Pharmaceutical Stability and Storage Services Market Witness High Growth Owing To Increased Need For Pharmaceutical Stability Testing

  • Ronak Shah
  • U.S.A
  • January 14, 2025

The pharmaceutical stability and storage services market is estimated to be valued at US$ 3.18 Bn in 2024 and is expected to exhibit a CAGR of 5.8% over the forecast period 2024- 2031, as highlighted in a new report published by Coherent Market Insights’The growth of the pharmaceutical stability and storage services market is majorly driven by the increasing requirement for pharmaceutical stability testing by regulatory authorities.

Drug manufacturers need to conduct stability testing as per the guidelines of International Council for Harmonization (ICH) and U.S. FDA to ensure safe clinical usage of drugs. Moreover, the growing complexity of drug formulations with introduction of novel drug delivery systems such as nanoparticles, liposomes etc. has propelled the need for advanced real-time stability testing facilities.

Key Market Trends:Real-time stability testing: Real-time stability testing enables early identification of drug degradation during clinical development to avoid late stage failures. Leading players are focusing on development of innovative real-time stability testing solutions such as Nanophoton RT-DSC by TA Instruments for simultaneous analysis of drug crystallinity, phase transitions and degradation kinetics.

Accelerated stability testing: Accelerated stability testing helps in faster evaluation of shelf-life at elevated temperatures as compared to long-term storage conditions. Contract research organizations are extensively utilizing accelerated stability testing combined with machine learning predictive modeling for early forecast of drug stability. This is expected to significantly reduce the time and costs associated with long-term stability studies.

Pharmaceutical Stability and Storage Services Market Opportunity: By Service Type Insights– The service type segment of the market includes stability storage, raw material storage, and finished drug storage. Stability storage dominates the segment with a revenue share of over 50% in 2024 due to the need for ensuring batch-to-batch consistency and drug stability over specific time intervals under various temperature and humidity conditions. Various regulatory agencies mandate testing of drug batches at pre-defined time intervals to ensure the efficacy and safety of drugs over their shelf life.

By Product Type Insights-Non-commercial and Commercial products are the key segments based on product type. The non-commercial segment accounts for the largest share of around 60% of the total market revenue due to the high demand for stability testing services from drug manufacturers during clinical trials. Regulatory approvals require comprehensive documentation of stability profiles of drug candidates under various conditions before approval and commercialization.

Key Market Takeaways

The pharmaceutical stability and storage services market is anticipated to witness a CAGR of 5.8% during the forecast period 2024-2031, owing to the stringent regulatory requirements for drug stability and quality compliance.

On the basis of service type, the stability storage segment is expected to hold a dominant position, accounting for over 50% market share owing to mandatory stability testing requirements.

On the basis of product type, the non-commercial segment dominates with a 60% market share due to higher outsourcing of stability testing services by pharma companies during drug development and clinical trial phases.

By region, North America is expected to hold a dominant position over the forecast period, owing to presence of major contract service providers and stringent regulatory norms mandating drug stability programs by the FDA.

Competitor Insights:Key players operating in the pharmaceutical stability and storage services market include Intertek Group Plc., Alloga, and Labor Dr. Merk. These players are focusing on geographical expansion and diversification of service portfolios.

Recent Developments: In November 2023, temperature monitoring specialist SwiftSense launched SwiftCloud – a cloud-based software platform that allows remote management of wireless loggers. The platform generates predictive alerts, analyzes environmental variations and integrates with LIMS systems. The growing use of IoT, AI and automation is allowing stakeholders to remotely track products across the temperature-controlled supply chain with high accuracy. More information in full report.

Summary

TDS NEWS