Process Analytical Technology Market Overview
Global process analytical technology market size was valued at $1,744.5 million in 2016, and it is forecasted to grow at 12.9% CAGR during 2017-2023. Among the different techniques used in process analytical technology, spectroscopy held the largest share in the market in 2016 followed by chromatography, capillary electrophoresis, particle size analysis and other techniques. Spectroscopy held the largest share of the market owing to the growing number of pharmaceutical companies in the emerging economies, rising research and development expenditure by pharmaceutical companies and increasing compliance of regulatory guidelines by pharmaceutical companies.
PROCESS ANALYTICAL TECHNOLOGY MARKET SPLIT, BY PRODUCT (2016)
Among various spectroscopy techniques, molecular spectroscopy is expected to grow at the fastest rate as compared to atomic spectroscopy, and mass spectrometry, in the process analytical technology market during the forecast period. The growth in the category will be driven by wider application and increasing demand for molecular spectroscopy in the pharmaceutical as well as biopharmaceutical industry.
In-line measurement was the largest measurement category in the process analytical technology market in 2016. With batch production being the most widely employed type of production in pharmaceutical industry, in-line and at-line measurement based technologies are the most widely utilized categories in the process analytical technology market. However, with the advancements in the process analytical technology industry, on-line measurement is being adapted at a fast rate in developed countries.
Analyzers, sensors and probes, and samplers are the main products used in the process analytical technology market, whereas chemometrics and statistics data processing, repair and maintenance of instruments and training services are the main services associated with process analytical technology industry. The services category is expected to witness faster growth as compared to the products during the forecast period, due to the increasing demand for chemometrics and statistics data processing services.
Pharmaceutical manufacturers were the largest end users in the process analytical technology market, compared to biopharmaceutical manufacturers, contract research and manufacturing organizations, due to the growing pharmaceutical industry in emerging economies.
Globally, North America held the largest share of the process analytical technology market, followed by Europe, Asia-Pacific, Latin America, and Middle East & Africa. Asia-Pacific is predicted to garner the fastest growth in the market during the forecast period, owing to the growing demand for pharmaceutical and biotechnology products, increasing number of USFDA approved plants, and expanding generics industry in countries such as India, and China. According to the Pharmaceuticals Export Promotion Council of India, India’s pharmaceutical exports were $16.4 billion in 2016-17 and are expected to grow by 30% over next three years to reach $20 billion by 2020.
Process Analytical Technology Market Dynamics
Rising R&D expenditure by drug manufacturers and investments by government in emerging economies on implementation of process analytical technology, growing adherence to the quality by design (QbD) principles, and rising focus on increasing quality and manufacturing process efficiency are some of the key factors driving the demand in process analytical technology market. Technological advancements in the analytical devices industry has led to a greater adoption and implementation of process analytical technology in pharmaceutical as well as biopharmaceutical industry. The factors that hinder the growth of the market include, high cost of implementation and lack of skilled professionals.
The trend of outsourcing the manufacturing of pharma products to pure contract manufacturing organisations (CMOs) has been witnessed significantly in process analytical technology market in the recent past, due to the various advantages these CMOs offer such as low cost of production, low capital investment, desired quality production, time saving, and flexibility to divert resources to focus on other areas, such as marketing.
Outsourcing also allows for easier compliance with different regulations of various regulatory bodies. The USFDA has begun an aggressive inspection schedule over the past few years, and external contractors are now under the spotlight. For instance, in July 2017, Pfizer Inc. partnered with Catalent Pharma Solutions for the production of Advil Liqui-Gels Minis (ibuprofen), Pfizer Inc.’s over-the-counter (OTC) pain relief product, following a 20-year collaboration on the development and production of Advil Liqui-Gels. The trend of outsourcing the manufacturing to contact manufacturing organization is expected to continue in the process analytical technology market during the forecast period.
Due to the high capital investment as well as operational costs, the growth of process analytical technology market is dependent on the research and development (R&D) expenditure in the pharmaceutical industry. The R&D expenditure by pharmaceutical 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.
Also, according to the Organization for Economic Co-operation and Development (OECD), the R&D spending in emerging economies such as BRICS nations have increased considerably in recent past. Furthermore, in January 2011, the USFDA released a Process Validation guidance that noted the need for companies to continually improve the process lifecycle by making adaptations, to assure root causes of manufacturing problems are quickly corrected. With such regulations imposed by the USFDA and other regulatory authorities, adherence to QbD principles is increasing among pharma and biopharma companies during manufacturing process. This, in turn, is driving the growth of process analytical technology market.
Process Analytical Technology Market Competitive Landscape
Key players in the process analytical technology market are developing new products that offer advantages over older ones such as higher sensitivity for analysis of pharmaceutical products, to gain higher process analytical technology market share than competitors. For instance, in June 2017, Agilent Technologies Inc. introduced several 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 May 2017, Thermo Fisher Scientific Inc. launched a capillary electrophoresis (CE) system, the SeqStudio Genetic Analyzer, intended to offer a low-throughput, cartridge-based system for Sanger sequencing and fragment analysis.
Some of the other key players operating in the process analytical technology market include Brucker Corporation, PerkinElmer, Inc., Shimadzu Corporation, Carl Zeiss AG, Mettler-Toledo International Inc., Emerson Electric Co., Danaher Corporation, and ABB Group.