Summary

Global Biomanufacturing Viral Detection and Quantification Market Industry Overview

The global biomanufacturing viral detection and quantification market was valued at $474.3 million in 2022 and is anticipated to reach $1,149.7 million by 2032, witnessing a CAGR of 9.37% during the forecast period 2023-2032. The global biomanufacturing viral detection and quantification market is expected to be driven by the rising utilization of biopharmaceutical products and the technological advancements in the viral testing industry.

Market Lifecycle Stage

The global biomanufacturing viral detection and quantification market is in progressing phase. The biomanufacturing viral detection and quantification market is experiencing rapid growth due to the increasing adoption of biopharmaceuticals. Robust quality control processes are essential to ensure the safety, efficacy, and consistency of biopharmaceuticals. These factors are expected to drive the demand for consumables and instruments for quantification of viral contaminants during biomanufacturing of biologics, thereby augmenting the growth of the biomanufacturing viral detection and quantification market.

Impact

Viral detection and quantification is used to evaluate and improve the biomanufacturing process throughout process development. Manufacturers can detect potential viral contamination sources and make the required adjustments to reduce risks and boost process effectiveness by detecting and quantifying viral contaminants at different stages. Emerging cell and gene therapies, along with other biotherapeutics, are at risk of contamination, including viral contaminants. Detecting these contaminants early on is important to prevent any delays in the production process, which can have a direct impact on the commercialization of therapy. Cell and gene therapies utilize viral vectors to deliver therapeutic genes or manipulate cells for therapeutic purposes. In addition, the entry of several established players, such as Thermo Fisher Scientific Inc., Merck KGaA, Charles River Laboratories, Bio-Rad Laboratories, Inc., QIAGEN N.V., and others, is expected to aid the market growth.

Due to better cleanliness, people witnessed global advancement in the control of infectious contamination over the past few years. The market for biomanufacturing viral detection and quantification is expanding due to the growing demand for precise viral testing in the biomanufacturing of therapies. In conclusion, as the field of emerging cell and gene therapies continues to advance, it is imperative to address the potential risks of viral contamination.

Market Segmentation:

Segmentation 1: by Offering Type
• Consumables
• Instruments
• Services

Consumables Segment Accounted for Major Share in the Global Biomanufacturing Viral Detection and Quantification Market (by Offering Type)

Based on offering type, the consumables segment dominated the global biomanufacturing viral detection and quantification market in FY2022. The increasing adoption of kits, assays, and accessories contributed to the prominence of the consumables segment. Consumables are products and materials that are constantly consumed throughout the viral testing process. Several consumables are utilized in viral detection and quantification during biomanufacturing to simplify testing and analysis of viral samples. These consumables are necessary to carry out the several procedures and tests required to determine the quantity or concentration of a particular virus in a biological sample.

Segmentation 2: by Technology
• PCR
• ELISA
• Flow Cytometry
• Plaque Assay
• Others

PCR Technology Segment Accounted for Major Share in the Global Biomanufacturing Viral Detection and Quantification Market (by Technology)

Based on technology, the PCR segment dominated the global biomanufacturing viral detection and quantification market in FY2022. In the field of molecular biology and viral testing, polymerase chain reaction (PCR) is a commonly used technique. It is a method for identifying and measuring viral nucleic acids that are sensitive and focused during the production of biopharmaceuticals. In addition, PCR is essential for measuring the viral load, or the quantity of viral genetic material, in a biological sample.

Segmentation 3: by Application
• Blood and Blood Products Manufacturing
• Vaccines and Therapeutics Manufacturing
• Cellular and Gene Therapy Products Manufacturing
• Stem Cell Products Manufacturing
• Tissue and Tissue Products Manufacturing

Blood and Blood Products Manufacturing Segment Accounted for Major Share in the Global Biomanufacturing Viral Detection and Quantification Market (by Application)

Based on application, the global biomanufacturing viral detection and quantification market was dominated by the blood and blood products manufacturing segment in FY2022. In biomanufacturing processes, viral testing is an essential component in verifying the safety and quality of blood and blood products. This test involves identifying and measuring viral particles or viral nucleic acids that are present in blood samples. To identify and measure viral nucleic acids, methods such as nucleic acid amplification testing (NAT) are often employed.

Segmentation 4: by End User
• Life Science Companies
• Testing Laboratories
• CROs and CDMOs

Life Science Companies to Continue its Dominance in the End User Segment

Based on end user, the life science companies segment accounted for the largest share of the global biomanufacturing viral detection and qauntification market in FY2022. In the life science sector, viral detection and quantification refers to the measuring and evaluation of viral particles or viral components at distinct stages of medication development, production, and evaluation. Viral load, or the quantity or concentration of viruses present in each sample or system, must be detected and quantified.

Segmentation 5: by Region
• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

North America held the largest share of 38.72% in 2022 in the global biomanufacturing viral detection and quantification market, owing to the presence of most key players and rising funding in the region.

In addition, Asia-Pacific is expected to grow at the highest CAGR of 10.47% in the forecast period 2023-2032, owing to the continuous research and development in the viral detection and quantification industry as well as the supportive regulatory landscape.

Demand - Drivers and Limitations

Market Demand Drivers:

• Increasing Utilization of Biopharmaceuticals
• Technological Advancements in Viral Detection and Quantification

Market Restraints:

• High Cost of Advanced Viral Detection and Quantification Equipment
• Lack of Trained Professionals in the Field of Viral Detection and Quantification

Market Opportunities:

• Increasing Need in Viral Contamination Considerations for the Development of Cell and Gene Therapies

How can this report add value to an organization?

Workflow/Innovation Strategy: The biomanufacturing viral detection and quantification market (by offering type) has been segmented into consumables, instruments, and services. Moreover, the study provides the reader with a detailed understanding of the different applications of biomanufacturing viral detection and quantification in raw material preparation, upstream processing, downstream processing, and packaging.

Growth/Marketing Strategy: Biomanufacturing viral detection and quantification is being used for raw material preparation, upstream processing, downstream processing, and packaging. Various companies are providing products and services to aid in the viral testing of various biologic production, which is also the key strategy for market players to excel in the current biomanufacturing viral detection and quantification market.

Competitive Strategy: Key players in the global biomanufacturing viral detection and quantification market have been analyzed and profiled in the study, including manufacturers. Moreover, a detailed competitive benchmarking of the players operating in the global biomanufacturing viral detection and quantification market has been done to help the reader understand how players stack against each other, presenting a clear market landscape.

Key Market Players and Competition Synopsis

Viral contamination poses a significant risk to both animal- and human-derived biopharmaceuticals. This form of contamination can occur at any stage of the bioproduction process, necessitating viral testing studies and the implementation of viral clearance methods by biomanufacturers. In this study, several types of fundamental technologies have been examined that have facilitated these advances, namely, polymerase chain reaction (PCR), plaque assays, flow cytometry, and enzyme-linked immunosorbent assay (ELISA), among others. The global biomanufacturing viral detection and quantification market is strongly driven by the continuous introduction of new technologies as well as increased investments and funding from both the government and private sectors.

Key Companies Profiled:

• Danaher Corporation
• Merck KGaA
• New England Biolabs
• TAKARA HOLDINGS INC.
• Thermo Fisher Scientific Inc.
• Agilent Technologies, Inc.
• Sartorius AG
• Charles River Laboratories
• Bio-Rad Laboratories, Inc.
• PerkinElmer, Inc.
• Promega Corporation
• QIAGEN N.V.
• Genscript Biotech Corporation
• Norgen Biotek Corp.

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