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市场调查报告书
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1771569

美国生物安全检测产品和服务市场规模、份额、趋势分析报告：按产品类型、应用、检测类型和细分市场预测，2025 年至 2033 年

U.S. Biological Safety Testing Products And Services Market Size, Share & Trends Analysis Report By Product, By Application, By Test Type, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 100 Pages | 商品交期: 2-10个工作天内

价格

市场规模与趋势：

预计 2024 年美国生物安全检测产品和服务市场规模将达到 14.4 亿美元，2025 年至 2033 年的复合年增长率为 9.88%。

美国生物製药和生物技术产业的快速发展是生物安全检测市场最大的驱动力之一。生技药品、生物相似药、基因疗法和再生医学领域的研发投入不断增加，推动了对有效且准确的生物安全检测的需求。这些治疗方法复杂且敏感，需要严格的安全通讯协定才能满足监管和临床的期望。

新型候选治疗药物的快速成长导致检测量不断扩大，对新型检测的需求也随之增加，加速了尖端生物安全平台的开发。个人化医疗的策略推动，加上人口老化和慢性病的盛行率上升，进一步加剧了这项需求。默克公司于2024年10月在马里兰州开设了一家耗资3.05亿美元的生物安全检测和细胞库设施。该设施将整合检测、分析开发和生产，以简化工作流程。该公司专有的Blazar CHO AOF试剂盒可将检测时间缩短一半以上，反映了生物安全服务对速度和可靠性的重视。此类投资彰显了生物安全在确保治疗管道和推动高价值生技药品快速进入市场方面发挥的重要作用。

美国食品药物管理局(FDA) 和美国药典 (USP) 等机构要求在生技药品的整个开发和生产生命週期中进行严格的安全测试。这包括无菌测试、内毒素测试、微生物附着量测试、霉浆菌测试等。对于单株抗体、疫苗和基因治疗药物等可能有污染风险且危及安全性和有效性的产品，监管要求尤其严格。因此，製药公司和委外研发机构(CRO) 必须实施高品质、经过验证的生物安全程序，以确保核准并最大限度地降低风险。

违规可能导致临床暂停、产品召回和市场撤回，因此，建立健全的安全框架至关重要。赛默飞世尔科技于2024年2月扩建了位于威斯康辛州米德尔顿的GMP实验室，新增了基于qPCR的霉浆菌快速检测技术。这项新方法只需五天即可获得结果，使製造商能够在不影响品质的情况下满足FDA的时间表。随着生物製药的製备方式日益复杂和分散，监管协调方面的努力持续推动安全基础设施的创新和投资，使美国公司能够在保持合规的同时加快治疗方法的交付。

定量PCR、次世代定序(NGS)、生物感测器和自动化等技术创新正在改变传统的检测模式。这些技术能够及早发现微生物和病毒污染物，显着缩短批次放行和产品开发所需的时间和成本。自动化和整合平台也在提高通量，随着治疗药物管线的扩大，检测需求也随之增加，通量至关重要。各公司不仅在对现有设施进行现代化改造，还在建造配备数位化和机器人系统的新中心，以支援大批量检测并最大程度地减少人为错误。 SGS北美公司位于伊利诺伊州剪切机的卓越中心于2024年7月进行了扩建，就反映了这一趋势。这次6万平方英尺的升级改造新增了设备，以支援所有药物开发阶段的生物相似药和新型生物製药检测。这些整合系统提供端到端的分析支持，并增强了可追溯性和资料完整性。未来，人工智慧和机器学习的整合或将实现预测性生物安全分析，开启主动污染风险管理的新时代。此类先进工具的日益普及将巩固美国在生物安全创新领域的世界领先地位。

目录

第一章调查方法与范围

第二章美国生物安全检测产品与服务市场：执行摘要

  • 市场概述
  • 产品和服务概览
  • 应用程式和测试类型的简介
  • 竞争格局简介

第三章美国生物安全测试产品和服务市场变数、趋势和范围

  • 市场区隔和范围
  • 市场展望
    • 母市场展望
    • 相关/支持市场展望
  • 市场动态
  • 市场驱动因素分析
    • 增加政府倡议和建议的数量
    • 疾病负担的增加导致新型生技药品的产量增加
    • 在临床和生命科学研究方面投入大量研发资金
  • 市场限制因素分析
    • 冗长的核准流程
  • 美国生物安全检测产品与服务市场分析工具
    • 产业分析-波特五力分析
    • PESTLE分析

