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Biomanufacturing Viral Detection & Quantification Market - Global Forecast 2025-2032

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    Report

  • 193 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 5924772
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Amid evolving regulatory demands and accelerated scientific innovation, biomanufacturing viral detection and quantification is driving operational reliability and effective risk management for senior leaders across the life sciences ecosystem. This market report provides actionable perspective for those seeking competitive advantage in decision-making and compliance.

Market Snapshot: Growth of the Biomanufacturing Viral Detection & Quantification Market

The biomanufacturing viral detection and quantification market is experiencing strong growth, moving from USD 2.89 billion in 2024 to USD 3.14 billion in 2025, and is projected to reach USD 5.63 billion by 2032, representing an 8.67% CAGR. Growth is fueled by robust investment in advanced detection platforms and the flexibility to address global regulatory requirements. Senior decision-makers view this market as pivotal for supporting both research innovation and manufacturing efficiency in compliance-focused settings.

Scope & Segmentation

Tailored for executive insight, this report delivers detailed segmentation and market intelligence essential for strategic planning:

  • Product: Instruments and systems such as digital PCR, real-time PCR, next-generation sequencing platforms (NGS), CRISPR-based detection, immunoassay analyzers, and thermal cyclers. Reagents, immunoassay and sequencing kits, software solutions, and consulting services are included for full workflow optimization.
  • Technology: Cutting-edge techniques like CRISPR, chemiluminescent immunoassays, ELISA, multiple PCR formats, nanopore technology, and the latest NGS advances, all designed to maximize detection speed and precision.
  • Application: Quality control for gene therapy, clinical trial support, vaccine development, viral load monitoring, and comprehensive safety testing—spanning the full spectrum from R&D through scalable delivery.
  • End User: Academic institutions, CROs, diagnostics laboratories, hospitals, clinics, and top-tier pharmaceutical and biotechnology companies—each contributing to standards elevation and market expansion.
  • Sample Type: Specialized testing for blood, plasma, respiratory, tissue, and environmental samples, providing adaptable solutions to diverse manufacturing and clinical use cases.
  • Geographic Coverage: Comprehensive analysis by region, including the Americas (notably the United States and Canada), Europe, Middle East & Africa, and Asia-Pacific (with focus on China, India, Japan, Australia, Korea, and selected ASEAN economies), identifying both established and emerging growth centers.
  • Company Analysis: Strategic review of leading global competitors: Thermo Fisher Scientific, Danaher Corporation, Merck KGaA, Roche Holding AG, QIAGEN N.V., Illumina, Agilent Technologies, Bio-Rad Laboratories, PerkinElmer, and Sartorius—highlighting their influence in shaping the market framework.

Key Takeaways for Senior Decision-Makers

  • Decentralized diagnostics, through integration with digital and AI-driven platforms, are streamlining connectivity between advanced sequencing tools and operational teams, accelerating results.
  • Greater platform interoperability is smoothing the transition from clinical research to commercial manufacturing, providing agility against emerging viral threats and process changes.
  • Focus on standardized assay validation and end-to-end workflow integration is advancing data reliability, enabling compliance across diverse regulatory environments.
  • Facilities are adopting modular, scalable instruments and multiplex-ready reagents, which create adaptable capacity and provide long-term value as demands evolve.
  • Real-time analytics and cloud-based resource tools support more efficient compliance management and simplify monitoring in complex production settings.
  • Distinct regional market dynamics offer opportunities for local and international expansion, reflected in infrastructure strengths in the Americas, regulatory progress in Europe, and rapid tech adoption in Asia-Pacific.

Impact of United States Tariff Policies on Market Dynamics

Recent US tariff policy adjustments have increased import costs for diagnostic equipment and materials. Organizations are mitigating these challenges by broadening their supplier base, partnering with local vendors, and refining distribution methods. Enhanced inventory and supply strategies, continuous product evaluation, and regular policy review are helping to maintain steady access to critical technologies—ensuring operations remain uninterrupted despite fluctuations in global trade environments.

Methodology & Data Sources

This market intelligence is based on structured interviews with domain experts, targeted research of published literature and patents, and disciplined triangulation. All findings are subject to thorough internal review, ensuring strategic relevance and reliability for investment, planning, and risk management decisions.

Why This Report Matters

  • Enables senior executives to navigate technology advances, compliance priorities, and supply chain complexities with actionable, evidence-based insight.
  • Supports strategic market entry, partnership development, and solution scaling through a practical segmentation and decision-making framework.
  • Strengthens resilience with proven approaches for mitigating supply chain disruption and tariff-related risk, securing business continuity across global and regional contexts.

