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市场调查报告书
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美国过滤器完整性测试市场：市场规模、份额、趋势分析（按测试方法、模式、类型和最终用途划分）、细分市场预测（2025-2033 年）

U.S. Filter Integrity Test Market Size, Share & Trends Analysis Report By Test Method (Forward Flow (Diffusion) Test, Bubble Point Test, Pressure Hold Test, Water Intrusion Test), By Mode, By Type, 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

美国过滤器完整性测试市场规模及趋势：

2024 年美国过滤器完整性测试市场规模估计为 3,212 万美元，预计到 2033 年将达到 4,736 万美元，2025 年至 2023 年的复合年增长率为 4.44%。

市场成长的主要驱动力是生物製药产业的快速发展。对生技药品、单株抗体和先进疗法的需求不断增长，导致对无菌过滤过程的依赖性日益增强，因此完整性检测对于维持产品品质和符合法规要求至关重要。美国食品药物管理局 (FDA) 对生技药品生产各个阶段的严格监管和无菌保证要求，促使企业在先进的生产设施和过滤系统方面投入巨资，从而在全国范围内催生了对完整性检测解决方案的强劲需求。

近期案例印证了这一趋势。 2025年4月，专注于治疗严重的生物製药公司UCB宣布计画在美国新建一座最先进的生技药品生产设施。此次扩建凸显了美国生技药品生产规模的不断扩大，并强调了美国製造的滤芯完整性测试系统对于确保合规性和产品安全性的重要性。随着越来越多的公司投资于生技药品产能和尖端製造技术，对滤芯完整性测试解决方案的需求预计将进一步成长。

技术创新和不断变化的监管预期也是推动市场发展的因素。随着美国在生技药品、疫苗以及细胞和基因疗法领域巩固其领先地位，完整性检测，特别是使用前灭菌后完整性检测 (PUPSIT)，正日益成为一项关键的品质指标。这些检测有助于製造商满足全球标准，同时最大限度地降低污染风险并避免代价高昂的召回。将自动化检测解决方案整合到良好生产规范 (GMP) 环境中，可进一步提高效率、合规性和可靠性。

例如，2025年5月，派克汉尼汾公司旗下的派克生物科学过滤部门推出了SciLog NFF+PF，这是一款紧凑型多用途正流过滤系统，具备PUPSIT功能。该系统解决了PUPSIT的复杂性问题（包括减少人工操作、降低操作失误和减少产品浪费），从而支援更安全、更精简的生物製药生产。此类创新为该产业树立了新的标桿，并有望在未来几年推动美国FIT市场持续成长。

目录

第一章 分析方法和范围

第二章执行摘要

第三章美国过滤器完整性测试市场：影响因素、趋势与范围

  • 市场关联性展望
    • 母市场展望
    • 相关/附随市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 美国过滤器完整性测试市场：分析工具
    • 产业分析：波特五力分析
    • PESTEL 分析
    • 定价分析
    • 市场规模分析（销售量、设备）

第四章美国过滤器完整性测试市场：按测试方法分類的估算和趋势分析

  • 美国过滤器完整性测试市场（按仪錶板和测试方法划分）
  • 美国过滤器完整性测试市场：按测试方法分類的差异分析
  • 美国过滤器完整性测试市场：按测试方法分類的收入预测（2021-2033 年）
  • 前向流动（扩散）测试
  • 气泡点测试
  • 压力保持试验
  • 水侵入测试
  • 其他的

第五章美国过滤器完整性测试市场：按模式分類的估算与趋势分析

  • 美国过滤器完整性测试市场按仪錶板和模式划分
  • 美国过滤器完整性测试市场：按模式分類的变异分析
  • 美国过滤器完整性测试市场：按模式分類的收入预测（2021-2033 年）
  • 自动的
  • 手动的

第六章：美国过滤器完整性测试市场：按类型分類的估算和趋势分析

  • 美国过滤器完整性测试市场：仪錶板，按类型划分
  • 美国过滤器完整性测试市场：按类型分類的差异分析
  • 美国过滤器完整性测试市场：按类型分類的收入预测（2021-2033 年）
  • 液体过滤器完整性测试
  • 气体过滤器完整性测试

第七章美国过滤器完整性测试市场：按最终用途分類的估算和趋势分析

  • 美国过滤器完整性测试市场（按仪錶板和最终用途划分）
  • 美国过滤器完整性测试市场：按最终用途分類的差异分析
  • 美国过滤器完整性检测市场：按最终用途分類的收入预测（2021-2033 年）
  • 生物製药和製药业
  • 食品饮料业
  • 其他的

第八章 竞争情势

  • 主要市场参与企业的最新趋势和影响分析
  • 公司/竞争对手分类
  • 供应商概况
    • 主要经销商和通路合作伙伴名单
    • 主要客户
    • 主要企业市占率分析（2023）
    • Merck KGaA
    • Sartorius AG
    • Parker Hannifin Corp
    • PALL Corporation
    • Donaldson Company, Inc.
    • Pentair Ltd.
    • 3M
    • Meissner Filtration Products, Inc.
    • Beijing Neuronbc Laboratories Co., Ltd.
    • Brother Filtration
    • Analytical Technologies Limited
    • Thermo Fisher Scientific, Inc.
Product Code: GVR-4-68040-737-7

U.S. Filter Integrity Test Market Size & Trends:

The U.S. filter integrity test market size was estimated at USD 32.12 million in 2024 and is projected to reach USD 47.36 million by 2033, growing at a CAGR of 4.44% from 2025 to 2023. The market is primarily driven by the rapid growth of the biopharmaceutical industry. Increasing demand for biologics, monoclonal antibodies, and advanced therapies has heightened reliance on sterile filtration processes, where integrity testing is essential for maintaining product quality and regulatory compliance. With strict FDA oversight and sterility assurance requirements across every stage of biologics production, companies are making significant investments in advanced manufacturing facilities and filtration systems, creating strong demand for integrity testing solutions nationwide.

A recent example underscores this trend. In April 2025, UCB, a biopharmaceutical company committed to treating severe diseases, announced plans to establish a new, state-of-the-art biologics manufacturing facility in the U.S. This expansion highlights the growing biomanufacturing footprint in the country and underscores the importance of U.S. filter integrity testing systems to support compliance and ensure product safety. As more organizations invest in biologics capacity and cutting-edge production capabilities, demand for FIT solutions is expected to rise further.

The market is also being propelled by technological innovation and evolving regulatory expectations. As the U.S. strengthens its position as a leader in biologics, vaccines, and cell and gene therapies, integrity testing-particularly Pre-Use Post-Sterilization Integrity Testing (PUPSIT)-is gaining traction as a critical quality measure. These tests help manufacturers meet global standards while minimizing contamination risks and avoiding costly recalls. The integration of automated testing solutions into Good Manufacturing Practice (GMP) environments further ensures efficiency, compliance, and reliability.

For instance, in May 2025, Parker Bioscience Filtration, a division of Parker Hannifin, launched the SciLog NFF+ PF, a compact, multipurpose normal flow filtration system equipped with onboard PUPSIT functionality. By addressing the complexities of PUPSIT-such as reducing manual handling, operator errors, and product waste-this system supports safer and more streamlined biopharmaceutical production. Such innovations are setting new industry benchmarks, positioning the U.S. FIT market for sustained growth in the years ahead.

U.S. Filter Integrity Test Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the U.S. filter integrity test market report based on test method, mode, type, and end-use:

  • Test Method Outlook (Revenue, USD Million, 2021 - 2033)
  • Forward Flow (Diffusion) Test
  • Bubble Point Test
  • Pressure Hold Test
  • Water Intrusion Test
  • Others
  • Mode Outlook (Revenue, USD Million, 2021 - 2033)
  • Automated
  • Manual
  • Type Outlook (Revenue, USD Million, 2021 - 2033)
  • Liquid Filter Integrity Test
  • Air Filter Integrity Test
  • End-use Outlook (Revenue, USD Million, 2021 - 2033)
  • Biopharmaceutical & Pharmaceutical Industry
  • Food & Beverage Industry
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Data for primary interviews in Latin America
  • 1.2. Data for Primary interviews in MEA
  • 1.3. Information or Data Analysis
    • 1.3.1. Data analysis models
  • 1.4. Market Formulation & Validation
  • 1.5. Model Details
    • 1.5.1. Commodity flow analysis (Model 1)
    • 1.5.2. Approach 1: Commodity flow approach
    • 1.5.3. Volume price analysis (Model 2)
    • 1.5.4. Approach 2: Volume price analysis
  • 1.6. List of Secondary Sources
  • 1.7. List of Primary Sources
  • 1.8. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
    • 2.2.1. Test Method
    • 2.2.2. Mode
    • 2.2.3. Type
    • 2.2.4. End Use
    • 2.2.5. Regional outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. Filter Integrity Test 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. Rising demand for biopharmaceuticals
      • 3.2.1.2. Presence of stringent safety regulatory guidelines
      • 3.2.1.3. Growing awareness with respect to product purity and stability requirements across several industries
      • 3.2.1.4. Higher Spending in R&D Activities
    • 3.2.2. Market restraint analysis
      • 3.2.2.1. Occurrence of failures in U.S. filter integrity testing
      • 3.2.2.2. High cost of integrity testing
  • 3.3. U.S. Filter Integrity Test Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
      • 3.3.1.1. Supplier power
      • 3.3.1.2. Buyer power
      • 3.3.1.3. Substitution threat
      • 3.3.1.4. Threat of new entrant
      • 3.3.1.5. Competitive rivalry
    • 3.3.2. PESTEL Analysis
      • 3.3.2.1. Political landscape
      • 3.3.2.2. Technological landscape
      • 3.3.2.3. Economic landscape
    • 3.3.3. Pricing Analysis
    • 3.3.4. Volume Analysis (Instruments)

