U.S. & Europe Extractable And Leachable Testing Services Market To Reach $1,867.7 Million By 2030

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.

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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.

U.S. & Europe Extractable And Leachable Testing Services Market Segmentation

Grand View Research has segmented the U.S. & Europe extractable and leachable testing services market based on product, application, and region:

U.S. & Europe Extractable And Leachable Testing Services Product Outlook (Revenue, USD Million, 2018 - 2030)

• Container Closure Systems

• Single-use Systems

• Drug Delivery Systems

• Others

U.S. & Europe Extractable And Leachable Testing ServicesApplication Outlook (Revenue, USD Million, 2018 - 2030)

• Parenteral Drug Products

• Orally Inhaled and Nasal Drug Products (OINDP)

• Ophthalmic

U.S. & Europe Extractable And Leachable Testing Services Country Outlook (Revenue, USD Million, 2018 - 2030)

• U.S.

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

List of Key Players in the U.S. & Europe Extractable And Leachable Testing Services Market

• 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)