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Chromatography in Pharmaceuticals and Biotechnology: Global Markets

Chromatography in Pharmaceuticals and Biotechnology: Global Markets

  • November 2018
  • 336 pages
  • ID: 5628478
  • Format: PDF
  • BCC Research

Summary

Table of Contents

Report Scope:
According to the BCC Research report BIO011G Separation Systems for Commercial Biotechnology, chromatography accounted for nearly 21% of the overall market in 2015. In another BCC report, MST034E Global Markets for Reagents for Chromatography, the market that was valued at $7.6 billion in 2014 is estimated to reach $10.7 billion by 2019, growing at a compound annual growth rate (CAGR) of 5.2% through 2019. Chromatography is a valuable tool particularly in the pharmaceutical and biotechnology sectors as it can provide highly sensitive information about product quality and purity. The implementation of process analytical technology has also given a boost to this market. The growing demands of biopharmaceuticals, particularly monoclonal antibodies, biosimilar drugs and others have also necessitated biotechnology and biopharmaceutical industries to invest in high-throughput bioprocessing and downstream processing instruments. The advances in technology for the development of improved systems, innovative and disposable columns, better-performing resins, and other accessories are helping this market to grow significantly.

This BCC report provides a comprehensive analysis of the chromatography market in the global context, including market forecasts and sales through 2023.The report includes assessment of the chromatography market by segmenting it into the broad categories of instruments and reagents followed by thorough analyses of various techniques of chromatography for each category.

These include liquid chromatography (ion-exchange, hydrophobic-interaction, size-exclusion, flash), high-pressure liquid chromatography (HPLC)/ultra-high-pressure liquid chromatography (UHPLC), thin layer chromatography, gas chromatography, supercritical fluid chromatography and affinity chromatography.This study surveys the chromatography market in all the geographic regions including North America, Europe and emerging markets.

The emerging markets include countries such as India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America and others. BCC Research has analyzed the chromatography market by applications in the pharmaceutical and biotechnology sectors.

Chromatography is a continuously evolving technique, and its success is dependent on the innovations in technology.Therefore, this report discusses the emerging trends in chromatography technology, particularly the instruments and the reagents.

It also features the new developments and new product launches in the global market.

The report provides relevant patent analyses and comprehensive profiles of market players in the industry.The Industry Structure chapter focuses on the important chromatography instruments and reagent manufacturers and suppliers, their market shares and product offerings.

The chapter also covers the mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that are expected to shape the industry.

BCC’s new report on chromatography elaborates on the strengths, weaknesses, threats and opportunities of the global chromatography market. Any regulatory changes or new initiatives are also highlighted.

Excluded from this report are the applications of chromatography in industries other than pharmaceutical and biotechnology such as chemicals, food and beverage, environment, oil and gas and others.Also, instruments and reagents for capillary electrophoresis and solid phase extraction (SPE) are not included.

The sales for LC/MS instruments are not included as part of this study, although the systems are referred to in this report to show the uptake of liquid chromatography instruments in related applications.

Report Includes:
- 47 data tables and 44 additional tables
- An overview of the global market for chromatography in pharmaceuticals and biotechnology applications
- Analyses of global market trends with data from 2016 and 2017, estimates for 2018, and projections of compound annual growth rates (CAGRs) through 2023
- Characterization and quantification of market potential for chromatography instruments and reagents by technology type, application and geographical region
- Identification of the segments that should experience high growth during the time frame covered
- Information on competitor initiatives, and information pertaining to research and development status of chromatography in pharmaceuticals and biotechnology
- Coverage of significant patents and their allotments in each category
- Comprehensive profiles of major players in the industry, including Bio-Rad Laboratories Inc., Danaher Corp., MilliporeSigma, Qiagen, N.V., Scion Instruments and Thermo Fisher Scientific Inc.

Summary
Chromatography occupies a prominent place in the analytical and separation domain, particularly in the pharmaceutical and biotechnology sectors.The technique has evolved from a simple paper chromatography method to a high-pressure, high-performance method that has the capacity to detect in the range of nanomolar and picomolar concentrations in substances.

The advances in technology have brought about improvements in chromatography methods leading to higher resolutions, peak separation, enhanced sensitivity, and faster speeds of analysis. The growing need for data integrity and automation has led to the integration of sophisticated software with contemporary chromatography
systems.

There are a growing number of diseases and aging populations around the world.The need for innovative therapies and drugs has intensified drug research activities.

Proteomics and metabolomics studies have also been directed at the characterization of new biomarkers and unidentified proteins that will lead to better diagnoses. An increase in the demand for chromatography instruments and reagents for research and development is a major factor driving the growth of the global chromatography market. The addition of high-throughput capabilities to the modern chromatography systems in addition to improved resolutions and sensitivities by combining the use of chromatography with mass
spectrometry-based methods have greatly increased the scope of use in clinical diagnostics. The growing stringency of U.S. FDA (Food and Drug Administration) regulations to meet the CGMP (current good manufacturing practices) guidelines in drug manufacturing processes, as well as final drug quality, has increased the demand for chromatography in drug quality control. Downstream processing of biologics drugs has witnessed an increased activity since biosimilar drugs and other innovative biologics (monoclonal antibodies) have gained popularity.

The traditional chromatography techniques suffered from limitations of poor resolution, slow analysis, and low detection limits.Enhancements in technologies for detection, multiple sample injection, fraction collection and inert and pressure-resistant accessories, coupled with innovation in column technologies and novel stationary phases, have resulted in new chromatography modes and systems.

These include ultra-high-performance liquid chromatography (UHPLC) and supercritical fluid chromatography (SFC).High-performance TLC and affinity chromatography have also gained prominence as superior analytical methods.

Another domain of chromatography that is rapidly developing is the multi-dimensional chromatography (MDC) that can achieve far higher resolutions than possible with the usual one-dimensional methods. Designs of miniaturized systems and chip-based chromatography systems with micro-and nano-flow technology are the latest additions driving the growth of the chromatography market.

Merger and acquisition activities are also driving the chromatography market in the pharmaceutical/ biotechnology sectors, increased budgets for research (from both government andindustries), and growing healthcare infrastructure particularly in the emerging countries.

The restraints that hinder the growth of the global chromatography market are the high cost of chromatography equipment and expensive resins and packing material.Moreover, the need for skilled personnel also limits the use of chromatography techniques in routine applications.

The ever-increasing complexity of drug compounds and biomolecules has necessitated innovation in chromatography resin chemistries and functional groups to meet these demands.

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