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全球溶瘤病毒免疫療法市場：市場機會、技術平台、已批准療法劑量、定價及臨床試驗展望（至2031年）

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

出版日期: 2026年03月01日 | 出版商:

KuicK Research | 英文 410 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

全球溶瘤病毒免疫療法市場機會、技術平台、已批准療法劑量、定價及臨床試驗洞察2031年報告的主要發現和亮點：

到2031年，全球溶瘤病毒免疫療法市場機會：超過 50億美元
已核准的溶瘤病毒免疫療法數量：3 種
已批准溶瘤病毒免疫療法的可用性、劑量和定價分析
本報告涵蓋的溶瘤病毒免疫療法臨床試驗：超過 150 種
依公司、適應症和臨床試驗類型劃分的溶瘤病毒免疫療法臨床試驗洞察階段
市售溶瘤病毒免疫療法的臨床現狀
溶瘤病毒免疫療法開發中使用的專有平台：本報告涵蓋超過15種
溶瘤病毒免疫療法與其他治療藥物合併應用概述

溶瘤病毒免疫療法的必要性及本報告的意義

溶瘤病毒免疫療法是腫瘤免疫學領域最令人振奮且發展最快的治療選擇之一。溶瘤病毒能夠選擇性地感染、複製和破壞腫瘤細胞，同時誘導全身性抗腫瘤免疫反應，其治療潛力已廣泛研究。然而，由於腫瘤學領域目前面臨許多挑戰，例如腫瘤異質性、免疫逃脫機制以及對傳統治療方案日益增強的抗藥性，傳統的單一標靶或單機制腫瘤藥物開發方法正變得越來越不適用。溶瘤病毒的雙重作用機制，即透過直接溶解腫瘤細胞和活化免疫系統發揮作用，為應對腫瘤學領域的複雜挑戰提供了差異化的治療機會。

溶瘤病毒療法的臨床有效性已通過多種溶瘤病毒藥物的批准得到證實，例如中國的Oncoline、美國和歐盟的Imligic以及日本的Delitac。除了已核准的溶瘤病毒藥物外，目前全球還有大量溶瘤病毒藥物臨床試驗中，這些藥物單獨或與免疫檢查點抑制劑和細胞療法共同開發，用於治療黑色素瘤、膠質母細胞瘤、頭頸癌、肺癌和其他實體腫瘤。

本報告對全球溶瘤病毒免疫療法市場進行了全面、前瞻性的分析。報告分析了溶瘤病毒免疫療法市場的臨床、監管、技術和策略格局，以及競爭格局。隨著多種溶瘤病毒藥物進入中後期臨床試驗，競爭格局發生顯著變化。

本報告包含的臨床試驗洞察

溶瘤病毒免疫療法市場成長和發展的關鍵因素之一是臨床開發，這將繼續在市場的成熟過程中發揮關鍵作用。因此，目前進行各種臨床試驗，以評估安全性、最佳化給藥方案、比較全身性和腫瘤內給藥途徑，並評估其在多種腫瘤適應症中的治療效果。本報告全面系統性地闡述了從早期首次人體臨床試驗到後期驗證性試驗的臨床試驗情況。

溶瘤病毒免疫療法藥物臨床試驗和開發的關鍵方面之一是Replimune Group, Inc.的RP1（也稱為vusolimogene oderparepvec）。它目前正處於後期臨床開發階段，與免疫檢查點抑制劑聯合用於治療晚期黑色素瘤患者。儘管監管流程複雜且包括大量審查，但持續的對話和第三期臨床試驗的確認是人們對溶瘤病毒免疫療法藥物及其在未來腫瘤治療方案中的作用信心日益增強的重要指標。

活躍於溶瘤病毒免疫療法研發領域的主要公司

溶瘤病毒免疫療法市場的競爭格局由眾多生技公司和跨國製藥公司共同塑造。生物技術公司在病毒載體和基因有效載荷技術的創新和進步方面處於領先地位，而跨國製藥公司也致力於拓展其自主研發的溶瘤病毒免疫療法產品組合。

Merck & Co.、Bristol-Myers Squibb、Astellas Pharma、Roche等企業在免疫療法領域佔據戰略地位，其中許多公司已經在評估和開發基於病毒的解決方案。同時，Calidi Biotherapeutics, Inc.、Lokon Pharma、TILT Biotherapeutics、Genelux Corporation、Candel Therapeutics 和 Imugene Limited 等生物技術公司開發創新病毒載體和新型免疫刺激有效載荷。

這些因素，加上科學創新、策略聯盟和全球臨床部署，為免疫療法的發展創造了令人振奮的環境。亞洲新進業者的崛起也促進了下一代腺病毒和幹細胞衍生病毒載體的開發，進一步豐富了競爭格局。

技術平台、合作關係與協定

溶瘤病毒免疫療法的開發需要先進的技術平台，這些平台可用於最佳化病毒特異性、刺激免疫系統、改進生產流程並增強病毒的系統穩定性。各公司正致力於開發可用於插入免疫刺激基因（例如細胞激素和免疫檢查點抑制劑）的專有技術平台。

策略聯盟已成為免疫療法領域的關鍵特徵。生技公司與大型製藥公司之間的合作有助於成本分攤、拓展臨床能力並加快監管審批流程。例如，Carivia Immunotherapeutics 已與Roche公司合作，以評估病毒療法與現有免疫療法的聯合應用。澳洲生物技術公司 Imugene Limited 與中國生物技術公司 JW Therapeutics 的合作也表明，人們對將病毒療法與 CAR-T 細胞療法相結合的興趣日益濃厚。

生產合作也非常重要，尤其是在 GMP 規模下生產病毒面臨許多技術挑戰的情況下。此類合作在研發和商業化規劃過程中變得越來越重要。這些合作將共同促進平台模組化，並加速向臨床應用的過渡。

報告揭示溶瘤病毒免疫療法領域未來發展方向

報告也指出，關鍵的溶瘤病毒免疫療法候選藥物有望進入後期研發階段。此外，關鍵的臨床結果有望成為溶瘤病毒免疫療法領域發展和應用的重要轉捩點。同時，聯合療法的研發預計將持續擴展，溶瘤病毒免疫療法作為一種免疫誘導劑，在癌症治療的多維度方法中具有巨大潛力，未來或將成為主要的癌症治療選擇。

溶瘤病毒免疫療法領域的未來發展和研究可能側重於最佳化全身給藥方法、開發增強型免疫載荷以及開發用於識別合適癌症患者群體的生物標記。總而言之，監管支持機制的建立、機構對該領域的投資增加以及產業合作的建立，有望促進溶瘤病毒免疫療法的未來發展和廣泛應用。這很可能使溶瘤病毒免疫療法在未來成為全球癌症治療領域不可或缺乏的一部分。

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

簡介目錄圖表

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.

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

簡介目錄圖表

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