Protein A Resin Market
The global protein A resin market in terms of revenue was estimated to be worth $1.2 billion in 2023 and is poised to reach $2.1 billion by 2030, growing at a CAGR of 9.8% from 2023 to 2030The new research study includes a market industry trend analysis. The new study report covers industry trends, price analysis, patent analysis, conference and webinar materials, important stakeholders, and market purchasing behaviour. Rising R&D expenditure in the pharmaceutical sector, as well as growing demand for protein modified products utilised in vaccine and therapy development, are driving market growth.
Protein A resin Market Dynamics
Driver: Increasing demand for therapeutic antibodies
The purification of monoclonal antibodies (mAbs) requires the use of chromatography. The need for monoclonal antibodies in cancer and numerous other therapeutic areas, including neurological, autoimmune, and inflammatory illnesses, has skyrocketed during the last decade. As a result, practically all major pharmaceutical firms are focusing on therapeutic antibody research and development.
During the purification of monoclonal antibodies, anionic impurities, such as nucleic acids and endotoxins, are removed by chromatography. In drug discovery applications, this process consumes a large number of resins, since the use 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 over the forecast period. In June 2020, the UK Medicines and Healthcare Products Regulatory Agency predicted that new regulations would come into force in 2023. Products already marked for compliance, either UKCA or CE, will be able to remain on the market after the entry into force of the regulations.
Restraint: High cost of resins
Protein A resins cost about 5-10 times more than other types of resins. Although there are no alternative techniques that can achieve such high levels of purification as protein A resins, their high cost drives end users to seek alternatives. Some of the techniques that provide acceptable levels of purification include both chromatographic and non-chromatographic methods. Crystallization and precipitation of mAbs by polyethylene glycol (PEG) precipitation are being explored as alternatives to protein A chromatography.
The impact of this restraining factor is most evident in emerging markets such as Asia-Pacific and Latin America. However, with new players entering the market, the cost of protein A resins is expected to drop significantly. Growing pressure on major market players is expected to lead to lower prices as smaller market entrants are offering resins at much lower prices while simultaneously offering comparable product quality.
Opportunity: Increasing number of CMOs and CROs
A growing number of CMOs and CROs are providing services to pharmaceutical businesses all around the world. During the projected period, this is likely to provide significant growth prospects for protein A resin makers.
Pharmaceutical companies are increasingly relying on contract manufacturers to provide a wide range of fundamental needs, including specific expertise and cost savings. The pharmaceutical contract manufacturing industry has expanded quickly in recent years, and this trend is expected to continue. Rising government pressure to reduce healthcare costs, along with declining R&D efficiency, has driven core pharmaceutical corporations to rely on contract manufacturing. Furthermore, rising generic drug demand in China and India is propelling CMO sales.
The biosimilars market is predicted to expand the fastest in the biologics industry. During the projected period, the patent expiration of blockbuster biologics is likely to drive a number of firms to invest in biosimilars. Chromatography is one of the most important bioseparation methods utilised in the production of biosimilar antibodies. As a result of the increased demand for biosimilars, it is expected that the usage of chromatographic resins would expand throughout the projection period.
Biosimilars are biologic drugs that are similar to but not the same as their reference biologic medicine. They are manufactured using the same method as the reference medicine and must meet the same high criteria of safety, effectiveness, and quality.
Biosimilars are now licenced for the treatment of a number of chronic diseases, including:
Cancer
Arthritis rheumatoid
Infectious illnesses
Psoriasis
Anemia
Kidney failure
Diabetes Types I and II
Osteoporosis after menopause
Hormonal imbalances
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Biosimilars: A new treatment option for chronic disorders
Biosimilars are a type of biologic drug that are similar to, but not identical to, their reference biologic drug. They are made using the same manufacturing process as the reference drug, and they are held to the same high standards of safety, efficacy, and quality.
Biosimilars are currently approved to treat a variety of chronic disorders, including:
- Cancer
- Rheumatoid arthritis
- Infectious diseases
- Psoriasis
- Anemia
- Kidney failure
- Type I and Type II diabetes
- Post-menopausal osteoporosis
- Hormonal disorders
In addition to these approved indications, biosimilars are being developed for other chronic disorders, such as:
- Meningitis
- Breast cancer
- Adult T-cell leukemia
- Obesity
- Hypertension
- Hepatitis E
Biosimilars offer a number of potential benefits over traditional biologic drugs, including:
- Lower cost
- Increased availability
- Similar safety and efficacy
As biosimilars continue to be developed and approved, they are expected to play an increasingly important role in the treatment of chronic disorders.
Here are some additional details about the potential benefits of biosimilars:
- Lower cost: Biosimilars are typically priced lower than their reference biologic drugs. This is because biosimilars do not require the same level of investment in research and development as traditional biologic drugs.
- Increased availability: Biosimilars can help to increase the availability of biologic drugs. This is because biosimilars can be manufactured by multiple companies, which can help to increase competition and drive down prices.
- Similar safety and efficacy: Biosimilars have been shown to be safe and effective, and they are held to the same high standards of safety, efficacy, and quality as their reference biologic drugs.
If you are considering treatment with a biosimilar, it is important to talk to your doctor about the potential benefits and risks.
Many of today's best-selling medications will lose patent protection in the future years, as did most early biologic drugs in the early twentieth century. This opens up new avenues for biosimilar medications. The patent for Vyrologix (Leronlimab), which is used to treat cancer, COVID-19, HIV, and cancer, will expire in the United States in 2020. This is anticipated to open up major prospects in the United States and Europe for lower-cost Vyrologixbiosimilars.
Challenge: Issues associated with scaling up production of protein A resins
Protein manufacturing The production of resins is a multi-step process that includes fermentation, extraction, purification, and packaging. Scaling up production to meet rising demand necessitates careful planning and management to assure consistency and quality throughout the manufacturing process.
When the production process is scaled up, the quality and consistency of the resin might vary. Variability can be caused by a variety of factors, including changes in the source material, equipment, and personnel. Maintaining uniformity in the production process is critical to ensuring the end product's quality.
By product, the agarose-based protein A resin segment of global protein A resin market, accounted for the largest share during the forecast period.
The market is divided into three product categories: agarose-based protein A resin, glass/silica-based protein A resin, and organic polymer-based protein A resin. The agarose-based protein A resin group has the biggest market share. Protein Agarose resins offer improved durability, mechanical toughness, and the capacity to include metal dopant absorption at appropriate pH levels.
By type, the recombinant protein A resin segment of protein A resin market, accounted for the largest share during the forecast period.
The market is divided into two types: recombinant and natural protein A resin. The recombinant protein A resin category has the biggest market share. Recombinant protein resins are in high demand in the pharmaceutical business due to technical advancements in the drug discovery process. This is because they provide more focused binding capacity, which is projected to drive segment growth throughout 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.
The market is divided into two sections based on application. The protein A resin is classified into two applications: antibody purification and immunoprecipitation. During the projected period, the antibody purification segment is predicted to increase significantly. Immunoprecipitation applications have advanced in the R&D sector thanks to the biopharmaceutical and biotechnology sectors, which will lead to considerable growth and domination in the industry in the next years.
By End User, pharmaceutical & biopharmaceutical companies’ segment of protein A resin market to grow at the fastest rate during the forecast period.
Pharmaceutical and biopharmaceutical companies, academic and research organisations, and other end users comprise the global market. Pharmaceutical and biopharmaceutical companies have aided in the expansion of immunoprecipitation applications in the R&D industry, resulting in significant market growth and dominance in the coming years. Furthermore, the predicted revenue growth of this sector is tied to the rapid global expansion of the biopharmaceutical industry and technological advancements in the pharmaceutical and biotechnology sectors.
North America is expected to be the largest region of the global protein A resin market during the forecast period.
North America, which includes the United States and Canada, accounted for the largest share of the global market. This region is seeing a surge in demand for protein-based medicines to combat infectious diseases, which is worsened by the region's growing number of FDA-approved pharmaceutical and biotechnology companies.
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, Agilent Technologies joined with Delaware State University (DSU) as part of its humanitarian initiatives through the Agilent Foundation to increase the number of minority students pursuing STEM jobs.
- Tosoh Biosciences LLC completed the purchase of Semba Biosciences in October 2021, a privately held leading pioneer in the field of multi-column chromatography (MCC) instruments and technology for biologics downstream purification.
- Repligen and Navigo completed co-development of a new affinity ligand that tackles aggregation concerns associated with pH-sensitive antibodies and Fc-fusion proteins in September 2021. NGL-Impact HipH is manufactured and provided to Purolite for use in a platform utilisation resin product.
In May 2021, Danaher Corporation purchased GE Healthcare's Life Sciences unit and renamed it as Cytiva.