第四章美国生物安全检测产品与服务：产品评估与趋势分析

  • 2024年及2033年的产品市场占有率
  • 细分仪表板
  • 美国生物安全检测产品与服务市场：产品展望
  • 2021 年至 2033 年市场规模、预测与趋势分析
    • 试剂和套件
    • 服务
    • 装置

第五章美国生物安全检测产品与服务：应用评估与趋势分析

  • 2024 年和 2033 年应用市场占有率
  • 细分仪表板
  • 美国生物安全检测产品与服务市场：应用展望
  • 2021 年至 2033 年市场规模、预测与趋势分析
    • 疫苗和治疗
    • 血液和血液相关产品
    • 基因治疗
    • 组织和基于组织的产品
    • 干细胞

6. 生物安全检测产品和服务：检测类型的估计和趋势分析

  • 2024年及2033年测试类型市场占有率
  • 细分仪表板
  • 美国生物安全检测产品与服务市场（按检测类型）展望
  • 2021 年至 2033 年市场规模、预测与趋势分析
    • 内毒素检测
    • 无菌测试
    • 细胞株鑑定和特性测试
    • 微生物附着量测试
    • 外来性病原体检测
    • 残留宿主污染检测试验
    • 其他的

第七章 竞争态势

  • 主要市场参与企业的近期趋势和影响分析
  • 公司/竞争对手分类
  • 供应商格局
    • List Of Key Distributors And Channel Partners
    • Key Customers
    • Key Company Market Share Analysis, 2024
    • Charles River Laboratories
    • BSL Bioservice
    • Merck KGaA
    • Samsung Biologics
    • Sartorius AG
    • Eurofins Scientific
    • SGS Societe Generale de Surveillance SA
    • Thermo Fisher Scientific Inc.
    • BIOMERIEUX
    • Lonza
Product Code: GVR-4-68040-619-9

Market Size & Trends:

The U.S. biological safety testing products and services market size was estimated at USD 1.44 billion in 2024 and is expected to grow at a CAGR of 9.88% from 2025 to 2033. The rapid growth of the biopharmaceutical and biotechnology industries in the U.S. is one of the foremost drivers of the biological safety testing market. With increasing R&D investment in biologics, biosimilars, gene therapies, and regenerative medicines, there is heightened demand for validated, precise biosafety testing. These therapies, being complex and sensitive, require robust safety protocols to meet regulatory and clinical expectations.

The surge in novel therapeutic candidates has led to an expansion in testing volumes and a need for new assay types, accelerating the development of cutting-edge biosafety platforms. The strategic push toward personalized medicine, combined with an aging population and increasing prevalence of chronic diseases, further amplifies this need. Merck's October 2024 launch of a USD 305 million biosafety testing and cell bank facility in Maryland illustrates how major players are responding to this demand. The site integrates testing with analytical development and manufacturing, streamlining workflows. Its proprietary Blazar CHO AOF panel, which reduces testing timelines by more than half, exemplifies the emphasis on speed and reliability in biosafety services. Such investments signify the foundational role of biological safety in securing the therapeutic pipeline and enabling rapid market entry for high-value biologics.

Regulatory oversight in the U.S. is a key force shaping the biological safety testing market. agencies like the U.S. Food and Drug Administration (FDA) and the U.S. Pharmacopeia (USP) enforce rigorous safety testing mandates for biologics throughout their development and manufacturing lifecycle. These include sterility, endotoxin, bioburden, and mycoplasma tests, among others. Regulatory expectations are especially strict for products such as monoclonal antibodies, vaccines, and gene therapies, where contamination risks can compromise safety and efficacy. As a result, pharmaceutical companies and contract research organizations (CROs) are compelled to implement high-quality, validated biosafety procedures to secure approvals and minimize risks.

Non-compliance can result in clinical holds, product recalls, or market withdrawal, increasing the strategic importance of robust safety frameworks. Thermo Fisher Scientific's February 2024 enhancement of its GMP lab in Middleton, Wisconsin-adding rapid qPCR-based mycoplasma testing-demonstrates industry alignment with these expectations. The new method delivers results in just five days, enabling manufacturers to meet FDA timelines without compromising quality. As biologic modalities become more complex and distributed, regulatory harmonization efforts will continue to drive innovations and investments in safety infrastructure, ensuring that U.S.-based firms remain compliant while accelerating therapeutic delivery.

