Chromatography Resins

• Demand for chromatographic resins has been increasing with growth in drug discovery by major pharmaceutical companies. Pharmaceutical applications contribute to nearly 30 percent of the end-use market

• Top five players in the market accounted for nearly 70 percent of the global chromatographic resins market. Cytiva is the market leader with 30-40 percent market share

• Chromatographic resins are majorly driven by the need for more monoclonal antibodies in the market and highly specific purification techniques

Category Definition

• Chromatography is a separation technique which involves a mobile phase (which drives the sample) and the stationary phase (which supports the purification). Chromatography resins constitute the stationary phase in the purification process.

• Chromatography resin’s applications in pharma include separation of biomolecules like monoclonal antibodies, protein, antibody fragments and vaccines

• Suppliers offer chromatography resins as standard or custom resins and also as prepacked columns. These resins can be used at varying scales from laboratory to pilot to large scale manufacturing

Chromatography Resins Demand Market Outlook 

Demand for chromatography resins has been increasing since the evolution of biologic drugs.

• North America has been supporting the manufacture of several biologic drugs and hence the demand is high in the region

• Europe is home to most of the biologic manufacturing facilities and hence the demand is expected to be high, especially due to COVID-19 drug development

• India and China have been driving the demand for chromatography resins in Asia. Major biologic drug and vaccine manufacturers are located in these regions

Chromatography Resins Market Overview

Demand for chromatographic resins has been increasing with growth in drug discovery particularly after the impact of COVID-19. Increased R&D activities and production of biopharmaceuticals has been a major end use demand

• The chromatography resins market expected to witness more growth due to a rise in the number of contract manufacturing organizations

• Asian markets like China and India are seeing continuous growth in pharmaceuticals. This is expected to have a positive effect on the chromatography resins market. China’s domestic bioprocessing suppliers have acquired up to 20% market share, however the major players like Cytiva, Tosoh, BioRad and Agilent is still prevalent in the market

• All major resin manufacturers have been involved in research and developmental activities to produce new and improved resin beads

Drivers and Constrains : Chromatography Resins

Chromatographic resins are mostly driven by the need for more monoclonal antibodies in the market and highly specific purification techniques.

Drivers

• Increasing production of monoclonal antibodies has escalated the need for chromatographic resins. E.g. Protein A

• There is a large number of drug development and drug related research for COVID-19 treatment which will also contribute to the demand for resins

• Need for purification and separation of proteins and other bio-molecules in biotechnology, pharmaceutical, food manufacturing, and environmental analysis have been immense

Constrains

• Chromatographic resins are often sourced from a single supplier owing to reasons such as their unique properties, complexity, and cost. Therefore, supply security is a major concern and suppliers need to be evaluated for their business continuity plan

• Binding capacity of certain resins may still be lagging behind and need to be increased, so that it will be beneficial for process economy reasons

Cost Structure Analysis : Chromatography Resins

• Below cost structure has been developed for Protein A resin manufacturing which is one of the widely used resins in biologic drug purification

• Apart from raw material labour cost contributes to a major part of the cost since resin manufacturing involves some amount of skilled labor and technical expertise

• Raw material cost for manufacturing Protein A resin may vary depending on the manufacturer’s ability to produce Protein A ligand in-house or through contract manufacturing. The other major raw materials include agarose and cellulose to which the ligand is immobilized/coupled

• Requirement of skilled labor in various stages of protein A resin manufacturing e.g., cross-linking, resin activation contribute to 50 percent of the manufacturing cost

• Other costs apart from raw material, labor and utilities include, warehousing and packaging cost for the resin. The texture and the composition of these resins demand proper packaging, so that they can be put to use in their original form without any damage

• The use of pre-packed and disposable columns have increased nowadays. This is expected to minimize the costs of packaging, since the resins are already being packed safely in their columns