The global viral clearance market was valued at $425.93 million in 2021, and is projected to reach $977.84 million by 2031, registering a CAGR of 8.6% from 2022 to 2031.
Viral clearance is the removal of viral contamination using specialized membranes (mostly proteins) or chromatography. These protein solutions undergo viral clearance to inactivate or remove viral materials to ensure that therapeutic drugs derived from certain sources are fully rid of any viral contamination.
Viral clearance is a critical step in the manufacturing process that helps assure the safety of biologics such as biosimilars, antibodies, stem cell products, biopharmaceuticals, and others. Pharmaceutical and other product manufacturers need to be confirmed of its purification and manufacturing processes' capacity to inactivate or eliminate viruses or Transmissible spongiform encephalopathies(TSE) agents, as well as assure product safety.
The key factors that drive the growth of the market are rise in investments in the biotechnology and the pharmaceutical companies. There has been a rise in drug launches, increase in R&D investments, and rise in the possibility of cell culture contamination, recent advancements in nano-filtration technology, large economic burden and incidence of chronic diseases which is projected to provide huge opportunities for the growth of the viral clearance market. Along with this, rise in pharmaceutical outsourcing and increase in emerging markets are creating opportunities for the growth of the viral clearance market.
However, ever increasing cost and time-intensive drug development process are creating hurdles in the viral clearance market. In addition, increased degree of consolidation is also obstructing the growth of the market.
The viral clearance market is segmented on the basis of method, application, end user, and region. By method, it is categorized into viral removal, and viral inactivation. Viral removal is further divided into chromatography, nanofiltration, and precipitation. Viral inactivation is further categorized into low pH, solvent detergent method, heat pasteurization, and other viral inactivation methods. Depending on application, it is classified into recombinant proteins, blood and blood products, cellular and gene therapy products, vaccines, and other applications. By end user, it is categorized into pharmaceutical & biotechnology companies, contract research organizations, academic research institutes, and others.
Region wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and Rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and Rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and Rest of LAMEA).
North America accounted for the largest market share in the viral clearance market in 2021 and is expected to retain its dominance throughout the forecast period. This is primarily attributed to increase in demand for biopharmaceutical and upsurge in demand for advanced technologies in the purification of recombinant proteins produced by animal cell cultures to create high-value products of modern biotechnology.
The report provides a comprehensive analysis of the key players that operate in the global viral clearance market. The key companies profiled in the report include Allure Medical Group, Charles River Laboratories International, Inc., Clean Cells, Creative Biogene, Eurofins Scientific SE, Maravai Lifesciences Holding, Inc., Merck KGaA, Sartorius Stedium Biotech, Syngene International Limited, and Wuxi Biologics Inc.
Viral clearance is the removal of viral contamination using specialized membranes (mostly proteins) or chromatography. These protein solutions undergo viral clearance to inactivate or remove viral materials to ensure that therapeutic drugs derived from certain sources are fully rid of any viral contamination.
Viral clearance is a critical step in the manufacturing process that helps assure the safety of biologics such as biosimilars, antibodies, stem cell products, biopharmaceuticals, and others. Pharmaceutical and other product manufacturers need to be confirmed of its purification and manufacturing processes' capacity to inactivate or eliminate viruses or Transmissible spongiform encephalopathies(TSE) agents, as well as assure product safety.
The key factors that drive the growth of the market are rise in investments in the biotechnology and the pharmaceutical companies. There has been a rise in drug launches, increase in R&D investments, and rise in the possibility of cell culture contamination, recent advancements in nano-filtration technology, large economic burden and incidence of chronic diseases which is projected to provide huge opportunities for the growth of the viral clearance market. Along with this, rise in pharmaceutical outsourcing and increase in emerging markets are creating opportunities for the growth of the viral clearance market.
However, ever increasing cost and time-intensive drug development process are creating hurdles in the viral clearance market. In addition, increased degree of consolidation is also obstructing the growth of the market.
