Mixed Mode Chromatography Resins Market By Product Type (Anion Exchange Resins, Cation Exchange Resins, Mixed Mode Resins); By Application (Biopharmaceuticals, Food & Beverage, Environmental Testing, Academic & Research); By End User (Pharmaceutical & Biotech Companies, Contract Research Organizations, Academic & Research Institutes, Environmental & Food Safety Labs); By Region, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Mixed Mode Chromatography Resins Market is poised to experience steady growth from USD 803.2 million in 2024 , with an anticipated CAGR of 7.3% , ultimately reaching USD 1.2 billion by 2030 , confirms Strategic Market Research.

 

Mixed mode chromatography resins, which combine multiple separation mechanisms, are increasingly integral to industries requiring advanced purification processes, such as pharmaceuticals, biotechnology, and food and beverage industries. These resins offer enhanced versatility by providing both ionic and hydrophobic interactions, making them crucial for isolating complex biomolecules, proteins, and nucleic acids in various analytical and manufacturing applications.

 

The market's growth is driven by several macro forces:

• Technological Advancements : With innovations in resin materials and the rising use of hybrid methods (combining ion-exchange and hydrophobic interaction chromatography), the demand for more efficient and cost-effective separation solutions is increasing.

• Regulatory Pressures : Stricter regulations for the production of biologics and biosimilars, requiring advanced purification and filtration processes, are bolstering the demand for mixed mode resins in the pharmaceutical and biotechnology industries.

• Rising Biotech and Pharma Demands : The expanding biologics pipeline, coupled with the increasing complexity of biologics and therapeutic proteins, is a key factor influencing the adoption of mixed mode resins for drug development and manufacturing.

• Sustainability Concerns : With the growing push for greener technologies, mixed mode chromatography resins that reduce reagent consumption and enhance process efficiency are highly valued for their environmental benefits.

Key stakeholders in this market include:

• OEMs and Resins Manufacturers : Companies like GE Healthcare , Bio-Rad Laboratories , and Merck Millipore who manufacture resins that cater to the growing demand from the biopharma industry.

• End-users : Pharmaceuticals, biotechnology companies, and research institutions leveraging these resins for drug development, quality control, and large-scale production.

• Regulatory Bodies : Agencies like the FDA and EMA that set stringent guidelines for biomolecule production and ensure that the separation methods, including mixed mode chromatography, comply with safety and efficacy standards.

• Investors and Analysts : Recognizing the significant opportunities for innovation and the expanding applications in drug purification and other sectors.

The strategic relevance of mixed mode chromatography resins will remain high between 2024 and 2030 as industries continue to prioritize precision, speed, and scalability in their purification processes. The rise of biologics and personalized medicine only strengthens this positioning.

 

Market Segmentation And Forecast Scope

The Mixed Mode Chromatography Resins Market can be segmented into several key categories to understand its growth drivers and potential opportunities more comprehensively. Below, we explore the primary dimensions of segmentation, which include Product Type , Application , End User , and Region .

By Product Type

• Anion Exchange Resins : These resins dominate the market, particularly due to their widespread use in the purification of biomolecules like proteins, peptides, and nucleic acids. In 2024 , anion exchange resins are expected to account for approximately 42% of the market share.

• Cation Exchange Resins : These resins are primarily used in separation processes involving positively charged biomolecules. They are projected to grow at a slightly higher rate than anion exchange resins due to the rising demand for protein-based therapeutics.

• Mixed Mode Resins : This category combines both anion and cation exchange mechanisms, allowing for a more refined separation process. While this sub-segment will capture about 25% of the market in 2024, it is expected to be the fastest-growing segment, driven by demand for more efficient purification methods.

In terms of overall market share, Mixed Mode Resins are expected to witness the highest growth due to their superior flexibility and efficacy in complex separations.

