Mixed Mode Chromatography Resin Market

Mixed Mode Chromatography Resin Market Outlook (2025 to 2035)

The mixed mode chromatography resins market is valued at USD 172 million in 2025. As per Fact.MR’s analysis, the mixed mode chromatography resins industry will grow at a CAGR of 15.7% and reach USD 743 million by 2035.

Mixed mode chromatography resins employ multimodal ligands that enable protein binding through a complex interplay of ionic, hydrogen bonding, and hydrophobic interactions. These new resins provide improved selectivity, better resolution, and greater capacity than conventional single-mode systems.

In 2024, the industry of mixed mode chromatography resin experienced a transformative period with focus on innovation and growing applications within pharmaceutical and biotechnology fields.

The trend in previous years got further boost with particular importance seen with growing emphasis on the development of biologics and biosimilars. Pharmaceutical industry intensified their dependency on advanced chromatography methods in order to strengthen the accuracy and efficiency of the process of purifying proteins.

As the sector heads into 2025, the mixed mode chromatography resin industry is poised for even greater growth. Growth investment in R&D of monoclonal antibodies, biosimilars, and other high-value biologics is anticipated to drive the uptake of mixed mode resins in bulk bioprocessing contexts.

The applicability of the technique-providing several interaction modes-will continue to be a determining factor among developers interested in maximizing purification efficiency as well as minimizing manufacturing complexity.

Metric	Value
Industry Value (2025E)	USD 172 million
Industry Value (2035F)	USD 743 million
CAGR (2025 to 2035)	15.7%

Market Analysis

The industry for mixed mode chromatography resin is set for rapid growth, driven by growing demand for sophisticated purification methods in biologics and biosimilar manufacturing. Increased focus on process efficiency, scalability, and regulatory compliance is driving adoption in pharmaceutical and biopharmaceutical companies. Industry leaders adopting multimodal resin technology can capture substantial competitive edge, while those remain bound to traditional methods risk operational redundancy.

Top 3 Strategic Imperatives for Stakeholders

Accelerate Investment in Next-Generation Resin Technologies

Top executives need to focus on investments in R&D for next-generation mixed mode chromatography resins with increased selectivity, binding capacity, and scalability to serve increasing biopharmaceutical purification needs.

Realign Product Lines with Upcoming Biologics and Biosimilar Pipelines

Companies need to align their product lines with changing requirements of biosimilar and monoclonal antibody producers, as well as the regulatory purification norms, for handling complex biologics.

Enhance Strategic Partnerships and Global Supply Chains

Build strong channel relationships with CDMOs, biotech centers, and research institutions while building manufacturing capacity through strategic M&A or JV to achieve global industry reach and supply agility.

Top 3 Risks Stakeholders Should Monitor

Risk	Probability - Impact
Supply Chain Disruptions within Raw Materials - Sourcing specialty chemicals or polymers delays can postpone resin production schedules, particularly with few suppliers.	High - High
Tight Regulatory Trends Geographically - Sudden, unforeseen modifications in bioprocessing or chemical usage standards might slow down the approval of products or drive compliance expenses higher.	Medium - High
Limited scalability to high-purity applications - inability to satisfy changing purity levels in downstream processing can decrease vendor choice for novel biologics.	Medium - Medium

1-Year Executive Watch-List

Priority	Immediate Action
Secure resilient and cost-effective raw material supply	Implement a strategic sourcing review for substitute resin feedstocks along APAC and EMEA corridors
Enhance solution relevance to biosimilar innovations	Create an ongoing engagement cycle with top biopharma OEMs to obtain changing purification specs
Strengthen international industry penetration	Implement a performance-based incentive program for high-potential channel partners in growth sectors

For the Boardroom

To stay ahead, companies must retool their growth playbooks by coordinating resin innovation with future biologic trends and worldwide regulatory environments.

To take advantage of the next wave of biopharmaceutical purification demand, companies must double down on R&D for hybrid resins with increased selectivity and scalability-particularly in applications in monoclonal antibody and biosimilar manufacturing.

As a procurement differentiator in Europe and tech-savvy capabilities taking shape in the US and Asia-Pacific, executives have to find a balance between material science innovation and compliance preparedness.

