Viral Clearance Market Size, Share & COVID-19 Impact 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 Biotech Industry, Academic Research Institutes, CROs, and Others), and Regional Forecast, 2023-2030

The global viral clearance market size was valued at USD 539.6 million in 2022. The market is projected to grow from USD 621.1 million in 2023 to USD 1,867.5 million by 2030, exhibiting a CAGR of 17.0% during the forecast period. 

Viral clearance is an important process to manufacture biologics, such as biosimilar, antibodies, stem cell products, biopharmaceuticals, and others, to ensure product safety. Manufacturers of pharmaceuticals and other products derived from animal or human tissues are required to validate the ability of their purification and manufacturing process to inactivate or remove viruses or TSE agents and ensure product safety.

The market growth of viral clearance is mainly attributed to increasing investment in pharmaceutical and biotechnology companies and increasing demand for vaccines and other biotherapeutic agents. Moreover, other factors such as increasing R&D activities due to the rising incidence and large economic burden of chronic diseases are enhancing the overall market growth. As per WHO, in 2020, the prevalence of chronic diseases was increased by 57.0%.

However, the high cost associated with the virus clearing process and the consuming process for developing the drug has been restraining the market growth. For instance, Bio-Pharm International, in December 2020, stated that demonstrating virus clearance during the downstream process is the biggest challenge as it depends on many major factors.

COVID-19 IMPACT

Supply Chain Disruptions to Hinder Market Revenues 

The COVID-19 pandemic negatively affected the market in 2020. The lack of staff & workforce, risk of infection spread, and slowed manufacturing rate in the biopharmaceutical and biotech industries challenged the market. The decrease in production is attributable to supply chain disruptions, implementation of safety precautions, and logistical challenges.

However, in 2021, the market observed a sudden rise in its growth. This growth was attributed to the increase in the number of clinical trials, and the increase in demand for novel and effective vaccines for COVID-19 were the key factors responsible for the market's growth. Due to the COVID-19 outbreak, many pharmaceutical and biopharmaceutical companies boosted their R&D and manufacturing processes to develop vaccines and drugs against the SARS-CoV-2 virus. For instance, as per Regulatory Affairs Professional Society, as of January 2022, there are 34 COVID-19 vaccines approved.

Moreover, after the COVID-19 outbreak, many new partnerships and collaborations worldwide with pharmaceutical companies and academic institutes for COVID-19 vaccine research & development were recorded to develop effective drugs.

LATEST TRENDS

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Increasing Biosimilar Approvals to Positively Impact Market Growth

Biosimilar has been experiencing a boost in its demand globally due to the varied features such as low treatment cost, easy availability, high efficiency, and others. The increase in biosimilar approval can improve patient access to care by increasing the number of medication options at considerably lower costs.

The commercialization of biosimilar began in Europe, where broad reimbursement coverage, high treatment rates, and dedicated regulatory pathways created a thriving market. As per a report by NCBI in 2020, the EMA received 65 marketing authorization applications for biosimilar medicines, and 55 biosimilars are available in the European Union market.

Biological products used for human use have to pass through viral clearance every time as it is being manufactured to remove viral contamination.

Every approved biosimilar has to pass through these clearance studies. Therefore, the increasing number of approved drugs has also increased these services’ demand, thereby aiding the viral clearance market growth.

DRIVING FACTORS

Increasing R&D Expenditure in Pharmaceutical & Biotechnology Sectors to Boost Market Growth

Most pharmaceutical and biopharmaceutical businesses continue to put significant resources into developing new medications and technologies.

• For instance, as per the Indian Brand Equity Foundation (IBEF) 2019 analysis, Indian pharmaceutical companies spend around 8-13% of their total turnover on R&D. Expenditure on R&D is likely to increase due to the introduction of product patents; companies need to develop new drugs to boost sales.


• The increased investment and focus of the pharmaceutical and biotech companies in biologic product development have been boosting the demand for the viral clearing services.

The pharmaceutical business, in particular, is heavily investing in research and development. Pharmaceutical firms engage in research and development initiatives to bring high-quality, innovative goods to market.

The development and manufacturing of new biopharmaceuticals require to go through virus safety procedures. Therefore, the increasing number of R&D for new biological products has increased the demand for these services.

