Most antibody drugs treat cancer and autoimmune diseases, and many of the rest are used to treat orphan and infectious diseases. Unfortunately, antibodies are complex proteins in many ways, which complicates their purification and characterization, making it difficult for their developers to meet the rigid requirements for therapeutics.
Process development scientists, faced with an increasing number of proteins or complex biomolecules, continuously search for robust purification methods that can be rapidly scaled for manufacturing. Several chromatography resins may be suitable for a given separation; however, specific physiochemical differences among resins can impact their performance, affecting purity and yield. Therefore, resin selection is critical for optimization of the purification process.
Protein A resins are the most frequently used affinity resins in biomanufacturing. Protein A chromatography is a very efficient purification procedure and is used as a capture step due to its specificity. Depending on the intended use for the target molecule (antibodies for diagnostic testing) Protein A capturing could be the sole chromatographic step required to achieve adequate product purity.
Protein A is a bacterial cell wall protein outlying from Staphylococcus aureus that combine to mammalian mainly through Fc regions. Protein A is a 42-kDa protein anchored in the cell wall of Staphylococcus aureus with the ability to selectively interact with immunoglobulins (IgGs). It binds strongly to all classes of human IgGs except for IgG3. The dynamic binding capacity will vary depending on certain factors such as flow rate, target antibody, etc.
Full-length protein A consists of five homologous domains (referred to as E, D, A, B, and C, in order of their arrangement from the N-terminus) and one cell-wall– associated domain. At first, protein A was produced by culturing the Cowan strain of S. aureus and extracting the protein from the bacterial cell walls. Later, a strain of S. aureus was discovered that secreted protein A into its culture supernatant. As recombinant DNA technology advanced, protein A could be expressed as a fragment without its cell-wall domain using Escherichia coli as an expression host.
However, protein A is expensive (with costs an order of magnitude over conventional chromatography resins), susceptible to degradation by proteases (cleaved domains can adhere to a MAb product, complicating separations), and not fully stable to column washing and elution conditions. It can generate an immunomodulation response and has limited capacity to accommodate the increasingly high titers found in modern upstream feeds.
Since 1990 the adoption of protein A resins has rapidly increased with increasing clinical trials. Owing to its several advantages, protein A affinity chromatography has been used widely for monoclonal antibody products purification.
Global Protein A Resin Market was valued at USD 1.2 billion in 2021 and it is anticipated to grow up to USD 3.0 billion by 2031, at a CAGR of 9.6% during the forecast period.
Biopharmaceutical industry are extensively using protein engineered products in their research activities to develop broad range of protein-based drugs.
Growing investment in synthetic biology and increasing focus on drug development by biotechnology and pharmaceutical companies will propel the industry’s growth. The biopharmaceutical industry is broadly using protein-engineered products in their research activities to develop a broad range of protein-based drugs.
Protein A resins are the most frequently used affinity resins in biomanufacturing. Because of the high selectivity and affinity of protein A resins, 99 percent purity can be gained in the most generic form. Therefore, rising use of chromatography in drug discovery and research industry will propel the market growth over the forecasted time period.
With better treatment options with the help of immunotherapy, the adoption will also surge. The rise in the market can mainly be attributed to elements such as demand for pre-packed disposable columns, increasing demand for therapeutic antibodies, and increasing pharmaceutical R&D spending.
With increasing demand of therapeutic antibodies, protein A resins market will witness significant growth. It is mainly used for chromatography technique for detection of vitamins and additives in the food. Protein A has been used for capturing monoclonal antibodies in most of the legal product submissions.
Increasing demand of monoclonal antibodies (mAb) globally for the better treatment of chronic diseases and increasing number of pharmaceutical and biotechnology companies will boost the overall protein A resins industry growth.
Market Restraints and Challenges
High cost of resins may impede the market growth. Protein A resins cost around 5-10 times more than other types of resins. Though there are no alternative techniques that can achieve purification levels as high as protein A resins, their high cost makes end users look for alternatives. Some of the techniques that provide acceptable levels of purification include both chromatography and non-chromatography methods. mAb crystallization and precipitation by polyethylene glycol (PEG) precipitation are being explored as alternatives for protein A chromatography. The impact of this restraining factor is more evident in emerging markets such as APAC and Latin America. However, with the entry of new market players, the cost of protein A resins is expected to come down significantly. The increasing pressure on major market players is expected to result in price reduction, as small market entrants are offering resins at far lower prices, while simultaneously offering comparable product quality.
