The oncolytic virus cancer therapy market is poised for significant growth, driven by increasing research and development of genetically engineered viruses that selectively target and destroy cancer cells while stimulating anti-tumor immune responses. The expanding clinical pipeline of therapies such as Cretostimogene grenadenorepvec (CG Oncology), CAN-2409 (Candel Therapeutics), AdAPT-001 (EpicentRx), LOAd703 (Lokon Pharma), RP1 (Replimune), VG 161 (Virogin Biotech), RP2 (Replimune), and others are expected to further accelerate market growth.
LAS VEGAS, Aug. 26, 2026 /PRNewswire/ -- DelveInsight's Oncolytic Virus Cancer Therapy Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Melanoma, Biliary Tract Cancer, Head and Neck Cancer, Pancreatic Cancer, NSCLC, Hepatocellular Carcinoma, Breast Cancer, Prostate Cancer, Brain Cancer, Bladder Cancer, Ovarian Cancer, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging oncolytic virus cancer therapy, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets (the US, EU4, UK, and Japan).
Key Takeaways from the Oncolytic Virus Cancer Therapy Market Report
- The market size for oncolytic virus cancer therapy was found to be USD 177 million in the 7MM in 2025.
- The United States accounted for the largest oncolytic virus immunotherapy market size of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- The report provides the total potential number of patients in the indications, such as Melanoma, Biliary Tract Cancer, Head and Neck Cancer, Pancreatic Cancer, NSCLC, Hepatocellular Carcinoma, Breast Cancer, Prostate Cancer, Brain Cancer, Bladder Cancer, Ovarian Cancer, and others.
- 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.
- Leading oncolytic virus companies, such as CG Oncology, Candel Therapeutics, EpicentRx, Lokon Pharma, Replimune, Virogin Biotech, Binhui Bio, Genelux, Imugene, BioInvent, Transgene, Oncolytics Biotech, and others, are developing novel oncolytic virus cancer therapies that can be available in the oncolytic virus therapy market in the coming years.
- Some of the key oncolytic virus cancer therapies in clinical trials include Cretostimogene grenadenorepvec, CAN-2409, AdAPT-001, LOAd703, RP1, RP2, VG 161, BS001, Olvi-Vec, CF33, BT-001, TG6050, Pelareorep, and others.
Discover real-time oncolytic virus analysis @ https://www.delveinsight.com/report-store/oncolytic-virus-cancer-therapy-market
Key Factors Driving the Oncolytic Virus Cancer Therapy Market
- Growing Adoption of Novel Cancer Immunotherapies: The increasing shift toward innovative immuno-oncology approaches is driving interest in oncolytic virus therapies. These treatments can selectively infect and destroy tumor cells while also stimulating broader antitumor immune responses.
- Rising Cancer Burden Worldwide: The growing incidence of cancer and the need for more effective treatment options are creating demand for alternative therapeutic modalities. Oncolytic viruses offer a promising approach, particularly for patients with advanced or treatment-resistant cancers.
- Advancements in Viral Engineering Technologies: Progress in genetic engineering is enabling the development of more targeted and potent oncolytic viruses. Researchers can modify viral platforms to improve tumor selectivity, enhance immune activation, and deliver therapeutic genes directly to cancer cells.
- Increasing Clinical Development and Pipeline Activity: Pharmaceutical and biotechnology companies are expanding their oncolytic virus therapy pipelines across multiple tumor types. Growing clinical trial activity of therapies such as Cretostimogene grenadenorepvec (CG Oncology), CAN-2409 (Candel Therapeutics), AdAPT-001 (EpicentRx), LOAd703 (Lokon Pharma), RP1 (Replimune), VG 161 (Virogin Biotech), and others, and encouraging efficacy data are supporting greater investment and market interest.
Aparna Thakur, an oncology expert at DelveInsight, said that with ongoing advancements and strategic collaborations, oncolytic viruses are positioned to play a pivotal role in the future of oncology, providing patients with new hope and facilitating the development of more effective and personalized cancer therapies.
Oncolytic Virus Cancer Therapy Market Analysis
- Oncolytic viruses represent a promising immunotherapeutic approach in which viruses are used to selectively infect and eliminate cancer cells. Beyond their inherent tumor-targeting properties, these viruses can be genetically engineered to introduce therapeutic genes into malignant cells, thereby enhancing their antitumor activity.
- In 2015, IMLYGIC became the first oncolytic virus to receive U.S. FDA approval for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that had recurred following initial surgery.
- Subsequently, in June 2021, DELYTACT (teserpaturev/G47∆; Daiichi Sankyo) obtained conditional and time-limited approval from Japan's Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with malignant glioma.
- A diverse range of oncolytic virus platforms is currently being investigated in clinical development, including adenoviruses, herpes simplex viruses, Maraba viruses, measles viruses, Newcastle disease viruses, picornaviruses, reoviruses, vaccinia viruses, vesicular stomatitis viruses, and other viral platforms.
- Encouraging clinical trial outcomes across multiple cancer types, including melanoma, bladder cancer, biliary tract cancer (BTC), glioblastoma, ovarian cancer, pancreatic cancer, and other solid tumors, have further accelerated interest in and development of these emerging therapeutic modalities.
- As a result, the oncolytic virus therapy (OVT) pipeline is expanding rapidly, with companies such as Genelux (Olvi-Vec), Candel Therapeutics (CAN-2409), CG Oncology (cretostimogene grenadenorepvec), Oncolytics Biotech (pelareorep), Replimune (RP1), Lokon Pharma (LoAd703), Imugene (CF33), and SillaJen (Pexa-Vec [JX-594]) advancing candidates through clinical development.
- In parallel, SillaJen is progressing next-generation oncolytic immunotherapy candidates, including the SJ-600 and JX-900 series, further highlighting ongoing efforts to develop innovative virus-based treatments for cancer.
Learn more about the hydroxychloroquine oncolytic virus cancer therapy @ Oncolytic Virus Analytics
Oncolytic Virus Cancer Therapy Competitive Landscape
Some of the oncolytic viruses under development include Cretostimogene grenadenorepvec (CG Oncology), CAN-2409 (Candel Therapeutics), AdAPT-001 (EpicentRx), LOAd703 (Lokon Pharma), RP1 (Replimune), VG 161 (Virogin Biotech), RP2 (Replimune), BS001 (Binhui Bio), Olvi-Vec (Genelux), CF33 (Imugene), BT-001 (BioInvent/Transgene), TG6050 (Transgene), Pelareorep (Oncolytics Biotech), and others.
Genelux's Olvi-Vec is a genetically modified vaccinia virus with a triple mechanism of action. It directly targets and destroys cancer cells, activates a tumor-specific immune response, and transforms the tumor microenvironment from an immunosuppressive 'cold' state into an immunoreactive 'hot' state. The therapy is currently under clinical development for several cancers, including platinum-resistant/refractory ovarian cancer, recurrent non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and pancreatic cancer. In November 2023, Genelux announced that the US FDA had granted Fast Track Designation (FTD) to olvi-vec for its development in patients with platinum-resistant/refractory ovarian cancer.
CG Oncology's Cretostimogene is an investigational oncolytic immunotherapy administered intravesically and is being studied in the Phase III BOND-003 trial for patients with Bacillus Calmette–Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC). It is also being evaluated as a monotherapy in the Phase III PIVOT-006 trial for patients with intermediate-risk NMIBC. The US FDA has granted both Fast Track Designation (FTD) and Breakthrough Therapy Designation (BTD) to cretostimogene grenadenorepvec for the treatment of high-risk, BCG-unresponsive NMIBC with carcinoma in situ, with or without Ta or T1 papillary tumors.
BioInvent/Transgene's BT-001 is a drug candidate being developed through a collaboration with French biotechnology company Transgene. It is an oncolytic virus engineered to deliver BioInvent's anti-CTLA-4 antibody directly within tumors. By releasing the antibody locally as the virus infects tumor cells, BT-001 is designed to enhance tumor-targeted activity while potentially reducing systemic side effects. The candidate is currently being investigated in combination with pembrolizumab in a Phase 1/2a clinical trial.
The anticipated launch of these emerging therapies are poised to transform the oncolytic virus market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the oncolytic virus cancer therapy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about oncolytic virus therapies developers companies, visit @ Oncolytic Virus Landscape
Recent Developments in the Oncolytic Virus Cancer 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.
Oncolytic Virus Cancer Therapy Epidemiology Segmentation
The oncolytic virus market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2022–2036 across the leading markets. 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.
The oncolytic virus cancer therapy target patient pool is segmented into:
- Total Cases of Selected Cancer Types
- Target Patient Pool of OVTs by Cancer Types
- Treated Cases by Cancer Types
Oncolytic Virus Cancer Therapy Report Metrics |
Details |
Study Period |
2022–2036 |
Oncolytic Virus Cancer Therapy Report Coverage |
7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
Key Indications Covered in the Report |
Melanoma, Biliary Tract Cancer, Head and Neck Cancer, Pancreatic Cancer, NSCLC, Hepatocellular Carcinoma, Breast Cancer, Prostate Cancer, Brain Cancer, Bladder Cancer, Ovarian Cancer, and others |
Oncolytic Virus Therapies Market Size in 2025 |
USD 177 Million |
Key Oncolytic Virus Companies |
CG Oncology, Candel Therapeutics, EpicentRx, Lokon Pharma, Replimune, Virogin Biotech, Binhui Bio, Genelux, Imugene, BioInvent, Transgene, Oncolytics Biotech, Amgen, Daiichi Sankyo, and others |
Key Oncolytic Virus Cancer Therapy |
Cretostimogene grenadenorepvec, CAN-2409, AdAPT-001, LOAd703, RP1, RP2, VG 161, BS001, Olvi-Vec, CF33, BT-001, TG6050, Pelareorep, IMLYGIC, DELYTACT, and others |
Scope of the Oncolytic Virus Cancer Therapy Market Report
- Oncolytic Virus Cancer Therapy Patient Population Forecast
- Oncolytic Virus Cancer Therapy Therapeutics Market Size
- Oncolytic Virus Cancer Therapy Pipeline Analysis
- Oncolytic Virus Cancer Therapy Market Size and Trends
- Oncolytic Virus Cancer Therapy Market Opportunity
- Oncolytic Virus Cancer Therapy Market Unmet Needs
- KOL's Views on Oncolytic Virus Cancer Therapy
- Oncolytic Virus Cancer Therapy Market Access and Reimbursement
Discover the oncolytic virus manufacturing analytics @ Oncolytic Virus Cancer Therapy Clinical Trials
Table of Contents
1 |
Oncolytic Virus Cancer Therapy Market Key Insights |
2 |
Oncolytic Virus Cancer Therapy Market Report Introduction |
3 |
Executive Summary of Oncolytic Virus Therapies |
4 |
Key Events |
5 |
Epidemiology and Market Forecast Methodology |
6 |
Oncolytic Virus Therapies Market Overview at a Glance in the 7MM |
6.1 |
Market Share (%) Distribution by Therapies in 2025 |
6.2 |
Market Share (%) Distribution by Therapies in 2036 |
7 |
Background and Overview |
7.1 |
Introduction |
7.2 |
Different Types of Oncolytic Viruses |
7.3 |
Application of Oncolytic Viruses |
7.4 |
Multiple Mechanisms of Action of OVTs for Cancer Therapy |
7.5 |
Routes of Administration |
8 |
Epidemiology and Target Patient Pool |
8.1 |
Key Findings |
8.2 |
Assumptions and Rationale: 7MM |
8.3 |
Epidemiology Scenario in the 7MM |
8.3.1 |
Target Patient Pool of OVTs by Cancer Types in the 7MM |
8.4 |
The United States |
8.4.1 |
Total Cases of Selected Cancer Types in the United States |
8.4.2 |
Target Patient Pool of OVTs by Cancer Types in the United States |
8.4.3 |
Treated Cases by Cancer Types in the United States |
8.5 |
EU4 and the UK |
8.6 |
Japan |
9 |
Marketed Oncolytic Viruses |
9.1 |
Marketed Competitive Landscape of Oncolytic Virus Cancer Therapy (OVTs) |
9.2 |
IMLYGIC (talimogene laherparepvec): Amgen |
9.2.1 |
Product Description |
9.2.2 |
Regulatory Milestones |
9.2.3 |
Others Developmental Activities |
9.2.4 |
Ongoing Clinical Developmental Activities |
9.2.4.1 |
Clinical Trial Information |
9.2.5 |
Safety and Efficacy |
9.2.6 |
Analyst Views |
9.3 |
DELYTACT (G47Δ): Daiichi Sankyo |
10 |
Emerging Oncolytic Viruses |
10.1 |
Emerging Competitive Landscape of Oncolytic Virus Cancer Therapy (OVTs) |
10.2 |
Olvi-Vec: Genelux |
10.2.1 |
Product Description |
10.2.2 |
Other Developmental Activity |
10.2.3 |
Clinical Developmental Activities |
10.2.3.1 |
Clinical Trial Information |
10.2.4 |
Safety and Efficacy |
10.2.5 |
Analyst Views |
10.3 |
CAN-2409: Candel Therapeutics |
10.4 |
RP1: Replimune |
10.5 |
Pelareorep: Oncolytics Biotech |
10.6 |
Cretostimogene grenadenorepvec: CG Oncology |
10.7 |
CAN-3110: Candel Therapeutics |
10.8 |
LoAd703: Lokon Pharma |
10.9 |
CF33: Imugene |
List to be continued… |
|
11 |
Oncolytic Virus Market: 7MM analysis |
11.1 |
Key Findings |
11.2 |
Oncolytic Virus Cancer Therapy Market Outlook |
11.3 |
Conjoint Analysis |
11.4 |
Key Oncolytic Virus Cancer Therapy Market Forecast Assumptions |
11.5 |
Market Size by Indications in the 7MM |
11.6 |
Market Size by Therapies in the 7MM |
11.7 |
United States Oncolytic Virus Cancer Therapy Market Size |
11.7.1 |
Market Size by Indications in the US |
11.7.2 |
Market Size by Therapies in the US |
11.8 |
EU4 and the UK Oncolytic Virus Cancer Therapy Market Size |
11.9 |
Japan Oncolytic Virus Cancer Therapy Market Size |
12 |
Unmet Needs |
13 |
SWOT Analysis |
14 |
KOL Views |
15 |
Market Access and Reimbursement |
15.1 |
United States |
15.2 |
EU4 and the UK |
15.3 |
Japan |
15.4 |
Summary and Comparison of Market Access and Pricing Policy Developments in 2025 |
15.5 |
Oncolytic Virus Therapies: Market Access and Reimbursement |
16 |
Bibliography |
17 |
Oncolytic Virus Cancer Therapy Market Report Methodology |
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