U.S. Viral Clearance Market Size, Share & Industry Analysis, By Method (Viral Removal Method, Viral Inactivation Method, and Viral Detection Method), By Application (Blood and Blood Products, Recombinant Proteins, Cellular & Gene Therapy Products, Vaccines, and Others), By End-user (Pharmaceutical and Biotechnology Companies, Academic & Research Institutes, Contract Research Organizations (CRO), and Others), and Country Forecast, 2024-2032

The U.S. viral clearance market size was worth USD 215.6 million in 2023 and is projected to grow at a CAGR of 18.7% during the forecast period.

Viral clearance studies are used to assess and remove the presence of viruses from a downstream process. Biological products derived from human or animal sources must undergo viral removal to ensure the drug's safety. The increasing pharma and biotech companies’ emphasis on developing and manufacturing biological drugs and vaccines has been fueling the U.S. viral clearance market growth.

• For instance, in November 2022, GSK plc announced that the U.S. Food & Drug Administration (FDA) approved its Biologics License Application (BLA) and granted Priority Review for the company’s Respiratory Syncytial Virus (RSV) older adult vaccine candidate.

Moreover, the increasing government initiative for viral safety and the rising number of clinical studies involving biologics has fueled the market growth of viral clearance.

Due to the sudden outbreak of COVID-19, the market experienced slower growth in 2020. The manufacturing capacity of the pharmaceutical and biotechnological companies slowed, and many research studies other than that on COVID-19 vaccine development were put on hold. This led to the slow growth of the U.S. market in 2020.

LATEST TRENDS

Adoption of Advanced Technology, such as Next Generation Sequencing (NGS) in Validation of Viral Clearance, has been Increasing Significantly

Certain limitations are associated with the in-vitro adventitious virus assays of viral removal studies. For instance, these methods can only detect viral families that cause cytopathic effects, hemadsorption, or hemagglutination. Thus, viral species that do not cause these effects would go undetected by this methodology.

The use of Next Generation Sequencing (NGS) can overcome this limitation. NGS uses the notion of sequencing millions of DNA fragments simultaneously.

The significant advantage of NGS is that its detection does not require prior knowledge of potential adventitious viral agents, as it can detect a broad range of viral contaminations of both novel and unknown viral sequences.

The utilization of NGS for adventitious virus testing is a new approach in viral testing, as this methodology can detect novel or unknown viruses without prior knowledge of potential viral targets. Moreover, advances in nucleic assay detection technologies have enabled the capability to generate hundreds of mega-bases to several giga-bases worth of sequences in hours, days, or weeks.

Such advantages associated with the NGS have increased its adoption for viral detection and removal studies.

DRIVING FACTORS

Increasing R&D investment by Pharmaceutical and Biotechnological Companies in the U.S is Fueling the Market Growth

It is mandatory for the drug molecule being derived from the human or animal source to go through a viral detection and removal study to validate its safety. Therefore, the increasing investment by life science companies in R&D activities for new drug development has been fueling the U.S. viral clearance market growth.

• For instance, the R&D expenditure of Bristol-Myers Squibb Company and Abbvie was USD 11,354.0 million and USD 7,984 million, respectively, in 2022.

The increasing R&D expenditure by these companies increased the new drug development, fueling the demand for these studies.

RESTRAINING FACTORS

Lack of Skilled the Workforce Tends to Limit the Viral Clearance Market Growth

Demand for viral detection and removal studies has increased with the increasing R&D in the biotech and pharmaceutical industry. However, it is challenging for the market players to find and maintain qualified scientists with experience in the life science sector.

Despite the increasing demand for viral detection and removal studies in manufacturing biological drugs, the industry lacks the presence of an experienced workforce.

• For instance, as per the article published by Forbes in 2022, there was around 20,000-25,000 shortage of medical laboratory professionals in the U.S. and Canada. Moreover, as per the same data, vacancy rates in the U.S. was around 7%-11%. The lack of skilled professionals for viral detection and clearance services hindered the efficacy and efficiency of the viral removal and detection processes. Therefore, this had a negative impact on the growth of the market.

