Process Analytical Technology Demand To Remain High in North America

According to the European Federation of Pharmaceutical Industries and Associations, the pharmaceutical R&D expenditure in the continent rose from EUR 17,849 million in 2000 to EUR 39,000 million in 2020. This classifies pharmaceutical as an investment-intensive industry, where R&D forms a crucial aspect. Around the world, strict guidelines are in place to ensure the efficacy and safety of pharmaceutical products for humans, which warrants a rather high expenditure in controlling and optimizing processes such as initial pharmacological studies, API and excipient discovery, final drug manufacturing, quality control and testing, and the all-important clinical trials.

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The compelling need to meet the standards set by the FDA, EMA, and other regulatory agencies is credited by P&S Intelligence as the biggest factor that will take the process analytical technology (PAT) market size to $13,626.5 million by 2030 from an estimated $3,283.8 million in 2021, at a robust 17.1% CAGR. 'PAT' is the collective for the instruments, software, and processes used in the pharma sector to control the manufacturing process and ensure that the final products meet the government regulations. This is done by collecting and analyzing the data generated through various stages of the process and taking requisite actions.

The demand for such technologies was further escalated by the COVID-19 pandemic, which sparked a race to come up with effective vaccines and therapeutic drugs. With permanent hospital beds filling up rapidly and space at temporary isolation and care centers also reducing, the need for effective pandemic control resounded across the world in 2020, prompting governments to give a strong push to pharmaceutical and biotechnology companies. This led to high investments in R&D not only by well-known pharma and biotech firms, but also contract research and manufacturing organizations.

The pandemic and the lessons learned during it with regard to being prepared for a pandemic or other medical emergencies have fueled the demand for the software, instruments, and services used as part of PAT. Among these, the instruments, including analyzers, samplers, and sensors and probes, hold the larger process analytical technology market share due to the fact that the actual process control is enabled by them. They help in collecting and analyzing data, which is imperative for process control. Moreover, compared to services, the instruments are more expensive, and services are often offered complimentary for a certain period with the purchase of the instruments.

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Moreover, to cater to the dynamic needs of drug manufacturers and ever-stringent government regulations on drug safety, PAT instruments are being advanced. For instance, Thermo Fisher Scientific Inc. launched the Orbitrap Exploris MX mass detector in November 2021. It enables the usage of multi-attribute methods, conduction of oligonucleotide mass determination, performing of intact analyses of monoclonal antibodies, and carrying out of peptide mapping. This way, the technology allows biotech companies to streamline process monitoring, biopharmaceutical characterization, and release testing via the usage of one comprehensive analysis that offers insights into numerous critical attributes of product quality.

Currently, the North American process analytical technology market witnesses the highest demand for these solutions on account of its large pharma sector. According to the FDA, the U.S. was home to 28% of the API manufacturing plants in the world in 2019, which reflects a huge demand for PAT solutions. Additionally, the drug safety and pharma process control regulations implemented by the FDA are among the strictest on earth, which further necessitates a proper data analysis system. In addition, any new technology is first adopted in North America, which is another key reason for its market dominance.

Hence, fueled by the global urge to find better drugs for widely known and emerging diseases, the demand for technologies that help in the optimization of the pharmaceutical and biotechnology manufacturing process will only rise.

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