Increasing Regulations on Viral Safety to Spike Industry Development

Viral safety and its evaluation are significant steps for product safety. Regulatory bodies strongly focus on viral safety and expect high-quality data to support it, especially for IND and BLA approvals. Familiarity with the process and regulatory requirements and expertise in the key areas of these processes are important for strategic planning and can yield savings in time, effort, and money.

Regulations on viral safety of pharmaceutical products have evolved over decades to decrease the risk of transmitting viruses.

• For instance, as per the EMEA’s 2008 Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products, the design, contribution and interpretation of studies validating the inactivation and removal of viruses and CPMP’s note for guidance on plasma-derived medicinal products provide detailed recommendations for the biopharmaceutical manufacturers to follow while performing viral validations. These recommendations also set specific values for virus clearance levels that had to be attained.

Such regulations on viral safety during pharmaceutical product development have increased the need for the services to conduct studies more effectively.

RESTRAINING FACTORS

High Costs Associated with Novel Technologies of Viral Clearance to Limit Market Growth

The high cost associated with technologies used for virus clearing have restricted the global growth of the market.

• For instance, as per Teknos's 2018 article, chromatography systems can cost up to USD 30,000.0, and a single column component of these systems can cost nearly USD 1,000.0 on its own. Higher costs associated with the products used in viral clearing processes cause restraints in the sale of those, which can negatively impact the market growth.

Furthermore, the viral clearance service providers confront issues in attracting and maintaining highly competent experts as they compete for qualified and experienced scientists with pharmaceutical, biotechnology, medical device businesses, and academic and research institutions. Companies must give higher compensations and other incentives to compete effectively, impacting players' finances and operational outcomes, particularly small-scale analytical testing providers. This scarcity of qualified specialists could hinder the adoption of new technologies and procedures, limiting the market growth in the coming years.

Hence, rising cost of these processes is expected to limit the industry’s progress in the coming years.

SEGMENTATION

By Type Analysis

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Viral Removal Segment to Dominate Owing to its High Efficiency

Based on method, the market of viral clearance is classified into viral removal method, viral inactivation method, and viral detection method.

The viral removal method segment held the major share in 2022. This segment may experience strong growth due to the method's efficiency, flexibility, and many advantages.

• For instance, the viral removal process removes viruses and impurities, and no further steps are required to remove solvents and detergents after virus removal or inactivation, which is necessary for viral inactivation.

The viral inactivation method segment is anticipated to exhibit strong growth. This growth is attributable to the increasing number of new vaccines and therapeutics approval and demand for new products such as plasma proteins and gene therapy products.  

Furthermore, the viral detection method segment is expected to grow at a considerable CAGR. Viral detection is an important step in the viral clearing process as this step determines how virus removal or inactivation can be used. This factor has been boosting the growth of the viral removal segment.

By Application Analysis

Increasing Manufacture of Vaccines to contribute to the Growth of Vaccines Segment

Based on application, the market is segmented into vaccines, blood & blood products, recombinant proteins, cellular & gene therapy products, and others.

The vaccines segment is anticipated to hold the largest shares of the market by the end of the forecast period due to the rise in demand for COVID-19 vaccines, immunization against chronic diseases polio, hepatitis, cervical cancer, and others.

• For instance, as per WHO, in 2020, 83% of infants worldwide received three doses of polio vaccine.

The blood & blood products segment is anticipated to expand substantially during the upcoming years. The cardiology segment is expected to grow due to the strong demand for blood transfusion and therapeutics derived from blood components.

• For instance, as per WHO 2020 data, out of 118.5 million blood donations globally, 40.0% of this collection took place in high-income countries, which is home to 16.0% of the world’s population. This increase in the demand for blood transfusion led to a positive impact on the demand for virus clearance from blood products.

Cellular & gene therapy products are expected to grow at the highest CAGR during the forecast period due to increasing use of cellular therapies in treating various disorders, increasing public and private funding for stem cell research, rising awareness about stem cell therapies, and the use of tissue-based therapies to treat various diseases.

By End-user Analysis

High Procedural Volume in Clinics & Hospital to Propel Segmental Growth

Based on end-user, the market is segmented into pharmaceutical and biotech industry, academic research institutes, CROs, and others.

