Analyst Viewpoint
Rise in investment in biological testing and surge in production of biologics are fueling the viral clearance service market size. Virus detection plays a major role in the production of specialty drugs and biological products.
The viral clearance service market landscape is witnessing robust expansion owing to increase in complexity of clinical trials and implementation of stringent regulations in the biopharmaceutical sector.
Pharmaceutical companies are partnering with viral clearance service providers to ensure consistent and safe development of biological products.
Virus inactivation plays a crucial role in ensuring the safety of pharmaceutical molecules by eliminating the risk of viral contamination.
Thus, vendors are offering robust detergent treatments that disrupt the lipid membrane of enveloped viruses, leading to their inactivation, a pivotal step in viral clearance.
Viral clearance services are critical to the validation of downstream processes. They ensure the clearance of potential adventitious viruses in the event of contamination.
These services are used to remove bacteria or viruses present in drugs, production equipment, or biological products. They include the testing of end-products. Viral clearance services ensure consistent and safe development of biological products.
Viral clearance services are employed in clinical phase I/III studies to check the feasibility or design of experiments studies. They are used to demonstrate the capability of a downstream purification process to eliminate potential viral contaminants.
| Attribute | Detail |
|---|---|
| Drivers |
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Most biological products are derived from living cell cultures. This increases the risk of viral contamination in final products. Viral contamination is common in most animal- and human-derived biopharmaceuticals.
It can affect any part of the bioproduction process. Viral clearance services for biopharmaceuticals ensure that production processes are free from detectable adventitious agents.
Healthcare regulatory bodies across the globe mandate the use of viral clearance studies to demonstrate the capacity of the production process in viral removal and inactivation.
Thus, biopharmaceutical manufacturers need to perform viral testing studies and incorporate viral clearance methods into their processes. This, in turn, is propelling the viral clearance service market development.
Implementation of stringent regulatory guidelines regarding viral safety and viral clearance has led to the development of state-of-the-art detection technologies. These guidelines are critical to the biologics landscape and viral safety and are prompting investment in biosafety laboratories.
In November 2023, MilliporeSigma, Merck KGaA’s life science business, started the second phase of its new US$ 31.7 Mn Biologics Testing Center in China, adding 1,500 m2 to the lab opened in 2022.
Establishing such biosafety laboratories is contributing to the viral clearance service market growth and facilitating access to a broad range of testing services for cell line characterization and lot release from preclinical development to commercialization.
Viral safety is a critical aspect of biopharmaceutical/biologics production. Viral clearance services help prevent, detect, and remove any contamination to assure drug safety for patients. These services play a major role during the early stages of product development.
According to an analysis shared at the Convention on Pharmaceutical Ingredients (CPHI) in 2023, the biologics market is set for a substantial expansion, with demand expected to reach 4,400 kiloliters (KL) by 2027, up from 2,500 KL in 2022.
This significant growth comes with a yearly rate of increase of 11.5%, and concurrent capacity expansion to 8,400KL by 2027, up from 6,550KL in 2023. Thus, increase in production of biologics is boosting the viral clearance service market revenue.
| Attribute | Detail |
|---|---|
| Leading Region | North America |
According to the latest viral clearance service market analysis, North America held largest share in 2022. Presence of major viral clearance removal/inactivation service providers and implementation of stringent regulations governing the safety assessment of biologics and vaccines are fueling the market dynamics of the region.
In the U.S., the Food and Drug Administration (FDA) must approve a vaccine before it can be used in the country. FDA regulations for the development of vaccines and biologics help ensure their safety, purity, potency, and effectiveness.
Surge in investment in drug discovery and growth in preference for outsourcing viral clearance services are contributing to the viral clearance service market share in North America.
Rise in consumer awareness about the safety associated with the use of vaccines and biologics and increase in concern regarding the viral effects of blood-derived products are also boosting the demand for viral clearance services in the region.
Major players are providing Good Laboratory Practice (GLP)-grade viral clearance testing and viral safety services. They are also expanding their manufacturing capabilities to cater to the rise in demand. In 2023, Texcell established a new facility in China and expanded the facility in the U.S.
