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PUBLISHER: KuicK Research | PRODUCT CODE: 1962957

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PUBLISHER: KuicK Research | PRODUCT CODE: 1962957

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

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

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
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