The limited availability of experienced technicians tends to hamper the efficacy of the viral removal procedure, thereby negatively impacting the market growth.

In 2022, around 9,901 new clinical trials were registered in the U.S., experiencing a growth of 7.4% from 2016.

SEGMENTATION

By Method Analysis

Based on method, the market is fragmented into viral removal method, viral inactivation method, and viral detection method.

The viral removal method dominated the market in 2022. The segment's dominance is attributed to the growing investments in R&D by key viral clearance players in the market and the increasing demand for vaccines and other biopharmaceuticals in the region.

• For instance, as per the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group, in 2022, PhRMA's member companies' research and development (R&D) expenditure reached the highest level of record of USD 102.30 billion worldwide.

By Application Analysis

On the basis of application, the market is segmented into blood and blood products, recombinant proteins, cellular & gene therapy, vaccines, and others.

The cellular & gene therapy products segment is expected to grow at the highest CAGR during the forecast period owing to increasing drug development and approval of cellular & gene therapy products.

• For instance, as per the U.S. FDA, in March 2021, Celgene Corporation, a Bristol-Myers Squibb Company, announced the approval of its product ABECMA to treat relapsed/refractory multiple myeloma in adult patients. Every biological drug has to pass through viral detection and removal during its development. Therefore, the increasing biological treatment or drug approvals of cellular & gene therapy products have been fueling the segment’s growth.

By End-user Analysis

Based on end-user, the market is segmented into pharmaceutical and biotechnology companies, academic & research institutes, Contract Research Organizations (CRO), and others.

The CRO segment is expected to grow significantly during the forecast period. The growth of the segment is attributed to the increased collaboration between the market players to enhance their service offerings and research outputs.

• For instance, in December 2021, Calyx, an eClinical and Regulatory solutions and services provider, announced an extended partnership with one of the world’s top CROs to achieve more efficient, successful clinical trials.

KEY INDUSTRY PLAYERS

The market includes significant players such as WuXi Biologics, Merck KGaA, and Charles River Laboratories. These players together accounted for a significant U.S. viral clearance market share. The growth of these players in the market was due to their focus on expanding their presence in the U.S.

• In October 2020, WuXi Biologics announced the opening of a new process development and testing lab in the U.S. This expansion helped the company strengthen its presence in the U.S.

Other players operating in the U.S. market, such as Vironova, Kedrion, Sartorius AG, Texcell, and Clean Cells, have been focusing on mergers and acquisitions to expand their presence in the market. 

LIST OF KEY COMPANIES PROFILED:

• Charles River Laboratories (U.S.)


• WuXi Biologics (China)


• Texcell (France)


• Kedrion (Italy)


• Clean Cells (France)


• ViruSure GmbH (Asahi Kasei Medical) (Austria)


• Sartorius AG (Germany)


• Merck KGaA (Germany)


• Syngene International Limited (India)


• Microbiologics (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• January 2022 – Texcell announced the expansion of its facility in the U.S. to increase capabilities for all of its service lines, including customized R&D cell culture, GLP viral clearance studies, and select GMP assay capabilities for viral safety testing. This strengthened the company’s presence in the U.S.


• April 2021 – Microbiologics invested in an additional 650 sq. ft. Biosafety Level 3 (BSL-3) facility within its existing building in Minnesota, U.S. The additional BSL-3 facility allowed for increased capabilities and capacity to provide anti-infective testing, assay development, and others.


• December 2020 – Charles River and PathoQuest SAS announced their partnership in the U.S. This expansion helped the company to bring Next-Generation Sequencing (NGS) capabilities to clients in North America as part of a fully integrated, reliable, and more convenient solution for rapid viral safety testing of biologic drugs and vaccines.

REPORT COVERAGE

The U.S. market research report provides a detailed analysis of the market. The research report includes key points such as an overview of technological advancements and others. Additionally, it includes the increased use of viral removal services in the U.S., new service launches, key industry developments such as mergers, collaborations, & acquisitions, and the impact of COVID-19 on the market. Besides this, the report also offers insights into the market trends and highlights key industry dynamics. In addition to the aforementioned factors, it encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation