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市场调查报告书
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1790199

美国药品无菌测试市场规模、份额、趋势分析报告：按类型、产品、测试、样品、最终用途、细分市场预测，2025-2033

U.S. Pharmaceutical Sterility Testing Market Size, Share & Trends Analysis Report By Type, By Product, By Test, By Sample, By End-use, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10个工作天内

价格

美国药品无菌检测市场概况

美国药品无菌测试市场规模预计在 2024 年为 6.7 亿美元，预计到 2033 年将达到 17 亿美元，2025 年至 2033 年的复合年增长率为 11.04%。市场受到研发活动活性化、药品创新增加、对品质和无菌性的日益关注以及政府对医疗保健的投资增加的推动。

此外，生技药品和个人化医疗需求的不断增长，以及美国食品药物管理局 (FDA) 和美国药典 (USP) 的严格监管要求，预计将推动市场成长。此外，快速微生物学方法（例如 PCR 和 ATP 生物发光）的采用、自动化程度的提高以最大限度地减少错误，以及使用人工智慧主导的分析技术来改进数据解读，都推动了外包和高效成本管理趋势的日益增长。此外，随着药品生产的日益复杂以及对患者安全的日益重视，市场正在转向更快、更可靠的检测解决方案，以确保产品安全和合规性。

此外，全球药品上市数量的不断增加继续成为药品无菌检测行业的主要驱动力。据美国FDA 称，仅在 2024 年，药品评估和研究中心 (CDER) 就核准了50 种新分子生技药品(NME) 和生技药品，由于个人化医疗、基因治疗和新型生技药品的进步，预计这一趋势将在 2025 年加速。每种新推出的无菌药品，包括注射剂、疫苗和先进治疗程序 (ATMP)，都需要进行严格的无菌测试，以符合 FDA、EMA 和 WHO 等严格的法规结构。

药物传递系统和生技药品的创新正在增加无菌药品的复杂性和多样性，进一步推动无菌检测的需求。研究表明，到2024年，无菌注射剂药物的研发管线将年增15%以上，这反映了持续的研发投入以及针对尚未满足的医疗需求的新型疗法的市场进入。这种扩张需要提高无菌检测能力，采用快速微生物检测方法，并调整检测通讯协定以确保安全性和有效性。

此外，随着创新技术的采用，美国药品无菌检测领域正在快速发展。 ATP生物发光和PCR等新型快速微生物学方法正在加速污染检测，缩短产品放行时间。自动化和机器人技术的日益普及，提高了测试准确性，减少了人为错误。此外，人工智慧正在辅助数据分析并提供预测性洞察，从而改善决策流程。这些进步与日益严格的FDA和USP要求一致，确保了复杂生技药品和个人化疗法的安全标准得到提升。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国药品无菌测试市场变数、趋势与范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 定价模式分析
  • 科技
  • 市场分析工具
    • 波特五力分析
    • PESTEL 与 SWOT 分析
    • COVID-19影响分析

第四章：美国药品无菌测试市场类型、估价与趋势分析

  • 美国药品无菌测试市场（按类型）：细分仪表板
  • 美国药品无菌测试市场（按类型）：波动分析
  • 按类型，2021-2033年
  • 内部
  • 外包

第五章：美国药品无菌测试市场（按产品、估计和趋势分析）

  • 美国药品无菌检测市场（按产品）：细分仪表板
  • 美国药品无菌检测市场（依产品）：变异分析
  • 按产品，2021-2033
  • 套件和试剂
  • 装置
  • 服务

第六章：美国药品无菌测试市场：依测试、估算与趋势分析

  • 美国药品无菌测试市场（按测试）：细分仪表板
  • 美国药品无菌测试市场（按测试）：变异分析
  • 按考试，2021-2033
  • 无菌测试
    • 薄膜过滤
    • 直接接种
    • 产品快讯
  • 微生物附着量测试
  • 细菌内毒素检测

第七章美国药品无菌测试市场：按最终用途的估计和趋势分析

  • 美国药品无菌测试市场（依最终用途）：细分仪表板
  • 美国药品无菌检测市场（依最终用途）：差异分析
  • 按应用，2021-2033 年
  • 配药药房
  • 医疗设备公司
  • 製药公司
  • 其他的

第 8 章：美国药品无菌测试市场：样本、估算与趋势分析

  • 美国药品无菌测试市场（按样本）：细分仪表板
  • 美国药品无菌检测市场（依样本）：变异分析
  • 按样本，2021-2033年
  • 製药
  • 医疗设备
  • 生物製药

