PUBLISHER: Grand View Research | PRODUCT CODE: 1362935
PUBLISHER: Grand View Research | PRODUCT CODE: 1362935
The global extractable and leachable testing services market size is expected to reach a value of USD 2.57 billion by 2030, according to a new report by Grand View Research, Inc.., exhibiting a CAGR of 15.13% from 2023 to 2030. The market is expanding due to several factors, including the rising demand for biopharmaceuticals and the increasing concern about cross-contamination and patient safety. E&L testing ensures the identification of potential sources of contamination and helps in delivering safe and compatible drug products.
The significant growth in bioprocess engineering innovations has driven notable advancements in single-use systems. The increased adoption of biopharmaceuticals has further fueled progress in this field. Additionally, a growing number of studies evaluating the efficacy of single-use bioprocesses are raising awareness about these technologies. Single-use systems offer numerous advantages, including reduced risk of cross-contamination, faster turnaround times, cost-effectiveness, and greater flexibility in adjusting production volumes. Thus, the rising demand for single-use systems is anticipated to propel the growth of the market over the period of time.
Furthermore, the evolving regulatory norms have created significant demand for E&L testing capabilities to analyze healthcare products. This encouraged E&L testing service providers to develop precise and custom testing solutions. For instance, in November 2022, Smithers organized the Europe E&L conference in Germany. The company has been organizing such events past 15 years. These conferences focus on the growing importance of E&L testing and updates about dynamic regulations for E&L testing. Thus, such initiatives are anticipated to fuel the growth of the market over the forecast period.
The leachable and extractable testing services are crucial in identifying foreign substances in single-use systems and finished formulations that could potentially impact human health. However, these services are complex and subject to change due to factors like evolving regulatory requirements, diverse product types, various analytical techniques, and result variations. Service providers must navigate these variables appropriately. For instance, a wide range of analytical techniques, including UPLC, HPLC, Q-TOF, FTIR, accelerated solvent extraction, and GC-TEA, are used for extractable analysis. Selecting the right analytical techniques for specific product types can be a challenging and intricate task.