ONCOLYTIC VIRUS THERAPY MARKET ANALYSIS

The global market for oncolytic virus therapy is projected to experience substantial growth, with an estimated value of US$ 46.1 Mn by 2030. This represents a significant increase from US$ 9.4 Mn in 2023, reflecting a remarkable compound annual growth rate (CAGR) of 25.5% during the period of 2023-2030. The anticipated growth is driven by advancements in the field, increasing adoption of oncolytic virus therapy, and its potential to revolutionize cancer treatment approaches. For instance, in April 2021, Elicera Therapeutics, a clinical phase cell and gene therapy company that develops immunooncological treatments focusing on CAR T cells and oncolytic viruses, announced that it had filed a patent application to protect the development of its drug candidate, ELC- 201, a next generation of oncolytic virus. ELC-201 is the second oncolytic virus in Elicera Therapeutic's product portfolio. It is based on an adenovirus that has been genetically modified in a way that makes the treatment applicable to most cancers, and the patent application protects the application of two more genetic modifications in combination that together give the drug candidate three mechanisms of action.

Oncolytic virus therapy is a promising approach to cancer treatment that utilizes modified viruses to selectively target and destroy cancer cells while minimizing harm to healthy cells. This innovative therapy holds great potential for various cancer types, including melanoma, lung, breast, and pancreatic cancer. The market's expansion is driven by advancements in viral engineering, an improved understanding of cancer biology, and positive outcomes from clinical trials.

Ongoing research efforts and collaborations among pharmaceutical companies and academic institutions are fostering the development of new oncolytic virus therapies, offering the potential for groundbreaking advancements in cancer treatment and enhanced patient outcomes.

Oncolytic Virus Therapy Market Regional Insights

• North America: North America, primarily the U.S., has emerged as a leading region for oncolytic virus therapy research and development. The region benefits from a well-established infrastructure for conducting clinical trials, strong collaborations between academia and industry, and supportive regulatory frameworks that foster innovation. Numerous clinical trials have been initiated, and certain oncolytic virus therapies have received approval in North America. This region holds a significant market share, estimated to be around 33.5%. For instance, in November 2021, City of Hope, a world-renowned research and treatment organization for cancer, diabetes and other life-threatening diseases, announced the opening of a first-in-human clinical trial evaluating the use of a cancer-killing oncolytic virus to treat patients with metastatic triple-negative breast cancer. The City of Hope-developed therapy, CF33-hNIS-antiPDL1, is genetically engineered from a naturally occurring virus (chimeric oncolytic orthopoxvirus). The patents covering CF33-hNIS-antiPDL1 have been licensed to Imugene Limited, a company developing immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. CF33-hNIS-antiPDL1 is designed to infect, replicate in and kill cancer cells while sparing healthy cells.
• Europe: Europe has also demonstrated considerable interest in oncolytic virus therapy. Several Europe countries such as Germany, UK and others are actively participate in clinical trials and research programs focused on the development and evaluation of oncolytic viruses as cancer treatments. Regulatory agencies in Europe have established pathways for the approval and commercialization of oncolytic virus therapies, enabling their availability in certain markets. Europe accounts for approximately 30.7% of the market share.
• Asia Pacific: The Asia Pacific region, including countries like Japan, China, and South Korea, has exhibited a growing interest in oncolytic virus therapy. Research institutions and pharmaceutical companies in this region have played an active role in conducting clinical trials and forming collaborations to explore the efficacy of oncolytic viruses for cancer treatment. Regulatory frameworks in select Asian countries have also supported the progress of oncolytic virus therapies. Moreover, increasing drug approvals in the region is expected to boost the growth of the market over the forecast period. Asia Pacific represents approximately 16.8% of the market share. For instance, in June 2021, Daiichi Sankyo Company, Limited, a pharmaceutical company, announced that it had received conditional and time-limited approval from the Japan Ministry of Health, Labour, and Welfare (MHLW) for DELYTACT (teserpaturev/G47∆), an oncolytic virus, for the treatment of patients with malignant glioma.

