U.S. & Europe Extractable And Leachable Testing Services Market Size, Share, Report 2023-2032
The U.S. & Europe extractable and leachable testing services market was surpassed at USD 0.66 billion in 2022 and is expected to hit around USD 2.73 billion by 2032, growing at a CAGR of 15.24% from 2023 to 2032.
Key Pointers
Report Scope of the U.S. & Europe Extractable And Leachable Testing Services Market
| Report Coverage | Details |
| Market Size in 2022 | USD 0.66 billion |
| Revenue Forecast by 2032 | USD 2.73 billion |
| Growth rate from 2023 to 2032 | CAGR of 15.24% |
| Base Year | 2022 |
| Forecast Period | 2023 to 2032 |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Companies Covered | 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) |
Increasing regulatory scrutiny on the quality of healthcare products and rising emphasis on product safety are key drivers fueling market growth. Moreover, flourishing pharmaceutical and biotechnology sectors across the U.S. & Europe and supportive government legislation are further projected to support market expansion. The COVID-19 pandemic positively impacted market growth owing to the high demand for novel therapeutics and healthcare products.
The pandemic created a higher demand for pharmaceuticals, comprising treatments, vaccines, and medical devices. As companies scaled up manufacturing these products, the demand for extractable and leachable testing services increased to ensure product safety and compliance with regulatory requirements. In addition, with the introduction of new drugs and medical devices during the pandemic, regulatory bodies increased their emphasis on product safety and quality. As a result, companies had to perform exhaustive leachable testing as a part of their new product development process. Extractable and leachable testing is the analysis of harmful foreign materials that could enter a patient’s body with devices or medicines.
Various pharmaceutical and biotechnology companies use different extractable testing services to safeguard their products from regulatory scrutiny. The regulatory framework for extractable and leachable testing has become more stringent as it is directly concerned with patient safety. In March 2022, the UK government with its Medicines and Healthcare Products Regulatory Agency announced a change in the UK clinical trial regulations. Thereby increasing the demand for extractable and leachable testing services over the forecast period. In addition, rising government support and increasing investment opportunities in the biopharmaceutical domain are anticipated to boost industry growth & positively affect the market.
For instance, in April 2021, venture capital firms invested over USD 36.6 billion in biopharmaceutical companies in the U.S., the UK, and countries in the European Union, accounting for an increase of around 281% from 2017. Thereby increasing the market demand over the forecast period. Furthermore, the growing demand for innovations in bioprocess engineering has led to considerable developments in single-use systems. Advancements in this domain are also fueled by the high usage rate of biopharmaceuticals in recent times.
Furthermore, the increasing number of studies conducted to evaluate the efficiency of single-use bioprocesses is also aiding the rise in awareness about these technologies. Single-use technologies also offer a wide range of benefits, such as a lower risk of cross-contamination, shorter turnaround times, cost-effectiveness, and higher flexibility for altering production volumes. Thus, the rising adoption of single-use technology raised several issues regarding leachable and extractable, as single-use systems can easily come in contact with products and affect their safety and quality. Thus, augmenting the demand for extractable and leachable testing services.
Product Insights
On the basis of products, the container closure systems segment held the largest revenue share of 31% in 2022. 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 16.94% from 2023 to 2032. 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 2022 andaccounted for the largest revenue share of 42%. 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 17.36% 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 Segmentations:
By Product
By Application
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. COVID 19 Impact on U.S. & Europe Extractable And Leachable Testing Services Market
5.1. COVID-19 Landscape: U.S. & Europe Extractable And Leachable Testing Services Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
Chapter 6. Market Dynamics Analysis and Trends
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
Chapter 7. Competitive Landscape
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
Chapter 8. U.S. & Europe Extractable And Leachable Testing Services Market, By Product
8.1. U.S. & Europe Extractable And Leachable Testing Services Market, by Product, 2023-2032
8.1.1. Container Closure Systems
8.1.1.1. Market Revenue and Forecast (2020-2032)
8.1.2. Single-use Systems
8.1.2.1. Market Revenue and Forecast (2020-2032)
8.1.3. Drug Delivery Systems
8.1.3.1. Market Revenue and Forecast (2020-2032)
8.1.4. Others
8.1.4.1. Market Revenue and Forecast (2020-2032)
Chapter 9. U.S. & Europe Extractable And Leachable Testing Services Market, By Application
9.1. U.S. & Europe Extractable And Leachable Testing Services Market, by Application, 2023-2032
9.1.1. Parenteral Drug Products
9.1.1.1. Market Revenue and Forecast (2020-2032)
9.1.2. Orally Inhaled and Nasal Drug Products (OINDP)
9.1.2.1. Market Revenue and Forecast (2020-2032)
9.1.3. Ophthalmic
9.1.3.1. Market Revenue and Forecast (2020-2032)
Chapter 10. U.S. & Europe Extractable And Leachable Testing Services Market, Regional Estimates and Trend Forecast
10.1. U.S.
10.1.1. Market Revenue and Forecast, by Product (2020-2032)
10.1.2. Market Revenue and Forecast, by Application (2020-2032)
Chapter 11. Company Profiles
11.1. Eurofins Scientific
11.1.1. Company Overview
11.1.2. Product Offerings
11.1.3. Financial Performance
11.1.4. Recent Initiatives
11.2. Intertek Group plc
11.2.1. Company Overview
11.2.2. Product Offerings
11.2.3. Financial Performance
11.2.4. Recent Initiatives
11.3. SGS Société Générale de Surveillance SA
11.3.1. Company Overview
11.3.2. Product Offerings
11.3.3. Financial Performance
11.3.4. Recent Initiatives
11.4. WuXi AppTec
11.4.1. Company Overview
11.4.2. Product Offerings
11.4.3. Financial Performance
11.4.4. LTE Scientific
11.5. Merck KGaA
11.5.1. Company Overview
11.5.2. Product Offerings
11.5.3. Financial Performance
11.5.4. Recent Initiatives
11.6. West Pharmaceutical Services, Inc.
11.6.1. Company Overview
11.6.2. Product Offerings
11.6.3. Financial Performance
11.6.4. Recent Initiatives
11.7. Wickham Micro Ltd. (Medical Engineering Technologies Ltd.)
11.7.1. Company Overview
11.7.2. Product Offerings
11.7.3. Financial Performance
11.7.4. Recent Initiatives
11.8. Pacific Biolabs
11.8.1. Company Overview
11.8.2. Product Offerings
11.8.3. Financial Performance
11.8.4. Recent Initiatives
11.9. Boston Analytical
11.9.1. Company Overview
11.9.2. Product Offerings
11.9.3. Financial Performance
11.9.4. Recent Initiatives
11.10. Sotera Health (Nelson Laboratories, LLC)
11.10.1. Company Overview
11.10.2. Product Offerings
11.10.3. Financial Performance
11.10.4. Recent Initiatives
Chapter 12. Research Methodology
12.1. Primary Research
12.2. Secondary Research
12.3. Assumptions
Chapter 13. Appendix
13.1. About Us
13.2. Glossary of Terms
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers