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溶瘤病毒免疫治療的全球市場：市場機會與臨床試驗趨勢（2030）

Global Oncolytic Virus Immunotherapy Market Opportunity & Clinical Trials Insight 2030

出版日期: 2024年05月01日 | 出版商:

KuicK Research | 英文 420 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄圖表

預計2030年，全球溶瘤病毒免疫治療市場規模將超過15億美元。

癌症是無情的敵人，為世界各地的病患和醫學界帶來課題。尋找創新和有針對性的治療方法來對抗這種多方面的疾病已經在癌症治療領域取得了顯著的進展。在許多新策略中，溶瘤病毒免疫療法作為一種有前景的癌症治療途徑最近引起了研究人員和臨床醫生的關注。溶瘤病毒免疫治療領域利用病毒的自然特性選擇性地靶向並破壞癌細胞，提供了一種獨特的、精準的治療方法。隨著這種治療範式從科學發現領域發展到商業潛力，它帶來了許多塑造商業市場動態的機會和課題。

迄今為止，三種藥物已被用於治療各種類型的癌症，包括頭頸癌、惡性黑色素瘤和惡性神經膠質瘤：Oncorin (H101)、Imlik (Talimogene laherparepvec) 和Tesel Paturev (G47-Delta; Delytact )。然而，Oncos 102、CAN-2409、Pelareorep、CG070和VG161等尖端溶瘤病毒免疫療法已獲得FDA和EMA等監管機構的快速通道、孤兒藥和PRIME指定，我們預計會看到更多。該領域的批准。

在臨床領域，溶癌病毒處於創新研究和治療開發的前沿。這些病毒經過精心設計或選擇，具有先天的溶瘤特性，可以滲透癌細胞，在癌細胞內複製，並在誘導癌細胞破壞的同時刺激免疫反應。此外，溶瘤病毒免疫治療領域從實驗室和臨床試驗進入商業領域的過程以製藥公司的參與為特徵，並且預計這將成為全球癌症治療領域的關鍵因素。

其他免疫療法的勝利，例如檢查點抑制劑和 CAR-T 細胞療法，引發了人們對利用免疫系統對抗癌症的濃厚興趣。溶瘤病毒免疫療法透過使用病毒刺激針對癌細胞的免疫反應來補充這些方法。這些免疫療法的正面結果激發了人們對利用免疫系統對抗癌症的興趣，從而促使對溶瘤病毒免疫療法作為補充和協同方法的研究增加。

因此，為了治療胰臟癌、胃腸道癌、乳癌等多種癌症亞型的患者，delolimogene mupadenorepvec和atezolizumab、OH2注射液和伊立替康、HX008、ADV/HSV-tk和Pembrolizumab正在進行多項研究，包括針對免疫檢查點受體和溶瘤病毒的各種類型抗體的組合，例如派姆單抗。

隨著製藥業投資、聯盟和合作夥伴關係的監管批准不斷增加，癌症溶細胞病毒免疫治療市場預計將在未來幾年進一步擴大和激增。截至2024 年5 月，各種類型的溶瘤病毒（例如單純皰疹病毒1 病毒(HSV-1) 和腺病毒）與化療相結合，以優化癌症治療、針對PD-1 和PD 的單株抗體的遞送和性能。

本報告審視了全球溶瘤病毒免疫治療市場，並提供了市場概況，包括藥物趨勢、臨床試驗趨勢、區域趨勢以及進入市場的公司競爭格局。

Global Oncolytic Virus Immunotherapy Therapy Market Opportunity: > USD 1.50 Billion By 2030
Oncolytic Viruses Immunotherapies Clinical Trials By Company, Indication & Phase
Comprehensive Insight On Oncolytic Virus Immunotherapies In Clinical Trials: > 180 Therapies
FDA & EMA Designations: Breakthrough Therapy, Fast Track, Orphan, PRIME
Patent Analysis Therapies in Clinical Trials
IMLYGIC, Oncorine, Delytact: Availability, Dosage and Price Analysis
Platforms Used For Developing Advanced Oncolytic Virus Immunotherapy