Analyst View: Increasing adoption of technology by market players, growing inorganic growth strategies by market players and increasing product launches will drive the growth of the global oncolytic virus therpay market. For instance, in December 2022, Ferring Pharmaceuticals, a pharmaceutical company, announced the U.S. Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg), a novel adenovirus vector-based gene therapy, for the treatment of adult patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Figure 1. Global Oncolytic Virus Therapy Market Share (%), by Region, 2023

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Oncolytic Virus Therapy Market Drivers:

• Advancements in Viral Engineering: Advancements in viral engineering are allowing for more precise and targeted oncolytic virus therapies, which is significantly contributing to the growth of the global oncolytic virus therapy market. Scientists are learning to genetically modify viruses to better detect and destroy cancer cells while avoiding healthy tissue. This allows the viruses to spread within the tumor and induce cancer cell death more effectively. For example, researchers have modified the herpes simplex virus to insert genetic sequences that program the virus to selectively replicate inside cancers. In preclinical research, this modified herpes virus showed highly targeted cytotoxicity against various cancers, like melanoma, without toxic effects in normal cells.
• Increasing Understanding of Cancer Biology: Oncolytic virus therapy takes advantage of the unique characteristics of cancer cells, such as their susceptibility to viral infection and impaired antiviral responses. The growing knowledge of cancer biology has facilitated the development of oncolytic virus therapies that can selectively target and destroy cancer cells while sparing normal healthy cells.
• Successful Clinical Trial Results: Positive results from clinical trials have generated excitement and momentum in the oncolytic virus therapy field. Promising outcomes, including tumor regression and increased survival rates, have been observed in patients treated with oncolytic viruses. These encouraging clinical trial results have contributed to the growing interest and investment in this therapeutic approach. For instance, in April 2022, Mustang Bio, Inc., a clinical-stage biopharmaceutical company, announced its plan to initiate a Phase I clinical trial combining CAR T cells and oncolytic virus for the treatment of recurrent glioblastoma (rGBM), supported by interim data from two ongoing investigator-sponsored Phase 1 clinical trials evaluating two clinical candidates, MB-108 (C134 oncolytic virus) and MB‐101 (City of Hope’s IL13Rα2‐targeted CAR T cell therapy). Preclinical data also presented supports the safety of administering these two therapies sequentially in a regimen designated as MB-109. The data are from a late-breaking poster at the American Association for Cancer Research (“AACR”) Annual Meeting 2022.
• Need for Innovative Cancer Treatments: There is a significant unmet need for effective and targeted cancer treatments. Conventional therapies such as chemotherapy and radiation can have limitations and adverse side effects. Oncolytic virus therapy offers a novel and potentially more targeted approach to cancer treatment, addressing the need for innovative and personalized therapies.

Oncolytic Virus Therapy Market Opportunities:

• Expansion of Indications: There is a vast potential for oncolytic virus therapy to be explored in various cancer types and indications. As research and clinical trials progress, there are opportunities to expand the use of oncolytic viruses beyond the current indications and explore their efficacy in different cancer subtypes and stages.
• Combination Therapies: Oncolytic virus therapy can be combined with other treatment modalities such as chemotherapy, immunotherapy, or targeted therapies to enhance treatment outcomes. The synergistic effects of combining oncolytic viruses with other therapies have shown promise in preclinical and clinical studies. Exploring and optimizing combination therapies can lead to improved patient responses and better treatment outcomes.
• Personalized Medicine: Oncolytic virus therapy has the potential to be tailored to individual patients based on their specific cancer characteristics. The ability to customize the oncolytic viruses to target specific genetic alterations or biomarkers in tumors can enhance treatment efficacy and minimize off-target effects. Personalized medicine approaches offer opportunities for more precise and effective cancer treatment.
• Development of Next-Generation Viruses: Advancements in viral engineering and genetic modification techniques present opportunities to develop next-generation oncolytic viruses with improved tumor specificity, enhanced replication, and increased safety profiles. Ongoing research and development can lead to the discovery and optimization of new viral platforms with enhanced therapeutic potential. For instance, according to data published by the University of Houston, a public research university in July 2022, the development of oncolytic virus therapy is carried out in the Center for Nuclear Receptors and Cell Signaling Department at the  University of Houston, U.S. The department has also received the funding of US$1.8 million from the National Institutes of Health.

