Process Analytical Technology Market Size, Share & Trends Analysis Report By Product (Analyzers, Sensors & Probes), By Technique, By Monitoring Method, By End Use, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global process analytical technology market was valued at USD 2.07 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 10.2% from 2022 to 2030. Process analytical technology (PAT) is used to design, analyze, and control pharmaceutical manufacturing processes by determining critical control parameters that affect the critical quality attributes. The growing demand for quality-based products in various industries including pharma and biotech has led to the incorporation of PAT in the operations while generating end-products such as drugs, antibiotics, and vaccines. In addition, PAT reduces downtime, improves yield, and enables faster process development and scale-up in industries.

The outbreak of the COVID-19 pandemic led to an upsurge in the use of PAT. The operating players in the advanced manufacturing division have introduced PAT to aid in the production of drugs and other essential products such as sanitizers, masks, and gloves. Moreover, the drug shortage observed during the COVID-19 pandemic has compelled pharmaceutical companies to focus on finding quicker ways to deliver medications by utilizing PAT.

The growing adoption of process analytical technology by the pharma and biotech industry is positively impacting the market growth. The incorporation of analyzers, sensors, probes, and software in industries can enhance product quality, reduce process costs, and ensure product safety. PAT also helps in eliminating product re-work, easing regulation compliance, and smoothening the process cycles. At the same time, this technology offers modern synthesis, transforms organizational productivity, provides insights for every reaction, takes control of crystallization, sustains a culture of safety, and delivers from lab to plant in the pharmaceutical sector. These advantages are likely to boost the implementation of process analytical technology and can drive the market during the forecast period.

Furthermore, technological advancements such as digital twins and artificial intelligence in PAT are expanding the growth prospects. Artificial intelligence in the pharmaceutical industry provides correction mechanisms applied to the pharmaceutical manufacturing process and autonomous control and automated feedback. In addition, digital twins are the virtual counterparts of real-world manufacturing systems that collect information from monitoring devices to dynamically adjust manufacturing processes and perform analytics. Bio manufacturers may combine digital twins and artificial intelligence in the coming years to obtain additional value from monitoring technology and enhance process control.

Moreover, growing adherence to quality by design (QbD) principles can boost market growth during the projected period. Quality is a vital parameter for all pharmaceutical and biopharmaceutical products. FDA guidelines on QbD are encouraging manufacturers to guarantee consistency in the quality of products by constantly monitoring process streams and unit operations. PAT is renowned as a critical fundamental shift in approving and inspecting procedures for the pharmaceutical production process. The adoption of the QbD principles, supported by PAT, is altering this paradigm.

Additionally, digital transformation in the biopharma industry represents new opportunities for the implementation of integrated monitoring and optimization systems using PAT. With significant developments in data management solutions and computing power, novel and effective analytics methods are being developed. Implementation of these improved technologies can eliminate many challenges and risks associated with control, automation, and monitoring. In addition, innovations in sensor systems, data analysis, data management, computation, modeling and simulation, and engineering approaches are required to support the deployment of PAT at the manufacturing scale.

Product Insights

The analyzers segment held the largest revenue share of over 30.0% 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 10.3% 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 40.0% 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 10.3% 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 40.0% in 2021. In-line is a real-time monitoring method that provides both qualitative and quantitative data. Process parameters such as pH, dissolved CO₂, 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 10.8% 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 50.0% 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 11.6% 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 35.0% 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 Companies & Market Share Insights

Key players in this market are implementing various strategies including partnerships through mergers and acquisitions, geographical expansion, and strategic collaborations to expand their market presence. For instance, in May 2022, Agilent Technologies, Inc. announced its collaboration with APC Ltd. to combine their technologies for providing unique workflows to users that can support automated process analysis by liquid chromatography (LC). In addition, in April 2022, Thermo Fisher Scientific Inc. launched a user-friendly Raman spectroscopic analyzer for process monitoring and various applications such as biopharmaceutical manufacturing. Some prominent players in the global process analytical technology market include:

• 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

Process Analytical Technology Market Report Scope

Global Process Analytical Technology Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the global process analytical technology market report based on product, technique, monitoring method, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Analyzers

  • Sensors & Probes

  • Samplers

  • Software & Services

• Technique Outlook (Revenue, USD Million, 2018 - 2030)

  • Spectroscopy

    • NIR Spectroscopy

    • Raman Spectroscopy

    • NMR Spectroscopy

    • Mass Spectroscopy

    • Others

  • Chromatography

    • Liquid Chromatography

    • Gas Chromatography

  • Particle Size Analysis

  • Electrophoresis

  • Others

• Monitoring Method Outlook (Revenue, USD Million, 2018 - 2030)

  • On-line

  • In-line

  • At-line

  • Off-line

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical & Biotechnology Companies

  • CROs

  • CMOs & CDMOs                 

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • 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