Cancer endures to be a relentless adversary, challenging both patients and the medical community across the world. The quest of innovative and targeted therapies to battle against this multifaceted disease has led to remarkable advancements in the field of cancer therapy. Amidst the many emerging strategies, oncolytic virus immunotherapy has captured the attention of researchers and clinicians as a promising avenue for cancer treatment in the recent years. The realm of oncolytic virus immunotherapy harnesses the natural characteristics of viruses to selectively target and destroy cancer cells, offering a unique and precision oriented approach to treatment. As this therapeutic paradigm progresses from the realm of scientific discovery to commercial viability, it brings forth a multitudinous of opportunities and challenges that shape the dynamics of the commercial market.

Hitherto, 3 oncolytic virus immunotherapies, namely Oncorine (H101), Imlygic (Talimogene laherparepvec), and teserpaturev (G47-Delta; Delytact), have been approved over the preceding decennium for the treatment of different types of cancer like head and neck cancer, melanoma and malignant glioma. However, it is expected that the domain will observe many more approvals in the upcoming years because of that fact that a handful of advanced oncolytic virus immunotherapies such as Oncos 102, CAN-2409, Pelareorep, CG070, VG161 have received designations like Fast Track, Orphan Drug, PRIME from regulatory agencies, FDA and EMA.

In the clinical field, oncolytic viruses are at the forefront of innovative research and therapeutic development. These viruses, carefully engineered or selected for their innate oncolytic properties, are designed to infiltrate cancer cells, replicate within them, and induce their destruction while simultaneously stimulating an immune response. Moreover, as the sphere of oncolytic virus immunotherapy surpasses the confines of laboratories and clinical trials, its journey into the commercial arena is characterized by an involvement of pharma companies that will aid to shape its trajectory in the global cancer treatment landscape.

The triumph of other immunotherapies, such as checkpoint inhibitors and CAR-T cell therapies, has generated considerable interest in harnessing the immune system to fight cancer. Oncolytic virus immunotherapy complements these approaches by utilizing viruses to stimulate an immune response against cancer cells. The positive outcomes from these immunotherapies have fueled interest in leveraging the immune system to combat cancer, leading to increased exploration of oncolytic virus immunotherapy as a complementary and synergistic approach.

On that account, multiple studies are ongoing in the clinical pipeline which comprise the combinations of oncolytic viruses with different types of antibodies targeting immune checkpoint receptors such as delolimogene mupadenorepvec with atezolizumab, OH2 injection, with or without irinotecan or HX008, ADV/HSV-tk with Pembrolizumab, for the treatment of patients suffering from wide array of cancer subtypes such as pancreatic cancer, Gastrointestinal Cancer, breast cancer etc.

Competition from the involvement of multitudinous pharmaceutical companies such as Merck, Bristol-Myers Squibb, Astellas Pharma, Roche, Lokon Pharma, NRG oncology, CG oncology, Genemedicine, Binhui Biopharmaceutical Barinthus Biotherapeutics, TILT Biotherapeutics, Genelux Corporation, Replimune, and Candel Therapeutics have created wave in the commercial market of oncolytic virus immunotherapy. As a result, the clinical development landscape will observed several pharmaceuticals companies commencing research in order to understand the oncolytic virus mode of actions which will aid to develop advanced and innovative oncolytic virus immunotherapy with least possible side effects.

It is projected that the market of oncolytic virus immunotherapy is poised to expand and multiply further in the forthcoming years due to the augmenting government regulatory approvals in conjugation with snow balling investments, collaborations and partnerships in the pharmaceutical sector. As of May 2024, the oncolytic virus is crowded by usage of different types of oncolytic virus like herpes simplex type-1 virus (HSV-1) or adenoviruses with or without chemotherapy, monoclonal antibodies directing against PD-1 and PD-L1 receptors, therapeutic peptide vaccines or nanoparticles in order to optimize delivery and performance for cancer treatments.

