September 25, 2018

Extractables and Leachables Testing: Emerging Opportunities for Service Providers

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 companies have established suitable packaging / other processes to ensure that their products are free from chemical impurities

Specifically for extractables and leachables, 100+ companies, spread across the globe, are actively providing services to identify their presence across various drugs / devices

The 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