Viral Sensitizers Market: Distribution by Application Area (Viral Vaccines, Oncolytic Viral Therapies and Viral Vectors) and Key Geographical Regions (North America, Europe and Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2023-2035

Viral Sensitizers Market Thrives as Gene Therapies Gain FDA Approval

The viral sensitizers market, a notable segment of the viral manufacturing consumables market, is anticipated to grow at a compounded annual growth rate (CAGR) of 14% during the forecast period 2023-2035.

Viral sensitizers are synthetic small molecule compounds that are added to the cell culture media; these reagents attenuate the antiviral defenses in the production cell lines, thereby enhancing the manufacturing of research grade viruses and virotherapies. In recent years, virotherapies have revolutionized the approach to treating various medical conditions by harnessing the unique biological characteristics of viruses, thereby transcending the traditional perception that viruses only cause diseases. Virotherapies encompass a variety of treatment modalities, including vaccines (live, attenuated and recombinant), viral vector-based gene and cell therapies, and oncolytic viral therapies, which provide benefits to the patients with their unique mechanisms of action. The manufacturing of these viral therapies is a complex multi-tiered process involving various steps. For instance, the production of live or attenuated viral vaccines, which induce in-vivo immune response activation, encompasses viral genome replication, viral proteins / capsid production, and convergence of the units to form a functional viral particle. Similarly, viral vector manufacturing includes complicated procedures primarily involving the culturing of adherent or suspension mammalian cells in a suitable media, followed by transfection of the cells using a plasmid formulation. The viral vectors are then harvested and formulated for further applications, such as gene therapy, gene-modified cell therapy, and recombinant vaccines. One of the major bottlenecks faced by the viral medicine and vaccine manufacturers during bioproduction is the intrinsic defense mechanisms in virus / viral vector producing cells against pathogens. This innate cellular defense mechanism, triggered by antiviral signaling, results in the activation of genes and their corresponding proteins, which serve the purpose of halting essential cellular functions to disrupt viral replication. This can significantly affect not only the quality of genomes enclosed in vectors but also the post-translational changes to the capsid structure, consequently leading to decreased viral production yield and scalability constraints.

In order to optimize the manufacturing of viral medicines, synthetic compounds, known as viral sensitizers / enhancers / feed enhancers have been developed to supplement the cell culture media. These small molecules enhance virus production by momentarily debilitating the antiviral immune system in cells. The molecules operate by suppressing antiviral defense mechanisms of cells through alteration of cell signaling pathways, thereby allowing the virus to infect, transduce and replicate effectively. Further, some of the viral enhancers are designed to promote viral penetration of the cortical actin barrier, thereby expediting more effective viral infection. In addition to clinical and commercial scale manufacturing of viral medicine, several viral sensitizers are available as laboratory research reagents used for studies involving the transduction of viruses. As the applications of viral sensitizers continue to expand, the market for these compounds is poised to grow at a significant pace, in the foreseen future.

Key Market Insights

This report features an extensive study of the current market landscape, market size and future opportunities associated with this industry, for the given forecast period. The market research report highlights the efforts of several stakeholders engaged in this rapidly evolving segment of the viral manufacturing industry. Key takeaways of the viral sensitizers market report are briefly discussed below.

Breakthroughs related to Development of Gene Therapies, a Key Growth Driver for Viral Sensitizers

Over the last two decades, the gene therapy industry has witnessed several breakthroughs including the FDA approval of Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma and the commercialization approval of Libmeldy™ in Europe, for the treatment of early onset metachromatic leukodystrophy (MLD). Further, in 2021, more than 200 gene therapies were being evaluated in phase I and phase II clinical trials. In 2022, five new cell and gene therapies were approved by the FDA, taking the total count to 27. Considering the continuous progress in this domain, the demand for gene therapies is poised to increase at a rapid rate. An increase in demand for gene therapies would result in a similar surge in the demand for viral vectors, such as AAV (adeno-associated viruses), retroviruses and lentiviruses. According to an article published in The Science Advisory Board, a bioreactor capacity of 2-3 billion liters is required to meet the current industry demand for viral vectors. However, the current production capacity is insufficient to keep up with such high demands. A feasible solution to overcome the ongoing capacity crunch is to enhance the viral production by incorporating GMP grade viral sensitizers / infection and transduction enhancers into the production workflows. Besides addressing the challenges associated with supply constraints, viral sensitizers can also aid to bring down the cost of manufacturing of gene therapies by increasing the yield. It is interesting to note that in order to expand the capacity for in-house manufacturing of gene therapies for rare disorders and to commit towards lowering the cost of gene therapies for patients, the government has collaborated with several companies. For instance, in May 2022, Virica Biotech was awarded with a grant worth USD 400,000 by Innovation, Science and Economic Development (ISED) Canada to enhance the manufacturing of a gene therapy for people with lipoprotein lipase deficiency (LPLD), being developed by National Research Council Canada.