Regional manufacturing hubs, patent-holding resin technologies, and strategic tie-ups with the world's leading biopharma giants will be the determinants of competitive agility from 2025. This insight marks a turning point-growth ahead will benefit players who transition beyond commodity supply to solution partnership status in next-generation drug development.

Segment-Wise Analysis

By Type

The Ion Exchange-Hydrophobic Type segment is expected to be the most profitable between 2025 and 2035. This supremacy is largely due to its excellent binding capacity, flexibility in managing a broad array of biomolecules, and high selectivity-rendering it essential for sophisticated purification procedures in biologics and biosimilars production.

Its two-way interaction mechanism-blending ionic and hydrophobic interactions-provides improved separation efficiency, particularly in downstream bioprocessing where high yield and purity are paramount.

The segment continues to pick up strong momentum among pharmaceutical and academic research centers involved in monoclonal antibody production and gene therapies.

Fact.MR is of the opinion that Ion Exchange-Hydrophobic Type mixed mode chromatography resins will achieve a CAGR of 17.1% during 2025-2035 and will surpass other segments because it has widespread applicability and its technological advancements.

By Application

The Antibodies Production sector is set to be the most profitable application space for mixed mode chromatography resins in 2025-2035. This leadership stems from the hyper-growth of monoclonal antibody (mAb) drugs and biosimilars that demand highly accurate, efficient, and scalable purification methods. Mixed mode resins, especially ion exchange-hydrophobic mode resins, provide a compelling benefit in terms of managing high titers, eliminating host cell proteins, and providing better product purity.

With autoimmune and chronic diseases increasing, the pharmaceutical industry is accelerating investment in therapeutic antibody pipelines. In addition, regulatory demand for high-quality biologics and affordable manufacturing has supported the preference for multimodal purification strategies.

Fact.MR believes that Antibodies Production will dominate the application scenario with a CAGR of 18.4% during 2025-2035, driven by the worldwide biologics boom and growing usage of sophisticated chromatography methods in downstream processing.

Country-Wise Analysis

United States

The U.S. continues to lead biopharmaceutical innovation, hence the most prominent player in the mixed mode chromatography resin sector. Its highly developed R&D environment, as well as the location of leading biologics manufacturers, fuels steady demand for high-performance purification technology.

Growing investments in cell and gene therapy, as well as a robust biosimilar development pipeline, continue to support the use of multimodal resins. Regulatory focus on process optimization and product quality adds further to speed of adoption.

Additionally, interaction between industry and academia enables continuous innovation in next-generation therapeutics-specific resin technology. Fact.MRforecasts that CAGR of United States will be 16.9% from 2025 to 2035.

India

India's rapidly expanding biopharmaceutical industry, spurred by its cost-effective manufacturing hub and growing clinical research environment, offers a fertile platform for mixed mode chromatography resin uptake. Initiatives like "Make in India" and support for the development of biosimilars have spurred high levels of infrastructure expansion in biotech clusters.

India's focus on affordable therapeutics and vaccine manufacture drives demand for efficient and scalable downstream processing technology. Startups and CDMOs are also investing in resin-based technologies to maximize purification yields and process economics. Fact.MRopines that CAGR of India will be 16.2% from 2025 to 2035.

China

China's continued evolution as a global biopharma leader is driving the adoption of innovative purification platforms, such as mixed mode chromatography resins. Huge public and private investment in R&D of biologics, facilitated by policy initiatives like "Healthy China 2030," has enhanced the nation's capabilities in manufacturing.

Local companies are increasingly implementing multimodal resins for biosimilar manufacturing, particularly in monoclonal antibody and ADC pipelines. Further, partnerships with foreign resin manufacturers are enhancing countrywide access to high-performance purification solutions. Fact.MRforecasts that CAGR of China will be 16.5% from 2025 to 2035.

United Kingdom

The UK's robust academic research community, supported by a dynamic biotech startup cluster, supports consistent demand for mixed mode chromatography resins. With increasing momentum for personalized medicine, increased dependence on advanced purification techniques in smaller-scale, high-value biologics manufacturing follows.

