Extractable and Leachable Testing Services Market Size Drives at 15.17% CAGR by 2034

The global extractable and leachable (E&L) testing services market valued at USD 1.29 billion in 2025 projected to reach USD 4.6 billion by 2034, registering a CAGR of 15.17%.

Ottawa, Sept. 16, 2025 (GLOBE NEWSWIRE) -- According to a study by Towards Healthcare, a sister firm of Precedence Research, the global extractable and leachable testing services market was worth USD 1.12 billion in 2024. The market is expected to surge to nearly USD 4.6 billion by 2034, growing at a robust CAGR of 15.17% over the forecast period.

The extractable and leachable testing services market is rising due to stricter global regulatory requirements, increasing pharmaceutical and biopharmaceutical production, and growing reliance on advanced packaging and single-use systems that demand rigorous safety validation.

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Key Takeaways:

North America dominated the global market share by 44% in 2024.
Asia Pacific is expected to grow at a notable CAGR from 2025 to 2034.
By product, the container closure system segment held the major market share in 2024.
By product, the single-use systems segment is projected to grow at a CAGR between 2025 and 2034.
By application, the orally inhaled and nasal drug products (OINDP) segment contributed the biggest market share in 2024.
By application, the parenteral drug products segment is expanding at a significant CAGR between 2025 and 2034.

Market Overview:

The extractable and leachable testing services market generates analytical results for chemical compounds that can migrate away from packaging, container closure systems or process contact materials into active drug formulations or biologicals. Testing for extractable & leachable is directly related to patient safety, regulatory compliance (FDA, EMA, ICH etc), as well as ensuring product efficacy and stability/useful life.

Increasing amounts of pharmaceuticals and biopharmaceuticals produced, more innovative drug delivery modalities and increased scrutiny on packaging safety are driving the market. Dynamic advances in instrumentation from chromatography and mass spectrometry to increased sample preparation processes are enabling much more sensitive detection.

Major Growth Drivers:

Regulations Impacting E&L Testing Demand: regulatory agencies globally are imposing stricter and stricter testing requirements for extractables and leachable especially for new dosage forms with sensitive dosages or high patient exposure. All manufacturers must comply with the requirements or they risk product delays.
Increasing Biopharmaceutical and Pharmaceutical Output: New drugs, biologics and biosimilars are increasing directly equivalent to increases in the amount of material contact there will be. The more complex the formulation, with each new dosage or packaging innovation, creates potential leachable.
Technological Advances: Advanced analytical technologies such as high-resolution mass spectrometry, next-generation chromatography and sample prep automation, all serve to rapidly provide detection, lower detection thresholds for leachable, and all work together to provide accurate, fast, reliable and safer results.

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Key Drifts:

What is Influencing the Market and the Trends in E&L Testing services?

The product and regulatory focus show that container closure systems dominate the E&L market in product type share, with extensive use and high risk of contact with drug substances. Single-use technologies are rising quickly in prevalence and use because they help minimize cleaning issues, but there are far more materials to with differing leachable that need characterizing. With drug product types, orally inhaled and nasal drug products (OINDP) dominate. These dosage forms are far more susceptible to leachable and traditionally require tighter control. Parenteral drug products are the fastest growing application, fuelled by the high demand for safety because they are injected, intravenous, etc.

Significant Challenge:

The capitalized need for costly equipment and controlled labs to develop could lead to thousands of dollars of cost per material/formulation for full extractables and leachable studies. Smaller firms or those in developing geographies often experience barriers with cost. We have a shortage of highly trained chemists or analysts with expertise in method development, sample prep, data, preparation, and understanding of regulation and material science; skills which need to work together in coordination to keep this industry growing, particularly in the emerging markets.

Regulatory bodies have different levels of thresholds, guidelines, or expectations for E&L testing, material databases are incomplete, and methods are not always harmonized. This situation results in duplication of effort, slower approval timelines, variations in results, and cost escalation.

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Regional Analysis:

North America leads the extractables & leachable testing services market share by 44%, due to stringent FDA regulations, superior laboratory infrastructure and density of pharmaceuticals and biotechnology. The region benefits from high research and development spending, a rapid transition to new innovative package solutions, and the presence of global leaders.

Asia Pacific is the fastest growing region for Extractable and leachable testing services, given the growing pharmaceutical manufacturing hubs in China, India, and Japan. Regulatory enforcement is increasing, along with biologics production and investment in single-use technologies. Strong support from government initiatives and outsourcing in case of in-house identification and analysis are all reasons why APAC is the most dynamic growth region globally.

Segmental Insights:

By Product:

The container-closure systems dominated the market in 2024; this is primarily due to the regulatory expectations to test all materials that come in contact with drug, and container-closure systems can encompass any dosage form.

Single-use systems are continuing to expand rapidly given the trend for pharmaceutical manufacturers to utilize disposable process equipment, bag systems, and other consumables which all do have associated extractables/leachable testing.

By Application:

Orally inhaled and nasal drug products dominate the majority of share because of their high exposure risk, regulatory requirements, and patient safety concerns involve known material leachable undergoing rigorous testing.

The parenteral segment appears to be the fastest growing because, given the risk of leachable when the product is injected, regulators/companies are paying more attention to safety in the parenteral segment.

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Recent Developments:

On January 31, 2024, Kindeva announced that its new Analytical Services Business Unit will offer extractables and leachable testing, elemental impurities assessment, medical device testing, and container-closure integrity testing.
On March 21, 2024, Element Materials Technology Launches Rapid Response Pharmaceutical Testing Service. Element Materials Technology introduced a “Rapid Response Pharmaceutical Testing Service” at its Manchester lab to deliver faster turnaround times, including for E&L studies.
In July 2023, Broughton Launches E&L Services for Reduced-Risk Nicotine Products: Broughton released adapted extractable and leachable testing services tailored to reduced‐risk nicotine industry products, targeting compliance pathways like PMTA and MAA.

Extractable and Leachable Testing Services Market Key Players

Intertek Group plc
Thermo Fisher Scientific
Medical Engineering Technologies Ltd.
Eurofins Scientific
SCHOTT Pharma
Nelson Labs
SGS S.A.
Sartorius AG
Analytica Chemie Inc.
Auriga Research Pvt. Ltd.
Merck Millipore
Dalton Pharma Services
Gateway Analytical

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Segments Covered in the Report

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

By Region

North America
- US
- Canada
Asia Pacific
- China
- Japan
- India
- South Korea
- Thailand
Europe
- Germany
- UK
- France
- Italy
- Spain
- Sweden
- Denmark
- Norway
Latin America
- Brazil
- Mexico
- Argentina
Middle East and Africa (MEA)
- South Africa
- UAE
- Saudi Arabia
- Kuwait

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About Us

Towards Healthcare is a leading global provider of technological solutions, clinical research services, and advanced analytics, with a strong emphasis on life science research. Dedicated to advancing innovation in the life sciences sector, we build strategic partnerships that generate actionable insights and transformative breakthroughs. As a global strategy consulting firm, we empower life science leaders to gain a competitive edge, drive research excellence, and accelerate sustainable growth.

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