United States Oncolytic Virus Therapy Market to Reach USD 199.98 Million by 2033 | 24.9% CAGR | North America Leads with 45% Share | Key Players: Amgen, Shanghai Sunway Biotech, Daiichi Sankyo, Oncolytics Biotech

Oncolytic Virus Therapy Market Overview

The global oncolytic virus therapy market was valued at US$ 27.33 million in 2024 and is projected to reach US$ 199.98 million by 2033, expanding at a robust CAGR of 24.9% during the forecast period (2025-2033). The market's growth is primarily driven by advancements in viral engineering, expanding clinical pipelines, and the rising demand for targeted cancer therapies. Oncolytic virus therapy (OVT) represents a novel class of immuno-oncology treatments that utilize genetically engineered or naturally occurring viruses to selectively infect and destroy cancer cells while stimulating systemic anti-tumor immunity. Recent breakthroughs in synthetic biology and gene editing have enabled the development of viruses that can deliver therapeutic genes, express cytokines, and enhance immune checkpoint activity, thereby improving efficacy and safety.

The market is also benefitting from innovations in viral delivery mechanisms, which now allow systemic administration routes beyond traditional intratumoral injections. AI and computational biology are increasingly being used to optimize viral structures, predict immune responses, and accelerate candidate selection. Moreover, synergistic therapies that combine OVT with immune checkpoint inhibitors, CAR-T therapies, and radiotherapy are demonstrating strong clinical outcomes. Regulatory agencies such as the U.S. FDA and EMA are granting breakthrough and orphan drug designations to promising OVT candidates, expediting development timelines. Additionally, biopharmaceutical companies and CDMOs are expanding their manufacturing capabilities to meet rising demand for clinical and commercial production.

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Recent Developments:

✅ October 2025: Amgen Inc. announced positive Phase III clinical trial results for its oncolytic virus therapy Imlygic (Talimogene Laherparepvec) in combination with pembrolizumab (Keytruda), demonstrating improved overall survival rates in advanced melanoma patients.

✅ September 2025: Replimune Group, Inc. received FDA Fast Track Designation for RP2, a next-generation herpes simplex virus-based therapy engineered with anti-CTLA-4 and GM-CSF genes for enhanced immune activation against solid tumors.

✅ August 2025: Sorrento Therapeutics initiated Phase II trials for Seprehvir, its proprietary oncolytic HSV-1 therapy targeting pediatric neuroblastoma and glioma, supported by strong preclinical safety data.

✅ June 2025: Transgene SA announced a collaboration with Merck KGaA to develop an AI-assisted viral vector design platform, accelerating the creation of targeted oncolytic constructs for hepatocellular carcinoma and lung cancer.

✅ March 2025: Oncolys BioPharma launched a partnership with Chugai Pharmaceutical for the co-development of OBP-301 (Telomelysin), an oncolytic adenovirus therapy showing potential in esophageal and gastric cancers.

Mergers & Acquisitions:

✅ November 2025: Bristol Myers Squibb (BMS) acquired a biotech startup specializing in oncolytic vaccinia virus platforms, strengthening its immuno-oncology pipeline and expanding its viral immunotherapy capabilities.

✅ September 2025: Merck & Co., Inc. completed the acquisition of a UK-based oncolytic virus developer to integrate novel viral delivery systems into its cancer immunotherapy portfolio, enhancing synergy with its checkpoint inhibitors.

✅ July 2025: Roche Holding AG entered into a strategic merger with a clinical-stage virotherapy firm to co-develop next-generation oncolytic viruses expressing immune-stimulatory transgenes for combination cancer therapies.

✅ May 2025: Replimune Group, Inc. announced a partnership and minority acquisition deal with an AI-based drug discovery company to accelerate design and optimization of next-generation oncolytic constructs.

✅ March 2025: Takara Bio Inc. acquired a viral vector manufacturing company in Japan, expanding its GMP production capacity to support rising global demand for oncolytic virus and gene therapy programs.

Key Players:
Amgen | Shanghai Sunway Biotech | Daiichi Sankyo | Oncolytics Biotech | TILT Biotherapeutics | KaliVir Immunotherapeutics | Memgen | Candel Therapeutics | Genelux | CG Oncology

Key Highlights:

• Amgen - Holds a 22% market share, driven by its FDA-approved Imlygic (Talimogene Laherparepvec), the first commercially available oncolytic virus therapy. Amgen continues to expand its OVT pipeline through combination studies with checkpoint inhibitors and strategic collaborations.

• Shanghai Sunway Biotech - Holds a 15% share, leading the Asia-Pacific market with its H101 (Oncorine) adenovirus therapy, approved in China for head and neck cancers. The company is also advancing next-generation viral vectors targeting solid tumors.

• Daiichi Sankyo - Holds an 11% share, focusing on oncology partnerships and virus-based immunotherapy research aimed at enhancing immune modulation and viral selectivity for solid and hematological malignancies.

• Oncolytics Biotech - Holds a 10% share, recognized for its Reolysin (pelareorep) platform, which leverages the reovirus to activate anti-tumor immune responses and is being evaluated in breast and gastrointestinal cancers.

• TILT Biotherapeutics - Holds an 8% share, developing adenovirus-based OVTs expressing cytokines such as TNF-α and IL-2, with strong preclinical synergy shown alongside CAR-T and checkpoint therapies.

• KaliVir Immunotherapeutics - Holds a 7% share, specializing in engineered vaccinia virus platforms designed for systemic delivery and immune reprogramming in advanced solid tumors.

