Gel permeation chromatography market is expected to gain significant traction with increasing development in novel drugs and excipients by manufacturers and increasing R&D initiatives by research foundations. Furthermore, new product launches and regulatory demand for manufacturing quality pharmaceuticals is expected to drive growth of the market for the gel permeation chromatography market.
New products and collaboration among key players to integrate gel permeation chromatography system and component is expected to drive growth of the market
Key players are launching innovative products in gel permeation chromatography system and component, in order to cater to increasing demand. For instance, in January 2015, Malvern Instruments launched novel OMNISEC gel permeation chromatography/ size exclusion chromatography system, which has one of most sensitive light scattering detector that allows measurement even at minute sample quantity. It has multidetectors component OMNI REVEAL that has different kinds of detectors such as refractive index meter, light scattering detectors, and Viscometer, which allows precise measurement of different analytes. Postnova Analytics in 2016, launched first filed flow fractionation based gel permeation chromatography instrument called TF2000 Thermal FFF, which allows better separation and purification of polymers over conventional GPC system. In 2016, Agilent launched AdvanceBio size exclusion chromatography columns at Analytica China.
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Companies are focusing on co-marketing agreement, for integration of component of one company with GPC systems of other. For instance, in January 2018, Waters Corporation and Malvern Panalytical entered into a co-marketing agreement with Malvern Panalytical. It would result in pairing of the Waters ACQUITY Advanced Polymer Chromatography System with Malvern Panalytical’ s OMNISEC REVEAL, which provides high sensitivity, higher resolution data, and access to samples without the need for column calibration. Some companies are focusing on mergers to expand their footprint in the global market. For instance, in 2017, Malvern Instruments Ltd. and PANalytical B.V. merged together, and combined to form an entity, Malvern Panalytical. In 2014, Malvern acquired MicroCal from GE healthcare whose microcalorimetry range is used for its innovative OMNISEC GPC/SEC platform
Figure 1. Global Gel Permeation Chromatography Market (US$ Mn), by Region
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.
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.
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