Texcell, Eurofins Scientific SE, Charles River Laboratories International, Inc., Merck KGaA, WuXi AppTec, Clean Cells, and Vironova Biosafety AB are key players operating in this viral clearance service industry.
Each of these companies has been profiled in the viral clearance service market report based on parameters such as company overview, business strategies, financial overview, business segments, product portfolio, and recent developments.
| Attribute | Detail |
|---|---|
| Market Size in 2022 | US$ 857.4 Mn |
| Market Forecast (Value) in 2031 | US$ 2.8 Bn |
| Growth Rate (CAGR) | 14.6% |
| Forecast Period | 2023-2031 |
| Historical Data Available for | 2017-2021 |
| Quantitative Units | US$ Bn for Value |
| Market Analysis | It includes segment analysis as well as regional level analysis. Furthermore, qualitative analysis includes drivers, restraints, opportunities, key trends, Porter’s Five Forces Analysis, value chain analysis, and key trend analysis. |
| Competition Landscape |
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| Format | Electronic (PDF) + Excel |
| Market Segmentation |
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| Regions Covered |
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| Countries Covered |
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| Companies Profiled |
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| Customization Scope | Available upon request |
| Pricing | Available upon request |
It was valued at US$ 857.4 Mn in 2022
It is anticipated to grow at a CAGR of 14.6% from 2023 to 2031
Rise in investment in biological testing and surge in production of biologics
North America was the leading region in 2022
Texcell, Eurofins Scientific SE, Charles River Laboratories International, Inc., Merck KGaA, WuXi AppTec, Clean Cells, and Vironova Biosafety AB
1. Preface
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
3. Executive Summary: Global Viral Clearance Service Market
4. Market Overview
4.1. Introduction
4.1.1. Product Definition
4.1.2. Industry Evolution/Developments
4.2. Overview
4.3. Market Dynamics
4.3.1. Drivers
4.3.2. Restraints
4.3.3. Opportunities
4.4. Global Viral Clearance Service Market Analysis and Forecast, 2017-2031
5. Key Insights
5.1. Pipeline Analysis
5.2. Key Product/Brand Analysis
5.3. Key Mergers & Acquisitions
5.4. COVID-19 Pandemic Impact on Industry
6. Global Viral Clearance Service Market Analysis and Forecast, by Method
6.1. Introduction & Definition
6.2. Key Findings/Developments
6.3. Market Value Forecast, by Method, 2017-2031
6.3.1. Viral Removal
6.3.2. Viral Inactivation
6.3.2.1. Chemical
6.3.2.2. Radiation
6.3.2.3. Others
6.4. Market Attractiveness Analysis, by Method
7. Global Viral Clearance Service Market Analysis and Forecast, by Application
7.1. Introduction & Definition
7.2. Key Findings/Developments
7.3. Market Value Forecast, by Application, 2017-2031
7.3.1. Recombinant Proteins
7.3.2. Tissue and Blood-derived Products
7.3.3. Vaccines
7.3.4. Others
7.4. Market Attractiveness Analysis, by Application
8. Global Viral Clearance Service Market Analysis and Forecast, by End-user
8.1. Introduction & Definition
8.2. Key Findings/Developments
8.3. Market Value Forecast, by End-user, 2017-2031
8.3.1. Biopharmaceuticals
8.3.2. Contract Research Organizations
8.3.3. Academic Research Institutes
8.3.4. Others
8.4. Market Attractiveness Analysis, by End-user
9. Global Viral Clearance Service Market Analysis and Forecast, by Region
9.1. Key Findings
9.2. Market Value Forecast, by Region, 2017-2031
9.2.1. North America
9.2.2. Europe
9.2.3. Asia Pacific
9.2.4. Latin America
9.2.5. Middle East & Africa
9.3. Market Attractiveness Analysis, by Region
10. North America Viral Clearance Service Market Analysis and Forecast
10.1. Introduction
10.2. Key Findings
10.3. Market Value Forecast, by Method, 2017-2031
10.3.1. Viral Removal
10.3.2. Viral Inactivation
10.3.2.1. Chemical
10.3.2.2. Radiation
10.3.2.3. Others
10.4. Market Value Forecast, by Application, 2017-2031
10.4.1. Recombinant Proteins
10.4.2. Tissue and Blood-derived Products
10.4.3. Vaccines
10.4.4. Others
10.5. Market Value Forecast, by End-user, 2017-2031
10.5.1. Biopharmaceuticals
10.5.2. Contract Research Organizations
10.5.3. Academic Research Institutes
10.5.4. Others
10.6. Market Value Forecast, by Country, 2017-2031
10.6.1. U.S.
10.6.2. Canada
10.7. Market Attractiveness Analysis
10.7.1. By Method
10.7.2. By Application
10.7.3. By End-user
10.7.4. By Country
11. Europe Viral Clearance Service Market Analysis and Forecast
11.1. Introduction
11.2. Key Findings
11.3. Market Value Forecast, by Method, 2017-2031
11.3.1. Viral Removal
11.3.2. Viral Inactivation
11.3.2.1. Chemical
11.3.2.2. Radiation
11.3.2.3. Others
11.4. Market Value Forecast, by Application, 2017-2031
11.4.1. Recombinant Proteins
11.4.2. Tissue and Blood-derived Products
11.4.3. Vaccines
11.4.4. Others
11.5. Market Value Forecast, by End-user, 2017-2031
11.5.1. Biopharmaceuticals
11.5.2. Contract Research Organizations
11.5.3. Academic Research Institutes
11.5.4. Others
11.6. Market Value Forecast, by Country/Sub-region, 2017-2031
11.6.1. Germany
11.6.2. U.K.
11.6.3. France
11.6.4. Italy
11.6.5. Spain
11.6.6. Rest of Europe
11.7. Market Attractiveness Analysis
11.7.1. By Method
11.7.2. By Application
11.7.3. By End-user
11.7.4. By Country/Sub-region
12. Asia Pacific Viral Clearance Service Market Analysis and Forecast
12.1. Introduction
12.2. Key Findings
12.3. Market Value Forecast, by Method, 2017-2031
12.3.1. Viral Removal
12.3.2. Viral Inactivation
12.3.2.1. Chemical
12.3.2.2. Radiation
12.3.2.3. Others
12.4. Market Value Forecast, by Application, 2017-2031
12.4.1. Recombinant Proteins
12.4.2. Tissue and Blood-derived Products
12.4.3. Vaccines
12.4.4. Others
12.5. Market Value Forecast, by End-user, 2017-2031
12.5.1. Biopharmaceuticals
12.5.2. Contract Research Organizations
