The precision oncology market is on a rapid growth trajectory, projected to expand from $139.4 billion in 2025 to $317.5 billion by 2035. This surge is driven by a transformative approach to cancer treatment that emphasizes biomarker-guided therapy, enabling healthcare professionals to tailor treatments to the unique characteristics of individual tumors. This shift is reshaping investment opportunities in the sector, particularly for companies like Oncolytics Biotech Inc. (NASDAQ: ONCY), Exact Sciences Corp. (NASDAQ: EXAS), Veracyte, Inc. (NASDAQ: VCYT), Hologic, Inc. (NASDAQ: HOLX), and Personalis, Inc. (NASDAQ: PSNL).
In addition to the growth in precision oncology, the market for artificial intelligence in oncology is set to explode, anticipated to grow from $5.1 billion in 2024 to $53.1 billion by 2034, with a compound annual growth rate (CAGR) of 26.4%. AI is enhancing diagnostic accuracy and enabling real-time clinical decision-making, which bridges the gap between early detection and personalized treatment selection.
Oncolytics Biotech Inc. is at the forefront of this innovation, developing pelareorep, an investigational immunotherapy aimed at activating the immune response against cancer. Recent clinical data shows that pelareorep achieved a noteworthy 33% objective response rate in patients with second-line KRAS-mutant metastatic colorectal cancer when used alongside standard chemotherapy. This response rate significantly surpasses the historical response rates of 6-11% associated with chemotherapy alone in this challenging patient group.
Dr. Sanjay Goel, a Professor of Medicine at the Rutgers Cancer Institute of New Jersey, expressed optimism regarding the findings: “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.” This data positions pelareorep as a promising precision immunotherapy that could offer substantial clinical benefits over current treatment standards.
Further analysis revealed that pelareorep enhances KRAS-mutant-specific T-cell populations, providing a mechanistic understanding of its efficacy against this genetic mutation, which is prevalent in many gastrointestinal cancers. Notably, results in patients with anal cancer showed a 30% response rate in second-line squamous cell carcinoma, which more than doubles the 13.8% benchmark set by the only FDA-approved immunotherapy in this context.
Jared Kelly, CEO of Oncolytics Biotech, indicated the potential market impact: “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.” The company is preparing to sponsor a controlled study in second-line KRAS-mutant colorectal cancer, having consulted with key opinion leaders and regulatory bodies. This strategic move allows Oncolytics to manage the data generated and communicate updates to investors and potential partners.
Oncolytics has also formed a Gastrointestinal Tumor Scientific Advisory Board to refine its registration strategy across various cancers, including pancreatic, colorectal, and anal cancers. This board includes leading oncologists from esteemed institutions such as the Rutgers Cancer Institute and Northwestern University. Additionally, the company has received FDA agreement on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to initiate the only immunotherapy registration trial currently planned for this disease. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer.
In related industry advancements, Exact Sciences (NASDAQ: EXAS) has reported promising results from its Oncodetect molecular residual disease test. This test demonstrated significant prognostic capabilities in early triple-negative breast cancer, one of the most aggressive subtypes. The study conducted by the NSABP Foundation and German Breast Group revealed a 30-fold higher risk of distant recurrence in MRD-positive patients compared to MRD-negative patients. Among those analyzed, 95% of patients who remained ctDNA-negative post-surgery stayed free of distant recurrence at three years.
Veracyte, Inc. has also made strides with its Afirma GRID research tool, which aims to advance thyroid nodule evaluation. Publications in Frontiers in Endocrinology and Surgery highlighted the tool’s potential in developing molecular signatures that could enhance prognostic information prior to surgery. In a Cleveland Clinic study, two molecular signatures were identified, one of which predicted a 30% greater likelihood of intermediate or high-risk cancer.
Hologic (NASDAQ: HOLX) has released data indicating that its Genius AI Detection mammography solution can identify nearly one-third of breast cancer cases initially interpreted as negative. This retrospective analysis of 7,500 digital breast tomosynthesis screening exams showed that the AI technology effectively flagged approximately 90% of the breast cancer cases previously diagnosed by radiologists.
Lastly, Personalis (NASDAQ: PSNL) announced a publication in Clinical Cancer Research highlighting its NeXT Personal assay’s ability to predict patient outcomes across various cancers and immunotherapy treatments. This study demonstrated that the assay could detect ctDNA in 98% of patients with stage IV solid tumors treated with immune checkpoint inhibitors.
These advancements and the overall growth in the precision oncology market underscore the significant potential for innovative therapies and technologies that are reshaping cancer treatment landscapes globally.
