Extractables and Leachables Testing: Emerging Opportunities
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.
Over time, pharmaceutical contract manufacturers have established suitable packaging / other processes to ensure that their products are free from chemical impurities
Specifically for extractables and leachables testing, 100+ companies, spread across the globe, are actively providing services to identify their presence across various drugs / devices
The extractables and leachables testing market landscape features the presence of small, mid and large sized players, having the capabilities to test several product types using multiple analytical techniques
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
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
Driven by the evolution in the pharmaceutical industry, the US is currently the largest hub for analytical evaluation services including extractables and leachables testing
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
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
The opportunity is likely to be distributed across various device types and is driven by companies operating at varying scales in different geographical regions
To learn more, please click Extractables and Leachables Testing market. For any queries / suggestions, please do not hesitate to contact us at sales@rootsanalysis.com. You can also download the SAMPLE REPORT on extractables testing by Roots Analysis.
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Arun_Gupta
Arun is an enthusiastic professional and has been associated with Roots Analysis since the very early years. He has led multifaceted roles over the years be it business research, consulting, competitive intelligence, IT & technology, sales and marketing. He currently drives strategic thinking and execution within the sales and marketing domain. With educational background in life sciences from Thapar University and digital marketing credentials from Indian School of Business, he has led a lot of critical initiatives at the organization. His background in life sciences has been one of the key reasons for quick understanding and implementation of customized marketing strategies. During his early years, he has led multiple consulting assignments for global clients ranging from competitive landscaping, deal structuring and preparing go-to-market strategy for his clients.