Oncolytic Virus Immunotherapy Strategic Research Business Report 2025: Market To Reach $429.1 Million By 2030 - Breakthrough Designation Status And Fast Track Approvals Accelerate Regulatory Momentum

(MENAFN- GlobeNewsWire - Nasdaq) Growth is fueled by advancements in molecular virology and gene editing, revitalizing oncolytic viruses as key cancer treatments. The report details market trends, drivers, and forecasts, offering insights into regional growth patterns, notably the U.S. and China's robust market expansion. It discusses regulatory impacts, especially recent global tariff changes, and highlights key players, such as Amgen Inc. and Merck & Co. Expand your strategic business outlook with comprehensive market analysis and actionable insights.

Dublin, June 05, 2025 (GLOBE NEWSWIRE) -- The "Oncolytic Virus Immunotherapy - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.
The global market for Oncolytic Virus Immunotherapy was valued at US$156.8 Million in 2024 and is projected to reach US$429.1 Million by 2030, growing at a CAGR of 18.3% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Oncolytic Virus Immunotherapy market.

Oncolytic virus immunotherapy is gaining renewed momentum in oncology as a dual-action therapeutic strategy that combines direct tumor lysis with immune system priming. These genetically engineered or naturally occurring viruses selectively infect and replicate in tumor cells, causing their destruction while releasing tumor-associated antigens that stimulate anti-cancer immune responses. Unlike traditional chemotherapy or radiation, oncolytic viruses act locally at the tumor site and systemically through immune activation, positioning them as versatile agents in both solid and hematologic malignancies.

What Is Powering Long-Term Growth and Scientific Innovation in the Oncolytic Virus Immunotherapy Market?
The growth in the oncolytic virus immunotherapy market is powered by a paradigm shift toward immune-driven cancer control, rising incidence of refractory tumors, and growing regulatory openness to gene-modified biologicals. Oncolytic viruses offer a platform approach with customizable payloads and delivery options, making them highly adaptable to evolving immuno-oncology landscapes. Their ability to initiate cold-to-hot tumor conversion addresses one of the biggest challenges in cancer immunotherapy today.
Pharmaceutical companies are accelerating R&D through collaborations with academic virologists, biotech firms, and clinical oncology networks. AI-driven viral vector design, CRISPR-enabled transgene integration, and intratumoral microdosing techniques are improving specificity and safety profiles. Investment in scalable manufacturing, lyophilized formulations, and cold-chain logistics is supporting broader market readiness. As personalized cancer vaccines and immune cell therapies gain traction, oncolytic viruses are poised to serve as immune amplifiers that bridge innate and adaptive response layers. The future of cancer immunotherapy will be increasingly shaped by these programmable, self-amplifying, and immune-sensitizing viral agents.
How Are Genetic Engineering and Combination Protocols Expanding the Potential of Oncolytic Virotherapy?
Recent breakthroughs in synthetic biology and vector engineering are significantly enhancing the safety, selectivity, and immune-stimulatory capabilities of oncolytic viruses. New viral constructs - based on herpes simplex virus (HSV), adenovirus, vaccinia virus, and reovirus - are being armed with immune-boosting transgenes such as GM-CSF, interleukins, or checkpoint blockade peptides. These modifications allow the virus to not only destroy tumor cells but also convert the tumor microenvironment (TME) into an immunologically active site.
Combination therapies are a major focus, with oncolytic viruses increasingly paired with immune checkpoint inhibitors (e.g., anti-PD-1/PD-L1), CAR-T therapies, or radiotherapy to overcome resistance mechanisms and enhance systemic anti-tumor responses. Intratumoral delivery methods, dose escalation protocols, and multi-site administration strategies are improving virus biodistribution and reducing off-target effects. Liquid biopsy and imaging biomarkers are being developed to monitor viral persistence, immune infiltration, and treatment response in real time. These advancements are transitioning oncolytic virotherapy from a niche modality into an integral component of multi-modal cancer treatment frameworks.
Which Tumor Types and Geographies Are Shaping the Clinical and Commercial Landscape for Oncolytic Viruses?
Solid tumors with immunosuppressive microenvironments - such as melanoma, glioblastoma, pancreatic cancer, and hepatocellular carcinoma - are prime candidates for oncolytic virotherapy. These cancers typically respond poorly to conventional therapies and often lack T-cell infiltration, which oncolytic viruses can help overcome. Hematologic malignancies like lymphoma and multiple myeloma are also being targeted through engineered viruses capable of engaging both innate and adaptive immunity.
North America leads clinical development, with the U.S. hosting the majority of early-phase and pivotal trials. The presence of major virotherapy developers, robust funding ecosystems, and an innovation-friendly regulatory environment accelerates translational progress. Europe follows with strong academic-industry partnerships and regulatory support through the EMA's Advanced Therapy Medicinal Product (ATMP) designation. Asia-Pacific is emerging as a competitive landscape, particularly in China, where biotech firms are investing heavily in oncolytic platforms and regulatory reforms are enabling faster trial initiation. Global oncology centers are increasingly integrating oncolytic viruses into compassionate use programs and combination trial protocols.
Report Scope

