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市場調查報告書
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1771569

美國生物安全檢測產品和服務市場規模、佔有率、趨勢分析報告：按產品類型、應用、檢測類型和細分市場預測，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個工作天內

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市場規模與趨勢：

預計 2024 年美國生物安全檢測產品和服務市場規模將達到 14.4 億美元，2025 年至 2033 年的複合年成長率為 9.88%。

美國生物製藥和生物技術產業的快速發展是生物安全檢測市場最大的驅動力之一。生技藥品、生物相似藥、基因療法和再生醫學領域的研發投入不斷增加，推動了對有效且準確的生物安全檢測的需求。這些治療方法複雜且敏感，需要嚴格的安全通訊協定才能滿足監管和臨床的期望。

新型候選治療藥物的快速成長導致檢測量不斷擴大，對新型檢測的需求也隨之增加，加速了尖端生物安全平台的開發。個人化醫療的策略推動，加上人口老化和慢性病的盛行率上升，進一步加劇了這項需求。默克公司於2024年10月在馬裡蘭州開設了一家耗資3.05億美元的生物安全檢測和細胞庫設施。該設施將整合檢測、分析開發和生產，以簡化工作流程。該公司專有的Blazar CHO AOF試劑盒可將檢測時間縮短一半以上，反映了生物安全服務對速度和可靠性的重視。此類投資彰顯了生物安全在確保治療管道和推動高價值生技藥品快速進入市場方面發揮的重要作用。

美國食品藥物管理局(FDA) 和美國藥典 (USP) 等機構要求在生技藥品的整個開發和生產生命週期中進行嚴格的安全測試。這包括無菌測試、內毒素測試、微生物附著量測試、黴漿菌測試等。對於單株抗體、疫苗和基因治療藥物等可能有污染風險且危及安全性和有效性的產品，監管要求尤其嚴格。因此，製藥公司和委外研發機構(CRO) 必須實施高品質、經過驗證的生物安全程序，以確保核准並最大限度地降低風險。

違規可能導致臨床暫停、產品召回和市場撤回，因此，建立健全的安全框架至關重要。賽默飛世爾科技於2024年2月擴建了位於威斯康辛州米德爾頓的GMP實驗室，新增了基於qPCR的黴漿菌快速檢測技術。這項新方法只需五天即可獲得結果，使製造商能夠在不影響品質的情況下滿足FDA的時間表。隨著生物製藥的製備方式日益複雜和分散，監管協調方面的努力持續推動安全基礎設施的創新和投資，使美國公司能夠在保持合規的同時加快治療方法的交付。

定量PCR、次世代定序(NGS)、生物感測器和自動化等技術創新正在改變傳統的檢測模式。這些技術能夠及早發現微生物和病毒污染物，顯著縮短批次放行和產品開發所需的時間和成本。自動化和整合平台也在提高通量，隨著治療藥物管線的擴大，檢測需求也隨之增加，通量至關重要。各公司不僅在對現有設施進行現代化改造，還在建造配備數位化和機器人系統的新中心，以支援大批量檢測並最大程度地減少人為錯誤。 SGS北美公司位於伊利諾伊州剪切機的卓越中心於2024年7月進行了擴建，就反映了這一趨勢。這次6萬平方英尺的升級改造新增了設備，以支援所有藥物開發階段的生物相似藥和新型生物製藥檢測。這些整合系統提供端到端的分析支持，並增強了可追溯性和資料完整性。未來，人工智慧和機器學習的整合或將實現預測性生物安全分析，開啟主動污染風險管理的新時代。此類先進工具的日益普及將鞏固美國在生物安全創新領域的世界領先地位。

目錄

第1章調查方法與範圍

第2章美國生物安全檢測產品與服務市場：執行摘要

  • 市場概述
  • 產品和服務概覽
  • 應用程式和測試類型的簡介
  • 競爭格局簡介

第3章美國生物安全測試產品和服務市場變數、趨勢和範圍

  • 市場區隔和範圍
  • 市場展望
    • 母市場展望
    • 相關/支持市場展望
  • 市場動態
  • 市場促進因素分析
    • 增加政府計劃和建議的數量
    • 疾病負擔的增加導致新型生技藥品的產量增加
    • 在臨床和生命科學研究方面投入大量研發資金
  • 市場限制因素分析
    • 冗長的核准流程
  • 美國生物安全檢測產品與服務市場分析工具
    • 產業分析-波特五力分析
    • PESTLE分析

第4章美國生物安全檢測產品與服務：產品評估與趨勢分析

  • 2024年及2033年的產品市場佔有率
  • 細分儀表板
  • 美國生物安全檢測產品與服務市場：產品展望
  • 2021 年至 2033 年市場規模、預測與趨勢分析
    • 試劑和套件
    • 服務
    • 裝置

第5章美國生物安全檢測產品與服務：應用評估與趨勢分析

  • 2024 年和 2033 年應用市場佔有率
  • 細分儀表板
  • 美國生物安全檢測產品與服務市場：應用展望
  • 2021 年至 2033 年市場規模、預測與趨勢分析
    • 疫苗和治療
    • 血液和血液相關產品
    • 基因治療
    • 組織和基於組織的產品
    • 幹細胞

6. 生物安全檢測產品和服務：檢測類型的估計和趨勢分析

  • 2024年及2033年測試類型市場佔有率
  • 細分儀表板
  • 美國生物安全檢測產品與服務市場（按檢測類型）展望
  • 2021 年至 2033 年市場規模、預測與趨勢分析
    • 內毒素檢測
    • 無菌測試
    • 細胞株鑑定和特性測試
    • 微生物附著量測試
    • 外來性病原體檢測
    • 殘留宿主污染檢測試驗
    • 其他

第7章 競爭態勢

  • 主要市場參與企業的近期趨勢和影響分析
  • 公司/競爭對手分類
  • 供應商格局
    • 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