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市场调查报告书
商品编码
1799565

全球过滤器完整性测试市场规模研究与预测，依测试方法（前进流（扩散）测试、泡点测试、压力保持测试）、模式（自动、手动）、类型、最终用途和区域预测 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个工作天内

价格
简介目录

全球过滤器完整性测试市场规模在2024年约为8亿美元，预计在2025年至2035年期间的年复合成长率将超过5.15%。过滤器完整性测试是无菌过滤验证的基石，可确保过滤器在使用前后均在合规阈值范围内运行，从而保障产品安全并符合法规要求。这些测试在製药、生物技术、医疗器材以及食品饮料等关键产业进行，在检测可能影响製程无菌性的违规或故障方面发挥关键作用。品质保证日益受到重视，生物製剂生产规模不断扩大，以及一次性过滤系统的普及，这些因素共同扩大了市场需求。同时，全球监管机构也收紧了相关准则，进一步迫使製造商采用严格的过滤器验证规程。

高通量生物製程的日益普及，加上自动化完整性测试设备的进步，推动了从手动方法到精准驱动、软体整合系统的显着转变。在製药生产中，尤其是在无菌药物生产中，过滤器完整性测试可以降低污染风险，保障病人安全，并帮助企业避免代价高昂的召回。疫苗产量的激增以及细胞和基因治疗产品线的成长，使得维护不受影响的过滤过程更加重要。此外，无尘室标准的不断提高和连续生产的趋势正在为市场参与者开闢利润丰厚的途径。然而，先进自动化系统的资本密集特性以及对专业环境中熟练操作员的要求可能会降低其采用率，尤其是在小型製造商中。

从地理上看，北美在2024年仍占据最大市场份额，这得益于其强大的製药生产基地、严格的FDA监管规定以及大型生物技术公司的大量研发投入。欧洲紧随其后，得益于EMA指南等成熟的监管框架以及全球过滤解决方案供应商的强大影响力。然而，受中国、印度和韩国生物製药业快速扩张以及政府支持的促进国内药品生产的倡议的推动，亚太地区有望在预测期内实现最快的增长。随着本地製造能力的增强和监管力度的加强，拉丁美洲以及中东和非洲正逐渐成为前景光明的市场，从而导致整个供应链越来越多地采用完整性测试解决方案。

本研究旨在确定近年来不同细分市场和国家的市场规模，并预测未来几年的市场规模。报告旨在结合研究对象国家/地区的产业定性和定量分析。报告还提供了决定市场未来成长的关键因素（例如驱动因素和挑战）的详细资讯。此外，报告还涵盖了微观市场中利害关係人的潜在投资机会，以及对竞争格局和主要参与者产品供应的详细分析。市场区隔和子细分市场的详细解释如下：

目录

第一章：全球过滤器完整性测试市场报告范围与方法

  • 研究目标
  • 研究方法
    • 预测模型
    • 案头研究
    • 自上而下和自下而上的方法
  • 研究属性
  • 研究范围
    • 市场定义
    • 市场区隔
  • 研究假设
    • 包容与排斥
    • 限制
    • 研究考虑的年份

第二章：执行摘要

  • CEO/CXO 立场
  • 战略洞察
  • ESG分析
  • 主要发现

第三章：全球过滤器完整性测试市场力量分析

  • 影响全球过滤器完整性测试市场的市场力量（2024-2035）
  • 驱动程式
    • 製药/生物技术製造中对无菌保证和品质设计的监管重点加强
    • 生物製剂、疫苗和一次性系统的兴起加速了使用前/使用后完整性测试
  • 限制
    • 自动化测试仪和验证/资格要求的资本支出较高
    • 缺乏熟练的操作员和合规专业知识，尤其是在新兴市场
  • 机会
    • 数位化、软体整合、符合 21 CFR Part 11 的解决方案，可实现自动化、资料丰富的测试
    • 扩大细胞和基因治疗、连续/高通量生物加工以及亚太地区製造业的投资

第四章：全球过滤器完整性测试产业分析

  • 波特五力模型
    • 买方议价能力
    • 供应商的议价能力
    • 新进入者的威胁
    • 替代品的威胁
    • 竞争对手
  • 波特五力预测模型（2024-2035）
  • PESTEL分析
    • 政治的
    • 经济
    • 社会的
    • 科技
    • 环境的
    • 合法的
  • 最佳投资机会
  • 最佳制胜策略（2025年）
  • 市占率分析（2024-2025）
  • 2025年全球定价分析与趋势
  • 分析师建议与结论

第五章：全球过滤器完整性测试市场规模及预测：依测试方法划分 - 2025-2035

  • 市场概览
  • 全球过滤器完整性测试市场表现-潜力分析（2025年）
  • 前进流（扩散）试验
  • 泡点测试
  • 压力保持测试

第六章：全球过滤器完整性测试市场规模与预测：按模式 - 2025 年至 2035 年

  • 市场概览
  • 全球过滤器完整性测试市场表现-潜力分析（2025年）
  • 自动化
  • 手动的

第七章：全球过滤器完整性测试市场规模与预测：按地区 - 2025 年至 2035 年

  • 区域市场概况
  • 领先国家和新兴国家
  • 北美洲
    • 我们
    • 加拿大
  • 欧洲
    • 英国
    • 德国
    • 法国
    • 西班牙
    • 义大利
    • 欧洲其他地区
  • 亚太地区
    • 中国
    • 印度
    • 日本
    • 澳洲
    • 韩国
    • 亚太地区其他地区
  • 拉丁美洲
    • 巴西
    • 墨西哥
  • 中东和非洲
    • 阿联酋
    • 沙乌地阿拉伯（KSA）
    • 南非

第 8 章：竞争情报

  • 顶级市场策略
  • Sartorius AG
    • 公司概况
    • 主要高阶主管
    • 公司概况
    • 财务表现（取决于数据可用性）
    • 产品/服务端口
    • 近期发展
    • 市场策略
    • 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
简介目录

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