Viral Clearance Market - Distribution by Scale of Operation (Discovery Phase, Preclinical Phase and Clinical Phase), Method of Viral Clearance Testing (Viral Detection, Viral Inactivation and Viral Removal), End User (Biotechnology and Pharmaceutical Companies and Academic / Research Institutes) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2023-2035
The viral clearance market is expected to reach USD 554 million in 2023 anticipated to grow at a CAGR of 10% during the forecast period 2023-2035.
Viral clearance testing plays a pivotal role in ensuring the safety of biopharmaceutical products by identifying and eliminating viral impurities. This process has become increasingly crucial for securing regulatory approvals, particularly with the Food and Drug Administration (FDA) having already approved over 630 biologics and more than 8,000 undergoing clinical evaluation. The growing number of approved products and ongoing trials in this field has heightened the demand for comprehensive viral clearance studies. However, the methods employed for virus removal, inactivation, and detection are intricate, demanding specialized expertise, resources, and time. Consequently, there's a keen interest among innovators to overcome these challenges. One popular solution is outsourcing these studies to service providers equipped with FDA-accredited laboratories. This trend has gained traction among biopharmaceutical manufacturers seeking efficient solutions.
Currently, several global service providers are actively engaged in offering robust viral clearance testing services across the entire research and development phase. With a surge in biologics entering the development pipeline, the market for viral clearance services is anticipated to witness significant growth with a robust Compound Annual Growth Rate (CAGR) during the forecasted period.
Report Coverage
Viral clearance testing plays a pivotal role in ensuring the safety of biopharmaceutical products by identifying and eliminating viral impurities. This process has become increasingly crucial for securing regulatory approvals, particularly with the Food and Drug Administration (FDA) having already approved over 630 biologics and more than 8,000 undergoing clinical evaluation. The growing number of approved products and ongoing trials in this field has heightened the demand for comprehensive viral clearance studies. However, the methods employed for virus removal, inactivation, and detection are intricate, demanding specialized expertise, resources, and time. Consequently, there's a keen interest among innovators to overcome these challenges. One popular solution is outsourcing these studies to service providers equipped with FDA-accredited laboratories. This trend has gained traction among biopharmaceutical manufacturers seeking efficient solutions.
Currently, several global service providers are actively engaged in offering robust viral clearance testing services across the entire research and development phase. With a surge in biologics entering the development pipeline, the market for viral clearance services is anticipated to witness significant growth with a robust Compound Annual Growth Rate (CAGR) during the forecasted period.
Report Coverage
- The report examines the viral clearance market, focusing on operational scale, testing methods, end-user demographics, and key geographic regions.
- An analysis is conducted to evaluate factors such as drivers, restraints, opportunities, and challenges impacting market growth.
- It assesses potential advantages and challenges within the market landscape, providing insights into the competitive environment for leading market players.
- Revenue forecasts for market segments are provided concerning four major regions.
- The research comprehensively evaluates companies offering viral clearance testing services, covering aspects like establishment year, company size, headquarters and testing facility locations, identified virus types, key services offered, types of biologics analyzed, viral clearance methods employed, and types of testing services provided.
- A detailed comparative analysis of viral clearance testing service providers across North America, Europe, and Asia-Pacific is conducted, focusing on their strengths based on supplier and service capabilities. Factors such as experience, company size, key offerings, detected virus types, clearance methods, types of biologics analyzed, and additional services are considered.
- Comprehensive profiles of major players in North America, Europe, and Asia-Pacific engaged in viral clearance testing services are presented. These profiles encompass company overviews, financial details (if available), information about viral clearance and testing services, recent developments, and future prospects.
- An in-depth analysis of patents filed or granted for viral clearance testing since 2017 is carried out. This analysis considers parameters such as patent types, publication and application years, involved organizations, emerging focus areas, geographical locations, patent characteristics, valuation analysis, and leading patents based on citations.
- The recent industry developments section covers partnerships, mergers, acquisitions, service agreements, and expansions among stakeholders since 2015. It evaluates these deals by year, type, purpose, involved organizations, geographical locations, and active market players. Additionally, it assesses expansion initiatives by service providers to augment viral clearance testing capabilities, highlighting the most active providers in this domain.
