Biomanufacturing Viral Detection and Quantifications Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented 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, CDMOs), By Region, Competition

Market Overview

Global Biomanufacturing Viral Detection and Quantifications Market has valued at USD 480.24 Million in 2022 and is anticipated to project robust growth in the forecast period with a CAGR of 8.43% through 2028. Biomanufacturing Viral Detection and Quantifications are process of using biotechnological methods and techniques to produce and manufacture tools, reagents, and systems that are used in the detection and quantification of viruses. This field combines principles from biotechnology, molecular biology, and engineering to create efficient and reliable methods for identifying and measuring the presence of viruses in various samples, such as clinical samples, environmental samples, and research settings. Biomanufacturing Viral Detection and Quantifications involves the large-scale production of reagents, such as antibodies, probes, primers, and enzymes, which are essential for detecting and quantifying viruses through techniques like polymerase chain reaction (PCR), enzyme-linked immunosorbent assay (ELISA), and various molecular biology assays. Biomanufacturing plays a crucial role in producing diagnostic kits that are used by clinical laboratories and healthcare facilities to identify specific viral infections. These kits contain all the necessary components for conducting tests and interpreting results. However, Biomanufacturing Viral Detection and Quantifications contributes to the development of advanced sensor platforms, biosensors, and microfluidic devices that can detect viruses in real-time or high-throughput settings. These platforms often incorporate molecular recognition elements, such as antibodies or nucleic acid probes, to capture and detect viral particles. Biomanufacturing for viral detection and quantification can be categorized into several key areas based on the techniques, methods, and products involved such as Molecular Diagnostics, Immunodiagnostics, Biosensors and Microfluidics, Cell Based Assays.

Key Market Drivers

Increasing Incidence of Viral Diseases Drive the Market Growth

The increasing incidence of viral diseases plays a significant role in driving the growth of the global biomanufacturing viral detection and quantification market. The World Health Organization (WHO) estimates that about half of the world’s population is currently at risk of contracting dengue, with an estimated annual infection rate of 100–400 million. Dengue is a mosquito-borne virus that thrives in tropical and subtropical climates around the world, with the majority of infections occurring in cities and semi-urban regions. The number of dengue cases reported to WHO has increased significantly over the past decade, from 505 430 in 2000 to 5,2 million in 2019. The rise in viral diseases underscores the importance of early detection and diagnosis to initiate timely medical interventions. Biomanufactured viral detection and quantification tools, such as diagnostic kits and assays, provide healthcare professionals with accurate and rapid means to identify the presence of viruses in patient samples. Early detection allows for prompt treatment and containment, which can help reduce the spread of infections and improve patient outcomes. As viral diseases become more prevalent, there is a growing need for robust surveillance and epidemiological monitoring. Biomanufactured viral detection products contribute to surveillance efforts by enabling the tracking of viral outbreaks, understanding disease patterns, and assessing the effectiveness of control measures. This information is crucial for public health agencies, governments, and healthcare providers to make informed decisions and allocate resources effectively. Recent global health crises, such as the COVID-19 pandemic, have highlighted the necessity of having strong viral detection and quantification capabilities in place. Governments, healthcare systems, and industries recognize the importance of investing in biomanufacturing infrastructure to enhance preparedness for future viral outbreaks. This drives the demand for reliable and scalable viral detection solutions that can be rapidly deployed during emergencies. The increase in viral diseases fuels research and development activities focused on understanding the viruses, developing treatments, and improving diagnostics. Biomanufacturing supports the production of reagents, controls, and assays that are essential for conducting research on viral detection methods, disease mechanisms, and therapeutic interventions.

