Prepacked Chromatography Columns Market

Market Overview

The global prepacked chromatography columns market size was valued at USD 327.5 million in 2023 and is projected to reach a value of USD 577.4 million by 2032, registering a CAGR of 6.5% during the forecast period (2024-2032). Prepackaged Chromatography Columns' Market share is expected to increase due to the rising need for efficient separation techniques in the pharmaceuticals, biotechnology, and food and beverage industries.

Prepacked chromatography columns are pre-assembled columns containing stationary phase materials that separate and purify biomolecules, chemicals, and other analytes depending on their physicochemical properties. These columns are widely used in various analytical, preparative, and process-scale chromatography applications in pharmaceuticals, biotechnology, food and beverage, environmental analysis, and academic research.

Increasing demand for process development, low-cost purification, and technological improvements in prepacked chromatography columns are some of the key drivers driving market expansion. In the biopharmaceutical business, prepacked columns are commonly used for process development and biomanufacturing. Prepacked chromatographic columns are increasingly used to eliminate the need for costly and time-consuming packing methods and validation protocols, resulting in consistent manufacturing. Furthermore, increased expenditure in pharmaceutical research and technological developments in prepacked chromatography columns are expected to drive market growth throughout the forecast period. However, the column's technical constraints will likely hinder the growth of the Prepackaged Chromatography Columns Market. 

Highlights

• >1 L holds the significant market share by product type.
• Ion Exchange Chromatography occupies the maximum share of the market by technique.
• Sample Preparation is the most common application in the market.
• Biotechnology and Pharmaceutical Companies dominate the market by end-user.

Market Dynamics

Global Prepacked Chromatography Columns Market Drivers

Increasing Demand for Biopharmaceuticals

The growing need for biopharmaceuticals, including monoclonal antibodies, recombinant proteins, and vaccines, is a significant driver of the prepacked chromatography columns market. These columns are critical for downstream purification operations in biopharmaceutical manufacturing, allowing for the isolation and purification of therapeutic proteins with high purity and yield. Monoclonal antibodies (mAbs) are one of the most common biopharmaceuticals used to treat various diseases, including cancer, autoimmune disorders, and infections.

Furthermore, the synthesis of mAbs typically requires upstream cell culture followed by downstream purification techniques that use chromatography columns to purify and isolate. For example, According to PAHO/WHO, there will be an estimated 20 million new cancer cases worldwide in 2023, with 10 million cancer-related deaths. In the United States, 1,958,310 new instances of cancer are predicted to be detected by 2023, with 609,820 individuals dying from the disease.

As a result, as the biopharmaceutical industry expands, fueled by advances in biotechnology and rising healthcare demands, the need for prepacked chromatography columns for downstream purification procedures is projected to stay high, providing possibilities for market players.

Global Prepacked Chromatography Columns Market Restraints

Environmental Concerns

Using plastic materials and waste generation to produce and dispose of prepacked chromatography columns can create environmental concerns. Plastic materials, such as the column body, fittings, and packing, are commonly used to produce prepacked chromatography columns. The extensive usage of single-use columns, meant for only one or a few uses, contributes to plastic waste creation in laboratory and industrial settings. Plastic garbage disposal presents issues for waste management systems and can have negative environmental consequences, such as pollution of land and water sources. The European Union (EU) has struck a tentative agreement to restrict single-use plastics and decrease packaging waste, such as retail fruit bags and little hotel shampoo bottles. 

Furthermore, single-use chromatography columns, developed for disposable biopharmaceutical manufacturing use, are a prime example of prepacked columns contributing to plastic waste generation. These columns are utilized to purify operations in biologics production, provide convenience, and lower the danger of cross-contamination. However, due to their single-use nature, plastic components are discarded after each usage, contributing to the accumulation of plastic waste in healthcare institutions and laboratories.

According to research by the Nordic Council of Ministers and Systemiq, global plastic output in 2023 will be 159 million tonnes, with 43% (68.5 million tonnes) of it resulting in pollution. The analysis also estimates that the yearly volume of mismanaged plastics will nearly double, from 110 million tonnes in 2019 to 205 million tonnes by 2040. The disposal of plastic trash poses substantial environmental concerns, with contamination endangering land and marine ecosystems, wildlife habitats, and human health. Using single-use chromatography columns and other disposable plastic goods in laboratories and biopharmaceutical facilities contributes to the plastic waste stream. 