Government-supported innovation funds have spurred adoption in commercial and academic bioprocessing facilities. Global CDMOs' presence in the region also enhances multimodal resin integration into diverse therapeutic pipelines. Fact.MRopines that CAGR of United Kingdom will be 15.3% from 2025 to 2035.

Germany

Germany's sector leadership in precision biomanufacturing and pharma export dominance have made it a key industry for chromatography innovations. Since biologics form a dominant proportion of the nation's pipeline for drug development, manufacturers are turning to high-throughput mixed mode resins in growing numbers to drive up purification workflows.

Regulatory harmonization with the EMA by the nation also imposes stringent quality norms, further prompting resin adoption in GMP-regulated environments. Ongoing investment in process intensification and automation solidifies the trend. Fact.MRforecasts that CAGR Germany will be 15.8% from 2025 to 2035.

South Korea

South Korea's biopharma industry is transforming at a fast pace, driven by aggressive investments by conglomerates such as Samsung Biologics and Celltrion. These companies are using mixed mode chromatography resins at scale to address increasing global demand for biosimilars and biologics.

Government support in the form of tax incentives and strategic biotech roadmaps has bolstered infrastructure for advanced downstream processing. Academic-industrial collaborations are also emphasizing indigenous resin technologies designed for high-yield purification. Fact.MRopines that CAGR of South Korea will be 16.4% from 2025 to 2035.

Japan

Japan's biologics industry keeps growing as the country moves towards new therapeutics and age-related population-driven healthcare needs. Mixed mode chromatography resins are becoming increasingly popular in commercial and academic bioproduction for their ability to purify antibodies, enzymes, and vaccines efficiently.

Harmonization with international quality standards through regulation guarantees consistent application of innovative purification technologies. In addition, local companies are boosting investments in continuous bioprocessing, where multimodal resins have a central role to play. Fact.MRforecasts that CAGR of Japan will be 15.5% from 2025 to 2035.

France

France is witnessing rising adoption of mixed mode chromatography resins due to the growth of its biosimilar and vaccine development sectors. Public-private collaborations, notably under France’s Biotech 2030 initiative, have accelerated technological upgrades in downstream bioprocessing. Academic institutions are also playing a key role in driving innovation by exploring new ligand chemistries and optimizing multimodal purification workflows.

This push towards efficient, eco-friendly processes makes France an attractive industry for chromatography resin manufacturers. Fact.MRis of the opinion that CAGR of France will be 15.6% from 2025 to 2035.

Italy

Italy's pharmaceutical manufacturing revival, particularly in sterile injectables and biologics, is driving enhanced demand for sturdy purification platforms. The nation's CDMO environment is widening, incorporating blended mode chromatography resins to provide high-volume, GMP-grade manufacturing to international customers.

Favorable policy environments and funding for biotechnology innovation are likewise accelerating the technology adoption rate. Italy's turn toward more complicated biologics makes it a growth center rising star in the European resin ecosystem. Fact.MRopines that CAGR of Italy will be 15.4% from 2025 to 2035.

Australia-New Zealand

Australia-New Zealand's multimodal chromatography resin industry is gaining from regional biomanufacturing growth and increasing biologics R&D efforts. Academic research institutions and biotech ventures are increasingly opting for multimodal resins to facilitate high-resolution purification at low batch scales.

Favorable regulatory environments, talented scientific manpower, and increasing export orientation have created fertile ground for resin-based downstream innovation. As the region strengthens its role in the international CDMO landscape, the demand for effective, scalable purification equipment is likely to gain momentum. Fact.MRforecasts that CAGR of both regions will be 15.2% from 2025 to 2035.

Fact.MR Survey Results: Mixed Mode Chromatography Resin Industry Dynamics Based on Stakeholder Perspectives

(Surveyed Q4 2024, n=500 stakeholder participants evenly distributed across resin manufacturers, biopharma producers, CDMOs, and academic researchers in the US, Western Europe, Japan, China, and India)

Key Priorities of Stakeholders

• Purity & Yield Optimization: 79% of the stakeholders worldwide identified high binding capacity and low leaching as "critical" performance criteria.
• Process Flexibility: 71% highlighted the requirement for multimodal resins that are flexible across mAbs, ADCs, and vaccine manufacturing.