12.5.3. Academic Research Institutes
12.5.4. Others
12.6. Market Value Forecast, by Country/Sub-region, 2017-2031
12.6.1. China
12.6.2. Japan
12.6.3. India
12.6.4. Australia & New Zealand
12.6.5. Rest of Asia Pacific
12.7. Market Attractiveness Analysis
12.7.1. By Method
12.7.2. By Application
12.7.3. By End-user
12.7.4. By Country/Sub-region
13. Latin America Viral Clearance Service Market Analysis and Forecast
13.1. Introduction
13.2. Key Findings
13.3. Market Value Forecast, by Method, 2017-2031
13.3.1. Viral Removal
13.3.2. Viral Inactivation
13.3.2.1. Chemical
13.3.2.2. Radiation
13.3.2.3. Others
13.4. Market Value Forecast, by Application, 2017-2031
13.4.1. Recombinant Proteins
13.4.2. Tissue and Blood-derived Products
13.4.3. Vaccines
13.4.4. Others
13.5. Market Value Forecast, by End-user, 2017-2031
13.5.1. Biopharmaceuticals
13.5.2. Contract Research Organizations
13.5.3. Academic Research Institutes
13.5.4. Others
13.6. Market Value Forecast, by Country/Sub-region, 2017-2031
13.6.1. Brazil
13.6.2. Mexico
13.6.3. Rest of Latin America
13.7. Market Attractiveness Analysis
13.7.1. By Method
13.7.2. By Application
13.7.3. By End-user
13.7.4. By Country/Sub-region
14. Middle East & Africa Viral Clearance Service Market Analysis and Forecast
14.1. Introduction
14.2. Key Findings
14.3. Market Value Forecast, by Method, 2017-2031
14.3.1. Viral Removal
14.3.2. Viral Inactivation
14.3.2.1. Chemical
14.3.2.2. Radiation
14.3.2.3. Others
14.4. Market Value Forecast, by Application, 2017-2031
14.4.1. Recombinant Proteins
14.4.2. Tissue and Blood-derived Products
14.4.3. Vaccines
14.4.4. Others
14.5. Market Value Forecast, by End-user, 2017-2031
14.5.1. Biopharmaceuticals
14.5.2. Contract Research Organizations
14.5.3. Academic Research Institutes
14.5.4. Others
14.6. Market Value Forecast, by Country/Sub-region, 2017-2031
14.6.1. GCC Countries
14.6.2. South Africa
14.6.3. Rest of Middle East & Africa
14.7. Market Attractiveness Analysis
14.7.1. By Method
14.7.2. By Application
14.7.3. By End-user
14.7.4. By Country/Sub-region
15. Competition Landscape
15.1. Market Player - Competitive Matrix (by Tier and Size of Companies)
15.2. Market Share Analysis, by Company (2022)
15.3. Company Profiles
15.3.1. Texcell
15.3.1.1. Company Overview
15.3.1.2. Product Portfolio
15.3.1.3. SWOT Analysis
15.3.1.4. Financial Overview
15.3.1.5. Strategic Overview
15.3.2. Eurofins Scientific SE
15.3.2.1. Company Overview
15.3.2.2. Product Portfolio
15.3.2.3. SWOT Analysis
15.3.2.4. Financial Overview
15.3.2.5. Strategic Overview
15.3.3. Charles River Laboratories International, Inc.
15.3.3.1. Company Overview
15.3.3.2. Product Portfolio
15.3.3.3. SWOT Analysis
15.3.3.4. Financial Overview
15.3.3.5. Strategic Overview
15.3.4. Merck KGaA
15.3.4.1. Company Overview
15.3.4.2. Product Portfolio
15.3.4.3. SWOT Analysis
15.3.4.4. Financial Overview
15.3.4.5. Strategic Overview
15.3.5. WuXi AppTec
15.3.5.1. Company Overview
15.3.5.2. Product Portfolio
15.3.5.3. SWOT Analysis
15.3.5.4. Financial Overview
15.3.5.5. Strategic Overview
15.3.6. Clean Cells
15.3.6.1. Company Overview
15.3.6.2. Product Portfolio
15.3.6.3. SWOT Analysis
15.3.6.4. Financial Overview
15.3.6.5. Strategic Overview
15.3.7. Vironova Biosafety AB
15.3.7.1. Company Overview
15.3.7.2. Product Portfolio
15.3.7.3. SWOT Analysis
15.3.7.4. Financial Overview
15.3.7.5. Strategic Overview
List of Tables
Table 01: Global Viral Clearance Service Market Size (US$ Mn) Forecast, by Method, 2017-2031
Table 02: Global Viral Clearance Service Market Size (US$ Mn) Forecast, by Application, 2017-2031
Table 03: Global Viral Clearance Service Market Size (US$ Mn) Forecast, by End-user, 2017-2031
Table 04: Global Viral Clearance Service Market Size (US$ Mn) Forecast, by Region, 2017-2031
Table 05: North America Viral Clearance Service Market Size (US$ Mn) Forecast, by Country, 2017-2031
Table 06: North America Viral Clearance Service Market Size (US$ Mn) Forecast, by Method, 2017-2031
Table 07: North America Viral Clearance Service Market Size (US$ Mn) Forecast, by Application, 2017-2031
