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The biotherapeutic manufacturing chromatography market is on track to experience significant growth from 2024 to 2035, fueled by increasing demand for biotherapeutics like monoclonal antibodies (mAbs), vaccines, and gene therapies. Chromatography remains a pivotal technique in ensuring the purity and efficacy of these products during manufacturing. The market expansion is driven by advancements in chromatography technologies and increased investments in biologics, supported by strong regulatory backing for biopharmaceuticals.
Innovations such as AI-driven chromatography systems and continuous bioprocessing technologies are projected to become more prevalent by 2035. Customized chromatography solutions will gain traction as precision medicine demands grow, with next-generation resins and hybrid matrices offering cost-effective and scalable production options.
The surge in biotherapeutics, including mAbs, vaccines, biosimilars, and gene therapies, is notably propelling the market. In 2022, biologics represented approximately 40% of total drug approvals by the FDA, highlighting the industry's investment in advanced chromatography systems to meet production demands. The COVID-19 pandemic also amplified the need for efficient purification technologies, especially for viral vectors in vaccine development, underscoring chromatography's crucial role.
Regulatory agencies like the FDA and EMA advocate for high-throughput purification strategies to enhance manufacturing efficiency, further driving market growth. Gene therapy and RNA therapeutics present opportunities for chromatography manufacturers, as these therapies require high-purity purification. The rise of mRNA vaccines, such as those by Pfizer-BioNTech and Moderna, has increased demand for nucleic acid purification technologies.
Despite its bright prospects, the market faces challenges due to the substantial cost of chromatography equipment, particularly Protein A resins, which are essential for mAb purification. The high cost poses financial constraints, especially for smaller companies.
Leading companies are actively expanding their portfolios and market presence. In May 2023, Pall Life Sciences merged with Cytiva to form a new Biotechnology Group, aimed at streamlining bioprocessing operations. Merck KGaA is also advancing its technology to meet growing demands. In June 2024, Purolite, partnered with Repligen Corporation, launched DurA Cycle, a protein A chromatography resin designed for large-scale mAb purification.
Key market players include Pall Corporation, Merck KGaA, Bio-Rad Laboratories, Thermo Fisher Scientific Inc., Cytiva, YMC CO., LTD., and Purolite Repligen Corporation.
Market Segmentation:
- By Product: Consumables, Equipment, Software
- By Type: Affinity Chromatography, Ion Exchange Chromatography, Size Exclusion Chromatography, Hydrophobic Interaction Chromatography
- By Matrix Type: Polystyrene-Based Matrices, Methacrylate-Based Matrices, Silica-Based Matrices, Polyacrylamide-Based Matrices, Inorganic Hybrid and Composite Matrices
- By Application: Monoclonal Antibodies (mAbs), Vaccines, Cell & Gene Therapy, Other Biotherapeutics
- By End User: Biopharmaceutical Companies, Contract Manufacturing Organizations (CMOs), Academic and Research Institutions
- By Region: North America, Europe, Asia-Pacific, Latin America, Middle East and Africa
Consumables lead the product segment, driven by ongoing R&D activities requiring high-quality chromatography consumables. Polystyrene-based matrices dominate the matrix type segment due to their durability and efficiency in large-scale operations. Monoclonal antibodies are the leading application segment, with high demand for robust purification processes. Biopharmaceutical companies remain primary investors in chromatography systems, and North America leads the regional market due to its established biopharmaceutical sector and supportive regulatory environment.
Key Topics Covered:
Executive Summary
Scope of the Study
Research Methodology
1. Market
1.1 Market Outlook
1.2 Industry Outlook
1.3 Business Dynamics
2. Global Biotherapeutic Manufacturing Chromatography Market (By Product Type), $ Million
2.1 Overview
2.2 Opportunity Assessment
3. Global Biotherapeutic Manufacturing Chromatography Market (By Type), $ Million
3.1 Overview
3.2 Opportunity Assessment
4. Global Biotherapeutic Manufacturing Chromatography Market (By Matrix Type), $ Million
4.1 Overview
4.2 Opportunity Assessment
5. Global Biotherapeutic Manufacturing Chromatography Market (By Application), $ Million
5.1 Overview
5.2 Opportunity Assessment
6. Global Biotherapeutic Manufacturing Chromatography Market (By End User), $ Million
6.1 Overview
6.2 Opportunity Assessment
7. Global Biotherapeutic Manufacturing Chromatography Market (By Geography), $ Million
7.1 Overview
7.2 Opportunity Assessment
8. Competitive Benchmarking and Company Profiles
8.1 Competitive Benchmarking
8.2 Key Development Analysis
8.6 Market Share Analysis
8.7 Company Profiles
8.8 Other Players
Companies Featured
- Pall Corporation
- Merck KGaA
- Bio-Rad Laboratories
- Thermo Fisher Scientific
- Cytiva
- YMC CO., LTD.
- Purolite
- Repligen Corporation
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