Pharmaceutical Stability And Storage Services Market is driven by Regulatory Mandates

These services are vital for drugs and biologics at various stages of development to ensure stability profiles comply with regulatory standards prior to commercialization. There is a need to establish shelf life of pharmaceutical products along with storage, transportation, and distribution conditions which calls for testing under various climatic zones and temperatures over durations.

The Global 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 to 2031.

Key Takeaways

Key players operating in the Pharmaceutical Stability And Storage Services Market Size are Intertek Group plc, Eurofins Scientific, SGS Société Générale de Surveillance SA., Q Laboratories, BioLife Solutions Inc., Cencora, Inc., Alloga, PCI Pharma Services, Pharmaserv GmbH, Catalent, Inc, Almac Group, Charles River Laboratories, Lucideon, Alcami Corporation, Element Materials Technology, Nelson Laboratories, LLC, ALS. The growing demand from pharmaceutical and biotech companies for stability testing and storage services to comply with stringent regulations is a key factor driving growth. Several companies are expanding their global footprint by opening new facilities across regions to support clients with clinical trials and commercial product storage and testing needs.

The demand for pharmaceutical stability and storage services is growing significantly owing to rising requirement from pharmaceutical companies to establish expiry and shelf life for drugs. Stringent regulations established by authorities such as FDA, ICH and EMA have increased the need to conduct stability studies as per defined protocols. Furthermore, the ongoing COVID-19 pandemic has further accelerated stability testing needs for vaccines and therapeutics.

Market drivers

Regulatory mandates established by authorities are a major driver for the pharmaceutical stability and storage services market. Stringent guidelines by FDA, EMA, and ICH regarding long-term and accelerated stability testing, container-closure evaluation, and photo-stability testing have compelled pharmaceutical companies to outsource such specialized testing. Additionally, the demand for sample receiving, logging, transportation and storage services is driven by the need to comply with distribution, import/export and cGMP regulations. Growing R&D investments into biologics development will also necessitate reliable storage and testing partners.

Impact of geopolitical situation on the Pharmaceutical Stability And Storage Services market growth:

The current geopolitical tensions and conflicts around the world are negatively impacting the Pharmaceutical Stability And Storage Services market growth. The ongoing Russia-Ukraine war has disrupted supply chains and logistics while increasing costs of raw materials and transportation. This has made stability testing and storage of pharmaceutical products more challenging and expensive. Growing tensions between major global powers are also making international cooperation in healthcare more difficult. At the same time, the trend towards localization of drug manufacturing to ensure supply security is boosting demand for stability testing and storage facilities within regions. However, managing different regulatory standards across territories remains a major hurdle. To sustain growth, service providers will need to establish localized testing infrastructure as well as forge new partnerships to ensure supply continuity despite geopolitical pressures. Diversifying supply networks across friendly nations can help mitigate risks from future conflicts or trade disputes.