Oncolytic Virus Immunotherapy Market

Oncolytic Virus Immunotherapy Market Size:

The oncolytic virus immunotherapy market size reached US$ 162.7 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 709 Million by 2032, exhibiting a growth rate (CAGR) of 17.2% during 2024-2032. The market is propelled by the inadequacy of traditional treatments, increased research and development (R&D) investments, expansion in emerging economies, and ongoing technological advancements like virus engineering, biomarker identification, and combining oncolytic virus therapy with other cancer treatments.

Oncolytic Virus Immunotherapy Market Analysis:

• Major Market Drivers: The limitation of traditional cancer therapies, substantial investments in research and development (R&D), and technological advancements in genetic engineering and viral therapy, are some of the key drivers of the oncolytic virus immunotherapy market.
• Key Market Trends: Key trends include the sophisticated engineering of oncolytic viruses, which involves modification at genetic levels to target specific cancer cells. Also, the identification of biomarkers that aid in treatment optimization, which enhance efficacy and safety of this therapy is another significant trend.
• Geographical Trends: North America is leading the market due to robust research infrastructure and rising prevalence of cancer. Other regions are also witnessing significant progress because of favorable regulatory policies and elevating awareness of cancer.
• Competitive Landscape: Some of the major market players in the oncolytic virus immunotherapy industry include Amgen Inc., Creative Biolabs, Daiichi Sankyo Company Limited, Genelux Corporation, Oncorus Inc., Replismune Inc., Siga Technologies, Sorrento Therapeutics Inc., TILT Biotherapeutics, Viralytics Ltd., among many others.
• Challenges and Opportunities: Oncolytic virus immunotherapy faces several challenges like regulatory hurdles, high therapy costs, and the need for extensive clinical trials. However, increasing healthcare investment and improving infrastructure are providing considerable opportunities for market expansion.

Oncolytic Virus Immunotherapy Market Drivers:

Limitations of Traditional Therapies

Conventional cancer treatments, such as radiation and chemotherapy, may not be able to successfully treat all cancer kinds or stages and have serious adverse effects. They also have negative side effects, quick drug metabolism, difficulties choosing dosages, and lack of selectivity. An estimated 18.1 million cases of cancer were reported globally in 2020, with 9.3 million cases affecting men and 8.8 million cases involving women. This emphasizes the need for more sophisticated, safe, and effective cancer therapy choices. Using genetically modified viruses that selectively infect and kill cancer cells while sparing healthy cells, oncolytic virus immunotherapy offers a viable alternative in this regard.

Rising Investments in R&D

Research and development (R&D) funding from the public and private sectors has significantly increased as a result of doctors and patients realizing the potential of oncolytic viral immunotherapy. To continue the development of its pipeline medications, Calidi Biotherapeutics, a prominent oncolytic virus business, committed $25 million in series B funding in June 2023. Additionally, CG Oncology declared in January 2024 that its $437 million initial public offering (IPO) had closed. The encouraging outcomes of clinical trials and the possibility of generating large profits from ground-breaking treatments are what motivate these investments. Additionally, as research facilities and pharmaceutical corporations delve deeper into the sector, the potential benefits of these therapies are being swiftly pushed.

Technological Advancements

Oncolytic virus immunotherapy is becoming more and more popular because of advancements in genetic engineering and viral therapy. Through the application of sophisticated molecular biology techniques, viruses can be precisely modified to increase their effectiveness and selectivity against cancer cells. The Vaccinia Enhanced Template (VET) Platform, for instance, was created by KaliVir Immunotherapeutics and is capable of producing oncolytic vaccinia viruses with alterations that enhance viral replication. Oncolytic viruses may now target previously inaccessible tumors and have improved delivery systems, which are important advancements that increase their therapeutic potential and make them a feasible treatment choice for a wider spectrum of patients. Calidi Biotherapeutics has created a universal cell-based delivery platform that enables the transmission of oncolytic viruses by their incorporation into stem cells. Also, in December 2023, Calidi announced its plan to commence phase 1b/2 clinical trial for NeuroNova1 (NNV1), company’s leading virus delivery candidate, in collaboration with Northwestern University.

