Global Biomanufacturing Viral Detection and Quantification Market

MARKET SCOPE:

The global Biomanufacturing Viral Detection and Quantification market is projected to grow significantly, and registering a CAGR of 9.1 % during the forecast period (2024 – 2032).

Biomanufacturing viral detection and quantification refer to the processes and methodologies employed in the biopharmaceutical industry to identify, measure, and quantify the presence of viruses in biomanufacturing processes. These processes are crucial to ensure the safety, quality, and efficacy of biopharmaceutical products, including vaccines, monoclonal antibodies, gene therapies, and other biologics. The continuous growth of the biopharmaceutical industry, driven by the development of novel therapies and vaccines, fuels the demand for robust viral detection and quantification methods. Strict regulatory standards mandate thorough viral detection in biomanufacturing processes to ensure product safety. Compliance with these regulations drives the demand for reliable detection and quantification technologies. The ongoing awareness of emerging viral threats, including the potential for adventitious agents, underscores the need for advanced detection methods to mitigate risks. Biopharmaceutical manufacturers seek continuous improvement in their processes. This includes adopting advanced viral detection technologies to enhance efficiency, reduce false positives/negatives, and improve overall process control. Events such as the COVID-19 pandemic highlight the importance of preparedness and the need for rapid, accurate viral detection methods for both ongoing production and pandemic response.

MARKET OVERVIEW:

Driver: Growing demand for digitalization and data ana is driving the market growth.

Digital technologies enable real-time data analysis during viral detection processes. By processing and analyzing data in real time, researchers and biomanufacturers can quickly identify trends, patterns, and potential issues, allowing for timely interventions and decision-making. Data analytics can contribute to improving the sensitivity and specificity of viral detection methods. By leveraging advanced algorithms and machine learning techniques, digital solutions can enhance the accuracy of detecting viral particles, reducing the likelihood of false positives or false negatives. Predictive modeling using data analytics allows for the creation of models that predict outcomes based on historical and real-time data. This can be applied to optimize viral detection processes, predict potential contamination risks, and improve overall process efficiency. Implementing digital solutions enables the development of early warning systems for viral contamination events. By continuously monitoring key parameters and analyzing data trends, these systems can provide alerts in advance, allowing for proactive measures to prevent or mitigate contamination. Digital integration facilitates remote monitoring and control of viral detection processes. Researchers and operators can access real-time data, monitor experiments, and make adjustments remotely, enhancing flexibility and accessibility.

Opportunities: Growing demand for emphasis on biosafety is expected to grow more opportunities in the upcoming years.

Comprehensive viral detection solutions help prevent contamination events in biopharmaceutical production. By implementing robust detection methods, companies can identify and eliminate the presence of viruses early in the manufacturing process, reducing the risk of contamination. Viral contamination poses a significant risk to the safety of biopharmaceutical products. Accurate quantification and detection of viruses ensure that final products meet the required safety standards, reducing the potential for adverse effects on patients. Biosafety assurance involves protecting the integrity of cell lines and bioreactors used in biomanufacturing. Viral detection solutions contribute to this by monitoring and safeguarding cell cultures and bioreactor environments from potential viral contaminants. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have stringent requirements for biosafety in biopharmaceutical production. Companies providing comprehensive viral detection solutions help biopharmaceutical manufacturers comply with these regulatory standards. In the context of gene and cell therapies, where viral vectors are used, comprehensive viral detection is crucial to mitigate the risk of unintended viral vector presence. This is essential for the safety and efficacy of advanced therapies.

COVID IMPACT:

The COVID – 19 positive impacts on the Biomanufacturing Viral Detection and Quantification market were seen on various fronts that include the major vertical is the various technology sector. The urgency of addressing the COVID-19 pandemic led to a surge in demand for viral detection tools, including those used in biomanufacturing. Laboratories and biomanufacturing facilities worldwide experienced heightened requirements for viral detection and quantification to support COVID-19 testing, vaccine development, and related activities. Biomanufacturing facilities were under pressure to scale up production not only for biopharmaceuticals related to COVID-19 treatment and prevention but also for the diagnostic tools required for widespread testing. This increased demand impacted the production and consumption of consumables related to viral detection. The need for mass testing and rapid results prompted the adoption of high-throughput technologies for viral detection. Automated systems and consumables compatible with high-throughput assays became essential to meet the testing demands posed by the pandemic. The pandemic exposed vulnerabilities in global supply chains, affecting the availability and delivery of consumables used in biomanufacturing. Disruptions in the supply chain for reagents, assay kits, and other consumables could have impacted the efficiency of viral detection processes. The pandemic accelerated the adoption of digital technologies and automation in biomanufacturing and laboratory settings. This shift aimed to enhance efficiency, reduce manual labor, and ensure the continuity of operations during lockdowns and social distancing measures.