Innovations such as qPCR, next-generation sequencing (NGS), biosensors, and automation are transforming traditional testing models. These technologies enable earlier detection of microbial or viral contaminants, significantly reducing the time and cost associated with batch release and product development. Automated and integrated platforms are also enhancing throughput, a crucial capability as testing demand increases with larger therapeutic pipelines. Companies are not only modernizing existing facilities but also building new centers equipped with digital and robotic systems to support high-volume testing with minimal human error. SGS North America's July 2024 expansion of its Center of Excellence in Lincolnshire, Illinois, exemplifies this trend. The 60,000 sq. ft. upgrade added new instrumentation to support biosimilar and novel biologic testing across all drug development stage. These integrated systems offer end-to-end analytical support, enhancing traceability and data integrity-two core requirements in regulated environments. Looking ahead, technology convergence with AI and machine learning may enable predictive biosafety analytics, ushering in a new era of proactive contamination risk management. The increasing availability of such sophisticated tools cements the U.S.'s position as a global leader in biosafety innovation.

U.S. Biological Safety Testing Products And Services Market Report Segmentation

This report forecasts revenue growth at regional & country levels and provides an analysis on the industry trends in each of the sub-segments from 2021 to 2033. For the purpose of this study, Grand View Research has segmented the U.S. biological safety testing products and services market report on the basis of product, application, and test type:

  • Product and Service Outlook (Revenue, USD Million, 2021 - 2033)
  • Reagents & Kits
  • Instruments
  • Services
  • Application Outlook (Revenue, USD Million, 2021 - 2033)
  • Vaccines & Therapeutics
    • Vaccines
    • Monoclonal Antibodies
    • Recombinant Protein
  • Blood & Blood-based Products
  • Gene Therapy
  • Tissue & Tissue-based Products
  • Stem Cell
  • Test Type Outlook (Revenue, USD Million, 2021 - 2033)
  • Endotoxin Tests
  • Sterility Tests
  • Cell Line Authentication & Characterization Tests
  • Bioburden Tests
  • Adventitious Agent Detection Tests
  • Residual Host Contamination Detection Tests
  • Others

Table of Contents

Chapter 1. Methodology And Scope

  • 1.1. Market Segmentation And Scope
    • 1.1.1. Segment Definitions
      • 1.1.1.1. Products Segment
      • 1.1.1.2. Application Segment
      • 1.1.1.3. Test Type Segment
  • 1.2. Regional Scope
  • 1.3. Estimates And Forecast Timeline
  • 1.4. Objectives
    • 1.4.1. Objective - 1
    • 1.4.2. Objective - 2
  • 1.5. Research Methodology
  • 1.6. Information Procurement
    • 1.6.1. Purchased Database
    • 1.6.2. GVR's Internal Database
    • 1.6.3. Secondary Sources
    • 1.6.4. Primary Research
  • 1.7. Information Or Data Analysis
    • 1.7.1. Data Analysis Models
  • 1.8. Market Formulation & Validation
  • 1.9. Model Details
    • 1.9.1. Commodity Flow Analysis
  • 1.10. List Of Primary Sources
  • 1.11. List Of Abbreviations

Chapter 2. U.S. Biological Safety Testing Products & Services Market: Executive Summary

  • 2.1. Market Snapshot
  • 2.2. Products And Services Snapshots
  • 2.3. Application and Test Type Snapshot
  • 2.4. Competitive Landscape Snapshot

Chapter 3. U.S. Biological Safety Testing Products & Services Market Variables, Trends, & Scope

  • 3.1. Market Segmentation And Scope
  • 3.2. Market Lineage Outlook
    • 3.2.1. Parent Market Outlook
    • 3.2.2. Related/Ancillary Market Outlook
  • 3.3. Market Dynamics
  • 3.4. Market Drivers Analysis
    • 3.4.1. Increase number of government initiatives and recommendations
    • 3.4.2. Increasing production of new biologics due to high disease burden
    • 3.4.3. High R&D investments in clinical research and life sciences research
  • 3.5. Market Restraint Analysis
    • 3.5.1. Time-consuming approval process
  • 3.6. U.S. Biological Safety Testing Products & Services Market Analysis Tools
    • 3.6.1. Industry Analysis - Porter's
      • 3.6.1.1. Supplier Power
      • 3.6.1.2. Buyer Power
      • 3.6.1.3. Substitution Threat
      • 3.6.1.4. Threat Of New Entrant
      • 3.6.1.5. Competitive Rivalry
    • 3.6.2. PESTLE Analysis
      • 3.6.2.1. Political Landscape
      • 3.6.2.2. Technological Landscape
      • 3.6.2.3. Economic Landscape

Chapter 4. U.S. Biological Safety Testing Products & Services: Products Estimates & Trend Analysis

  • 4.1. Product Market Share, 2024 & 2033
  • 4.2. Segment Dashboard
  • 4.3. U.S. Biological Safety Testing Products & Services Market By Product Outlook
  • 4.4. Market Size & Forecasts And Trend Analyses, 2021 To 2033 For The Following
    • 4.4.1. Reagents & Kits
      • 4.4.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 4.4.2. Services
      • 4.4.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 4.4.3. Instruments
      • 4.4.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)

Chapter 5. U.S. Biological Safety Testing Products & Services: Application Estimates & Trend Analysis

  • 5.1. Application Market Share, 2024 & 2033
  • 5.2. Segment Dashboard
  • 5.3. U.S. Biological Safety Testing Products & Services Market By Application Outlook
  • 5.4. Market Size & Forecasts And Trend Analyses, 2021 To 2033 For The Following
    • 5.4.1. Vaccine & Therapeutics Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
        • 5.4.1.1.1. Vaccines Market Estimates And Forecasts 2021 To 2033 (USD Million)
          • 5.4.1.1.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
        • 5.4.1.1.2. Monoclonal Antibodies Market Estimates And Forecasts 2021 To 2033 (USD Million)
          • 5.4.1.1.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
        • 5.4.1.1.3. Recombinant Protein Market Estimates And Forecasts 2021 To 2033 (USD Million)
          • 5.4.1.1.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 5.4.2. Blood & Blood-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 5.4.3. Gene Therapy Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 5.4.4. Tissue & Tissue-based Products Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.4.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 5.4.5. Stem Cells Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
      • 5.4.5.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)

Chapter 6. Biological Safety Testing Products & Services: Test Type Estimates & Trend Analysis

  • 6.1. Test Type Market Share, 2024 & 2033
  • 6.2. Segment Dashboard
  • 6.3. Global U.S. Biological Safety Testing Products & Services Market By Test Type Outlook
  • 6.4. Market Size & Forecasts And Trend Analyses, 2021 To 2033 For The Following
    • 6.4.1. Endotoxin Tests
      • 6.4.1.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 6.4.2. Sterility Tests
      • 6.4.2.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 6.4.3. Cell Line Authentication & Characterization Tests
      • 6.4.3.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 6.4.4. Bioburden Tests
      • 6.4.4.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 6.4.5. Adventitious Agent Detection Tests
      • 6.4.5.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 6.4.6. Residual Host Contamination Detection Tests
      • 6.4.6.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)
    • 6.4.7. Others
      • 6.4.7.1. Market Estimates And Forecasts 2021 To 2033 (USD Million)

Chapter 7. Competitive Landscape

  • 7.1. Recent Developments & Impact Analysis, By Key Market Participants
  • 7.2. Company /Competition Categorization
  • 7.3. Vendor Landscape
    • 7.3.1. List Of Key Distributors And Channel Partners
    • 7.3.2. Key Customers
    • 7.3.3. Key Company Market Share Analysis, 2024
    • 7.3.4. Charles River Laboratories
      • 7.3.4.1. Overview
      • 7.3.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.4.3. Product Benchmarking
      • 7.3.4.4. Strategic Initiatives
    • 7.3.5. BSL Bioservice
      • 7.3.5.1. Overview
      • 7.3.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.5.3. Product Benchmarking
      • 7.3.5.4. Strategic Initiatives
    • 7.3.6. Merck KGaA
      • 7.3.6.1. Overview
      • 7.3.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.6.3. Product Benchmarking
      • 7.3.6.4. Strategic Initiatives
    • 7.3.7. Samsung Biologics
      • 7.3.7.1. Overview
      • 7.3.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.7.3. Product Benchmarking
      • 7.3.7.4. Strategic Initiatives
    • 7.3.8. Sartorius AG
      • 7.3.8.1. Overview
      • 7.3.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.8.3. Product Benchmarking
      • 7.3.8.4. Strategic Initiatives
    • 7.3.9. Eurofins Scientific
      • 7.3.9.1. Overview
      • 7.3.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.9.3. Product Benchmarking
      • 7.3.9.4. Strategic Initiatives
    • 7.3.10. SGS Societe Generale de Surveillance SA
      • 7.3.10.1. Overview
      • 7.3.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.10.3. Product Benchmarking
      • 7.3.10.4. Strategic Initiatives
    • 7.3.11. Thermo Fisher Scientific Inc.
      • 7.3.11.1. Overview
      • 7.3.11.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.11.3. Product Benchmarking
      • 7.3.11.4. Strategic Initiatives
    • 7.3.12. BIOMERIEUX
      • 7.3.12.1. Overview
      • 7.3.12.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.12.3. Product Benchmarking
      • 7.3.12.4. Strategic Initiatives
    • 7.3.13. Lonza
      • 7.3.13.1. Overview
      • 7.3.13.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 7.3.13.3. Product Benchmarking
      • 7.3.13.4. Strategic Initiatives