The viral clearance market is segmented on the basis of method, application, end user, and region. By method, it is categorized into viral removal, and viral inactivation. Viral removal is further divided into chromatography, nanofiltration, and precipitation. Viral inactivation is further categorized into low pH, solvent detergent method, heat pasteurization, and other viral inactivation methods. Depending on application, it is classified into recombinant proteins, blood and blood products, cellular and gene therapy products, vaccines, and other applications. By end user, it is categorized into pharmaceutical & biotechnology companies, contract research organizations, academic research institutes, and others.
Region wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and Rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and Rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and Rest of LAMEA).
North America accounted for the largest market share in the viral clearance market in 2021 and is expected to retain its dominance throughout the forecast period. This is primarily attributed to increase in demand for biopharmaceutical and upsurge in demand for advanced technologies in the purification of recombinant proteins produced by animal cell cultures to create high-value products of modern biotechnology.
The report provides a comprehensive analysis of the key players that operate in the global viral clearance market. The key companies profiled in the report include Allure Medical Group, Charles River Laboratories International, Inc., Clean Cells, Creative Biogene, Eurofins Scientific SE, Maravai Lifesciences Holding, Inc., Merck KGaA, Sartorius Stedium Biotech, Syngene International Limited, and Wuxi Biologics Inc.
KEY BENEFITS FOR STAKEHOLDERS
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the viral clearance market analysis from 2021 to 2031 to identify the prevailing viral clearance market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the viral clearance market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global viral clearance market trends, key players, market segments, application areas, and market growth strategies.
Key Market Segments
By Method
- Viral Removal
- Type
- Chromatography
- Nanofiltration
- Precipitation
- Viral Inactivation
- Type
- Low pH
- Solvent Detergent Method
- Heat Pasteurization
- Other Viral Inactivation Methods
By Application
- Recombinant Proteins
- Blood and Blood Products
- Cellular and Gene Therapy Products
- Vaccine
- Other Applications
By End User
- Pharmaceutical and Biotechnology Companies
- Contract Research Organizations
- Academic Research Institutes
- Others
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Italy
- Spain
- Germany
- France
- UK
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- LAMEA
- Brazil
- South Africa
- Saudi Arabia
- Rest of LAMEA
Key Market Players
- ALLURE MEDICAL GROUP
- Charles River Laboratories International, Inc.
- CLEAN CELLS
- CREATIVE BIOGENE
- EUROFINS SCIENTIFIC SE
- MARAVAI LIFESCIENCES HOLDINGS, INC.
- MERCK KGAA
- SARTORIUS STEDIM BIOTECH
- SYNGENE INTERNATIONAL LIMITED
- WUXI BIOLOGICS INC.
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Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: VIRAL CLEARANCE MARKET, BY METHOD
CHAPTER 5: VIRAL CLEARANCE MARKET, BY APPLICATION
CHAPTER 6: VIRAL CLEARANCE MARKET, BY END USER
CHAPTER 7: VIRAL CLEARANCE MARKET, BY REGION
CHAPTER 8: COMPANY LANDSCAPE
CHAPTER 9: COMPANY PROFILES
List of Tables
List of Figures
Executive Summary
According to the report, titled, “Viral clearance Market," the viral clearance market size was $425.93 million in 2021, and is estimated to reach $977.8 million by 2031, growing at a CAGR of 8.6% from 2022 to 2031.Viral detection and clearance is performed to demonstrate clearance of viruses known to be related to a process. Viral clearance services industry are useful before launching a biologic to the market.
There is no such test present to detect all viruses at once, which lead to a minimum level of viruses test for detection. Some methods measure markers of infection, providing results long after infection occurs. Hence, ensuring that a product is free from viral contamination depends on ensuring that a process can inactivate or remove viruses as well as testing for their presence. Such an approach is the only way to ensure that biopharmaceuticals will be free from viral contamination and safe for human use. It is also important to recognize which viruses can possibly contaminate a product and enter its manufacturing process.
The viral clearance market is segmented on the basis of method, application, end user, and region. By method, it is categorized into viral removal, and viral inactivation. Viral removal is further divided into chromatography, nanofiltration, and precipitation. Viral inactivation is further categorized into low pH, solvent detergent method, heat pasteurization, and other viral inactivation methods. Depending on application, it is classified into recombinant proteins, blood and blood products, cellular and gene therapy products, vaccines, and other applications. By end user, it is categorized into pharmaceutical & biotechnology companies, contract research organizations, academic research institutes, and others.
Region wise, the market is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, the UK, Italy, Spain, and Rest of Europe), Asia-Pacific (Japan, China, Australia, India, South Korea, and Rest of Asia-Pacific), and LAMEA (Brazil, South Africa, Saudi Arabia, and Rest of LAMEA).
By method, the viral removal segment currently dominates the global viral clearance market share and is expected to remain dominant during the forecast period, owing to increase in awareness about the benefits of using viral removals among healthcare professionals and consumers fueling the demand for the viral removals. By application, the recombinant proteins segment dominated the market in 2021, and this trend is expected to continue during the forecast period owing to continuous rise of chronic illnesses across the globe. Apart from the surge in chronic diseases, the rise in funding of the worldwide government on R&D activities are also fuelling the viral clearance market growth efficiently. By end user, the pharmaceutical and biotechnology companies segment dominated the market in 2021, and this trend is expected to continue during the forecast period owing to increase in utilization of viral clearance processing during production of biopharmaceuticals, and key players operating in the market are adopting various key strategies to expand their business and rising investment on R&D segment, these also form key viral clearance market trends.
By region, North America accounted for the largest market share in the viral clearance testing industry in 2021 and is expected to retain its dominance throughout the forecast period. This is primarily attributed to increase in demand for biopharmaceutical and upsurge in demand for advanced technologies in the purification of recombinant proteins produced by animal cell cultures to create high-value products of modern biotechnology.
Asia-Pacific witnessed the highest growth rate for the viral clearance market and is expected to continue this trend throughout the forecast period, which is attributed to its R&D activities for biopharmaceuticals, rise in investments made by the market players and increase in government support.
The report provides a comprehensive analysis of the key players that operate in the global viral clearance market. The key companies profiled in the report include Allure Medical Group, Charles River Laboratories International, Inc., Clean Cells, Creative Biogene, Eurofins Scientific SE, Maravai Lifesciences Holding, Inc., Merck KGaA, Sartorius Stedium Biotech, Syngene International Limited, and Wuxi Biologics Inc.
Key Findings of the Study
- On the basis of method, the viral removal segment held 59.39% share in the global market in 2021.
- On the basis of application, the recombinant proteins segment held the largest market share in 2021, and is expected to remain dominant throughout the forecast period.
- On the basis of end user, the pharmaceutical and biotechnology companies segment held the largest market share in 2021, and is expected to remain dominant throughout the forecast period.
- Region wise, North America is expected to experience the highest market share during the forecast period. This was attributed to biopharmaceutical and upsurge in demand for advanced technologies in the purification of recombinant proteins produced by animal cell cultures to create high-value products of modern biotechnology.
Companies Mentioned
- Allure Medical Group
- Charles River Laboratories International, Inc.
- Clean Cells
- Creative Biogene
- Eurofins Scientific Se
- Maravai Lifesciences Holdings, Inc.
- Merck Kgaa
- Sartorius Stedim Biotech
- Syngene International Limited
- Wuxi Biologics Inc.
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 288 |
| Published | July 2022 |
| Forecast Period | 2021 - 2031 |
| Estimated Market Value ( USD | $ 425.93 million |
| Forecasted Market Value ( USD | $ 977.84 million |
| Compound Annual Growth Rate | 8.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
