CHROMATOGRAPHY DATA SYSTEM MARKET ANALYSIS

Market Challenges And Opportunities

Chromatography Data System Market Drivers

Addition of new features in the existing CDS, to enhance user interface is expected to boost growth of the chromatography data system market. For instance, Data Apex, a chromatography software development company, in July 2018, launched Clarity version 8.0. Chromatography Software, which has advanced features such as excellent performance, cost-effectiveness, and proficient technical support.

Chromatography Data System Market Restraint

Data integrity violations, enforcements, and criminal investigations of companies during audit by U.S. Food and Drug Administration (USFDA) and failure to meet Current Good Manufacturing Practices (CGMP) by companies is expected to hamper growth of the chromatography data system market. For instance, in January 2016, USFDA sent warning letter to Ipca Laboratories Limited for manipulating the processing parameters used for CDS, in order to obtain approvals for its drug products.

Furthermore, in June 2016, SEKISUI MEDICAL CO., LTD., a Japan-based firm, failed to clear the USFDA and Department of Health and Human Services inspection, due to manipulation in the chromatography data by deleting failed chromatograms, absence of raw data back-up, and nonfunctional CDS.