第九章 竞争态势

  • 市场参与企业分类
  • 2024 年公司市场占有率/估值分析
  • 公司简介
    • Pacific Biolabs
    • Steris Plc
    • Boston Analytical
    • Nelson Laboratories, LLC（Sotera Health）
    • Sartorius AG
    • SOLVIAS AG
    • SGS SA
    • Labcorp
    • Pace Analytical
    • Charles River Laboratories
    • Thermo Fisher Scientific, Inc.
    • Rapid Micro Biosystems
    • Almac Group

第十章 主要建议

Product Code: GVR-2-68038-403-1

U.S. Pharmaceutical Sterility Testing Market Summary

The U.S. pharmaceutical sterility testing market size was estimated at USD 0.67 billion in 2024 and is projected to reach USD 1.70 billion by 2033, growing at a CAGR of 11.04% from 2025 to 2033. The market is driven by increasing R&D activities, growing drug innovations, rising focus on quality & sterility, and rising government investments in healthcare.

Besides, rising demand for biologics, personalized medicines, and stringent regulatory requirements from the FDA and USP is expected to support the market growth. In addition, the adoption of rapid microbiological methods (such as PCR and ATP bioluminescence), increased automation to minimize errors, and the use of AI-driven analytics for improved data interpretation is contributing to growing trends toward outsourcing and managing costs effectively. Also, the market is shifting towards faster and more reliable testing solutions that ensure product safety and compliance, especially as the complexity of pharmaceutical manufacturing increases and there is an increased focus on patient safety.

Moreover, the rising number of drug launches globally continues to be a significant growth driver for the pharmaceutical sterility testing industry. According to the U.S. FDA, 50 new molecular entities (NMEs) and biologics were approved by Center for Drug Evaluation and Research (CDER) in 2024 alone, the trend is expected to accelerate in 2025 due to advancements in personalized medicine, gene therapies, and novel biologics. Each newly launched sterile drug, including injectables, vaccines, and advanced therapy medicinal products (ATMPs), requires stringent sterility testing to comply with rigorous regulatory frameworks such as those from the FDA, EMA, and WHO.

The growing complexity and diversity of sterile formulations, driven by innovations in drug delivery systems and biologics, further intensify sterility testing demands. As per the research study, the pipeline of sterile injectable drugs expanded by over 15% year-on-year in 2024, reflecting sustained R&D investment and market entry of novel therapies targeting unmet medical needs. This expansion requires enhanced sterility testing capacity, adoption of rapid microbiological methods, and tailored testing protocols to ensure safety and efficacy.

Furthermore, the U.S. pharmaceutical sterility testing sector is evolving rapidly due to the adoption of innovative technologies. Emerging rapid microbiological methods, such as ATP bioluminescence and PCR, are accelerating contamination detection and shortening product release times. The increased use of automation and robotics enhances testing accuracy while reducing manual errors. In addition, artificial intelligence aids in data analysis and provides predictive insights, improving decision-making processes. These advancements align with stricter FDA and USP requirements, ensuring enhanced safety standards for complex biologics and personalized therapies.

U.S. Pharmaceutical Sterility Testing Market Report Segmentation

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. pharmaceutical sterility testing market report based on type, product, test, sample, and end-use.

  • Type Outlook (Revenue, USD Million, 2021 - 2033)
  • In-House
  • Outsourcing
  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Kits and Reagents
  • Instruments
  • Services
  • Test Outlook (Revenue, USD Million, 2021 - 2033)
  • Sterility Testing
    • Membrane Filtration
    • Direct Inoculation
    • Product Flush
  • Bioburden Testing
  • Bacterial Endotoxin Testing
  • Sample Outlook (Revenue, USD Million, 2021 - 2033)
  • Pharmaceuticals
  • Medical Devices
  • Biopharmaceuticals
  • End-use Outlook (Revenue, USD Million, 2021 - 2033)
  • Compounding Pharmacies
  • Medical Device Companies
  • Pharmaceutical Companies
  • Others

Table of Contents

Chapter 1. Research Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Market Definitions
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased Database
    • 1.4.2. GVR's Internal Database
    • 1.4.3. Secondary Sources
    • 1.4.4. Primary Research
  • 1.5. Information Or Data Analysis
    • 1.5.1. Data Analysis Models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity flow analysis (Model 1)
    • 1.7.2. Value chain based analysis (Model 2)
    • 1.7.3. Multivariate Analysis (Model 3)
  • 1.8. List Of Secondary Sources
  • 1.9. List Of Abbreviations
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. Pharmaceutical Sterility Testing Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Related/Ancillary Market Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
      • 3.2.1.1. Supportive Government Investment in Healthcare Industry
      • 3.2.1.2. Increasing R&D Activities
      • 3.2.1.3. Increasing Number of Drug Launches
      • 3.2.1.4. Increasing Focus on Quality and Sterility
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Compliance Issues While Outsourcing
      • 3.2.2.2. Third Party Performance
  • 3.3. Pricing Model Analysis
  • 3.4. Technology Landscape
  • 3.5. Market Analysis Tools
    • 3.5.1. Porter's Five Force Analysis
    • 3.5.2. PESTEL by SWOT Analysis
    • 3.5.3. COVID-19 Impact Analysis

Chapter 4. U.S. Pharmaceutical Sterility Testing Market: Type Estimates & Trend Analysis

  • 4.1. U.S. Pharmaceutical Sterility Testing Market, By Type: Segment Dashboard
  • 4.2. U.S. Pharmaceutical Sterility Testing Market, By Type: Movement Analysis
  • 4.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Type, 2021-2033 (USD Million)
  • 4.4. In-House
    • 4.4.1. In-House Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Outsourcing
    • 4.5.1. Outsourcing Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Pharmaceutical Sterility Testing Market: Product Estimates & Trend Analysis

  • 5.1. U.S. Pharmaceutical Sterility Testing Market, By Product: Segment Dashboard
  • 5.2. U.S. Pharmaceutical Sterility Testing Market, By Product: Movement Analysis
  • 5.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Product, 2021-2033 (USD Million)
  • 5.4. Kits and Reagents
    • 5.4.1. Kits and Reagents Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Instruments
    • 5.5.1. Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.6. Services
    • 5.6.1. Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Pharmaceutical Sterility Testing Market: Test Estimates & Trend Analysis

  • 6.1. U.S. Pharmaceutical Sterility Testing Market, By Test: Segment Dashboard
  • 6.2. U.S. Pharmaceutical Sterility Testing Market, By Test: Movement Analysis
  • 6.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Test, 2021-2033 (USD Million)
  • 6.4. Sterility Testing
    • 6.4.1. Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.2. Membrane Filtration
      • 6.4.2.1. Membrane Filtration Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.3. Direct Inoculation
      • 6.4.3.1. Direct Inoculation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 6.4.4. Product Flush
      • 6.4.4.1. Product Flush Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Bioburden Testing
    • 6.5.1. Bioburden Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Bacterial Endotoxin Testing
    • 6.6.1. Bacterial Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Pharmaceutical Sterility Testing Market: End-Use Estimates & Trend Analysis

  • 7.1. U.S. Pharmaceutical Sterility Testing Market, By End-Use: Segment Dashboard
  • 7.2. U.S. Pharmaceutical Sterility Testing Market, By End-Use: Movement Analysis
  • 7.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By End-Use, 2021-2033 (USD Million)
  • 7.4. Compounding Pharmacies
    • 7.4.1. Compounding Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5. Medical Device Companies
    • 7.5.1. Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6. Pharmaceutical Companies
    • 7.6.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7. Others
    • 7.7.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. U.S. Pharmaceutical Sterility Testing Market: Sample Estimates & Trend Analysis

  • 8.1. U.S. Pharmaceutical Sterility Testing Market, By Sample: Segment Dashboard
  • 8.2. U.S. Pharmaceutical Sterility Testing Market, By Sample: Movement Analysis
  • 8.3. U.S. Pharmaceutical Sterility Testing Market Estimates & Forecasts, By Sample, 2021-2033 (USD Million)
  • 8.4. Pharmaceuticals
    • 8.4.1. Pharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 8.5. Medical Devices
    • 8.5.1. Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 8.6. Biopharmaceuticals
    • 8.6.1. Biopharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

  • 9.1. Market Participant Categorization
  • 9.2. Company Market Share/Assessment Analysis, 2024
  • 9.3. Company Profiles
    • 9.3.1. Pacific Biolabs
      • 9.3.1.1. Company overview
      • 9.3.1.2. Financial performance
      • 9.3.1.3. Service benchmarking
      • 9.3.1.4. Strategic initiatives
    • 9.3.2. Steris Plc
      • 9.3.2.1. Company overview
      • 9.3.2.2. Financial performance
      • 9.3.2.3. Service benchmarking
      • 9.3.2.4. Strategic initiatives
    • 9.3.3. Boston Analytical
      • 9.3.3.1. Company overview
      • 9.3.3.2. Financial performance
      • 9.3.3.3. Service benchmarking
      • 9.3.3.4. Strategic initiatives
    • 9.3.4. Nelson Laboratories, LLC (Sotera Health)
      • 9.3.4.1. Company overview
      • 9.3.4.2. Financial performance
      • 9.3.4.3. Service benchmarking
      • 9.3.4.4. Strategic initiatives
    • 9.3.5. Sartorius AG
      • 9.3.5.1. Company overview
      • 9.3.5.2. Financial performance
      • 9.3.5.3. Service benchmarking
      • 9.3.5.4. Strategic initiatives
    • 9.3.6. SOLVIAS AG
      • 9.3.6.1. Company overview
      • 9.3.6.2. Financial performance
      • 9.3.6.3. Service benchmarking
      • 9.3.6.4. Strategic initiatives
    • 9.3.7. SGS SA
      • 9.3.7.1. Company overview
      • 9.3.7.2. Financial performance
      • 9.3.7.3. Service benchmarking
      • 9.3.7.4. Strategic initiatives
    • 9.3.8. Labcorp
      • 9.3.8.1. Company overview
      • 9.3.8.2. Financial performance
      • 9.3.8.3. Service benchmarking
      • 9.3.8.4. Strategic initiatives
    • 9.3.9. Pace Analytical
      • 9.3.9.1. Company overview
      • 9.3.9.2. Financial performance
      • 9.3.9.3. Service benchmarking
      • 9.3.9.4. Strategic initiatives
    • 9.3.10. Charles River Laboratories
      • 9.3.10.1. Company overview
      • 9.3.10.2. Financial performance
      • 9.3.10.3. Service benchmarking
      • 9.3.10.4. Strategic initiatives
    • 9.3.11. Thermo Fisher Scientific, Inc.
      • 9.3.11.1. Company overview
      • 9.3.11.2. Financial performance
      • 9.3.11.3. Service benchmarking
      • 9.3.11.4. Strategic initiatives
    • 9.3.12. Rapid Micro Biosystems
      • 9.3.12.1. Company overview
      • 9.3.12.2. Financial performance
      • 9.3.12.3. Service benchmarking
      • 9.3.12.4. Strategic initiatives
    • 9.3.13. Almac Group
      • 9.3.13.1. Company overview
      • 9.3.13.2. Financial performance
      • 9.3.13.3. Service benchmarking
      • 9.3.13.4. Strategic initiatives

Chapter 10 Key Recommendations

List of Tables

  • Table 1. List of Tables
  • Table 2. List of Secondary Sources
  • Table 3. List of Abbreviations
  • Table 4. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Type, 2021 - 2033 (USD Million)
  • Table 5. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Product, 2021 - 2033 (USD Million)
  • Table 6. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Test, 2021 - 2033 (USD Million)
  • Table 7. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Sterility Testing, 2021 - 2033 (USD Million)
  • Table 8. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by End-Use, 2021 - 2033 (USD Million)
  • Table 9. U.S. Pharmaceutical Sterility Testing Market Estimates and Forecasts, by Sample, 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 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 U.S. Pharmaceutical Sterility Testing Market Dynamics
  • Fig. 17 Porter's five forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. Pharmaceutical Sterility Testing Market: Type outlook and key takeaways
  • Fig. 20 U.S. Pharmaceutical Sterility Testing Market: Type movement analysis
  • Fig. 21 In-House Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Outsourcing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 U.S. Pharmaceutical Sterility Testing Market: Product outlook and key takeaways
  • Fig. 24 U.S. Pharmaceutical Sterility Testing Market: Product movement analysis
  • Fig. 25 Kits and Reagents Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 U.S. Pharmaceutical Sterility Testing Market: Test outlook and key takeaways
  • Fig. 29 U.S. Pharmaceutical Sterility Testing Market: Test movement analysis
  • Fig. 30 Sterility Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 Membrane Filtration Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 32 Direct Inoculation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 33 Product Flush Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Bioburden Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Bacterial Endotoxin Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 U.S. Pharmaceutical Sterility Testing Market: End-Use outlook and key takeaways
  • Fig. 37 U.S. Pharmaceutical Sterility Testing Market: End-Use movement analysis
  • Fig. 38 Compounding Pharmacies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 U.S. Pharmaceutical Sterility Testing Market: Sample outlook and key takeaways
  • Fig. 43 U.S. Pharmaceutical Sterility Testing Market: Sample movement analysis
  • Fig. 44 Pharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 45 Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 46 Biopharmaceuticals Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Key company categorization
  • Fig. 48 Service heat map analysis
  • Fig. 49 Strategic framework