Oncolytic Virus Immunotherapy Market Opportunities:

Market Expansion in Emerging Economies

Significant prospects exist for the development and uptake of oncolytic viral immunotherapy in emerging economies. The need for cutting-edge cancer treatments is rising in these areas due to elevating healthcare spending, increased patient awareness, and improved healthcare infrastructure. The Health Minister's Cancer Patient Fund (HMCPF), established by the Indian government, offers patients receiving cancer treatment at one of the nation's 27 Regional Cancer Centers (RCCs) who are below the poverty level support of Rs 2 lakhs. In addition, these nations' governments and healthcare institutions are eager to lower the rates of cancer morbidity and death, which could result in positive regulatory support and possible market expansion for cutting-edge treatments like oncolytic viral immunotherapy.

Expanded Clinical Trials

Global clinical trial expansion presents a significant opportunity for oncolytic viral therapy development and validation. A phase 1 clinical trial combining MB-101 (IL13Rα2‐targeted CAR T cell therapy) and MB-108 (C134 oncolytic virus) for the treatment of glioblastoma was announced by Mustang Bio in April 2022. Furthermore, a preliminary study conducted by CG oncology in December 2023 revealed that oncolytic viruses were able to eradicate tumors in 64 percent of 66 individuals with bladder cancer who had not responded to conventional treatments. In addition, a well-known oncology business called Akamis announced in January 2023 that it would be funding the development of its clinical-stage products, NG-350A and NG-641, with $30 million.

Key Technological Trends & Development:

Engineering of Oncolytic Viruses

Oncolytic viral engineering is a significant technological development in the field. Scientists are now able to modify the genetic makeup of viruses, enabling them to carry therapeutic genes that either suppress malignant processes within the cell or enhance their ability to specifically target cancer cells. For instance, CG Oncology created the modified oncolytic adenovirus cretostimogene grenadenorepvec, which is intended to reproduce only in cells with retinoblastoma gene pathway defects. In patients with high-risk non-muscle-invasive bladder cancer (NMIBC) that is refractory to Bacillus Calmette-Guérin (BCG) treatment, it has produced a full response rate of 75.7%. These modified viruses provide new opportunities for cancer treatment and improve the efficacy of therapy.

Biomarker Identification

One important technological development is the discovery of biomarkers that can be used to forecast the effectiveness of oncolytic virus treatment. They support the process of choosing appropriate patients for therapy, tracking responses, and forecasting results. In addition to increasing treatment success rates, this individualized method helps create viral constructions that are more precise and potent. A new study from 2023 discovered a biomarker known as clonal neoantigens that is more accurate in predicting the immunotherapy response in humans. Should this biomarker be validated in extensive research, it may eventually serve as a more accurate instrument for assessing the efficacy of oncolytic viral immunotherapy.

Combination Therapy

Combining oncolytic virus therapy with other cancer treatments, such as immunotherapy agents, chemotherapy, and radiation, is another significant trend. For instance, Genelux’s most advanced oncolytic virus immunotherapy candidate, Olvi-Vec is undergoing phase 3 clinical trial, evaluating its safety and efficacy when used in combination with platinum-based chemotherapy. Also, the company is planning to initiate a phase 2 clinical trial of Olvi-Vec in combination with chemotherapy in patients with recurrent non-small cell lung cancer (NSCLC). These approaches are designed to enhance overall efficacy by attacking cancer on multiple fronts. Also, early studies indicate that such combinations can overcome resistance mechanisms and produce synergistic effects, leading to improved patient outcomes. This trend underscores the collaborative and integrative future of cancer therapy in which oncolytic viruses play a pivotal role.

Oncolytic Virus Immunotherapy Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on virus type, application, end-user, and route of administration.

Breakup by Virus Type:

• Herpes Simplex Virus
• Adenovirus
• Vaccinia Virus
• Newcastle Disease Virus
• Reovirus
• Others
   

Adenovirus accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the virus type. This includes herpes simplex virus, adenovirus, vaccinia virus, Newcastle disease virus, reovirus, and others. According to the report, adenovirus represented the largest segment.

Adenovirus stands out as the largest segment due to its unique characteristics and therapeutic potential. It is widely studied and utilized in cancer immunotherapy due to its ability to selectively target and replicate within cancer cells while sparing normal cells. Also, its inherent oncolytic properties, coupled with its capacity for genetic engineering to enhance tumor specificity and immunogenicity, make it a promising platform for developing novel cancer therapies. Moreover, adenovirus-based vectors can be engineered to deliver therapeutic genes, cytokines, or checkpoint inhibitors directly to tumor sites, thereby augmenting the antitumor immune response and improving treatment outcomes.

Breakup by Application:

• Melanoma
• Breast Cancer
• Lung Cancer
• Ovarian Cancer
• Prostate Cancer
• Myeloma
• Bladder Cancer
• Colorectal Cancer
• Others
   

Breast cancer holds the largest share of the industry

A detailed breakup and analysis of the market based on the application have also been provided in the report. This includes melanoma, breast cancer, lung cancer, ovarian cancer, prostate cancer, myeloma, bladder cancer, colorectal cancer, and others. According to the report, breast cancer accounted for the largest market share.

Breast cancer represents the largest application segment, reflecting the significant unmet medical need and growing interest in developing targeted therapies for this prevalent cancer type. Breast cancer affects millions of individuals worldwide and is a leading cause of cancer-related mortality among women. Despite advances, there remains a subset of patients with aggressive or treatment-resistant breast cancer who require alternative therapeutic approaches. In this regard, oncolytic virus immunotherapy offers a promising strategy for addressing this challenge by leveraging the immune system to selectively target and eliminate cancer cells while minimizing toxicity to healthy tissues. Additionally, clinical trials investigating the use of oncolytic viruses, including adenovirus-based vectors, in breast cancer patients have shown promising results, fueling optimism about their potential as a new treatment modality.

Breakup by End-User:

• Hospitals & Clinics
• Cancer Research Institutes
• Ambulatory Surgical Centers
• Others
   

Hospitals & clinics represent the leading market segment 

The report has provided a detailed breakup and analysis of the market based on the end-user. This includes hospitals & clinics, cancer research institutes, ambulatory surgical centers, and others. According to the report, hospitals & clinics represented the largest segment.

Hospitals and clinics emerge as the largest end-user segment due to their central role in cancer diagnosis, treatment, and patient care. Oncolytic virus immunotherapy, including adenovirus-based treatments, is typically administered in clinical settings by trained healthcare professionals, emphasizing the importance of hospitals and clinics as key stakeholders in the delivery of these innovative therapies. Furthermore, hospitals and clinics provide the necessary infrastructure, expertise, and resources to support the development, clinical testing, and implementation of oncolytic virus immunotherapies, facilitating patient access to these cutting-edge treatments. Moreover, collaboration between academic medical centers, research institutions, and biopharmaceutical companies often occurs within hospital and clinic settings, fostering translational research and accelerating the development of novel oncolytic virus-based therapies.

Breakup by Route of Administration:

• Intratumoral
• Intravenous
• Others
   

A detailed breakup and analysis of the market based on the route of administration have also been provided in the report. This includes intratumoral, intravenous, and others.

Intratumoral administration involves directly injecting the oncolytic virus into the tumor site. This offers several advantages, including precise targeting of the tumor, high local concentrations of the virus, and reduced systemic toxicity compared to systemic administration. Furthermore, intratumoral administration maximizes the interaction between the virus and cancer cells, enhancing the antitumor immune response and promoting tumor regression. Additionally, it allows for repeated dosing and combination with other therapies, making it a promising approach for treating localized tumors and metastatic lesions.

Intravenous administration involves systemic delivery of the oncolytic virus via the bloodstream. It offers the advantage of reaching both primary and metastatic tumor sites throughout the body. Additionally, researchers are exploring strategies to enhance the tumor-targeting specificity and immunogenicity of intravenously administered oncolytic viruses, including genetic engineering to incorporate tumor-specific targeting ligands or immune-stimulatory molecules. Also, intravenous administration remains an attractive option for reaching disseminated tumors and achieving a systemic antitumor immune response, especially in cases where intratumoral injection is not feasible due to tumor location or accessibility.

