Virus Safety Testing Services Market

Market Overview

The global virus safety testing services market size was valued at USD 539.6 million in 2022. It is estimated to reach USD 2,216.89 million by 2031, growing at a CAGR of 17.00% during the forecast period (2023–2031). Robust pipeline and increasing investment for the development of new biologics and market growth of commercialized biologics over five years promote market expansion.

Virus Safety Testing Services refers to a series of procedures and evaluations conducted to evaluate the safety of biological products concerning the presence of viruses, such as vaccines, medications, and other biopharmaceuticals. The motive of this evaluation is to determine the potential risks associated with the use of these biological products. These services aim to ensure that the products are free of harmful viruses that could cause infections or other adverse effects in humans or animals. The primary purpose of virus safety testing is to determine the presence and infectivity of known viruses and any unknown or accidental viruses that may have contaminated the biological product during its creation, production, or handling. This can occur during product development, manufacturing, or handling.

It is important to range these tests to secure the health and safety of the patients using the products and to satisfy the regulatory requirements of the Food and Drug Administration (FDA) and any other applicable organizations. In most instances, the safety testing services for viruses consist of a battery of exhaustive laboratory examinations conducted by trained professionals.

Market Dynamics

Global Virus Safety Testing Services Market Drivers

Robust Pipeline and Increasing Investment for the Development of New Biologics

The key element driving the viral safety testing market is the increasing amount of research and development activities being done to generate novel biopharmaceuticals. Due to this, there has been a surge in demand for viral safety testing services that are extremely effective, which is driving the market. Due to the development of biopharmaceutical treatments like antibodies, recombinant proteins, and gene therapy, the treatment of a wide variety of diseases has been completely transformed due to this advancement.

In recent years, the market for biopharmaceuticals has displayed amazing growth, and industry analysts believe that this trend will continue into the not-too-distant future. There are currently many substantial and revolutionary treatments in the biopharmaceutical pipeline. These treatments have the potential to fulfill medical requirements that are currently not being met.

Market Growth of Commercialized Biologics Over Five Years

Innovative treatment options made possible by biologics have revolutionized how thousands of patients worldwide are cared for. Biologics have overtaken small-molecule pharmaceuticals as the therapeutic compound class, with the fastest increase during the last five years. The market for biopharmaceuticals currently has more than 350 commercially licensed biologics. The United States and Europe now hold a monopoly on the biologics market. The biologics market is expanding most quickly in Asia-Pacific. The region's rapid growth can be mostly due to the developing biopharma sector in nations like Japan, China, South Korea, and India. The rising prevalence of chronic disorders such as cancer, infectious diseases, cardiovascular diseases, autoimmune diseases, diabetes mellitus, and nephrological diseases has significantly impacted the biologics market growth.

Additionally, important markets' growing senior population and increased healthcare spending have generated a favorable climate for growth. Some well-known biologics, like Humira, Epogen, Enbrel, and Avastin, have shown phenomenal growth since their introduction.

Global Virus Safety Testing Services Market Restraint

Increasing R&D Cost for Biopharmaceutical Development

The creation of biopharmaceutical goods requires significant investment. The costs of research and development (R&D) for creating a new biopharmaceutical have also dramatically escalated over the previous few decades. The same source added that a significant portion of the overall cost of developing biopharmaceuticals is spent on clinical trials. The most important restraints on market expansion are predicted to be the rising R&D expenses and lengthy approval procedures for biopharmaceuticals over the forecast period. Further preventing major firms from investing in R&D is the restricted availability and funding prospects for new players in emerging and less developed nations.

Additionally, it is projected that the absence of uniform viral safety norms and a limited understanding of virus safety testing practices in developing nations like Africa will hurt market growth. Most less-developed nations lack adequate regulatory frameworks for testing virus safety. These nations do not closely follow any one set of biosafety regulations, which results in the application of inconsistent or arbitrary regulations.

Global Virus Safety Testing Services Market Opportunities

Potential Markets in the Asia-Pacific Region

The biopharmaceutical industry in significant economies in the Asia Pacific region, including Japan, China, South Korea, and India, has demonstrated remarkable expansion in recent years. The fruitful expansion is attributable to the continual government backing for the company in these nations, which the respective governments of these countries have supplied. Increasing private investments to expand biologic manufacturing capabilities in these countries is also projected to fuel market growth. This growth is expected to occur as a direct result of these expenditures.

Demand for contract research organizations (CROs) that offer services for developing both effective and economical biologics has increased due to the expanding biopharmaceutical industry in these countries. Lucrative potential in these economies, which both emerging and existing viral safety-testing service providers may exploit with their cheaper testing services to obtain a competitive edge, would help the market expand. Rising and existing service providers can exploit attractive prospects in these economies.

Regional Analysis

Based on region, the global virus safety testing services market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global virus safety testing services market shareholder and is estimated to exhibit a CAGR of 12.2% over the forecast period. The global market for virus safety testing services was dominated by North America, which had a significant share of the overall market. It is mostly due to the presence of a mature biotechnology and biopharmaceutical industry in the United States, which has resulted in a significant increase in the demand for virus safety testing services in the region, which accounts for the majority of this market's big share. Significant research and development initiatives and the increased public-private investments in developing innovative gene therapies, regenerative medicines, vaccines, and plasma proteins have further spurred the need for viral safety testing services. This has led to the rapid expansion of the market.

In addition, biopharmaceutical companies are increasingly outsourcing their research and development (R&D), medication development, and manufacturing activities to reduce overhead costs and boost profit margins. It is anticipated that the fast acceptance of services provided by CROs in the region will continue to provide a good environment for expanding the viral safety testing services market.