Conclusion

Leadership in biomanufacturing viral detection is enabled by continuous adaptation to regulatory, technology, and operational change. This report offers the strategic alignment needed for enduring resilience and market success.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of digital PCR and next-generation sequencing to enhance viral load quantification accuracy across large-scale bioprocesses
5.2. Adoption of AI-enabled real-time monitoring of viral clearance steps to mitigate biosafety risks during biomanufacturing
5.3. Implementation of continuous flow bioreactors with inline viral detection sensors to optimize vaccine production scalability
5.4. Regulatory harmonization efforts for global approval of novel rapid molecular assays in viral contamination monitoring
5.5. Development of multiplexed CRISPR-based assays for simultaneous detection of multiple viral contaminants in biologics
5.6. Advances in microfluidic-based point-of-care viral quantification platforms for decentralized biologics manufacturing oversight
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Biomanufacturing Viral Detection & Quantification Market, by Product
8.1. Instruments & Systems
8.1.1. Crispr Detection Systems
8.1.2. Digital Pcr Systems
8.1.3. Immunoassay Analyzers
8.1.4. Ngs Platforms
8.1.5. Real Time Pcr Systems
8.1.6. Thermal Cyclers
8.2. Reagents & Kits
8.2.1. Immunoassay Reagents
8.2.2. Ngs Library Preparation Kits
8.2.3. Pcr Master Mixes
8.2.4. Rna Extraction Kits
8.2.5. Sequencing Reagents
8.3. Software & Services
9. Biomanufacturing Viral Detection & Quantification Market, by Technology
9.1. Crispr Technology
9.2. Immunoassay
9.2.1. Chemiluminescent Immunoassay
9.2.2. Elisa
9.2.3. Lateral Flow Assay
9.3. Next Generation Sequencing
9.3.1. Illumina Sequencing
9.3.2. Ion Torrent Sequencing
9.3.3. Nanopore Sequencing
9.4. Polymerase Chain Reaction
9.4.1. Conventional Pcr
9.4.2. Digital Pcr
9.4.3. Real-Time Pcr
10. Biomanufacturing Viral Detection & Quantification Market, by Application
10.1. Gene Therapy Quality Control
10.2. Research Applications
10.3. Vaccine Development
10.4. Viral Load Monitoring
10.5. Viral Safety Testing
11. Biomanufacturing Viral Detection & Quantification Market, by End User
11.1. Academic & Research Institutions
11.2. Contract Research Organizations
11.3. Diagnostic Laboratories
11.4. Hospitals & Clinics
11.5. Pharmaceutical & Biotechnology Companies
12. Biomanufacturing Viral Detection & Quantification Market, by Sample Type
12.1. Blood & Plasma
12.2. Environmental Samples
12.3. Respiratory Samples
12.4. Tissue Samples
13. Biomanufacturing Viral Detection & Quantification Market, by Region
13.1. Americas
13.1.1. North America
13.1.2. Latin America
13.2. Europe, Middle East & Africa
13.2.1. Europe
13.2.2. Middle East
13.2.3. Africa
13.3. Asia-Pacific
14. Biomanufacturing Viral Detection & Quantification Market, by Group
14.1. ASEAN
14.2. GCC
14.3. European Union
14.4. BRICS
14.5. G7
14.6. NATO
15. Biomanufacturing Viral Detection & Quantification Market, by Country
15.1. United States
15.2. Canada
15.3. Mexico
15.4. Brazil
15.5. United Kingdom
15.6. Germany
15.7. France
15.8. Russia
15.9. Italy
15.10. Spain
15.11. China
15.12. India
15.13. Japan
15.14. Australia
15.15. South Korea
16. Competitive Landscape
16.1. Market Share Analysis, 2024
16.2. FPNV Positioning Matrix, 2024
16.3. Competitive Analysis
16.3.1. Thermo Fisher Scientific Inc.
16.3.2. Danaher Corporation
16.3.3. Merck KGaA
16.3.4. Roche Holding AG
16.3.5. QIAGEN N.V.
16.3.6. Illumina, Inc.
16.3.7. Agilent Technologies, Inc.
16.3.8. Bio-Rad Laboratories, Inc.
16.3.9. PerkinElmer, Inc.
16.3.10. Sartorius AG

Samples

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Companies Mentioned

The key companies profiled in this Biomanufacturing Viral Detection & Quantification market report include:
  • Thermo Fisher Scientific Inc.
  • Danaher Corporation
  • Merck KGaA
  • Roche Holding AG
  • QIAGEN N.V.
  • Illumina, Inc.
  • Agilent Technologies, Inc.
  • Bio-Rad Laboratories, Inc.
  • PerkinElmer, Inc.
  • Sartorius AG

Table Information