+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

U.S. & Europe Extractable And Leachable Testing Services Market Size, Share & Trends Analysis Report By Application (OINDP, Parenteral Drug Products), By Product (Single-use, Drug Delivery Systems), And Segment Forecasts, 2023 - 2030

  • PDF Icon

    Report

  • 236 Pages
  • August 2023
  • Region: Europe, United States
  • Grand View Research
  • ID: 5876218
The U. S. & Europe extractable and leachable testing services market size is expected to reach USD 1.86 billion by 2030., exhibiting a CAGR of 15.20% from 2023 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 forthe largest revenue share of 30.68% in 2022 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 41.70% in 2022 due to the increasing demand for innovative drug delivery methods
  • In 2022, the U. S. dominated the market and is anticipated to grow at the fastest CAGR of 15.45% over the forecast period
  • The large share and rapid growth are attributed to the presence of major market players and robust healthcare infrastructure in the U. S.


This product will be delivered within 1-3 business days.

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. 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
1.11.1. Objective - 1
1.11.2. Objective - 2
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Product and Application 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: U.S. & Europe Extractable and Leachable Testing Services Market
Chapter 4. U.S. & Europe Extractable and Leachable Testing Services Market: Product Estimates & Trend Analysis
4.1. U.S. & Europe Extractable and Leachable Testing Services Market: Product Movement Analysis
4.2. Container Closure Systems
4.2.1. Container Closure Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.3. Single-use Systems
4.3.1. Single-use Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4. Drug Delivery Systems
4.4.1. Drug Delivery Systems Market Estimates and Forecasts, 2018 - 2030 (USD Million)
4.5. Others
4.5.1. 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. U.S. & Europe Extractable and Leachable Testing Services Market: Application Movement Analysis
5.2. Parenteral Drug Products
5.2.1. Parenteral Drug Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.3. Orally Inhaled & Nasal Drug Products
5.3.1. Orally Inhaled and Nasal Drug Products Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.4. Ophthalmic
5.4.1. Ophthalmic Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 6. U.S. & Europe Extractable and Leachable Testing Services Market: Regional Business Analysis
6.1. Regional Market Snapshot
6.2. U.S.
6.2.1. Key Country Dynamics
6.2.2. U.S. Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.2.3. Competitive Scenario
6.2.4. Regulatory Framework
6.3. Europe
6.3.1. Europe Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.2. UK
6.3.2.1. Key Country Dynamics
6.3.2.2. UK Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.2.3. Competitive Scenario
6.3.2.4. Regulatory Framework
6.3.3. GERMANY
6.3.3.1. Key Country Dynamics
6.3.3.2. Germany Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.3.3. Competitive Scenario
6.3.3.4. Regulatory Framework
6.3.4. SPAIN
6.3.4.1. Key Country Dynamics
6.3.4.2. Spain Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.4.3. Regulatory Framework
6.3.4.4. Competitive Scenario
6.3.5. FRANCE
6.3.5.1. Key Country Dynamics
6.3.5.2. France Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.5.3. Competitive Scenario
6.3.5.4. Regulatory Framework
6.3.6. ITALY
6.3.6.1. Key Country Dynamics
6.3.6.2. Italy Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.6.3. Competitive Scenario
6.3.6.4. Regulatory Framework
6.3.7. DENMARK
6.3.7.1. Key Country Dynamics
6.3.7.2. Denmark Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.7.3. Competitive Scenario
6.3.7.4. Regulatory Framework
6.3.8. SWEDEN
6.3.8.1. Key Country Dynamics
6.3.8.2. Sweden Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.8.3. Competitive Scenario
6.3.8.4. Regulatory Framework
6.3.9. NORWAY
6.3.9.1. Key Country Dynamics
6.3.9.2. Norway Extractable and Leachable Testing Services Market, 2018 - 2030 (USD Million)
6.3.9.3. Competitive Scenario
6.3.9.4. Regulatory Framework
Chapter 7. U.S. & Europe Extractable and Leachable Testing Services Market: Competitive Landscape
