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January 2025
The global extractable and leachable testing services market size is calculated at USD 1.12 billion in 2024, grew to USD 1.29 billion in 2025, and is projected to reach around USD 4.6 billion by 2034. The market is expanding at a CAGR of 15.17% between 2024 and 2034. The growing pharmaceutical production, stringent regulatory guidelines, and technological advancements drive the market.
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Extractables are compounds extracted from the container closure system in the presence of a solvent. Leachables are compounds that leach into the drug product formulations from the container closure system due to direct contact with the formulation. Pharmaceutical packaging, bioprocess materials, drug delivery systems, or implantable medical devices may include plastic, polymer, rubber, and glass components. Extractable and leachable testing analyzes potentially harmful materials in drug products and storage container materials that could be administered to a patient along with a drug or device. These compounds pose a significant risk to the patient's health. They are determined using a wide range of analytical instruments, such as spectrometric and chromatographic instruments.
The burgeoning pharmaceutical sector leads to increasing its manufacturing of numerous products, including drugs and devices. Several regulatory agencies impose guidelines for the effective analysis of pharmaceutical products, ensuring they do not contain any harmful chemicals. Additionally, technological advancements in the instruments used for analyzing extractable and leachable favor market growth. The growing research and development activities related to new drug discovery and novel drug development processes necessitate extractable and leachable testing.
Artificial intelligence (AI) finds diverse applications in the healthcare sector, especially in the pharmaceutical sector. However, the applications of AI in extractable and leachable testing services are still under investigation. Integrating AI into analytical instruments can result in more accurate and precise data with reproducible results. Machine learning (ML) algorithms can predict the presence of extractable and leachable in the sample. They can also aid in predictive analysis of the analytical instruments for the early identification of potential issues in the instruments. ML can help in peak detection and integration. Moreover, advanced AI technologies, such as robotic systems, can be used for automated sample preparation. Hence, AI in extractable and leachable testing services enhances learning capability and adaptability as well as favors decision-making and problem-solving.
Stringent Regulatory Guidelines
Extractable and leachable testing is an essential requirement for pharmaceutical products. Several regulatory agencies impose and continuously evolve stringent regulatory guidelines for the evaluation of drug product packaging associated with each new product. E&L analysis studies are performed following regional guidance and nationally and internationally recognized standards. The Good Manufacturing Practice (GMP) guidelines and Q3-E Guideline for Extractables and Leachables (E&L) by ICH mandate E&L testing by defining specified limits per sample. Additionally, the US Food and Drug Administration, European Medicine Agency, etc. agencies, favor extractable and leachable testing in their respective nations. Manufacturers require approval of every component, material, or chemical element involved in preparing pharmaceutical products.
Generation of Databases and Lack of Skilled Professionals
The major challenge of the extractable and leachable testing services market is the generation of extractable and leachable databases. Several organizations are making efforts to generate databases to reduce the number of extractable and leachable testing studies. Generating databases can significantly reduce duplication of efforts, thereby restricting market growth. Another major challenge of the market is the lack of skilled professionals. Highly skilled and experienced analysts are required to develop instrument methods and sample preparation techniques. Thus, the lack of skilled professionals, especially in low- and middle-income countries, hinders market growth.
Novel Developments
The future of the extractable and leachable testing services market is promising, driven by improving analytical methods, increased collaborations, and technological advancements. Current analytical methods are continuously evolving to improve the accuracy of identification and quantification of samples. The improvements in analytical instruments are driven by increased collaborations between instrument vendors and analytical labs. Additionally, technological advancements such as mathematical modeling and simulation can be used to study how different factors impact the production of leachable. Introducing automation in sample workup facilitates automation in data processing and analyte identification, thereby driving efficiencies in E&L studies. Hence, these advancements can further revolutionize extractable and leachable testing services.
By product, the container closure systems segment held a dominant presence in the extractable and leachable testing services market in 2023. Container closure systems are comprised of packaging components to protect the drug product. They maintain the sterility of the medication and increase the shelf-life of the product. They are used to store almost all pharmaceutical products. They are more prone to release extractable and leachable impurities. Several regulatory agencies have mandated the testing of container closure systems to assess the presence of extractable and leachable.
By product, the single-use systems segment is predicted to witness significant growth in the extractable and leachable testing services market over the forecast period. Single-use systems based on the application of disposable components have found validation and increasing popularity in the pharmaceutical industry. Some common examples of single-use systems include bioreactors, bioprocess containers, disposable mixers, plastic bags, media bags, filters, tubing, etc. They are processing materials that require validation regarding their integrity. Manufacturers collaborate to ensure patient safety and product efficacy. The testing of single-use systems before the transportation and storage of such systems is also essential. The increasing development of new drug delivery systems with new combination products leads to the increasing use of single-use disposable systems for manufacturing.
By application, the orally inhaled and nasal drug products (OINDP) segment led the global extractable and leachable testing services market in 2023. OINDPs have growing significance in the pharmaceutical sector as they can treat both local and systemic diseases, thereby possessing superior benefits over traditional dosage forms. These systems can expand pharmaceutical commercialization opportunities. OINDP represents the highest-risk drug products with the potential introduction of impurities via container closure contact. The Product Quality Research Institute (PQRI) recommends safety evaluation thresholds for extractable and leachable in OINDP. The growing incidences of respiratory disorders lead to the increasing development of OINDP, augmenting market growth.
By application, the parenteral drug products segment will gain a significant share of the extractable and leachable testing services market over the studied period. The regulatory guidelines for parenteral drug products are more stringent than other dosage forms. According to the IQVIA report, parenteral products account for nearly half or 47% of the global pharmaceutical sales in 2023. They are directly administered into the body fluids. Hence, the presence of impurities causes significant harm to the patient and adversely affects the stability and potency. Primary packaging is the main source of E&Ls in parenteral drugs, followed by manufacturing componentry and secondary packaging. Parenteral products come in contact with various surfaces and materials, from vulcanized rubber tubing to lubricants and metal alloys during manufacturing. Hence, testing E&L in parenteral drug products is mandatory.
North America held the largest share of the extractable and leachable testing services market share by 44% in 2023. The presence of key players, stringent regulatory guidelines, and technological advancements drive the market. Regulatory agencies such as the US Food and Drug Administration and Health Canada regulate the testing of extractable and leachable in the region. The market is also driven by the state-of-the-art research and development infrastructure. The advancements in unique packaging materials and novel formulations have increased, which necessitate the testing of E&L in these products before conducting clinical trials. The rising adoption of advanced technologies to revolutionize analytical instruments also governs market growth. Furthermore, the increasing number of pharmaceutical and biotechnology companies in North America require testing services for their pharmaceutical products.
Asia-Pacific is anticipated to grow at a significant rate in the extractable and leachable testing services market during the forecast period. The increasing number of pharmaceutical products manufacturing, stringent regulatory guidelines, and growing research and development drive the market. Countries like China, India, and Japan are at the forefront of driving market growth. China and India are the countries with the highest pharmaceutical manufacturing in Asia-Pacific and among the top ten in the world. India is projected to be the third largest in terms of volume and contributes around 3.5% of total drugs and medicines exported globally. The increasing manufacturing results in increased demand for E&L testing owing to regulatory approval. Additionally, increasing investments support advanced R&D activities and expansion of E&L testing capabilities.
Chris Allen, CEO of Broughton, commented that extractable and leachable studies are an essential part of product development to ensure safety and manage risk. He added that pharmaceutical companies should stay updated about the evolving regulatory requirements on the impact of organic compounds and elemental impurities that leach into the product from the manufacturing process, container closure system, packaging materials, or delivery mechanism.
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