Process analytical technology in the pharmaceutical industry: a toolkit for continuous improvement with errorless analysis of each and every step

Pharmaceutical product manufacturing comprises stringent procedure in which monitoring and regulation of each and every step is highly essential and crucial affair. The pharmaceutical products are related with the health and life of an individual; hence the errorless analysis of each and every step is required.

According to the U.S. FDA, process analysis technology (PAT) can be defined as a mechanism or system used to analyze, evaluate and control pharmaceutical manufacturing process with the help of evaluation of critical process parameters (CPP) that influences critical quality attributes (CQA). Owing to tight regulations and requirements of various international certificates such as ISO and GMP for critical monitoring of pharmaceutical processes, the demand of these techniques has been increased.

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The market of process analytical technologies for pharmaceuticals can be segmented on the basis of processes (services), equipment and applications of PAT. The equipment are further divided into spectrophotometers (mass spectrometer, UV-Visible spectrophotometer, nuclear magnetic resonance spectrophotometer, infrared spectrometers), chromatography instrument set (thin layer chromatography, gas chromatography, liquid chromatography), dissolution instrument, particle size analyzers (sieving, sedimentation, dynamic light scattering, aerosol mass spectrometry), capillary electrophoresis devices and others (hardness tester, physical properties [size, shape, color], friability test). On the basis of services, it is segmented into consultancy, calibration and database management system (DBMS). Moreover, on the basis of applications, it is divided into lyophilization, coating, compression, evaporation, raw material selection, packaging and others. Additionally, the market is segmented on the basis of geography, such as North America, Europe, Asia-Pacific and Rest of the World (RoW). At present, North America and Europe are the most prominent markets, owing to extensive pharmaceutical industries. However, Asia-Pacific and some countries in RoW are expected to show lucrative growth in the upcoming period, owing to increase in number of pharmaceutical infrastructure and technologies.

The market of process analytical technologies for pharmaceuticals is expected to show a lucrative growth during the forecast period from 2014 to 2020. This growth is expected to fuel by the factors such as strong pharmaceutical infrastructure in developed countries and rapid increase in number of pharmaceutical production units in the developing countries and technological advancements. Increasing pharmaceutical production and R&D are considered as the most important drivers of this market. For instance, according to the statistics provided by the European Federation of Pharmaceutical Industries and Association (EFPIA), the pharmaceutical production in Europe has increased from USD 112,000 million in 1990 to USD 2,620,000 million in 2012. This astonishing increase in pharmaceutical sector is expected to propel the market growth during the forecast period from 2014 to 2020. Furthermore, owing to technological advancements, a number of new and technologically sound devices are entering in the global market and the entry of these devices is anticipated to contribute in the growth of the market. Other important factors that are likely to drive market growth include increasing regulatory and government pressure to implement various tests during manufacture, rising prevalence of different diseases that fuels the demand of pharmaceutical formulations and others. On the other hand, high cost and tedious operations of the instruments, lack of technically competent workforce and threat of malfunctions and false results are the key hurdles that are likely to limit the growth of PAT market during the forecast period from 2014 to 2020.

Some of the major companies operating in this market include Danaher Corporation, Honeywell, Agilent Technologies, Fluke Biomedical, Tektronix, Inc. Thermo Fisher Scientific, Inc. and Carl Zeiss AG amongst others.

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This release was published on openPR.