Oncolytic Virus Therapy Market Trends:

• Advancements in Virotherapy Platforms: Advancements in virotherapy platforms are having a significant influence on the global oncolytic virus therapy market. Researchers are developing newer platforms that can more effectively deliver engineered viruses to tumor cells while avoiding healthy tissues. Certain novel platforms enable the precise delivery of oncolytic viruses by combining them with ligands that bind to receptors that are overexpressed in cancerous cells. This enhances the specificity and efficacy of virus therapy. Others are engineering viral particles with enhanced transduction abilities, enabling them to more easily enter tumor cells. For example, certain viruses are now being equipped with mutations that help them evade detection by the immune system, allowing them to replicate for longer within the body. Some groups are also working on multimodal platforms where oncolytic viruses can be combined with immunotherapy or chemotherapeutics to produce enhanced anti-tumor responses. The development of armed oncolytic viruses that can locally produce therapeutic proteins is another area witnessing innovations.
• Targeted Delivery Systems: Efforts are being made to develop targeted delivery systems for oncolytic viruses. These systems aim to enhance tumor-specific targeting and reduce off-target effects. Strategies include incorporating specific ligands or antibodies on the viral surface to improve tumor cell recognition and uptake.
• Immune Modulation Strategies: Immune modulation is an important aspect of oncolytic virus therapy. Researchers are focusing on strategies to enhance the immune response, including combining oncolytic viruses with immune checkpoint inhibitors, cytokines, and other immunomodulatory agents. The aim is to create a more favorable tumor microenvironment and improve overall treatment outcomes.
• Manufacturing and Commercialization Challenges: The manufacturing and commercialization of oncolytic virus therapies present unique challenges. Developing scalable and cost-effective manufacturing processes while adhering to regulatory requirements is a significant trend. Companies are also focusing on establishing partnerships and collaborations to facilitate the commercialization and distribution of oncolytic virus therapies.

Oncolytic Virus Therapy Market Restraints:

• High Cost Associated with Treatment: The high costs associated with oncolytic virus therapy treatment are a major factor restraining the growth of the global oncolytic virus therapy market. Developing oncolytic virus therapies requires extensive research and clinical trials over many years, which makes it an extremely expensive process. A major portion of the development costs comes from conducting different phases of clinical trials to test the efficacy and safety of these virus therapies in human patients. Clinical trials are often long drawn processes that can span 5-10 years and require enrolling a large number of patients. Considering the rarity of certain cancers, it becomes very difficult to find eligible patients for trials within a short timeframe, further increasing costs.
• Side Effects of Treatment: The side effects of treatment pose a major challenge for the growth of the global oncolytic virus therapy market. Oncolytic virus therapy involves the use of engineered viruses to target and destroy cancer cells while leaving normal cells unharmed. However, in some cases, the viruses can cause side effects in patients similar to chemotherapy. Common side effects reported include flu-like symptoms such as fever, chills, fatigue, and body aches. More severe side effects, such as nausea, vomiting, and diarrhea, have also been seen in some cases.

Recent Developments

New product

• Imlygic (talimogene laherparepvec): Imlygic is an oncolytic virus therapy developed by Amgen, a biotechnology company. It was approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of unresectable melanoma lesions in the skin and lymph nodes. Imlygic was one of the first oncolytic virus therapies to receive regulatory approval.
• T-VEC (talimogene laherparepvec): T-VEC, also known as Imlygic, is the same oncolytic virus therapy developed by Amgen as mentioned above. It received marketing authorization in Europe in 2015 for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic.
• DNX-2440 (tasadenoturev): DNX-2440 is an oncolytic adenovirus therapy developed by DNAtrix. It has shown promise in early clinical trials for the treatment of glioblastoma, a type of brain cancer. While the exact approval and launch dates may vary, the product has been under development and evaluated in clinical trials.

