Gel Permeation Chromatography Market - The Exclusive Exclusion Technique
Gel permeation chromatography is size exclusion technique used for separation and characterization of polymers. It is an exclusive technique to perform polymer characterization, in order to assess the molecular weight distribution of an analyte. Profiling of the polymer is important as it affects physical properties such as brittleness, elasticity, and toughness in its end use. Gel permeation chromatography system is based on principle that different component shows different affinity towards stationary phase (Column Packing material). Smaller component gets trapped in the pores of the packing material therefore, these show high retention time. On the other hand, larger component in analyte surpasses stationary phase without much affinity therefore, has lower retention time. Based on this data, processing unit shows varying peaks on display according to which cauterization and separation of the analyte can be done. Gel permeation chromatography system consists of various component such as pump system, injector system, columns, detectors, and data proceeding systems.
The global gel permeation chromatography system was valued at US$ 929.2 million in 2016 and is expected to witness a robust CAGR of 7.0% over the forecast period (2017–2025).
Figure 1. Global Gel Permeation Chromatography Market (US$ Mn), by Region, 2016
Increasing research and development by pharmaceutical and biotech companies in chronic disease is expected to propel growth of the gel permeation chromatography market
Increasing focus on research and development activities by pharmaceutical and biotech companies across the globe, targeting chronic diseases such as cancer to bring novel therapies, is expected to aid in growth of the market. These are protein (Natural Polymer) based therapies such as CAR-T cell therapy, antibody-drug conjugates, and immune check point inhibitors. According to report in 2017 by International Federation of Pharmaceutical Manufacturers and Associations, research based pharmaceutical and biotech companies annually invest around US$ 149 billion on research and development. Over 7,000 molecule are under investigation, out of which around 2,000 candidate are for cancer. Therefore, separation and characterization of new chemical entity, which are polymer-based is possible efficiently with gel permeation chromatography and this is expected to aid in growth of the market in the near future. Moreover, most of these drug under investigation are in preclinical study, which consists of studying structure and component of new chemical entity, which demands GPC system. However, cost associated with gel permeation chromatography system and its component is high, which limits use of instrument in academic institutes except pharmaceutical companies. Other analytical instruments are such as LC-MS are more widely used, due to large number application, which is expected to hinder growth of gel permeation chromatography market.
Regulatory approvals for use of novel excipients (Polymers) is expected to drive growth of the gel permeation chromatography market
Pharmaceutical and biotech companies widely use polymers as excipient (Binder, Diluent, coating agents, suspending agent, viscosity agent, and Disintegrant) to produce variety of dosage form. There is increasing use of natural polymers instead of synthetic one due to inertness, low cost, and higher acceptability of consumers towards natural polymers. Various recently launched natural polymers from different manufacturers are Solutol HS 15, Soluplus, Kollicoat Smartseal 30 D, Polyplasdone Ultra, and Prosolv ODT. However, before using polymers in formulation, end user (pharmaceutical and biotech companies) has to be confident about quality of polymers used as excipients. USFDA demands Quality by Design in manufacturing the formulations (non-adherence otherwise leads to product recalls). Therefore companies have to characterize these polymers for quality parameters. This needs efficient GPC systems. Moreover, companies have to adhere to ICH guideline (M4Q), which requires novel excipients to characterize their functionality and physicochemistry.
Key players operating in gel permeation chromatography market are Agilent Technologies, Waters Corporation, Malvern Panalytical, Shimadzu Corporation, and Polymer Char.
Gel permeation chromatography is a size exclusion based chromatography technique. It is most commonly used to determine the molecular weight distribution of the polymer which confirms its purity. It is also used to separate various component of the analyte, based on their retention with stationary phase. Both aqueous and non-aqueous mobile phases are used in gel permeation chromatography based on analyte and column’s packing material. Variety of detectors can be used such as refractive index detectors, light scattering detectors, viscometer, and diode array/UV detectors, which measures concentration, informs about size, and structure of analyte.
Major factor driving growth of the gel permeation chromatography market is increasing research for chronic disease such as cancer. According to report by International Agency for Research on Cancer (IARC) in 2012, around 14.1 million new cases, 8.8 million deaths, and 32.6 million people were suffering from cancer worldwide. North America has high incidence of cancer with an estimated 1,735,350 new cancer cases to be diagnosed in the U.S. in 2018, as reported by American Cancer Society’s Cancer Journal for Clinicians. Companies are focusing on protein-based gene therapy also termed as personalized medicine that studies various body proteins such as monoclonal antibodies for developing novel therapies. GPC system is used in this process to know molecular weight, separation as it would decide final physical attribute of the analyte. Expiration of patent of blockbuster drugs such as Rituximab is leading to development of biosimilar versions of the same drugs, where GPC system is important to compare and profile biosimilar and innovator molecule. Major players are also bringing products with new technologies and multiple detectors to precisely analyze the polymers.
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