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

Pharma packaging trend analysis between 2014-2018 by prefilled or blister or pouches

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

Peer group benchmarking done for extractables and leachables service provider includes more than 100 companies as per Roots Analysis

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

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

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

USA and Europe represents 39% of the intercontinental acquisitions which happened in the segment in five years between 2013-18 as per Roots Analysis

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

As per the analysis done, the future market growth is spread across multiple device types, geography and company size

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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