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Oncolytic Virus Immunotherapy Market Opportunity, Technology Platforms, Approved Therapy Dosage, Price & Clinical Trials Insight 2031

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    Report

  • 410 Pages
  • March 2026
  • Region: Global
  • Kuick Research
  • ID: 6233651

Report Findings & Highlights:

  • Global Oncolytic Virus Immunotherapy Market Opportunity by 2031: > USD 5 Billion
  • Number of Approved Oncolytic Virus Immunotherapies: 3 Therapies
  • Approved Oncolytic Virus Immunotherapy Availability, Dosage & Price Analysis
  • Oncolytic Viruses Immunotherapies in Clinical Trials Included in the Report: > 150 Therapies
  • Insight on Oncolytic Viruses Immunotherapies in Clinical Trials by Company, Indication & Phase
  • Marketed Oncolytic Viruses Immunotherapies Clinical
  • Proprietary Platforms Used for Developing Oncolytic Virus Immunotherapy: > 15 in Report
  • Oncolytic Virus Immunotherapy Combinations With Other Therapeutic Agents Overview

Need for Oncolytic Virus Immunotherapy & Why This Report?

Oncolytic virus immunotherapy is one of the most exciting and rapidly advancing therapeutic options within the immuno oncology space. The therapeutic potential of oncolytic viruses, which selectively infect, replicate, and destroy tumor cells while generating systemic anti-tumor immune responses, has been extensively studied. With the challenges that the oncology therapeutic space is currently facing, from tumor heterogeneity to immune escape mechanisms, and the rise of resistance to conventional therapeutic options, the traditional single-target or single mechanism approaches to oncology drug development have become increasingly inadequate. The dual mechanism of oncolytic viruses, which work through direct tumor lysis and immune system activation, offers a differentiated therapeutic opportunity to address the complex challenges of oncology.

The clinical validity of this therapeutic modality has been proved through the approval of oncolytic virus-based therapies like Oncorine in China, Imlygic in the US and EU, and Delytact in Japan. In addition to the approved oncolytic virus-based drugs, there is a significant global pipeline of oncolytic virus-based drugs currently under clinical investigation for the treatment of melanoma, glioma, head and neck cancer, lung cancer, and other solid tumors, alone or in combination with immune checkpoint inhibitors and cell therapy.

This report is a comprehensive and forward looking report on the global oncolytic virus immunotherapy market. It analyzes the clinical, regulatory, technology, and strategic landscape of the oncolytic virus immunotherapy market, and the competitive dynamics of the oncolytic virus market that is currently undergoing significant change with the initiation of several oncolytic virus-based drugs into the mid and late stages of clinical trials.

Clinical Trials Insight Included in the Report

One of the significant aspects of the growth and development of the oncolytic virus immunotherapy market is clinical development and how it will continue to play an important role in the maturation of the market itself. As such, various clinical trials are currently underway and are assessing safety, dosing regimen optimization, systemic versus intratumoral delivery routes of administration, and therapeutic activity across a wide range of different oncology indications. Our report provides a comprehensive and structured understanding of clinical trials from first-in-human early-stage clinical trials through to late-stage confirmatory trials.

One of the significant aspects of clinical trials and their role in the development of oncolytic virus immunotherapy drugs is RP1 or vusolimogene oderparepvec by Replimune Group, Inc., currently undergoing late-stage clinical development in combination with checkpoint inhibitors in patients with advanced melanoma. Although it must be said that regulatory processes are complex and involve significant review processes, ongoing dialogue and confirmation of Phase 3 clinical trials are a significant indicator of the growing credibility of oncolytic virus immunotherapy drugs and their role in the future of oncology treatment protocols.

Major Companies Active in the R&D of Oncolytic Virus Immunotherapies

The competitive landscape of the oncolytic virus immunotherapy market is dominated by a wide range of different biotechnology innovators and multinational pharmaceutical corporations. While it must be said that biotechnology firms have led the way in terms of innovation and advancements in viral backbone and genetic payload technology, multinational pharmaceutical corporations are increasingly looking to develop and expand their own portfolios of oncolytic virus immunotherapy drugs.

Companies such as Merck & Co., Bristol-Myers Squibb, Astellas Pharma, and Roche are strategically placed in the immunotherapy landscape, with many already evaluating or working on viral-based solutions. On the other hand, biotechnology companies such as Calidi Biotherapeutics, Inc., Lokon Pharma, TILT Biotherapeutics, Genelux Corporation, Candel Therapeutics, and Imugene Limited are working on innovative viral vectors and novel immune stimulatory payloads.