Surging Demand for Vaccines, a Key Growth Driver for Viral Sensitizers

At present, vaccines are available for the prevention of more than 20 life-threatening indications. As per the estimates of World Health Organization (WHO), vaccines prevent 3.5-5 million deaths annually by preventing diseases, such as tetanus, pertussis, and measles. According to the Global Vaccine Market report 2022, published by WHO, 5.3 billion doses of vaccines were administered in 2021 (excluding COVID-19 vaccines). Further, over the past few years, a notable shift in reducing the overall number of zero-dose children (children who did not receive any dose of DTP immunization) was observed. With public health organizations rolling out strategies to increase vaccinations, the demand for vaccines is likely to spur. However, a major limitation of viral vaccines is the insubstantial affinity exhibited by viruses for their target cells. This necessitates the administration of large titer counts (up to 1012 viral particles) per dose of treatment, to attain therapeutic effects. This, in turn, entails maximizing the viral yield during large scale production through optimization of the upstream production steps and the downstream purification and formulation steps. Subsequently, the demand for viral sensitizers that can enhance viral vaccine production is expected to witness a rise.

Advantages of Viral Sensitizers

An alternative strategy for addressing antiviral defenses involves the genetic modification of cell lines. However, this approach presents challenges since the factors that affect cell viability cannot be permanently eliminated without risking cell death. Attempting to alter these pathways through genetic engineering may result in the development of either tumorigenic cell lines or cell lines with slow proliferation rates, rendering them unsuitable for manufacturing purposes. In such cases, the use of viral sensitizers (which are cell culture reagents) remain the only feasible solution since they can be easily integrated within an existing manufacturing workflow. Further, it has been observed that efficient formulation of media permits production yield to increase manifold. Additionally, these molecules interfere with the cell signaling pathway in order to inhibit the innate immune response against viral particles; however, no residual trace of these molecules are found post purification.

Current Viral Sensitizers Market Landscape

The viral sensitizers market features the presence of close to 20 manufacturers. Of these, 50% of the players are small companies with less than 50 employees. In terms of geographical presence, nearly 55% of the manufacturers of viral sensitizer / enhancers are based in North America, while more than 40% of the players are headquartered in Europe. It is interesting to note that majority of the players in this domain are involved in manufacturing cell culture reagents; however, only one company, named Virica Biotech, is solely focused on the development of viral sensitizers for a variety of applications.

Viral Sensitizers Market: Viral Vaccines Market Segment to hold the Largest Market Share in 2023

Given the increasing demand for viral vaccines and the growing world population, the viral sensitizers market size is anticipated to grow at an annualized rate (CAGR) of nearly 14% during the forecast period 2023-2035. It is worth highlighting that, in terms of application area, viral vaccines segment is expected to capture the majority market share in the viral sensitizers market in 2023; however, this trend is likely to change through the forecast period. By 2035, it is anticipated that the majority market share will be captured by viral vectors segment, owing to the increasing demand for gene therapies, gene-modified cell therapies and recombinant viral vector vaccines.

Recent Developments

Several developments have taken place in the field of viral sensitizers over the past few years. Some of these recent initiatives have been mentioned below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that we have been outlined in our analyses.

• In April 2023, the ECI Cell Culture Engineering Conference was held in Cancun, Mexico. The conference provided a platform for the exchange of scientific advances related to cell culture and related technologies, with vaccine and therapeutic development as one of the key focus areas.
• In April 2023, Virica Biotech announced expansion of its bioprocessing facilities, with an aim to increase its capacity. The company received a grant worth USD 790,000 from the Government of Ontario to support its initiative to scale-up manufacturing to keep pace with surging client demand.

Scope of the Report

The market report presents an in-depth analysis, highlighting the capabilities of various viral sensitizer companies, across different geographies. Amongst other elements, the market research report features:

• A preface providing an overview to the full report, Viral Sensitizers Market 2020-2022 (Historical Trends) and 2023-2035 (Forecasted Estimates).
• An outline of the systematic research methodology adopted to conduct the study on viral sensitizers market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
• An overview of economic factors that impact the overall viral sensitizers market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An overview of the current market landscape of viral sensitizers / enhancers manufacturers based on relevant parameters, such as year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe and Asia-Pacific), type of developer (industry and non-industry) and company ownership (privately held and publicly listed).
• An in-depth analysis of the factors that can impact the growth of viral sensitizers market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.

The key objective of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity for viral sensitizer / enhancer companies over the next decade. We have extensively studied the historical market data within this industry, in order to develop a deeper understanding of the evolutionary market trends. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2023-2035. The market report also features the likely distribution of the historical, current and forecasted opportunity within the viral sensitizers market across various segments, such as application area (viral vaccines, oncolytic viral therapies and viral vectors), and geography (North America, Europe and Asia-Pacific). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s market growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.