The global viral clearance service market was valued at US$ 261.9 Mn in 2017 and is anticipated to reach US$ 902.1 Mn by 2026, expanding at a CAGR of 14.9% from 2018 to 2030.
Global Viral Clearance Service Market – Snapshot
Increase in demand for detection of virus removal/inactivation in products during their early stages of development, rise in R&D expenditure, growing preference for outsourcing of viral clearance service to contract research organizations, rise in consumer awareness about safety associated with the use of health care and vaccines, and increase in concern of viral effects of blood-derived products are some factors boosting the demand for viral clearance service. Moreover, emergence of technologies, such as nanofilteration and chromatography services, and choice of choosing the method depends on type of product, process, and regulatory. The user would need to determine the level of virus clearance required (as per logarithmic reduction) before marketing approval of new molecules. Companies have started focusing on efficacy and quality with high investments in R&D owing to stringent restructuring of regulations by both U.S. FDA and the European Medicines Agency that have put in place requirements for viral safety in relation to biologics. This has ultimately helped boost the viral clearance service market.
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The viral clearance service market is witnessing robust expansion owing to increasing complexity of clinical trials, greater number of regulatory hurdles, and high investment required for infrastructure that results in greater clinical trials cost. Consequently, rising number of pharmaceutical companies are partnering with viral clearance service providers having the requisite infrastructure and expertise to manage costs and deadlines. Moreover, increasing focus on specialty drugs is likely to fuel the market, as specialty drugs require scientific expertise and highly tailored clinical trials that significantly increase costs.
The viral clearance service market has been segmented based on application, method, end-user, and region. In terms of applications, the recombinant proteins segment is estimated to account for a prominent share of the market. Rising prevalence of diseases, such as cardiovascular, diabetes, and oncological, robust pipeline of pharmaceutical and biopharmaceutical products, increasing expenditure on research and development, rising emphasis on innovative treatment therapies for existing as well upcoming diseases, increasing demand for outsourcing analytical testing, and optimal service provided by the viral clearance service provider companies are major factors driving the global viral clearance service market.
In terms of method, the global viral clearance services has been classified into viral removal and viral inactivation method. The viral removal segment leads the market and accounts for a major share, as it is a robust and effective method of removal of different types of viruses. It is also expensive, safe, and brings about a high degree of purity of sample. The viral inactivation segment has been further sub-segmented into chemical, radiation, and others such as pasteurization and dry and moist heat treatment.
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In terms of end-user, the global viral clearance service market has been categorized into biopharmaceuticals, contract research organizations, academic research institutes and other end-users. The biopharmaceuticals segment held a major market share in 2017. This can be attributed to the rise in R&D expenditure of these industries, increased outsourcing of clinical studies to contract research organizations that enables them to manage R&D costs and focus on their core competencies, and increase in pressure from regulatory agencies for viral removal/inactivation process in order to prove product safety to obtain market approval.
In terms of region, the global viral clearance service market has been categorized into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominates the global viral clearance services market due to the presence of a large number of viral clearance removal/inactivation service providers, high health care spending, and stringent regulations governing safety assessment of biologics and vaccines. Europe follows North America in terms of share of the market, which can be ascribed to the amendment of regulation made by governments in Europe in order to assess the safety of biological substances. The market in Asia Pacific is projected to expand at a significant CAGR during the forecast period owing to the emergence of CROs offering viral clearance services, as per regulatory requirements at a lower cost than that in other developed regions.
Prominent players operating in the global viral clearance service market include Texcell, Eurofins Scientific SE, Charles River Laboratories International, Inc., Merck KGaA (BioReliance), WuXi AppTec, Clean Cells, and Vironova Biosafety. Key players are expanding their product portfolio through mergers & acquisitions and partnerships & collaborations with leading pharmaceutical and biotechnology companies and by providing better services at a lower cost.
Growing Need for Safe Drug Development to Bring Tremendous Growth Opportunities for the Viral Clearance Service Market
The viral clearance service market is expected to gain good growth opportunities across the assessment period of 2018-2026 on the back of the rising demand for virus detection in specialty drugs and biological products. The growing demand for virus inactivation among a large number of drugs and biological products may bring extensive growth opportunities for the viral clearance service market.
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Viral clearance services are utilized for the removal of bacteria or viruses that are present on drugs, production equipment, or biological products. The services include the testing of end-products and ensure consistent and safe development of biological products. All these aspects bode well for the growth of the viral clearance service market.
