Viral Clearance Market Industry Insights & Analysis 2020 | Growth Market Reports
                     *Viral Clearance Market Industry 
Insights & Analysis 2020
*What exactly is viral clearance?
*The development of drugs or biological processes involves 
the usage of human and animal tissues/proteins. These 
proteins or tissues may contain viruses that can be deadly 
or can threaten human life. Thus, to ensure that the 
biological product is safe to use, elimination of virus 
contamination is crucial. The process of virus removal or 
virus inactivation is called viral clearance.
Viral clearance is usually performed before phase I and 
phase II clinical trials. The total virus clearance validation 
is done before rolling out the Phase III clinical trials. To 
achieve the risk-free biological product, there are certain 
procedures that need to be followed which depends on 
the method chosen for viral safety.
*It’s recommended that there should be two significant 
steps involved in the removal or inactivation of the virus. 
During the early phase, the tests must be performed on 
enveloped viruses such as herpes and non-enveloped virus 
such as parvovirus. The first step in the procedure 
involves inactivation/removal by a chemical method and 
the other step includes removal by a physical setup.  
If viral contamination is not done properly, it can affect 
the raw materials, bioreactor contamination, and 
downstream processing in the biopharmaceutical industry. 
The rising prevalence of viruses such as HIV, hepatitis A, 
and Parvovirus B19, among others has surged the 
importance of viral safety. For instance, according to the 
study by the World Health Organization (WHO), the 
prevalence of Parvovirus B19 was witnessed to be 1 in 
1,000-7,000 donors while for Hepatitis B it was 1 in 10,000 
donors.
*3 Viral Removal Methods/Procedures That Are Used in the Pharmaceutical 
Industry
*Precipitation:
*This method is usually considered effective against viruses such as HAV and 
parvovirus B19. As compared to other methods, precipitation is difficult to 
model. During the process, the protein concentration, pH, and temperature 
are to be recorded for successful viral removal. Furthermore, the degree of 
contamination with supernatant should also be considered. Small and medium 
enterprise usually uses PEG precipitation virus kit owing to its inexpensive and 
time-saving nature. Some common chemical compounds that are used during 
precipitation are ethanol, polyethylene, and acetone.
*Chromatography:
*Chromatography is used in the virus purification of protein as it can be 
effectively used for viruses such as parvovirus B19 and HAV. In this method, 
virus removal depends on the choice of buffers, proteins, and resins. Under 
the umbrella of the chromatography method, there are various types of 
methods such as ion exchange, affinity, and mixed-mode. Amongst all, the 
ionic exchange has been considered as an effective method. Few relevant 
properties that need to be recorded are flow rate and buffer volumes. 
Moreover, the number of cycles of resin use and resin package should be taken 
into consideration. In 2019, the chromatography method accounted for 
significant revenue in the viral clearance market.
*Nanofiltration:
*In this virus removal method, the viruses are removed by 
size exclusion technique. This method is usually used for 
both enveloped and non-enveloped viruses such as 
parvovirus B19 and HAV which has a protein coating on 
it. In this process, the risk of downstream contamination 
is lower as compared to the aforementioned method. 
Moreover, it has a higher recovery of smaller proteins 
and does not denature proteins.
Nanofiltration depends on the size of the filter while 
during the process properties such as protein 
concentration, filter integrity, and flow-rate needs to be 
taken into consideration. According to the market 
trends, the nanofiltration method segment is anticipated 
to exhibit a higher CAGR owing to the growing demand 
for filtration and advancement in the technology.
*Viral Inactivation Methods in the Biopharmaceutical Industry
*Solvent/detergent:
*In the viral clearance industry, enveloped viruses such as HAV, HBC, 
and HCV, among others are the most difficult ones to inactive. 
Solvent/detergent has turned out to be the well-established method as 
it uses simple equipment and has high process recovery. The solvents 
and detergents being used in the market are tri-(n-butyl) phosphate 
(TNBP) and Triton-X compounds. After the inactivation, solvents and 
detergents should be removed. This method is not feasible for the 
removal of non-enveloped viruses. During the process, reagent 
concentration levels should be observed for the successful viral 
inactivation.
*Pasteurization:
*One of the advantages of this method that it inactivates both 
enveloped and non-enveloped viruses. Along with this, it uses simple 
equipment which makes it feasible in the biopharma industry. Few 
protein stabilizers utilized during the process are sodium caprylate, 
caprylic acid, and acetyl tryptophan chemical compounds. During the 
process, temperature homogeneity and duration should be taken into 
consideration.
*pH Treatment:
*Low pH and high pH are the two type of treatment which 
depends on the type of virus. For instance, low pH 
inactivation is used for the monoclonal antibody 
purification process while high pH inactivation is used for 
certain types of enveloped and non- enveloped viruses. 
Currently, low pH treatment is the most common viral 
clearance method. In this method, the equipment used are 
easily available and simple. The vital parameters that 
need to be observed are time, pH, and temperature.
*There are other methods such as irradiation, microwave 
heating, terminal dry heating, Ultraviolet-C (UVC) & high-
temperature short time (HTST), and vapor heating, among 
others which are not extensively used in the market.
