Protein stability analysis helps ensure the safety and efficacy of protein-based drugs and plays a vital role in pharmaceutical R&D. Protein stability analysis involves assessing how external factors like temperature, mechanical stress and storage duration impact the structure and function of proteins. This helps determine a drug's shelf life, optimal storage conditions and compatibility with drug delivery systems. The growing number of biologics and complex generics in pharmaceutical pipelines has increased the demand for protein stability analysis.
The Global Protein Stability Analysis Market is estimated to be valued at US$ 2.43 BN in 2024 and is expected to exhibit a CAGR of 11% over the forecast period 2024 to 2031.
Key Takeaways
Key players operating in the Protein Stability Analysis Market Size are Thermo Fisher Scientific, Inc., Enzo Biochem, Inc., PerkinElmer Inc., NanoTemper, GE Healthcare, HORIBA, Ltd., Malvern Panalytical Ltd., Agilent Technologies, Inc., SETARAM Instrumentation, Unchained Labs, Waters Corporation, and Applied Photophysics Ltd. Thermo Fisher and Waters hold a major share owing to their diverse product portfolio.
The growing pipeline of protein drugs and biologics is a major driver of demand for protein stability analysis technologies and services. Biologics now account for over 30% of new drug approvals and the biopharma industry requires stability assessment throughout the drug development life cycle.
Technological advancements like auto-sampling, High Throughput Screening (HTS), label-free detection and Cloud analytics are helping analyze a large number of samples rapidly and cost-effectively. This is improving pharmaceutical R&D productivity.
Market Trends
Surface Plasmon Resonance (SPR) and microscale thermophoresis (MST) are gaining widespread adoption for their ability to provide fast, sensitive analysis of protein-protein and protein-ligand interactions under near-native conditions. This is enabling stability assessments at an early stage.
Automation is a key trend with vendors offering fully automated systems for analyzing unfolding/refolding kinetics, conformational changes and aggregation propensity using techniques such as DSC and DLS. This is boosting lab productivity and minimizing manual errors.
Market Opportunities
Outsourcing of protein stability testing to well-equipped contract service providers is growing among small biotech companies lacking specialized infrastructure. This is driving revenues for global CROs with stability testing capabilities.
The development of lab-on-a-chip and microfluidic platforms promises miniaturized, high-throughput stability assessment reducing sample volumes and costs. This could make routine stability screening more accessible.
Impact of COVID-19 on Protein Stability Analysis Market
The COVID-19 pandemic has significantly impacted the growth of the global protein stability analysis market. The imposition of lockdowns and social distancing norms across various countries led to disruptions in supply chain and logistics, adversely affecting market growth in 2020. Suppliers faced difficulties in delivering instruments and consumables to end-users such as pharmaceutical and biotechnology companies engaged in protein therapeutics development. Research activities in academia were also hampered due to restricted laboratory access during lockdowns. However, with the resumption of economic activities post lockdowns, the market is expected to recover and witness robust growth over the forecast period driven by rising investments in pharmaceutical R&D and new product development.
Geographically, North America holds the largest share of the protein stability analysis market in terms of value, owing to presence of major players and significant research expenditures in the region. The United States contributes maximum to the North American market owing to early availability of advanced technologies and robust biopharmaceutical industry in the country. On the other hand, Asia Pacific is poised to be the fastest growing regional market between 2024-2031. Countries such as China, India and South Korea are witnessing increased government funding and investments in life sciences research which is fueling market growth. In addition, availability of cheap skilled labor and raw materials is attracting outsourcing of protein stability analysis services to Asia Pacific.
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