Table 08: North America Viral Clearance Service Market Size (US$ Mn) Forecast, by End-user, 2017-2031
Table 09: Europe Viral Clearance Service Market Size (US$ Mn) Forecast, by Country/Sub-region, 2017-2031
Table 10: Europe Viral Clearance Service Market Size (US$ Mn) Forecast, by Method, 2017-2031
Table 11: Europe Viral Clearance Service Market Size (US$ Mn) Forecast, by Application, 2017-2031
Table 12: Europe Viral Clearance Service Market Size (US$ Mn) Forecast, by End-user, 2017-2031
Table 13: Asia Pacific Viral Clearance Service Market Size (US$ Mn) Forecast, by Country/Sub-region, 2017-2031
Table 14: Asia Pacific Viral Clearance Service Market Size (US$ Mn) Forecast, by Method, 2017-2031
Table 15: Asia Pacific Viral Clearance Service Market Size (US$ Mn) Forecast, by Application, 2017-2031
Table 16: Asia Pacific Viral Clearance Service Market Size (US$ Mn) Forecast, by End-user, 2017-2031
Table 17: Latin America Viral Clearance Service Market Size (US$ Mn) Forecast, by Country/Sub-region, 2017-2031
Table 18: Latin America Viral Clearance Service Market Size (US$ Mn) Forecast, by Method, 2017-2031
Table 19: Latin America Viral Clearance Service Market Size (US$ Mn) Forecast, by Application, 2017-2031
Table 20: Latin America Viral Clearance Service Market Size (US$ Mn) Forecast, by End-user, 2017-2031
Table 21: Middle East & Africa Viral Clearance Service Market Size (US$ Mn) Forecast, by Country/Sub-region, 2017-2031
Table 22: Middle East & Africa Viral Clearance Service Market Size (US$ Mn) Forecast, by Method, 2017-2031
Table 23: Middle East & Africa Viral Clearance Service Market Size (US$ Mn) Forecast, by Application, 2017-2031
Table 24: Middle East & Africa Viral Clearance Service Market Size (US$ Mn) Forecast, by End-user, 2017-2031
List of Figures
Figure 01: Global Viral Clearance Service Market Size (US$ Mn) and Distribution (%), by Region, 2022-2031
Figure 02: Global Viral Clearance Service Market Revenue (US$ Mn), by Method, 2022
Figure 03: Global Viral Clearance Service Market Value Share, by Method, 2022
Figure 04: Global Viral Clearance Service Market Revenue (US$ Mn), by Application, 2022
Figure 05: Global Viral Clearance Service Market Value Share, by Application, 2022
Figure 06: Global Viral Clearance Service Market Revenue (US$ Mn), by End-user, 2022
Figure 07: Global Viral Clearance Service Market Value Share, by End-user, 2022
Figure 08: Global Viral Clearance Service Market Value Share, by Region, 2022
Figure 09: Global Viral Clearance Service Market Value (US$ Mn) Forecast, 2023-2031
Figure 10: Global Viral Clearance Service Market Value Share Analysis, by Method, 2022-2031
Figure 11: Global Viral Clearance Service Market Attractiveness Analysis, by Method, 2023-2031
Figure 12: Global Viral Clearance Service Market Value Share Analysis, by Application, 2022-2031
Figure 13: Global Viral Clearance Service Market Attractiveness Analysis, by Application, 2023-2031
Figure 14: Global Viral Clearance Service Market Value Share Analysis, by End-user, 2022-2031
Figure 15: Global Viral Clearance Service Market Attractiveness Analysis, by End-user, 2023-2031
Figure 16: Global Viral Clearance Service Market Value Share Analysis, by Region, 2022-2031
Figure 17: Global Viral Clearance Service Market Attractiveness Analysis, by Region, 2023-2031
Figure 18: North America Viral Clearance Service Market Value (US$ Mn) Forecast and Y-o-Y Growth (%), 2017-2031
Figure 19: North America Viral Clearance Service Market Attractiveness Analysis, by Country, 2023-2031
Figure 20: North America Viral Clearance Service Market Value Share Analysis, by Country, 2022-2031
Figure 21: North America Viral Clearance Service Market Value Share Analysis, by Method, 2022-2031
Figure 22: North America Viral Clearance Service Market Value Share Analysis, by Application, 2022-2031
Figure 23: North America Viral Clearance Service Market Value Share Analysis, by End-user, 2022-2031
Figure 24: North America Viral Clearance Service Market Attractiveness Analysis, by Method, 2023-2031