- Charles River Laboratories
- Eurofins Scientific
- Microbac Laboratories
- Nelson Labs
- Pall
- Syngene International
- Texcell
1. PREFACE
1.1. Chapter Overview
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
2. EXECUTIVE SUMMARY
3 INTRODUCTION
3.1. Chapter Overview
3.2. Viral Contamination in Biologics
3.3. Need for Viral Clearance and Testing
3.4. Process of Viral Clearance and Testing
3.5. Regulatory Guidelines Related to Viral Contamination
3.6. Future Perspectives
4. VIRAL CLEARANCE TESTING SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Viral Clearance Testing Service Providers: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters (Region)
4.2.5. Analysis by Location of Viral Clearance Testing Facilities
4.2.6. Analysis by Type of Virus Detected (by Envelope)
4.2.7. Analysis by Type of Virus Detected (by Class)
4.2.8. Analysis by Key Offerings
4.2.9 Analysis by Type of Biologic(s) Analyzed
4.2.10 Analysis by Method(s) of Viral Clearance (Inactivation)
4.2.11 Analysis by Method(s) of Viral Clearance (Removal)
4.2.12 Analysis by Type of Viral Testing Service(s) Offered
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2 Methodology and Key Parameters
5.3. Viral Clearance Testing Service Providers in North America
5.4. Viral Clearance Testing Service Providers in Europe
5.5. Viral Clearance Testing Service Providers in Asia-Pacific and Rest of the World
6. VIRAL CLEARANCE TESTING SERVICE PROVIDERS IN NORTH AMERICA
6.1. Chapter Overview
6.2. Charles River Laboratories
6.2.1. Company Overview
6.2.2. Financial Information
6.2.3. Viral Clearance and Testing Related Services
6.2.4. Recent Developments and Future Outlook
6.3. Microbac Laboratories
6.3.1. Company Overview
6.3.2. Viral Clearance and Testing Related Services
6.3.3. Recent Developments and Future Outlook
6.4. Nelson Labs (subsidiary of Sotera Health)
6.4.1. Company Overview
6.4.2. Financial Information
6.4.3. Viral Clearance and Testing Related Services
6.4.4. Recent Developments and Future Outlook
6.5. Pall (subsidiary of Danaher)
6.5.1. Company Overview
6.5.2. Financial Information
6.5.3. Viral Clearance and Testing Related Services
6.5.4. Recent Developments and Future Outlook
7. VIRAL CLEARANCE TESTING SERVICE PROVIDERS IN EUROPE AND ASIA-PACIFIC
7.1. Chapter Overview
7.2. Eurofins Scientific
7.2.1. Company Overview
7.2.2. Financial Information
7.2.3. Viral Clearance and Testing Related Services
7.2.4. Recent Developments and Future Outlook
7.3. Syngene International
7.3.1. Company Overview
7.3.2. Financial Information
7.3.3. Viral Clearance and Testing Related Services
7.3.4. Recent Developments and Future Outlook
7.4. Texcell
7.4.1. Company Overview
7.4.2. Viral Clearance and Testing Related Services
7.4.3. Recent Developments and Future Outlook
8. PATENT ANALYSIS
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Viral Clearance Testing: Patent Analysis
8.3.1. Analysis by Patent Publication Year
8.3.2. Analysis by Patent Applications
8.3.3. Analysis by Type of Patent and Patent Publication Year
8.3.4. Analysis by Type of Organization
8.3.5. Word Cloud Analysis: Emerging Focus Areas
8.3.6. Analysis by Geography
8.3.7. Analysis by CPC Symbols
8.3.8. Leading Players: Analysis by Number of Patents
8.4. Viral Clearance Testing : Patent Benchmarking Analysis
8.4.1. Analysis by Patent Characteristics
8.5. Viral Clearance and Testing Services: Patent Valuation Analysis
8.6. Leading Patents by Number of Citations
9. RECENT DEVELOPMENTS
9.1 Chapter Overview
9.2. Partnerships and Collaborations
9.2.1. Partnership Models
9.2.2. Viral Clearance Testing Service Providers: List of Partnerships and Collaborations
9.2.3. Analysis by Year of Partnership
9.2.4. Analysis by Type of Partnership
9.2.5. Analysis by Year and Type of Partnership
9.2.6. Analysis by Purpose of Partnership
9.2.7. Analysis by Type of Organization
9.2.8. Analysis by Location of Facility (Country)
9.2.9. Analysis by Location of Facility (Region)
9.2.10. Most Active Players: Analysis by Number of Partnerships
