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The global Process Analytical Technology market is projected to add an opportunity of US$ 4,923.41 Mn during 2022-2030 and is estimated to reach US$ 7,828.03 Mn by 2030. Furthermore, the market is expected to register a CAGR of 13.2% during the forecast period. The driving factors of the market are rising R&D spending by CMOs and pharmaceutical manufacturers and investment by governments of emerging economies.
The term PAT depicts a method used to measure and control the attributes in drug manufacturing that determine product efficacy and quality. It includes characterizing the Critical Process Parameters (CPPs) of the hardware used to make the product, which influences its Critical Quality Attributes (CQAs), and afterward controlling these CPPs inside defined limits.
The five major players held a share of close to 30% in the market in 2021. Some of the key players in the market are Agilent Technologies Inc, Shimadzu Corporation, Thermo Fisher Scientific Inc., and Danaher Corporation. Product development is one of the key strategies adopted by key players in the market. For example, in April 2022, Thermo Fisher Scientific Inc. launched a new Ramina Process Analyzer, it is user-friendly and has a portable design that helps to reduce time-to-results without the burden of taking up too much valuable laboratory space.
Recent strategies adopted by key market players are:
Factors influencing Process Analytical Technology (PAT) market
Rising R&D Expenditure by Pharmaceutical Manufacturers
The global process analytical technology market's growth is reliant on R&D spending because the implementation of these solutions necessitates a large capital investment and hefty operational costs. According to Research America, spending on health and medical R&D climbed by ~38% in the United States between 2013-2018. Furthermore, increased government investment in the pharmaceutical sector by emerging economies is strengthening the market.
Investment by Governments of Emerging Economies
Many well-known contract manufacturing organizations (CMOs) like Agilent Technologies, have been increasingly focusing on the use of continuous manufacturing for biologics production following FDA approval. Real-time process monitoring during drug manufacturing can help in continuous manufacturing. Additionally, National Resilience had raised US$ 625 million in series D financing.
Lack of skilled technical experts/operators and
There are several technical and financial challenges associated with implementing PAT. The cost of implementation of PAT involves a lot of parameters like modifications to existing infrastructure, adoption of the new technology, long-term maintenance of hardware and software, as well as training personnel. PAT is important to eliminate operational barriers in pharmaceutical manufacturing. Therefore, it is important that right from the senior management to technical staff are well-versed with PAT. This will require a significant amount of investment in training & development. A survey conducted by the Coalition of State Bioscience Institutes found that continuous assembling processes were the easiest functional roles to carry out. However, the skill set is required to be considered expected to manage biopharmaceutical producing processes - specifically around designing, information investigation, and cycle improvement - the range of abilities lack challenge continues that hinders the growth of process analytical technology market.
PAT can be offered in two ways; one is through products and the other is through services. The product segment holds 84.4% market share in the global process analytical technology market. Process Analytical Technology (PAT) uses various devices, like spectroscopic and chromatographic compositional analyzers, and fixed reason sensors. Process analytical technology (PAT) is a crucial instrument for implementing quality by design (QbD) and ensuring effective monitoring of process parameters to manufacture high-quality finished pharma products. Process sensors are a set of instruments that manufacturing scientists can use to design, monitor, and regulate processes.
Measurement Method Analysis
In terms of the measurement method, on-line measurement holds 42.4% of the global market share in 2021, followed by the In-line segment. On-line measurement is when a sample is taken during the production process, its appropriateness is decided, and the sample is diverted from the manufacturing process with a bypass stream and may be returned to the bioreactor. The advantage of this measuring method is its simple sterilization and straightforward access to the sample in stationary conditions. However, its complex setup makes it a less favorable choice in some conditions than in-line monitoring.
Based on Technique, spectroscopy holds the highest market share of approximately 55.6% in 2021 and is projected to grow at the highest CAGR of 13.7% over the forecast period.
As spectroscopy technology is well-suited to measuring the composition of gas-phase samples, using it to monitor a distillation process is a natural fit. Other spectroscopic techniques can be used to monitor distillation, but mass spectrometry (MS) provides several advantages like rapid response time, greater selectivity and sensitivity, and the capacity to handle a wide range of sample pressures while simultaneously monitoring many species are just a few of them. On the other hand, the chromatography technique provides for the on-line separation and measurement of the components of a mixture in a chemical process.
Based on application, Lithiation & Organolithium reaction accounted to grip 24% market share in 2021. Organolithium compounds are very basic and nucleophilic because the C-Li bond is highly polarized, and the carbon atom is electron-rich. As a result, lithiation and organolithium reactions are significant in organic synthesis and can be used to make complex compounds.
End User Analysis
In terms of end users, the pharmaceutical segment holds more than approximately 48.6% of the market share in 2021 and is further expected to continue its dominance during the forecast period. Pharmaceutical production requires creativity, cutting-edge scientific and engineering knowledge, as well as the best quality management system while manufacturing drugs, even the resources/raw materials used in these operations can fluctuate significantly in terms of characteristics such as moisture content, viscosity, or crystalline structure. PAT helps pharma manufacturers in enhancing efficiency, minimize waste, and over-processing, and reduce process variability.
North America holds the highest market share in the year 2021 at 43.8%. The presence of many pharmaceutical companies has contributed significantly to the market's expansion. In 2020, North America accounted for 49% of global pharmaceutical revenues. According to IQVIA (MIDAS April 2021), 63.7% of new drugs launched between 2015 and 2020 were sold in the United States, compared to 17.4% in Europe.
However, Asia Pacific is estimated to grow at an increasing CAGR over the forecast. As a result of rapid industrialization and government regulations Except for Japan, almost other Asian countries were latecomers to these revolutions.
Global Process Analytical Technology (PAT) Market is sub-segmented into:
By End User
The Global Process Analytical Technology Market was valued at US$ 2,638.89 Mn in 2021.
Factors such as increasing R&D efforts in pharmaceutical and biopharmaceutical firms and quick technological improvements in analytical devices are propelling the market growth.
Outsourcing manufacturing processes to Contract Manufacturing Organizations (CMOs) is an emerging opportunity in the global market.
Lack of skilled technical experts may hinder the market growth during the forecast period.
The various segmentations considered to analyze the Global Process Analytical Technology Market are based on offering, measurement, technique, application, end-user, and region.
Spectroscopy, Chromatography, Capillary Electrophoresis, and Particle Size Analysis are the different techniques of process analytics.
Lithiation & Organolithium are the top application segment in the Global Process Analytical Technology Market in 2021.
Pharmaceutical manufacturers are the highest end users in the PAT market.
North America is the highest shareholder region in the Global Process Analytical Technology Market.
The key market players are Fisher Scientific Inc., Agilent Technologies Inc., Shimadzu Corporation, and Mettler-Toledo International Inc. among others.
The Covid-19 pandemic had a positive impact on the market growth with a 0.5% YoY growth in 2020-21.