Advancement In Diagnostic Technology Propels the Market Growth

Advancements in diagnostic technologies play a crucial role in driving the growth of the global biomanufacturing viral detection and quantification market. These technological innovations enhance the accuracy, speed, sensitivity, and scalability of viral detection methods, leading to a wider range of applications and increased demand for biomanufactured viral detection and quantification products. New diagnostic technologies leverage innovative molecular and immunological techniques to achieve higher sensitivity and specificity in detecting viral pathogens. Biomanufacturing supports the production of highly specific reagents, such as antibodies and probes, which are essential for accurate viral detection. Advancements in microfluidics, miniaturization, and sensor technologies enable the development of portable and rapid POC diagnostic devices. These devices facilitate on-site viral detection, reducing the need for sample transportation and enabling real-time decision-making. Biomanufacturing contributes to the production of POC test components. Modern diagnostic technologies allow for the simultaneous detection of multiple viral targets in a single assay. This multiplexing capability improves efficiency, reduces testing time, and conserves sample volume. Biomanufacturing supports the creation of multiplex assays and reagent panels. Digital PCR, droplet digital PCR (ddPCR), and other quantitative techniques provide accurate and precise measurements of viral load. Biomanufactured standards and controls are crucial for establishing calibration curves and ensuring accurate quantification. Automation, robotics, and high-throughput platforms enhance the capacity to process a large number of samples efficiently. Biomanufactured reagents and assay components enable the scaling up of viral detection workflows, making them suitable for screening purposes. Nanotechnology-based diagnostic platforms offer high sensitivity and rapid detection capabilities. Biomanufacturing contributes to the production of nanosensors and nanoparticles used in viral detection. NGS technologies enable the comprehensive analysis of viral genomes and provide insights into viral diversity, evolution, and transmission. Biomanufacturing supports the preparation of NGS libraries and the production of sequencing reagents.

The Pandemic Preparedness and Response Drives the Market Growth

Pandemic preparedness and response significantly drive the growth of the global biomanufacturing viral detection and quantification market. The experience and lessons learned from past pandemics, as well as ongoing and potential future outbreaks, underscore the importance of having robust viral detection capabilities. High-profile pandemics, such as the H1N1 influenza pandemic and the COVID-19 pandemic, have raised global awareness about the rapid spread of infectious diseases. Governments, public health agencies, and industries recognize the critical need for effective viral detection and quantification tools to identify and control outbreaks. This awareness leads to increased investment in biomanufacturing infrastructure to develop and produce diagnostic reagents, kits, and assays. In response to pandemics, there is a pressing need for rapid and accurate diagnostic tests that can be deployed quickly to identify infected individuals. Biomanufacturing facilitates the rapid development, validation, and production of diagnostic tools that enable timely screening and surveillance, aiding in early case identification and containment. Pandemic preparedness requires the establishment of emergency response systems and infrastructure. Biomanufacturing plays a pivotal role in building this infrastructure by supplying the necessary components for diagnostic tests, such as viral antigens, antibodies, and molecular probes. Pandemic experiences highlight the vulnerabilities in global supply chains. To enhance supply chain resilience, countries and organizations invest in domestic biomanufacturing capabilities to ensure a steady and reliable supply of critical viral detection products during emergencies. Responding to pandemics requires collaborative efforts among countries, research institutions, diagnostic manufacturers, and healthcare providers. Biomanufacturing companies contribute to these partnerships by providing essential viral detection components and expertise, fostering innovation and knowledge sharing. Pandemic situations catalyze research and development efforts to improve diagnostic technologies. Biomanufacturing supports the production of reagents and materials used in developing novel diagnostic methods, enhancing the sensitivity, specificity, and speed of viral detection.

Rapidly Evolving Viruses

The rapid evolution of viruses poses significant challenges to the global biomanufacturing viral detection and quantification market. Viral mutations can lead to changes in the genetic sequences targeted by detection assays. If a mutation occurs in a region critical for assay detection, it may result in false negatives, where the assay fails to detect the virus even though it is present. Biomanufactured assays need to be continually updated to account for emerging viral variants. Mutations in viral genomes can affect the binding affinity of detection reagents, such as antibodies and primers, leading to reduced sensitivity or specificity of assays. Biomanufacturers must adapt reagents to maintain optimal performance against evolving viral strains.

Complex Sample Matrices

Complex sample matrices pose a significant challenge to the global biomanufacturing viral detection and quantification market. The term "complex sample matrices" refers to the diverse mixture of substances that can be present in clinical, environmental, or other types of samples being tested for viral presence. These substances can interfere with viral detection methods and impact the accuracy of results. Components present in complex samples, such as blood, saliva, or environmental samples, can interact with detection reagents, antibodies, or primers, leading to false-positive or false-negative results. Substances like proteins, lipids, and inhibitors can hinder the binding of detection molecules to viral targets. Complex matrices can dilute the viral target or reduce its concentration, making it harder to detect. This can lower the sensitivity of the assay and result in missed infections or inaccurate quantification.