9.2.11. Analysis by Geography
9.2.11.1. Intercontinental and Intracontinental Agreements
9.3. Recent Expansions
9.3.1. Viral Clearance Testing Service Providers: List of Recent Expansions
9.3.2. Analysis by Year of Expansion
9.3.3. Analysis by Type of Expansion
9.3.4. Analysis by Focus of Expansion
9.3.5. Analysis by Type of Service(s) Offered
9.3.6. Analysis by Type of Biologic(s) Involved
9.3.7. Analysis by Type of Expansion and Biologic(s) Involved
9.3.8. Most Active Players: Analysis by Number of Expansions
9.3.9. Analysis by Geography
10. VIRAL CLEARANCE TESTING SERVICES: MARKET FORECAST AND OPPORTUNITY ANALYSIS
10.1. Chapter Overview
10.2. Forecast Methodology and Key Assumptions
10.3. Global Viral Clearance Market, 2023-2035
10.3.1. Global Viral Clearance Market: Distribution by Scale of Operation, 2023 and 2035
10.3.1.1. Viral Clearance Market for Discovery Phase, 2023-2035
10.3.1.2. Viral Clearance Market for Preclinical Phase, 2023-2035
10.3.1.3. Viral Clearance Market for Clinical Phase, 2023-2035
10.3.2. Global Viral Clearance Market: Distribution by Method of Viral Clearance and Testing, 2023 and 2035
10.3.2.1. Viral Clearance Market for Viral Detection, 2023-2035
10.3.2.2. Viral Clearance Market for Viral Inactivation, 2023-2035
10.3.2.3. Viral Clearance Market for Viral Removal, 2023-2035
10.3.3. Global Viral Clearance Market: Distribution by End-User, 2023 and 2035
10.3.3.1. Viral Clearance Market for Biotechnology and Pharmaceutical Companies, 2023-2035
10.3.3.2. Viral Clearance Market for Academic / Research Institutes, 2023-2035
10.3.4. Global Viral Clearance Market: Distribution by Key Geographical Regions, 2023 and 2035
10.3.4.1. Viral Clearance Market in North America, 2023-2035
10.3.4.2. Viral Clearance Market in Europe, 2023-2035
10.3.4.3. Viral Clearance Market in Asia-Pacific, 2023-2035
10.3.4.4. Viral Clearance Market in Rest of the World, 2023-2035
11. CONCLUSION
12. EXECUTIVE INSIGHTS
13. APPENDIX 1: TABULATED DATA
14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
1.1. Chapter Overview
1.2. Key Market Insights
1.3. Scope of the Report
1.4. Research Methodology
1.5. Frequently Asked Questions
1.6. Chapter Outlines
2. EXECUTIVE SUMMARY
3 INTRODUCTION
3.1. Chapter Overview
3.2. Viral Contamination in Biologics
3.3. Need for Viral Clearance and Testing
3.4. Process of Viral Clearance and Testing
3.5. Regulatory Guidelines Related to Viral Contamination
3.6. Future Perspectives
4. VIRAL CLEARANCE TESTING SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Viral Clearance Testing Service Providers: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters (Region)
4.2.5. Analysis by Location of Viral Clearance Testing Facilities
4.2.6. Analysis by Type of Virus Detected (by Envelope)
4.2.7. Analysis by Type of Virus Detected (by Class)
4.2.8. Analysis by Key Offerings
4.2.9 Analysis by Type of Biologic(s) Analyzed
4.2.10 Analysis by Method(s) of Viral Clearance (Inactivation)
4.2.11 Analysis by Method(s) of Viral Clearance (Removal)
4.2.12 Analysis by Type of Viral Testing Service(s) Offered
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2 Methodology and Key Parameters
5.3. Viral Clearance Testing Service Providers in North America
5.4. Viral Clearance Testing Service Providers in Europe
5.5. Viral Clearance Testing Service Providers in Asia-Pacific and Rest of the World
6. VIRAL CLEARANCE TESTING SERVICE PROVIDERS IN NORTH AMERICA
6.1. Chapter Overview
6.2. Charles River Laboratories
6.2.1. Company Overview
6.2.2. Financial Information
6.2.3. Viral Clearance and Testing Related Services
6.2.4. Recent Developments and Future Outlook
6.3. Microbac Laboratories
6.3.1. Company Overview
6.3.2. Viral Clearance and Testing Related Services
6.3.3. Recent Developments and Future Outlook
6.4. Nelson Labs (subsidiary of Sotera Health)
6.4.1. Company Overview
6.4.2. Financial Information
6.4.3. Viral Clearance and Testing Related Services
6.4.4. Recent Developments and Future Outlook
6.5. Pall (subsidiary of Danaher)
