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In Vitro Diagnostics

PUBLISHER: Grand View Research | PRODUCT CODE: 1587562

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PUBLISHER: Grand View Research | PRODUCT CODE: 1587562

U.S. & Europe Extractable And Leachable Testing Services Market Size, Share & Trends Analysis Report By Product (Container Closure Systems, Single-use Systems), By Application, By Country, And Segment Forecasts, 2025 - 2030

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Description

Table of Contents

List of Tables

U.S. & Europe Extractable And Leachable Testing Services Market Growth & Trends:

The U.S. & Europe extractable and leachable testing services market size is expected to reach USD 1,867.7 million by 2030, according to a new report by Grand View Research, Inc., exhibiting a CAGR of 15.3% from 2025 to 2030. Increasing regulatory scrutiny on the quality of healthcare products and a rising emphasis on product safety is anticipated to propel the growth of the market. Furthermore, the market expansion is projected to be supported by the flourishing pharmaceutical and biotechnology sectors across the U.S. & Europe and the implementation of supportive government legislation. The significance of E & L testing for healthcare products has been heightened due to the adverse effects on human health that can be caused due to product contamination.

Various strategic initiatives undertaken by key participants to strengthen E&L testing capabilities are anticipated to support market growth. For instance, in April 2023, Eurofins Medical Devices Testing, an industry leader with a robust network of scientists, expanded its E&L testing service capabilities in Germany. In addition, in February 2022, Merck and Waters Corporation collaborated to expand the E&L library to include ion mobility measurements. This collaboration provided confidence to testing laboratories in terms of results and outcomes. Furthermore, the growing number of conferences and exhibitions for E&L testing hold prominent promise for the market.

For instance, in November 2022, Smithers organized the Europe E&L conference in Germany. The company has been organizing such events past 15 years. Such initiatives are fueling the growth of the market in the U.S. and Europe over the forecast period. Market players focus on several other initiatives, such as collaboration, mergers, and acquisitions, to strengthen their industry presence. The main aim was to increase the production of pharmaceutical products that help detect and treat COVID-19 patients without compromising quality and following regulatory procedures. For instance, in April 2021, SGS acquired SYNLAB Analytics, a pharmaceutical, food, and environmental testing service provider.

This acquisition added more than 37 laboratories to SGS, and the key aim of this acquisition was to expand its analytical testing capabilities in pharmaceutical, environment, and food testing. Leachable and extractable testing services help determine the level of foreign substances in single-use systems and finished formulations, which, if not detected, can affect human health. However, these testing services are often complex and are subject to change owing to different factors, such as dynamic regulatory requirements, diverse product types, use of different analytical techniques, and variability in results. Thus, the service provider is required to comply with all these variables.

U.S. & Europe Extractable And Leachable Testing Services Market Report Highlights:

  • Based on products, the container closure systems segment accounted for the largest revenue share of 30.4% in 2024 owing to their ability to provide long-term stability.
  • Based on applications, the orally inhaled & nasal drug products segment dominated the market with a revenue share of 41.2% in 2024 due to the increasing demand for innovative drug delivery methods.
  • In 2024, the U.S. held the largest market share of 57.5% in 2024.
  • The large share and rapid growth are attributed to the presence of major market players and robust healthcare infrastructure in the U.S.
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Product Code: GVR-4-68040-108-3

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
    • 1.1.1. Segment Definitions
      • 1.1.1.1. Product Segment
      • 1.1.1.2. Application Segment
  • 1.2. Regional Scope
  • 1.3. Estimates and Forecast Timeline
  • 1.4. Research Methodology
  • 1.5. Information Procurement
    • 1.5.1. Purchased Database
    • 1.5.2. GVR's Internal Database
    • 1.5.3. Secondary Sources
    • 1.5.4. Primary Research
  • 1.6. Information or Data Analysis
  • 1.7. Market Formulation & Validation
  • 1.8. Market Model
    • 1.8.1. Commodity Flow Analysis
  • 1.9. List of Secondary Sources
  • 1.10. List of Abbreviations
  • 1.11. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Snapshot
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. 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 Drivers Analysis
      • 3.2.1.1. Supportive regulatory framework and rising emphasis on patient safety
      • 3.2.1.2. Growing pharmaceutical and biotechnology industry
      • 3.2.1.3. Widespread adoption of single-use technology
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Complexity associated with extractable and leachable testing
  • 3.3. Business Environment Analysis
    • 3.3.1. Porter's Five Forces Analysis
    • 3.3.2. PESTLE Analysis
    • 3.3.3. COVID-19 Impact Analysis

Chapter 4. U.S. & Europe Extractable and Leachable Testing Services Market: Product Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. & Europe Extractable and Leachable Testing Services Market: Product Movement Analysis
  • 4.3. U.S. & Europe Extractable and Leachable Testing Services Market Size & Trend Analysis, by Product, 2018 to 2030 (USD Million)
  • 4.4. Container Closure Systems
    • 4.4.1. Container Closure Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.5. Single-use Systems
    • 4.5.1. Single-use Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.6. Drug Delivery Systems
    • 4.6.1. Drug Delivery Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 4.7. Others
    • 4.7.1. Others Market Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 5. U.S. & Europe Extractable and Leachable Testing Services Market: Application Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. & Europe Extractable and Leachable Testing Services Market: Application Movement Analysis
  • 5.3. U.S. & Europe Extractable and Leachable Testing Services Market Size & Trend Analysis, by Application, 2018 to 2030 (USD Million)
  • 5.4. Parenteral Drug Products
    • 5.4.1. Parenteral Drug Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.5. Orally Inhaled and Nasal Drug Products
    • 5.5.1. Orally Inhaled and Nasal Drug Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  • 5.6. Ophthalmic
    • 5.6.1. Ophthalmic Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

Chapter 6. U.S. & Europe Extractable and Leachable Testing Services Market: Regional Business Analysis by Product & Application

  • 6.1. Regional Market Share Analysis, 2024 & 2030
  • 6.2. Regional Market Dashboard
  • 6.3. U.S.
    • 6.3.1. Key Country Dynamics
    • 6.3.2. U.S. Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.3.3. Competitive Scenario
    • 6.3.4. Regulatory Framework
  • 6.4. Europe
    • 6.4.1. Europe Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
    • 6.4.2. UK
      • 6.4.2.1. Key Country Dynamics
      • 6.4.2.2. UK Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.2.3. Competitive Scenario
      • 6.4.2.4. Regulatory Framework
    • 6.4.3. Germany
      • 6.4.3.1. Key Country Dynamics
      • 6.4.3.2. Germany Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.3.3. Competitive Scenario
      • 6.4.3.4. Regulatory Framework
    • 6.4.4. Spain
      • 6.4.4.1. Key Country Dynamics
      • 6.4.4.2. Spain Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.4.3. Regulatory Framework
      • 6.4.4.4. Competitive Scenario
    • 6.4.5. France
      • 6.4.5.1. Key Country Dynamics
      • 6.4.5.2. France Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.5.3. Competitive Scenario
      • 6.4.5.4. Regulatory Framework
    • 6.4.6. Italy
      • 6.4.6.1. Key Country Dynamics
      • 6.4.6.2. Italy Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.6.3. Competitive Scenario
      • 6.4.6.4. Regulatory Framework
    • 6.4.7. Denmark
      • 6.4.7.1. Key Country Dynamics
      • 6.4.7.2. Denmark Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.7.3. Competitive Scenario
      • 6.4.7.4. Regulatory Framework
    • 6.4.8. Sweden
      • 6.4.8.1. Key Country Dynamics
      • 6.4.8.2. Sweden Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.8.3. Competitive Scenario
      • 6.4.8.4. Regulatory Framework
    • 6.4.9. Norway
      • 6.4.9.1. Key Country Dynamics
      • 6.4.9.2. Norway Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
      • 6.4.9.3. Competitive Scenario
      • 6.4.9.4. Regulatory Framework

Chapter 7. U.S. & Europe Extractable and Leachable Testing Services Market: Competitive Landscape