List of Tables

  • Table 1 List of key distributors and channel partners
  • Table 2 List of key emerging companies'/technology disruptors/innovators
  • Table 3 U.S. Biological Safety Testing Products and Services Market, by Product, 2021 - 2033 (USD Million)
  • Table 4 U.S. Biological Safety Testing Products and Services Market, by Application, 2021 - 2033 (USD Million)
  • Table 5 U.S. Biological Safety Testing Products and Services Market, by Test Type, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information Procurement
  • Fig. 3 Primary Research Pattern
  • Fig. 4 Market Research Approaches
  • Fig. 5 Value Chain-Based Sizing & Forecasting
  • Fig. 6 Market Formulation & Validation
  • Fig. 7 U.S. Biological Safety Testing Products and Services Market Segmentation
  • Fig. 8 Market Snapshot, 2024
  • Fig. 9 Market Trends & Outlook
  • Fig. 10 Market Driver Relevance Analysis (Current & Future Impact)
  • Fig. 11 Market Restraint Relevance Analysis (Current & Future Impact)
  • Fig. 12 Market Challenge Relevance Analysis (Current & Future Impact)
  • Fig. 13 SWOT Analysis, By Factor (Political & Legal, Economic and Technological)
  • Fig. 14 Porter's Five Forces Analysis
  • Fig. 15 Market Penetration Vs Growth Prospect Mapping, 2024
  • Fig. 16 U.S. Biological Safety Testing Products & Services Market: Product Movement Analysis
  • Fig. 17 U.S. Biological Safety Testing Products & Services Market: Product Outlook And Key Takeaways
  • Fig. 18 Reagents & Kits Market Estimates And Forecast, 2021 - 2033
  • Fig. 19 Services Estimates And Forecast, 2021 - 2033
  • Fig. 20 Instruments Estimates And Forecast, 2021 - 2033
  • Fig. 21 U.S. Biological Safety Testing Products & Services Market: Application Movement Analysis
  • Fig. 22 U.S. Biological Safety Testing Products & Services Market: Application Outlook And Key Takeaways
  • Fig. 23 Vaccines & therapeutics Market Estimates And Forecasts, 2021 - 2033
  • Fig. 24 Blood & Blood-based Products Market Estimates And Forecasts,2021 - 2033
  • Fig. 25 Gene Therapy Market Estimates And Forecasts,2021 - 2033
  • Fig. 26 Tissue & Tissue-based Products Market Estimates And Forecasts,2021 - 2033
  • Fig. 27 Stem Cell Market Estimates And Forecasts,2021 - 2033
  • Fig. 28 U.S. Biological Safety Testing Products & Services Market: Test Type Movement Analysis
  • Fig. 29 U.S. Biological Safety Testing Products & Services Market: End Use Outlook And Key Takeaways
  • Fig. 30 Endotoxin Tests Market Estimates And Forecasts, 2021 - 2033
  • Fig. 31 Sterility Tests Market Estimates And Forecasts,2021 - 2033
  • Fig. 32 Cell Line Authentication & Characterization Tests Estimates And Forecasts, 2021 - 2033
  • Fig. 33 Bioburden Tests Estimates And Forecasts, 2021 - 2033
  • Fig. 34 Adventitious Agent Detection Tests Estimates And Forecasts, 2021 - 2033
  • Fig. 35 Residual Host Contamination Detection Tests Estimates And Forecasts, 2021 - 2033
  • Fig. 36 Others Estimates And Forecasts, 2021 - 2033