This creates an exciting environment for the development of immunotherapies, with elements of scientific innovation, strategic partnership, and clinical expansion across the world. The emergence of new players in Asia is also contributing to the development of the next generation of adenoviral vectors as well as stem cell-derived viral vectors, thus diversifying the competitive landscape.

Technology Platforms, Collaborations & Agreements

The development of oncolytic virus immunotherapies requires sophisticated technology platforms that can be utilized for the optimization of the specificity of the viruses, the stimulation of the immune system, the manufacturing process, as well as the systemic stability of the viruses. Companies are increasingly focusing on developing proprietary technology platforms that can be utilized for the insertion of immune-stimulatory genes such as cytokines or checkpoint inhibitors.

Strategic partnerships have become an important characteristic of the immunotherapy landscape. The partnerships between biotechnology companies and large pharmaceutical companies facilitate the sharing of costs, expansion of clinical capabilities, as well as the acceleration of the regulatory process. For instance, KaliVir Immunotherapeutics, Inc. has entered into a partnership with Roche for the evaluation of the viral therapy with existing immunotherapies. The partnerships between companies such as Imugene Limited, an Australian biotech, and JW Therapeutics, a Chinese biotech, also illustrate the increased interest in the combination of viral therapies with CAR-T cell therapies.

Manufacturing partnerships are also important, especially due to the technical challenge of viral production at GMP scale. Such partnerships are becoming increasingly integral to the development and commercialization planning process. These partnerships will collectively help to support the modularity of the platforms and speed up the process of translating them into the clinic.

Report Indicating Future Direction of the Oncolytic Virus Immunotherapy Segment

The report also indicates that the leading oncolytic virus immunotherapy candidates are likely to move into the late-stage development pipeline in the future. Moreover, the key clinical results are likely to be major inflection points in the development and acceptance of the oncolytic virus immunotherapy segment in the future. Additionally, the development of combination strategies is likely to continue to expand in the future, which may result in oncolytic virus immunotherapy becoming the prime choice in the treatment of cancer in the future due to its ability to be used as an immune primer in the multidimensional treatment of cancer.

The future development and research in the oncolytic virus immunotherapy segment are likely to be directed towards the optimization of systemic delivery, the development of enhanced immune payloads, and the development of biomarkers to identify the right kind of cancer patients in the future. Overall, the future development and acceptance of the oncolytic virus immunotherapy segment are likely to be supported through the development of regulatory support mechanisms, the increasing trend of institutional investment in the sector, and the development of partnerships in the sector, which is likely to result in the oncolytic virus immunotherapy segment becoming an integral part of the global cancer treatment sector in the future.

