Process Analytical Technology Market (By Product: Analyzers, Sensors & Probes; By Technique; By Monitoring Method; By End Use) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2022-2030

The global process analytical technology market was surpassed at USD 2.1 billion in 2021 and is expected to hit around USD 5.6 billion by 2030, growing at a CAGR of 11.51% from 2022 to 2030.

Report Highlights

• The analyzers segment held the largest revenue share of over 30.04% in 2021. 
• Sensors and probes are expected to expand at a CAGR of 10.51% during the forecast period. 
• Spectroscopy dominated the market in 2021 and accounted for over 40.07% share. 
• The chromatography technique is anticipated to expand at a CAGR of 10.44% during the projected period. 
• The in-line segment accounted for the largest revenue share of over 40.02% in 2021.
• The on-line segment is likely to register the fastest growth rate of 10.86% during the forecast period. 
• Pharmaceutical and biotechnology companies dominated the market in 2021 and accounted for over 50.08% share. 
• CMOs and CDMOs are expected to grow at the fastest rate of 11.74% over the forecast period. 
• North America accounted for the largest share of over 35.16% in 2021. 

The rising R&D spending by pharmaceutical companies, government investment in emerging markets, growing adherence to reliability by design (QbD) principles, increasing emphasis on improving quality and manufacturing process efficiency, and technological developments in the analytical technology industry are the main drivers in the market.

Process analytical technology is crucial to the manufacturing of pharmaceuticals as it provides data that aids in decision-making, quality assurance, product development, and factory implementation. Such technology also aids in spotting possible issues, such as contamination or foreign materials, in drug production procedures. Process analytical technology can detect contamination at levels as low as 0.1 parts per million, according to a report on the global process analytical technology. This could result in considerable time and financial savings and further boost the adoption of analytical technology in bioprocessing.

The COVID-19 pandemic has been a significant growth driver for several process analytical technology offerings. The search for efficient preventive and curative medications is intensifying in response to rising infection and mortality rates. Due to the fact that process analytical technology is largely used to monitor and assess the drug development process, demand for it significantly increased in 2020. For instance, in August 2022, as per the article published on InsideTele, modernizing synthesis workstations, offering precise reactor control, enabling the capture and digitalization of response process information, and securing the reproducibility as well as the link among users, experiments, and sites are all possible with the use of process analytical technology in drug formulation.

Due to the numerous benefits the technology provides, including lower production costs, lower capital expenditures, the desired quality, time savings, and the flexibility to allow pharmaceutical companies to direct their resources to other areas, such as marketing, the trend of outsourcing the production of pharma products to pure CMOs has risen significantly in recent years. For instance, in July 2021, Arvinas Inc. and Pfizer Inc. established a worldwide partnership to manufacture and market ARV-471, an experimental oral PROTAC (proteolysis-targeting-chimera) estrogen receptor protein degrader. This is, in turn, driving the market for process analytical technology.

It is anticipated that the adoption of new and better process analytical technology by key industry players will accelerate the expansion of the global market. For instance, in November 2021, Thermo Fisher Scientific launched MS & chromatography equipment during the Human Proteome Organization (HUPO) Reconnect event. For proteomics investigations, the high-resolution Thermo Scientific Orbitrap MS equipment is complemented by the Thermo Scientific Vanquish Neo UHPLC system, which reduces the loss of sample and produces data of the best possible quality. It is intended for high-sensitive LC-MS applications and has strong analytical efficiency at a rate of flow that ranges from 1 nL/min to 100 L/min up to 1,500 bar.

Scope of The Report

Product Insights

The analyzers segment held the largest revenue share of over 30.04% in 2021. PAT analyzers enable effective process monitoring and improve process control of medicinal product manufacturing. Growing drug discovery research and development activities and stringent regulations on drug safety are encouraging the adoption of analyzers and leading to the demand in the market. Furthermore, analyzers being specifically designed for PAT applications are extensively used for the molecular level of understanding manufacturing processes. For instance, in September 2021, Merck KGaA launched a ProCellics Raman analyzer with Bio4C PAT Raman software designed specifically for the bioprocessing industry. This analyzer helps in performing in-line and real-time measurements of CQAs and CPPs from process development to manufacturing. Such developments in analyzers for PAT applications are driving the market.

Sensors and probes are expected to expand at a CAGR of 10.51% during the forecast period. PAT sensors and probes are used in the manufacturing process to measure the quality parameters of products to get instant data access and enable quick decision-making during product development and manufacturing. Furthermore, PAT sensors help in tracking the active pharmaceutical ingredient concentration of the powder being outputted from a continuous blender. The ongoing shift in single-use bioprocessing is promoting the use of single-use sensors and probes to continuously measure as many parameters as possible for the deepest understanding of the manufacturing process. The development of sensors and probes for single-use applications with all the properties of reusable sensors can provide real-time robust data, which can significantly boost the market growth in the near future. 

