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Report Code: LS11137
Category : Analytical & Scientific Instrumentation
The global process analytical technology market size was $1,744.5 million in 2016, which is expected to reach $4,027.5 million by 2023, growing at a CAGR of 12.9%. Process analytical technology is mainly used by pharmaceutical/chemical companies to control and analyze manufacturing processes of pharmaceuticals to assure that the quality of the products manufactured meets the required quality standards set by the USFDA. PAT involves measurement, in a timely manner, of critical process parameters (CPP) which affect critical quality attributes (CQA) of the process. A typical PAT project involves the use of a combination of tools such multivariate data collection and data analysis tools, process analytical chemistry (PAC) tools including different types of spectroscopy, biosensors, fiber optics, and knowledge management tools such as software packages and/or paper systems. The process analytical technology market has been segmented on the basis of technique, measurement, end user and products and services.
Based on technique, the market is categorized into spectroscopy, chromatography, particle size analysis, capillary electrophoresis, and other techniques. The spectroscopy segment held the largest market share in 2016, attributable mainly to the increasing number of pharmaceutical companies in emerging economies, rising research and development expenditure by pharmaceutical companies, and growing focus on compliance of regulatory guidelines by pharmaceutical companies.
The market has been categorized into in-line measurement, at-line measurement, on-line measurement, and off-line measurement, on the basis of measurement. With the batch production being the widely employed type of production in pharmaceutical industry, in-line and at-line measurement are the major segments of the global market. However, with advancements in the process analytical technology, on-line measurement is being adopted at the fastest rate in developed countries.
Based on end user, the market has been bifurcated into pharmaceutical manufacturers, biopharmaceutical manufacturers, contract research and manufacturing organizations, and others. The pharmaceutical manufacturers were the largest end user of in 2016, due to higher production and consumption of pharmaceuticals, as compared to biopharmaceutical products. The Biopharmaceutical segment is expected undergo fastest growth during the forecast period, due to the growing biotechnology industry in the developed as well as developing countries, rising demand for biochemical analysis, and increasing number of approval/launch of various biological drug products.
On the basis of products and services, products include analyzers, sensors and probes, and samplers, and held the larger share of the market in 2016. The services category is expected to grow faster than products, due to increasing demand for chemometrics and statistics data processing services, driven by the increasing number of capacitated professional on the market.
Process Analytical Technology Market Dynamics
The process analytical technology market is growing at a significant rate due to the rising R&D expenditure by pharmaceutical and biopharmaceutical companies and investments by government in emerging economies, growing adherence to quality by design (QBD) principles, increasing focus on quality improvement and growing manufacturing process efficiency by pharmaceutical as well as biopharmaceutical companies. Additionally, technological advancements in analytical devices industry have also been driving the growth of the industry. However, high cost of process analytical technology implementation and scarcity of skilled professionals hinders the growth of the process analytical technology market.
Increasing use of analytical instruments in bioprocesses, and growing demand for process analytical technology in emerging markets offers ample growth opportunities for the players in the process analytical technology market. Near-infrared (NIR) has been used for moisture detection in the pharmaceutical and food industries. However, NIR has potential application in performance of moisture detection on lyophilized protein-based products. Genentech, Inc. has completed initial investigations using four different products to examine the viability of NIR for moisture detection in final product vials. Also, the demand for process analytical technology products and services is increasing parallelly with the growth of pharma industry in emerging markets such as India, Russia, Brazil, and South Africa.
Since the implementation of process analytical technology requires high capital investment as well as operational costs, the growth of the process analytical technology market is very much dependent on the trend of research and development (R&D) expenditure in the pharmaceutical industry. The R&D expenditure by pharma companies has increased significantly over the past few decades. According to Research America, investment in medical and health R&D in the U.S. increased by 13.3% from 2013 to 2015. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), its member companies invested an estimated $58.8 billion in R&D in 2015, an increase of 10.3% from 2014. With increase in the R&D expenditure, pharma companies can invest more on process analytical technology products and services, eventually leading to growth of the process analytical technology market.
Quality by design (QbD) principles have been adopted by the USFDA as well for the discovery, development, and manufacture of drugs. A pilot program to allow pharma manufacturers to submit information for a New Drug Application (NDA) demonstrating use of QbD principles, product knowledge, and process understanding has been implemented by the USFDA. In 2006, Merck & Co.’s Januvia became the first product approved based upon such an application. In January 2011, USFDA released a process validation guidance which notes the need for companies to continue benefiting from knowledge gained, and continually improve throughout the process lifecycle by making adaptations to assure root causes of manufacturing problems are quickly corrected. With such regulation imposed by the USFDA and other regulatory authorities, the adherence to quality by design(QbD) principles is increasing among pharma and biopharma companies, by the implementation of advanced process analytical technology during manufacturing process.
Process Analytical Technology Market Competitive Landscape
The key players in the process analytical technology market have been putting great attention on new product development and have launched many new products in the process analytical technology market in recent years. For instance, in June 2017, Agilent Technologies Inc. launched several new analytical and purification products including Agilent InfinityLab LC Purification Solution, Agilent 1260 Infinity II Prime LC System, and Agilent 1260 Infinity II Supercritical Fluid Chromatography System.
In June 2017, Brucker Corporation launched verTera Terahertz Extension for VERTEX 80v making it the world's first hybrid Fourier transform infrared (FTIR)/continuous wave (cw) THz spectrometer. The new verTera THz extension for the VERTEX 80v combined the advantages of both technologies to add valuable information for many applications, such as polymorphism, polymer research, high resolution gas spectroscopy, crystal structure and pharma or drug related research.
Some of the other key players operating in the global process analytical technology market include PerkinElmer, Inc., Shimadzu Corporation, Carl Zeiss AG, Mettler-Toledo International Inc., Emerson Electric Co., Danaher Corporation, Thermo Fisher Scientific Inc., and ABB Group.
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