Protein A Resin Market, By Product
• Agarose-Based Protein A
• Glass/Silica-Based Protein A
• Organic Polymer-Based Protein A
Based on Product, The market is bifurcated into Agarose-Based, Glass/Silica-Based and Organic Polymer-Based Protein A on the basis of Type. The agarose-based protein A segment is holding the largest share of the Protein A Resin Market. Owing to its big gelling strength at low concentrations, anti-convection medium for, suitable pH range, gel electrophoresis and superior mechanical strength, this segment expected a significant growth in the upcoming years.
Protein A Resin Market, By Type
• Recombinant Protein A
• Natural Protein A
Based on Type, The market is bifurcated into Recombinant and Natural Protein A on the basis of Type. In today’s market Recombinant Protein, A holds the big share. Recombinant protein A is majorly used to upgrade solubility and to normalize the sensitivity of alkaline solutions. With the rising pharmaceuticals industry and expanding technological advancements in new drug development, the segment will grow at a significant rate. Natural protein A is derived from a bacterial cell of the staphylococcus aureus species and mainly used in the purification of monoclonal antibodies.
Protein A Resin Market, By Application
The market is bifurcated into Antibodies Purification and Immunoprecipitation on the basis of Application.
Immunoprecipitation segment held around USD 29 million revenue in 2019. IP is used for isolation of specific protein from complex mixtures such as tissue homogenate, blood sample and cell lysate. Immunoprecipitation (IP) is a small-scale enrichment of proteins. The process of IP is relatively easy and fast in comparison other chromatography techniques. Moreover, for the removal of immune complexes formed between an antigen and its specific antibody, protein A resins play a vital role. Thus, with wide application of immunoprecipitation in research and development sector, the segment will witness substantial growth.
The significance of antibody purification is constantly increasing owing to the achievement of fine grade purity of antibodies. Moreover, broad use of chromatography, technological advancements, and practical uses of antibody purification will increase its preference over immunoprecipitation.
Global Protein A Resin Market by End-use
Based on end-use, it is segmented into biopharmaceutical companies, clinical research laboratories, academic research institutes and contract research organizations. The biopharmaceutical companies segment dominated the market in 2021. Due to rising prevalence of various chronic diseases and increasing demand of better treatment methods, biopharmaceutical industry will foresee high demand for protein A resins. Increasing demand for protein engineering with various advancements will further boost segmental growth. Growing application in chromatography in biopharmaceutical industry will also provide substantial segment growth.
Protein A Resin Market, By Geography
On the basis of Regional Analysis, The Global Protein A Resin Market is classified into North America, Europe, Asia Pacific, and Rest of the world. North America expected a significant growth in the Protein A Resin Market owing to the rising demand for pharmaceuticals and biopharmaceuticals and the presence of major market players constantly investing in research and development activities in North America expected to fuel the Protein A Resin Market.
North America is the largest regional market in protein A resin market. Regional growth is mainly attributed to presence of major market players constantly investing into research and development activities. Furthermore, rising prevalence of autoimmune and orphan diseases and increasing demand of better treatment methods will boost the regional market growth in the region. Presence of major industry players in the U.S. and increasing incidence of chronic diseases will favor the U.S. protein A resins market growth. Moreover, growing demand of technologically advanced products in this country will highly impact the market growth. Furthermore, increasing drug delivery and development will offer positive market growth in the country.
The key players in the market are Agilent Technologies, GenScript Biotech Corporation, GE Healthcare (US), Merck Millipore (Germany), Novasep Holding SAS, PerkinElmer, Purolite Corporation, Repligen Corporation (US), Thermo Fisher Scientific (US), Tosoh Bioscience (Japan), Purolite Corporation (US), Novasep Holding SAS (France), Agilent Technologies (US), GenScript Biotech Corporation (China), and PerkinElmer (US) among others.