SEGMENTATION ANALYSIS:

The consumables segment is anticipated to grow significantly during the forecast period

The consumables segment within the biomanufacturing viral detection and quantification market encompasses various materials and products that are routinely used and consumed during the viral detection and quantification processes in biomanufacturing. These consumables play a crucial role in ensuring accurate and reliable results in the detection and quantification of viruses in biopharmaceutical production. Reagents and assay kits are fundamental consumables used in viral detection assays. These may include PCR reagents, enzyme-linked immunosorbent assay (ELISA) kits, and other specialized reagents tailored for specific viral detection methods. Consumables such as cell culture media and buffers are essential for maintaining cell lines and viral cultures in optimal conditions during the detection and quantification processes. The quality of these consumables is critical for reliable results. Single-use or disposable labware, including pipettes, tubes, plates, and other containers, falls under the consumables category. These items are used to handle samples, reagents, and other materials without the risk of cross-contamination. Consumables like syringe filters and membrane filters are used for sample preparation and filtration steps in viral detection processes. These aid in removing impurities and ensuring the purity of samples.

REGIONAL ANALYSIS:

The North American region is set to witness significant growth during the forecast period.

The growing interest in gene therapies and viral vector-based treatments contributes to the demand for reliable viral detection and quantification tools in developed countries like US and Canada. Viral vectors are commonly used in gene therapy applications, and accurate quantification is crucial for dosing and safety. The overall growth of the biopharmaceutical and biomanufacturing industry in North America fuels the demand for viral detection and quantification solutions. Biomanufacturing facilities require advanced technologies to meet the increasing demand for biologics. The trend toward single-use technologies in biomanufacturing extends to viral detection and quantification systems. Single-use sensors and disposable technologies contribute to process efficiency and reduce the risk of cross-contamination. Collaborations between technology providers, biopharmaceutical companies, and research institutions play a role in advancing viral detection and quantification solutions. Partnerships aim to develop and implement innovative technologies in manufacturing processes. Increased investments and funding in biotechnology and life sciences contribute to the development and commercialization of advanced viral detection and quantification technologies. Funding from both private and public sectors supports research and market expansion. North America, particularly the United States, is home to a significant concentration of biopharmaceutical companies and biomanufacturing facilities. The region's leadership in the industry influences the adoption of cutting-edge technologies, including viral detection tools. The regulatory environment in North America, governed by agencies like the FDA, sets stringent standards for biomanufacturing processes. Compliance with these regulations drives the adoption of state-of-the-art viral detection and quantification methods.

COMPETITIVE ANALYSIS

The global Biomanufacturing Viral Detection and Quantification market is reasonably competitive with mergers, acquisitions, and launches. See some of the major key players in the market.

Danaher Corporation

Sartorius AG

• In 2020, Sartorius completes the purchase of a portion of Danaher Life Sciences' assets. Sartorius, a renowned global collaborator in life science research and the biopharmaceutical sector, has effectively concluded the purchase of specific life science ventures from Danaher Corporation. On April 30, 2020, the deal was finalized following the acquisition of the necessary regulatory clearances.

Merck KGaA

• In October, 2023, an update on recent LAGEVRIOTM (molnupiravir) clinical and non-clinical studies is provided by Merck and Ridgeback Biotherapeutics.

New England Biolabs

TAKARA HOLDINGS INC.

Thermo Fisher Scientific Inc.

Agilent Technologies, Inc.

Charles River Laboratories

Bio-Rad Laboratories, Inc.

PerkinElmer, Inc.

Promega Corporation

QIAGEN N.V.

Genscript Biotech Corporation

Norgen Biotek Corp.

Scope of the Report

By Offering type

Consumables

Instruments

Services

By Technology

PCR

ELISA

Flow Cytometry

Plaque Assay

Others

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

By End - User

Life science Companies

Testing Laboratories

CROs and CDMOs

By Region

North America (the United States & Canada)

Europe (Germany, UK, France, Spain, Italy, and the Rest of Europe)

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

Rest of the World (the Middle East & Africa, Latin America, and Rest of The World)

Keys reasons to purchasing this report

It provides a technological development map over time to understand the industry’s growth rate and indicates how the Biomanufacturing Viral Detection and Quantification market is evolving.

The report offers a dynamic method to various factors that drive or restrain the growth of the market and specifies which Biomanufacturing Viral Detection and Quantification submarket will be the main driver of the overall market from 2024 to 2032.

It renders a definite analysis of changing competitive dynamics and stipulates the leading players and what are their prospects over the forecast period.

It builds a nine-year estimate based on how the market is predicted to grow and shows what will market shares of the global region change by 2032 and which country will lead the market in 2032.