Global Prepacked Chromatography Columns Market Opportunity

Rising Adoption of Single-Use Technologies

The growing use of single-use technologies in biopharmaceutical manufacturing, particularly single-use chromatography columns, represents a considerable opportunity for market expansion. Single-use chromatography columns have advantages over standard stainless-steel columns, including greater flexibility, lower cross-contamination risk, and simplified processes. The demand for single-use chromatography solutions will increase as the biopharmaceutical sector shifts toward more flexible and modular manufacturing methods.

For example, Thermo Scientific's HyPeak chromatography system. This technology was introduced in 2021 and is utilized in bioprocessing, specifically vaccine and therapeutic protein production. It has a modular system with a base configuration incorporating all purification-related capabilities and a batch reporting system that generates reports and stores batch data. Furthermore, biomanufacturers will implement single-use technology in their bioprocessing activities by 2023. Over 80% of bioprocessing activities have been carried out using single-use systems on a clinical size. Biomanufacturers are projected to continue to deploy single-use technologies on a more extensive commercial scale as pipeline items are approved and put into production.

As biopharmaceutical businesses embrace single-use technologies to improve operational efficiency, save capital expenditure, and shorten time-to-market for biologic pharmaceuticals, the need for prepacked chromatography columns designed for single-use applications is likely to grow. Market participants can capitalize on this potential by developing unique single-use chromatography solutions, increasing product portfolios, and responding to the biopharmaceutical industry's changing needs.

Regional Analysis

The global prepacked chromatography columns market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global prepacked chromatography columns market shareholder and is estimated to grow at a CAGR of 6.7% over the forecast period. North America will likely dominate the market due to significant R&D spending, well-established research organizations, and the widespread availability of prepackaged chromatography columns. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), member companies have spent approximately USD 1 trillion on research and development (R&D) since 2000. In 2023, the biggest pharmaceutical companies spent USD 58.5 billion on R&D, accounting for 18.29% of revenue. Furthermore, the presence of many pharmaceutical and biopharmaceutical businesses in the United States is one of the important factors driving the growth of the studied market in North America.

Additionally, some of the factors driving the expansion of the prepacked chromatography columns market include many partnerships and collaborations and a high concentration of market players in the United States. Astrea Bioseparations reached a deal with Thermo Fisher Scientific in March 2020 to supply prepacked bioseparation columns. This non-exclusive supply agreement with Thermo Fisher Scientific will result in prepacked EvolveD columns containing Thermo Fisher Scientific's CaptureSelect and POROS chromatography resins. This agreement is expected to increase their product offerings considerably. Continuous developments in the region are expected to boost the expansion of the studied market in North America. 

Moreover, biotechnology and pharmaceutical firms have the biggest output potential of any segment, owing to increased innovation, collaboration, and manufacturing by important participants in the North American region for production and R&D. For example, in June 2023, prepacked process-scale chromatography columns emerged as a promising solution to optimize biopharmaceutical production by increasing processing efficiency, maintaining high quality, and lowering costs, according to European pharmaceutical manufacturers.

Asia-Pacific is anticipated to exhibit a CAGR of 6.9% over the forecast period. The increasing creation of monoclonal antibodies is responsible for a bigger market share in biological goods due to therapeutic advances. According to the World Health Organization (WHO), Good Manufacturing Practices (GMP) are an indirect approach to assessing the quality of the food and medicine industries. This element is expected to boost market growth.

Furthermore, the Asia-Pacific region's biopharmaceutical industry is expanding rapidly, owing to factors such as an aging population, an increase in the frequency of chronic diseases, and growing healthcare costs.

The European market for prepacked chromatography columns is a robust and mature, owing to a significant presence of pharmaceutical and biotechnology businesses, well-established research institutions, and a favorable regulatory environment. 

Segmental Analysis

The global prepacked chromatography columns market is segmented based on product type, technique, application, and end-user.

The market is further segmented by product type into 1-100ML, 100-1000ML, and>1 L.

The 1L size will likely dominate the worldwide Prepacked Chromatography Columns market throughout the forecast period. These columns are intended for large-scale industrial chromatography applications, such as biopharmaceutical manufacturing, industrial purification operations, and large-scale protein production. The >1 L columns have high sample loading capacities, larger bed volumes, and higher processing throughput, making them ideal for commercial-scale biologic, vaccine, and pharmaceutical production. The market for prepacked chromatography columns is predicted to develop due to the lower cost of these columns.

The 100-1000ml sector has prepacked chromatography columns with capacities ranging from 100 to 1000 milliliters. These columns are excellent for medium-scale chromatographic separations and preparative chromatography applications, such as protein purification, sample enrichment, and target compound isolation. The 100-1000 mL columns have a larger sample loading capacity and processing throughput than smaller columns, making them ideal for lab-scale production of pure biomolecules and compounds. 

Based on technique, the market is fragmented into Ion Exchange Chromatography, Affinity Chromatography, Hydrophobic Interaction Chromatography, Multimodal Chromatography, and Gel Filtration Chromatography.

Ion Exchange Chromatography is expected to maintain its dominant position in the global Prepacked Chromatography Columns market during the forecast period. Ion Exchange Chromatography is a prominent player in the market due to its wide range of applications, excellent separation capabilities, and continuous technological advancements. Ion exchange chromatography separates analytes according to their charge characteristics. In this method, stationary phase materials have charged functional groups interacting with oppositely charged analytes in the mobile phase. Positively charged analytes attach to the negatively charged stationary phase (anion exchange), and negatively charged analytes bind to the positively charged stationary phase (cation exchange). Ion exchange chromatography is commonly used to purify proteins, peptides, nucleic acids, and other charged biomolecules.

Affinity chromatography relies on particular binding interactions between analytes and immobilized ligands on the stationary phase. The stationary phase is functionalized with ligands that preferentially interact with target analytes via antigen-antibody, enzyme-substrate, receptor-ligand, or other specific interactions. Affinity chromatography allows for the highly selective purification of biomolecules, including antibodies, enzymes, and recombinant proteins, while maintaining high purity and yield.

The market can be bifurcated by application into Sample Preparation, Resin Screening, Protein Purification, and Desalting.

Sample Preparation will likely dominate the worldwide Prepacked Chromatography Columns market throughout the forecast period. Before chromatographic analysis, samples must be pre-treated and conditioned. Prepacked chromatography columns for sample preparation make removing interfering chemicals, concentrating analytes, and modifying sample pH or composition easier to get the best chromatographic separation conditions possible. These columns are widely used in analytical laboratories, environmental monitoring, and quality control applications to prepare materials for future analysis using chromatography techniques such as HPLC, GC, and ion chromatography.

Prepacked chromatography columns are significantly employed in research and academic institutes to prepare samples for various scientific studies and tests. These columns are used in multiple research disciplines, including proteomics, genomics, and metabolism. The demand from these institutions derives from the necessity for effective separation and purification of molecules and chemicals when performing sample preparation for investigations.

Resin screening examines and selects chromatography resins or stationary phase materials for specific purification or separation applications. Prepacked chromatography columns for resin screening allow researchers and process developers to evaluate the performance, binding capacity, selectivity, and scalability of various chromatography resins under various chromatographic circumstances. These columns are utilized in biopharmaceutical process development, protein purification research, and chromatography protocol optimization to determine the best resin for downstream processing operations.

Based on end-users, the market is sub-segmented into Biotechnology and Pharmaceutical Companies and academic and research Institutes.

The pharmaceutical and biotechnology firms sector will likely dominate the market throughout the forecast period, owing to increased research and development activities for various therapeutic applications, including oncology. Biotechnology and pharmaceutical businesses are critical end-users of prepacked chromatography columns. These companies use chromatography columns at various drug discovery, development, and manufacturing stages. Prepacked chromatography columns are essential for purifying and characterizing biopharmaceuticals such as monoclonal antibodies, recombinant proteins, vaccines, and gene treatments. Affinity chromatography, ion exchange chromatography, and size exclusion chromatography are techniques used by biotechnology and pharmaceutical firms for protein purification, downstream processing, and quality control. These businesses require robust, scalable, and tested chromatography systems to meet regulatory standards, ensure product quality, and streamline bioprocessing operations.

Academic and research institutions are another key end-user group for prepacked chromatography columns. These institutions include universities, research laboratories, government agencies, and contract research organizations (CROs) that conduct basic and applied research and analytical services. Prepacked chromatography columns are frequently utilized in academic and research environments for biomolecule purification, chromatographic analysis, technique development, and teaching.

Researchers and students use chromatography columns in biochemistry, molecular biology, pharmacology, and biotechnology to purify proteins, isolate nucleic acids, analyze metabolites, and perform other biochemical tasks. Academic and research institutes require adaptable, cost-effective, and user-friendly chromatography solutions to support various research projects, accelerate scientific discovery, and train future scientists and technicians.

Recent Developments

• April 2024- Thermo Fisher Scientific Introduces New ENERGY STAR Certified TSX Universal Series ULT Freezers for Improved Temperature Control and Faster Recovery Times.
• April 2024- Sartorius and TheWell Bioscience collaborate to make more accurate forecasts in drug discovery.
• January 2024- Merck said that its Life Science business segment had signed a non-binding Memorandum of Understanding with Mycenax Biotech to explore collaboration in bringing innovative and high-capacity bioprocessing solutions to Taiwan and other global markets.