Currently, the US remains the market leader of the market as evident from rising collaborations, advancement and government bestow. The synergy between these clinical and commercial aspects propels the field forward, offering new expectation to cancer patients and shaping the future of cancer treatment. Continuous research, innovation, and collaboration are essential to sustaining this growth and realizing the full potential of oncolytic virus immunotherapy. As research further delves deeper into understanding the complexities of this innovative approach, there is optimism that oncolytic viruses will emerge as a valuable addition for cancer treatments, offering new avenues for improved outcomes and enhanced quality of life for patients.

1. Introduction to Oncolytic Virus Therapy

1.1 Overview
1.2 Need of Oncolytic Virus Immunotherapy

2. Globally Approved Oncolytic Virus Immunotherapies

2.1 Commercially Approved Therapies
2.2 FDA & EMA Designations: Breakthrough Therapy, Fast Track, Orphan, PRIME

3. Global Oncolytic Virus Immunotherapies Clinical Trials Overview

3.1 By Phase
3.2 By Country
3.3 By Company
3.4 By Indication
3.5 By Priority Status
3.6 Patient Segment

4. Global Oncolytic Virus Immunotherapy Market Trend & Developments

4.1 Current Market Outline
4.2 Future Market Forecast

5. Global Oncolytic Virus Immunotherapy Market Trends By Region

5.1 South Korea
5.2 Japan
5.3 US
5.4 Europe
5.5 UK
5.6 China
5.7 Australia

6. Global Oncolytic Virus Immunotherapy Market Trends By Indications

6.1 Melanoma
6.2 Head & Neck Cancer
6.3 Glioma
6.4 Pancreatic Cancer
6.5 Ovarian Cancer
6.6 Lymphoma
6.7 Lung Cancer
6.8 Breast Cancer
6.9 Prostate Cancer
6.10 Hepatocellular carcinoma

7. Global Oncolytic Viruses Immunotherapies Clinical Trials By Company, Indication & Phase

7.1 Research
7.2 Preclinical
7.3 Phase-I
7.4 Phase-I/II
7.5 Phase-II
7.6 Phase-III
7.7 Registered

8. Marketed Oncolytic Viruses Immunotherapies Clinical Insight

9. Global Oncolytic Virus Immunotherapy - Availability, Dosage & Price Analysis

9.1 Imlygic
- 9.1.1 Overview & Patent Insights
- 9.1.2 Pricing & Dosage
9.2 Oncorine (H101)
- 9.2.1 Overview
- 9.2.2 Pricing & Dosage
9.3 Delytact
- 9.3.1 Overview
- 9.3.2 Pricing & Dosage

10. Platforms used for Developing Advanced Oncolytic Virus Immunotherapy

10.1 KaliVir VET Backbone Technology
10.2 Calidi's Platform Technology
10.3 RenovoRx TAMP Platform
10.4 ValoTx PeptiCRAd
10.5 ValoTx PeptiVAX / PeptiENV / PeptiBAC
10.6 Transgene's Invir.IO Platform
10.7 Transgene's myvac Platform
10.8 Imugene's CF33 Technology
10.9 EpicentRx AdAPT Platform
10.10 Genelux's Choice Discovery Platform

11. Oncolytic Virus Immunotherapy Combinations with Other Therapeutic Agents

11.1 Oncolytic Virus Immunotherapy with Nano materials
11.2 Oncolytic Virus Immunotherapy with Chemotherapeutic Drugs
11.3 Oncolytic Virus Immunotherapy with Peptides
11.4 Oncolytic Virus Immunotherapy with Targeted Immunotherapies

12. Global Oncolytic Virus Immunotherapy Market Dynamics

12.1 Market Drivers
12.2 Market Challenges

13. Competitive Landscape

13.1 AdCure Bio
13.2 Beijing SyngenTech
13.3 BioVex Inc. (Amgen)
13.4 Calidi Biotherapeutics
13.5 Genelux Corporation
13.6 Immvira Pharma
13.7 Jennerex Biotherapeutics
13.8 KaliVir
13.9 Lokon Pharma
13.10 Oncolys BioPharma
13.11 PsiOxus Therapeutics (Akamis Bio)
13.12 Seneca Therapeutics
13.13 Shanghai Sunway Biotech
13.14 Takara Bio
13.15 TILT Biotherapeutics
13.16 Transgene
13.17 Virogin Biotech