Regional Insights:

• North America
  • United States
  • Canada
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East
• Africa
   

North America leads the market, accounting for the largest oncolytic virus immunotherapy market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); Middle East; and Africa. According to the report, North America represents the largest regional market for oncolytic virus immunotherapy.

North America emerges as the largest market for oncolytic virus immunotherapy, driven by several factors, including robust research infrastructure, favorable regulatory environment, and high prevalence of cancer. It is home to a large number of biotechnology and pharmaceutical companies specializing in cancer research and development (R&D), as well as renowned academic institutions conducting pioneering research in oncolytic virus immunotherapy. Moreover, supportive regulatory agencies such as the Food and Drug Administration (FDA) in the United States have expedited the approval process for oncolytic virus-based therapies, facilitating their clinical translation and commercialization. Additionally, the high incidence of cancer, particularly breast cancer, in North America underscores the urgent need for innovative treatment modalities such as oncolytic virus immunotherapy to improve patient outcomes and survival rates.

Analysis Covered Across Each Country:

• Historical, current, and future market performance
• Historical, current, and future performance of the market based on virus type, application, end-user, and route of administration
• Competitive landscape
• Government regulations

Competitive Landscape:

• The market research report has provided a comprehensive analysis of the competitive landscape covering market structure, market share by key players, market player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant, among others. Detailed profiles of all major companies have also been provided. This includes business overview, product offerings, business strategies, SWOT analysis, financials, and major news and events. Some of the major market players in the oncolytic virus immunotherapy industry include Amgen Inc., Creative Biolabs, Daiichi Sankyo Company Limited, Genelux Corporation, Oncorus Inc., Replismune Inc., Siga Technologies, Sorrento Therapeutics Inc., TILT Biotherapeutics, and Viralytics Ltd.
• Leading companies are actively involved in conducting clinical trials to test the safety and efficacy of oncolytic viruses in treating different cancers. For instance, in 2023, IconOVir Bio announced that the first patient has been dosed in the phase 1 clinical trial of IOV-1042 (an oncolytic virus) in patients with refractory solid tumors. Additionally, companies are engaging in partnerships and collaboration to pool resources, share knowledge, and accelerate the development of oncolytic virus immunotherapy. For example, KaliVir has announced a collaboration with Roche in 2022 for the development and commercialization of novel oncolytic vaccinia viruses derived from KaliVir’s VET platform.

Analysis Covered for Each Player:

• Market Share
• Business Overview
• Products Offered
• Business Strategies
• SWOT Analysis
• Major News and Events

Oncolytic Virus Immunotherapy Market News:

• In January 2022, Siga Technologies entered into a pre-clinical collaboration with Bioarchitech to devise a viral immunotherapy for cancer. This collaboration involves investigating TPOXX (tecovirimat) in conjunction with vaccinia-based immunotherapy platform.
• In March 2024, Creative Biolabs unveiled OncoVirapy, which offer customized oncolytic virus therapy development to researchers worldwide. It provides a range of development services like cell biology, virus engineering, and animal testing.

Oncolytic Virus Immunotherapy Market Report Scope:

Key Questions Answered in This Report:

• How has the global oncolytic virus immunotherapy market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global oncolytic virus immunotherapy market?
• What is the impact of each driver, restraint, and opportunity on the global oncolytic virus immunotherapy market?
• What are the key regional markets?
• Which countries represent the most attractive oncolytic virus immunotherapy market?
• What is the breakup of the market based on the virus type?
• Which is the most attractive virus type in the oncolytic virus immunotherapy market?
• What is the breakup of the market based on the application?
• Which is the most attractive application in the oncolytic virus immunotherapy market?
• What is the breakup of the market based on the end-user?
• Which is the most attractive end-user in the oncolytic virus immunotherapy market?
• What is the breakup of the market based on the route of administration?
• Which is the most attractive route of administration in the oncolytic virus immunotherapy market?
• What is the competitive structure of the market?
• Who are the key players/companies in the global oncolytic virus immunotherapy market?

Key Benefits for Stakeholders:

• IMARC’s industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the oncolytic virus immunotherapy market from 2018-2032.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the global oncolytic virus immunotherapy market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the oncolytic virus immunotherapy industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.