U.S. & Europe Extractable And Leachable Testing Services Market (By Application: OINDP, Parenteral Drug Products; By Product: Single-use, Drug Delivery Systems) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. & Europe extractable and leachable testing services market size was surpassed at USD 690.62 million in 2023 and is expected to hit around USD 2,850.33 million by 2033, growing at a CAGR of 15.23% from 2024 to 2033. 

Key Pointers

• By Product, the container closure systems segment generated the maximum market share 32% in 2023.
• By Product, the single-use systems segment is expected to grow at the notable CAGR of 16.95% from 2024 to 2033.
• By Application, the orally inhaled and nasal drug products segment registered the maximum market share of 43% in 2023.
• By Application, the parenteral drug products segment is anticipated to grow at the noteworthy CAGR of 17.37% from 2024 to 2033.

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

The extractable and leachable (E&L) testing services market in the U.S. and Europe is witnessing substantial growth, fueled by increasing regulatory scrutiny, advancements in analytical techniques, and growing awareness among pharmaceutical and medical device manufacturers regarding product safety and quality.

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

The growth of the extractable and leachable (E&L) testing services market in both the U.S. and Europe is propelled by several the stringent regulatory requirements set by agencies such as the FDA in the U.S. and the EMA in Europe mandate comprehensive evaluation of extractables and leachables in pharmaceuticals and medical devices, driving the demand for testing services to ensure compliance and patient safety. Secondly, increasing focus on product safety and quality, coupled with growing awareness among stakeholders, has led pharmaceutical and medical device manufacturers to prioritize thorough E&L testing as part of their risk management strategies. Additionally, advancements in analytical technologies, such as high-resolution mass spectrometry and combinatorial testing approaches, have enhanced the capabilities and accuracy of E&L testing, further driving market growth.

Report Scope of the U.S. & Europe Extractable And Leachable Testing Services Market

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

• Increased Outsourcing of Testing Services: There is a growing trend among pharmaceutical and medical device companies in both the U.S. and Europe to outsource extractable and leachable testing services to specialized laboratories and contract research organizations (CROs). Outsourcing allows companies to access expertise, advanced technologies, and specialized facilities, while also streamlining their operational costs and timelines.
• Focus on Combinatorial Testing Approaches: To address the complexity and diversity of materials used in pharmaceutical and medical device manufacturing, there is a shift towards combinatorial testing approaches in E&L analysis. Combining various analytical techniques such as chromatography, mass spectrometry, and spectroscopy enables comprehensive screening of extractables and leachables, providing a more thorough understanding of potential risks.
• Integration of Advanced Analytical Technologies: The integration of advanced analytical technologies, such as high-resolution mass spectrometry (HRMS) and nuclear magnetic resonance (NMR) spectroscopy, is becoming increasingly common in E&L testing services. These technologies offer enhanced sensitivity, selectivity, and resolution, allowing for the detection and characterization of trace-level contaminants with greater accuracy and confidence.
• Focus on Extractable Profile Studies: There is a growing emphasis on conducting extractable profile studies as part of pre-formulation and material selection processes in pharmaceutical development. These studies involve systematically extracting compounds from packaging materials and medical devices to create comprehensive profiles of potential extractables, enabling informed decisions regarding material compatibility and safety.
• Emphasis on Leachable Risk Assessment: In addition to identifying and quantifying extractables, there is a heightened focus on leachable risk assessment in E&L testing services. Leachable risk assessment involves evaluating the potential impact of identified leachables on product safety, efficacy, and regulatory compliance, providing valuable insights for risk mitigation and product optimization.

Product Insights

On the basis of products, the container closure systems segment held the largest revenue share of 32% in 2023. The rising use of container closure systems in formulations because of their ability to provide long-term stability is boosting the revenue share of this segment. The container closure systems also consist of several package/delivery systems and can leach over time, making E & L testing extremely essential for CCS. Adequate container closure systems are important to maintain the drugs' safety, sterility, and quality. Various cases have been observed involving the loss of safety or formation of harmful contaminants due to the transfer of impurities from container closure systems to pharmaceutical products. For instance, Apotex Corp. recalled the Brimonidine Tartrate Ophthalmic Solution, 0.15%, in March 2023.

Thus, increasing demand for container closure systems in the market is anticipated to drive the segment growth over the forecast period. The single-use systems segment is expected to grow at a significant growth rate of 16.95% from 2024 to 2033. Single-use components and systems usage has increased significantly in commercial & clinical biopharmaceutical manufacturing. These components are generally made up of polymers or plastics. The single-use systems & components provide several advantages, such as speed, flexibility, and operation efficiency, over reusable components. However, the major concern with these SUS is that compounds can leach from the polymeric component, impacting the pharmaceutical product quality or process performance. Thus, extractable & leachable testing has become crucial for single-use systems.

Application Insights

The orally inhaled and nasal drug products segment was the largest in 2023 andaccounted for the largest revenue share of 43%. Orally inhaled and nasal drug products include nasal sprays, metered dose inhalers, dry powder inhalers, nebulizers, and inhalers. These products are widely used for systemic delivery of various therapeutics. These products represent the highest-risk drug products concerning the possible introduction of contaminants via container closure contact. Moreover, these products are used indiseases like asthma and Chronic Obstructive Pulmonary Disease (COPD). Therefore, extractable and leachable testing is vital for orally inhaled and nasal drug products.

Thus, increasing the demand for extractable and leachable testing services over the forecast period. The parenteral drug products segment is projected to witness the fastest CAGR of 17.37% over the forecast period. The segment growth is driven by the rising adoption of parenteral preparations across end-users and the increasing burden of chronic conditions requiring parenteral products. Moreover, parenteral products usually have high concentrations of additives like solubilizing agents, plasticizers, etc., which may leach over time, thus, growing the demand for extractable and leachable testing services market.

U.S. & Europe Extractable And Leachable Testing Services Market Key Companies

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

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

By Product 

• Container Closure Systems
• Single-use Systems
• Drug Delivery Systems
• Others

By Application 

• Parenteral Drug Products
• Orally Inhaled and Nasal Drug Products (OINDP)
• Ophthalmic