July 2024
The global oncolytic virus therapy market size accounted for USD 3.28 billion in 2024 and is predicted to increase from USD 3.71 billion in 2025 to approximately USD 11.13 billion by 2034, expanding at a CAGR of 13.00% from 2025 to 2034. The oncolytic virus therapy market is witnessing steady growth, driven by rising cancer prevalence, increased clinical trials, and growing adoption of innovative viral-based treatments worldwide.
The oncolytic virus therapy market is experiencing rapid growth due to the rising prevalence of cancer and increased demand for targeted therapies. Oncolytic virus therapies utilize genetically modified viruses to preferentially infect and kill cancer cells, while enhancing anti-tumor immunity. The oncolytic virus therapy market encompasses the research, development, and commercialization of oncolytic viruses for the treatment of various high-morbidity cancers, including melanoma, glioblastoma, and solid tumors.
The expansion of clinical trials, supportive regulatory approvals, and advances in viral engineering are expanding therapeutic options. Growing collaborations between biotechnology companies and academic institutions further augment innovation in oncolytic virus therapies, making it a promising and rapidly evolving segment of the oncology treatment market.
Artificial Intelligence is revolutionizing the oncolytic virus therapy landscape by enhancing various facets of research, development, and commercialization. AI-driven computational models accelerate the identification and engineering of novel oncolytic viruses with optimized tumor-targeting capabilities and reduced off-target effects. Machine learning algorithms analyze vast biomedical datasets to uncover novel biomarkers, enabling more precise patient stratification and personalized treatment regimens.
Artificial intelligence (AI) is emerging as an exciting new approach to oncolytic virus therapy, unlocking precision design, accelerated therapy development, and enhanced safety profiling. AI is now being harnessed to model tumor–virus interactions, optimize viral payloads, and discover biomarkers for patient selection. For example, in 2025, Biotech Company Guska and AI company Marvik announced their collaboration to develop a generative AI platform for designing tumor-targeting viruses with higher selectivity and fewer side effects. (Source: https://www.entnerd.com)
| Report Coverage | Details |
| Market Size in 2024 | USD 3.28 Billion |
| Market Size in 2025 | USD 3.71 Billion |
| Market Size by 2034 | USD 11.13 Billion |
| Market Growth Rate from 2025 to 2034 | CAGR of 13.00% |
| Dominating Region | North America |
| Fastest Growing Region | Asia Pacific |
| Base Year | 2024 |
| Forecast Period | 2025 to 2034 |
| Segments Covered | Virus Type, Modification / Engineering, Mechanism of Action, Indication / Cancer Type, End-User, and Region |
| Regions Covered | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
Increased Global Incidences of Cancer
The growing global burden of cancer is one of the most significant drivers for growth in oncolytic virus therapy. According to the World Health Organization (WHO), by 2050, more than 35 million people are expected to be diagnosed with cancer annually, a 77% increase from 20 million incidences in 2022. This growth is linked to aging populations and changing lifestyles. (Source: https://www.who.int)
As the burden of cancer rises, there is a need for new and effective treatment options. Oncolytic virus therapy has potential as a new and exciting way to mitigate the increasing burden of cancer. Oncolytic therapies utilize genetically modified viruses that preferentially infect and kill cancer cells. These therapies can precisely target tumors and activate the immune system, making them a significant step forward in cancer treatment.
What Makes the Tumor Microenvironment a Major Barrier to Oncolytic Virus Therapy?
The tumor microenvironment (TME) is one of the greatest limiting factors of oncolytic virus therapy due to the physical and immunosuppressive barriers it presents. A dense extracellular matrix, hypoxia, and immunosuppressive cytokines such as TGF-β and IL-10 severely hinder viral entry, spread, and replication.
In a leading biotech news article, it was noted that the TME continues to limit the efficacy of advanced candidates, such as CLD-201 and pelareorep. In addition, a recent mathematical model suggested that hypoxic tumor zones reduced viral infectivity and that therapeutic spread was slowed by 30-50% in their simulations.
