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Global Viral Clearance Market Share, Size, Forecast: By Method: Viral Removal Method, Viral Inactivation Method, Other Methods; By Application: Recombinant Proteins, Vaccines, Blood and Blood Products, Cellular and Gene Therapy Products, Others; By End User; Regional Analysis; Patent Analysis; Grants Analysis; Supplier Landscape; 2024-2032
Global Viral Clearance Market Outlook
The global viral clearance market would likely grow at a CAGR of 9.6% during 2024-2032. Viral contamination poses a common but significant threat to human and animal-derived biopharmaceuticals. Such contamination may affect any phase of a bioproduction process, and biomanufacturers must carry out viral testing studies and include viral clearance methods into their procedures.
Viral clearance refers to removal of viral contamination with the help of specialized membranes (generally proteins) or chromatography. To ensure that therapeutic drugs drawn from particular sources are free of viral contamination, protein solutions go through viral clearance to remove or inactivate viral material. Asia Pacific, North America and Europe are likely to be key markets.
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Global Market Likely to be Driven by Need to Ensure Biopharmaceutical Product Safety
Viral clearance studies are important to manufacturers’ programs to ensure product safety. Producers of biopharmaceutical products or auxiliary material drawn from human or animal tissue are needed to exhibit the capability of their purification and production processes to inactivate or remove viruses or TSE agents and ascertain product safety.
Most viral contaminations associated with raw materials are linked with the use of materials drawn from animals. Materials like trypsin, serum, plasma proteins, and tissue and protein extracts may possibly carry viral contaminants. Among non-animal raw materials, glucose has the greatest risk of viral contamination in the upstream process, if a chemically defined medium is employed.
Examples of human or animal tissue-driven products include recombinant proteins, blood products, polyclonal antibodies, hormones, enzymes, and medical devices that carry animal or human blood-derived elements.
Leading Companies Offer Sophisticated Solutions to Meet Client Needs
Leading companies hold significant databases of thousands of studies conducted for clients that guide their ability to execute, develop, and assess the viral/TSE clearance studies that best fulfil client requirement.
Companies like Syngene offer viral testing and clearance services catering to client needs to fulfil the viral safety requirements of their Biologics programs. Such services are expected to boost the global viral clearance market.
Texcell provides diverse alternatives for quality data for regulatory submissions. The company defines investigational Viral Clearance studies as For Information Only or “FIO”, and customizes them to be quick, economical, and offer the most vital info required to design a robust GLP Viral Clearance. Viral Clearance products experience include, among others, recombinant proteins, monoclonal antibodies, ortho biologics, gene therapy products, bone, tissues, and collagen, blood products, nanoparticles, and vaccines.
Organizations like Eurofins BioPharma offer Viral Clearance Services that include several types of validated and well characterized viral stocks to support animal and human-derived products.
In 2020, Merck expanded BioReliance® Viral Clearance offering in Singapore to save customers’ time. The services would enable customers to carry out viral clearance studies that ensured the quality and safety of their biological drugs during the clinical development process. Such services are expected to boost the global viral clearance market.
Market Segmentation
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By method, the market is divided into:
- Viral Removal Method
- Viral Inactivation Method
By application, the market is segmented into:
- Recombinant Proteins
- Vaccines
- Blood and Blood Products
- Cellular and Gene Therapy Products
- Others
By end use, the global viral clearance market is classified into;
- Contract Research Organisation (CRO)
- Pharmaceutical and Biotech Industry
- Academic Research Institutes
- Others
By region, the market is segmented into:
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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Key Industry Players in the Market
The report offers an extensive assessment of major players in the global viral clearance market; it evaluates their capability, observes latest occurrences such as mergers and acquisitions, capacity expansions, and plant turnarounds:
- Merck KGaA
- WuXi AppTec Co., Ltd
- Charles River Laboratories International, Inc.
- Texcell SA
- Vironova AB
- Sartorius AG
- Syngene International Limited
- Creative Biogene
- Eurofins Scientific
- Others
Using SWOT analysis and Porter’s Five Forces model, the EMR report offers deep insights into the industry.
Key Highlights of the Report
| REPORT FEATURES | DETAILS |
| Base Year | 2023 |
| Historical Period | 2017-2023 |
| Forecast Period | 2024-2032 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Method |
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| Breakup by Application |
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| Breakup by End User |
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| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Viral Clearance Market Overview
3.1 Global Viral Clearance Market Historical Value (2017-2023)
3.2 Global Viral Clearance Market Forecast Value (2024-2032)
4 Global Viral Clearance Market Landscape
4.1 Global Viral Clearance Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 Global Viral Clearance Service Landscape
4.2.1 Analysis by Method
4.2.2 Analysis by Application
4.2.3 Analysis by End User
5 Global Viral Clearance Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.3 Porter’s Five Forces Model
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Viral Clearance Market Segmentation
6.1 Global Viral Clearance Market by Method
6.1.1 Market Overview
6.1.2 Viral Removal Method
6.1.3 Viral Inactivation Method
6.1.4 Other Methods
6.2 Global Viral Clearance Market by Application
6.2.1 Market Overview
6.2.2 Recombinant Proteins
6.2.3 Vaccines
6.2.4 Blood and Blood Products
6.2.5 Cellular and Gene Therapy Products
6.2.6 Others
6.3 Global Viral Clearance Market by End User
6.3.1 Market Overview
6.3.2 Contract Research Organization (CRO)
6.3.3 Pharmaceutical and Biotech Industry
6.3.4 Academic Research Institutes
6.3.5 Others
6.4 Global Viral Clearance Market by Region
6.4.1 Market Overview
6.4.2 North America
6.4.3 Europe
6.4.4 Asia Pacific
6.4.5 Latin America
6.4.6 Middle East and Africa
7 North America Viral Clearance Market
7.1 Market Share by Country
7.2 United States of America
7.3 Canada
8 Europe Viral Clearance Market
8.1 Market Share by Country
8.2 United Kingdom
8.3 Germany
8.4 France
8.5 Italy
8.6 Others
9 Asia Pacific Viral Clearance Market
9.1 Market Share by Country
9.2 China
9.3 Japan
9.4 India
9.5 ASEAN
9.6 Australia
9.7 Others
10 Latin America Viral Clearance Market
10.1 Market Share by Country
10.2 Brazil
10.3 Argentina
10.4 Mexico
10.5 Others
11 Middle East and Africa Viral Clearance Market
11.1 Market Share by Country
11.2 Saudi Arabia
11.3 United Arab Emirates
11.4 Nigeria
11.5 South Africa
11.6 Others
12 Patent Analysis
12.1 Analysis by Type of Patent
12.2 Analysis by Publication year
12.3 Analysis by Issuing Authority
12.4 Analysis by Patent Age
12.5 Analysis by CPC Analysis
12.6 Analysis by Patent Valuation
12.7 Analysis by Key Players
13 Grants Analysis
13.1 Analysis by year
13.2 Analysis by Amount Awarded
13.3 Analysis by Issuing Authority
13.4 Analysis by Grant Application
13.5 Analysis by Funding Institute
13.6 Analysis by NIH Departments
13.7 Analysis by Recipient Organization
14 Funding Analysis
14.1 Analysis by Funding Instances
14.2 Analysis by Type of Funding
14.3 Analysis by Funding Amount
14.4 Analysis by Leading Players
14.5 Analysis by Leading Investors
14.6 Analysis by Geography
15 Partnership and Collaborations Analysis
15.1 Analysis by Partnership Instances
15.2 Analysis by Type of Partnership
15.3 Analysis by Leading Players
15.4 Analysis by Geography
16 Regulatory Framework
16.1 Regulatory Overview
16.1.1 US FDA
16.1.2 EU EMA
16.1.3 INDIA CDSCO
16.1.4 JAPAN PMDA
16.1.5 Others
17 Supplier Landscape
17.1 Merck KGaA
17.1.1 Financial Analysis
17.1.2 Product Portfolio
17.1.3 Demographic Reach and Achievements
17.1.4 Mergers and Acquisitions
17.1.5 Certifications