 
*Techniques (Viral Detection Methods) Used in the Viral Clearance 
Market
*qPCR (quantitative polymerase chain reaction):
*qPCR assays are the most common method used in the assessment of viral 
clearance studies or detection of the virus in the biopharmaceutical 
industry.
*RT PCR:
*Real-time PCR has been adopted for the detection of viruses such as the 
Zika Virus and COVID-19. It’s a successor of PCR with improved sensitivity 
and speed. Moreover, it has reduced the risk of carry-over contamination.
*ELISA (Enzyme-linked immunosorbent assay):
*ELISA is a plate-based assay technique for detecting various antibodies, 
hormones, and proteins. Many companies are providing ELISA kits to 
detect the host cell protein and other bioprocess impurities.
*Western Blot:
*Western blot assays are used for the detection of bovine 
immunodeficiency virus and HIV antibodies. Many companies such as GE 
Healthcare, Thermfisher Scientific are marketing their western blot based 
products.
*In 2019, the viral removal segment accounted for the 
largest market share and is expected to grow at a robust 
rate during the forecast period. The viral inactivation 
segment is anticipated to expand at a steady rate in the 
foreseeable future. In the two above-mentioned segments, 
chromatography and nanofiltration sub-segment are 
expected to offer innovations and technologies in the 
coming years. Meanwhile, the viral detection segment is 
expected to offer lucrative opportunities to the industry 
players in the coming years.
*Impact of COVID-19 to the Viral Clearance Market
*The coronavirus outbreak has slumped the burden of the 
healthcare system. Recently, various industry players 
grabbed the opportunity with the manufacturing of 
sanitizers, masks, and ventilators, among others. Today, 
government and private entities are releasing funds for the 
fast development of the vaccine. This has forced them to 
use efficient viral detection, removal, and inactivation 
methods and processes to compete in the market.
*Investors are heavily investing in Contract Research 
Organizations (CROs) and Contract Manufacturing 
Organizations (CMOs) in this period owing to the lucrative 
opportunities in the foreseeable future. Particularly, the 
growth of the viral clearance market is expected to be 
exponential in the period of 2020-2026. The incidence of 
new viruses across the globe has fueled the demand for 
chromatography systems, filters, and high-quality chemical 
compounds, among others.
Various Industry players are expanding their product 
portfolio in the viral clearance market while new entrants 
and emerging players are striving to gain a stronghold in 
the market share with help of collaboration, partnerships, 
and innovation in the existing products in the market. 
Moreover, the companies are not only providing products 
but have also ventured into the services segment to 
expand their market share.
*Top 6 Companies in the Viral Clearance Market
*WuXi Biologics:
*WuXi Biologics (Suzhou), a Chinese drug development &biosafety 
testing provider, offers downstream process development and has 
extensive infectivity and PCR virus detection assays. The company 
has developed over 15 qPCR assays for common model viruses utilized 
in viral clearance studies. In June 2020, Suzhou received an EMA GMP 
certificate for biosafety testing. During the year, it has completed 
the acquisition of drug product manufacturing in Germany and signed 
a lease for clinical manufacturing in the United States.
*Charles River Laboratories:
*Charles River Laboratories, an American company specializing in 
laboratory services, provides viral clearance and TSE clearance 
studies to its clients. This company offers in-process testing programs 
to detect the virus presence and ensure the absence of the virus. It 
uses qPCR analysis and TCID50 assay to find out the viral titer. In 
February 2019, the organization acquired Citoxlab, for approximately 
USD 510 Million. The latter company specializes in safety assessment 
services and non-regulated discovery services.
*Avance Biosciences:
*Avance Biosciences, Inc., a United States-based genomic service 
company, specializes in qPCR assay development, sample testing, and 
validation. The company offers Real-Time PCR/assays which is 
possible due to its ABI 7900 HT Sequence Detection System. Avance 
has been in the industry for nearly 20 years in the biopharmaceutical 
industry. Along with biological testing, it has expanded its portfolio in 
gene/cell therapy testing, and COVID-19 testing and vaccine 
development support.
*Clean Cells:
*Clean Cells, a France-based biopharmaceutical company, specializes 
in biosafety testing and quality control testing. In December 2018, 
ArchiMed, a healthcare equity firm, invested in Clean Cells to 
accelerate its growth in the industry. Over the years, the company 
has developed multiple assays to determine the purity of the 
product. It uses Residual Host Cell Protein (HCP) quantification, 
residual DNA testing, and endotoxin testing, among others to assess 
the purity of the biological product. In March 2019, Clean Cells 
acquired BE Vaccines to expand its share in virus production and cell 
structure.
*Eurofins Scientific:
*Eurofins Scientific, a Luxembourg-based biological product testing 
provider, includes a wide range of viral clearance services such as 
validated qPCR assays, purified virus stocks, large volume assays, 
viral stocks with titers of 107 pfu/ml, and infectivity assays, among 
others. Moreover, the company has four service models of viral 
clearance studies which range from issuing down-scale procedures 
to validating the down-scale procedure and performing all 
clearance steps for the company. Eurofins has been developing and 
launching assay for SARS-CoV-2 pathogen detection. In the year 
2018, the company acquired TestAmerica and Environex to expand 
its testing capabilities.
