The Total Addressable Market (TAM) for Oncolytic Virus Therapies was valued at USD 214 million in 2022. It is estimated to reach a projected value of USD 970 million by 2031 at a CAGR of 26.3% during the forecast period (2023-2031). "Cancer is a group of diseases marked by the uncontrolled growth and spread of aberrant cells," the American Cancer Society states. The World Health Organization (WHO) states that cancer will be the second most significant cause of death worldwide in 2021, accounting for 10.0 million deaths, or one in every five. Men are more likely to develop prostate, lung, stomach, liver, and colorectal cancer than women, who are more likely to develop colorectal, breast, lung, thyroid, and cervical cancer.
The global oncolytic virus therapies market is expected to witness high growth, attributed to the increasing burden of cancer coupled with the soaring demand for gene therapies and research methods. The continued significant investments by healthcare companies to meet the industry demand and the growing adoption of several therapies among major payors to manage early-stage detection are the major factors propelling the growth of the global oncolytic virus therapies market.
Increasing Incidence of Cancer
According to the WHO, cancer is one of the leading causes of death globally and is responsible for 10.0 million deaths in 2020. Globally, about one in one death is due to cancer. Moreover, according to the 2020 GLOBOCAN database, global cancer incidence is predicted to rise to 18.3 million new cases, with 44.2 million people living with cancer in 2021. Gene therapies have been extensively studied to offer advantages over advanced cancer therapies such as monoclonal antibodies. They also provide target specificity with high selectivity, affinity, and stability. This has led to the rise in the use of gene therapies for the treatment of cancer. Therefore, the rising cancer burden is a significant factor contributing to the market growth, driving oncolytic virus therapies in the forward direction.
Increasing Research Funding from National Cancer Institute
The National Cancer Institute routinely rolls out two grants, Small Business Innovation Research and Small Business Technology Transfer (SBIR & STTR), and a Translational research grant for cancer prevention, diagnosis, and research. The proceeding SBIR & STTR grant is being rolled out to create opportunities for the private sector and small business participation to develop and commercialize novel technologies for prevention, diagnosis, and cancer treatment. A translational research grant supports translating potential research areas into in-vitro diagnostics and therapeutic intervention research for cancer patients.
It is expected that the increase in cancer cases, coupled with responsive research advances, will significantly drive the growth of cancer research and diagnostics development. Moreover, the increased allocation of funds to NCI is expected to aggravate cancer research and diagnostic development due to the number of grants rolled out annually for cancer research to crucial players. The increasing number of grants received by key players is expected to drive the growth of the oncolytic virus therapies market during the forecast period.
High Cost of Therapy
The personalized nature of oncolytic virus therapies is responsible for the high costs. With several small-molecule drugs, the price per unit will decrease as production scales up. But these therapies are typically developed individually for each patient. As a result, per-unit production costs remain relatively consistent at different production levels, resulting in costly treatment. Thus, the high price of these therapies, once suitable reimbursement models are formulated, will pose a significant challenge to the market, restricting market growth.
Drug Approvals and Strong Pipeline of Oncolytic Virus Therapies
According to the FDA, there is a significant increase in the quantity of investigational new drug (IND) applications as oncolytic virus therapy products enter early development. The authority predicts that as a result of this activity, more oncolytic virus medicines will receive product approvals in the upcoming years, indicating significant scientific progress and the therapeutic promise of these novel inventions. By 2021, the FDA is anticipated to receive more than 200 INDs annually, adding to the more than 800 active INDs for directly administered or cell-based gene therapy that was on file with the FDA as of January 2019. Additionally, based on an evaluation of the current pipeline and the clinical success rates of these drugs, the FDA anticipates approving 10 to 20 gene treatments year by the year 2025. With such a promising outlook, businesses will soon have access to rich potential in the market for oncolytic virus medicines.
The global oncolytic virus therapies market is segmented by commercialized therapy, pipeline therapies, type of virus, application, and region.
Based on commercialized therapies, the global market is segmented into imlygic, oncorine, and rigvir. The Imlygic segment dominated the market and is expected to register a CAGR of 3% during the forecast period. As an oncolytic viral therapy, Imlygic provides another option for treating eligible patients with unresectable diseases that have recurred after the initial surgery. The rising number of cancer patients is expected to broaden the interest in oncolytic virus therapies. The development of new cancer therapies with low toxicity and high potency toward harmful cells is foreseen to spotlight the global oncolytic virus therapeutic market.
The RIGVIR segment is the second largest. RIGVIR was first registered in Latvia in 2004. Currently, the drug is also approved in Georgia, Armenia, and Uzbekistan, thus ensuring the availability of the medicine with a market of approximately 40 million people. From 2011-2019, RIGVIR was fully reimbursed for residents of Latvia, and over 70% of reimbursed melanoma patients have been treated with RIGVIR. Further, since 2015, RIGVIR has been included in the national guidelines for melanoma treatment in Latvia. Preregistration and post-registration studies have demonstrated a significant RIGVIR response to many cancer types besides melanoma, such as stomach and rectum cancer. Such factors drive segment growth.
By pipeline therapies, the global market is segmented into Phase I, Phase II, Phase III, and Phase IV. The phase I segment dominated the market during the forecast period. Oncolytic virus therapies are the newest wave of advanced technologies expected to transform the face of the contemporary biopharma industry, enabling the path to pinpoint a faulty sequence or cellular mechanism at the foundation of a particular disease. Despite challenges such as those mentioned above, there has been a growing influx of Phase I clinical trials in the global oncolytic virus therapies market in the past couple of years. This could be attributed to the rising number of oncolytic virus therapies products receiving marketing approvals in recent years, the growing number of multiple therapy-resistant patients, the increasing number of companies researching oncolytic virus therapies, and the rising success of pre-clinical research translation into clinical studies.