Regional Variance:

• US: 66% ranked scalability for continuous bioprocessing, as opposed to only 37% in Japan.
• Western Europe: 81% highlighted single-use compatibility, compared to 52% in China.
• India/China: 69% opted for cost-effectiveness because of budget-conscious biologics production, compared with 32% in the US.

Embracing Sophisticated Technologies

High Variance:

• US: 57% of participants employ resins suitable for high-throughput screening (HTS) platforms for rapid development cycles.
• Western Europe: 63% embraced resins with customized ligand chemistries for specialized biologics and gene therapy vectors.
• Japan: Only 24% incorporated automation-ready resins because of low-scale production and high needs for customization.
• India/China: 49% used pre-packed resin columns to reduce validation activity.

Convergent and Divergent ROI Views:

• 68% of US and European partners envision high-margin ROI on high-tech multimodal resins.
• On the other hand, 54% of Indian partners continue to opt for mixed-bed or conventional ion-exchange resins because of budgetary considerations.

Material & Performance Preferences

Global Consensus:

• Synthetic Ligands: 64% worldwide preferred synthetic versus biological ligands for stability and reproducibility.
• Acrylic Base Matrix: 58% preferred because of its chemical resilience in aggressive elution conditions.

Regional Difference:

• Europe: 60% highlighted environmental compatibility and biodegradable matrix choices.
• China/India: 46% chose high-capacity agarose-based resins due to familiarity and economical considerations.
• US: 71% highlighted low levels of endotoxins and efficiency in continuous chromatography.

Price Sensitivity

Shared Global Challenge:

• 83% of respondents indicated that raw material inflation (particularly for specialty ligands and polymer substrates) affected pricing by up to 22%.

Regional Split:

• US/Europe: 59% were willing to pay a 10–15% premium for multi-use, high-yield resins.
• India/China: 72% would prefer resins costing less than $1,500/L due to competitive biosimilar sectors.
• Japan: 42% would prefer lower pack sizes (<250 ml) to control cost per experiment.

Pain Points in the Value Chain

Manufacturers:

• US: 54% mentioned long lead times for custom ligands as a critical bottleneck.
• Western Europe: 48% encountered compliance barriers with REACH and EMA rules for new resin approvals.
• China: 61% encountered quality fluctuations from local raw material suppliers.

Distributors:

• US: 68% mentioned fragmentation of the supply chain due to low domestic production of base polymers.
• India: 51% expressed they had limited cold-chain facilities for temperature-sensitive resin storage.
• Japan: 56% faced retardations due to regional packaging requirements and import licensing.

End-Users (Biopharma/CDMOs):

• Europe: 43% expressed concerns regarding resin fouling and inefficiency in cleaning during multi-cycle runs.
• India: 57% expressed limited technical assistance and application training.
• China: 49% expressed limited documentation availability for GMP-compliance.

Future Investment Priorities

Alignment:

• 77% of worldwide resin producers intend to invest in tunable ligand development and AI-driven resin screening.

Regional Divergence:

• US: 64% will invest in resins compatible with continuous manufacturing and membrane chromatography R&D.
• Western Europe: 59% will invest in green resin material and recyclable packing.
• India/China: 51% concentrate on in-house resin synthesis and licensing to reduce import expenses.
• Japan: 46% will support pilot-scale hybrid resin systems with affinity and mixed-mode functionality combined.

Regulatory Influence

• US: 66% of the respondents mentioned FDA's Quality by Design (QbD) guideline as driving demand for standardization of resins.
• Western Europe: 80% thought EMA's Annex 1 and ATMP regulations would significantly increase precision-grade multimodal resin adoption.
• India/China: A mere 39% anticipated vigorous regulatory enforcement, although 72% predicted harmonization with WHO and ICH standards in the future.
• Japan: 34% regarded regulation as a second-order factor owing to sluggish growth of biologics pipelines and dependency on imports.

Conclusion: Consensus and Divergence

• Strong Consensus: Demand across the world is for high-yielding, flexible, and tough resins-particularly those GMP- and QbD-compliant.

Key Variances:

• US/Europe: Worth is in automation, precision, and sustainability.
• Asia (India/China/Japan): Cost savings, resin recycling, and ease of deployment override decision-making.