• Memgen - Holds a 6% share, pioneering Vesicular Stomatitis Virus (VSV)-based immuno-oncology treatments targeting tumor microenvironment modulation.

• Candel Therapeutics - Holds a 7% share, developing HSV-based oncolytic therapies such as CAN-2409, with promising data in prostate, brain, and pancreatic cancers.

• Genelux - Holds a 7% share, focusing on vaccinia virus-based therapies and advancing its lead candidate GL-ONC1, showing strong potential in ovarian and lung cancers.

• CG Oncology - Holds an 7% share, advancing CG0070, an oncolytic adenovirus therapy targeting non-muscle invasive bladder cancer, currently in late-stage clinical development.

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Market Segmentation:

➥ By drug, Imlygic (Talimogene Laherparepvec) dominates the market with approximately 45% share, as it remains the only FDA- and EMA-approved oncolytic virus therapy for advanced melanoma, developed by Amgen. Delytact (Teserpaturev), developed by Daiichi Sankyo, accounts for around 30%, primarily approved in Japan for malignant glioma and expanding rapidly in clinical research. Oncorine (H101) by Shanghai Sunway Biotech holds 25% share, leading the Asia-Pacific market with strong adoption in head and neck cancers and ongoing trials for other solid tumors.

➥ By virus type, Herpes Simplex Virus Type-1 (HSV-1) leads with approximately 50% share, owing to its genetic stability, large payload capacity, and strong immune activation potential, as used in Imlygic and Delytact. Adenovirus Type-5 accounts for 35%, driven by its broad tissue tropism and extensive use in Asian OVT pipelines, including Oncorine. Other viral platforms, such as reovirus, vaccinia virus, and vesicular stomatitis virus (VSV), collectively hold 15%, reflecting the early clinical development phase but significant potential for multi-cancer applications.

➥ By indication, unresectable melanoma dominates with 40% share, supported by extensive clinical data and regulatory approvals for Imlygic. Head and neck cancer accounts for 35%, propelled by Oncorine's therapeutic success in Asia. Malignant glioma represents 25%, largely driven by Delytact's growing clinical adoption in Japan and ongoing global trials targeting glioblastoma.

➥ By distribution channel, hospital pharmacies hold a commanding 70% share, given that oncolytic virus therapies require specialized administration, storage, and monitoring within hospital settings. Retail pharmacies account for 30%, primarily serving follow-up and supportive oncology care in advanced healthcare systems.

Regional Insights:

North America dominates the global oncolytic virus therapy market with an estimated 45% share, driven by early adoption of immuno-oncology therapies, strong R&D infrastructure, and supportive regulatory frameworks such as the FDA's Breakthrough Therapy Designation. The U.S. is the regional leader, fueled by the availability of advanced healthcare facilities, a large patient pool, and active clinical trial networks.

Asia-Pacific holds approximately 30% share, with China and Japan leading the adoption of oncolytic virus therapies. China's Oncorine (H101) and Japan's Delytact have created strong regional market penetration. Rapid government support for cancer immunotherapies, growing clinical trial activity, and increasing healthcare expenditure are key drivers in this region.

Europe accounts for around 20%, supported by regulatory approvals for Imlygic and ongoing trials of next-generation oncolytic viruses. Countries such as Germany, France, and the U.K. are focusing on advanced oncology research centers and hospital adoption of novel immunotherapies, boosting market growth.

Rest of the World (RoW) contributes the remaining 5%, with limited adoption due to infrastructure constraints, high therapy costs, and fewer clinical trials, although emerging markets in Latin America and the Middle East are beginning to invest in immuno-oncology infrastructure.

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Market Dynamics:

Drivers
The market growth is primarily driven by the rising prevalence of cancer globally, increasing demand for targeted immunotherapies, and advancements in viral engineering technologies. Oncolytic virus therapies (OVTs) offer dual action by directly lysing tumor cells and activating systemic anti-tumor immunity, making them highly attractive compared to conventional chemotherapy. The integration of AI and computational biology in viral design, coupled with combination therapies with checkpoint inhibitors, is accelerating clinical efficacy and adoption. Regulatory support, such as breakthrough therapy and orphan drug designations, is also facilitating faster market entry and clinical acceptance.

Restraints
High development and production costs, complex viral manufacturing processes, and stringent regulatory requirements can limit adoption. Additionally, safety concerns, such as off-target viral replication and immune-related adverse events, may slow clinician acceptance. Limited awareness in emerging markets and the need for specialized hospital infrastructure for administration are further challenges.

Opportunities
Significant opportunities exist in next-generation OVTs, including viruses engineered with cytokines, checkpoint inhibitors, or tumor-specific promoters. Expansion into emerging markets in Asia-Pacific and Latin America, where cancer incidence is rising, presents strong growth potential. Collaborations between biotech firms and AI platforms for precision viral design offer avenues for enhanced efficacy and broader therapeutic indications. Additionally, combination therapies with CAR-T cells, radiotherapy, and conventional immunotherapies open new revenue streams and clinical applications.

Trends
The market is witnessing a shift toward systemic administration of engineered viruses, replacing traditional intratumoral injections for deeper tissue penetration. Personalized oncolytic therapy, guided by tumor genomics and patient immune profiling, is gaining traction. There is increasing investor and governmental interest in expanding viral immunotherapy R&D, along with growth in CDMO capacity to meet global production demands. Sustainability in viral vector manufacturing and cost optimization in therapy delivery are also emerging trends shaping the market.

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