7.1. Company Categorization
7.2. Strategy Mapping
7.2.1. Service Launch
7.2.2. Partnerships & Collaboration
7.2.3. Expansion
7.2.4. Acquisition
7.2.5. Others
7.3. Key Company Market Share Analysis, 2022
7.4. Company Profiles
7.4.1. Eurofins Scientific
7.4.1.1. Company Overview
7.4.1.2. Financial Performance
7.4.1.3. Product Benchmarking
7.4.1.4. Strategic Initiatives
7.4.2. Intertek Group plc
7.4.2.1. Company Overview
7.4.2.2. Financial Performance
7.4.2.3. Product Benchmarking
7.4.2.4. Strategic Initiatives
7.4.3. SGS Société Générale de Surveillance SA
7.4.3.1. Company Overview
7.4.3.2. Financial Performance
7.4.3.3. Product Benchmarking
7.4.3.4. Strategic Initiatives
7.4.4. WuXi AppTec
7.4.4.1. Company Overview
7.4.4.2. Financial Performance
7.4.4.3. Product Benchmarking
7.4.4.4. Strategic Initiatives
7.4.5. Merck KGaA
7.4.5.1. Company Overview
7.4.5.2. Financial Performance
7.4.5.3. Product Benchmarking
7.4.5.4. Strategic Initiatives
7.4.6. West Pharmaceutical Services, Inc
7.4.6.1. Company Overview
7.4.6.2. Financial Performance
7.4.6.3. Product Benchmarking
7.4.6.4. Strategic Initiatives
7.4.7. Wickham Micro Limited (Medical Engineering Technologies Ltd.)
7.4.7.1. Company Overview
7.4.7.2. Product Benchmarking
7.4.7.3. Strategic Initiatives
7.4.8. Pacific Biolabs
7.4.8.1. Company Overview
7.4.8.2. Product Benchmarking
7.4.8.3. Strategic Initiatives
7.4.9. Boston Analytical
7.4.9.1. Company Overview
7.4.9.2. Product Benchmarking
7.4.9.3. Strategic Initiatives
7.4.10. Sotera Health (Nelson Laboratories, LLC)
7.4.10.1. Company Overview
7.4.10.2. Financial Performance
7.4.10.3. Product Benchmarking
7.4.10.4. Strategic Initiatives
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 Market research process
Fig. 2 Information procurement
Fig. 3 Market summary
Fig. 4 Market segmentation & scope
Fig. 5 Market size and growth prospects
Fig. 6 U.S. & Europe extractable & leachable testing services market - Key market driver analysis
Fig. 7 U.S. & Europe extractable & leachable testing services market - Key market restraint analysis
Fig. 8 U.S. & Europe extractable & leachable testing services market - Porter’s analysis
Fig. 9 U.S. & Europe extractable & leachable testing services market - PESTEL analysis
Fig. 10 U.S. & Europe extractable & leachable testing services market product outlook key takeaways
Fig. 11 U.S. & Europe extractable & leachable testing services market: Product movement analysis
Fig. 12 Container closure systems market estimates, 2018 - 2030 (USD Million)
Fig. 13 Single - use systems market estimates, 2018 - 2030 (USD Million)
Fig. 14 Drug delivery systems market estimates, 2018 - 2030 (USD Million)
Fig. 15 Others market estimates, 2018 - 2030 (USD Million)
Fig. 16 U.S. & Europe extractable & leachable testing services market application outlook key takeaways
Fig. 17 U.S. & Europe extractable & leachable testing services market: application movement analysis
Fig. 18 Parenteral drug products market estimates, 2018 - 2030 (USD Million)
Fig. 19 Orally inhaled and nasal drug products market estimates, 2018 - 2030 (USD Million)
Fig. 20 Ophthalmic market estimates, 2018 - 2030 (USD Million)
Fig. 21 Regional marketplace: Key takeaways
Fig. 22 U.S. extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 23 Europe extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 24 UK extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 25 Germany extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 26 France extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 27 Spain extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 28 Italy extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 29 Denmark extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 30 Sweden extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 31 Norway extractable & leachable testing services market, 2018 - 2030 (USD Million)
Fig. 32 Strategy framework

Companies Mentioned

  • Eurofins Scientific
  • Intertek Group plc
  • SGS Société Générale de Surveillance SA
  • WuXi AppTec
  • Merck KGaA
  • West Pharmaceutical Services, Inc
  • Wickham Micro Limited (Medical Engineering Technologies Ltd.)
  • Pacific Biolabs
  • Boston Analytical
  • Sotera Health (Nelson Laboratories, LLC)

Methodology

Loading
LOADING...

Table Information