17.2 WuXi AppTec Co., Ltd
17.2.1 Financial Analysis
17.2.2 Product Portfolio
17.2.3 Demographic Reach and Achievements
17.2.4 Mergers and Acquisitions
17.2.5 Certifications
17.3 Charles River Laboratories International, Inc.
17.3.1 Financial Analysis
17.3.2 Product Portfolio
17.3.3 Demographic Reach and Achievements
17.3.4 Mergers and Acquisitions
17.3.5 Certifications
17.4 Texcell SA
17.4.1 Financial Analysis
17.4.2 Financial Portfolio
17.4.3 Demographic Reach and Achievements
17.4.4 Mergers and Acquisitions
17.4.5 Certifications
17.5 Vironova AB
17.5.1 Financial Analysis
17.5.2 Product Portfolio
17.5.3 Demographic Reach and Achievements
17.5.4 Mergers and Acquisitions
17.5.5 Certifications
17.6 Sartorius AG
17.6.1 Financial Analysis
17.6.2 Product Portfolio
17.6.3 Demographic Reach and Achievements
17.6.4 Mergers and Acquisitions
17.6.5 Certifications
17.7 Syngene International Limited
17.7.1 Financial Analysis
17.7.2 Product Portfolio
17.7.3 Demographic Reach and Achievements
17.7.4 Mergers and Acquisitions
17.7.5 Certifications
17.8 Creative Biogene
17.8.1 Financial Analysis
17.8.2 Product Portfolio
17.8.3 Demographic Reach and Achievements
17.8.4 Mergers and Acquisitions
17.8.5 Certifications
17.9 Eurofins Scientific
17.9.1 Financial Analysis
17.9.2 Product Portfolio
17.9.3 Demographic Reach and Achievements
17.9.4 Mergers and Acquisitions
17.9.5 Certifications
17.10 ALLURE MEDICAL GROUP
17.10.1 Financial Analysis
17.10.2 Product Portfolio
17.10.3 Demographic Reach and Achievements
17.10.4 Mergers and Acquisitions
17.10.5 Certifications
17.11 MARAVAI LIFESCIENCES HOLDINGS, INC.
17.11.1 Financial Analysis
17.11.2 Product Portfolio
17.11.3 Demographic Reach and Achievements
17.11.4 Mergers and Acquisitions
17.11.5 Certifications
17.12 ViruSure GmbH
17.12.1 Financial Analysis
17.12.2 Product Portfolio
17.12.3 Demographic Reach and Achievements
17.12.4 Mergers and Acquisitions
17.12.5 Certifications
18 Global Viral Clearance Market - Distribution Model (Additional Insight)
18.1 Overview
18.2 Potential Distributors
18.3 Key Parameters for Distribution Partner Assessment
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
21.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
Key Questions Answered in the Report
The market is estimated to grow at a CAGR of 9.6% in the forecast period of between 2024 and 2032.
The major drivers of the market include the increasing application of viral clearance methods in pharmaceutical and biotechnological industries, rising cases of viral contaminations in animal and human-derived products, and growing health awareness.
The growing research and development activities by the pharmaceutical manufacturers and stringent regulations by various governments aimed towards bolstering safety standards, are the key trends in the market.
Viral removal method and viral inactivation method are the primary methods for viral clearance.
The different applications of viral clearance are recombinant proteins, vaccines, blood and blood products, and cellular and gene therapy products, among others.
The major players in the viral clearance market are Merck KGaA, WuXi AppTec Co., Ltd, Charles River Laboratories International, Inc., Texcell SA, Vironova AB, Sartorius AG, Syngene International Limited, Creative Biogene, and Eurofins Scientific, among others.
The cytotoxic cell, which is known to be a T-cell, is a common cause of viral clearance.
Viral clearance is important because various types of viral clearance methods reduce the risk of harmful contamination of viruses.
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