The precision oncology market has seen a remarkable expansion, reaching $139.4 billion in 2025, with projections suggesting it could soar to $317.5 billion by 2035. This growth is driven by a transformative shift in cancer treatment, emphasizing biomarker-guided therapy selection. This approach allows clinicians to tailor treatments based on specific tumor characteristics rather than relying on a standardized method.
Key players in this evolving landscape include Oncolytics Biotech Inc. (NASDAQ:ONCY), Exact Sciences Corp. (NASDAQ:EXAS), Veracyte, Inc. (NASDAQ:VCYT), Hologic, Inc. (NASDAQ:HOLX), and Personalis, Inc. (NASDAQ:PSNL). The convergence of diagnostic precision with targeted therapies underpins the investment rationale for these companies, particularly as the market for artificial intelligence (AI) in oncology is projected to grow from $5.1 billion in 2024 to $53.1 billion by 2034, representing a compound annual growth rate (CAGR) of 26.4%.
Oncolytics Biotech’s Innovative Approach
Oncolytics Biotech is at the forefront of this transformation with its investigational immunotherapy, pelareorep. Recent data highlighted a 33% objective response rate (ORR) in patients with second-line KRAS-mutant metastatic colorectal cancer when pelareorep was combined with standard chemotherapy. This rate significantly surpasses the historical 6-11% response rate for chemotherapy alone in this challenging patient demographic.
Dr. Sanjay Goel, a Professor of Medicine at the Rutgers Cancer Institute of New Jersey, commented, “These results are extremely encouraging. Achieving a 33% ORR in KRAS-mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study.” The data suggests that pelareorep can enhance the immune response against tumors harboring this genetic mutation, which is common in various gastrointestinal cancers.
Additionally, the drug has shown promise in anal cancer treatment, achieving a 30% response rate in second-line squamous cell anal carcinoma, well above the 13.8% benchmark for the only FDA-approved immunotherapy in this space. The median duration of response reached 15.5 months, compared to 9.5 months for standard care, indicating the potential for long-lasting tumor control.
Jared Kelly, CEO of Oncolytics Biotech, emphasized the significance of these findings, stating, “Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033.” He also noted plans for a controlled study in second-line KRAS-mutant colorectal cancer, which will be conducted under the guidance of key opinion leaders and regulatory bodies.
Innovative Developments in Oncology
The broader oncology landscape is also witnessing significant advancements. Exact Sciences recently reported results from its Oncodetect molecular residual disease test, which demonstrated strong prognostic performance in early triple-negative breast cancer, known for its aggressiveness. The study, conducted in collaboration with the NSABP Foundation and German Breast Group, indicated that post-surgery MRD-positive status was linked to a 30-fold higher risk of distant recurrence compared to MRD-negative patients.
Dr. Norman Wolmark, chairman of the NSABP Foundation, remarked, “The strength of these data highlights the prognostic power of ctDNA and its potential to guide post-surgical management strategies for high-risk breast cancer.”
Veracyte has introduced its Afirma GRID research tool, which aims to redefine thyroid nodule evaluation. The studies published in Frontiers in Endocrinology and Surgery demonstrated the identification of molecular signatures that could enhance prognostic information prior to surgery. Dr. Joshua Klopper, Veracyte’s medical director for Endocrinology, explained, “Now, Veracyte is working to help clinical researchers better answer the next critical question for thyroid nodule care.”
Hologic’s recent study on its Genius AI Detection mammography solution revealed that the AI flagged nearly one-third of breast cancer cases initially interpreted as negative, showcasing its potential to enhance detection accuracy. Dr. Manisha Bahl, Associate Director of Quality for Breast Imaging at Massachusetts General Hospital, stated, “While additional research is needed, these findings are promising and highlight AI’s tremendous potential to redefine breast cancer detection.”
Personalis announced a new publication in Clinical Cancer Research detailing its NeXT Personal assay, which effectively predicts patient outcomes across various cancers and immunotherapy modalities. The study indicated that patients with durable molecular clearance for at least 180 days achieved 100% overall survival. Dr. Rodrigo Toledo of VHIO noted the assay provides an early molecular view of treatment benefits, enhancing patient management across a spectrum of solid tumors.
As the precision oncology market continues to expand, these developments reflect a growing commitment to personalized cancer care, driven by innovative technologies and strategic research initiatives. The landscape is transforming, promising improved outcomes for patients facing challenging cancer diagnoses.