Chapter 4. U.S. Filter Integrity Test Market: Test Method Estimates & Trend Analysis

  • 4.1. U.S. Filter Integrity Test Market: Test Method Dashboard
  • 4.2. U.S. Filter Integrity Test Market: Test Method Movement Analysis
  • 4.3. U.S. Filter Integrity Test Market by Test Method, Revenue 2021 - 2033 (USD Million)
  • 4.4. Forward Flow (Diffusion) Test
    • 4.4.1. Forward Flow (Diffusion) Test market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.5. Bubble Point Test
    • 4.5.1. Bubble Point Test market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.6. Pressure Hold Test
    • 4.6.1. Pressure Hold Test market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.7. Water Intrusion Test
    • 4.7.1. Water Intrusion Test market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.8. Others
    • 4.8.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 5. U.S. Filter Integrity Test Market: Mode Estimates & Trend Analysis

  • 5.1. U.S. Filter Integrity Test Market: Mode Dashboard
  • 5.2. U.S. Filter Integrity Test Market: Mode Movement Analysis
  • 5.3. U.S. Filter Integrity Test Market by Mode, Revenue 2021 - 2033 (USD Million)
  • 5.4. Automated
    • 5.4.1. Automated market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.5. Manual
    • 5.5.1. Manual market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 6. U.S. Filter Integrity Test Market: Type Estimates & Trend Analysis

  • 6.1. U.S. Filter Integrity Test Market: Type Dashboard
  • 6.2. U.S. Filter Integrity Test Market: Type Movement Analysis
  • 6.3. U.S. Filter Integrity Test Market by Type, Revenue 2021 - 2033 (USD Million)
  • 6.4. Liquid Filter Integrity Test
    • 6.4.1. Liquid Filter Integrity Test market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.5. Air Filter Integrity Test
    • 6.5.1. Air Filter Integrity Test market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 7. U.S. Filter Integrity Test Market: End Use Estimates & Trend Analysis