Table of Contents

1. Research Methodology
2. Introduction to Oncolytic Virus Therapy
2.1 Overview
2.2 Need for Oncolytic Virus Immunotherapy
3. Globally Approved Oncolytic Virus Immunotherapies
3.1 Commercially Approved Therapies
3.2 Regulatory Designations: Breakthrough Therapy, Fast Track, Orphan, PRIME,
RMAT, RPDD
4. Global Oncolytic Virus Immunotherapy Market Trend & Developments
4.1 Current Market Outline
4.2 Future Market Opportunities
5. Global Oncolytic Virus Immunotherapies Clinical Trials Overview
5.1 by Phase
5.2 by Country
5.3 by Company
5.4 by Indication
5.5 by Priority Status
6. Global Oncolytic Virus Immunotherapies Clinical Trials by Company, Indication & Phase
6.1 Research
6.2 Preclinical
6.3 Phase 0
6.4 Phase I
6.5 Phase I/II
6.6 Phase II
6.7 Phase II/III
6.8 Phase III
6.9 Registered
7. Marketed Oncolytic Virus Immunotherapies Clinical Insight
8. Global Oncolytic Virus Immunotherapy Market Trends by Region
8.1 US
8.2 Europe
8.3 South Korea
8.4 Japan
8.5 Australia
8.6 UK
8.7 China
9. Global Oncolytic Virus Immunotherapy Market Trends by Indications
9.1 Melanoma
9.2 Head & Neck Cancer
9.3 Brain Cancers
9.4 Gynecological Cancers
9.5 Hematological Malignancies
9.6 Lung Cancer
9.7 Pancreatic Cancer
9.8 Breast Cancer
9.9 Prostate Cancer
9.10 Hepatocellular Carcinoma
10. Global Oncolytic Virus Immunotherapy - Availability, Dosage & Price Analysis
10.1 Imlygic
10.1.1 Overview & Patent Insights
10.1.2 Pricing & Dosage
10.2 Oncorine (H101)
10.2.1 Overview
10.2.2 Pricing & Dosage
10.3 Delytact
10.3.1 Overview
10.3.2 Pricing & Dosage
11. Platforms Used for Developing Advanced Oncolytic Virus Immunotherapy
12. Oncolytic Virus Immunotherapy Combinations With Other Therapeutic Agents
12.1 Oncolytic Virus Immunotherapy With Nanomaterials
12.2 Oncolytic Virus Immunotherapy With Chemotherapy
12.3 Oncolytic Virus Immunotherapy With Immunotherapy
12.4 Oncolytic Virus Immunotherapy With Epigenetic Therapy
13. Global Oncolytic Virus Immunotherapy Market Dynamics
13.1 Market Drivers
13.2 Market Challenges
14. Competitive Landscape
14.1 AdCure Bio
14.2 Adze Biotechnology
14.3 Akamis Bio
14.4 Beijing SyngenTech
14.5 Beijing WellGene Biotech
14.6 BioVex Inc. (Amgen)
14.7 Calidi Biotherapeutics
14.8 Creative Biolabs
14.9 Genelux Corporation
14.10 Immvira Pharma
14.11 KaliVir
14.12 Lokon Pharma
14.13 Oncolys BioPharma
14.14 Seneca Therapeutics
14.15 Shanghai Sunway Biotech
14.16 SillaJen Biotherapeutics
14.17 Takara Bio
14.18 TILT Biotherapeutics
14.19 Transgene
14.20 Virogin Biotech
List of Tables
Table 2-1: Comparison of Conventional Therapy vs Oncolytic Virotherapy
Table 2-2: Oncolytic Virotherapy - Advantages & Challenges
Table 2-3: Why Cancer Cells Are More Susceptible to Oncolytic Viruses
Table 3-1: Approved Oncolytic Virus Immunotherapies
Table 3-2: Oncolytic Virus Therapies Granted Regulatory Designations
Table 10-1: Imlygic - Recommended Dose & Schedule
Table 12-1: Oncolytic Virus & Nanomaterial Combination Therapy - Advantages
Table 12-2: How Chemotherapy Enhances Oncolytic Virus Therapy
Table 12-3: Immunotherapeutic Modalities Combined With Oncolytic Viruses
Table 12-4: Epigenetic Therapy & Oncolytic Viruses Combination - Advantages
List of Figures
Figure 2-1: Oncolytic Viruses - Mechanism of Action
Figure 2-2: Categorization of Oncolytic Viruses
Figure 2-3: Illustration of Major Events in Clinical Virotherapy
Figure 2-4: Transition From Natural Infection to Genetic Engineering
Figure 2-5: Tumor Immune “Field-Like” Defense & Viral Counteraction
Figure 2-6: Oncolytic Virus Immunotherapy - Double-Edged Sword Model
Figure 5-1: Global - Oncolytic Virus Immunotherapies Clinical Trials by Phase (Numbers), 2026 -2031
Figure 5-2: Global - Oncolytic Virus Immunotherapies Clinical Trials by Country (Numbers), 2026 2031
Figure 5-3: Global - Oncolytic Virus Immunotherapies Clinical Trials by Company (Numbers), 2026 2031
Figure 5-4: Global - Oncolytic Virus Immunotherapies Clinical Trials by Indication (Numbers), 2026 - 2031
Figure 5-5: Global - Oncolytic Virus Immunotherapies Clinical Trials by Priority Status (Numbers), 2026 - 2031
Figure 9-1: HCC 22-138 Phase I Study (NCT06216938) - Initiation & Completion Year
Figure 9-2: IGNYTE Phase II Study (NCT03767348) - Initiation & Completion Year
Figure 9-3: IGNYTE-3 Phase III Study (NCT06264180) - Initiation & Completion Year
Figure 9-4: ARTACUS Phase I/II Study (NCT04349436) - Initiation & Completion Year
Figure 9-5: OH2-I-ST-01 Phase I/II Study (NCT04386967) - Initiation & Completion Year
Figure 9-6: 16-557 Phase I Study (NCT03152318) - Initiation & Completion Year
Figure 9-7: Ad5-TD-nsIL-12 Phase I Study (NCT05717712) - Initiation & Completion Year
Figure 9-8: Ad-TD-nsIL12 Phase I Study (NCT05717699) - Initiation & Completion Year
Figure 9-9: OnPrime Phase III Study (NCT05281471) - Initiation & Completion Year
Figure 9-10: TILT-123 - Mode of Action
Figure 9-11: PROTA Phase I/II Study (NCT05271318) - Initiation & Completion Year
Figure 9-12: VM-002-101 Phase I Study (NCT06910657) - Initiation & Completion Year
Figure 9-13: STEALTH-001 Phase I Study (NCT06444815) - Initiation & Completion Year
Figure 9-14: NCI-2017-00049 Phase I Study (NCT06508463) - Initiation & Completion Year
Figure 9-15: NCI-2017-00049 Phase I Study (NCI-2017-00049) - Initiation & Completion Year
Figure 9-16: 2026-0013 Phase I Study (NCT07398963) - Initiation & Completion Year
Figure 9-17: LuTK02 Phase II Study (NCT04495153) - Initiation & Completion Year
Figure 9-18: Tilt-T610 Phase I Study (NCT06125197) - Initiation & Completion Year
Figure 9-19: VIRO-25 Phase II Study (NCT06463665) - Initiation & Completion Year
Figure 9-20: RADNET Phase I/II Study (NCT02749331) - Initiation & Completion Year
Figure 9-21: GOBLET Phase II Study (NCT07280377) - Initiation & Completion Year
Figure 9-22: TBI1401-03 Phase I Study (NCT03252808) - Initiation & Completion Year
Figure 9-23: MCC-18621 Phase I/II Study (NCT02779855) - Initiation & Completion Year
Figure 9-24: NCI-2020-02940 Phase II Study (NCT04445844) - Initiation & Completion Year
Figure 9-25: BRACELET-1 Phase II Study (NCT04215146) - Initiation & Completion Year
Figure 9-26: PrTK03 Phase III Study (NCT01436968) - Initiation & Completion Year
Figure 9-27: VM-002-101 Phase I Study (NCT06910657) - Initiation & Completion Year
Figure 9-28: VG161-C102 Phase I Study (NCT04806464) - Initiation & Completion Year
Figure 9-29: VG161-A201 Phase II Study (NCT05223816) - Initiation & Completion Year
Figure 9-30: VG161-C203 Phase I/II Study (NCT06124001) - Initiation & Completion Year
Figure 9-31: RP2-003 Phase II Study (NCT05733598) - Initiation & Completion Year
Figure 9-32: CHN-PLAGH-BT-096 Phase I Study (NCT07018518) - Initiation & Completion Year
Figure 9-33: GONGCHU Phase I Study (NCT06508307) - Initiation & Completion Year
Figure 10-1: US - Cost of Supply of c 1 mpfu/mL & 100 mpfu/mL (US$), May’2024
Figure 10-2: Imlygic - Dose for Initial Treatment Cycle & Subsequent Treatment Cycle (Million PFU/ml)
Figure 10-3: Imlygic - Duration of Initial & Subsequent Treatment Cycle (weeks)
Figure 10-4: Imlygic - Average Price of Initial Treatment Cycle & Each Subsequent Treatment Cycle (US$)
Figure 10-5: Imlygic - Maximum Volume Administered by Size of Lesion (ml)
Figure 11-1: Calidi Biotherapeutics Platform
Figure 11-2: Candel Therapeutics - enLIGHTEN
Figure 11-3: Codagenix - Core Concept
Figure 11-4: Codagenix OV Platform Manufacturing Benefitrs
Figure 11-5: Genelux - Choice Discovery platform
Figure 11-6: Imugene - OnCARlytics
Figure 11-7: KaliVir Immunotherapeutics - VET Backbone Technology
Figure 11-8: Lokon Pharma - LOAd Technology
Figure 11-9: SyngenTech - Synthetic Gene Circuit
Figure 11-10: SyngenTech - Synov OV Platform
Figure 11-11: ValoTx - PeptiCRAd
Figure 11-12: ValoTx - PeptiENV
Figure 11-13: ValoTx - PeptiVAX / PeptiENV / PeptiBAC
Figure 11-14: Virogin - Transcription & Translation Dual Regulation backbone
Figure 11-15: Virogin in Situ Personalized Tumor Vaccine - Abscopal effect
Figure 11-16: Vyriad - Oncolytic Virus Platforms
Figure 12-1: Combination of Oncolytic Virus With Other Therapies
Figure 12-2: Combination of Oncolytic Virus Immunotherapy With Nanomaterials
Figure 12-3: Oncolytic Virus Immunotherapy & Nanomaterials - Mode of Action
Figure 13-1: Global Oncolytic Virus Immunotherapy - Market Drivers
Figure 13-2: Global Oncolytic Virus Immunotherapy - Market Challenges

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • AdCure Bio
  • Adze Biotechnology
  • Akamis Bio
  • Beijing SyngenTech
  • Beijing WellGene Biotech
  • BioVex Inc. (Amgen)
  • Calidi Biotherapeutics
  • Creative Biolabs
  • Genelux Corporation
  • Immvira Pharma
  • KaliVir
  • Lokon Pharma
  • Oncolys BioPharma
  • Seneca Therapeutics
  • Shanghai Sunway Biotech
  • SillaJen Biotherapeutics
  • Takara Bio
  • TILT Biotherapeutics
  • Transgene
  • Virogin Biotech