By type of virus, the global market is segmented into the genetically engineered oncolytic virus (Herpes Simplex Virus (HSV), adenovirus, vaccinia virus, oncolytic wild-type virus), Reovirus (Respiratory Enteric Orphan Virus) (Newcastle Disease Virus (NDV) and Vesicular Stomatitis Virus (VSV)). Within genetically engineered oncolytic virus, the Herpes Simplex Virus (HSV) segment dominated the market and is expected to grow at a CAGR of 26% during the forecast period. Oncolytic viruses have been proposed to be deployed as a potential treatment for various types of cancer. They will serve the purpose of breaking tumor cells without causing damage to normal cells. In this type of oncolytic viral therapy, the human pathogens herpes simplex virus (HSV) is especially suitable for the cause. HSV has multiple mechanisms to evade responses created by the antiviral reaction in the host. Thus, the anti-tumor effect can be achieved with genetic manipulation of the HSV genes involved in deleting mutation mechanisms. Such factors propel the segment's growth.
By application, the global market is segmented into solid tumors (breast cancer, prostate cancer, lung cancer, glioblastoma melanoma, and other applications) and hematological malignancies (lymphoma, leukemia, and myeloma). The solid tumor application segment dominated the market and is anticipated to grow at a CAGR of 28.6% during the forecast period. A solid tumor is an abnormal tissue mass that usually does not contain liquid or cyst areas. Solid tumors can be benign or malignant and are divided based on affected cell lineage into sarcomas, carcinomas, and lymphomas. Recently, oncolytic gene therapy has impacted the prognostication and treatment decision-making for different solid tumors. This has led to a continuous improvement in the development of therapies for treating solid tumors.
By region, the global oncolytic virus therapies market is segmented into North America, Europe, and Asia Pacific.
North America dominated the market at the time and is anticipated to have the greatest CAGR throughout the projected period, at 26.2%. The existence of important market participants in the U.S. and the expanding use of virus therapies in cancer is credited with the region's rise. The dominance of North America in the global market for oncolytic viral therapy is primarily due to the rising prevalence of hematologic malignancies, such as leukemia and lymphoma, and the development of medications. The partial availability of reimbursement coverage is driving the market value growth.
The Asia-Pacific region is the second largest and is expected to exhibit the highest CAGR of 19.8% during the forecast period. According to the 2018 Chinese cancer report, the overall national incidence of all cancer types in 2018 was approximately 4.31 million, and cancer-related mortality was 2.84 million people. Therefore, there is a significant medical need for oncology therapies in China. Although a cancer diagnosis is not adopted mainly by emerging economies in the APAC region, research competency and access to considerable patient populations in urban markets have given rise to substantial opportunities for overseas companies in the oncolytic virus therapies market.
Europe is the third largest region. According to Cancer Research UK, there are roughly 16,000 new Hodgkin and non-Hodgkin lymphoma cases yearly and 9,900 new leukemia cases in the U.K. As a result, specific treatments like viral therapies based on DNA and RNA are being used more frequently. Hematologic malignancies testing is expanding in the UK thanks to several government programs. Following 2011, specific actions, such as the Department of Health's 2011 Cancer Strategy, were made to create a specialized commissioning framework.
Additionally, the Independent Cancer Taskforce published a cancer strategy in 2015. It proposed around 100 recommendations, including specific commissioning to enable funding and provide access to molecular diagnostics tests for cancers, including hematologic malignancies. The adoption of therapeutics has been further improved by incorporating test applications to Cancer Outcomes and Services Dataset (COSD) and undertaking an annual review on molecular therapeutics capacity.
Oncolytic virus therapy is a breakthrough in cancer treatment. Imlygic (talimogene laherparepvec), a second-generation oncolytic herpes simplex virus type 1 (HSV-1), was approved as the first oncolytic virus drug in the U.S. and Europe in 2015. Further, the Phase III trial proved local intralesional injections with T-Vec in advanced malignant melanoma patients. Additionally, other oncolytic viruses closing in on drug approval in Europe and North America include vaccinia. Further, for head and neck cancer, Reolysin(palareorep), JX-594 (pexastimogene devacirepvec) hepatocellular carcinoma, and GM-CSF expressing adenovirus CG0070 for bladder cancer, and Reolysin (pelareorep), a wild-type variant of reovirus, are in clinical trials.
Due to the ever-rising incidence of cancers, the need for better products and services is becoming more evident. Several key players are aligning their technologies per the market requirements to provide technologically advanced products and services by adopting inorganic strategies such as agreements, partnerships, and collaborations. Deals that center on the collaborative process for medicines development within a clinical study are primarily responsible for the increase.
It discusses the regulatory framework governing the approval and usage of oncolytic virus therapies worldwide. Analysis has been provided for major regulatory bodies, such as the Food and Drug Administration (FDA) in the U.S., the European Medical Agency (EMA), the National Medical Product Administration (NMPA) in China, the Ministry of Health, Labour, and Welfare (MHLW) and the Pharmaceutical and Medical Devices Association (PMDA) in Japan. Moreover, it also includes regulatory scenarios worldwide (with a list of regulatory authorities/associations/consortiums) and expedited approval processes of different drug regulatory bodies around the globe.
Oncolytic virus therapies have proven to be disruptive and highly advantageous in terms of life-altering benefits for cancer treatment. But due to their high cost, healthcare systems need to change how they pay for therapies. New approaches which may be implemented to improve reimbursement and market access are as follows:
The prominent players in the global oncolytic virus therapies market are
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