Protein A Resin Market

Updated on : Aug 22, 2024

The global protein A resin market in terms of revenue was estimated to be worth $1.2 billion in 2022 and is poised to reach $2.1 billion by 2028, growing at a CAGR of 9.8% from 2022 to 2028 The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Growth of the market is attributed to the increased R&D investments in pharmaceutical industries, the growing demand for protein engineered products used in the development of vaccines and therapeutics.

Global protein A resin market Trends

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Protein A resin Market Dynamics

Driver: Increasing demand for therapeutic antibodies

Chromatography is an essential step in the purification of monoclonal antibodies (mAbs). Over the past decade, there has been a tremendous increase in the demand for monoclonal antibodies in oncology and several other therapeutic areas, including neurological, autoimmune, and inflammatory disorders. As a result, almost all major pharmaceutical companies are focusing on the R&D of therapeutic antibodies.

In the purification of monoclonal antibodies, anionic impurities, such as nucleic acids and endotoxins, are removed through chromatography. In drug discovery applications, this process consumes a large number of resins, as the usage is not limited to purification but also includes the study of the ionic interaction of molecules. Impurities such as albumin and transferrin are removed by size-exclusion chromatography (SEC). High levels of purification can be achieved through the use of protein A affinity resins. This is because antibodies selectively bind protein A ligands with the resins. This is expected to drive the demand for protein A resins during the forecast period. In June 2020, UK’s Medicines and Healthcare Products Regulatory Agency planned for new regulations to come into force in 2023. Products that already have conformity markings, either UKCA or CE, will be able to remain in the market after the regulations come into force.

Restraint: High cost of resins

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 the Asia Pacific 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.

Opportunity: Increasing number of CMOs and CROs

An increasing number of CMOs and CROs are offering their services to pharmaceutical companies across the globe. This is expected to offer potential growth opportunities to protein A resin manufacturers during the forecast period.

Pharmaceutical companies are increasingly relying on contract manufacturers in various areas of research to fulfill a number of basic needs, such as specialized competencies and cost reduction. The pharmaceutical contract manufacturing industry has experienced robust growth in recent years, and this trend is expected to continue in the coming years. The increasing pressure from several governments to reduce healthcare costs and declining R&D productivity have compelled core pharmaceutical producers to rely on contract manufacturing. Moreover, the rising demand for generic drugs in China and India is a key driver for CMO sales.

In the biologics sector, the biosimilars market is expected to witness the highest growth. The patent expiry of blockbuster biologics is expected to encourage a number of companies to invest in biosimilars during the forecast period. Chromatography is one of the key bioseparation techniques used in the manufacturing of biosimilar antibodies. The rising demand for biosimilars is thus estimated to increase the use of chromatography resins during the forecast period.

The currently available biosimilars are used to treat cancer, rheumatoid arthritis, infectious diseases, psoriasis, anemia, kidney failure, Type I and Type II diabetes, post-menopausal osteoporosis, and hormonal disorders. The key targeted therapeutic areas for which various biosimilars are in the pipeline include oncology, autoimmune disorders, diabetes, and hepatitis. Besides these, biosimilars can be developed for other chronic disorders, such as meningitis, breast cancer, adult T-cell leukemia, obesity, hypertension, and hepatitis E.

Most of the early biologic drugs lost their patent protection in the first half of the 20th century, while many of the current best-selling drugs will lose their patent protection in the coming years. This is creating new opportunities for biosimilar drugs. For instance, in 2020, the patent of Vyrologix (Leronlimab), prescribed in the treatment of cancer, COVID-19, HIV, and cancer, expired in the US. This is expected to create significant opportunities for lower-priced Vyrologix biosimilars in the US and Europe.

Challenge: Issues associated with scaling up production of protein A resins

The production of protein A resins is a complex process that involves many steps, including fermentation, extraction, purification, and packaging. Scaling up the production process to meet the growing demand requires careful planning and management to ensure consistency and quality throughout the production process.

Scaling up the production process can result in variability in the quality and consistency of the resin. Factors such as changes in the source material, equipment, and personnel can all contribute to this variability. Maintaining consistency in the manufacturing process is essential to ensure the quality of the final product.

By product, the agarose-based protein A resin segment of global protein A resin market, accounted for the largest share during the forecast period.

Based on product, the market is segmented into agarose-based protein A resin, glass/silica based protein a resin and organic polymer based protein A resin. The agarose based protein A resin segment accounts for the largest share of the market. Agarose-based protein A resins exhibit enhanced durability, greater mechanical robustness, and a superior capacity to incorporate metal dopant absorption at pH levels that are appropriate.

By type, the recombinant protein A resin segment of protein A resin market, accounted for the largest share during the forecast period.

Based on type, the market is segmented into recombinant and natural protein A resin. The recombinant protein A resin segment accounts for the largest share of the market. Due to its advanced technological improvements in the drug discovery process, there is a rising need for recombinant protein resins in the pharmaceutical industry. This is because they offer a more targeted binding capacity, which is expected to propel the growth of this segment during the forecast period.

By application type, the antibody purification segment of protein A resin market is expected to witness a significant growth during the forecast period.

Based on application, the market is segmented into Based on application, the protein A resin is segmented into antibody purification, immunoprecipitation. The antibody purification segment is expected to witness a significant growth during the forecast period. The biopharmaceutical and biotechnology industries have facilitated the advancement of immunoprecipitation applications in the R&D sector, leading to its significant growth and dominance in the industry in the upcoming years.

By End User, pharmaceutical & biopharmaceutical companies’ segment of protein A resin market to grow at the fastest rate during the forecast period.

Based on end user, the global market is segmented into pharmaceutical & biopharmaceutical companies, academic and research institutes, other end users. The pharmaceutical and biopharmaceutical companies have facilitated the advancement of immunoprecipitation applications in the R&D sector, leading to its significant growth and dominance in the industry in the upcoming years. Also, the anticipated revenue growth of this segment during the forecast period is attributed to the rapid expansion of the biopharmaceutical industry worldwide and the technological advancements in the pharmaceutical and biotechnology sectors.

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North America is expected to be the largest region of the global protein A resin market during the forecast period.

North America, comprising the US and Canada, held the largest share of the global market. This region is witnessing a surge in demand for protein-based therapeutics to combat infectious diseases, which is further amplified by the growing number of FDA-approved pharmaceutical and biotechnology companies in this region.

As of 2021, prominent players in the market are Danaher Corporation (US), Merck KGAa (Germany), Repligen Corporation (US), Thermo Fisher Scientific (US), Agilent Technologies (US),  GenScript (China), PerkinElmer Inc. (US), Bio-Rad Laboratories, Inc. (US), Orochem Technologies Inc. (US), Kaneka Corporation (Japan), Abcam Plc. (UK), Agarose Bead Technologies (US), and Avantor, Inc. (US), among others.

Protein A Resin Market Report Scope:

This report has segmented the global protein A resin market to forecast revenue and analyze trends in each of the following submarkets:

By product

• Agarose based protein A resin
• Glass/Silica based protein A resin
• Organic polymer based protein A resin

By Type

• Recombinant protein A resin
• Natural protein A resin

By Application

• Antibody Purification
• Immunoprecipitation

By end user

• Pharmaceutical and biopharmaceutical companies
• Academic Research institutes
• Other end users

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Rest of the World

Recent Developments

• In September 2022, As part of its charitable efforts through the Agilent Foundation, Agilent Technologies partnered with Delaware State University (DSU) to boost the number of minority students who choose STEM careers.
• In October 2021, Tosoh Biosciences LLC completed the acquisition of Semba Biosciences, a privately held leading innovator in the field of multi-column chromatography (MCC) instrumentation and technology for the downstream purification of biologics.
• In September 2021, Repligen and Navigo completed their co-development of a novel affinity ligand that addresses aggregation issues associated with pH-sensitive antibodies and Fc-fusion proteins. This ligand, NGL-Impact HipH, is produced and supplied to Purolite for use in a platform usage resin product.
• In May 2021, The Life Sciences business of GE Healthcare was acquired by Danaher Corporation and rebranded as Cytiva.

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