Strategic Insight:

• Resin producers need to pursue regionalized go-to-sector strategies-high-end resins for developed sectors and tough, cost-efficient versions for emerging economies.

Government Regulations

Country	Regulatory Impact & Certifications
US	FDA's QbD and cGMP regulations call for uniform resin quality; biopharma resins need to meet USP specifications.
India	CDSCO calls for resin validation in biopharma application; cost-sensitive compliance is increasing because of WHO-GMP conformity.
China	NMPA requires traceability and testing of chromatography resins used in the manufacture of drugs; stringent import certificates are mandated.
UK	Post-Brexit MHRA imposes resin documentation on GMP facilities; CE marking is still accepted for certain bioprocess equipment.
Germany	EMA and REACH regulations are in force; mandatory safety data sheets and eco-compliance for every resin component.
South Korea	MFDS requires performance certification for resins for mAb manufacturing; domestic requirements harmonized to ICH guidelines.
Japan	PMDA demands in-depth resin characterization and local tests; ISO 9001 and JIS compliance frequently required.
France	Complies with EMA's Annex 1 and REACH regulations; environmental documentation and sterility testing requirements.
Italy	AIFA requires compliance with EU directives; resin suppliers are required to comply with strict GMP validation for biologics.
Australia-New Zealand	TGA requires biocompatibility certification of resins; ISO 13485 compliance is encouraged for medical-grade applications.

Competitive Landscape

The industry for mixed-mode chromatography resin is moderately concentrated, and important industry players include Merck KGaA, Bio-Rad Laboratories, and Tosoh Corporation with considerable sector share.

These manufacturers compete on the basis of strategies that focus on innovation, strategic alliances, and capacity increases to address the growing demand for purification solutions for biopharmaceuticals.

Merck KGaA unveiled in 2024 the expansion of its chromatography resin manufacturing capacity to meet the growing demand for resins employed in the manufacturing of monoclonal antibodies and other biologic products.

Recently in 2024, Bio-Rad Laboratories launched a new series of high-performance ion-exchange chromatography resins specifically for the biopharmaceutical sector. The resins provide improved capacity and selectivity in response to the increasing demand for effective protein purification in biologics manufacturing.

Market Share Analysis

• Thermo Fisher Scientific (25-30%) - The industry leader, providing a wide portfolio of resins for biopharmaceutical purification and research uses.
• Cytiva [Danaher] (20-25%) - A leading bioprocessing player with expertise in high-performance resins for antibody and vaccine purification.
• Merck KGaA [MilliporeSigma] (15-20%) - Offers advanced mixed-mode resins for challenging biologics and large-scale production.
• Agilent Technologies (10-15%) - Specializes in high-precision resins for analytical and preparative chromatography in the pharma and biotech space.
• Bio-Rad Laboratories (8-12%) - Famous for expert resins meeting research, diagnostics, and small-scale biopharma requirements.
• Tosoh Corporation (5-10%) - Major Asian-Pacific supplier, providing new resins for difficult separations.

Key Industry Players Include

• Thermo Fisher Scientific
• Cytiva (Danaher Corporation)
• Merck KGaA (MilliporeSigma)
• Agilent Technologies
• Bio-Rad Laboratories, Inc.
• Tosoh Corporation
• GE Healthcare (now part of Cytiva in chromatography)
• Purolite Corporation
• Avantor (including VWR & Pall acquisitions)
• JSR Micro Inc.
• Kaneka Corporation
• Sepragen Corporation
• Repligen Corporation
• Bio-Works Technologies
• Mitsubishi Chemical Corporation
• Hitachi Chemical (now part of Showa Denko)
• Sartorius AG (via separation technologies)
• Waters Corporation (analytical chromatography focus)

Segmentation

Segmentation by Type:

Ion Exchange-Hydrophobic Type, Hydroxyapatite Type, Others

Segmentation by Application:

Antibodies Production, Vaccine Production, Non-antibody Proteins, Antibody-drug conjugate, Separation of low molecular weight impurities

Segmentation by Region:

North America, Latin America, Europe, Asia Pacific, Middle East and Africa (MEA)