*Merck Millipore:
*Merck Millipore, a prominent name in the biopharma industry, 
provides services for the detection and removal of the viral 
contaminants for monoclonal antibodies (mAbs). The company uses 
molecular testing technologies such as Next Generation Sequencing 
(NGS) and PCR. It provides services such as detection of emerging 
viruses, raw material testing, cell line characterization, and rapid 
detection methods, among others.
*Additionally, it offers viral removal methods using 
downstream purification methods such as 
chromatography, filtration, and chemical treatment. 
Merck’s Viresolve® solution provides a complete solution 
for the viral clearance of mAbs and recombinant 
proteins.
The other industry players are Vironova, BSL Bioservice, 
Sigma-Aldrich Corporation, and Wuxi Pharmtech 
(Cayman), among others. Industry players are ensuring 
that their services are fully GMP compliant and client’s 
studies comply with FDA, EU, and ICH for Viral Safety 
Evaluation. They are focusing on product development 
to stronghold their market position.
*Viral Clearance Industry Trends 2020
*As per the detailed report, the global viral clearance market size was 
around 319.6 Million in 2019 and is expected to surpass USD 970 Million in 
valuation by the year 2026, expanding at a CAGR of at least 20.5% during 
the forecast period 2020-2026.
*Large scale production of Recombinant Proteins:
*Recombinant proteins are usually used for drug deliveries, tissue treatment, 
antibodies, and pharmaceutical products, among others. According to the 
research, this market segment is expected to expand at a CAGR of 8% 
during the forecast period. The growing demand for recombinant proteins 
in a wide range of applications has increased the demand for viral 
clearance of these proteins. Moreover, its expansion in the recombinant 
therapeutic use has propelled the applications for recombinant proteins.
*Growing demand for mAbs:
*mAbs are used in the treatment for various diseases such as cancer, 
cardiovascular disease, and arthritis, among others. The increasing number 
of government and private organizations supporting the R&D of mAbs is 
expected to positively influence the growth of this segment. Moreover, the 
innovative methods for the cost-effective production of mAbs are 
augmenting market growth.
*Development of Vaccines:
*The pandemic has encouraged various healthcare organizations to 
penetrate the vaccine development market. Currently, more than 20 
companies are working on the coronavirus treatments which has 
increased the demand for viral clearance or viral safety assurance 
services. Moreover, the incidence of biosimilars in emerging 
economies such as India and China is expected to propel the demand 
for these services.
*Stem-cell therapy:
*Stem-cell therapy is expected to offer lucrative opportunities to the 
healthcare industry players. Various companies are extensively 
investing in the development of stem-cell therapy which is 
eventually which is increasing the market share of the viral 
clearance market. Stem-cell therapy usually touted as the next 
chapter of organ transplantation and tissue engineering is expected 
to change the dynamics of the market by end of the year 2026. This 
market segment is expected to expand at a CAGR of at least 21% 
during the forecast period.
*Regional Analysis of the Market
*North American and European Region:
*In 2019, North America accounted for the largest market 
share and is expected to grow at a steady rate during the 
forecast period. The presence of a large number of 
industry players contributed to the maximum revenue in 
this market region. Various government state bodies are 
supporting the development of biotechnology and also 
investing heavily which is fueling the market growth. 
Moreover, the growing investment in stem cell therapy and 
gene therapy products has propelled the growth of this 
market region. Followed by this geographical region, 
Europe accounted for significant market share owing to 
the development of various clearance methods in the 
biopharmaceutical and pharmaceutical industry. 
Furthermore, the growing production of recombinant 
proteins and monoclonal antibodies is spurring the growth 
of this market region.
*Asia Pacific, Middle East & Africa, and Latin American Region:
*As per the research, the Asia Pacific region is anticipated to expand 
at a CAGR of at least 21% during the forecast period. The 
biopharmaceutical CRO and CMO market in the Asia Pacific is 
expected to register spectacular CAGR owing to the outsourcing of 
drug development and related to activities to emerging economies. 
This in turn is due to the low labor cost and manufacturing costs as 
compared to other regions. The adoption of the latest technology in 
the healthcare sector is one of the reasons for the growth of this 
market region. Moreover, the increasing number of biosimilars is 
expected to drive the market growth.
*Countries such as India and China is expected to offer lucrative 
opportunities owing to the government support to the local players. 
Talking about the Middle East & Africa, the market in this region is 
expected to grow at a considerable rate owing to the growing pharma 
sector. Meanwhile, the market in Latin America is anticipated to 
grow at a moderate rate during the forecast period.
*Give-Away for Viral Clearance Market
*The increasing number of CROs and CMOs are expected 
to fuel the demand for viral clearance market. However, 
the small and medium cell banks, cell structure 
laboratories, research institutions, and toxicology 
laboratories, among others is anticipated to help the 
industry players to gain a stronghold in the market.