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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U.S. & Europe Extractable And Leachable Testing Services Market Growth & Trends
The U.S. & Europe extractable and leachable testing services market size is expected treach USD 1,867.7 million by 2030, according ta new report by Grand View Research, Inc., exhibiting a CAGR of 15.3% from 2025 t2030. Increasing regulatory scrutiny on the quality of healthcare products and a rising emphasis on product safety is anticipated tpropel the growth of the market. Furthermore, the market expansion is projected tbe 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 tthe adverse effects on human health that can be caused due tproduct contamination.
Various strategic initiatives undertaken by key participants tstrengthen E&L testing capabilities are anticipated tsupport 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 texpand the E&L library tinclude ion mobility measurements. This collaboration provided confidence ttesting 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, tstrengthen their industry presence. The main aim was tincrease 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 tSGS, and the key aim of this acquisition was texpand 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 tchange owing tdifferent factors, such as dynamic regulatory requirements, diverse product types, use of different analytical techniques, and variability in results. Thus, the service provider is required tcomply with all these variables.
U.S. & Europe Extractable And Leachable Testing Services Market Report Highlights
U.S. & Europe Extractable And Leachable Testing Services Market Growth & Trends
The U.S. & Europe extractable and leachable testing services market size is expected treach USD 1,867.7 million by 2030, according ta new report by Grand View Research, Inc., exhibiting a CAGR of 15.3% from 2025 t2030. Increasing regulatory scrutiny on the quality of healthcare products and a rising emphasis on product safety is anticipated tpropel the growth of the market. Furthermore, the market expansion is projected tbe 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 tthe adverse effects on human health that can be caused due tproduct contamination.
Various strategic initiatives undertaken by key participants tstrengthen E&L testing capabilities are anticipated tsupport 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 texpand the E&L library tinclude ion mobility measurements. This collaboration provided confidence ttesting 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, tstrengthen their industry presence. The main aim was tincrease 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 tSGS, and the key aim of this acquisition was texpand 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 tchange owing tdifferent factors, such as dynamic regulatory requirements, diverse product types, use of different analytical techniques, and variability in results. Thus, the service provider is required tcomply 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 ttheir ability tprovide 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 tthe 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 tthe presence of major market players and robust healthcare infrastructure in the U.S.
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 Sociйtй Gйnйrale 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
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 Sociйtй Gйnйrale 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