簡介目錄圖表

List of Figures

Figure 1-1: Demonstration of Categorization of Oncolytic Viruses
Figure 1-2: Illustration of Major Events in Clinical Virotherapy
Figure 1-3: Comparison of Conventional Therapies v/s Oncolytic Virus Immunotherapy
Figure 1-4: Oncolytic Virus Immunotherapy - Advantages
Figure 3-1: Global - Oncolytic Virus Immunotherapies Clinical Trials By Phase (Numbers), 2024 -2030
Figure 3-2: Global - Oncolytic Virus Immunotherapies Clinical Trials By Country (Numbers), 2024 - 2030
Figure 3-3: Global - Oncolytic Virus Immunotherapies Clinical Trials By Company (Numbers), 2024 - 2030
Figure 3-4: Global - Oncolytic Virus Immunotherapies Clinical Trials By Indication (Numbers), 2024 - 2030
Figure 3-5: Global - Oncolytic Virus Immunotherapies Clinical Trials By Priority Status (Numbers), 2024 - 2030
Figure 3-6: Global - Oncolytic Virus Immunotherapies Clinical Trials By Patient Segment (Numbers), 2024 -2030
Figure 4-1: Global - Oncolytic Virus Immunotherapy Market Opportunity (US$ Million), 2023 -2030
Figure 4-2: Approved Oncolytic Virus Immunotherapy
Figure 4-3: Global Oncolytic Virus Immunotherapy Market - Key Players
Figure 4-4: Aspects Determining the Future of Oncolytic Virus Therapy Market
Figure 5-1: Barinthus Biotherapeutics - ChAdOx1-HBV & MVA-HBV Clinical Trials
Figure 5-2: GeneMedicine - Oncolytic Virus Pipeline
Figure 5-3: TBI-1401(HF10) Phase I Study - Initiation & Completion Year
Figure 5-4: Astellas Pharma - ASP1012
Figure 5-5: ASP1012 & Pembrolizumab Phase I Study - Initiation & Completion Year
Figure 5-6: CF33-hNIS-antiPDL Phase I Study - Initiation & Completion Year
Figure 5-7: Cretostimogene Grenadenorepvec Phase III Study - Initiation & Completion Year
Figure 5-8: Cretostimogene Grenadenorepvec FDA Designations to treat unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)
Figure 5-9: AdAPT-001 Phase I Study - Initiation & Completion Year
Figure 5-10: Pelareorep with INCMGA00012 Phase II Study - Initiation & Completion Year
Figure 5-11: Oncolytic Virus Immunotherapy Market Trend in the US
Figure 5-12: Aspects Influencing Oncolytic Virus Market in Europe
Figure 5-13: TILT-123 with Pembrolizumab Phase I Study - Initiation & Completion Year
Figure 5-14: BT-001 & Pembrolizumab Phase I Study - Initiation & Completion Year
Figure 5-15: Transgene - Oncolytic Virus Candidates
Figure 5-16: 21325-2-02 Phase IV Study - Initiation & Completion Year
Figure 5-17: OH2 - Combinations with Other Therapeutic Agents
Figure 5-18: VAXINIA - FDA Fast Track Designation
Figure 6-1: MQ710 & Pembrolizumab Phase I Study - Initiation & Completion Year
Figure 6-2: Combination of GALV-GP-R protein with PD1 antibody to Treat Melanoma
Figure 6-3: Replimune - Oncolytic Virus Candidates
Figure 6-4: Oncorine - Approved Oncolytic Virus Immunotherapy for Head & Neck Cancer
Figure 6-5: YSCH-01 Phase I Study - Initiation & Completion Year
Figure 6-6: Head & Neck Cancer - Clinical Pipeline of Oncolytic Viruses
Figure 6-7: Calidi Biotherapeutics - NSC.CRAd-S-pk7 for Glioblastoma
Figure 6-8: CRAd-S-pk7 Phase I Study - Initiation & Completion Year
Figure 6-9: CAN-3110 Phase I Study - Initiation & Completion Year
Figure 6-10: Pancreatic Cancer - Influencing Factors in Oncolytic Virus Immunotherapy Market
Figure 6-11: STI-1386 Phase I Study - Initiation & Completion Year
Figure 6-12: TBI-1401 (HF10) Phase I Study - Initiation & Completion Year
Figure 6-13: RenovoRx & Imugene - Collaboration
Figure 6-14: TILT-123 - Mode of Action
Figure 6-15: TILT-T563 Phase I Study - Initiation & Completion Year
Figure 6-16: Combinations of Oncolytic Virus with Other Therapies
Figure 6-17: Comparison of Olvi-Vec with Chemotherapy
Figure 6-18: RT-01 Phase I Study - Initiation & Completion Year
Figure 6-19: Advantages of Oncolytic Virus Immunotherapy to Treat Lymphoma
Figure 6-20: Lung Cancer - Commercial Market Landscape of Oncolytic Virus Immunotherapy
Figure 6-21: Pro2020000268 Phase II Study - Initiation & Completion Year
Figure 6-22: Combination of Radio Chemotherapeutic Drug with Oncolytic Virus
Figure 6-23: Prostate Cancer - Benefits of Oncology Virus Immunotherapy
Figure 6-24: HB-302/HB-301 Phase I/II Study - Initiation & Completion Year
Figure 6-25: CAN-2409 Phase III Study - Initiation & Completion Year
Figure 6-26: Reasons for Candel Therapeutics Decided to Reduce Staff
Figure 6-27: Pexavec - Mode of Action
Figure 6-28: OPTIONS-04 Phase III Study - Initiation & Completion Year
Figure 6-29: Replimune RP3 Oncolytic Virus Immunotherapy for Hepatocellular Carcinoma Treatment
Figure 9 -1: US - Cost of Supply of Imlygic 1 mpfu/mL & 100 mpfu/mL (US$), May'2024
Figure 9 -2: Imlygic - Dose for Initial Treatment Cycle & Subsequent Treatment Cycle (Million PFU/ml), September'2020
Figure 9 -3: Imlygic - Duration of Initial & Subsequent Treatment Cycle (weeks), September'2020
Figure 9 -4: Imlygic - Average Price of Initial Treatment Cycle & Each Subsequent Treatment Cycle (US$), September'2022
Figure 9 -5: Imlygic - Maximum Volume Administered by Size of Lesion (ml), September'2020
Figure 10-1: KaliVir Immunotherapeutics - VET Backbone Technology
Figure 10-2: Calidi Biotherapeutics Platform
Figure 10-3: ValoTx - PeptiCRAd
Figure 10-4: ValoTx - PeptiVAX / PeptiENV / PeptiBAC
Figure 10-5: Transgene - myvac
Figure 10-6: Genelux - Choice Discovery platform
Figure 11-1: Combination of Oncolytic Virus with Other Therapies
Figure 11-2: Combination of Oncolytic Virus Immunotherapy with Nano materials
Figure 11-3: Oncolytic Virus Immunotherapy & Nano materials - Mode of Action
Figure 11-4: Combination of Oncolytic Virus Immunotherapy with Peptides
Figure 12-1: Global Oncolytic Virus Immunotherapy - Market Drivers
Figure 12-2: Global Oncolytic Virus Immunotherapy - Market Challenges

List of Tables

Table 2-1: Approved Oncolytic Virus Immunotherapies
Table 5-1: US - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 5-2: Europe - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-1: Melanoma - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-2: Head & Neck Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-3: Glioma - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-4: Pancreatic Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-5: Ovarian Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-6: Lung Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 6-7: Breast Cancer - Ongoing Clinical Trials for Oncolytic Virus Immunotherapy
Table 9-1: Imlygic - Recommended Dose & Schedule