Introduction

Personalized cancer therapies are redefining the landscape of oncology in the United States, offering highly targeted, patient-specific treatment approaches that enhance outcomes while minimizing side effects. By harnessing genetic, molecular, and clinical data, these therapies enable oncologists to tailor interventions based on an individual’s unique cancer profile. Advancements in genomic sequencing, biomarker discovery, and precision drug development are rapidly accelerating the adoption of this model across the healthcare system.

The U.S. personalized cancer therapies market is on a strong growth trajectory, valued at approximately USD 340.5 billion in 2024 and projected to reach USD 640.2 billion by 2030. This represents a compound annual growth rate (CAGR) of 8.9% over the forecast period. Key growth catalysts include the rising incidence of cancer, increasing investment in precision medicine, and growing patient awareness of individualized treatment options. With a robust pipeline of novel targeted therapies and favorable regulatory support, the market is poised for continued expansion in the coming years.

Market Dynamics

The U.S. personalized cancer therapies market is evolving rapidly, driven by a convergence of technological innovation, shifting clinical priorities, and the increasing demand for more effective cancer treatments. The growing prevalence of diverse cancer types, coupled with the limitations of one-size-fits-all approaches, has prompted a surge in demand for tailored solutions that align with each patient’s molecular and genetic characteristics.

Breakthroughs in next-generation sequencing (NGS), proteomics, and molecular diagnostics have paved the way for highly individualized treatment strategies. These advances allow clinicians to accurately identify actionable mutations, select appropriate therapies, and monitor disease progression in real time. Additionally, AI and machine learning are increasingly being used to accelerate biomarker discovery, support therapeutic matching, and improve clinical decision-making.

Significant market opportunities are emerging through the expansion of companion diagnostics, integration of real-world evidence (RWE), and greater use of liquid biopsies to monitor treatment efficacy and detect recurrence. Investment in precision oncology research is also intensifying, with biopharma firms, diagnostics developers, and academic institutions forming cross-sector partnerships to drive innovation and accelerate approvals.

A notable example is the collaboration between Roche and Foundation Medicine, which has led to FDA-approved solutions such as FoundationOne CDx and FoundationOne Liquid CDx. These AI-powered diagnostics provide non-invasive, real-time insights into tumor behavior, enabling clinicians to fine-tune therapies and reduce treatment latency.

Emerging trends include the development of mRNA-based personalized cancer vaccines, growing interest in allogeneic cell therapies, and the use of value-based care frameworks that emphasize outcome-driven approaches. Moderna and Pfizer are leading initiatives in personalized mRNA cancer vaccines, while Gilead Sciences and Bristol Myers Squibb are advancing scalable allogeneic therapies aimed at broader patient accessibility. As these trends converge, personalized cancer therapies are becoming integral to the future of U.S. oncology, offering more precise, cost-effective, and durable solutions for patients and providers alike.

Segment Highlights and Performance Overview

By Treatment Type

Immunotherapy leads the treatment landscape, commanding a market share of around 40%. Its transformative role in cancer care stems from its ability to enhance the body’s natural immune response to identify and destroy cancer cells. Breakthroughs in immune checkpoint inhibitors, adoptive cell therapies, and CAR T-cell therapies have redefined treatment protocols for various cancer types. Immunotherapy’s versatility and durability—particularly in melanoma, lung cancer, and hematologic malignancies—have made it a foundational element in personalized cancer care strategies across the country.

By Cancer Type
Breast Cancer holds the largest share within the cancer type segment, accounting for approximately 25% of the market. This dominance is driven by the high prevalence of breast cancer in the U.S., widespread implementation of early detection and screening programs, and strong levels of patient awareness. Advances in precision medicine have played a pivotal role, particularly through the development of targeted treatments like HER2 inhibitors, CDK4/6 inhibitors, and hormone therapies. These therapies enable oncologists to tailor interventions based on specific genetic markers, significantly improving treatment efficacy and reducing systemic side effects.

By Diagnostic Techniques

Next-Generation Sequencing (NGS) stands out as the leading diagnostic tool in the personalized cancer space, with a market share of approximately 30.55% as of 2024. NGS offers unmatched depth and speed in genomic analysis, allowing for the simultaneous assessment of hundreds of genetic mutations from a single sample. This capability supports comprehensive tumor profiling, biomarker discovery, and real-time treatment matching. The widespread adoption of NGS-based companion diagnostics—such as FoundationOne CDx and Guardant360—has enabled clinicians to make more informed, data-driven decisions at every stage of cancer management.

By End-Users
Hospitals & Clinics account for the largest share among end users. These facilities serve as the central hubs for delivering personalized oncology services, encompassing everything from advanced diagnostics and genomic analysis to therapy administration and long-term monitoring. Their integration of multidisciplinary care teams—including oncologists, pathologists, genetic counselors, and clinical researchers—positions them as the primary setting for implementing individualized cancer treatment plans. The availability of infrastructure, access to clinical trials, and partnerships with biotech firms further solidify their role in advancing precision oncology.

Competition Landscape

The competitive environment in the U.S. personalized cancer therapies market is shaped by a strong mix of pharmaceutical leaders, biotech innovators, diagnostics developers, and AI-driven healthtech firms. Companies are investing aggressively in R&D to expand therapeutic pipelines, enhance companion diagnostics, and bring novel modalities—such as mRNA vaccines and cell therapies—to market faster.

Collaboration is a key competitive strategy. Strategic alliances between pharmaceutical giants and diagnostics platforms are enabling more seamless integration of genomic insights into therapeutic decision-making. For example, Roche’s investment in Foundation Medicine and Pfizer’s growing partnerships with AI-based biomarker firms highlight how ecosystem connectivity is becoming essential to competitive advantage.

Key players profiled in this report include Moderna Therapeutics, Pfizer, Gilead Sciences, Novartis, Johnson & Johnson, Bristol Myers Squibb, Foundation Medicine, Myriad Genetics, and Guardant Health. These companies are at the forefront of personalized cancer innovation, with strong clinical pipelines, regulatory momentum, and cross-sector capabilities that position them to lead the next era of oncology.

Key Developments

• May 2025: Pfizer entered a licensing agreement with Chinese biopharma firm 3SBio for SSGJ-707, an experimental cancer therapy. The deal includes a $1.25 billion upfront payment and up to $4.8 billion in milestone payouts. This move significantly expands Pfizer’s oncology pipeline and highlights growing international collaboration in personalized drug development.

March 2025: The European Commission approved Bristol Myers Squibb’s CAR T-cell therapy, Breyanzi, for use in relapsed or refractory follicular lymphoma. Although approved in Europe, the development has major implications for the U.S. market, reinforcing the clinical viability of CAR T-cell therapies and accelerating domestic research, regulatory attention, and adoption.

Segmentation:

Treatment Type:

• Targeted Therapy
• Immunotherapy
• Hormone Therapy
• Chemotherapy
• Others

Cancer Type:

• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Prostate Cancer
• Melanoma
• Others

Diagnostic Techniques:

• Genomic Sequencing
• Liquid Biopsy
• Immunohistochemistry
• Biomarker Testing
• Others

End-Users:

• Hospitals & Clinics
• Diagnostic Laboratories
• Research Institutes
• Biotechnology & Pharmaceutical Companies
• Others

Companies included in the report:

• Moderna Therapeutics
• Pfizer
• Gilead Sciences
• Novartis
• Johnson & Johnson
• Bristol Myers Squibb
• Foundation Medicine
• Myriad Genetics
• Guardant Health