Protein stability analysis involves studying the physical and chemical stability of protein therapeutics during development and storage. Proteins can undergo various degradations such as aggregation, fragmentation, deamidation, and oxidation when exposed to stress conditions like heat, light, and freeze-thaw cycles. This affects the safety, efficacy, and shelf life of protein drugs. Protein stability analysis helps evaluate the conformational changes in proteins under various conditions and identify the degradants to optimize formulation and storage parameters. The results aid in developing protein biologics with enhanced stability profiles. Various analytical techniques like differential scanning calorimetry, light scattering, and chromatography are utilized for stability indication and characterization.. With growing biologics revenues, protein stability analysis market is expected to expand significantly in the near future. The market is also influenced by the increasing number of recombinant protein therapeutics and biologics, as well as the need for more accurate and reliable methods to assess protein stability.
Market Dynamics:
The protein stability analysis market is driven by the rising demand for biologics and their growing contribution to the pharmaceutical pipeline. Biologics development requires extensive stability testing during various stages from pre-clinical to commercialization. Regulatory mandates from authorities like Food and Drug Administration (FDA) for stability testing and assignment of expiration dates fuels the market growth. However, high costs that are associated with analytical equipment and assay development poses a challenges. Meanwhile, outsourcing of stability studies to contract research organizations presents opportunities for market players. Also, automation and advanced techniques for high-throughput stability screening will further support the market expansion going forward.
Key features of the study:
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