Viral Clearance Market - Forecasts from 2023 to 2028

The viral clearance market is estimated to grow at a CAGR of 6.75% during the forecast period.

Viral clearance aims to prevent the contamination of the desired product by effectively eliminating viruses from the sample, either through complete removal or by rendering them non-infectious. The applications of viral clearance encompass various areas including blood products, recombinant proteins, cellular and gene therapy products, vaccines, as well as other relevant fields. The significant growth drivers for the viral clearance industry include the emergence and growth of the pharmaceutical and biotech industry, as well as academic research institutes.

Rising pharmaceuticals sector bolsters the viral clearance market growth.

Viral clearance is used in the pharmaceuticals industry to ensure the safety and efficiency of biopharmaceutical products and as the industry experiences significant growth due to the increasing demand for biologics coupled with the increased government investments and proactive initiatives the need for viral clearance becomes more prominent. For instance, in March 2022, in India, the Strengthening of Pharmaceutical Industry (SPI) Scheme unveiled a financial outlay of Rs. 500 crores for the duration of FY 2021-22 to FY 2025-26. Such initiatives are expected to provide a positive outlook to the market demand for viral clearance thereby augmenting the overall market growth.

Emerging research and development drive the viral clearance market expansion.

Viral clearance is used in research and development (R&D) to ensure the safety and efficiency of biopharmaceutical products. The growing demand for innovative biologics and advancements in biotechnology is promoting R&D activities in the pharmaceutical industry. Moreover, due to an increase in R&D investments, the need for viral clearance techniques to address regulatory requirements and mitigate viral contamination risks rises. Roche, a renowned healthcare leader, significantly increased its investment in research and development (R&D) to $14.7 billion in 2022, marking a notable rise from $13.3 billion in the previous year.

Technological advancements are driving viral clearance market growth.

The continuous progress in technological advancements of viral clearance techniques, including chromatography, filtration, and viral inactivation methods, has led to notable enhancements in the efficiency and effectiveness of viral clearance processes. As a result, these advancements play a pivotal role in driving the growth of the market, as they enable biopharmaceutical companies to ensure the safety and purity of their products through more efficient and reliable viral clearance procedures, meeting stringent regulatory requirements, and addressing growing concerns regarding viral contamination risks. For instance, in June 2022, Bio-Rad Laboratories, Inc., introduced EconoFit Low-Pressure Prepacked Chromatography Column Packs to aid protein purification workflow development and resin screening experiments.

North America is anticipated to be the market leader.

The North-American region will hold a significant share of the viral clearance market due to the region's robust pharmaceutical and biotech industry, characterized by major players, extensive research and development activities, and advanced infrastructure, which has contributed to the overall regional market growth. Furthermore, the region has witnessed substantial investments in the pharmaceutical and biotech industry propelled by the increasing demand for biologics, stringent regulatory guidelines, and the need for ensuring patient safety. For instance, in September 2022, the Department of Health and Human Services announced a $40 million investment to expand biomanufacturing's role in producing active pharmaceutical ingredients (APIs), antibiotics, and critical medication components, enhancing pandemic response capabilities in the United States.

High cost restrains the viral clearance market growth.

The viral clearance industry faces hindrances due to the high costs associated with specialized equipment, the need for skilled personnel, and the requirement for extensive testing. These expenses can create barriers for smaller companies with limited financial resources, impeding their ability to invest in viral clearance procedures. Consequently, market growth may be hindered as smaller companies struggle to meet the financial requirements for implementing effective viral clearance practices, limiting their participation in the market.

Key Developments

• November 2022: Cygnus Technologies introduced the MockV RVLP Kit which empowers bioprocess scientists to accurately measure the elimination of Retrovirus-Like Particles (RVLPs) that are naturally generated by Chinese Hamster Ovary (CHO) cell lines throughout the biopharmaceutical manufacturing process.
• March 2022: Thermo Fisher Scientific introduced the InhibiSURE Viral Inactivation Medium, a groundbreaking formulation that prioritizes safety by being non-hazardous, setting it apart from other inactivation media which often pose potential risks. Unlike traditional inactivation media, which often contain guanidine-based chemicals that can release toxic cyanide gas if mixed with bleach or strong acids, the InhibiSURE Viral Inactivation Medium ensures safety without compromising efficiency. Furthermore, the use of this medium eliminates the requirement for additional inactivation steps, streamlining laboratory workflows and enhancing overall throughput.

Company Products

• ClearancePlus: Charles River Laboratories offers ClearancePlus, a comprehensive viral clearance study that incorporates risk-based assessments. This service includes a standard practice of utilizing large-volume plating for all product-relevant samples, thereby enhancing claims of log reduction value (LRV) and effectively demonstrating robust virus reduction. The inclusion of these practices ensures a thorough evaluation of viral clearance efficacy, providing clients with reliable data on the effectiveness of their viral reduction strategies.
• USP Viral Clearance and Test Methodologies: Nelson Labs offers USP Viral Clearance and Test Methodologies, which are designed for conducting quality control testing on a range of animal-derived raw materials and processing reagents used in the manufacturing of biological products. These test methodologies serve to evaluate the potential for introducing viral contaminants, ensuring the safety and integrity of the final products. By employing USP-recommended viral clearance methods, Nelson Labs assists in maintaining high-quality standards and mitigating the risks associated with viral contamination during the production process.
• MockV RVLP Kit (M230): The MockV RVLP Kit, developed by Cygnus, utilizes a BSL-1 compatible stock solution containing non-infectious Retrovirus-like Particles (RVLP) derived from CHO cell culture. This solution serves as a spiking agent for viral clearance testing, ensuring the accuracy and reliability of the testing process. The kit includes essential components such as RVLP stock solution, a 96-well plate for sample analysis, RNA extraction and qPCR reagents, and a meticulously controlled RNA standard, enabling precise and dependable quantification of RVLP.

Segmentation

By Method

• Viral Removal Method
• Viral Inactivation Method
• Viral Detection Method

By Application

• Blood and Blood Products
• Recombinant Proteins
• Cellular & Gene Therapy Products
• Vaccines
• Others

By End-Users

• Pharmaceuticals and Biotech Industry
• Academic Research Institutes
• CROs
• Others

By Geography

• North America
• United States
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• United Kingdom
• Germany
• France
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Israel
• Others
• Asia Pacific
• Japan
• China
• India
• South Korea
• Indonesia
• Thailand
• Others