{"id":9199,"date":"2018-09-25T13:30:07","date_gmt":"2018-09-25T13:30:07","guid":{"rendered":"https:\/\/www.rootsanalysis.com\/blog\/?p=9199"},"modified":"2026-07-23T15:28:57","modified_gmt":"2026-07-23T09:58:57","slug":"extractables-and-leachables-testing-emerging-opportunities-for-service-providers","status":"publish","type":"post","link":"https:\/\/www.rootsanalysis.com\/blog\/extractables-and-leachables-testing-emerging-opportunities-for-service-providers\/","title":{"rendered":"Extractables and Leachables Testing: Emerging Opportunities"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">During drug product manufacturing and fill \/ finish, it is important to consider not only the impurity profiles of the drugs, but also identify potential sources of contamination in the containers \/ packaging material used. due to high variability in the type of impurities (organic (volatile, non-volatile or semi- volatile compounds) or inorganic (metals or salts) elements) that are usually extracted \/ leached out of various manufacturing components and container closures, it is not possible to identify, characterize and quantify all extractables, using a single analytical technique. Presently, a number of companies offer services for extractables and leachables testing, and such offerings have grown to become an important segment of the overall pharmaceutical industry.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Over time, <a href=\"https:\/\/www.rootsanalysis.com\/reports\/pharmaceutical-contract-manufacturing-market\/191.html\">pharmaceutical contract manufacturers<\/a> have established suitable packaging \/ other processes to ensure that their products are free from chemical impurities<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"672\" height=\"430\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Packaging-Trends-Analysis-Roots.webp\" alt=\"Pharma packaging trend analysis between 2014-2018 by prefilled or blister or pouches \" class=\"wp-image-17807\" style=\"object-fit:contain;width:800px;height:512px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Packaging-Trends-Analysis-Roots.webp 672w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Packaging-Trends-Analysis-Roots-300x192.webp 300w\" sizes=\"auto, (max-width: 672px) 100vw, 672px\" \/><\/figure>\n<\/div>\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Specifically for extractables and leachables testing, 100+ companies, spread across the globe, are actively providing services to identify their presence across various drugs \/ devices<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The <a href=\"https:\/\/www.rootsanalysis.com\/reports\/extractable-and-leachable-testing-market-2018-2028\/220.html\">extractables and leachables testing market<\/a> landscape features the presence of small, mid and large sized players, having the capabilities to test several product types using multiple analytical techniques<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>In order to achieve a competitive edge, companies have built sizeable portfolios, offering a wide range of testing services for pharmaceuticals, medical devices and container closures<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"672\" height=\"453\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Company-Benchmarking-Analysis-Roots.webp\" alt=\"Peer group benchmarking done for extractables and leachables service provider includes more than 100 companies as per Roots Analysis\" class=\"wp-image-17808\" style=\"object-fit:contain;width:800px;height:541px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Company-Benchmarking-Analysis-Roots.webp 672w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Company-Benchmarking-Analysis-Roots-300x202.webp 300w\" sizes=\"auto, (max-width: 672px) 100vw, 672px\" \/><\/figure>\n<\/div>\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The operations of such firms are closely regulated by elaborate guidelines laid down by regulatory authorities from across the globe, such as the USFDA, EMEA, and MHRA<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Driven by the evolution in the pharmaceutical industry, the US is currently the largest hub for analytical evaluation services including extractables and leachables testing<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"672\" height=\"444\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Testing-Geographical-Landscape-Roots.webp\" alt=\"North America dominates the geographical landscape of the service provides for extractables and leachables testing market in each of the segments - small, medium, large as per analysis done by Roots Analysis\" class=\"wp-image-19337\" style=\"object-fit:contain;width:800px;height:528px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Testing-Geographical-Landscape-Roots.webp 672w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Testing-Geographical-Landscape-Roots-300x198.webp 300w\" sizes=\"auto, (max-width: 672px) 100vw, 672px\" \/><\/figure>\n<\/div>\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Nearly 30 acquisitions took place between 2013 and 2018; this clearly indicates the rising interest amongst private \/ public entities in strengthening their foothold in this evolving domain<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"672\" height=\"428\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Recent-Acquisitions-Roots.webp\" alt=\"USA and Europe represents 39% of the intercontinental acquisitions which happened in the segment in five years between 2013-18 as per Roots Analysis\" class=\"wp-image-17809\" style=\"object-fit:contain;width:800px;height:509px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Recent-Acquisitions-Roots.webp 672w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Recent-Acquisitions-Roots-300x191.webp 300w\" sizes=\"auto, (max-width: 672px) 100vw, 672px\" \/><\/figure>\n<\/div>\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Given that regulators have made extractables and leachables testing a mandatory practice, the market is expected to grow at an annualized rate of 9.9% over the next decade<\/strong><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The opportunity is likely to be distributed across various device types and is driven by companies operating at varying scales in different geographical regions<\/strong><\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"672\" height=\"441\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Distributed-by-Device-Types-Roots.webp\" alt=\"As per the analysis done, the future market growth is spread across multiple device types, geography and company size\" class=\"wp-image-17810\" style=\"object-fit:contain;width:800px;height:526px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Distributed-by-Device-Types-Roots.webp 672w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Extractables-Leachables-Distributed-by-Device-Types-Roots-300x197.webp 300w\" sizes=\"auto, (max-width: 672px) 100vw, 672px\" \/><\/figure>\n<\/div>\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p class=\"wp-block-paragraph\">To learn more, please click <a href=\"https:\/\/www.rootsanalysis.com\/reports\/view_document\/extractables-and-leachables-testing-services-market-2018-2028\/220.html\">Extractables and Leachables Testing market<\/a>. For any queries \/ suggestions, please do not hesitate to contact us at <a href=\"mailto:sales@rootsanalysis.com\">sales@rootsanalysis.com<\/a>. You can also download the&nbsp;<a href=\"https:\/\/www.rootsanalysis.com\/reports\/220\/request-sample.html\">SAMPLE REPORT<\/a>&nbsp;on extractables testing by Roots Analysis.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Our Social Media Platform<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Web:&nbsp;<a href=\"https:\/\/www.rootsanalysis.com\/\">https:\/\/www.rootsanalysis.com\/<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">LinkedIn:&nbsp;<a href=\"https:\/\/in.linkedin.com\/company\/roots-analysis\">https:\/\/in.linkedin.com\/company\/roots-analysis<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Twitter:&nbsp;<a href=\"https:\/\/twitter.com\/RootsAnalysis\">https:\/\/twitter.com\/RootsAnalysis<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>During drug product manufacturing and fill \/ finish, it is important to consider not only the impurity profiles of the drugs, but also identify potential sources of contamination in the containers \/ packaging material used. due to high variability in the type of impurities (organic (volatile, non-volatile or semi- volatile compounds) or inorganic (metals or [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":19169,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[61,66],"tags":[238,239,218],"class_list":["post-9199","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-and-technology","category-pharmaceuticals","tag-extractables","tag-leachables","tag-service-providers"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Inside the Growing Business of E&amp;L Testing Services<\/title>\n<meta name=\"description\" content=\"According to Roots Analysis, the extractables and leachables testing market is expected to grow at an annualized rate of 9.9% 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