The Growing Importance of Chromatography in Biologics Production

Chromatography remains a foundational technology in pharmaceutical, biopharmaceutical, and life sciences manufacturing, enabling critical decisions from early development through commercial release. Rapid growth in biologics and advanced modalities, heightened regulatory oversight, digitalization of laboratories, and increasingly complex separations have collectively raised expectations for analytical performance, reproducibility, and system availability across industries.

Within biopharma’s evolving landscape, chromatography systems have become a strategic priority for industries due to their essential role in ensuring product purity, enabling rapid drug development, and meeting tightening regulatory standards. As analytical demands rise, these systems are now viewed as foundational tools for operational resilience, quality control, and accelerating time-to-market.

What was once viewed primarily as a laboratory separation technology is now evolving into a mission-critical manufacturing platform spanning process development, analytical characterization, purification, quality assurance, and commercial production.

The purity mandate

The global health care landscape is at a critical juncture. According to the International Agency for Research on Cancer, nearly 20 million new cancer cases were diagnosed in 2022, a figure projected to surge beyond 35 million by 2050.¹ In response to this rising disease burden and the explosion of chronic metabolic disorders, the industry is witnessing a massive influx of R&D investment. This effort was reflected in FDA’s 2025 approvals, which saw 46 novel therapies reach the market.²

Moving these therapies from the lab to the commercial production line hinges on high-resolution purification. To meet the purity mandate, manufacturers must choose between 2 primary chromatographic pathways:

• Gas chromatography (GC): While indispensable for analyzing volatile impurities and raw materials during quality control, GC involves nonreusable carrier gases. This makes it a high-cost operational expenditure, reserved primarily for specialized analytical tasks where no liquid-phase alternative exists.
• Liquid chromatography (LC): As the industry workhorse, LC (including high-performance LC [HPLC] and ultrahigh-performance LC [UHPLC]) commands more than 80% of the market.³ Its dominance is fueled by its ability to handle structurally sensitive biomolecules and the economic advantage of solvent recovery and reuse, making it the preferred choice for commercial-scale bioprocessing.

Rather than being competing technologies, LC and GC increasingly operate as complementary systems within integrated pharmaceutical analytical ecosystems.

The shift toward single-use manufacturing architectures

Traditional stainless-steel/multiuse systems still dominate large-volume commercial manufacturing due to their robustness and suitability for established blockbuster products. However, the economics of modern biologics development are rapidly favoring more flexible manufacturing models.

Clinical pipelines are becoming increasingly diversified. Smaller patient populations, personalized therapies, accelerated development timelines, and multiproduct manufacturing facilities are creating demand for purification systems that can be deployed quickly, reconfigured efficiently, and validated with minimal operational disruption.

Single-use chromatography platforms directly address those requirements. Their advantages extend beyond convenience. Disposable flow paths significantly reduce cleaning validation burdens, minimize cross-contamination risks, shorten turnaround times between batches, and improve manufacturing agility in multiproduct environments.

For contract development and manufacturing organizations (CDMOs), those operational efficiencies are particularly valuable. Facilities serving multiple sponsors must continuously switch between products, processes, and production scales. Single-use systems allow far greater scheduling flexibility while reducing downtime associated with cleaning and sterilization procedures.

Although multiuse systems still represent the majority of installed chromatography infrastructure, the growth trajectory of disposable platforms is substantially faster. Industry forecasts suggest the single-use segment could expand at nearly 2.5 times the growth rate of traditional systems through 2030.³

Suppliers are responding with increasingly sophisticated disposable architectures that integrate sensors, connectors, tubing assemblies, and process monitoring technologies into modular purification platforms. Material innovation is also advancing adoption. Several manufacturers are now developing reinforced polymer-based chromatography columns utilizing polypropylene and fiberglass composite structures designed specifically for disposable bioprocess environments.

How is Asia-Pacific reshaping the competitive landscape?

While North America (NA) will remain the unassailable leader of the biopharma chromatography market through 2030, the industry’s long-term geographic center of gravity is gradually shifting toward the Asia-Pacific region. NA, led mostly by the US, remains dominant due to its concentration of major life sciences companies, deep capital markets, mature CDMO infrastructure, and sustained R&D investment. Europe also maintains a strong position through established pharmaceutical manufacturing ecosystems in Germany, France, Switzerland, and the United Kingdom.

The most consequential expansion is occurring across Asia, however. China has rapidly emerged as the world’s second-largest chromatography systems market, supported by aggressive domestic biopharmaceutical investment and government-backed health care expansion initiatives. In response, major suppliers, including Cytiva, Merck, and Pall, have expanded local manufacturing footprints to strengthen regional supply resilience and support localized production demand.

India is simultaneously establishing itself as a major global bioprocessing hub. Investments in biologics manufacturing infrastructure, biosimilars production, and CDMO capabilities are accelerating demand for advanced purification technologies across the country. In addition, Singapore and South Korea are strengthening their positions as strategic biotechnology manufacturing centers, supported by advanced infrastructure, skilled technical workforces, and government-led life sciences investment programs.

This regional transition carries significant strategic implications for multinational pharmaceutical companies. Manufacturing networks are no longer concentrated solely around Western production hubs. A competitive advantage increasingly depends on building purification infrastructure capable of supporting geographically distributed biologics production at a global scale.

What key challenges are restraining the chromatography market?

Despite strong long-term demand, the chromatography market continues to face structural pressures. First, the high capital cost of chromatography infrastructure remains a major barrier, particularly for small biopharma firms, academic laboratories, and emerging-market manufacturers.

The average initial investment costs of skids range from $10,000 to $75,000 for HPLC, $50,000 to $150,000 for UHPLC, and $200,000 to $500,000 for single-use skids.³ Such high initial investment costs for HPLC and UHPLC systems create a steep entry barrier for budget-constrained testing laboratories. Also, as labs attempt to handle higher sample volumes, the need for additional equipment can strain operational budgets.

Secondly, competitive pressure from alternative separation technologies is intensifying. Techniques such as capillary electrophoresis, protein crystallization, and high-pressure refolding are gaining traction in select biologics and protein-processing applications due to their lower operational costs, faster processing capabilities, and simplified workflows.

To overcome high system costs, the industry is rapidly shifting toward single-use and modular chromatography platforms that reduce cleaning, validation, and facility overhead while improving manufacturing flexibility. Moreover, advances in continuous bioprocessing, automation, and process analytical technology-enabled real-time monitoring are helping manufacturers increase productivity, reduce batch failures, and improve cost efficiency against competing purification technologies.

The future of biomanufacturing will be defined by purification

The biopharma industry is entering an era in which purification capability directly influences market access, supply resilience, and commercial viability. For example, rare diseases are affecting more than 300 million people worldwide and remain one of the largest areas of unmet need in global health, according to the World Economic Forum.⁴ Meanwhile, competitive investment into obesity and metabolic therapies continues to intensify. Eli Lilly and Company, Novo Nordisk, AstraZeneca, and numerous emerging biotech companies are aggressively expanding R&D and manufacturing investment to capture these rapidly growing therapeutic markets.

Discovery alone is insufficient. Every monoclonal antibody, peptide therapy, gene therapy, or antibody-drug conjugate must ultimately move through a highly controlled purification infrastructure before reaching patients. That infrastructure must support regulatory compliance, process scalability, product consistency, and cost efficiency simultaneously.

Chromatography systems therefore occupy a far more strategic position than their historical laboratory association might suggest. Driven by rapid growth in biologics, cell and gene therapies, and next-generation therapeutic modalities, the global biopharmaceutical market is expected to surpass $5.7 billion by the early 2030s.³

These systems are no longer simply analytical tools operating behind the scenes of drug development. They have become foundational enablers of modern biologics manufacturing, and, increasingly, a critical determinant of which companies can successfully industrialize the next generation of advanced therapeutics.

About the author

Chandana Patnaik is a senior strategist (content) at Stratview Research.

References

1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834
2. Mullard, A. 2025 FDA approvals. Nat Rev Drug Discov. January 2, 2026. Accessed July 17, 2026. https://www.nature.com/articles/d41573-026-00001-z
3. Stratview Research. Biopharma chromatography systems market size, share, trend, forecast, competitive landscape, & growth opportunities: 2026-2030. November 2025. Accessed July 17, 2026. https://www.stratviewresearch.com/market-reports/biopharma-chromatography-systems-market
4. World Economic Forum. Making rare diseases count: how better data can unlock a multitrillion-dollar opportunity. February 24, 2026. Accessed July 17, 2026. https://www.weforum.org/publications/making-rare-diseases-count-how-better-data-can-unlock-a-multitrillion-dollar-opportunity/