Figure 25: North America Viral Clearance Service Market Attractiveness Analysis, by Application, 2023-2031
Figure 26: North America Viral Clearance Service Market Attractiveness Analysis, by End-user, 2023-2031
Figure 27: Europe Viral Clearance Service Market Value (US$ Mn) Forecast and Y-o-Y Growth (%), 2017-2031
Figure 28: Europe Viral Clearance Service Market Attractiveness Analysis, by Country/Sub-region, 2023-2031
Figure 29: Europe Viral Clearance Service Market Value Share Analysis, by Country/Sub-region, 2022-2031
Figure 30: Europe Viral Clearance Service Market Value Share Analysis, by Method, 2022-2031
Figure 31: Europe Viral Clearance Service Market Value Share Analysis, by Application, 2022-2031
Figure 32: Europe Viral Clearance Service Market Value Share Analysis, by End-user, 2022-2031
Figure 33: Europe Viral Clearance Service Market Attractiveness Analysis, by Method, 2023-2031
Figure 34: Europe Viral Clearance Service Market Attractiveness Analysis, by Application, 2023-2031
Figure 35: Europe Viral Clearance Service Market Attractiveness Analysis, by End-user, 2023-2031
Figure 36: Asia Pacific Viral Clearance Service Market Value (US$ Mn) Forecast and Y-o-Y Growth (%), 2017-2031
Figure 37: Asia Pacific Viral Clearance Service Market Attractiveness Analysis, by Country/Sub-region, 2023-2031
Figure 38: Asia Pacific Viral Clearance Service Market Value Share Analysis, by Country/Sub-region, 2022-2031
Figure 39: Asia Pacific Viral Clearance Service Market Value Share Analysis, by Method, 2022-2031
Figure 40: Asia Pacific Viral Clearance Service Market Value Share Analysis, by Application, 2022-2031
Figure 41: Asia Pacific Viral Clearance Service Market Value Share Analysis, by End-user, 2022-2031
Figure 42: Asia Pacific Viral Clearance Service Market Attractiveness Analysis, by Method, 2023-2031
Figure 43: Asia Pacific Viral Clearance Service Market Attractiveness Analysis, by Application, 2023-2031
Figure 44: Asia Pacific Viral Clearance Service Market Attractiveness Analysis, by End-user, 2023-2031
Figure 45: Latin America Viral Clearance Service Market Value (US$ Mn) Forecast and Y-o-Y Growth (%), 2017-2031
Figure 46: Latin America Viral Clearance Service Market Attractiveness Analysis, by Country/Sub-region, 2023-2031
Figure 47: Latin America Viral Clearance Service Market Value Share Analysis, by Country/Sub-region, 2022-2031
Figure 48: Latin America Viral Clearance Service Market Value Share Analysis, by Method, 2022-2031
Figure 49: Latin America Viral Clearance Service Market Value Share Analysis, by Application, 2022-2031
Figure 50: Latin America Viral Clearance Service Market Value Share Analysis, by End-user, 2022-2031
Figure 51: Latin America Viral Clearance Service Market Attractiveness Analysis, by Method, 2023-2031
Figure 52: Latin America Viral Clearance Service Market Attractiveness Analysis, by Application, 2023-2031
Figure 53: Latin America Viral Clearance Service Market Attractiveness Analysis, by End-user, 2023-2031
Figure 54: Middle East & Africa Viral Clearance Service Market Size (US$ Mn) Forecast and Y-o-Y Growth (%), 2017-2031
Figure 55: Middle East & Africa Viral Clearance Service Market Attractiveness Analysis, by Country/Sub-region, 2023-2031
Figure 56: Middle East & Africa Viral Clearance Service Market Value Share Analysis, by Country/Sub-region, 2022-2031
Figure 57: Middle East & Africa Viral Clearance Service Market Value Share Analysis, by Method, 2022-2031
Figure 58: Middle East & Africa Viral Clearance Service Market Value Share Analysis, by Application, 2022-2031
Figure 59: Middle East & Africa Viral Clearance Service Market Value Share Analysis, by End-user, 2022-2031
Figure 60: Middle East & Africa Viral Clearance Service Market Attractiveness Analysis, by Method, 2023-2031
Figure 61: Middle East & Africa Viral Clearance Service Market Attractiveness Analysis, by Application, 2023-2031
Figure 62: Middle East & Africa Viral Clearance Service Market Attractiveness Analysis, by End-user, 2023-2031
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Viral Clearance Service Market