Could Combination Therapies Be the Key to the Next Major Advancement in Oncolytic Virus Therapy?
The oncolytic virus therapy market presents a significant opportunity in the realm of combination therapies, particularly in conjunction with immune checkpoint inhibitors. In recent years, clinical trials have started to demonstrate increasing patient responses when combining checkpoint inhibitors or other immunotherapy with a virus. For instance, in March 2025, Genelux’s Olvi-Vec achieved a 71% disease control rate in patients with small-cell lung cancer, with one patient experiencing nearly 79% tumor reduction when given Olvi-Vec as part of the dose escalation co-horts. (Source: https://investors.genelux.com)
Most other ongoing research in the U.S. and Europe provides clear evidence of the ability of these combinations to escape immune resistance or immune escape targeting cancer cells. The evidence is growing, and combinations stand out as a change agent in patients previously deemed untreatable with advanced-stage cancers.
Why Did the Adenovirus Segment Dominate the Market in 2024?
The adenovirus segment dominated the oncolytic virus therapy market with the largest share in 2024. This is mainly due to its proven safety and efficacy in clinical trials, its ease of genetic modification, and high levels of transduction efficiency across various cancer types. It has been a key component in approved therapies, such as Oncorine in China, making it the most widely used oncolytic virus platform for therapeutic development.
The vaccinia virus segment is expected to grow at the fastest rate in the coming years because of its larger genome capacity, which allows for the insertion of more therapeutic genes and its innate tumor selectivity. The available preclinical and early clinical data to date support its safety and immune activation, making it a reasonable option for developing next-generation oncolytic virotherapy programs.
How Does the Genetically Engineered Segment Lead the Market in 2024?
The genetically engineered segment led the oncolytic virus therapy market in 2024 due to its ability to precisely incorporate genes that boost the immune response, cytokines, and elements that target malignant tumor cells. In terms of safety, selectivity, and efficacy, genetically engineered constructs are superior to wild-type viruses. The flexibility of engineered viruses, particularly in ongoing clinical trials, represents the most logical platform for emphasizing engineered constructs as the best option for new virotherapies.
The retargeting / tumor-selective tropism engineering segment is likely to grow at the fastest CAGR over the forecast period. This is primarily due to its ability to target the virus's attack only at malignant cells, while causing minimal damage to normal tissues. This concept or methodology is truly cutting-edge, as it enhances combination precision while exacerbating side effects; hence, there has been increased investment in research, including next-generation platforms with greater selectivity and oncolytic virotherapy.
What Made Direct Oncolysis the Dominant Segment in the Market in 2024?
The direct oncolysis segment dominated the oncolytic virus therapy market in 2024. This is due to its demonstrated clinical efficacy, simplified mechanism of action, and favorable regulatory traction. Unlike genetically modified approaches, direct oncolytic viruses utilize innate tumor-selective replication and lytic activity, enabling faster translation from bench to bedside. This mechanism has been validated across numerous tumors in both models and clinical contexts, providing a reliable therapeutic avenue. Its established success continues to put it ahead of strategies employing oncolytic viruses.
The virotherapy-mediated gene delivery segment is likely to grow at the fastest rate in the coming years, driven by its dual therapeutic advantage, direct oncolysis coupled with targeted transgene expression. This mechanism converts oncolytic viruses into platforms for delivering therapeutic transgenes, such as cytokines and immune modulators. The simultaneous effect of destroying tumor cells, combined with immune receptor activation, makes this approach extremely appealing. As vector engineering ideal continues to improve, this mechanism will likely serve as a primary growth driver in virotehapy research and development.
Which Indication / Cancer Type Holds the Largest Share of the Market?
The melanoma segment held the largest share of the oncolytic virus therapy market in 2024, as it was the first malignancy to receive regulatory approval for oncolytic virus treatment with talimogene laherparepvec (T-VEC). Melanoma's high immunogenicity lends to greater responsiveness to virotherapy, which has resulted in more clinical studies of oncolytic virus therapies in melanoma, and therefore wider acceptance of oncolytic virus treatment into oncology treatment pathways.
The lung cancer segment is expected to grow at the fastest rate in the upcoming period, given the increasing global burden and pressing unmet need for therapies other than standard of care. Oncolytic viruses have shown promise in both non-small cell and small cell lung cancer indications, and ongoing trials are exploring combined approaches that could potentially alter immune responses and expand treatment options.
Which End-User Leads the Market in 2024?
The small & mid-sized biotech companies / startups segment led the oncolytic virus therapy market in 2024, as these organizations conduct ground-breaking clinical trials and are leading the way to address informational gaps regarding the status of oncolytic viruses. These firms were at the forefront of advancing novel viral platforms, personalized transgene payloads, and combination strategies, often outpacing larger pharmaceutical companies in translational speed and scientific differentiation.
The large pharmaceutical companies / big biotech segment is expected to grow at the fastest rate over the projection period, driven by their late-stage clinical programs to augment their oncology pipelines. Their dominance was further reinforced by the ability to scale complex manufacturing, navigate regulatory pathways across multiple jurisdictions, and integrate oncolytic virus therapies into broader immuno-oncology portfolios.
The U.S. oncolytic virus therapy market size was evaluated at USD 1.16 billion in 2024 and is projected to be worth around USD 4.01 billion by 2034, growing at a CAGR of 13.21% from 2025 to 2034.
What Made North America a Leader in the Oncolytic Virus Therapy Market?
North America registered dominance in the oncolytic virus therapy market by capturing the largest share in 2024. The region’s dominance is attributed to several factors, including robust research infrastructure, substantial investments in biotechnology, and a favorable regulatory environment. In fact, the FDA granted Fast Track designations for therapies such as ImmVira’s MVR-T3011 and Genelux’s Olvi-Vec in March 2024, which demonstrates North America’s commitment to fast-tracking groundbreaking therapies. The U.S. was the first to approve an oncolytic virus therapy, Talimogene laherparepvec (T-VEC), for melanoma as well. (Source: https://immviragroup.com)
The U.S. is the predominant force in North America and has contributed a substantial share of the oncolytic virus therapy market in North America. The U.S. became a leader due to its advanced healthcare system, leading research institutions, and collaboration between academia and industry. Additionally, the FDA took a major step in this direction by grant Fast-Track designations to the oncolytic virus therapies.
Why is Asia Pacific Considered the Fastest-Growing Market?
Asia Pacific is expected to experience the fastest growth during the forecast period, driven by a combination of increasing incidences of cancer and advancements in biotechnology. Important players in the region, such as China, Japan, and South Korea, are competing for supremacy, with China currently leading in the number of clinical trials. During the period from 2019 to 2024, the Asia Pacific has experienced remarkable growth in the number of clinical trials in oncolytic virus therapy, supported by the countries' ability to recruit and enroll patients effectively, as well as the size of the oncology patient population in these countries.
China has emerged as a significant player in the development of oncolytic virus therapy, accounting for a notable share of oncolytic virus therapy clinical trials in the region. The large patient population in China, government support, healthcare investments, and the development of a biomedical ecosystem in the country position China as a leader in the development and initiation of oncolytic virus therapies.
Tier I
These are large biopharma / biotech firms with existing approvals or advanced clinical programs, strong global footprint, and resources to generate meaningful revenue from oncolytic virus therapies.
Cumulative contribution of this tier is estimated at ~ 45 50% of total market revenue.
Tier II
These are mid sized biotech / specialized firms with significant pipeline activity, often in late phase or advanced clinical trials, partly licensed technologies, increasing revenues but not yet matching the Tier I giants.
Estimated combined share ~ 25 35%.
Tier III
These are smaller biotech or early stage firms, often preclinical or early clinical, with potentially high upside but relatively low present revenue.
Other smaller players / academic spin outs or firms focusing on earlier stage assets.
By Virus Type
By Modification / Engineering
By Mechanism of Action
By Indication / Cancer Type
By End-User
By Region
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