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as Amgen Inc., CG Oncology, Creative Biolabs, Daiichi Sankyo Co., Ltd., Genelux Corporation and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Key Insights:

• Market Growth: Understand the significant growth trajectory of the Herpes Simplex Virus segment, which is expected to reach US$189.7 Million by 2030 with a CAGR of a 18.6%. The Vaccinia Virus segment is also set to grow at 15.3% CAGR over the analysis period.
• Regional Analysis: Gain insights into the U.S. market, valued at $42.7 Million in 2024, and China, forecasted to grow at an impressive 24.8% CAGR to reach $99.7 Million by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Segments

• Type (Herpes Simplex Virus, Vaccinia Virus, Adenovirus, Reovirus, Other Types)
• Administration Route (Intratumoral Route, Intravenous Route)
• Application (Melanoma Application, Non-small Cell Lung Cancer Application, Pancreatic Cancer Application, Breast Cancer Application, Other Applications)

Tariff Impact Analysis: Key Insights for 2025
What's Included in This Edition:

• Tariff-adjusted market forecasts by region and segment
• Analysis of cost and supply chain implications by sourcing and trade exposure
• Strategic insights into geographic shifts

Buyers receive a free July 2025 update with:

• Finalized tariff impacts and new trade agreement effects
• Updated projections reflecting global sourcing and cost shifts
• Expanded country-specific coverage across the industry

Key Attributes:

Report Attribute	Details
No. of Pages	383
Forecast Period	2024 - 2030
Estimated Market Value (USD) in 2024	$156.8 Million
Forecasted Market Value (USD) by 2030	$429.1 Million
Compound Annual Growth Rate	18.3%
Regions Covered	Global

Key Topics Covered:
MARKET OVERVIEW

• Influencer Market Insights
• World Market Trajectories
• Impact of COVID-19 and a Looming Global Recession
• Oncolytic Virus Immunotherapy - Global Key Competitors Percentage Market Share in 2025 (E)
• Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2025 (E)

MARKET TRENDS & DRIVERS

• Rising Focus on Precision Oncology Spurs Development of Oncolytic Virus Platforms With Tumor Selectivity
• Expansion of Immunotherapy Research Pipelines Strengthens Business Case for Oncolytic Virus Modalities
• Increased Approval of Cancer Immunotherapies Throws the Spotlight on Next-Generation Viral Vectors
• Breakthrough Designation Status and Fast Track Approvals Accelerate Regulatory Momentum
• Advancements in Genetic Engineering of Viruses Drive Enhanced Tumor Targeting and Immune Activation
• Surge in Clinical Trials Combining Oncolytic Viruses With Checkpoint Inhibitors Expands Therapeutic Horizons
• Increased Use of Oncolytic Viruses as Neoadjuvant Therapies Supports Multimodal Cancer Management
• Growing Investment From Biopharma and Venture Capital Enhances Innovation and Clinical Translation
• Development of Tumor-Specific Viral Payloads Strengthens Oncolytic Virus Selectivity and Safety Profiles
• Adoption of Intratumoral and Systemic Delivery Routes Expands Accessibility to Diverse Tumor Types
• Improved Understanding of Tumor Microenvironment Enhances Viral Mechanism Optimization
• Collaborative Efforts Between Academia and Industry Propel Translational Research in Viral Oncology
• Expansion of Cold Chain Logistics Infrastructure Supports Global Supply of Virus-Based Therapies
• Public and Philanthropic Funding for Rare Cancer Treatment Drives Orphan Application Development
• Manufacturing Scale-Up of Viral Vectors Remains a Bottleneck for Commercialization Readiness
• Development of Immune Response Biomarkers Facilitates Patient Selection and Treatment Monitoring
• Increased Advocacy for Personalized Cancer Immunotherapy Supports Patient Enrollment in Viral Trials
• Challenges in Viral Shedding and Immunogenicity Highlight Need for Improved Safety Profiling
• Rising Global Cancer Incidence and Limited Success in Refractory Cancers Propel Need for Disruptive Modalities
• Regulatory Alignment on Gene and Virus Therapies Enhances Global Clinical Trial Harmonization

FOCUS ON SELECT PLAYERS: Some of the 41 companies featured in this report

• Amgen Inc.
• CG Oncology
• Creative Biolabs
• Daiichi Sankyo Co., Ltd.
• Genelux Corporation
• ImmVirX
• Imugene Limited
• Lokon Pharma AB
• Merck & Co., Inc.
• Oncolys BioPharma Inc.
• Oncolytics Biotech Inc.
• Oncorus Inc.
• Replimune Group Inc.
• SillaJen, Inc.
• Sorrento Therapeutics, Inc.
• Syneos Health, Inc.
• TILT Biotherapeutics Ltd.
• Transgene S.A.
• Viralytics Ltd.
• ViraTherapeutics GmbH

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