The pharmaceutical stability and storage services market involves stability testing services, sample storage, raw material storage, drug substance storage, and packaging material storage services. Stability testing protocol determines a product’s shelf life by assessing factors such as appearance, package integrity, potency, purity, and degradation. The pharmaceutical stability and storage services help manufacturers ensure safety and efficacy of drugs until their expiry date, in accordance with stringent regulatory guidelines.
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 Growth 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 rising demand for outsourcing stability studies and storage facilities to specialty CROs and CMOs has been boosting market growth. Technological advancements in stability chambers, analytical instrumentation, and customized sample management software have increased efficacy and efficiency of stability testing and sample storage services.
Market trends
The market is witnessing higher adoption of real-time stability monitoring, a technique that uses innovative technologies like NIR, Raman, and UV spectroscopy to continuously track drug substance and product degradation. This has enabled early detection of changes and provided better understanding of degradation kinetics. Another ongoing trend is automation of stability testing through development of integrated analytical systems, robotic sampling and liquid handling platforms to boost productivity and meet stricter regulations.
Market Opportunities
One major opportunity lies in emerging markets where the need to meet stringent drug regulations is mounting manufacturing capacities. Growing biosimilars market will also drive market opportunities as these products require elaborate stability testing programs. Expanding applications of cell and gene therapies also present bright prospects. Latest techniques like continuous monitoring of samples using smart sensors promises lucrative scope.
The COVID-19 pandemic has significantly impacted the growth of the pharmaceutical stability and storage services market. There was surge in demand for various drugs including antiviral drugs, antibiotics, analgesics during the onset of pandemic in early 2020. However, pharmaceutical companies faced challenges in drug stability and shelf-life testing due to lockdowns and supply chain disruptions. This delayed the development and launch of new drugs. Post-COVID, the demand increased further for stability testing and storage of COVID vaccines.
The European region accounted for the largest share in the pharmaceutical stability and storage services market in terms of value prior to COVID-19 pandemic due to presence of largest pharmaceutical companies and stringent regulations regarding drug stability. However, Asia Pacific region is expected to witness fastest growth post-pandemic. Countries like India and China has emerged as global manufacturing hubs and exporters of generic drugs. Therefore, drug makers are outsourcing stability testing and commercial material storage to Asia Pacific countries to reduce costs. Governments in Asia Pacific are also supporting local pharmaceutical industries through incentives and investments in technology and infrastructure.
To sustain growth in future, pharmaceutical companies need to undertake measures like expanding regional stability testing facilities, investments in continuous monitoring technologies, establishment of regional vaccine banks and supply chain collaborations. Outsourcing of stability studies to compliant third-party service providers can also help companies launch products faster while ensuring quality and adherence to regulatory guidelines. Digitalization of stability data management and remote monitoring of storage facilities will further aid business continuity.
The geographical region where the pharmaceutical stability and storage services market in terms of value was concentrated prior to the COVID-19 pandemic was Europe. Several factors contributed to Europe accounting for the largest share of the market, including the presence of some of the largest pharmaceutical companies in the world. stringent regulations surrounding drug stability testing and storage, as well as a well-established pharmaceutical industry overall.
However, the fastest growing region for the pharmaceutical stability and storage services market in the post-COVID era is expected to be Asia Pacific. Several Asian countries such as India and China have emerged as major global exporters and manufacturing hubs for generic drugs. To reduce costs, many drugmakers are increasingly outsourcing stability testing and commercial drug material storage to Asia Pacific nations. Additionally, governments across Asia Pacific are actively supporting the growth of their domestic pharmaceutical industries through incentives, investments in infrastructure and technology, and other initiatives. These factors are fueling the rapid market expansion in the Asia Pacific region.
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