(Albany, US) On November 04, 2026, DelveInsight’s “Oncolytic Viruses Market Size, Target Population, Competitive Landscape & Market Forecast – 2036” report provides comprehensive insights into the Oncolytic Viruses market and pipeline landscape across the 7MM. It covers marketed and emerging therapy profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by virus platform, stage, and indication, and examines the market drivers and barriers shaping the space.
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Key Takeaways from the Oncolytic Viruses Report
In August 2026, Replimune received FDA accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg, formerly RP1) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed after an anti-PD-1-based regimen.
In July 2026, CG Oncology published Phase III BOND-003 Cohort C results for cretostimogene grenadenorepvec in high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, showing a 75.5% complete response rate with durable responses and a favorable safety profile. The company remains on track for a BLA submission in 2026, and the therapy holds FDA Fast Track and Breakthrough Therapy designations.
In July 2026, UroGen Pharma received FDA IND clearance for UGN-501, a next-generation oncolytic virus, to start a Phase 1 trial in NMIBC.
In June 2026, Candel Therapeutics started the global pivotal Phase 3 AURORA trial of aglatimagene besadenovec (CAN-2409) plus valacyclovir with pembrolizumab in metastatic non-squamous NSCLC that progressed after pembrolizumab and platinum chemotherapy.
In March 2026, Genelux reported that Phase III ovarian cancer topline data for Olvi-Vec are expected in 2H26, and in June 2026 it published Phase Ib/II VIRO-15 data supporting immune activation and possible reversal of platinum resistance.
IMLYGIC (T-VEC, Amgen) was the first oncolytic virus approved by the FDA, in 2015, and DELYTACT (Daiichi Sankyo) received conditional, time-limited approval in Japan in 2021 for malignant glioma. The US market generated about USD 100 million in 2025.
DelveInsight’s report depicts a rapidly expanding pipeline across adenovirus, herpes simplex virus, vaccinia virus, reovirus, and other platforms.
Leading Oncolytic Viruses companies include Amgen, Daiichi Sankyo, Replimune, Genelux, Candel Therapeutics, CG Oncology, Oncolytics Biotech, Lokon Pharma, Imugene, SillaJen, UroGen Pharma, and others.
Promising therapies include IMLYGIC, DELYTACT, TUDRIQEV, Olvi-Vec, cretostimogene grenadenorepvec, CAN-2409, pelareorep, LoAd703, CF33, Pexa-Vec (JX-594), and others.
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Oncolytic Viruses Overview
Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy cancer cells. They naturally target cancer and can also be engineered to deliver additional genes directly into tumor cells to enhance tumor destruction. Platforms in clinical evaluation include adenovirus, herpes simplex virus, maraba virus, measles virus, Newcastle disease virus, picornavirus, reovirus, vaccinia virus, and vesicular stomatitis virus. Positive results in melanoma, bladder cancer, biliary tract cancer, glioblastoma, ovarian cancer, pancreatic cancer, and other solid tumors have driven the field forward. These therapies are mainly being developed for relapsed or refractory settings, which could address nearly 20% of all cancer cases. In the 7MM in 2025, prostate cancer (about 49.5%) and bladder cancer (about 40%) made up the largest shares of the target patient pool.
Key features include:
Direct killing of cancer cells
Stimulation of tumor-specific immune responses
Conversion of “cold” tumors into “hot” tumors
Ability to carry therapeutic genes
Focus on relapsed or refractory disease
Oncolytic Viruses Emerging Drugs Profile
Olvi-Vec (Olvimulogene Nanivacirepvec): Genelux Olvi-Vec is a modified vaccinia virus with a triple mode of action: it directly kills cancer cells, stimulates a tumor-specific immune response, and converts the tumor microenvironment from immunosuppressive to immunoreactive. It is in development for platinum-resistant/refractory ovarian cancer (PRROC), recurrent NSCLC, small cell lung cancer, and pancreatic cancer, and holds FDA Fast Track Designation for PRROC. Phase III ovarian cancer topline data are expected in 2H26. Currently, the therapy is in Phase III.
