Viral inactivation study is one of the most important aspects of clinical trials, to manufacture and commercialize the biopharmaceutical products derived from human and animal sources. Biologics products that are developed from human, plants and animal resources represents the higher risk levels for viral contamination as these sources are said to carry several human and other pathogenic viruses. Viral contamination of these biologic products used to treat a variety of disease can have several implications from severe clinical complications to economic loss. Viral inactivation method is an important and mandatory step in the process of manufacturing of biological products for removing or inactivating potential contaminant viruses. These biological products are used to treat and diagnose in humans.
Viral inactivation testing is necessary for investigational new drug (IND) submission by regulatory authorities and is mainly critical in the development process for biologicals such as tissue and tissue products, stem cell products, blood and blood products, cellular and gene therapy products, and vaccine and therapeutics.
The main drivers for the market include rapid growth in pharmaceutical and biotechnology industries and strong R&D investments trend in the life sciences industry. Increase in the number of new drug launches, rise in chronic disease burden, an increase in government support for the pharmaceutical and biotechnology industries will also aid for the growth of the market. For instance, Virosart® Max developed by Sartorius AG is the platform virus prefilter of choice. This virus prefilter protects whatever virus filter you choose irrespective of process conditions. Virosart® Max will downsize your process and reduce your total virus filtration costs. A strong pharmaceutical product pipeline will aid the growth of the pharmaceutical and biotechnology industry, which is an important end-user of viral inactivation products.
The introduction of many new drugs into the market has necessitated the testing of these drugs and has created demand within the global viral inactivation market. The bio-similar products and biologics field has undergone rapid advancements in recent times that have furthered the global viral inactivation market growth. A wide range of instruments is used in the viral inactivation process. For instance, FlexAct VI is considered a single-use technology developed by Sartorius AG, which allows virus inactivation by using low pH. This device is designed in a way for addressing the production capacity and tailored to adjust features like pH, temperature, pump speed, pressure, and fluid level.
The biopharmaceutical industry attracted the attention of several governments, organizations, and international entities, and the need for developing this industry has become a need across the globe. This is expected to be a huge plus for the global viral inactivation market and is projected to reap tremendous revenues into the market over the forthcoming years. Further, the smaller market players are expected to stick to the basics and are learning from the footsteps of their developed counterparts. Thus, it is safe to prognosticate that the market players in the global viral inactivation market can see the emergence of several new growth opportunities over the forthcoming years. For instance, Parker Hannifin Corporation announced the acquisition of SciLog Inc, which is a provider of proprietary and unique single-use technologies and systems for biopharmaceutical markets for supporting their on-going development, which is a key supplier to the growing single-use market.
The high degree of market consolidation is a major factor restraining the growth of this market. Despite the growth of the global market for viral inactivation, the high costs that are associated with the manufacturing of biosimilar products are expected to restrain the market growth. Further, the discovery of new types of viruses that cannot be countered with the current forms of vaccinations has also proved to a roadblock for the growth of the global viral inactivation market. Nevertheless, the rising incidence of contagious diseases and an outburst of viral infections are expected to keep bolstering demand within the global market. Furthermore, the rising geriatric population that is frequently in need of biologic therapeutics is also an advantage for vendors in the global viral inactivation market.
The global viral inactivation market is segmented on method, product, application, end user, and geography.
By Method: Solvent detergent method, Alkylating agent, Pasteurization, and other methods. Other viral inactivation method includes low pH, microwave heating, irradiation, and high-energy light. Of these, the solvent detergent method segment accounted for the largest share of the global viral inactivation market.
By Product: Kits and reagents, Services, and viral inactivation systems and accessories. Kits and reagents are projected to account for the largest market share in the global viral inactivation market owing to their continuous usage by pharmaceutical and biopharmaceutical companies. Services are projected at the highest growth rate due to the ease of management and specialized services that are offered by service providing companies.
By Application: Blood & blood products, Stem cell products, Tissue & tissue products, Cellular & gene therapy products, and Vaccines and therapeutics. Vaccines & Therapeutics is anticipated to grow at the fastest rate owing to biologics production growth and increasing government funding for the promotion of usage of biologics to treat diseases.
By End-user: Pharmaceutical and biotechnology companies, academic research institutes, contract research organizations, and other end users. Other end user segment primarily includes cell banks, small cell culture laboratories and consultants, microbiology laboratories, immunology laboratories, molecular laboratories, animal facilities, toxicology laboratories, and media/sera manufacturers. Pharmaceutical and biopharmaceutical companies are expected to account for the largest share due to an increased usage of these products for the drug development process and drug manufacturing process. CROs provide customized services and efficient management of the entire viral inactivation process. Hence, these are expected to gain considerable share during the forecast period.
By Geography: North America, Europe, Asia and Rest of the World (RoW).
North America has dominated the market during the forecast period due to the adoption of many methods by blood testing center. The splendid biopharmaceutical industry in the US and Canada is expected to fortify the market for viral inactivation in North America.
Some of the dominant players in the viral inactivation market are Sartorius AG, Merck KGaA, Parker Hannifin, Rad Source Technologies, Clean Cells, WuXi PharmaTech (Cayman) Inc., and Danaher. The other market players include Charles River Laboratories International, SGS S.A., Texcell, Inc., Viral Inactivated Plasma Systems SA, Macopharma, TERUMO BCT, INC., Weigao group, V.I.P.S. SA, Cerus Corporation, BioReliance, Thermo Fisher Scientific Inc., and others.
The report covers in-depth analysis of Global Viral Inactivation Market. The report assesses the market products pipeline by stage of development (early development, pre-clinical, clinical and in approval), by application (Trauma, Hemorrhage, Coagulopathy, Influenza, Heart Valve diseases, and others). In addition, the report includes key insights on other development activities, including (but not limited to) – licensing (In and Out), collaborations, acquisitions, reimbursement, patent, and regulatory designations.
The report includes in-depth company profiles of key players in the Global Viral Inactivation Market. The company profile includes key information on the overview, financial highlights, product portfolio, business strategies, and key recent developments.
The report highlights information on emerging companies with potentially disruptive technologies and new market entrants.
Data Collation (Primary & Secondary)
In-house Estimation (Based on proprietary databases and Models)
Market-related information is assembled from both primary and secondary sources.
Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services.
Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others.
Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained.