세계의 필터 완전성 시험 시장 : 시장 규모 분석 - 시험 방법별, 모드별, 유형별, 최종 용도별, 지역별 예측(2025-2035년)

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