Europe is anticipated to exhibit a CAGR of 12.9% over the forecast period. The fact that Europe held the second-largest share may have to do with the increase in government efforts that promote awareness about the necessity of virus safety testing in biological items. It is anticipated that the presence of large healthcare organizations like the EMA, which are attempting to protect patient safety and enforce substantial viral safety standards, will increase the utilization of virus safety testing services. These organizations are already working to improve patient safety. These agencies can develop strict guidelines and recommendations, which have the potential to improve the incorporation of viral safety testing and provide a considerable boost to the sector as a whole.

For instance, it has been hypothesized that the European Medical Device Directives significantly influence the implementation of distinctly defined obligatory legislation to fulfill ever-increasing safety requirements. This, in turn, corresponds to an increased level of biological safety and adds to the overall expansion of the industry in the region.

Asia-Pacific will display the quickest CAGR throughout the projection period. In biopharmaceutical drug development, countries such as Japan, South Korea, Australia, and Singapore adhere to a regulatory framework built to a high standard. In the future, there will be increased development possibilities brought about by regulatory rules implemented by healthcare organizations that favor advances in biosafety and the quality of healthcare infrastructure. The creation of biologics and the clinical trial operations that are associated with it are both difficult and need a significant expenditure. CROs have been increasingly popular among biotechnology and pharmaceutical businesses due to the high cost of R&D operations and the absence of in-house R&D infrastructure. The viral safety testing services market is anticipated to be presented with numerous lucrative prospects shortly because of the rapid expansion of the CRO industry in the Asia-Pacific region.

In Latin America, virus safety testing services are related to expanding biotechnology and biopharmaceutical sectors in major regions, such as Brazil and Mexico. This is the present market landscape in Latin America, driving demand for these services. Brazil is anticipated to be the most prosperous country in the area. In Brazil, there are many prospects for research and development, as well as for the manufacturing of biopharmaceutical goods. As a result, a sizable increase in demand for services related to virus safety testing in the context of carrying out research is projected to result. In addition, various important players come to the country because its biopharmaceutical market is expanding. The entrance of such significant global firms into the region is anticipated to produce further profitable opportunities for providing virus safety testing services.

South Africa, Saudi Arabia, and the UAE are some of the most important markets in the Middle East and Africa. This region's market for virus safety testing services is expected to grow steadily over the forecast period due to limited investments in the biotechnology sector, low affordability of expensive services, and low intensity of biotechnology R&D activities. Shortly, robust government initiatives to promote the biotechnology industry in countries such as Saudi Arabia and the UAE are expected to generate lucrative opportunities. In Saudi Arabia, biotechnology R&D activities are facilitated by institutions such as the King Abdullah University of Science and Technology (KAUST). In addition, increasing public and private partnerships for expanding the biopharmaceutical industry in the country are anticipated to increase the demand for virus safety testing services.

Segmental Analysis

The global virus safety testing services market is bifurcated into test types and applications.

Based on the test type, the global market is bifurcated into adventitious virus tests, antibody production tests, retrovirus tests, and specific virus tests. 

The adventitious virus tests segment dominates the global market and is projected to exhibit a CAGR of 13.8% over the forecast period. Contamination of biopharmaceutical therapies with adventitious viruses is a significant safety risk that can diminish public confidence in biopharmaceuticals. Throughout the past few decades, there have been several instances in which contamination of the biopharmaceutical product of an adventitious virus has endangered public confidence in immunization programs. Using adventitious agent assays, cell banks, and biologics are routinely evaluated for purity and safety. Adventitious virus assays are performed as part of raw materials testing, lot-release testing, and cell-line characterization of biologicals such as vaccines, gene therapy vectors, monoclonal antibodies, and recombinant proteins.

Currently, in vivo and in vitro assays are used extensively to identify potential contaminants of adventitious viruses. Several organizations are dedicated to raising awareness about adventitious virus contamination and reduction, which is anticipated to contribute to segment expansion. This includes the Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB), founded by the Center for Biomedical Innovation at the Massachusetts Institute of Technology.

Based on application, the global market is bifurcated into vaccines, plasma proteins, antibodies, gene therapy, and regenerative medicine. 

The antibody segment owns the highest virus safety testing services market share and is predicted to exhibit a CAGR of 13.84% over the forecast period. Antibody treatments are a form of biologics suggested for treating a wide variety of disorders. Some of these conditions include psoriasis, rheumatoid arthritis, Crohn's Disease, and multiple sclerosis. Regarding revenue, the Antibody segment was responsible for most of the market share over the projection year. The high growth of blockbuster monoclonal antibodies like Humira (adalimumab), Remicade (infliximab), Stelara (ustekinumab), Cosentyx (secukinumab), Actemra (tocilizumab), and Simponi (golimumab) might be credited with the dominance. The increased frequency of chronic diseases and the growing demand for innovative monoclonal antibodies have contributed considerably to the huge demand for virus safety testing services for the development processes.

In addition, factors such as the anticipated approval of novel monoclonal antibodies currently in the late-phase clinical trial stage and enhanced research and development endeavors by major players to develop new medicines are likely to assist the segment's expansion during the projection period.

Recent Developments

• April 2022 - WuXi Biologics awarded the bioprocessing excellence in viral clearance and safety accolade for the second time at the Asia Pacific Bioprocessing Excellence Awards (ABEA) event.
• January 2022 - Texcell announced the expansion of its facility in the U.S. to increase capabilities for all their service lines, including customized R&D cell culture, GLP viral clearance studies, and select GMP assay capabilities for viral safety testing.