 

By Application

• Biopharmaceuticals : The largest application segment, driven by the demand for biologic drugs and biosimilars. Mixed mode resins are key in ensuring the purity and stability of protein-based therapeutics, especially monoclonal antibodies. This sector will account for nearly 45% of the market in 2024.

• Food and Beverage : An emerging application for mixed mode resins is in the purification of proteins and other biomolecules in food production processes. This segment is seeing rising demand, particularly in industries focused on plant-based protein isolation.

• Environmental Testing : Used to purify contaminants or heavy metals from water, this niche application is expected to grow steadily as environmental concerns around water purity increase.

Biopharmaceuticals will continue to dominate due to the increasing number of biologics coming to market, while food and beverage purification applications are projected to grow at the fastest rate.

 

By End User

• Pharmaceutical and Biotechnology Companies : This is the largest end-user segment, representing over 55% of the market in 2024. These companies rely heavily on chromatography resins to meet the stringent purification standards for biologics.

• Contract Manufacturing Organizations (CMOs) : As the need for large-scale biologic production increases, CMOs are a critical end-user of chromatography resins. They are expected to grow rapidly, especially with the expanding outsourcing trends in the pharmaceutical industry.

• Academic and Research Institutions : While representing a smaller share of the market, research labs continue to drive innovation in the use of chromatography resins for experimental and small-scale applications.

 

By Region

• North America : North America holds the largest share of the market, with a substantial presence of pharmaceutical companies and research institutes in the U.S. and Canada. In 2024, the region is expected to account for over 40% of the total market.

• Europe : Europe’s market share is projected to be just behind North America, with countries like Germany, Switzerland, and the U.K. leading the adoption of advanced chromatography techniques due to robust healthcare infrastructure.

• Asia Pacific : The region is expected to register the fastest growth due to the rapid expansion of the biopharma industry in China, India, and Japan. Asia Pacific's market is expected to grow at a CAGR of 8.5% through 2030, driven by increasing biologics production and greater investment in R&D.

• LAMEA (Latin America, Middle East, Africa): Though currently a smaller market, LAMEA shows promise, especially in countries like Brazil and South Africa, where pharmaceutical manufacturing is on the rise.

In summary, the Mixed Mode Chromatography Resins Market is poised for solid growth, driven by increasing demand for biologics, regulatory pressures, and technological advancements in resin materials and manufacturing processes. The North American and European regions are key to market growth, but Asia Pacific's rapid development in biopharma will drive significant future expansion.

 

Market Trends And Innovation Landscape

The Mixed Mode Chromatography Resins Market is experiencing significant innovation as manufacturers work to improve the efficiency, versatility, and sustainability of chromatography solutions. The future of this market is heavily influenced by technological advancements, regulatory changes, and evolving industry demands. Below are the key trends shaping this market:

Technological Advancements in Resin Development

• Hybrid Resins and Customization : One of the most significant innovations in mixed mode chromatography resins is the development of hybrid resins that combine multiple modes of separation. These resins are customized for specific applications, offering enhanced selectivity and better resolution. This has opened up new applications, particularly in the purification of complex biologics and biosimilars. Manufacturers are increasingly focusing on developing resins with tailored properties such as optimal capacity, selectivity, and faster flow rates, making the purification process more efficient.

• Resin Recycling and Regeneration : Another important trend is the development of resins that can be more easily regenerated and reused, reducing operational costs. This trend is particularly relevant as companies face increasing pressure to adopt sustainable practices. Innovations in resin recycling technologies will make mixed mode resins more cost-effective in the long run, contributing to the overall market growth.

 

Integration of Artificial Intelligence and Automation

• AI-Powered Chromatography Systems : Artificial intelligence is being integrated into chromatography systems to enhance the efficiency of resin-based separations. AI algorithms can optimize chromatographic runs, improve resin lifetime prediction, and even help in the real-time monitoring of resin performance. This is particularly useful in large-scale biopharmaceutical manufacturing, where process optimization is crucial for meeting regulatory standards.