  • 7.1. Participant Categorization
  • 7.2. Company Market Position Analysis, 2024
  • 7.3. Participant's Overview
    • 7.3.1. Eurofins Scientific
      • 7.3.1.1. Company Overview
      • 7.3.1.2. Financial Performance
      • 7.3.1.3. Product Benchmarking
      • 7.3.1.4. Strategic Initiatives
    • 7.3.2. Intertek Group plc
      • 7.3.2.1. Company Overview
      • 7.3.2.2. Financial Performance
      • 7.3.2.3. Product Benchmarking
      • 7.3.2.4. Strategic Initiatives
    • 7.3.3. SGS Societe Generale de Surveillance SA
      • 7.3.3.1. Company Overview
      • 7.3.3.2. Financial Performance
      • 7.3.3.3. Product Benchmarking
      • 7.3.3.4. Strategic Initiatives
    • 7.3.4. WuXi AppTec
      • 7.3.4.1. Company Overview
      • 7.3.4.2. Financial Performance
      • 7.3.4.3. Product Benchmarking
      • 7.3.4.4. Strategic Initiatives
    • 7.3.5. Merck KGaA
      • 7.3.5.1. Company Overview
      • 7.3.5.2. Financial Performance
      • 7.3.5.3. Product Benchmarking
      • 7.3.5.4. Strategic Initiatives
    • 7.3.6. West Pharmaceutical Services, Inc
      • 7.3.6.1. Company Overview
      • 7.3.6.2. Financial Performance
      • 7.3.6.3. Product Benchmarking
      • 7.3.6.4. Strategic Initiatives
    • 7.3.7. Wickham Micro Limited (Medical Engineering Technologies Ltd.)
      • 7.3.7.1. Company Overview
      • 7.3.7.2. Product Benchmarking
      • 7.3.7.3. Strategic Initiatives
    • 7.3.8. Pacific Biolabs
      • 7.3.8.1. Company Overview
      • 7.3.8.2. Product Benchmarking
      • 7.3.8.3. Strategic Initiatives
    • 7.3.9. Boston Analytical
      • 7.3.9.1. Company Overview
      • 7.3.9.2. Product Benchmarking
      • 7.3.9.3. Strategic Initiatives
    • 7.3.10. Sotera Health (Nelson Laboratories, LLC)
      • 7.3.10.1. Company Overview
      • 7.3.10.2. Financial Performance
      • 7.3.10.3. Product Benchmarking
      • 7.3.10.4. Strategic Initiatives
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Product Code: GVR-4-68040-108-3

List of Tables

  • Table 1 List of secondary sources
  • Table 1 List of abbreviation
  • Table 2 U.S. extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 3 U.S extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 4 Europe extractable & leachable testing services market, by country, 2018 - 2030 (USD Million)
  • Table 5 Europe extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 6 Europe extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 7 UK extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 8 UK extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 9 Germany extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 10 Germany extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 11 France extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 12 France extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 13 Italy extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 14 Italy extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 15 Spain extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 16 Spain extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 17 Denmark extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 18 Denmark extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 19 Sweden extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 20 Sweden extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)
  • Table 21 Norway extractable & leachable testing services market, by product, 2018 - 2030 (USD Million)
  • Table 22 Norway extractable & leachable testing services market, by application, 2018 - 2030 (USD Million)

List of Figures

  • Fig. 1 U.S. & Europe extractable & leachable testing services market segmentation
  • Fig. 2 Market research process
  • Fig. 3 Data triangulation techniques
  • Fig. 4 Primary research pattern
  • Fig. 5 Market research approaches
  • Fig. 6 Market formulation & validation
  • Fig. 7 Market outlook
  • Fig. 8 Segment snapshot
  • Fig. 9 Competitive landscape snapshot
  • Fig. 10 Parent market outlook
  • Fig. 11 U.S. & Europe extractable & leachable testing services market driver analysis
  • Fig. 12 U.S. & Europe extractable & leachable testing services market restraint analysis
  • Fig. 13 U.S. & Europe extractable & leachable testing services market: Porter's analysis
  • Fig. 14 U.S. & Europe extractable & leachable testing services market: PESTEL analysis
  • Fig. 15 U.S. & Europe extractable & leachable testing services market: Product outlook and key takeaways
  • Fig. 16 U.S. & Europe extractable & leachable testing services market: Product market share analysis, 2025-2030
  • Fig. 17 Container closure systems market estimates, 2018 - 2030 (USD Million)
  • Fig. 18 Single-use systems market estimates, 2018 - 2030 (USD Million)
  • Fig. 19 Drug delivery systems market estimates, 2018 - 2030 (USD Million)
  • Fig. 20 Others market estimates, 2018 - 2030 (USD Million)
  • Fig. 21 U.S. & Europe extractable & leachable testing services market: Application outlook and key takeaways
  • Fig. 22 U.S. & Europe extractable & leachable testing services market: Application market share analysis, 2025-2030
  • Fig. 23 Parenteral drug products market estimates, 2018 - 2030 (USD Million)
  • Fig. 24 Orally inhaled and nasal drug products market estimates, 2018 - 2030 (USD Million)
  • Fig. 25 Ophthalmic market estimates, 2018 - 2030 (USD Million)
  • Fig. 26 Regional marketplace: Key takeaways
  • Fig. 27 U.S. extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 28 Europe extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 29 UK extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 30 Germany extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 31 France extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 32 Spain extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 33 Italy extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 34 Denmark extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 35 Sweden extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 36 Norway extractable & leachable testing services market, 2018 - 2030 (USD Million)
  • Fig. 37 Strategy framework
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