High Research and Development Costs

High research and development (R&D) costs represent a significant challenge to the global biomanufacturing viral detection and quantification market. Developing, optimizing, and validating new viral detection methods and products can incur substantial expenses. The high costs of R&D can strain the financial resources of biomanufacturers, especially smaller companies and startups. Limited funds may hinder their ability to invest in innovative research and product development. High R&D costs can act as a barrier to entry for new players in the market, limiting competition and potentially slowing down the pace of innovation. This could result in a lack of diverse and cutting-edge viral detection solutions. Lengthy and expensive R&D processes can delay the introduction of new products to the market. This delay could impact the availability of timely and up-to-date viral detection tools during outbreaks or emerging viral threats. Rigorous validation and testing of new viral detection methods to ensure accuracy and reliability can contribute to higher R&D costs. This is particularly important in the context of complex sample matrices and rapidly evolving viruses. Developing and producing high-quality reagents and materials suitable for viral detection methods requires investments in research, manufacturing, and quality control.

Key Market Trends

Emerging Infectious Diseases Preparedness

Emerging infectious diseases (EIDs) preparedness is a significant trend in the global biomanufacturing viral detection and quantification market. This trend reflects the increasing recognition of the need to be well-equipped to rapidly respond to new and unexpected infectious disease outbreaks. EID preparedness drives the development of rapid and accurate viral detection tests that can be quickly deployed during outbreaks. Biomanufacturers focus on creating diagnostic assays that can detect new pathogens or variants with high sensitivity and specificity. To respond to EIDs, biomanufacturers need to have flexible manufacturing capabilities that can quickly switch to producing reagents, kits, and assays for emerging pathogens. This may involve adaptable production processes and scalable manufacturing facilities. Rigorous and swift validation of new viral detection assays becomes crucial during EID outbreaks. Biomanufacturers work to validate and ensure the performance of their assays against new viral strains to maintain reliability. EID preparedness often involves collaboration between biomanufacturing companies, research institutions, public health agencies, and governments. This collaboration accelerates the development and distribution of effective viral detection solutions. During EID outbreaks, regulatory agencies may expedite the approval process for new viral detection products to facilitate their swift deployment. Biomanufacturers need to work closely with regulatory authorities to navigate this process. Biomanufactured viral detection products play a critical role in global surveillance efforts to monitor the spread and impact of emerging pathogens. Early detection and monitoring are essential for effective outbreak response. Biomanufactured viral detection tools are essential for assessing vaccine efficacy during EID outbreaks. They help track the prevalence of the pathogen and monitor the impact of vaccination campaigns.

Segmental Insights

Offering Type Insights

In 2022, the Biomanufacturing Viral Detection and Quantifications market was dominated by the Consumables Segments and is predicted to continue expanding over the coming years. Consumables are essential components in viral detection workflows and need to be replenished regularly as they are used up. This results in repeat purchases and a consistent revenue stream for biomanufacturing companies. Viral detection and quantification assays are routinely performed in various settings, including clinical laboratories, research institutions, and public health agencies. The constant demand for testing fuels the need for consumables. Viral detection assays often require customized or specialized consumables to suit different viral targets, sample types, and assay formats. Biomanufacturers can offer a diverse range of consumables to meet specific testing needs. High-quality consumables are critical for accurate and reliable viral detection. Biomanufacturer consumables undergo rigorous quality control processes and validation to ensure consistent performance. The segment is projected to experience the highest compound annual growth rate (CAGR) from 2023 to 2030.

Technology Insights

In 2022, the Biomanufacturing Viral Detection and Quantifications market was dominated by PCR Technology Segment and is predicted to continue expanding over the coming years. PCR is known for its high sensitivity and specificity, enabling the detection of even low viral loads accurately. This makes it an ideal choice for diagnosing viral infections, especially in the early stages of an outbreak. PCR can be used for both qualitative (presence/absence) and quantitative (viral load) analysis of viral genetic material. This quantitative information is valuable for disease monitoring, treatment efficacy assessment, and research purposes. PCR can target specific viral genes or regions, allowing customization for various viral targets. This versatility makes it suitable for detecting a wide range of viral pathogens. Real-time PCR (qPCR) variants provide rapid results, often within hours. This rapid turnaround time is crucial for timely clinical decision-making and outbreak response. Multiplex PCR enables simultaneous detection of multiple viral targets in a single reaction, enhancing efficiency and conserving sample volume. This capability is essential for efficient screening and surveillance. PCR assays can be standardized across laboratories, ensuring consistent and comparable results. Standardized assays are vital for accurate disease monitoring and research collaboration. PCR technology is well-established and widely accepted in clinical settings, with numerous assays receiving regulatory approvals for diagnostic use.

