United States Oncolytic Viral Therapy Market is expected to reach US$ 3.7 Billion by 2033 | Major Companies - Amgen, Inc., Daiichi Sankyo Co., Ltd., Lokon Pharma AB.

Market Size and Growth:

The Oncolytic Viral Therapy Market Size reached US$ 24.48 Million in 2024 and is expected to reach US$ 164.51 Million by 2033, growing at a CAGR of 23.8% during the forecast period 2025-2033. The Market is growing rapidly due to increasing cancer prevalence and rising adoption of innovative immunotherapy treatments. According to DataM Intelligence

Get a Free Sample Research PDF: https://datamintelligence.com/download-sample/oncolytic-viral-therapy-market?sz

The Oncolytic Viral Therapy Market involves the development, production, and commercialization of viruses engineered to selectively infect and destroy cancer cells while stimulating anti-tumor immune responses. It encompasses innovative treatments, including genetically modified viruses, combination therapies, and delivery technologies, targeting various cancers to improve efficacy, safety, and patient outcomes, driving growth in personalized oncology therapeutics worldwide.

Industry Recent Developments: United States

✅ October 2025: Calidi Biotherapeutics' oncolytic virus CLD-201 received FDA fast track designation for treating soft tissue sarcoma. The virus is stem cell-loaded and has shown promising tumor reduction in clinical trials.

✅ September 2025: UroGen Pharma acquired IconOVir Bio's engineered oncolytic adenovirus ICVB-1042 for bladder cancer treatment. They have been working with the FDA for therapy approval.

✅ November 2025: Positive developments in combination therapies involving oncolytic viruses and immune checkpoint inhibitors or chemotherapy have been reported, showing enhanced anti-tumor immune responses and patient outcomes.

Industry Recent Developments: Japan

✅ September 2025: DELYTACT, the first third-generation oncolytic HSV-1, received conditional and temporary approval in Japan for treating malignant gliomas, based on Phase II clinical trials.

✅ November 2025: The Japanese healthcare ecosystem is integrating AI and machine learning to optimize oncolytic virus therapy through early detection, precise tumor characterization, and personalized treatments.

✅ October 2025: Japan hosted the International Conference on Oncolytic Virus Therapeutics (ICOVT) in Kyoto, focusing on advances in oncolytic viral therapies and their clinical applications.

Get Customization in the report as per your requirements: https://datamintelligence.com/customize/oncolytic-viral-therapy-market?sz

Key Regulatory Developments in 2025:

Oncovita - Orphan Drug Designation (ODD):

✅ Oncovita received FDA Orphan Drug Designation in June 2025 for its lead oncolytic candidate MVΔC for pleural mesothelioma.

✅ MVΔC is a genetically modified measles virus (Schwarz strain), engineered to selectively replicate in tumor cells and trigger immune responses.

✅ Orphan designation provides benefits like tax credits, waiver of application fees, and up to 7 years of market exclusivity if approved.

Calidi Biotherapeutics - Fast Track Designation for CLD-201:

✅ In July 2025, the FDA granted Fast Track designation to CLD-201 (SuperNova) for soft tissue sarcoma.

✅ CLD-201 is a first-in-class therapy: adipose-derived mesenchymal stem cells (AD‐MSCs) loaded with an oncolytic vaccinia virus.

✅ IND (Investigational New Drug) clearance for CLD-201 was announced in April 2025.

✅ According to OncLive, the planned Phase 1 trial will evaluate safety, tolerability, and efficacy in sarcoma, triple-negative breast cancer, and head & neck squamous cell carcinoma (HNSCC).

✅ The Fast Track status gives Calidi more frequent interactions with FDA and potential for priority review or accelerated approval (depending on future data).

Oncovirus Pipeline - Transgene / BioInvent Collaboration:

✅ Transgene and BioInvent are co-developing an oncolytic virus, BT-001, using Transgene's Invir.IO® platform.

✅ BT-001 encodes an anti-CTLA-4 antibody and GM‐CSF, aiming to modulate tumor microenvironment.

✅ Clinical data: in the Phase 1 part, BT-001 showed tolerability alone and in combination with pembrolizumab; there was evidence of converting "cold" tumors to "hot" (increased immune infiltration) in some patients.

Mergers & Acquisitions / Corporate Deals in 2025:

UroGen Pharma acquires IconOVir's Oncolytic Virus Assets:

✅ In Feb 2025, UroGen Pharma acquired ICVB‐1042, a next-generation oncolytic virus, from IconOVir Bio.

✅ The deal: ~US$ 4 million in UroGen stock as upfront payment, plus future milestones and royalties.

✅ UroGen assumed certain liabilities as part of the transaction.

✅ This expands UroGen's oncology / viral therapy pipeline, especially for locally administered therapies (e.g., for bladder cancer) given ICVB-1042's properties.

Platform and Strategic Collaborations:

✅ As mentioned, Transgene-BioInvent deal for BT-001 is a notable partnership in 2025.

✅ While not a full "acquisition," such collaborations are critical in this space because many oncolytic-virus companies rely on platforms + immune-oncology partners to bring therapies forward.

Major Key Players:

1. Amgen, Inc. - A leading U.S. biopharma company that develops, manufactures and markets innovative therapies for cancer, cardiovascular, bone, and inflammatory diseases.

2. Daiichi Sankyo Co., Ltd. - Japan's global pharmaceutical company with a strong R&D focus, especially in oncology, cardiovascular and autoimmune diseases.

3. Lokon Pharma AB - A Swedish biotech specializing in oncolytic adenoviruses engineered to express immunostimulatory genes, aiming to reshape the tumor microenvironment.

4. Vyriad, Inc. - Clinical-stage company based in Minnesota, developing oncolytic virus therapies (VSV and measles virus-based) for cancer treatment.

5. Transgene SA - A French biotech firm focused on immuno-oncology, developing therapeutic cancer vaccines and oncolytic viruses based on viral vector platforms.

6. Coastar Therapeutics Inc. - (Limited public information found) - A small biotech company that works on (presumably) viral-based therapeutics; lesser known compared to big pharmas but active in advanced biologic drug discovery.

Segments Covered in the Oncolytic Viral Therapy Market:

By Virus Type: Adenoviruses, Herpes Simplex Virus, Maraba Virus, Measles, Newcastle Disease Virus, Picornavirus, Reovirus, Vaccinia Virus, Vesicular Stomatitis Virus, Others.

By Application: Melanoma, Breast Cancer, Prostate Cancer, Ovarian Cancer, Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Head and Neck Cancer, Others.

By Mode of Administration: Intratumoral Injection, Intravenous Infusion, Intracavitary Injection, Others.

By End-User: Hospitals, Oncology Centers, Ambulatory Surgical Centers, Cancer Research Institutes, Others.

Regional Analysis for Oncolytic Viral Therapy Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Buy Now & Get 30% OFF - Grab 50% OFF on 2+ reports: https://www.datamintelligence.com/buy-now-page?report=oncolytic-viral-therapy-market

Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Oncolytic Viral Therapy market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Oncolytic Viral Therapy Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Oncolytic Viral Therapy market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Oncolytic Viral Therapy Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

Unlimited Insights. One Subscription: https://www.datamintelligence.com/reports-subscription

Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Oncolytic Viral Therapy market?

➠ Who are the global key manufacturers of the Oncolytic Viral Therapy Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Oncolytic Viral Therapy market opportunities and threats faced by the vendors in the global Oncolytic Viral Therapy Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Oncolytic Viral Therapy market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

Contact Us -
Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -
DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.
Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

This release was published on openPR.