6.5.1. Company Overview
6.5.2. Financial Information
6.5.3. Viral Clearance and Testing Related Services
6.5.4. Recent Developments and Future Outlook
7. VIRAL CLEARANCE TESTING SERVICE PROVIDERS IN EUROPE AND ASIA-PACIFIC
7.1. Chapter Overview
7.2. Eurofins Scientific
7.2.1. Company Overview
7.2.2. Financial Information
7.2.3. Viral Clearance and Testing Related Services
7.2.4. Recent Developments and Future Outlook
7.3. Syngene International
7.3.1. Company Overview
7.3.2. Financial Information
7.3.3. Viral Clearance and Testing Related Services
7.3.4. Recent Developments and Future Outlook
7.4. Texcell
7.4.1. Company Overview
7.4.2. Viral Clearance and Testing Related Services
7.4.3. Recent Developments and Future Outlook
8. PATENT ANALYSIS
8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Viral Clearance Testing: Patent Analysis
8.3.1. Analysis by Patent Publication Year
8.3.2. Analysis by Patent Applications
8.3.3. Analysis by Type of Patent and Patent Publication Year
8.3.4. Analysis by Type of Organization
8.3.5. Word Cloud Analysis: Emerging Focus Areas
8.3.6. Analysis by Geography
8.3.7. Analysis by CPC Symbols
8.3.8. Leading Players: Analysis by Number of Patents
8.4. Viral Clearance Testing : Patent Benchmarking Analysis
8.4.1. Analysis by Patent Characteristics
8.5. Viral Clearance and Testing Services: Patent Valuation Analysis
8.6. Leading Patents by Number of Citations
9. RECENT DEVELOPMENTS
9.1 Chapter Overview
9.2. Partnerships and Collaborations
9.2.1. Partnership Models
9.2.2. Viral Clearance Testing Service Providers: List of Partnerships and Collaborations
9.2.3. Analysis by Year of Partnership
9.2.4. Analysis by Type of Partnership
9.2.5. Analysis by Year and Type of Partnership
9.2.6. Analysis by Purpose of Partnership
9.2.7. Analysis by Type of Organization
9.2.8. Analysis by Location of Facility (Country)
9.2.9. Analysis by Location of Facility (Region)
9.2.10. Most Active Players: Analysis by Number of Partnerships
9.2.11. Analysis by Geography
9.2.11.1. Intercontinental and Intracontinental Agreements
9.3. Recent Expansions
9.3.1. Viral Clearance Testing Service Providers: List of Recent Expansions
9.3.2. Analysis by Year of Expansion
9.3.3. Analysis by Type of Expansion
9.3.4. Analysis by Focus of Expansion
9.3.5. Analysis by Type of Service(s) Offered
9.3.6. Analysis by Type of Biologic(s) Involved
9.3.7. Analysis by Type of Expansion and Biologic(s) Involved
9.3.8. Most Active Players: Analysis by Number of Expansions
9.3.9. Analysis by Geography
10. VIRAL CLEARANCE TESTING SERVICES: MARKET FORECAST AND OPPORTUNITY ANALYSIS
10.1. Chapter Overview
10.2. Forecast Methodology and Key Assumptions
10.3. Global Viral Clearance Market, 2023-2035
10.3.1. Global Viral Clearance Market: Distribution by Scale of Operation, 2023 and 2035
10.3.1.1. Viral Clearance Market for Discovery Phase, 2023-2035
10.3.1.2. Viral Clearance Market for Preclinical Phase, 2023-2035
10.3.1.3. Viral Clearance Market for Clinical Phase, 2023-2035
10.3.2. Global Viral Clearance Market: Distribution by Method of Viral Clearance and Testing, 2023 and 2035
10.3.2.1. Viral Clearance Market for Viral Detection, 2023-2035
10.3.2.2. Viral Clearance Market for Viral Inactivation, 2023-2035
10.3.2.3. Viral Clearance Market for Viral Removal, 2023-2035
10.3.3. Global Viral Clearance Market: Distribution by End-User, 2023 and 2035
10.3.3.1. Viral Clearance Market for Biotechnology and Pharmaceutical Companies, 2023-2035
10.3.3.2. Viral Clearance Market for Academic / Research Institutes, 2023-2035
10.3.4. Global Viral Clearance Market: Distribution by Key Geographical Regions, 2023 and 2035
10.3.4.1. Viral Clearance Market in North America, 2023-2035
10.3.4.2. Viral Clearance Market in Europe, 2023-2035
10.3.4.3. Viral Clearance Market in Asia-Pacific, 2023-2035
10.3.4.4. Viral Clearance Market in Rest of the World, 2023-2035
11. CONCLUSION
12. EXECUTIVE INSIGHTS
13. APPENDIX 1: TABULATED DATA
14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
