Liquid Chromatography for Biopharmaceuticals Market | 2032

Report Description

Liquid Chromatography for Biopharmaceuticals Market Outlook 2032 

The global liquid chromatography for biopharmaceuticals market size was USD 7.2 Billion in 2023 and is likely to reach USD 12.2 Billion by 2032, expanding at a CAGR of 6.0% during 2024–2032. The market is attributed to the rising demand for biopharmaceuticals and increasing pharmaceutical R&D activities.

Liquid chromatography (LC) and mass spectrometry (MS) are widely used techniques for characterizing biopharmaceuticals during drug development. It is used for routine analysis using UV-visible, fluorescence, and light-scattering detectors. LC methods assess critical quality attributes such as purity, chemical modifications, aggregation, charge variants, and impurities in complex matrices.

Several methods are well established for identifying proteins or separate other molecules. Peptide mapping is a method for identifying proteins, monitoring structural integrity, and determining amino acid modifications. It involves digestion with enzymes such as trypsin, followed by fragment identification.

A rapid method using reverse phase chromatography or HPLC with UV detection has been developed for monoclonal antibody estimation. Size-exclusion chromatography (SEC) is a technique used to separate molecules based on size or molecular weight, with UV detection being preferred for studying protein aggregation and disintegration. Ion-exchange chromatography (IEX) with UV detection is effective in detecting charge-variants and understanding protein-protein interactions in native states.

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Impact of Artificial Intelligence (AI) in Liquid Chromatography for Biopharmaceuticals Market

Artificial Intelligence significantly impact the liquid chromatography for biopharmaceutical market in several ways which are potentially enhancing the process. The optimization of method with reduced time and experimentation involves intensive experimentation. AI analyses historical data to predict optimal separation parameters and reduces the time of research.

The improved accuracy and reliability automate peak identification in chromatograms by minimizing human errors. Moreover, the advanced data analysis and interpretation allows researchers to gain deep insights and drive the global market. Predictive maintenance and system optimization detects the faults before they actually occur resulting in the reduction of downtime an ensuring the consistent performance of liquid chromatography.

Liquid Chromatography for Biopharmaceuticals Market Dynamics

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Major Drivers

Increasing pharmaceutical R&D activities is driving the global liquid chromatography for biopharmaceuticals market. Rising investments of key players and government organization for enhancing biopharmaceutical production are increasing the demand for a precise purification process. Liquid chromatography provides specific purification, identification, and separation of proteins, ions, and molecules.

Rising demand for biopharmaceuticals is fueling the global market. Development of complex drugs such as, monoclonal antibodies and gene therapies requires stringent quality control and characterization of molecules. This process requires a reliable method for quality drug development and discovery, propelling the global market.

Growing importance of HPLC tests in drug approvals is boosting the market significantly. Regulatory agencies such as, the US Food and drug Administration (FDA) increasingly recognize liquid chromatography as a reliable and valid technique for biopharmaceutical analysis. Rising demand of high-quality drugs increases the importance of advanced liquid chromatography methods for purification.  

Advancements in technologies in liquid chromatography such as, ultra high-performance chromatography (UHPLC), offers a fast analysis with greater resolution as compared to traditional HPLC, enhances the efficiency and accuracy of biopharmaceutical analysis and drive the market share.

Existing Restraints

High cost of instruments and other consumables for research labs are expected to restrain the market. The ongoing cost of purchasing replacements columns, solvents, and other consumables adds up in the high costs significantly.

Limited availability of skilled professional for operating and maintaining sophisticated liquid chromatography systems is hindering the market. The adoption and efficient utilization of these specialized systems requires training and knowledge of the system and labs.

Emerging Opportunities

Combining LC with other analytical tools such as, mass spectrometry (MS) or spectroscopy offers a more comprehensive analysis of biopharmaceuticals. New developments in hyphenation technology are expected to enhance sensitivity, resolution, and overall characterization capabilities. The advancements in hyphenated techniques are expected to drive the global market during the forecast period.

Rise in microfluidic liquid chromatography systems offers a miniaturized form of the system allowing fast analysis and low solvent consumption and providing potentially high throughput. Microfluidic technology holds a promising future of point of care application and streamlined biopharmaceutical analysis workflows, attributing to the market in the coming years.

Expansion into emerging markets with growing investments in biopharmaceutical research and development in regions such as, Asia Pacific, the demand for liquid chromatography for biopharmaceuticals surge. This presents an opportunity in the market expansion for liquid chromatography in biopharmaceuticals.

Scope of the Liquid Chromatography for Biopharmaceuticals Market Report

The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Liquid Chromatography for Biopharmaceuticals Market  Segment Insights

Technique Segment Analysis

Based on technique, the liquid chromatography for biopharmaceuticals market is divided into HPLC, LPLC, FPLC, and UPLC. The HPLC segment is expected to expand at a significant pace during the projection period due to the high efficiency and dependability. The high-pressure liquid chromatography (HPLC) is an emerging field with recent developments and advancements in the technology. The purpose of HPLC in drug analysis is drug identification and monitoring the therapeutic progress.

Major HPLC manufacturers expanding their product lines for specialized markets such technique development, clinical diagnostics, preparative purification, amino acid analysis, and two-dimensional liquid chromatography is boosting the segment growth. For instance,

• In 2020, With a combined reported 85% of the HPLC market share, the four leading producers of HPLC equipment (Agilent, Shimadzu, Thermo Fisher Scientific, and Waters) remain dominant in the instrumental industry.
  

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Type Segment Analysis

On the basis of type, the global market is segregated into instruments, consumables, software & accessories. The instrument segment is anticipated to register a considerable CAGR in the coming years due to its high cost. Furthermore, the growing focus on automation and streamlined workflows is propelling segment growth. Modern LC instruments are equipped with automation capabilities that facilitate faster sample processing and data analysis. This not only saves time but also minimizes human error, leading to improved efficiency, and data consistency.

The biopharmaceutical market is constantly evolving, with new applications and research areas emerging. Instrument manufacturers are continuously developing new LC systems or modifying existing ones to cater to these evolving needs. This continuous adaptation to market demands fuels growth in the instrument segment.

End-user Segment Analysis

On the basis of end-user, the liquid chromatography for biopharmaceuticals market is segmented into pharmaceutical companies, research & academics, contract research organizations. The pharmaceutical companies’ segment is expected to register a robust growth rate during the forecast period due to increasing demand for pharmaceutical products and growing R&D investments in drug discoveries and development. The efficiency of liquid chromatography to separate the molecules and impurities from the biopharmaceutical products is leading to a significant rise in the segment share.

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Regional Analysis

In terms of region, the global liquid chromatography for biopharmaceuticals market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the forecast period owing to increasing R&D activities. Rising investments for the R&D activities by government organization and key market players residing in this region is fueling the global market. Moreover, increasing incidences of chronic diseases is boosting the demand for a sophisticated system for diagnostics and drug discovery. Furthermore, increasing approval rates of biopharmaceutical products in this region is fueling the regional market. For instance,

• In 2022, according to the Nature Biotechnology, the survey period between January 2018 and June 2022 reported that, when sorted by product trade name, 197 biopharmaceutical products were approved in the US and/or EU. The total number of biopharmaceutical products licensed in these territories has increased to 541 with these additional approvals, comprising 435 different active biopharmaceutical ingredients. However, over time, 98 products, almost invariably for commercial reasons have been taken off the market after receiving approval in one or both regions.
  

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