Cretostimogene Grenadenorepvec: CG Oncology Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in the Phase III BOND-003 trial in BCG-unresponsive NMIBC and the Phase III PIVOT-006 monotherapy trial in intermediate-risk NMIBC. It holds FDA Fast Track and Breakthrough Therapy designations. In May 2026, Phase II CORE-008 data with gemcitabine showed encouraging high-grade event-free survival and complete response rates. Currently, the therapy is in Phase III.
Aglatimagene Besadenovec (CAN-2409): Candel Therapeutics CAN-2409 is an adenoviral gene therapy given with valacyclovir. The pivotal Phase 3 AURORA trial began in June 2026 in metastatic non-squamous NSCLC after progression on pembrolizumab and platinum chemotherapy. Currently, the therapy is in Phase III.
UGN-501: UroGen Pharma UGN-501 is a next-generation investigational oncolytic virus for NMIBC. IND clearance was received in July 2026 to start a Phase 1 trial. Currently, the therapy is entering Phase I.
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Oncolytic Viruses Market Drivers
Recent approvals: TUDRIQEV’s accelerated approval adds to IMLYGIC and DELYTACT, showing a regulatory path for the class.
Late-stage momentum: Cretostimogene, Olvi-Vec, and CAN-2409 are in Phase III, with a BLA planned in 2026 for cretostimogene.
Large unmet need in refractory cancers: These therapies target relapsed or refractory settings, addressing a substantial portion of cancer cases.
Positive clinical data: Results in melanoma, bladder, ovarian, lung, and other tumors have attracted investment.
Combination potential: Pairing with checkpoint inhibitors and chemotherapy may restore sensitivity in resistant tumors.
Platform diversity: Multiple virus platforms and engineered payloads support next-generation candidates.
Regulatory support: Fast Track and Breakthrough Therapy designations accelerate development.
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Oncolytic Viruses Market Barriers
Limited uptake of first-generation products: IMLYGIC’s sales are constrained by narrow patient suitability and modest efficacy versus other melanoma immunotherapies.
Restricted access in Japan: DELYTACT’s conditional approval limits sales to hospitals that served as trial sites.
Complex delivery: Intratumoral, intravesical, or other local administration requires specialized handling and centers.
Cost and reimbursement: Pricing pressures and varied access across the US, Europe, and Japan may limit uptake.
Clinical risk: Some programs depend on combination data and confirmatory trials, and results can vary by tumor type.
Funding constraints: Smaller developers face cash runway limits.
Competition: Established immunotherapies and other post-checkpoint options compete for the same patients.
Scope of the Oncolytic Viruses Report
Coverage: 7MM (US, EU4, UK, Japan)
Companies: As listed above
Therapies: IMLYGIC, DELYTACT, TUDRIQEV, Olvi-Vec, cretostimogene grenadenorepvec, CAN-2409, pelareorep, LoAd703, CF33, Pexa-Vec (JX-594), SJ-600 and JX-900 series, UGN-501, and others
Study Period: 2022–2036
Analysis: Target patient pool, epidemiology, market size by therapy and indication, drug uptake, patient journey and biomarker testing, KOL views, SWOT, market access and reimbursement, unmet needs
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Table of Contents
Introduction
Executive Summary
Oncolytic Viruses: Overview
Pipeline Therapeutics
Therapeutic Assessment
DelveInsight’s Analytical Perspective
Late Stage Products (Phase III): Olvi-Vec (Genelux), Cretostimogene (CG Oncology), CAN-2409 (Candel Therapeutics)
Mid Stage Products (Phase II): Pelareorep (Oncolytics Biotech), LoAd703 (Lokon Pharma), CF33 (Imugene)
Early Stage Products (Phase I): UGN-501 (UroGen Pharma)
Preclinical and Discovery Stage Products
Inactive Products
Key Companies
Key Products
Unmet Needs
Market Drivers and Barriers
Future Perspectives and Conclusion
Analyst Views
Appendix
About Us
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