HPLC- The giant in the laboratory market
Coupled with the global healthcare crisis from the pandemic, strengthening India’s pharma sector is now a national security imperative. With the FSSAI stiffening rules, the HPLC industry is expected to get the requisite impetus.
Despite the fact that chromatography has been around for a while, both the method and the applications for it continue to develop. In 2022, the approach was modified to address brand-new, difficult applications. Since its inception, high-performance liquid chromatography (HPLC) has benefited from numerous technological developments, including improvements in detectors, column and pump technology, accuracy, and automation. These developments have made it possible to conduct high-quality analyses that deliver more precise results in less time while improving user convenience in general.
As the industry develops, pharmaceutical companies are focusing more on novel biologic therapies. An unprecedented range of applications, particularly in the pharmaceutical and biopharmaceutical industries, has been made possible by improvements in columns, stationary phases, detectors, injection devices, and chromatography techniques. In particular, monoclonal antibody characterization, antibody-drug conjugates, quality control, and analytical technologies have seen an increase in the use of ultra-high-performance liquid chromatography (UHPLC) in bioprocessing applications. These systems were developed to satisfy the requirements of the time-consuming drug development processes, which also require extensive data gathering, organization, analysis, precise findings, and quick separation.
The Indian HPLC instruments market is estimated at ₹1260.94 crore in 2021 by value, and 5900 units by quantity. This is a 9.95-percent increase over 2020 and a 6.68-percent increase over 2019, by value. By quantity, it is an 11.59-percent increase over 2020 and a 7.27-percent increase over 2019. The market had declined in 2019, largely because of FDA approvals pending for most vendors.
Shimadzu and Waters continue to dominate, with Agilent and Thermo Fisher also aggressive in this segment. The other brands, Trivitron, PerkinElmer, Hitachi, Tosoh, Knauer, Young Ling, and Jasco, have a miniscule presence.
Indian HPLC systems market
|Tier I||Tier II||Others|
|Waters and Shimadzu||Agilent and Thermo Fisher||Trivitron, PerkinElmer, Hitachi, Tosoh, Knauer, Young Ling, and Jasco|
|*Vendors are placed in different tiers on the basis of their sales contribution to the overall revenues of the Indian HPLC systems market.|
ADI Media Research
2022 was a better year, with pharma, food, and chemical sectors showing traction. The global movement to de-risk from China has presented opportunities for India for building sustainable businesses that can cater to the global and local demand for medicines well into the future. In 2020, over 70 percent of India’s key starting materials (KSM), intermediaries, and APIs came from China. Coupled with the global healthcare crisis from the pandemic, strengthening India’s pharma sector is now a national security imperative. With the Food Safety and Standards Authority of India (FSSAI) stiffening rules, the HPLC industry is expected to get the requisite impetus too.
The focus of the government buying that was diverted to addressing issues from Covid is now back to procuring HPLC systems. The replacement market is also gaining momentum.
New products have been introduced Shimadzu Scientific Instruments announced the new i-Series LC-2050/LC-2060 integrated high-performance liquid chromatographs (HPLC). Building on the exceptional performance of previous versions, the i-Series LC-2050/LC-2060 models incorporate analytical intelligence functions, enable complete automation from start-up to analysis preparations, and allow remote monitoring and data processing.
Waters Corporation launched the next generation in liquid chromatographs solution that leverages HPS to vastly improve analytical data quality and eliminate the need for time-consuming and costly passivation. It is designed to alleviate the problem of analyte/metal surface interactions when analyzing organic acids, organophosphates, oligonucleotides, phosphopeptides, acidic glycans, and phospholipids by reversed phase and hydrophilic interaction chromatography.
New technologies are continuously being introduced to improve the efficiency of the analytical laboratory. One area where efficiency could be increased is the analysis of samples at the source. This is particularly important in a range of analytical processes, and has resulted in a significant rise in the use of hand-held spectroscopic instrumentation, for example. However, it is not just spectroscopic devices that can be employed for at-source sample analysis. Portable LC systems, in particular, also offer significant advantages for certain applications.
There is a growing need for scientists to be able to perform analytical measurements at the sample source, instead of collecting samples and returning them to a central laboratory for analysis. This approach can help in terms of reducing the analysis costs but will also have an impact on the timeliness of the data and potentially its integrity as well if the sample degrades. Historically, this has been difficult to achieve due to the size, cost, and complexity of the instrumentation that is required to perform the analysis. Recent advances in fluidics and LED technology have facilitated the design of HPLC systems small enough to be fully portable rather than luggable. This allows samples to be analyzed in situ, bringing substantial benefits; however, it is important that in doing so there is no compromise in the quality of the data that is being produced. There is a range of such instruments that are currently available.
Recent years have also seen the development of HPLC instruments that can monitor operational readiness through routine and automated system health checks. As a result, the early tell-tale signs of poor performance can be flagged in good time, ensuring any potential issues are resolved early, and significantly reducing unscheduled downtime or the need to re-run samples. Some of the most advanced LC instruments also incorporate intuitive diagnostic tools to quickly identify and troubleshoot issues. These systems can even display step-by-step maintenance videos on intuitive touch-screen displays, helping analysts quickly remedy issues and get workflows back online and running again faster.
Productivity is a key challenge for analytical laboratories across a variety of sectors, and the pharmaceutical industry is no exception. For contract development and manufacturing organizations (CDMOs), who work with a wide range of customers, diversity in analytical capability is an important consideration.
This was the situation facing a global CDMO looking to increase the flexibility and efficiency of its LC systems in order to enhance its capabilities and expand its customer base. A key factor in this decision was the need for an LC platform that would simplify and accelerate method transfer workflows. Design features, such as active solvent pre-heating, were critical. This allowed the laboratory to standardize analytical performance through enhanced unit-to-unit thermal consistency, while the ability to use tool-free fluidic connections ensured full compatibility with any separation column. Other innovations, including built-in adjustable gradient delay volume control and multiple column heating modes, allowed teams to fine-tune method parameters to achieve the highest levels of reproducibility, further supporting faster method transfer.
Deployment of the new UHPLC platforms at its sites across the globe helped the organization expand its assays, such as released glycan analysis, peptide mapping and monitoring, as well as purity and ratio analysis. By increasing operational flexibility, these solutions played a critical role in boosting efficiency and productivity, while maintaining the highest standards of analytical excellence.
Analytical laboratories in a variety of industries are turning to the most recent HPLC technologies to boost productivity as workloads rise and companies look to grow. Innovative labs are streamlining the movement of both analysts and samples, thanks to modern HPLC solutions to achieve significant increases in capacity and efficiency.