Viral Clearance Services Market Size
Study Period | 2019 - 2029 |
Base Year For Estimation | 2023 |
CAGR | 15.00 % |
Fastest Growing Market | Asia Pacific |
Largest Market | North America |
Market Concentration | Medium |
Major Players*Disclaimer: Major Players sorted in no particular order |
Viral Clearance Services Market Analysis
The viral Clearance Services Market is Poised to grow at a CAGR of 15% over the forecast period. The major factors attributing to the growth of the market are the rising need for viral clearance and the increasing demand for specialty drugs
COVID-19 has a significant impact on the market studied. During COVID-19, the isolation of patients was the priority across the globe. A study published in the Journal of Infection and Chemotherapy in June 2021 stated that a classification of the isolation times based on age could be taken into consideration while processing the viral clearance since the length of the viral clearance periods from COVID-19 patients can vary with age. Due to biases including underlying medical disorders, it may be challenging to establish a uniform viral clearance duration for elderly patients. With the increased incidence of COVID-19, the demand for viral clearance was raised which contributed to the growth of the market.
Viral clearance studies are a necessary component of any regulatory submission for clinical trials or approval of all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove inactivated viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house.
Biological and biotechnological products are at risk from impurities, bacteria and fungi, and viruses. With such products, the potential for transmission of viral diseases is a real risk. Viral contamination can affect raw materials, cell culture processes, bioreactor contamination, and downstream processing. It is for these reasons that pharmaceutical organizations practice viral safety and incorporate virus clearance into the manufacturing process.
Viral Clearance Services Market Trends
This section covers the major market trends shaping the Viral Clearance Services Market according to our research experts:
Recombinant Proteins Segment is Expected to Dominate the Market During the Forecast Period
Large-scale recombinant protein production is becoming progressively critical for applications in the field of proteomics, structural biology and protein therapeutics. When large quantities of protein need to be produced cells must be cultured in large volume by the implementation of fermentation techniques. As the production of these proteins increases the demand for the viral clearance process also increases.
The major factors driving the growth of the segment are the increasing demand for biopharmaceuticals for treating chronic conditions like diabetes cancers, and these drugs are forging their ways in the field of inflammatory disease management, such as psoriasis, multiple sclerosis, rheumatic diseases, and inflammatory bowel diseases. The introduction of recombinant proteins has revolutionized the development and manufacturing processes of biotherapeutics. The number of recombinant drugs is expected to grow further as multiple biologics and vaccines consisting of recombinant proteins are currently in the pipeline and are expected to get FDA approval. Thus, considering all the above mentioned factors the market is expected to grow.
North America Dominates the Market and Expected to do Same in the Forecast Period
North America is expected to dominate the overall viral clearance services market, throughout the forecast period. The largest share is mainly due to the presence of key players and their usage of advanced medical technologies to develop. The rise in the production of recombinant proteins, and vaccines and the necessity to keep them risk-free and virus-free, is the major factor for the growth of the market. Furthermore, growing awareness among the population to use biopharmaceuticals and thus increasing demand for viral clearance services.
Additionally, increasing funding for pharmaceuticals across the United States is contributing to the growth of the market studied. The American pharmaceutical industry creates a wide range of brand-new medications each year that have significant clinical advantages. Many of those medications are costly, which drives up the cost of healthcare for both the federal government and the private sector. Lawmakers have considered measures that would cut federal spending on drugs and lower drug prices. Such regulations will likely lessen the industry's incentive to produce innovative medicines. In the year 2020, the federal government in the United States invested USD 11 billion in late-stage vaccine development and expansion of manufacturing capacity through Operation Warp Speed and the Biomedical Advanced Research and Development Authority.
Hence, with the above-mentioned factors, the market for viral clearance is expected to witness strong growth in the North America region.
Viral Clearance Services Industry Overview
The viral clearance services market is moderately competitive and consists of several major players. Some of the companies which are currently dominating the market are Charles River, Labor Dr. Merk & Kollegen GmbH, Texcell, Merck KGaA, WuXi AppTec, Sartorius AG, Eurofins Scientific, Bioscience Laboratories, Syngene and Vironova.
Viral Clearance Services Market Leaders
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Charles River
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Labor Dr. Merk & Kollegen GmbH
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Merck KGaA
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Texcell
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WuXi AppTec
*Disclaimer: Major Players sorted in no particular order
Viral Clearance Services Market News
- In September 2022, Merck opened a viral clearance (VC) laboratory as part of the first building phase of its new EUR 29 million China Biologics Testing Center.
- In April 2022, Abzena, a partner research organization (PRO), announced the opening of a biologics testing laboratory situated near the company's biologics process development and manufacturing hub in San Diego, California. The facility will give partners access to cell-based and PCR safety assays; and viral clearance studies to support their IND, IMPD, BLA, and MAA applications.
Viral Clearance Services Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Increasing Need of Viral Clearance
- 4.2.2 Rise in Research and Development Funding
- 4.2.3 Growing Demand for Specialty Drugs
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4.3 Market Restraints
- 4.3.1 Lack of Approval of Outsourcing of Preclinical Procedures
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4.4 Porter's Five Force Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size - Value in USD million)
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5.1 By Method
- 5.1.1 Viral Removal
- 5.1.2 Viral Inactivation
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5.2 By Application
- 5.2.1 Recombinant Proteins
- 5.2.2 Tissue and Blood Derived Products
- 5.2.3 Vaccines
- 5.2.4 Others
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5.3 By End-User
- 5.3.1 Biopharmaceuticals
- 5.3.2 Contract Research Organizations
- 5.3.3 Academic Research Institutes
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5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle-East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle-East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Charles River Laboratories, Inc.
- 6.1.2 Labor Dr. Merk & Kollegen GmbH
- 6.1.3 Merck KGaA
- 6.1.4 Texcell SA
- 6.1.5 WuXi AppTec
- 6.1.6 Sartorius AG
- 6.1.7 Eurofins Scientific
- 6.1.8 Bioscience Laboratories
- 6.1.9 Vironova
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityViral Clearance Services Industry Segmentation
As per the scope of the report viral clearance services include the removal of viruses or bacteria that have been unintentionally left behind on the production equipment and biological products. These services include testing the end-products and equipment for any viruses and ensuring in safe and consistent development of biological products. The Viral Clearance Services Market is segmented by Method (Viral Removal, Viral Inactivation), Application (Recombinant Proteins, Tissue & Blood-Derived Products, Vaccines, Others), by End-User (Biopharmaceuticals, Contract Research Organizations, Academic Research Institutes), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.
By Method | Viral Removal | |
Viral Inactivation | ||
By Application | Recombinant Proteins | |
Tissue and Blood Derived Products | ||
Vaccines | ||
Others | ||
By End-User | Biopharmaceuticals | |
Contract Research Organizations | ||
Academic Research Institutes | ||
Geography | North America | United States |
Canada | ||
Mexico | ||
Geography | Europe | Germany |
United Kingdom | ||
France | ||
Italy | ||
Spain | ||
Rest of Europe | ||
Geography | Asia-Pacific | China |
Japan | ||
India | ||
Australia | ||
South Korea | ||
Rest of Asia-Pacific | ||
Geography | Middle-East and Africa | GCC |
South Africa | ||
Rest of Middle-East and Africa | ||
Geography | South America | Brazil |
Argentina | ||
Rest of South America |
Viral Clearance Services Market Research FAQs
What is the current Global Viral Clearance Services Market size?
The Global Viral Clearance Services Market is projected to register a CAGR of 15% during the forecast period (2024-2029)
Who are the key players in Global Viral Clearance Services Market?
Charles River, Labor Dr. Merk & Kollegen GmbH, Merck KGaA, Texcell and WuXi AppTec are the major companies operating in the Global Viral Clearance Services Market.
Which is the fastest growing region in Global Viral Clearance Services Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Global Viral Clearance Services Market?
In 2024, the North America accounts for the largest market share in Global Viral Clearance Services Market.
What years does this Global Viral Clearance Services Market cover?
The report covers the Global Viral Clearance Services Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Viral Clearance Services Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Global Viral Clearance Services Industry Report
Statistics for the 2024 Global Viral Clearance Services market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global Viral Clearance Services analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.