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市場調查報告書
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1799565

全球過濾器完整性測試市場規模研究與預測，依測試方法（前進流（擴散）測試、泡點測試、壓力保持測試）、模式（自動、手動）、類型、最終用途和區域預測 2025-2035

Global Filter Integrity Test Market Size Study & Forecast, by Test Method (Forward Flow (Diffusion) Test, Bubble Point Test, Pressure Hold Test), Mode (Automated, Manual), Type, End-use and Regional Forecasts 2025-2035
出版日期: | 出版商: Bizwit Research & Consulting LLP | 英文 285 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球過濾器完整性測試市場規模在2024年約為8億美元，預計在2025年至2035年期間的年複合成長率將超過5.15%。過濾器完整性測試是無菌過濾驗證的基石，可確保過濾器在使用前後均在合規閾值範圍內運行，保障產品安全並符合法規要求。這些測試在製藥、生物技術、醫療器材以及食品飲料等關鍵產業進行，在檢測可能影響製程無菌性的違規或故障方面發揮關鍵作用。品質保證日益受到重視，生物製劑生產規模不斷擴大，以及一次性過濾系統的普及，這些因素共同擴大了市場需求。同時，全球監管機構也收緊了相關準則，進一步迫使製造商採用嚴格的過濾器驗證規程。

高通量生物製程的日益普及，加上自動化完整性測試設備的進步，推動了從手動方法到精準驅動、軟體整合系統的顯著轉變。在製藥生產中，尤其是在無菌藥物生產中，過濾器完整性測試可以降低污染風險，保障病人安全，並幫助企業避免代價高昂的召回。疫苗產量的激增以及細胞和基因治療產品線的成長，使得維護不受影響的過濾過程更加重要。此外，無塵室標準的不斷提高和連續生產的趨勢為市場參與者開闢有利的途徑。然而，先進自動化系統的資本密集特性以及對專業環境中熟練操作員的要求可能會降低其採用率，尤其是在小型製造商中。

從地理上看，北美在2024年仍佔據最大市場佔有率，這得益於其強大的製藥生產基地、嚴格的FDA監管規定以及大型生物技術公司的大量研發投入。歐洲緊隨其後，得益於EMA指南等成熟的監管框架以及全球過濾解決方案供應商的強大影響力。然而，受中國、印度和韓國生物製藥業快速擴張以及政府支持的促進國內藥品生產的舉措的推動，亞太地區有望在預測期內實現最快的成長。隨著本地製造能力的增強和監管力度的加強，拉丁美洲以及中東和非洲正逐漸成為前景光明的市場，導致整個供應鏈擴大採用完整性測試解決方案。

本研究目的是確定近年來不同細分市場和國家的市場規模，並預測未來幾年的市場規模。報告目的是結合研究對象國家/地區的產業定性和定量分析。報告還提供了決定市場未來成長的關鍵因素（例如促進因素和挑戰）的詳細資訊。此外，報告還涵蓋了微觀市場中利害關係人的潛在投資機會，以及對競爭格局和主要參與者產品供應的詳細分析。市場區隔和子細分市場的詳細解釋如下：

目錄

第1章 全球過濾器完整性測試市場報告範圍與方法

  • 研究目標
  • 研究方法
    • 預測模型
    • 案頭研究
    • 自上而下和自下而上的方法
  • 研究屬性
  • 研究範圍
    • 市場定義
    • 市場區隔
  • 研究假設
    • 包括與排除
    • 限制
    • 研究涵蓋的年份

第2章 執行摘要

  • CEO/CXO 立場
  • 戰略洞察
  • ESG分析
  • 主要調查結果

第3章 全球過濾器完整性測試市場力量分析

  • 影響全球過濾器完整性測試市場的市場力量（2024-2035）
  • 促進因素
    • 製藥/生物技術製造中對無菌保證和品質設計的監管重點加強
    • 生物製劑、疫苗和一次性系統的興起加速了使用前/使用後完整性測試
  • 限制
    • 自動化測試儀和驗證/資格要求的資本支出較高
    • 缺乏熟練的操作員和合規專業知識，尤其是在新興市場
  • 機會
    • 數位化、軟體整合、符合 21 CFR Part 11 的解決方案，可實現自動化、資料豐富的測試
    • 擴大細胞和基因治療、連續/高通量生物加工以及亞太地區製造業的投資

第4章 全球過濾器完整性測試產業分析

  • 波特五力模型
    • 買方議價能力
    • 供應商的議價能力
    • 新進入者的威脅
    • 替代品的威脅
    • 競爭對手
  • 波特五力預測模型（2024-2035）
  • PESTEL分析
    • 政治
    • 經濟
    • 社會
    • 科技
    • 環境
    • 合法
  • 最佳投資機會
  • 最佳制勝策略（2025年）
  • 市場佔有率分析（2024-2025）
  • 2025年全球定價分析與趨勢
  • 分析師建議與結論

第5章 全球過濾器完整性測試市場規模及預測：依測試方法分類 -2025-2035

  • 市場概覽
  • 全球過濾器完整性測試市場表現-潛力分析（2025年）
  • 前進流（擴散）試驗
  • 泡點測試
  • 壓力保持測試

第6章 全球過濾器完整性測試市場規模與預測：依模式 -2025年至2035年

  • 市場概覽
  • 全球過濾器完整性測試市場表現-潛力分析（2025年）
  • 自動
  • 手動

第7章 全球過濾器完整性測試市場規模與預測：依地區 -2025年至2035年

  • 區域市場概況
  • 領先國家和新興國家
  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 英國
    • 德國
    • 法國
    • 西班牙
    • 義大利
    • 歐洲其他地區
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 澳洲
    • 韓國
    • 亞太地區其他地區
  • 拉丁美洲
    • 巴西
    • 墨西哥
  • 中東和非洲
    • 阿拉伯聯合大公國
    • 沙烏地阿拉伯（KSA）
    • 南非

第8章 競爭情報

  • 最佳市場策略
  • Sartorius AG
    • 公司概況
    • 主要高階主管
    • 公司概況
    • 財務表現（取決於資料可用性）
    • 產品/服務端口
    • 近期發展
    • 市場策略
    • SWOT分析
  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Parker Hannifin Corporation
  • Pall Corporation
  • Donaldson Company, Inc.
  • 3M Company
  • Danaher Corporation
  • Porvair Filtration Group
  • Cobetter Filtration Equipment Co., Ltd.
  • Meissner Filtration Products, Inc.
  • Pentair plc
  • GEA Group AG
  • Eaton Corporation plc
  • TSI Incorporated
簡介目錄

The Global Filter Integrity Test Market, valued at approximately USD 0.08 billion in 2024, is set to progress at a compound annual growth rate exceeding 5.15% from 2025 to 2035. Filter integrity testing, a cornerstone of sterile filtration validation, ensures that filters are operating within compliance thresholds before and after use-protecting product safety and regulatory adherence. These tests, performed in critical sectors such as pharmaceuticals, biotechnology, medical devices, and food & beverage, play a pivotal role in detecting breaches or failures that could compromise process sterility. Rising emphasis on quality assurance, expanding biologics manufacturing, and the proliferation of single-use filtration systems have converged to amplify market demand. Simultaneously, global regulatory bodies have tightened guidelines, further compelling manufacturers to integrate stringent filter validation protocols.

The escalating adoption of high-throughput bioprocessing, coupled with advancements in automated integrity testing equipment, has driven a notable shift from manual methods to precision-driven, software-integrated systems. In pharmaceutical production, particularly in sterile drug manufacturing, filter integrity testing mitigates contamination risks, safeguards patient safety, and helps companies avoid costly recalls. The surge in vaccine production and the growth of cell and gene therapy pipelines have placed additional emphasis on maintaining uncompromised filtration processes. Moreover, rising cleanroom standards and the trend toward continuous manufacturing are opening lucrative avenues for market players. Nevertheless, the capital-intensive nature of advanced automated systems and the requirement for skilled operators in specialized environments could temper adoption rates, especially among small-scale manufacturers.

Geographically, North America retained the lion's share of the market in 2024, underpinned by a robust pharmaceutical manufacturing base, stringent FDA mandates, and extensive R&D investments from major biotech firms. Europe followed closely, supported by established regulatory frameworks such as EMA guidelines and the strong presence of global filtration solution providers. Asia Pacific, however, is poised for the fastest growth over the forecast period, spurred by rapid biopharmaceutical expansion in China, India, and South Korea, along with government-backed initiatives to boost domestic drug production. Latin America and the Middle East & Africa are gradually emerging as promising markets, as local manufacturing capabilities strengthen and regulatory oversight intensifies, leading to increased adoption of integrity testing solutions across the supply chain.

Major market players included in this report are:

  • Sartorius AG
  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Parker Hannifin Corporation
  • Pall Corporation
  • Donaldson Company, Inc.
  • 3M Company
  • Danaher Corporation
  • Porvair Filtration Group
  • Cobetter Filtration Equipment Co., Ltd.
  • Meissner Filtration Products, Inc.
  • Pentair plc
  • GEA Group AG
  • Eaton Corporation plc
  • TSI Incorporated

Global Filter Integrity Test Market Report Scope:

  • Historical Data - 2023, 2024
  • Base Year for Estimation - 2024
  • Forecast period - 2025-2035
  • Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
  • Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
  • Customization Scope - Free report customization (equivalent up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players. The detailed segments and sub-segments of the market are explained below:

By Test Method:

  • Forward Flow (Diffusion) Test
  • Bubble Point Test
  • Pressure Hold Test

By Mode:

  • Automated
  • Manual

By Type:

  • [Detailed segmentation as per type specifications]

By End-use:

  • [Detailed segmentation as per end-use specifications]

By Region:

  • North America
  • U.S.
  • Canada
  • Europe
  • UK
  • Germany
  • France
  • Spain
  • Italy
  • ROE
  • Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • RoAPAC
  • Latin America
  • Brazil
  • Mexico
  • Middle East & Africa
  • UAE
  • Saudi Arabia
  • South Africa
  • Rest of Middle East & Africa

Key Takeaways:

  • Market Estimates & Forecast for 10 years from 2025 to 2035.
  • Annualized revenues and regional level analysis for each market segment.
  • Detailed analysis of geographical landscape with country-level analysis of major regions.
  • Competitive landscape with information on major players in the market.
  • Analysis of key business strategies and recommendations on future market approach.
  • Analysis of competitive structure of the market.
  • Demand side and supply side analysis of the market.

Table of Contents

Chapter 1. Global Filter Integrity Test Market Report Scope & Methodology

  • 1.1. Research Objective
  • 1.2. Research Methodology
    • 1.2.1. Forecast Model
    • 1.2.2. Desk Research
    • 1.2.3. Top Down and Bottom-Up Approach
  • 1.3. Research Attributes
  • 1.4. Scope of the Study
    • 1.4.1. Market Definition
    • 1.4.2. Market Segmentation
  • 1.5. Research Assumption
    • 1.5.1. Inclusion & Exclusion
    • 1.5.2. Limitations
    • 1.5.3. Years Considered for the Study

Chapter 2. Executive Summary

  • 2.1. CEO/CXO Standpoint
  • 2.2. Strategic Insights
  • 2.3. ESG Analysis
  • 2.4. key Findings

Chapter 3. Global Filter Integrity Test Market Forces Analysis

  • 3.1. Market Forces Shaping The Global Filter Integrity Test Market (2024-2035)
  • 3.2. Drivers
    • 3.2.1. Heightened regulatory focus on sterility assurance and quality-by-design in pharma/biotech manufacturing
    • 3.2.2. Rise of biologics, vaccines, and single-use systems accelerating pre/post-use integrity testing
  • 3.3. Restraints
    • 3.3.1. High capital outlay for automated testers and validation/qualification requirements
    • 3.3.2. Shortage of skilled operators and compliance expertise, particularly in emerging markets
  • 3.4. Opportunities
    • 3.4.1. Digital, software-integrated, 21 CFR Part 11-ready solutions enabling automated, data-rich testing
    • 3.4.2. Expansion of cell & gene therapy, continuous/high-throughput bioprocessing, and APAC manufacturing investments

Chapter 4. Global Filter Integrity Test Industry Analysis

  • 4.1. Porter's 5 Forces Model
    • 4.1.1. Bargaining Power of Buyer
    • 4.1.2. Bargaining Power of Supplier
    • 4.1.3. Threat of New Entrants
    • 4.1.4. Threat of Substitutes
    • 4.1.5. Competitive Rivalry
  • 4.2. Porter's 5 Force Forecast Model (2024-2035)
  • 4.3. PESTEL Analysis
    • 4.3.1. Political
    • 4.3.2. Economical
    • 4.3.3. Social
    • 4.3.4. Technological
    • 4.3.5. Environmental
    • 4.3.6. Legal
  • 4.4. Top Investment Opportunities
  • 4.5. Top Winning Strategies (2025)
  • 4.6. Market Share Analysis (2024-2025)
  • 4.7. Global Pricing Analysis And Trends 2025
  • 4.8. Analyst Recommendation & Conclusion

Chapter 5. Global Filter Integrity Test Market Size & Forecasts by Test Method 2025-2035

  • 5.1. Market Overview
  • 5.2. Global Filter Integrity Test Market Performance - Potential Analysis (2025)
  • 5.3. Forward Flow (Diffusion) Test
    • 5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
    • 5.3.2. Market size analysis, by region, 2025-2035
  • 5.4. Bubble Point Test
    • 5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
    • 5.4.2. Market size analysis, by region, 2025-2035
  • 5.5. Pressure Hold Test
    • 5.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
    • 5.5.2. Market size analysis, by region, 2025-2035

Chapter 6. Global Filter Integrity Test Market Size & Forecasts by Mode 2025-2035

  • 6.1. Market Overview
  • 6.2. Global Filter Integrity Test Market Performance - Potential Analysis (2025)
  • 6.3. Automated
    • 6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
    • 6.3.2. Market size analysis, by region, 2025-2035
  • 6.4. Manual
    • 6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
    • 6.4.2. Market size analysis, by region, 2025-2035

Chapter 7. Global Filter Integrity Test Market Size & Forecasts by Region 2025-2035

  • 7.1. Filter Integrity Test Market, Regional Market Snapshot
  • 7.2. Top Leading & Emerging Countries
  • 7.3. North America Filter Integrity Test Market
    • 7.3.1. U.S. Filter Integrity Test Market
      • 7.3.1.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.3.1.2. Mode breakdown size & forecasts, 2025-2035
    • 7.3.2. Canada Filter Integrity Test Market
      • 7.3.2.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.3.2.2. Mode breakdown size & forecasts, 2025-2035
  • 7.4. Europe Filter Integrity Test Market
    • 7.4.1. UK Filter Integrity Test Market
      • 7.4.1.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.4.1.2. Mode breakdown size & forecasts, 2025-2035
    • 7.4.2. Germany Filter Integrity Test Market
      • 7.4.2.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.4.2.2. Mode breakdown size & forecasts, 2025-2035
    • 7.4.3. France Filter Integrity Test Market
      • 7.4.3.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.4.3.2. Mode breakdown size & forecasts, 2025-2035
    • 7.4.4. Spain Filter Integrity Test Market
      • 7.4.4.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.4.4.2. Mode breakdown size & forecasts, 2025-2035
    • 7.4.5. Italy Filter Integrity Test Market
      • 7.4.5.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.4.5.2. Mode breakdown size & forecasts, 2025-2035
    • 7.4.6. Rest of Europe Filter Integrity Test Market
      • 7.4.6.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.4.6.2. Mode breakdown size & forecasts, 2025-2035
  • 7.5. Asia Pacific Filter Integrity Test Market
    • 7.5.1. China Filter Integrity Test Market
      • 7.5.1.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.5.1.2. Mode breakdown size & forecasts, 2025-2035
    • 7.5.2. India Filter Integrity Test Market
      • 7.5.2.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.5.2.2. Mode breakdown size & forecasts, 2025-2035
    • 7.5.3. Japan Filter Integrity Test Market
      • 7.5.3.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.5.3.2. Mode breakdown size & forecasts, 2025-2035
    • 7.5.4. Australia Filter Integrity Test Market
      • 7.5.4.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.5.4.2. Mode breakdown size & forecasts, 2025-2035
    • 7.5.5. South Korea Filter Integrity Test Market
      • 7.5.5.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.5.5.2. Mode breakdown size & forecasts, 2025-2035
    • 7.5.6. Rest of APAC Filter Integrity Test Market
      • 7.5.6.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.5.6.2. Mode breakdown size & forecasts, 2025-2035
  • 7.6. Latin America Filter Integrity Test Market
    • 7.6.1. Brazil Filter Integrity Test Market
      • 7.6.1.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.6.1.2. Mode breakdown size & forecasts, 2025-2035
    • 7.6.2. Mexico Filter Integrity Test Market
      • 7.6.2.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.6.2.2. Mode breakdown size & forecasts, 2025-2035
  • 7.7. Middle East and Africa Filter Integrity Test Market
    • 7.7.1. UAE Filter Integrity Test Market
      • 7.7.1.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.7.1.2. Mode breakdown size & forecasts, 2025-2035
    • 7.7.2. Saudi Arabia (KSA) Filter Integrity Test Market
      • 7.7.2.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.7.2.2. Mode breakdown size & forecasts, 2025-2035
    • 7.7.3. South Africa Filter Integrity Test Market
      • 7.7.3.1. Test Method breakdown size & forecasts, 2025-2035
      • 7.7.3.2. Mode breakdown size & forecasts, 2025-2035

Chapter 8. Competitive Intelligence

  • 8.1. Top Market Strategies
  • 8.2. Sartorius AG
    • 8.2.1. Company Overview
    • 8.2.2. Key Executives
    • 8.2.3. Company Snapshot
    • 8.2.4. Financial Performance (Subject to Data Availability)
    • 8.2.5. Product/Services Port
    • 8.2.6. Recent Development
    • 8.2.7. Market Strategies
    • 8.2.8. SWOT Analysis
  • 8.3. Thermo Fisher Scientific Inc.
  • 8.4. Merck KGaA
  • 8.5. Parker Hannifin Corporation
  • 8.6. Pall Corporation
  • 8.7. Donaldson Company, Inc.
  • 8.8. 3M Company
  • 8.9. Danaher Corporation
  • 8.10. Porvair Filtration Group
  • 8.11. Cobetter Filtration Equipment Co., Ltd.
  • 8.12. Meissner Filtration Products, Inc.
  • 8.13. Pentair plc
  • 8.14. GEA Group AG
  • 8.15. Eaton Corporation plc
  • 8.16. TSI Incorporated