Published: March 2023
In order to avail benefits, such as technical competence, compliance with regulations, reduced production costs and on-time approval of biologics, innovators have shown preference to leverage expertise of viral clearance and testing service providers
With the growing pipeline of biologics and the continuous revision of regulatory guidelines, the demand for viral clearance and testing services has increased in the biopharmaceutical industry. As a result, biopharmaceutical developers are outsourcing their viral clearance and testing operations to reliable and specialized contract research organizations (CROs), which provide a plethora of advanced technologies and dedicated expertise to cater to their evolving needs.
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More than 30 service providers are offering viral clearance and testing services for a wide variety of biologics
Over 90% of the players offer both viral inactivation and removal services; of these, close to 60% of the players provide such services for RNA enveloped viruses, followed by DNA non-enveloped viruses (~40%).
Around 260 patents related to viral clearance and testing have been filed / granted, since 2017
Based on the distribution of intellectual property across the world, R&D activity related to viral clearance and testing is largely concentrated in the US (around 25%), followed by China (over 15%). Further, it is worth highlighting that majority of the patents in this domain were filed by industry players (97%).
Partnership activity in this domain has increased between 2015 and 2022
The maximum number of partnerships related to viral clearance and testing were inked in 2016 (six), followed by 2021 (four). It is worth highlighting that majority of the deals were mergers and acquisitions, representing more than 75% of the total number of partnerships signed in the given time period.
Expansion activities in this domain have grown at a CAGR of ~20%, between 2017 and 2022
Around 90% of the initiatives were focused on the addition of new viral clearance and testing facilities / plants; of these, more than 50% of the expansion initiatives were undertaken for viral clearance services, followed by viral testing services (38%).
North America and Europe are anticipated to capture over 65% of the market share by 2035
In terms of end-users, biopharmaceutical and pharmaceutical companies are expected to contribute more than 70% of the total service revenues generated in 2035. Further, over 25% of the market share is anticipated to come in from academic / research institutes. In addition, it is worth noting that viral removal methods are likely to capture more than 55% of the market.
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The financial opportunity within the viral clearance and testing services market has been analyzed across the following segments:
The research also includes profiles of key players (listed below), engaged in providing services related to viral clearance and testing; each profile features an overview of the company, financial information (if available), details on its service portfolio, recent developments, and an informed future outlook:
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