerging trial hubs in Brazil and Argentina for cost-effective patient recruitment and clinical research.

Middle East & Africa - 7% Share
Middle East & Africa hold 7%, with growing focus on oncology research centers in GCC countries, South Africa, and select African regions.

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