Viral Clearance and Testing Services Market, 2023-2035

Viral Clearance and Testing Services Market, 2023-2035

INTRODUCTION

Viral clearance and testing refers to the detection and elimination of viral contaminants, using a wide array of methods, to ensure the product’s safety for human use. Over the past few years, viral clearance and testing has emerged as one of the key pre-requisites for biopharmaceutical regulatory approvals. It is worth mentioning that, till date, over 630 biologics have already been approved by the Food and Drug Administration (FDA), while more than 8,000 biopharmaceuticals are in the clinical evaluation process. , , This increased number of approvals and ongoing clinical trials in the biopharmaceutical industry has resulted in a rise in the demand for such studies. However, virus removal, inactivation and detection requires specialized expertise as it is a complex, cost intensive, and time consuming process. Therefore, innovators are actively exploring avenues that would enable them to overcome the existing challenges. Among other alternatives, outsourcing these studies to service providers having FDA accredited laboratories has emerged as a preferred option for most of the biopharmaceutical manufacturers. Presently, a number of players across the globe are actively engaged in providing efficient viral clearance and testing services throughout the research and development process. Further, as more biologics enter into the development pipeline, the market of viral clearance and testing services is anticipated to witness a healthy growth.

KEY MARKET INSIGHTS

The Viral Clearance and Testing Services Market - Distribution by Scale of Operation (Discovery Phase, Preclinical Phase and Clinical Phase), Method of Viral Clearance and 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 report features an extensive study of the current market landscape and future opportunity for the players involved in offering services related to viral clearance and testing. The report answers many key questions related to this domain.

Benefits and Growing Demand for Viral Clearance and Testing Services

Viral clearance and testing studies have emerged as a mandatory step for regulatory submissions of biologics for commercial applications. These studies result in streamlined manufacturing of contamination free / safe products and on-time delivery of biologics. Owing to this, the demand for these services has increased significantly. It is worth highlighting that, with the continuous revision of the regulatory guidelines, viral clearance and testing studies are already amongst the most essential steps in the manufacturing of biologics, including antibodies, blood products, cell and gene therapies, hormones, recombinant proteins, therapeutic proteins and vaccines.

Need for Outsourcing Viral Clearance and Testing Studies

The rise of biologics has resulted in an increasing demand for viral clearance and testing studies. However, these studies are quite cost intensive, time-consuming and follow stringent regulatory guidelines. In addition, they require specialized technical skills and good scientific expertise. This has prompted the biopharmaceutical developers to outsource these studies to the service providers, which have aseptic laboratories, GMP-certified facilities and specialized equipment in accordance with the requirements of regulatory authorities.

Current Market Landscape of Viral Clearance and Testing Service Providers

The viral clearance and testing service providers landscape features a mix of large, mid-sized and small companies, which have the required expertise to offer various services for the viral clearance and testing of biologics, across the manufacturing and purification stages. It is worth highlighting that majority of the service providers are large companies. Recent developments in this segment of the biopharmaceutical industry indicate that the service providers are upgrading their capabilities and infrastructure to accommodate the current and anticipated demand for these services.

Key Drivers in the Viral Clearance and Testing Services Market

Since the onset of the COVID-19 pandemic, viral clearance and testing services for biopharmaceuticals have garnered significant attention. In addition, the success of next-generation sequencing in efficiently detecting a wide variety of viruses has created an enormous need for the consistent usage of such advanced tools / methods in viral clearance and testing studies. In the coming decade, several promising techniques, specifically those exhibiting enhanced efficacy, are anticipated to develop at a faster rate. Moreover, considering the active involvement of large players as well as the new entrants, the viral clearance and testing services market is likely to witness healthy growth. Further, to address the growing demand for these services, various large players have undertaken several initiatives, including strengthening their respective service portfolios, entering into strategic deals, and expanding their facility and capacity.

Market Size of the Viral Clearance and Testing Services Market

Driven by the rising interest in research and development activities and the demand for viral clearance and testing services, the future opportunities and growth associated with this market are anticipated to witness a noteworthy growth in the foreseen future. Specifically, in terms of end-users, the market is anticipated to be driven by biotechnology and pharmaceutical industry. In addition, presently, more than 60% of the market is captured by players based in North America and Europe.

Key Players in the Viral Clearance and Testing Services Market

Examples of key players engaged in this domain (which have also been captured in this report) include Charles River Laboratories, Creative Biolabs, Eurofins Scientific, Microbac Laboratories, MilliporeSigma, Nelson Labs, Syngene International, Texcell, Vironova and WuXi Biologics.