The pharmaceutical and biotech industry segment accounted for the highest viral clearance market share in 2022 and is expected to expand at a significant CAGR during the forecast period.  This segment’s high growth rate is attributed to the mandatory requirement for virus removal or inactivation during the development of biopharmaceutical and other biological products by regulatory bodies.

• For instance, as per the Biosimilar Development, in 2019, the number of follow-on biosimilar products in the pipeline was 1,041 observing a growth of 27.0% in the past five years. The increase in the number of approved biosimilar is expected to increase the demand for virus clearance studies while in its development stage.

The CROs segment is anticipated to expand at the substantial CAGR during the forecast period, 2023-2030. The growth rate is attributed to the pharmaceutical companies' increased outsourcing of early-phase development services and clinical and laboratory testing services.

• For instance, as per the Parexel Biopharmaceutical report, around 64.0% of clinical development services are outsourced, only 38%-40% are carried out in-house. This factor can be due to the lack of presence of required resources. This increase in outsourcing by biopharmaceutical and biotech companies positively impacted the market progress.   

The academic and research institutes segment is expected to grow at the highest CAGR during the forecast period. The growing number of research and study on new drug development by research institutes in the region is anticipated to accelerate the segment's growth globally.

REGIONAL INSIGHTS

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The market in North America reached USD 201.9 million in 2022 and is anticipated to grow strongly in the forthcoming years. The presence of national institutes supporting biotechnology and life science research, growth in the pharmaceuticals industry, and the increasing number of drug approvals across the region are expected to drive market growth.

• For instance, as per World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP), the annual number of registered clinical trials by high-income countries increased from 21,028 in 2010 to 29,538 in 2020.

Europe is expected to experience the second-highest growth in the market on account of the strong foundation of biotechnology in the European countries such as France and Germany and an increase in the amount of research and development initiatives by biotechnological companies in the region.

• For instance, according to BioSpace, in 2018, 386 drugs were registered for clinical development, observing a significant growth from 2008, when the number of drugs was only 178. The increase in the number of drugs in the development process has increased viral clearing services’ demand.

Simultaneously, Asia Pacific may expand during the upcoming years. This growth is attributed to the increase in generics development and manufacturing, surge in funding for medical research, and a large number of CROs in the region.

The Latin American and the Middle East and Africa regions may witness slow growth because of rising healthcare expenditures and increasing demand for biopharmaceuticals.

KEY INDUSTRY PLAYERS

Players with Strong and Diverse Product Portfolio to Dominate Market Position

Based on the competitive landscape, prominent market players such as Merck KGaA, Charles River, Wuxi Biologics, and Kedrion account for a major market share. These companies focus on several strategies such as continuous R&D, mergers, acquisitions, and product portfolio expansion resulting in strong regulatory approvals.

• In November 2021, WuXi Biologics announced the official opening of its advanced therapies testing facility, including 140,000 square feet laboratories, to enhance the company’s Contract Testing, Development and Manufacturing Organization (CTDMO) business model by tripling the company’s previous testing capacity to meet the increasing needs of customers in cell and gene therapy industry.

Other key players, such as Texcell, Vironova, and Sartorius AG, had substantial market shares in 2022.

LIST OF KEY COMPANIES PROFILED:

• Merck KGaA (Germany)


• Charles River Laboratories (U.S.)


• WuXi Biologics (China)


• Texcell (France)


• Vironova (Sweden)


• Kedrion (Italy)


• Clean Cells (France)


• ViruSure GmbH (Austria)


• Sartorius AG (Germany)


• Syngene International Limited (India)


• Microbiologics (U.S.)

KEY INDUSTRY 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.


• December 2021 - ViruSure GmbH announced the acquisition of Bionique Testing Laboratories LLC., the U.S.-based leader in mycoplasma testing services for the biologics and life-sciences industries.


• July 2021 - Charles River announced the expansion of its viral clearing facilities and capacities in Germany, Cologne, and Wayne, Pennsylvania due to the need for increased viral testing capacity.


• May 2021 - ViruSure GmbH received the “accreditation for biological products as foreign manufacturer” from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

REPORT COVERAGE

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The global viral clearance market research report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, product type, and application. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the market's growth in recent years.

Report Scope & Segmentation