Global Extractables and Leachables Testing Services Market: Overview
The testing of extractable and leachable materials is extremely important across protection of patients and majorly for regulatory documentation for establishments such as FDA and EMA. Additionally, the pharmaceutical sector has undergone a robust development for its betterment, the extractables and leachables plays a crucial role in the patient’s safety and drug product interaction.
The vast market research data included in the study is the result of extensive primary and secondary research activities. Surveys, personal interviews, and inputs from industry experts form the crux of primary research activities and data collected from trade journals, industry databases, and reputable paid sources form the basis of secondary research. The report also includes a detailed qualitative and quantitative analysis of the extractables and leachables testing services market, with the help of information collected from market participants operating across key sectors of the extractables and leachables testing services market value chain. A separate analysis of macro- and micro-economic aspects, regulations, and trends influencing the overall development of the extractables and leachables testing services market is also included in the report.
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Global Extractables and Leachables Testing Services Market: Notable Development
Some of the key players in the global extractables and leachables testing services market include ABC Laboratories, AbbVie, ACADIA Pharmaceuticals, Actelion Pharmaceuticals, Achaogen, Acrux, Boston Scientific, Bristol-Myers Squibb, Bracco Diagnostics, Bureau Veritas, Cambrex, Catalent Pharma Solutions, Cambridge Polymer Group, Capsugel, and Celgene. These key players are investing robust the research and development activities in order to offer advanced services.
Global Extractables and Leachables Testing Services Market: Drivers and Restraints
Harmful contaminants or chemicals from packaging and especially primary packaging have often shown contamination of pharmaceutical products. This may lead to create threatening and challenge to the safety for several patients using these products regularly. In 2010, one of the company McNeil Consumer Healthcare, recall more than 500 lots of Tylenol, Benadryl, Motrin, and Zyrtec. In this case, the chemical is potential carcinogen reacted with the outer packaging into the drug containers. These factors have restrained the growth of the healthcare market; however, in order to avoid these kind of mishaps, the players are adopting extractables and leachables testing services, which is likely to drive market growth.
Considering the aforementioned cases, it can be inferred that, 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. Extractable is the term used to refer to a compound that is extracted from the material used to fabricate closed container systems, in the presence of a particular solvent. On the other hand, leachables are substances that passively migrate into drug formulations from the container closure system used, upon direct contact with the product.
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Global Extractables and Leachables Testing Services Market: Geographical Analysis
Based on the region, the extractables and leachables testing services market is segmented into five parts such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Of these, North America is expected to dominate the global extractables and leachables testing services market owing to presence of numerous key players in the region.