The global market for process analytical technologies (PAT) for pharmaceuticals should reach $412.7 million in 2017 and nearly $539.3 million by 2022 at a compound annual growth rate (CAGR) of 5.5% for the period of 2017 to 2022.
Although PAT was by and large developed for pharmaceuticals, its scope is much broader and ranges to the food, biotechnology, biopharmaceuticals and other process-prominent industries. However, this report covers only the pharmaceutical industry. The advancements and enhanced implementation of PAT solutions benefit primarily the overall pharmaceutical industry along with drug developers and manufacturers, and pharmaceutical and PAT solution development companies. The scope of the study is global. Its sales analyses are broken down geographically for North America (U.S. and Canada), Europe, Asia-Pacific and emerging markets. Applications of PAT tools are summed up from the perspective of commercial and R&D usage. BCC Research also analyzes the regulatory environment, new products and advancements, market projections and market shares.
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Also included in the report are relevant patent analysis and profiles of leading companies in the PAT industry, such as Siemens, Thermo Fisher Scientific Inc., Emerson Electric Co., Agilent Technologies Inc., Danaher Corp., ABB Group, Honeywell International Inc., Bruker, Shimadzu Corp. and PerkinElmer Inc.
– 70 data tables and 25 additional tables
– A comprehensive analysis of the global process analytical technology for pharmaceuticals markets with respect to tools, services, and applications
– Analyses of global market trends, with data from 2016, estimates for 2017, and projections of compound annual growth rates (CAGRs) through 2022
– Qualitative analysis, which covers such aspects as drivers, restraints, and opportunities, and provides insight into market forecasts of the PAT submarkets
– Details pertaining to the regulatory scenarios that are expected to boost or constrain the market’s potential
– Patent analysis
– Tracking of recent developments for key companies and strategies that may lead to a better understanding of the market from a practical perspective
– Profiles of companies that play major roles in the market including ABB Ltd., Agilent Technologies Inc., Bruker, Foss, GEA, Jeol Ltd, Sotex AG and Zeiss
Traditionally, each step of the pharmaceutical process is carefully monitored, and representative samples are taken and analyzed at each step, to ensure the highest quality. If the final product does not meet the desired criteria, the batch needs to be repeated, adding cost and time to the overall process. In order to enhance process productivity as well as achieve the product quality during the manufacturing process itself, the U.S. FDA announced the “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century—A Risk-Based Approach” initiative in 2002. The initiative encouraged the implementation of several new technologies, one of which was PAT. The goal of PAT is to incorporate quality by design (QbD), innovation and real-time monitoring into pharmaceutical manufacturing.
A variety of analytical techniques are used in the pharmaceutical industry, including ultra-violet (UV)spectroscopy, gas chromatography, high performance liquid chromatography (HPLC), X-ray diffraction spectroscopy, near infrared (NIR) spectroscopy, mass spectrometry, particle size analysis, dissolution testing and titration tools. These methods can be used at-line or on-line to assist in monitoring, controlling and/or designing the process and its performance. The continuous real-time control and multivariate analysis features of a PAT process allow increased productivity and shorter manufacture-tomarket time. A comparison of patent analysis from the last report offers insight into the growing trend towards innovation in the analytical methods currently available. The number of patents issued jumped from 592 in the period 2011 to 2013 to 867 for the period of this report (2015-August 2017). A significant increase in technology improvements was seen for chromatographic methods, spectrophotometric tools and techniques, particle size analysis methods and capillary electrophoresis methods.
There are many technology and process solution providers in the global market for PAT instrumentation. Recognizable names include Agilent Technologies Inc., Thermo Fisher Scientific Inc., PerkinElmer Inc., Bruker Corp., Jeol Ltd., Hitachi High-Technologies Corp., ABB Ltd., GEA, Rockwell Automation Inc., and Shimadzu Corp. There are also many small and medium-sized businesses (SMBs) in the instrumentation market. The global market for PAT technologies is currently small when compared to the multi-billiondollar pharmaceutical market it caters to. The market forces of innovation and the need to implement PAT in the pharmaceutical processes will drive this market in the coming years. There is a growing trend by the pharmaceutical manufacturers to implement the process analytical technologies in their manufacturing processes. In February 2017, Eli Lilly and Co. received the Facility of the Year award for Process Innovation by the International Society for Pharmaceutical Engineering (ISPE). The company’s continuous direct compression process for oral solid dosage drugs employs spectroscopic PAT, automation, real-time monitoring and sensors to estimate the critical quality attributes. Increased R&D budgets, collaborations among public-private and private-private entities, and favorable government initiatives are other factors driving the PAT market. The market of spectrophotometry offers huge potential for the growth of the overall PAT market, owing to the integration of spectrophotometric tools in almost every analytical method for increased ease of use and higher accuracy. Restraints and challenges limiting the growth of this market include the high cost of the technology, cultural barriers, changing political conditions and strict governmental regulations
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