Application Insight

In 2022, the Biomanufacturing Viral Detection and Quantifications market was dominated by Blood and Blood Products Manufacturing Segment and is predicted to continue expanding over the coming years. Blood and blood products are critical components of healthcare systems, and ensuring their safety from viral contamination is of utmost importance. Viral detection assays are used to screen blood donations for the presence of infectious viruses, such as HIV, hepatitis B and C viruses, and human T-cell lymphotropic virus (HTLV). This is essential to prevent the transmission of these viruses through blood transfusions. Blood plasma is used to produce various plasma-derived products, including clotting factors and immunoglobulins. Viral detection ensures that plasma donations are free from viral contaminants.

End-User Insight

In 2022, the Biomanufacturing Viral Detection and Quantifications market was dominated by PCR Technology Segment and is predicted to continue expanding over the coming years. Clinical laboratories and hospital settings are primary users of viral detection and quantification technologies for diagnostic purposes. They perform routine testing for viral infections to aid in patient care and treatment decisions. These companies use viral detection methods during various stages of drug development, including research, quality control, and production of biologics such as vaccines and monoclonal antibodies. Academic and research institutions use viral detection and quantification technologies for basic research, epidemiological studies, and the development of new diagnostic methods.

Regional Insights

The Asia Pacific region has established itself as the leader in the Global Biomanufacturing Viral Detection and Quantifications Market. The Asia-Pacific region has the largest and fastest-growing population in the world. This is driving the demand for healthcare services, including biomanufacturing viral detection and quantification. The Asia-Pacific region has a high prevalence of viral diseases, such as HIV, hepatitis B, and hepatitis C. This is driving the demand for viral detection and quantification tests to diagnose and treat these diseases.

Recent Developments

• In March 2023, A global leader in research and technology, Danaher Corporation, and the University of Pennsylvania (Penn) have joined forces to develop new cell therapy techniques. The multi-year partnership's objectives are to create new technologies, reduce production bottlenecks, and provide next-generation engineered cell products to patients with more consistent clinical outcome.
• In June 2023, Merck, one of the world’s leading science and technology companies, is increasing production capacity for highly purified reagents at its Nantong site, one of China’s leading transportation hubs and a major hub for the Yangtze river delta region. The investment, worth approximately € 70 million, will enable the large-scale production of high- purity reagents for the purpose of quality control and testing to meet the needs of biopharma clients, with an annual output increase of several thousand tons. Today, Merck signed the agreement to support the expansion of the Nantong site with the Nantong economic and technological development area (NETDA).
• In March 2023, Milton Park, one of the UK's top life science clusters, will serve as the site of New England Biolabs' (NEB's) first overseas product development and manufacturing facility. NEB is a global leader in the discovery and production of enzymes for molecular biology applications. A fully owned subsidiary of NEB, NEB Lyophilization SciencesTM specialises in the design, development, and production of cutting-edge solutions for products that are ambiently stored.

Key Market Players

·              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

Report Scope:

In this report, the Global Biomanufacturing Viral Detection and Quantifications Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biomanufacturing Viral Detection and Quantifications Market, By Offering Type:

o   Consumables

o   Instruments

o   Services

• Biomanufacturing Viral Detection and Quantifications Market, By Technology:

o   PCR

o   ELISA

o   Flow Cytometry

o   Plaque Assay

o   Others

• Biomanufacturing Viral Detection and Quantifications Market, By Application:

o   Blood and Blood Products Manufacturing

o   Vaccines and Therapeutics Manufacturing

o   Cellular and Gene Therapy Products Manufacturing

o   Stem Cell Products Manufacturing

o   Tissue and Tissue Products Manufacturing

• Biomanufacturing Viral Detection and Quantifications Market, By End User:

o   Life Science Companies

o   Testing Laboratories

o   CROs and CDMOs

• Global Biomanufacturing Viral Detection and Quantifications Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biomanufacturing Viral Detection and Quantifications Market.

Available Customizations:

Global Biomanufacturing Viral Detection and Quantifications Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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