Single-use systems to drive E&L testing market growth

The global extractable and leachable (E&L) testing services market is projected to value $2.57 million by 2030, according to a report by ResearchAndMarkets. Between 2023 to 2030, this represents a CAGR of 15.13 percent, the authors stated.

The report shared that due to the key role of these services for single-use systems and finished formulations, many analytical techniques, “including UPLC, HPLC, Q-TOF, FTIR, accelerated solvent extraction, and GC-TEA, are used for extractable analysis”.

Market growth factors

Pharmaceutical extractable and leachable (E&L) testing services

The heightened and increasing demand for biopharmaceutical medicines has resulted in greater demand for E&L testing in drug safety, such as when mitigating cross-contamination risks, the report highlighted.

As part of this development, the authors noted that this has driven the growth of single-use systems. These systems facilitate faster, more flexible production and are a cost-effective solution. Crititically, they also enable a lower cross-contamination risk, enhancing patient safety.

With the developing precise and custom E&L testing solutions, these must meet regulatory requirements. This this demand is a factor in the expected expansion of this market, the research highlighted.

A predictor of future growth

The E&L testing services market in 2022

In 2022, container closure systems as a container type, accounted for 31 percent of the E&L testing services market, due to the long-term stability these systems offer, the report acknowledged.

Additionally, the authors covered the market share of drug product types within the E&L testing services market. They found that orally inhaled and nasal drug products had the highest share in the market in 2022. With “growing demand for novel drug delivery methods”, this rate was found to be 41.88 percent.

North America was leading the E&L testing services market with a revenue share of 43.71 percent in 2022. This was driven by the players in the market incorporating innovative technologies and biopharmaceuticals, the data found.

As the expansion of the biopharmaceutical industry has continued, in 2022, increased demand for vaccine production enabled the Asia Pacific region to witness “significant growth”, with a CAGR of 15.32 percent, the report added.

As such, the report predicted that E&L testing services will continue to “play a pivotal role in ensuring the safety and quality of healthcare products”, especially up to 2030.  

Companies in the market include Eurofins Scientific, WuXi AppTec, Merck KGaA and West Pharmaceutical Services, Inc.

Increasing efficacy in extractables and leachable testing