Global Extract and Leachate Testing Services Market - Forecast (2024 - 2030)

The global extract & leachate testing services market size is forecast to reach USD 4,472.14 million by 2030, after growing at a CAGR of 6.8% during the forecast period 2024-2030. An increasing need for cutting-edge facilities and laboratories has resulted from extensive research and development activities analysis of pharmaceutical products. To ensure patient safety, pharmaceutical companies are constantly creating new medications and excipients regulations. The strict pharmaceutical product release regulations set forth by the FDA and the European Union ensure the patients' safety. 

The European Medicines Agency (EMA) is paying closer attention to how different manufacturing elements, drug delivery systems, and container-closure systems (CCS) interact with the finished pharmaceutical product. The drug's primary packaging contains a dangerous chemical that is contagious and poses a serious risk to patients if they use the products. As a result, early migration of pharmaceutical products is crucial, which has increased demand for extractable and leachable testing services to assure patient safety.

The report “Global Extract & Leachate Testing Service Market–Forecast (2024-2030)”, by Industry ARC, covers an in-depth analysis of the following segments of the global extract and leachate testing service market.

By Product Tested: Container Materials/Packaging, Single-Use, Medical Devices, Biopharmaceuticals/Biologicals, and Others

By Technique: Spectrometry, Spectroscopy, Total Organic, Conductivity, and Others.

By Geography:  North America, Europe, APAC, South America, and Middle East & Africa

• North America plays a dominant role in the global extract and leachate testing market. Due to recent huge investments and rapid technological breakthroughs, North America now holds the largest market revenue share for biopharmaceuticals. The USA leads the world in biotechnology research and innovation with approximately 2,500 firms and a strong corporate network. Extractables & Leachables testing market is increasingly linked with Biopharmaceuticals, which reflects the strong growth of the Extractables & Leachables testing market.

• According to the 2020 EU Industrial R&D Investment Scoreboard, 18.4% of all company R&D spending worldwide is spent by the pharmaceutical and biotechnology industries. With the increase in pharmaceutical and biotechnology industries, there is a demand for extractable and Leachable testing services market. Biopharmaceuticals/Biologicals plays a major role in Europe’s extractable and Leachable testing services market.

Biopharmaceuticals are the leading product-tested in the global extract and leachate testing services market which occupies a major market share 33% in 2023. The rise in chronic diseases, infectious diseases, and lifestyle disorders has raised the demand for advancements in pharmaceuticals and medical technology. Governments and other governing bodies are making significant investments in pharmaceutical research and development as well as upgrading their container closure systems, which is boosting the market for extractable & leachable testing services. In the future five years, the global market for extractable & leachable testing services will develop as a result of rising demand for bio-safe medical devices and the compatibility of pharmaceutical container closing systems.

The spectrometry segment dominated the global extract & leachate testing services market with a market share of 33% in 2023. Extract and Leachate Testing Services is driven by advancing capabilities in the field of mass spectrometry using instrumentation able to support both regulated and non-regulated activities, including pharmaceutical, food, cosmetic and chemical applications. As the pharmaceutical industry expands in importance, spectrometry technology is becoming more essential. In the market for extractable and leachable testing services, Total organic carbon helps identify contaminants in cooling water, drinking water, semiconductor production water, and pharmaceutical application water.

North America region dominated the global extract & leachate testing services market in with a market share 34% in 2023. Due to the presence of multiple major players, North America is predicted to dominate the worldwide extractable and leachable testing services market. 

Medical gadgets and pharmaceutical items are subjected to extractable and leachable testing. Orally inhaled and nasal drug products (OINDPs), electronic nicotine delivery systems (ENDSs), and many other products for which extractable and leachable can change the taste, smell, or color of a product, or change the stability or potency of an active pharmaceutical ingredient are also subject to extractable and leachable testing. 

Due to recent huge investments and rapid technological breakthroughs, North America now holds the largest market revenue share for biopharmaceuticals. The USA leads the world in biotechnology research and innovation with approximately 2,500 firms and a strong corporate network. Extractables & Leachables testing market is increasingly linked with Biopharmaceuticals, which reflects the strong growth of the global extract & leachates testing market.

The identification and quantification of potentially dangerous leachable contaminants that could escape from pharmaceutical container closure mechanisms and contaminate a pharmaceutical product, endangering patient health, is dependent on extractable and leachable testing. It has frequently been demonstrated that harmful chemicals or pollutants from primary packaging migrate into pharmaceutical items, threatening the safety of numerous people who utilize these medicines. Testing is primarily used to prevent the loss of pharmaceutical items due to extractable and leachable. Several businesses currently provide services for extractable and leachable testing, and these services have developed into a significant sector of the entire pharmaceutical industry.

Chemicals in the various forms of packaging and food contact materials (FCMs) that come into direct touch with the consumer product may endanger the safety of medications, cosmetics, and food products. The term "extractable and leachable" is frequently used to describe pollutants that come from food. One of the major sectors influencing the market for extractable and leachable testing is the food industry. It is used to test product packaging to make sure that dangerous chemicals won't leak into the product while it is being utilized. Many businesses place a high value on this research, but the food industry is particularly dependent on them because studies on packaging safety and toxicology are mandatory.

Leachables provide particular analytical challenges. The analytical techniques used to find contaminants in the drug product might not be able to find reachable since they are unrelated to the medicinal product. Leachables are frequently found at levels that are orders of magnitude lower than drug degradation products or related compounds, which puts them below the sensitivity of testing methods even when they are detectable by drug product impurity procedures. For the analysis of leachables in the drug product, several analytical techniques are typically required.

E&L becomes increasingly complex as a result of the increasing variety of equipment and materials employed. It is challenging to precisely classify and quantify each type given the limitations of the available analyzing tools and procedures. The largest problem is thus how to effectively identify and precisely measure the E&L given the current state of technology.

There are some extractable that are known to be extremely poisonous; depending on the material, further investigation may be needed. The guidelines and assistance for extractable and leachates are provided by several international organizations. These groups actively work to raise public knowledge of the toxicities of extractable and leachable through yearly meetings or by articulating the necessary guidelines in cooperation with regulatory bodies.

Technology launches, acquisitions, and R&D activities are key strategies adopted by players in the global extract and leachate testing service market. In 2023, the global extract & leachate testing services market share has been consolidated by the top players for 60% of the share. Major players in the global extract and leachate testing service market are SGS SA, Intertek Group PLC, ALS Limited, Smithers MSE Limited, Eurofins Scientific SE, Toxikon Corp, Leachate Solutions, LLC, Sartorius, AG, Pacific BioLabs Inc., Dalton Pharma Services

 In 2022, SGS acquired proderm, the leading provider of advanced clinical testing solutions for cosmetics, personal care, and medical products in Germany.

 A deal to purchase the majority of QSAI Analysis and Research Center Co., Ltd. was announced by Eurofins Scientific (EUFI.PA), the world leader in food testing and a scientific leader in bioanalytical testing, in 2022.

 In 2021, SGS has acquired Quay Pharmaceuticals Limited (Quay Pharma), a UK-based provider of innovative, formulation research and development services for the global biopharmaceutical sector.

 In 2021, Smithers, a leading provider of testing, consulting, information, and compliance services, completed the acquisition of Origo Labs.