Global Viral Clearance Market Size, Share, Growth Analysis, By Type, By Application, By End User, By Method - Industry Forecast 2023-2030

Viral Clearance Market size was valued at USD 492.9 billion in 2021 and is poised to grow from USD 535.6 billion in 2022 to USD 1519.7 billion by 2030, growing at a CAGR of 16.1% in the forecast period (2023-2030).

Viral clearance refers to the vital step of eliminating viral particles and Transmissible Spongiform Encephalopathy (TSE) agents from the manufacturing process of various medical products such as monoclonal antibodies, recombinant proteins, glycoproteins, tissue, blood-derived items, and medical devices. The reason for this meticulous process is that these products are susceptible to contamination by bacteria, chemical impurities, fungi, and viruses.

The presence of viral contamination can severely impact crucial aspects like cell culture processes, raw materials, bioreactor contamination, and downstream processing, underscoring the importance of implementing stringent viral safety measures. The market for viral clearance solutions is on the rise due to the escalating investments in the pharmaceutical and biotechnology sectors, as well as the growing demand for vaccines and other biotherapeutic agents in the coming years.

Top-down and bottom-up approaches were used to estimate and validate the size of Viral Clearance and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined by using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Viral Clearance Market Segmental Analysis

Global Viral Clearance Market segmentation is based on method, application, end-user, and region. Based on the method, the Viral Clearance Market is segmented into the Viral Removal Method, Viral Inactivation Method, and Viral Detection Method. Based on Application, the Viral Clearance Market is segmented into Recombinant Proteins, Blood and Blood Products, Vaccines, and Others. Based on end-user, the Viral Clearance Market is segmented into Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic Research Institutes, and Others. Based on Region the Viral Clearance Market is segmented into North America, Europe, Asia-Pacific, Latin America, and MEA.

Viral Clearance Market Analysis by Method

Based on the methodology, the market is categorized into three segments: viral removal method, viral inactivation method, and viral detection method. In 2022, the viral removal method segment held the largest market share, attributed to its efficient and flexible process. This segment is likely to experience robust growth in the future. However, in the upcoming years, the viral inactivation method segment is expected to witness even faster growth due to the rising demand for innovative products like plasma proteins and gene therapy products. As for the viral detection method segment, it is projected to grow steadily, playing a crucial role as the initial step in the viral clearance process and contributing to the overall market segment's expansion.

Viral Clearance Market Analysis by Application

Based on its application, the market is divided into recombinant proteins, blood and blood products, vaccines, and other categories. Vaccines have significantly dominated the global market share, and with the advent of the COVID-19 pandemic, people have now recognized the paramount significance of well-being and have developed a heightened awareness towards their health. Consequently, there is a surging demand for vaccine production and immunization against various chronic ailments like hepatitis, cervical cancer, and more, which is propelling substantial growth in the vaccine segment.

Viral Clearance Market Analysis by End User

The market is categorized into different end-user segments, including pharmaceutical & biotechnology companies, contract research organizations, academic research institutes, and others. Among these segments, pharmaceutical & biotechnology companies held a dominant position in 2022, commanding a significant market share. This growth can be attributed to the mandatory regulations mandating viral detection and viral inactivation during the biopharmaceutical development phase, which is expected to continue fueling the market's growth in the coming years.

Global Viral Clearance Market Regional Insights

In 2022, the North American region emerged as the dominant force in the market, accounting for more than 35% of the market share. This was attributed to the rapid advancements in biotechnology and life sciences, which paved the way for substantial growth in the pharmaceutical sector. Furthermore, the region experienced an upsurge in the number of drug approvals, significant investments in research and development, and the implementation of highly accurate and flexible methods in life sciences research, all contributing to the expansion of the market.

The primary drivers behind the thriving viral clearance industry in the US included the escalating prevalence of illnesses and an increased production of monoclonal antibodies. Government support for medication development further fueled this growth, while the pharmaceutical sector played a crucial role in supporting the region's overall progress. Following closely behind North America, Europe showed promise due to its strong foundation in research and development, as well as its well-established pharmaceutical industry, positioning it to capture the second-largest market share.

Looking to the future, Asia Pacific is expected to witness significant growth, with a surge in the development and manufacturing of generics and considerable government investments in medical research. Additionally, countries like China, Japan, and Malaysia have witnessed the establishment of Contract Research Organizations (CROs), further boosting the region's potential for expansion. Latin America and the Middle East, while likely to experience more modest growth, are also expected to benefit from increasing health expenditures and a growing demand for biopharmaceuticals.

Global Viral Clearance Market Dynamics

Viral Clearance Market Driver

Increase in Demand for Biologics and Vaccines to Boost the Market Growth

The evaluation of viral safety is an integral part of product safety protocols. For securing approvals like IND and BLA, regulatory authorities prioritize and demand impeccable data on viral safety. It is imperative to possess expertise in these essential aspects and be well-versed in the regulatory requirements and the process itself to facilitate strategic planning, ultimately leading to significant time, effort, and financial savings.

Furthermore, the viral inactivation market is being driven by various factors. The increasing prevalence of chronic viral infections and diseases, coupled with the escalating demand for effective treatment methods, plays a crucial role in its expansion. Additionally, the continuous growth in investments within the life sciences industry and the introduction of innovative and classified drugs are expected to further fuel the market's development.

Viral Clearance Market Restraint

Significant Costs and Lack of Skilled Specialists to Impede the Market Growth

The growth of the Viral Clearance Market may face limitations due to the substantial expenses related to novel viral clearance technologies. Moreover, the market is constrained by the high costs involved in ensuring viral safety during processes and operations. Additionally, the scarcity of proficient specialists is leading to increased overall expenses. Consequently, managing finances and operational costs has become a critical factor limiting the market's expansion.

Global Viral Clearance Market Competitive Landscape

The leading participants in the viral clearance market are tirelessly striving for constant advancements in research and development, as well as enhancing their product portfolio to ensure superior therapeutic results for their clientele. A noteworthy instance of such dedication is seen in Wuxi biologics, which inaugurated its cutting-edge therapies testing facility in November 2021. This facility spans an impressive 140,000 square feet and is dedicated to bolstering the company's capabilities in Contract Testing, Developing, and manufacturing Organization domains, all aimed at catering to the growing demands of the cell and gene therapy industry. Furthermore, various companies are actively pursuing mergers and acquisitions as a means to broaden their business reach.

Viral Clearance Market Top Players Company Profiles

Charles River Laboratories International, Inc.

Merck KGaA

Wuxi AppTec Inc.

Eurofins Scientific

Avance Biosciences Inc.

Lonza Group AG

Sigma-Aldrich Corporation

Sartorius AG

Texcell, Inc.

Kedrion Biopharma Inc.

ViruSure GmbH

Clean Cells Inc.

Cytovance Biologics Inc.

GE Healthcare Life Sciences

Vironova AB

F. Hoffmann-La Roche Ltd.

BSL Bioservice Scientific Laboratories GmbH

Nelson Laboratories LLC

BioReliance Corporation

Novartis AG

Viral Clearance Market Recent Development

In June 2022, Asahi Kasei Medical is expanding into the CDMO business with the acquisition of Bay Area biologics maker Bionova Scientific for an undisclosed price. Like many in the industry, Japan-based Asahi Kasei has been on an expansion tear during the past few years. It purchased Austrian viral safety testing services provider Virusure Forschung und Entwicklung in 2019 and last year snapped up U.S-based mycoplasma testing services company Bionique Testing Labs.

In August 2021, WuXi Biologics announced that just 13 months after receiving its first GMP certificate, it has also received European Medicines Agency (EMA) GMP certificate for Biosafety testing center in Suzhou. This certificate demonstrates WuXi Biologics' compliance with international cGMP safety assessment standards and regulatory guidelines.

Global Viral Clearance Key Market Trends

The ever-increasing desire for biosimilars and generics is a prevailing and continuous phenomenon. The global demand for cost-effective and advanced treatments for chronic illnesses is fueling the need for recombinant non-glycosylation proteins in the biosimilars market. Furthermore, the implementation of state-of-the-art technologies has opened up new possibilities for expansion.

In recent times, the biopharmaceutical sector has experienced a substantial surge in the adoption of single-use systems and disposable technologies. This surge has led to a significant rise in the demand for viral clearance services.

Global Viral Clearance Market SkyQuest Analysis

SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by the robust Secondary Desk research.

Based on the analysis provided in the global viral clearance market report, the viral removal method emerged as the leading player in the market in 2022 and is projected to maintain its supremacy throughout the forecast period. Concurrently, North America claimed a significant market share in the global arena, mainly attributed to robust support from prestigious National institutes in biotechnology and life sciences, a thriving pharmaceutical industry, and a surge in drug approvals.