  • 7.1. U.S. Filter Integrity Test Market: End Use Dashboard
  • 7.2. U.S. Filter Integrity Test Market: End Use Movement Analysis
  • 7.3. U.S. Filter Integrity Test Market by End Use, Revenue 2021 - 2033 (USD Million)
  • 7.4. Biopharmaceutical & Pharmaceutical Industry
    • 7.4.1. Biopharmaceutical & Pharmaceutical Industry market estimates and forecasts 2021 to 2033 (USD Million)
  • 7.5. Food & Beverage Industry
    • 7.5.1. Food & Beverage Industry market estimates and forecasts 2021 to 2033 (USD Million)
  • 7.6. Others
    • 7.6.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Recent Developments & Impact Analysis, By Key Market Participants
  • 8.2. Company/Competition Categorization
  • 8.3. Vendor Landscape
    • 8.3.1. List of key distributors and channel partners
    • 8.3.2. Key customers
    • 8.3.3. Key company market share analysis, 2023
    • 8.3.4. Merck KGaA
      • 8.3.4.1. Company overview
      • 8.3.4.2. Financial performance
      • 8.3.4.3. Product benchmarking
      • 8.3.4.4. Strategic initiatives
    • 8.3.5. Sartorius AG
      • 8.3.5.1. Company overview
      • 8.3.5.2. Financial performance
      • 8.3.5.3. Product benchmarking
      • 8.3.5.4. Strategic initiatives
    • 8.3.6. Parker Hannifin Corp
      • 8.3.6.1. Company overview
      • 8.3.6.2. Financial performance
      • 8.3.6.3. Product benchmarking
      • 8.3.6.4. Strategic initiatives
    • 8.3.7. PALL Corporation
      • 8.3.7.1. Company overview
      • 8.3.7.2. Financial performance
      • 8.3.7.3. Product benchmarking
      • 8.3.7.4. Strategic initiatives
    • 8.3.8. Donaldson Company, Inc.
      • 8.3.8.1. Company overview
      • 8.3.8.2. Financial performance
      • 8.3.8.3. Product benchmarking
      • 8.3.8.4. Strategic initiatives
    • 8.3.9. Pentair Ltd.
      • 8.3.9.1. Company overview
      • 8.3.9.2. Financial performance
      • 8.3.9.3. Product benchmarking
      • 8.3.9.4. Strategic initiatives
    • 8.3.10. 3M
      • 8.3.10.1. Company overview
      • 8.3.10.2. Financial performance
      • 8.3.10.3. Product benchmarking
      • 8.3.10.4. Strategic initiatives
    • 8.3.11. Meissner Filtration Products, Inc.
      • 8.3.11.1. Company overview
      • 8.3.11.2. Financial performance
      • 8.3.11.3. Product benchmarking
      • 8.3.11.4. Strategic initiatives
    • 8.3.12. Beijing Neuronbc Laboratories Co., Ltd.
      • 8.3.12.1. Company overview
      • 8.3.12.2. Financial performance
      • 8.3.12.3. Product benchmarking
      • 8.3.12.4. Strategic initiatives
    • 8.3.13. Brother Filtration
      • 8.3.13.1. Company overview
      • 8.3.13.2. Financial performance
      • 8.3.13.3. Product benchmarking
      • 8.3.13.4. Strategic initiatives
    • 8.3.14. Analytical Technologies Limited
      • 8.3.14.1. Company overview
      • 8.3.14.2. Financial performance
      • 8.3.14.3. Product benchmarking
      • 8.3.14.4. Strategic initiatives
    • 8.3.15. Thermo Fisher Scientific, Inc.
      • 8.3.15.1. Company overview
      • 8.3.15.2. Financial performance
      • 8.3.15.3. Product benchmarking
      • 8.3.15.4. Strategic initiatives

List of Tables

  • Table 1 List of abbreviation
  • Table 2 U.S. filter integrity test market, by test method, 2021 - 2033 (USD Million)
  • Table 3 U.S. filter integrity test market, by mode, 2021 - 2033 (USD Million)
  • Table 4 U.S. filter integrity test market, by type, 2021 - 2033 (USD Million)
  • Table 5 U.S. filter integrity test market, by end use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Data triangulation techniques
  • Fig. 3 Primary research pattern
  • Fig. 4 Primary interviews in North America
  • Fig. 5 Primary interviews in Europe
  • Fig. 6 Primary interviews in APAC
  • Fig. 7 Primary interviews in Latin America
  • Fig. 8 Primary interviews in MEA
  • Fig. 9 Market research approaches
  • Fig. 10 Value-chain-based sizing & forecasting
  • Fig. 11 QFD modeling for market share assessment
  • Fig. 12 Market formulation & validation
  • Fig. 13 U.S. Filter Integrity Test market: market outlook
  • Fig. 14 U.S. Filter Integrity Test competitive insights
  • Fig. 15 Parent market outlook
  • Fig. 16 Related/ancillary market outlook
  • Fig. 17 Filter integrity test market driver impact
  • Fig. 18 Filter integrity test market restraint impact
  • Fig. 19 Filter integrity test market: Test Method movement analysis
  • Fig. 20 Filter integrity test market: Test Method outlook and key takeaways
  • Fig. 21 Forward flow (Diffusion) test market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 22 Bubble point test estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 23 Pressure hold test market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 24 Water intrusion test estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 25 Others market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 26 Filter integrity test market: Mode movement analysis
  • Fig. 27 Filter integrity test market: Mode outlook and key takeaways
  • Fig. 28 Automated market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 29 Manual estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 30 Filter integrity test market: Type movement analysis
  • Fig. 31 Filter integrity test market: Type outlook and key takeaways
  • Fig. 32 Liquid integrity test market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 33 Air filter integrity test market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 34 Filter integrity test market: End Use movement analysis
  • Fig. 35 Filter integrity test market: End Use outlook and key takeaways
  • Fig. 36 Biopharmaceutical & pharmaceutical industry market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 37 Food & beverage industry market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 38 Others market estimates and forecast, 2021 - 2033 (USD Million)