Technique Insights

Spectroscopy dominated the market in 2021 and accounted for over 40.07% share. Spectroscopy is a well-suited technology for analyzing different phases of a sample. It is used across the pharmaceutical sector due to its specificity for quantitative and qualitative determination of components. Moreover, spectroscopy is broadly used in PAT as it assists in determining the atomic structure and alters the structures of drugs to enhance their effectiveness. NIR spectroscopy is the widely used technique in PAT owing to its non-destructive and cost-effective method of analysis. Technological advancements enabling process optimization and increasing the number of pharmaceutical and biotechnology R&D activities are the key factors fueling the growth of the spectroscopy segment. For instance, in November 2021, Thermo Fisher Scientific launched novel chromatography and mass spectrometry solutions at the ASMS event with advanced software technology to enhance data acquisition and analysis.

The chromatography technique is anticipated to expand at a CAGR of 10.44% during the projected period. Chromatography techniques are used for measuring CQAs including protein aggregation and charge heterogeneity, respectively in the manufacturing processes. The novel technological advancements in chromatography are likely to boost segment growth over the coming years. For instance, in March 2022, Thermo Fisher Scientific launched gas chromatography (GC) and GC-mass spectrometry (GC-MS) instruments with innovative software and hardware updates to enhance usability and productivity.

Monitoring Method Insights

The in-line segment accounted for the largest revenue share of over 40.02% in 2021. In-line is a real-time monitoring method that provides both qualitative and quantitative data. Process parameters such as pH, dissolved CO?, dissolved oxygen, ORP (redox potential), and conductivity and temperature measurements are sent in real-time to PLC/ SCADA systems for automated control. In line monitoring method helps in measuring these parameters without manual intervention over the process run for several weeks to months and provides reliable and accurate data in the industrial manufacturing process. Such aforementioned factors are anticipated to lift the pharmaceutical applications of PAT.

The on-line segment is likely to register the fastest growth rate of 10.86% during the forecast period. In this monitoring method, a sample is diverted from the manufacturing process with a by-pass stream. The sample is automatically measured in the by-pass by process sensors. Advantages of the on-line methods include minimal product variability, automated feedback with quality control attributes, and elimination of delays associated with other monitoring methods. Such advantages of the on-line methods are anticipated to fuel segment growth and contribute to the PAT market growth.

End-use Insights

Pharmaceutical and biotechnology companies dominated the market in 2021 and accounted for over 50.08% share. Applications of PAT in these companies include continuous analysis of the manufacturing process for monitoring physical and/or chemical quality attributes and quality control and evaluation of the stability of active ingredients in pharmaceuticals. Factors such as reduced downtime, maximum yields, quicker process development, and scale-up, and decreased human intervention with minimal errors are expected to fuel the market growth.

CMOs and CDMOs are expected to grow at the fastest rate of 11.74% over the forecast period. Implementation of PAT enables to accommodate a variety of processes and products. In addition, robust data analytics tools can help CMOs and CDMOs to reduce costs while maintaining product quality and meeting regulatory requirements. Also, PAT aids to diminish the losses from processes gone astray reduces errors and eliminates batch failures. These advantages are projected to increase the adoption of PAT in CMOs and CDMOs and drive the market in the coming years.

Regional Insights

North America accounted for the largest share of over 35.16% in 2021. This can be attributed to the rapid growth of the pharmaceutical and biotechnology industry, high research and development expenditure, and encouragement by regulatory compliance to use the PAT in industries. In addition, the presence of key players such as Thermo Fisher Scientific Inc.; Agilent Technologies, Inc.; and Repligen Corporation and their process analytics portfolio are boosting the market growth in the region. For instance, Repligen Corporation announced its strategic collaboration with DRS Daylight Solutions to expand the portfolio of Quantum Cascade Laser mid-IR (QCL-IR) based solutions on 19th September 2022.

Asia Pacific is projected to grow at the fastest rate over the forecast period due to increasing government funding in the biotechnology industry and regulations in the development of pharmaceuticals and biotechnology manufacturing. Furthermore, the rising focus of international players in emerging markets and the growing number of contract research and manufacturing organizations in the region are anticipated to open new growth opportunities for the market.

Key Players

• Thermo Fisher Scientific Inc.
• Agilent Technologies, Inc.
• Danaher Corporation (Ab Sciex LLC)
• Bruker Corporation
• PerkinElmer, Inc.
• ABB Ltd.
• Carl Zeiss AG (Zeiss Group)
• Emerson Electric Co.
• Mettler-Toledo
• Shimadzu Corporation
• Sartorius AG
• Hamilton Company
• Repligen Corporation

Market Segmentation

• By Product Outlook
• Analyzers
• Sensors & Probes
• Samplers
• Software & Services
• By Technique Outlook
• Spectroscopy

• NIR Spectroscopy
• Raman Spectroscopy
• NMR Spectroscopy
• Mass Spectroscopy
• Others
• Chromatography
• Liquid Chromatography
• Gas Chromatography
• Particle Size Analysis
• Electrophoresis
• Others
• By Monitoring Method Outlook
• On-line
• In-line
• At-line
• Off-line
• By End-use Outlook
• Pharmaceutical & Biotechnology Companies
• CROs
• CMOs & CDMOs                 
• By Regional Outlook
• North America
• U.S.
• Canada
• Europe
• U.K.
• Germany
• France
• Italy
• Spain
• Asia Pacific
• Japan
• China
• India
• South Korea
• Australia
• Latin America
• Brazil
• Mexico
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE