종양용해성 바이러스 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy cancer cells. These viruses not only naturally target cancer but can also be engineered to deliver additional genes directly into cancer cells, enhancing their tumor-destroying capabilities.
• IMLYGIC is the first oncolytic virus that the US FDA approved for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery in 2015. In June 2021, DELYTACT (teserpaturev/G47delta; Daiichi Sankyo) received conditional and time-limited approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with malignant glioma.
• Oncolytic virus platforms currently under evaluation in clinical trials include adenovirus, herpes simplex virus, maraba virus, measles virus, Newcastle disease virus, picornavirus, reovirus, vaccinia virus, vesicular stomatitis virus and others.
• Positive clinical trial results, in treating melanomas, bladder cancer, Biliary Tract Cancer (BTC), glioblastoma, ovarian cancer, pancreatic cancers, and various other solid tumors, have significantly propelled the advancement of these emerging therapies.
• Consequently, the pipeline for OVTs is expanding rapidly, with companies such as Genelux (Olvi-Vec), Candel Therapeutics (CAN-2409), CG Oncology (Cretostimogene grenadenorepvec), Oncolytics Biotech (Pelareorep), Lokon Pharma (LoAd703), and Imugene (CF33), SillaJen (Pexa-Vec [JX-594]), and others continuing the development.
• Additionally, SillaJen is advancing a pipeline of next-generation oncolytic immunotherapies, including the SJ-600 and JX-900 series, as part of its ongoing efforts to develop innovative cancer treatments.

DelveInsight's "Oncolytic Viruses Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" report delivers an in-depth understanding of Oncolytic Viruses, addressable patient pool, competitive landscape, and future market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.

The Oncolytic Viruses market report provides insights around existing treatment practices in patients with Oncolytic Viruses, approved (if any) and emerging Oncolytic Viruses, market share of individual therapies, patient pool eligible for treatment with Oncolytic Viruses, along with current and forecasted 7MM Oncolytic Viruses market size from 2022-2036 by therapies and by indication. The report also covers current unmet needs and challenges while incorporating new classes in treatment paradigm, variations in accessibility and acceptability of new Oncolytic Viruses in different geographies, along with insights on Oncolytic Viruses pricing reimbursements to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain), and the UK
• Japan

Study Period: 2022-2036

Oncolytic Viruses Overview

Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy cancer cells. These viruses not only naturally target cancer but can also be engineered to deliver additional genes directly into cancer cells, enhancing their tumor-destroying capabilities.

Epidemiology Insights

• In the 7MM, the highest contribution in target patient pool was observed in the prostate cancer, approximately 49.50%, followed by the bladder cancer (40.04%) in 2025. These cases are expected to increase by 2036.
• Oncolytic virus therapies are primarily being developed to treat cancers in relapsed refractory settings. Consequently, these therapies could address nearly 20% of all cancer cases, providing a significant treatable patient pool.
• In 2025, approximately 303,000 people in the US were living with breast cancer. In 2025, treatment-eligible cases of HR+/HER2- breast cancer in the US were ~203,000 for total metastatic patients, ~12,700 for first-line, and ~9,000 for relapsed/refractory pool.
• Effective therapies for gastrointestinal cancers are scarce, with less than 12% of pancreatic cancer patients surviving beyond five years with the current standard-of-care.

Oncolytic Viruses Drug Chapters

The drug chapter segment of the Oncolytic Viruses report encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the Oncolytic Viruses clinical trial details, pharmacological action, agreements and collaborations related to Oncolytic Viruses, their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

Oncolytic Viruses Marketed Drugs

IMLYGIC: Amgen

IMLYGIC (T-VEC) by Amgen, the first oncolytic virus approved by the US FDA for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after the initial surgery in 2015. After few months, in December 2015, the European Commission (EC) also approved it for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC, and IVM1a), with no bone, brain, lung or other visceral diseases. It is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF).

DELYTACT: Daiichi Sankyo

DELYTACT is a triple-mutated, replication-conditional herpes simplex virus type 1 (HSV-1) that has been developed to replicate only in cancer cells. In 2021, it received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) to commercialize only at hospitals (served as trial sites) for the treatment of patients with malignant glioma. for a duration of 7 years.

Oncolytic Viruses Emerging Drugs

Olvi-Vec (Olvimulogene nanivacirepvec): Genelux

Olvi-Vec is a modified vaccinia virus that utilizes a triple mode of action: it directly kills cancer cells, stimulates a tumor-specific immune response, and converts the tumor microenvironment from an immunosuppressive (cold state) to an immunoreactive (hot state). Currently, it is in clinical development for the treatment of ovarian cancer (resistant/refractory), recurrent NSCLC, SCLC, and pancreatic cancer. In November 2023, Genelux announced that the US FDA granted FTD for the development program of olvi-vec for the treatment of patients with PRROC.

In June 2026, Genelux published Phase Ib/II VIRO-15 data for Olvi-Vec, an oncolytic vaccinia virus, combined with immunochemotherapy in heavily pretreated PRROC; findings supported immune activation and potential reversal of platinum resistance.

In March 2026, Genelux reported positive clinical progress for Olvi-Vec, with Phase III ovarian cancer topline data expected in 2H26, encouraging lung cancer results, and cash runway extending into 1Q27.

In March 2025, Genelux and Newsoara BioPharma announced preliminary safety and anti-tumor activity data from the dose escalation Phase Ib portion of the companies' co-sponsored ongoing Phase Ib/II clinical trial (OLVI-VEC-SCLC-202) of Olvi-Vec immunochemotherapy in patients with platinum-relapsed or platinum-refractory extensive SCLC.

Cretostimogene grenadenorepvec: CG Oncology

Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase III clinical trial for the treatment of Bacillus Calmette-Guerin (BCG)-unresponsive NMIBC. Cretostimogene is also being evaluated in a Phase III monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. The US FDA granted both FTD and BTD for cretostimogene grenadenorepvec in high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without Ta or T1 (papillary) tumors.

In August 2026, CG Oncology reported its second-quarter 2026 financial results and business updates; it highlighted the July publication of BOND-003 Cohort C results in The Lancet Oncology, supporting the clinical evidence for cretostimogene grenadenorepvec in high-risk, BCG-unresponsive NMIBC with carcinoma in situ.

In July 2026, CG Oncology published Phase III BOND-003 Cohort C results for cretostimogene grenadenorepvec, an intravesical oncolytic immunotherapy, in patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ. The therapy demonstrated a 75.5% CRR, with durable responses and a favorable safety profile.

Recent Developments in the Oncolytic Virus Therapy Market

• In August 2026, Replimune Group, Inc. announced that the FDA has granted accelerated approval to TUDRIQEVTM (vusolimogene oderparepvec-wtpg), formerly known as RP1, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed following treatment with an anti-PD-1 antibody-based regimen.
• In July 2026, UroGen Pharma Ltd. announced that the FDA has cleared its Investigational New Drug (IND) application for UGN-501, a next-generation investigational oncolytic virus. The IND clearance paves the way for the initiation of a planned Phase 1 clinical trial evaluating UGN-501 in patients with non-muscle invasive bladder cancer (NMIBC).
• In June 2026, Candel Therapeutics, Inc. initiated the global pivotal Phase 3 AURORA trial (NCT07660094) to evaluate aglatimagene besadenovec (aglatimagene; CAN-2409) plus valacyclovir alongside continued pembrolizumab treatment in patients with metastatic non-squamous NSCLC who experienced disease progression following pembrolizumab and platinum-based chemotherapy.
• In May 2026, CG Oncology reported positive Phase II CORE-008 Cohort CX results, with cretostimogene grenadenorepvec plus gemcitabine demonstrating encouraging high-grade event-free survival (HG-EFS), high complete response (CR) rates, and favorable tolerability in high-risk NMIBC patients. The data, which demonstrate encouraging HG-EFS, high CR rates, and a well-tolerated safety profile, were presented at the Society of Urologic Oncology (SUO) Session at the 2026 American Urological Association (AUA) Annual Meeting.
• In March 2026, Genelux reported positive clinical progress for Olvi-Vec, with Phase III ovarian cancer topline data expected in 2H26, encouraging lung cancer results, and cash runway extending into 1Q27.
• In February 2026, CG Oncology reported accelerated enrollment and an expedited Phase III (PIVOT-006) timeline in intermediate-risk NMIBC, with topline data expected in 1H26. The company also reported strong efficacy and durability data for cretostimogene across high-risk NMIBC cohorts, announced upcoming Phase II combination results with gemcitabine, and remains on track for a BLA submission in high-risk BCG-unresponsive NMIBC during 2026.

Drug Class Insights

The Drug Class Insights section will provide comprehensive information on Oncolytic Viruses as a class. This will include a broad overview of the class and its role in treating specific conditions. Insights may cover the historical clinical development of Oncolytic Viruses, their mechanism of action, their subtypes and future commercial prospects. Additionally, the section will provide detailed information about current trends, challenges, and future prospects for this class of drugs.

Oncolytic Viruses Market Outlook

The approval of IMLYGIC by the US FDA in 2015 marked the beginning of revenue generation in the oncolytic virus therapies domain in the US. In 2025, the US market generated approximately USD 100 million. With further approvals, the market is poised for significant growth.

Despite being the first in class, IMLYGIC's sales and revenue have been hindered due to its limited patient suitability (~10% of ineligible surgery patients) and lower efficacy compared to other melanoma immunotherapies, resulting in a modest market share in the 7MM throughout the forecast period.

The conditional and time-limited marketing approval of DELYTACT for 7 years in Japan, along with its current commercial availability limited to hospitals that served as trial sites, could initially constrain its sales and revenue potential.

Oncolytic Viruses Drugs Uptake

This section focuses on the uptake rate of potential Oncolytic Viruses already launched and expected to be launched in the market during 2020-2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Oncolytic Viruses Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Oncolytic Viruses Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Oncolytic Viruses.

KOL Views

To keep up with current and future market trends, we incorporate Key physicians, Therapy Area Researcher's, and other Industry Experts' opinions working in the domain through primary research to fill in the data gaps and validate our secondary research. 25+ Key Opinion Leaders (KOLs) were contacted for insights on Oncolytic Viruses' incorporation in the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the cost analysis and existing and evolving treatment landscape.

Market Access and Reimbursement

This section will include insights around the standard HTA pricing, recent reformations in 2024 and modifications in reimbursement process in the 7MM. For example, In the United States, a multi payer model exists when it comes to drug pricing regime, which is currently undergoing significant changes, with recent federal legislation, such as the Prescription Drug Pricing Reform provisions of the Inflation Reduction Act, significantly altering the pricing regime under certain federal programs. Whereas in Germany, the market access differs from the systems followed in many other countries as no pricing and reimbursement approval is required during launch of a new therapy.

Moreover, this section will also provide details on reimbursement of approved therapy, if any.

Scope of the Report:

• The report covers a segment of key events, an executive summary, target patient pool, epidemiology and market forecasts, information around patient journey and varying biomarker testing rates
• Additionally, an all-inclusive account of the current and emerging therapies drug chapters, insights on Oncolytic Viruses addressable patient pool
• A detailed review of the Oncolytic Viruses market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, and treatment preferences that help in shaping and driving the 7MM Oncolytic Viruses market.
• Market Size of Inhibitors by therapies and indication will be provided

Oncolytic Viruses Report Key Strengths

• 11 Years Oncolytic Viruses Market Forecast
• The 7MM Coverage
• Oncolytic Viruses Competitive Landscape of current and emerging therapies
• Oncolytic Viruses Total Addressable patient population
• Drugs Uptake and Key Market Forecast Assumptions
• Approved and Emerging therapy Profiles
• Physician's perspectives/KOL opinions
• Biomarker testing and Patient journey
• Qualitative Analysis (SWOT and Analyst Views)
• Oncolytic Viruses Market Size by therapy and indication
• Existing and Future Market Opportunity
• Unmet Needs

FAQs:

• What was the Oncolytic Viruses total market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2036? What are the contributing factors for Oncolytic Viruses market growth?
• Which KRAS Inhibitor is going to be the largest contributor by 2036?
• What is the market access and reimbursement scenario of Oncolytic Viruses?
• What are the pricing variations among different geographies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Oncolytic Viruses Market.
• Understand the existing Oncolytic Viruses market opportunities and future trends in varying geographies
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility and acceptability of emerging treatment options along with unmet need of current therapies
• Details on report methodology, top indications covered, market assumptions, patient journey and KOLs to strengthen the pharmaceutical companies' development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Oncolytic Viruses

4. Key Events

5. Oncolytic Viruses Market Overview At A Glance

• 5.1. Market Share (%) Distribution of Oncolytic Viruses By Therapy in 2025
• 5.2. Market Share (%) Distribution of Oncolytic Viruses By Therapy in 2036

6. Background And Overview

7. Target Population

8. Oncolytic Viruses Marketed Drugs

• 8.1. Key Competitors
  • 8.1.1. Product Description
  • 8.1.2. Regulatory Milestones
  • 8.1.3. Other Developmental Activities
  • 8.1.4. Ongoing Clinical Development
  • 8.1.5. Safety and Efficacy

9. Oncolytic Viruses Emerging Drugs

• 9.1. Key Competitors
  • 9.1.1. Product Description
  • 9.1.2. Other Development Activities
  • 9.1.3. Clinical Development
    • 9.1.3.1. Clinical Trials Information
  • 9.1.4. Safety and Efficacy

10. Oncolytic Viruses: The 7MM Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of Oncolytic Viruses in the 7MM
  • 10.4.1. Market Size of Oncolytic Viruses By Therapies In the 7MM
  • 10.4.2. Market Size of Oncolytic Viruses By Indication In the 7MM
• 10.6. United States Market
  • 10.6.1. Total Market Size of Oncolytic Viruses in the United States
  • 10.6.2. Market Size of Oncolytic Viruses By Therapies in the United States
• 10.7. EU4 and the UK Market
  • 10.7.1. Total Market Size of Oncolytic Viruses in EU4 and the UK
  • 10.7.2. Market Size of Oncolytic Viruses By Therapies in EU4 and the UK
• 10.8. Japan Market
  • 10.8.1. Total Market Size of Oncolytic Viruses in Japan
  • 10.8.2. Market Size of Oncolytic Viruses By Therapies in Japan

11. Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Market Access and Reimbursement

• 14.1. United States
  • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. United Kingdom
• 14.3. Japan
  • 14.3.1. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. Delveinsight Capabilities

17. Disclaimer

18. About DelveInsight