In the typical scenario of a drug discovery, development cycle and manufacturing, stability studies play a crucial role in validating the sustainability of the drug substance or the drug product when exposed to varied temperatures and storage conditions. The studies offer much-needed information on the product’s shelf life, the appropriate storage requirements along with the packaging essentials. These specifics are extremely critical as they directly influence the product performance in the market. These specifics of the product determine its quality which is assessed through a rigorous set of procedures and analysis.
It is mandatory as per regulations to have representative stability data for product approval and granting of marketing authorization. Studies performed during the product registration process are often referred to as Registration stability. Regulators also expect that the product stability is monitored during the product life cycle by placing representative batches of marketed product on stability.
As per a 2017 Frost & Sullivan report*1, the pharmaceutical stability testing market witnessed a revenue of $1.26 billion in 2015, globally. It is expected that by 2020 it will peak $1.97 billion growing at the CAGR of 9.4%. The report further states that the globalisation of small and large molecule drug manufacturers, new approval applications and consolidation are driving the market towards the next phase of immense growth. One of the key trends identified in that organizations prefer to collaborate with CROs to get end (from development to obtaining marketing authorization) and in turn saving of costs related to infrastructure and other resources.
The surge in new and generic product development has augmented the need for stability testing. Globalisation has increased the reach of distribution of drug products thereby making it a necessity to undergo stricter stability studies that take into account various climatic considerations. Further, conducting a stability study is a daunting activity and usually lasts anywhere between 2 to 5 years. This becomes even more challenging if the substances or formulations developed are less stable by nature. In such cases innovative technology and methods need to be employed for producing and testing the end products.
*1 Global Pharmaceutical Stability Testing Market Trends, Opportunities and Future, Frost & Sullivan, January, 2017