Partnerships and Acquisitions

• Merck & Co. and Viralytics: In February 2018, Merck & Co., known as MSD outside the U.S. and Canada, acquired Viralytics, an Australian biotechnology company specializing in oncolytic virus therapies. This acquisition aimed to strengthen Merck's position in the field of oncolytic virus therapy and advance the development of innovative cancer treatments.
• Pfizer and Western Oncolytics: In May 2019, Pfizer, multinational pharmaceutical and biotechnology corporation entered into a collaboration with Western Oncolytics, a biotechnology company focused on developing oncolytic virus therapies. The partnership aimed to combine Pfizer's expertise in immuno-oncology with Western Oncolytics' viral therapy platform to develop potential new treatments for cancer.
• Regeneron Pharmaceuticals, Inc. and Vyriad, Inc.: In November 2019, Regeneron Pharmaceuticals, Inc., a biotechnology company, and Vyriad, Inc., a clinical-stage company, announced a research collaboration and option licensing agreement focused on the development of new oncolytic (cancer-killing) virus-based treatments for various forms of cancer. The agreement includes a Phase 2 clinical study, slated to begin in 2020, evaluating Regeneron's PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with Vyriad's oncolytic virus Voyager-V1 in multiple types of cancer, including melanoma, lung, liver, and endometrial cancers. The companies will also enter into a five-year research effort that utilizes Regeneron's VelociSuite technologies to jointly design and validate novel Vesicular Stomatitis Virus (VSV)-based oncolytic virus treatments.
• Merck & Co. and Oncorus: In June 2020, Merck & Co. announced a collaboration with Oncorus, a biotechnology company specializing in oncolytic virus therapies. The partnership aimed to leverage Oncorus' oncolytic virus platform to develop next-generation viral immunotherapies for the treatment of cancer.
• AbbVie and Turnstone Biologics: In January 2021, AbbVie, a pharmaceutical company announced an acquisition of Turnstone Biologics, a biotechnology company focused on the development of oncolytic viral immunotherapies. This acquisition aimed to strengthen AbbVie's oncology pipeline and expand its capabilities in the field of oncolytic virus therapy.
• Virogin Biotech and The University of Texas MD Anderson Cancer Center: In September 2022, The University of Texas MD Anderson Cancer Center and Virogin Biotech, a biotechnology company, announced a strategic collaboration to accelerate the development of investigational treatments, including oncolytic viruses and immunotherapies, for patients with advanced cancers. The agreement brings together MD Anderson’s clinical trial expertise and infrastructure with Virogin’s innovative pipeline of investigational oncolytic viruses. The five-year collaboration will support the clinical development of Virogin’s therapies with multiple clinical trials in various cancer types to evaluate the safety and clinical benefit of these therapies and to identify prognostic biomarkers of response.
• In December 2021, Synthetic Biologics, Inc., a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, announced it had signed a definitive agreement to acquire VCN Biosciences, S.L., which is developing a new oncolytic adenovirus (OV) platform designed for intravenous (IV) delivery to trigger tumor cell death and promote immune cell infiltration into tumors.

Figure 2. Global Oncolytic Virus Therapy Market Share (%), by Product Type, 2023

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Top companies in oncolytic virus therapy Market

• Amgen Inc.
• Merck & Co., Inc.
• Oncolytics Biotech Inc.
• Circio Holding ASA
• Akamis Bio
• Vyriad, Inc.
• SillaJen Biotherapeutics
• Cold Genesys Inc.
• Sorrento Therapeutics, Inc.
• Takara Bio Inc.
• Replimune Group Inc.
• Genelux Corporation
• Synthetic Biologics, Inc.
• Lokon Pharma AB
• Elicera Therapeutics

Definition: Oncolytic virus therapy is a cancer treatment approach that utilizes modified viruses to selectively target and destroy cancer cells while sparing healthy cells. These viruses are designed to replicate within tumor cells, leading to their destruction. Oncolytic virus therapy shows promise for various cancer types and aims to provide a more targeted and effective treatment option for patients.