查看購物車
  • Simplified Chinese
  • English
  • Japanese
封面
市場調查報告書
商品編碼
1842183

美國過濾器完整性測試市場：市場規模、佔有率、趨勢分析（按測試方法、模式、類型和最終用途分類）、細分市場預測（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個工作天內

價格

美國過濾器完整性測試市場規模及趨勢：

2024 年美國過濾器完整性測試市場規模估計為 3,212 萬美元，預計到 2033 年將達到 4,736 萬美元，2025 年至 2023 年的複合年成長率為 4.44%。

市場成長的主要驅動力是生物製藥產業的快速發展。對生技藥品、單株抗體和先進療法的需求不斷成長，導致對無菌過濾過程的依賴性日益增強，因此完整性檢測對於維持產品品質和符合法規要求至關重要。美國食品藥物管理局 (FDA) 對生技藥品生產各個階段的嚴格監管和無菌保證要求，促使企業在先進的生產設施和過濾系統方面投入巨資，從而在全國範圍內催生了對完整性檢測解決方案的強勁需求。

近期案例印證了這一趨勢。 2025年4月，專注於治療嚴重的生物製藥公司UCB宣布計畫在美國新建一座最先進的生技藥品生產設施。此次擴建凸顯了美國生技藥品生產規模的不斷擴大，並強調了美國製造的濾芯完整性測試系統對於確保合規性和產品安全性的重要性。隨著越來越多的公司投資於生技藥品產能和尖端製造技術，對濾芯完整性測試解決方案的需求預計將進一步成長。

技術創新和不斷變化的監管預期也是推動市場發展的因素。隨著美國在生技藥品、疫苗以及細胞和基因療法領域鞏固其領先地位，完整性檢測，特別是使用前滅菌後完整性檢測 (PUPSIT)，正日益成為一項關鍵的品質指標。這些檢測有助於製造商滿足全球標準，同時最大限度地降低污染風險並避免代價高昂的召回。將自動化檢測解決方案整合到良好生產規範 (GMP) 環境中，可進一步提高效率、合規性和可靠性。

例如，2025年5月，派克漢尼汾公司旗下的派克生物科學過濾部門推出了SciLog NFF+PF，這是一款緊湊型多用途正流過濾系統，具備PUPSIT功能。該系統解決了PUPSIT的複雜性問題（包括減少人工操作、降低操作失誤和減少產品浪費），從而支援更安全、更精簡的生物製藥生產。此類創新為該產業樹立了新的標桿，並有望在未來幾年推動美國FIT市場持續成長。

目錄

第1章 分析方法和範圍

第2章執行摘要

第3章美國過濾器完整性測試市場：影響因素、趨勢與範圍

  • 市場關聯性展望
    • 母市場展望
    • 相關/附隨市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 美國過濾器完整性測試市場：分析工具
    • 產業分析：波特五力分析
    • PESTEL 分析
    • 定價分析
    • 市場規模分析（銷售量、設備）

第4章美國過濾器完整性測試市場：按測試方法分類的估算和趨勢分析

  • 美國過濾器完整性測試市場（按儀錶板和測試方法分類）
  • 美國過濾器完整性測試市場：按測試方法分類的差異分析
  • 美國過濾器完整性測試市場：按測試方法分類的收入預測（2021-2033 年）
  • 前向流動（擴散）測試
  • 氣泡點測試
  • 壓力保持試驗
  • 水侵入測試
  • 其他

第5章美國過濾器完整性測試市場：按模式分類的估算與趨勢分析

  • 美國過濾器完整性測試市場按儀錶板和模式分類
  • 美國過濾器完整性測試市場：按模式分類的變異分析
  • 美國過濾器完整性測試市場：按模式分類的收入預測（2021-2033 年）
  • 自動的
  • 手動的

第6章：美國過濾器完整性測試市場：按類型分類的估算和趨勢分析

  • 美國過濾器完整性測試市場：儀錶板，按類型分類
  • 美國過濾器完整性測試市場：按類型分類的差異分析
  • 美國過濾器完整性測試市場：按類型分類的收入預測（2021-2033 年）
  • 液體過濾器完整性測試
  • 氣體過濾器完整性測試

第7章美國過濾器完整性測試市場：按最終用途分類的估算和趨勢分析

  • 美國過濾器完整性測試市場（按儀錶板和最終用途分類）
  • 美國過濾器完整性測試市場：按最終用途分類的差異分析
  • 美國過濾器完整性檢測市場：按最終用途分類的收入預測（2021-2033 年）
  • 生物製藥和製藥業
  • 食品飲料業
  • 其他

第8章 競爭情勢

  • 主要市場參與企業的最新趨勢和影響分析
  • 公司/競爭對手分類
  • 供應商概況
    • 主要經銷商和通路合作夥伴名單
    • 主要客戶
    • 主要企業市佔率分析（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)