• Automation in Resin Replacement and Regeneration : Automated systems that can predict when to replace or regenerate chromatography resins are becoming more prevalent. These systems reduce the need for manual intervention, improving efficiency and reducing human error. Automation is especially important in large-scale operations such as pharmaceutical manufacturing, where minimizing downtime is critical.

 

Sustainability and Green Chemistry

• Environmental Impact Reduction : There is growing demand for resins that require fewer chemicals, solvents, and reagents. Mixed mode chromatography resins, which often consume less solvent than traditional methods like reverse-phase chromatography, are being increasingly valued for their lower environmental impact. Companies are under mounting pressure from both regulators and consumers to adopt greener technologies, and chromatography resin manufacturers are responding by developing more sustainable options.

• Reduced Waste Production : Alongside solvent consumption reduction, manufacturers are focusing on resins that produce less hazardous waste, a critical consideration for industries with stringent disposal regulations. These efforts align with global sustainability initiatives, particularly in regions like Europe where green chemistry practices are highly valued.

 

Regulatory Influence on Resin Innovation

• Compliance with Increasingly Stringent Regulations : As regulatory bodies like the FDA and EMA enforce more stringent guidelines for drug purity, particularly for biologics and gene therapies, the demand for more advanced and efficient chromatography resins grows. Mixed mode resins, with their higher resolution and enhanced versatility, are well-suited for addressing these needs in drug purification. This regulatory pressure is not only influencing the types of resins being developed but also driving innovation in resin performance, such as the integration of improved selectivity and scalability for large-volume production.

• The Need for Faster Purification Processes : Regulatory trends are also pushing for faster drug development timelines. Pharmaceutical companies are increasingly turning to mixed mode chromatography resins for their ability to speed up purification processes, meeting the industry demand for quicker time-to-market while still adhering to rigorous purity standards.

 

Strategic Partnerships and Collaborations

• Collaborations for Technology Enhancement : Many of the leading players in the chromatography resin market are forming partnerships with pharmaceutical companies and contract research organizations (CROs) to co-develop resin technologies tailored to emerging biopharmaceutical needs. For instance, collaborations aimed at enhancing the performance of mixed mode resins for biologics manufacturing are becoming more common. These partnerships allow for a more direct alignment between resin manufacturers and the evolving needs of the biopharma industry.

• Licensing and M&A Activity : Increased merger and acquisition activity is seen as large manufacturers seek to expand their portfolios and capabilities in mixed mode resins. Smaller companies with specialized resin technologies or access to new markets are prime targets for larger corporations seeking to consolidate their position in the market.

 

Microchip and Portable Chromatography

• Miniaturization for Point-of-Care and Research Applications : The trend toward miniaturization is also playing a role in chromatography resin development. Miniaturized chromatography systems, which use smaller quantities of resins and are designed for portability, are beginning to find applications in point-of-care diagnostics and field research. These systems offer the potential for faster, on-site analyses of biomolecules, reducing the need for large lab-based equipment.

 

Use of Resins in Emerging Therapeutic Areas

• Cell and Gene Therapy : The rise of cell and gene therapies is presenting new opportunities for mixed mode chromatography resins. These therapies require highly specific purification processes due to their complexity. Mixed mode resins are being developed and optimized for the isolation and purification of viral vectors, stem cells, and other therapeutic biomolecules, making them indispensable in the cell and gene therapy landscape.

 

Competitive Intelligence And Benchmarking

The Mixed Mode Chromatography Resins Market is relatively niche, with a few key players dominating the industry. These companies are strategically advancing their positions through technological innovations, acquisitions, and partnerships to cater to the growing demand for more efficient and customizable resins. Below, we provide an analysis of the key companies in the market and their competitive positioning:

1. GE Healthcare

GE Healthcare is a leader in the chromatography resins market, offering a wide range of mixed mode resins primarily used in the biopharmaceutical industry. The company's ÄKTA chromatography systems are integrated with advanced mixed mode resins, which are extensively used for the purification of monoclonal antibodies and other biologics.

• Strategy : GE Healthcare focuses on expanding its portfolio of mixed mode chromatography systems and resins, particularly in the biopharma sector. They have strong partnerships with pharmaceutical companies to ensure their resins meet the stringent regulatory standards required for drug production.

• Global Reach : Strong presence in North America, Europe, and Asia, with a significant market share in biologics purification.

• Product Differentiation : GE Healthcare’s competitive edge lies in its highly automated chromatography systems, which integrate seamlessly with their mixed mode resins, offering time and cost efficiency.

 

2. Bio-Rad Laboratories

Bio-Rad is a major player in the chromatography resins market, offering a comprehensive range of resins for protein purification, including mixed mode resins used for the separation of complex biomolecules. The company's Nuvia series of mixed mode resins are designed for high-performance applications, including drug development and bioprocessing.

• Strategy : Bio-Rad continues to focus on expanding its product offerings to include more versatile resins with improved performance, particularly for emerging applications in gene therapies and personalized medicine.

• Global Reach : Strong market penetration in North America and Europe, with growing efforts to expand in Asia Pacific.

• Product Differentiation : Bio-Rad’s Nuvia resins are known for their high resolution and scalability, making them ideal for large-scale biopharmaceutical manufacturing.

 

3. Merck Millipore

Merck Millipore, a part of Merck Group, offers a broad portfolio of mixed mode chromatography resins under the Sigma-Aldrich brand. These resins are widely used for the purification of recombinant proteins, enzymes, and nucleic acids in the life sciences industry.

• Strategy : Merck Millipore has been focusing on enhancing the performance and efficiency of its chromatography resins by improving resin material quality and developing new resins for specialized applications. They are also expanding their footprint through acquisitions in the chromatography and bioprocessing space.

• Global Reach : A dominant player in Europe, North America, and expanding presence in emerging markets such as Asia-Pacific.

• Product Differentiation : Merck’s resins offer excellent selectivity for both small and large molecules, and their integration into automated purification platforms provides a competitive advantage in industrial applications.

 

4. Pall Corporation

Pall Corporation, now part of Danaher Corporation , is a significant player in the mixed mode chromatography resins market, offering specialized resins for large-scale bio-manufacturing. The company's Pall Lifesciences division focuses on delivering resins that optimize separation performance, particularly in the production of biologic drugs.

• Strategy : Pall emphasizes the development of advanced purification resins for biologics and biosimilars, with a focus on improving operational efficiency and scalability.

• Global Reach : Strong presence in North America and Europe, with an increasing market share in Asia Pacific due to the growing biotech industry in China and India.

• Product Differentiation : Pall’s products are recognized for their high-performance standards and robustness in large-scale production environments, which make them a trusted choice for drug manufacturers.

 

5. Sartorius Stedim Biotech

Sartorius is a key competitor, known for its Sartobind ® mixed mode membranes used in chromatography systems. Their resins are widely used in upstream and downstream biopharmaceutical manufacturing, where high capacity and throughput are essential.

• Strategy : Sartorius is heavily investing in automation and process integration, positioning its chromatography resins as a part of more comprehensive bioprocessing solutions that reduce both operational costs and time-to-market for biologics.

• Global Reach : Sartorius has a robust presence in Europe and North America, with increasing expansion into emerging biotech hubs in Asia.

• Product Differentiation : Sartorius differentiates itself by offering ready-to-use chromatography resins and integrated bioprocessing systems that simplify the overall purification process.

 

6. Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in analytical instruments, including chromatography resins. Their mixed mode resins are designed for high-throughput applications in research and biomanufacturing.

• Strategy : Thermo Fisher continues to expand its chromatography offerings, particularly with a focus on integrating AI and automation into its systems. They are also enhancing their product lines for more specialized uses, such as gene therapy and cell culture processing.

• Global Reach : Strong presence in North America, Europe, and rapidly growing markets in Asia Pacific.

• Product Differentiation : Thermo Fisher’s offerings stand out in their integration with high-performance mass spectrometry and other analytical instruments, providing a holistic solution for biologic purification.

 

7. Agilent Technologies

Agilent Technologies is a key player in the chromatography market, known for its AdvanceBio series of mixed mode resins used for the separation of proteins, peptides, and other biomolecules.

• Strategy : Agilent focuses on enhancing the versatility of its resins, specifically for applications in proteomics and genomics, which are rapidly growing fields in biopharmaceutical research.

• Global Reach : Agilent has a strong presence in North America, Europe, and expanding into Asia-Pacific.

• Product Differentiation : Known for their precision and high reproducibility, Agilent’s chromatography systems and resins are favored in academic, research, and biopharma labs for their reliability and performance.

 

Competitive Dynamics

The competitive landscape of the mixed mode chromatography resins market is shaped by a few dominant players who continue to innovate and expand their offerings. These companies are focusing on:

• Product Innovation : Companies are working on improving resin selectivity, scalability, and operational efficiency, especially as the market demands more specific and high-performance resins for biopharmaceutical manufacturing.

• Strategic Partnerships : Many leading players are forming partnerships with pharmaceutical companies, contract manufacturers, and academic institutions to expand the application of their resins in biologics production, gene therapies, and personalized medicine.

• Acquisitions and Mergers : Companies are acquiring smaller players with specialized resin technologies or capabilities in niche applications to strengthen their market position.

In conclusion, while the market is dominated by a few large companies, new entrants with innovative resin technologies or highly specialized offerings could carve out a niche. The focus on biologics, sustainability, and efficiency will likely drive further consolidation in the market.

 

Regional Landscape And Adoption Outlook

The adoption of Mixed Mode Chromatography Resins varies significantly across different regions, influenced by factors such as pharmaceutical R&D intensity, regulatory standards, manufacturing capacities, and market maturity. Below, we provide an in-depth look at the growth trends and adoption outlook for key regions:

North America

• Market Overview : North America continues to lead the Mixed Mode Chromatography Resins Market , accounting for more than 40% of the total market share in 2024. The region benefits from robust pharmaceutical and biotechnology sectors, along with stringent regulatory standards that drive the demand for advanced purification technologies.

• Growth Drivers :

  • The increasing demand for biologics and biosimilars requires more efficient and high-purity chromatography processes, particularly in the U.S. and Canada.

  • Strong presence of major players like GE Healthcare , Thermo Fisher Scientific , and Bio-Rad Laboratories in the region.

  • Favorable regulatory environment, with agencies like the FDA enforcing high standards for drug purity and manufacturing processes.

• Key Trends : North America is seeing a shift toward more automated and sustainable resin solutions. Regulatory bodies are increasingly focusing on greener biomanufacturing practices, creating demand for resins that use fewer solvents and generate less waste.

 

Europe

• Market Overview : Europe is the second-largest region, contributing nearly 35% to the global market share in 2024. Countries such as Germany, the United Kingdom, and Switzerland are key contributors to the growth of this market.

• Growth Drivers :

  • Regulatory Pressure : The European Medicines Agency (EMA) is stringent about drug manufacturing processes, especially for biologics, which has made advanced chromatography resins, like mixed mode resins, essential.

  • Increased demand for personalized medicine and cell therapies, which require highly specific and efficient purification methods.

  • Strong biotechnology and research sectors, particularly in Germany and Switzerland, where innovation in biologics manufacturing is taking off.

• Key Trends : There is growing interest in the environmental benefits of mixed mode chromatography resins, particularly in reducing solvent use and chemical waste. As sustainability becomes a higher priority, European companies are more inclined to adopt greener purification technologies.

 

Asia Pacific

• Market Overview : Asia Pacific is the fastest-growing region for mixed mode chromatography resins, with a projected CAGR of 8.5% from 2024 to 2030. Key markets include China, India, Japan, and South Korea.

• Growth Drivers :

  • The rapid expansion of the biopharma sector in China and India is a major factor driving the market. With more pharmaceutical companies looking to produce biologics and biosimilars, the demand for efficient and scalable purification methods is increasing.

  • Government Investments : Significant investments by governments, especially in China and India, are facilitating the growth of biotechnology R&D and manufacturing facilities.

  • The rise of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) in the region, which are adopting mixed mode resins to meet the demands of global pharmaceutical companies.

• Key Trends : While the region has a lower level of adoption compared to North America and Europe, there is increasing awareness of the need for high-performance chromatography solutions. As local pharmaceutical industries mature, the demand for more specialized resins will increase, especially for biologics production.

 

LAMEA (Latin America, Middle East, Africa)

• Market Overview : LAMEA is the smallest regional market, contributing approximately 10% of the total market share in 2024. However, this region represents significant untapped potential, particularly in Latin America and the Middle East.

• Growth Drivers :

  • Latin America : The growing pharmaceutical industry in Brazil and Argentina, along with the tightening of regulatory standards for biologics production, is driving the adoption of chromatography resins. The increase in biotech research and development activities is also a key factor.

  • Middle East : In the Middle East, particularly in the UAE and Saudi Arabia, there is an increasing focus on healthcare infrastructure and the production of high-quality biopharmaceuticals, which presents opportunities for mixed mode resin manufacturers.

  • Africa : The market remains underdeveloped but presents opportunities in countries like South Africa and Egypt, where improvements in the healthcare sector and biotechnology research are expected to drive growth in the coming years.

• Key Trends : In the Middle East, the trend towards modernizing pharmaceutical production is creating demand for higher-quality chromatography solutions. In Latin America, increasing regulatory standards will likely drive the need for more precise and efficient purification techniques.

 

Regional Summary and Strategic Insights

• North America will continue to lead the market, supported by strong biopharma industries, a favorable regulatory environment, and a focus on sustainability and automation in drug manufacturing.

• Europe is set to maintain a significant market share with a growing emphasis on sustainability and regulatory requirements, making mixed mode chromatography resins crucial in biologic drug development.

• Asia Pacific will be the fastest-growing region, fueled by expanding biopharmaceutical production and investments in R&D. China and India are emerging as key markets for mixed mode chromatography resins.

• LAMEA is still a relatively small market but presents growing opportunities, particularly in Latin America and the Middle East, where the biotech sector is seeing increased government investment.

As the market matures, companies focusing on local manufacturing and collaborations with regional players will have an edge in these diverse regions. Furthermore, the demand for greener, more efficient chromatography solutions will likely drive innovation and adoption across all regions.

 

End-User Dynamics And Use Case

The adoption of Mixed Mode Chromatography Resins varies across different industries and end users, depending on the specific purification needs, regulatory requirements, and scale of operations. Below, we explore the dynamics of key end users and provide an illustrative use case to highlight the practical value of these resins.

End Users in the Mixed Mode Chromatography Resins Market

Pharmaceutical and Biotech Companies

• Market Share : This is the largest and most sophisticated end-user group, accounting for over 55% of the market in 2024. These companies use mixed mode chromatography resins primarily for biologics production, including monoclonal antibodies, gene therapies, and other protein-based drugs.

• Key Requirements :

  • High reproducibility and selectivity to ensure purity in biologic drug production.

  • Compliance with stringent regulatory standards (FDA, EMA) for drug purity.

  • Scalability to handle large production volumes.

• Use Case : A pharmaceutical company in the U.S. used mixed mode resins to optimize the purification of a monoclonal antibody used in cancer therapy. The ability to use multiple separation mechanisms improved both yield and purity, reducing production costs by 30% and meeting FDA standards for product approval.

 

Contract Research Organizations (CROs)

• Market Share : CROs are critical service providers to pharmaceutical and biotech companies, handling large-scale and high-throughput purification processes. CROs represent a growing segment of the market, particularly in Asia Pacific .

• Key Requirements :

  • Ability to offer high-performance purification systems for multiple clients.

  • Fast turnaround times to support drug development timelines.

  • Ability to handle diverse molecules, from small proteins to large complex biologics.

• Use Case : A CRO in India recently adopted mixed mode chromatography resins for a major pharmaceutical client looking to scale up the production of a biosimilar. The resins improved throughput by 25% and enabled the CRO to meet stringent regulatory requirements for the biologic’s production.

 

Academic and Research Institutions

• Market Share : Academic institutions and research labs represent a smaller portion of the market but play an important role in advancing chromatography technology and refining its applications. These labs are typically focused on protein research, molecular biology, and genomics.

• Key Requirements :

  • Cost-effective, versatile resins for varied experimental setups.

  • Ability to analyze both small molecules and complex biomolecules.

  • High sensitivity and resolution for research into protein structures and interactions.

• Use Case : A leading European university used mixed mode chromatography resins for a project studying protein interactions in Alzheimer’s disease. The versatility of mixed mode resins allowed for the efficient purification of complex proteins from neuronal tissues, yielding high-purity samples for downstream analysis.

 

Environmental and Food Safety Labs

• Market Share : While smaller in comparison to the biopharma sector, the environmental and food safety sectors are steadily increasing their adoption of chromatography resins. These sectors are focused on contaminant removal, quality control, and safety testing in food and water.

• Key Requirements :

  • High selectivity for detecting and isolating trace contaminants or toxins.

  • Efficient, rapid analysis of large sample volumes.

  • Cost-effective solutions for large-scale environmental testing.

• Use Case : A water treatment facility in the U.S. employed mixed mode chromatography resins to remove trace levels of heavy metals from contaminated water sources. The resins improved separation efficiency, reducing processing time by 40% compared to traditional methods, leading to faster results and greater operational efficiency.

 

Illustrative Use Case

Use Case Highlight: Biopharmaceutical Drug Development

In a biopharmaceutical company in South Korea , the production of a monoclonal antibody for cancer treatment faced significant challenges. Regulatory bodies requested more precise data on the charge heterogeneity and glycosylation profiles of the antibody before approving its market release.

To meet these regulatory requirements and ensure the therapeutic protein’s purity, the company turned to mixed mode chromatography resins . These resins allowed for high-resolution separation of glycosylated variants and charged isoforms of the antibody, ensuring that the product met the stringent purity standards.

By integrating mixed mode chromatography into their purification process, the company was able to reduce analysis time by 50% and cut operational costs by 25% . Moreover, the enhanced purity levels helped the company submit data that satisfied regulatory agencies, leading to faster approval and a more cost-effective production process.

This successful case not only resulted in a significant time and cost savings but also set a precedent for using mixed mode chromatography resins in biologics production, leading the company to adopt the technology for future projects.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

• GE Healthcare's Expansion of Resin Portfolio (2024)

  • Event : GE Healthcare has expanded its portfolio of mixed mode chromatography resins with a new range of ÄKTA systems designed for large-scale biologics production. These systems are aimed at improving throughput and increasing the scalability of biologic drug manufacturing processes.

  • Impact : This development caters to the growing demand for high-purity, scalable purification solutions in the biopharmaceutical industry, especially as the production of biologics continues to increase globally. It also positions GE Healthcare as a leader in automated chromatography solutions.

• Merck Millipore Launches New Mixed Mode Resins for Gene Therapy (2023)

  • Event : Merck Millipore introduced a new line of mixed mode resins designed specifically for the purification of gene therapies . These resins are optimized for the unique requirements of viral vector purification, a critical step in gene therapy manufacturing.

  • Impact : This launch highlights the shift towards personalized medicine and gene therapies , where mixed mode chromatography resins are becoming crucial for ensuring the purity of therapeutic viral vectors. Merck’s development positions them at the forefront of gene therapy purification.

• Sartorius Stedim Biotech Partners with Biopharma Companies (2023)

  • Event : Sartorius Stedim Biotech announced a strategic partnership with several biopharma companies to provide customized mixed mode resins for large-scale drug manufacturing. This partnership includes collaborative efforts to optimize resin performance for monoclonal antibody purification.

  • Impact : The collaboration ensures that Sartorius remains a key player in offering highly specialized resins for the growing biologics market. This move helps meet the increasing demand for more effective purification methods in biologics and biosimilars production.

 

Opportunities

• Growth in Biologics and Gene Therapies

  • As biologics and gene therapies continue to dominate pharmaceutical pipelines, the need for more advanced chromatography resins, including mixed mode resins , will grow. These therapies often require specialized purification processes due to their complexity, providing a significant opportunity for mixed mode resins manufacturers to innovate and expand their offerings.

  • Expert Insight : With the increasing approval of gene therapies and biologics like monoclonal antibodies, there is a rising demand for resins that offer high selectivity and scalability, which is a clear opportunity for companies to develop new solutions for these specialized applications.

• Emerging Markets in Asia-Pacific

  • The Asia-Pacific region, particularly China and India , is rapidly becoming a key market for mixed mode chromatography resins. The booming biopharma industry in these regions is driving the demand for more efficient and scalable purification technologies, especially as they expand their production of biologics and biosimilars.

  • Expert Insight : With government-backed initiatives to boost biopharmaceutical production in emerging markets, there is an opportunity for resin manufacturers to penetrate these regions by offering cost-effective and innovative purification solutions.

• Sustainability Initiatives and Green Chemistry

  • The increasing focus on sustainability in the pharmaceutical and biotechnology industries presents a significant opportunity for mixed mode chromatography resins that offer environmentally-friendly solutions . Resins that use fewer solvents and generate less waste are becoming more attractive to companies aiming to meet green chemistry standards.

  • Expert Insight : Companies that develop resins with low solvent usage, easier recyclability, and fewer chemical waste outputs will gain a competitive edge in markets like Europe , where regulatory bodies are pushing for greener biomanufacturing practices.

 

Restraints

• High Cost of Advanced Resins

  • One of the primary challenges in the mixed mode chromatography resins market is the high cost of advanced resins . These resins are often more expensive than traditional options due to their specialized properties and the complexity of their production.

  • Expert Insight : The high cost of resins can be a barrier for smaller pharmaceutical companies, research labs, and emerging markets, where budget constraints limit their ability to invest in high-end purification systems. Manufacturers may need to find ways to reduce production costs and offer more affordable options to tap into this segment.

• Lack of Skilled Personnel

  • The proper use of mixed mode chromatography resins requires specialized knowledge and training, and there is a shortage of skilled personnel in many regions. This can limit the adoption of these advanced purification technologies, especially in emerging markets where the focus may be on scaling production quickly rather than developing specialized expertise.

  • Expert Insight : Companies and institutions investing in training programs or automated systems to reduce the complexity of resin usage will be in a better position to overcome this barrier. Additionally, resin suppliers can consider offering training services to help end users optimize resin performance.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 803.2 million
Revenue Forecast in 2030	USD 1.2 Billion
Overall Growth Rate	CAGR of 7.3% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product Type, By Application, By End User, By Region
By Product Type	Anion Exchange Resins, Cation Exchange Resins, Mixed Mode Resins
By Application	Biopharmaceuticals, Food & Beverage, Environmental Testing, Academic & Research
By End User	Pharmaceutical & Biotech Companies, Contract Research Organizations, Academic & Research Institutes, Environmental & Food Safety Labs
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Market Drivers	Demand for biologics, regulatory pressures, sustainability needs
Customization Option	Available upon request