Medical R&D has been on the mission radar of the biopharmaceuticals realm since long, on the grounds of which protein A resins market has carved out an established space for itself in the overall healthcare & medical devices sphere. Thriving on the cusp of extensive research programs, severe chronic ailments seem to have found marginally viable treatment solutions via protein A resins. Having recognized the same and having identified the fact that the prevalence of such disorders is likely to increase in the years ahead, companies have been undertaking extensive research for conducting protein purification processes as well as protein separation techniques including filtration, chromatography, and precipitation. Validating the same is an incidence that occurred recently, when Teva, one of the most prominent protein A resins industry firms, announced that it has increased the lifespan of its Protein A resin, thereby lowering the costs of monoclonal antibody development. The company mentioned that with the deployment of the sterilization-in-place (SIP) and modified cleaning-in-place (CIP) processes has enabled it to raise the lifespan of its MabSelect SuRe Protein A resin to 150 monoclonal antibody production cycles from the initial 100. In consequence, this is likely to strengthen Teva’s product portfolio in protein A resins market while simultaneously encouraging industry players to periodically come up a range of highly innovative products.
A brief outline of agarose-based protein A resins market
As on today, it has been observed that major therapeutic antibodies are purified with agarose-based protein A resins, the impact of which has been felt across protein A resins industry. Indeed, one of the pivotal factors why agarose matrices are more popular than silica and organic polymer matrices is that the agarose protein A resins possess higher ligand binding stability and specificity.
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On the contrary, its counterparts demand rigid matrices of glass & organic polymers with excellent flow properties, thus limiting their applications. In consequence, agarose has emerged as a highly viable option – agarose matrices held a mammoth 80% of the protein A resins market share in 2015. In fact, estimates claim that agarose-based protein A resins industry size is expected to register a CAGR of 8.3% over 2016-2024.
Protein A resins market and the manufacture of monoclonal antibodies: Unveiling the connection
The development of monoclonal antibodies and the growth map of protein A resins market truly share a directly proportional relationship. As the demand for monoclonal antibodies to manage diseases such as rheumatoid arthritis and cancer witnesses an upsurge, the requirement of protein purification techniques is certain to increase simultaneously. Biopharmaceutical manufacturers have been constantly striving to improve mAb (monoclonal antibody) purification capacity, on the grounds of which protein A resins market giants have been on the uptake, bringing about a range of innovative resins. In 2013 for instance, Chugai Pharmaceutical, a pivotal player in Japan protein A resins industry, launched a new alkali-stable prototype Protein A resin that seemingly had the ability to fulfill the demand for an advanced, cost-efficient mAb purification technology.
Another recent instance validating the efforts of protein A resins market players in monoclonal antibody purification is that of GE Healthcare launching the MabSelect PrismA – a novel protein A chromatography resin that is alkaline-stable and will improve mAb capacity by 40%. Indeed, it is evident that mAb purification depicts extensive dependence on the quality of protein A. While it would be ambiguous to state if the manufacturing of monoclonal antibodies would be majorly impacted by the dynamics of protein A resins industry, it is certain that with the developments in protein A resin technology, the quality of mAb purification will witness an upsurge, encouraging scientists to expand their research spectrum on monoclonal antibodies. Vice-versa, the increasing R&D programs on mAbs is also certain to lucratively impel protein A resins market share.
A quick insight into the price trends of protein A resins industry
The competitive hierarchy of protein A resins market is inclusive of blue chip healthcare and biotech companies such as GenScript BioTech, Merck Millipore, Takara Bio, Tosoh Bioscience, Novasep, GE Healthcare, Danaher Corporation, Repligen, Purolite Life Sciences, Agarose Bead Technologies, Thermo Fisher Scientific, Sigma-Aldrich, Bio-Rad Laboratories, and Expedeon. These firms are tirelessly involved in brainstorming numerous methodologies to enhance the quality of protein purification techniques and lower the costs of protein A resins. Conventionally, these resins account for massive costs in mAb processing, especially for large feed streams that demand extensive labor and equipment and high downstream capacity. The efforts would seem to be worth it, solely in the event that all the clinical trial projects for protein A are successful. In order to address the cost issue, companies have been attempting to use less costly protein A in trials and a more efficient one designed for manufacturing, post the Phase I and II trials.
Analyzing the price trends of protein A resins market, it does seem that premium pricing is not exactly a major strategy adopted by companies to increase their ROI. Quite the contrary, myriad efforts are being made to lower the costs with regards to yield, cycles, resins, consumables, working capacity, elution pool volume, and more.
The impact of Protein A alternatives on Protein A resins market outlook
Given the exorbitant costs associated with protein A resins as well as the issues of ligand leaching and mechanical robustness, companies have been working toward developing suitable cost-efficient alternatives, which may prove detrimental for protein A resins market growth. GE Healthcare, in this regard, seems to have depicted quite some proactiveness in manufacturing alternate products. GE Healthcare Life Sciences has undertaken the investigation of complementary technologies such as aqueous two-phase separation and has even come up with alternative products such as protein A synthetic resins that depict lower affinity, non-specific adsorption, and selectivity. While alternatives may prove beneficial for the purification of next-gen biotherapeutics, they may potentially endanger the revenue graph of the core protein A resins industry in the ensuing years. However, it is imperative to note that in terms of capacity, operation, scaleup convenience, process development, and yield, protein A is much more beneficial and would lead to better process economy. Furthermore, the development of alternatives stands to bear the risks of process revalidation and changes, which may lead to financial losses instead of savings.
In essence, it can be inferred that despite the ongoing research to develop alternatives, protein A resins market is certain to continue depicting a lucrative growth graph in the forthcoming six years. Experts indeed, believe that while complementary technologies seem promising, they have not yet depicted sufficient aptitude to disrupt protein A resins industry trends. Aided by the convenience and efficient functionality exhibited by protein A resins in conjunction with the fact that resin manufacturers have been striving to bring about major enhancements in next-gen products, protein A resins market size is indeed likely to witness a massive upsurge by 2024.