SCOPE OF THE REPORT

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments as defined in the below table:

Viral Clearance and Testing Services Market: Report Attribute / Market Segmentations

Report Attribute Details

Forecast Period 2023 – 2035

Scale of Operation Discovery Phase, Preclinical Phase, Clinical Phase

Method of Viral Clearance and Testing Viral Detection, Viral Inactivation, Viral Removal

End-User Biotechnology and Pharmaceutical Companies, Academic / Research Institutes

Key Geographical Regions North America, Europe, Asia-Pacific, Rest of the World

Key Companies Profiled Charles River Laboratories, Eurofins Scientific, Microbac Laboratories, Nelson Labs, Pall, Syngene International, Texcell

(Full list of 30+ companies captured in the market landscape analysis of the report)

Customization Scope 15% Free Customization Option (equivalent to 5 analysts working days)

PowerPoint Presentation (Complimentary) Available

Excel Data Packs (Complimentary) Market Landscape Analysis, Company Competitiveness Analysis, Patent Analysis, Recent Developments, Market Forecast and Opportunity Analysis

Source: Roots Analysis

The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different geographies. Amongst other elements, the report includes:

An executive summary of the insights captured during our research. It offers a high-level view on the current state of viral clearance and testing services market and its likely evolution in the mid-long term.

A general overview of the viral clearance and testing studies, highlighting details on viral contamination in biologics and the need for viral clearance and testing. It also presents information on the process of viral clearance and testing, and regulatory guidelines related to viral contamination. Additionally, it features a discussion on the future perspectives of the viral clearance and testing industry.

A detailed assessment of the overall market landscape of the companies offering viral clearance and testing services, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of viral clearance and testing facilities, type of virus detected (by envelope - RNA enveloped, RNA non-enveloped, DNA enveloped and DNA non-enveloped), type of virus detected (by class - retrovirus, adenovirus, lentivirus, adeno-associated virus (AAV), herpesvirus and others), key offerings (viral clearance services, viral testing services and viral clearance products), type of biologic(s) analyzed (antibodies, cell and gene therapies, vaccines, recombinant proteins, blood and blood products, hormones and others), method(s) of viral clearance (inactivation - pH treatment, solvent detergent, heat pasteurization and others), method(s) of viral clearance (removal - chromatography, filtration, precipitation and others) and type of viral testing service(s) offered (cell bank testing, raw material testing, unprocessed bulk testing and end of production process testing).

A detailed competitiveness analysis of viral clearance and testing service providers based in North America, Europe and Asia-Pacific. The analysis compares the service providers based on supplier strength (in terms of years of experience and company size) and service strength (considering key offerings, type of virus detected (by envelope), type of virus detected (by class), method(s) of viral clearance (removal), method(s) of viral clearance (inactivation), viral testing service(s) offered, type of biologic(s) analyzed and additional services offered).

Tabulated profiles of key players based in North America, Europe and Asia-Pacific that are engaged in providing services related to viral clearance and testing (shortlisted based on strength of service portfolio). Each profile includes a brief overview of the company, financial information (if available), information on viral clearance and testing related services, recent developments and an informed future outlook.

An in-depth analysis of various patents that have been filed / granted for viral clearance and testing, since 2017, based on various relevant parameters, such type of patent, publication year, application year, type of organization, emerging focus areas, geographical location, CPC symbols, leading players (in terms of number of patents granted / filed), patent benchmarking (in terms of CPC symbols and leading players), patent characteristics and patent age. It also includes an insightful patent valuation analysis and list of leading patents by number of citations.

A detailed analysis of recent developments taking place in this domain. This chapter includes the partnerships inked between stakeholders engaged in this domain, since 2015, covering instances of mergers and acquisitions, service agreements, service alliances, technology assessment agreements and other agreements. Further, it comprises of analysis of the deals inked based on year of partnership, type of partnership, purpose of partnership, type of organization, location of facility, and geographical region. It also highlights the most active players (in terms of number of partnerships) in the domain. In addition, this chapter also includes a detailed assessment of the recent expansion initiatives undertaken by various service providers to enhance viral clearance and testing capabilities, based on various parameters, including year of expansion, type of expansion, focus of expansion, type of service(s) offered, type of biologic(s) involved, and geography. It also highlights the most active players (in terms of number of expansions) in the domain.

One of the key objectives of the report was to estimate the current opportunity and the future growth potential of the viral clearance and testing services market over the coming years. We have provided informed estimates on the likely evolution of the market for the period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as scale of operation (discovery phase, preclinical phase and clinical phase), method of viral clearance and 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). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

FREQUENTLY ASKED QUESTIONS

Question 1: What is viral contamination in biopharmaceutical industry?

Answer: Viral contamination is a serious threat to the biopharmaceutical industry; it occurs when the biologics are infected by the endogenous and adventitious viruses, during the production process. The potential sources of these viruses include cell lines, blood, hormones and other animal or human derived unprocessed material.

Question 2: How many players are providing services related to viral clearance and testing?

Answer: Presently, more than 30 companies offer various services related to viral clearance and testing, including viral testing services (such as cell bank testing, raw material testing, unprocessed bulk testing and end of production process testing) and viral clearance services (such as several virus inactivation and removal methods). In addition, few service providers offer services for the specialized detection and removal of prions and transmissible spongiform encephalopathies (TSE).

Question 3: How many patents, related to viral clearance and testing, have been filed / granted in the last few years?

Answer: More than 260 patents, related to viral clearance and testing, have been filed / granted in the last few years. It is worth mentioning that most of the patents have been filed by industry players and are focused on viral removal methods and techniques.

Question 4: What is the partnership and collaboration trend in viral clearance and testing services domain?

Answer: Currently, mergers and acquisitions are the most preferred type of partnership models adopted by the stakeholders in this domain. This is followed by service agreements, service alliances and technology assessment agreements.

Question 5: Which segment is likely to have the largest share in the viral clearance and testing services market?

Answer: Presently, viral removal dominates the viral clearance and testing services market. This can be attributed to the ongoing innovations and advancements in viral removal techniques, such as chromatography, filtration, and precipitation.

Question 6: What are the recent developments in the viral clearance and testing services market?

Answer: Viral clearance and testing service providers have made significant investments to expand their respective capabilities through the incorporation of advanced methods, technologies, and platforms; this is required for attracting a client base across different geographies. In addition, players have also inked a number of partnerships to enhance their expertise, technology and operations portfolio.

Question 7: Which geographical segment has the highest growth rate in viral clearance and testing services market?

Answer: Europe is likely to grow at the highest CAGR, during the period 2023- 2035.

CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, Viral Clearance and Testing Services Market, 2023-2035.

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the viral clearance and testing services market and its likely evolution in the short to mid-term and long term.

Chapter 3 provides general overview of viral clearance and testing studies, highlighting details on the viral contamination in biologics and the need for viral clearance and testing. It also presents information on the process of viral clearance and testing, and regulatory guidelines related to viral contamination. Additionally, it features a discussion on the future perspectives of the viral clearance and testing industry.

Chapter 4 includes detailed assessment of the overall market landscape of the companies offering viral clearance and testing services, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of viral clearance and testing facilities, type of virus detected (by envelope - RNA enveloped, RNA non-enveloped, DNA enveloped and DNA non-enveloped), type of virus detected (by class - retrovirus, adenovirus, lentivirus, adeno-associated virus (AAV), herpesvirus and others), key offerings (viral clearance services, viral testing services and viral clearance products), type of biologic(s) analyzed (antibodies, cell and gene therapies, vaccines, recombinant proteins, blood and blood products, hormones and others), method(s) of viral clearance (inactivation - pH treatment, solvent detergent, heat pasteurization and others), method(s) of viral clearance (removal - chromatography, filtration, precipitation and others) and type of viral testing service(s) offered (cell bank testing, raw material testing, unprocessed bulk testing and end of production process testing).

Chapter 5 presents a detailed competitiveness analysis of viral clearance and testing service providers based in North America, Europe and Asia-Pacific. The analysis compares the service providers based on supplier strength (in terms of years of experience and company size) and service strength (considering key offerings, type of virus detected (by envelope), type of virus detected (by class), method(s) of viral clearance (inactivation), method(s) of viral clearance (removal), viral testing service(s) offered, type of biologic(s) analyzed and additional services offered).

Chapter 6 features tabulated profiles of key players based in North America and are engaged in providing services related to viral clearance and testing (shortlisted based on strength of service portfolio). Each profile includes a brief overview of the company, financial information (if available), information on viral clearance and testing related services, recent developments and an informed future outlook.

Chapter 7 features tabulated profiles of key players based in Europe and Asia-Pacific and are engaged in providing services related to viral clearance and testing (shortlisted based on strength of service portfolio). Each profile includes a brief overview of the company, financial information (if available), information on viral clearance and testing related services, recent developments and an informed future outlook.

Chapter 8 provides an in-depth analysis of various patents that have been filed / granted for viral clearance and testing since 2017, based on various relevant parameters, such type of patent, publication year, application year, type of organization, emerging focus areas, geographical location, CPC symbols, leading players (in terms of number of patents granted / filed), patent benchmarking (in terms of CPC symbols and leading players), patent characteristics and patent age. It also includes an insightful patent valuation analysis and list of leading patents by number of citations.

Chapter 9 presents a detailed analysis of recent developments taking place in this domain. This chapter includes the partnerships inked between stakeholders engaged in this domain, since 2015, covering instances of mergers and acquisitions, service agreements, service alliances, technology assessment agreements and other agreements. Further, it comprises of analysis of the deals inked based on year of partnership, type of partnership, purpose of partnership, type of organization, location of facility, and geographical region. It also highlights the most active players (in terms of number of partnerships) in the domain. In addition, this chapter also includes a detailed assessment of the recent expansion initiatives undertaken by various service providers to enhance viral clearance and testing capabilities, based on various parameters, including year of expansion, type of expansion, focus of expansion, type of service(s) offered, type of biologic(s) involved, and geography. It also highlights the most active players (in terms of number of expansions) in the domain.

Chapter 10 features a comprehensive market forecast analysis, highlighting the future potential of the market till 2035. We have segregated the current and upcoming opportunity based on scale of operation (discovery phase, preclinical phase and clinical phase), method of viral clearance and 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).

Chapter 11 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it summarizes the various evolutionary trends that are likely to influence the future of this market.

Chapter 12 provides the transcripts of interviews conducted with key stakeholders in the industry.

Chapter 13 is an appendix, which contains tabulated data and numbers for all the figures included in this report.

Chapter 14 is an appendix, which contains a list of companies and organizations mentioned in this report.