The rising numbers of diseases and disorders around the world have prompted many pharmaceutical companies to launch novel drugs and medicines that treat the conditions or disorders at a faster pace. The growing drug production levels may bring extensive growth prospects for the viral clearance service market.
Research and development activities have a large role in the growth of the viral clearance service market. The players in the viral clearance service market invest in these activities for exploring insights that help in adding more features to the services. These features eventually help in boosting the growth prospects of the viral clearance service market.
Strategic collaborations are also playing a crucial role in the growth of the viral clearance service market. The players indulge in mergers, acquisitions, joint ventures, and partnerships for strengthening their foothold in the viral clearance service market, ultimately increasing the growth rate of the viral clearance service market.
The COVID-19 pandemic has a minimal effect on the growth of the viral clearance service market. The services and production related to the healthcare sector were exempted from the strict lockdown restrictions, which served as a relief for the players in the viral clearance service market.
The global viral clearance service market has been segmented as follows:
- Recombinant Proteins
- Tissue and Blood Derived Products
- Viral Removal
- Viral Inactivation
- Contract Research Organizations
- Academic Research Institutes
- Other End-users
- North America
- Rest of Europe
- Asia Pacific
- Australia & New Zealand
- Rest of Asia Pacific
- Latin America
- Rest of Latin America
- Middle East & Africa
- South Africa
- Rest of Middle East & Africa
TABLE OF CONTENT
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
2.2. Research Methodology
3. Executive Summary : Global Viral Clearance Service
3.1.Global Viral Clearance Service Market Value (US$ Mn) and Distribution, by Geography, 2017 and 2026
3.2. Global Viral Clearance Service Market Snapshot, 2017
3.3. Global Viral Clearance Service Market: Opportunity Map
4. Market Overview
4.1.1. Application Definition
4.1.2. Industry Evolution / Developments
4.3. Market Dynamics
188.8.131.52. Increased outsourcing of viral clearance testing studies
184.108.40.206. Rise in R&D expenditure
220.127.116.11. Rise in focus on early clearance of virus in biologics
18.104.22.168. Increased burden of regulatory requirements
22.214.171.124. Technological advancements
126.96.36.199. Growing economies of the world
188.8.131.52. Reduction of preclinical outsourcing budget by some of the large pharma companies
184.108.40.206. High cost and complexity involved in the development and approval of biologics and biosimilars
4.4. Global Viral Clearance Service Market Analysis and Forecast, 2016–2026
4.4.1. Global Viral Clearance Service Market Value (US$ Mn) Forecast
4.5. Porter’s Five Force Analysis
5. Market Outlook
5.1. Regulatory Scenario by Region/globally
5.2. Key Mergers & Acquisitions
5.3. Technological Advancements
5.4. Key Market Trends
5.5. Competitive Landscape Analysis (based on strategic developments of players)
5.6. Future Prospects Assessment
6. Global Viral Clearance Service Market Analysis and Forecast, by Application
6.1. Introduction & Definition
6.2. Key Findings / Developments
6.3. Global Viral Clearance Service Market Value Forecast, by Application, 2016–2026
6.3.1. Recombinant Proteins
6.3.2. Tissue and Blood Derived Products
6.4. Global Viral Clearance Service Market Attractiveness, by Application
7. Global Viral Clearance Service Analysis and Forecast, by Method
7.1. Introduction & Definition
7.2. Key Findings / Developments
7.3. Global Viral Clearance Service Market Value Forecast, by Method, 2016–2026
7.3.1. Viral Removal
7.3.2. Viral Inactivation
7.4. Global Viral Clearance Service Market Attractiveness, by Method
8. Global Viral Clearance Service Analysis and Forecast, by End-user
8.1. Introduction & Definition
8.2. Key Findings / Developments
8.3. Global Viral Clearance Service Market Value Forecast, by End-user, 2016–2026
8.3.2. Contract Research Organizations
8.3.3. Academic Research Institutes
8.3.4. Other End-users
8.4. Global Viral Clearance Service Market Attractiveness by End-user
9. Global Viral Clearance Service Analysis and Forecast, by Region
9.1. Key Findings
9.2. Global Viral Clearance Service Market Value Forecast, by Region
9.2.1. North America
9.2.3. Asia Pacific
9.2.4. Latin America
9.2.5. Middle East & Africa
9.3. Global Viral Clearance Service Market Attractiveness, by Region
10. North America Viral Clearance Service Analysis and Forecast
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