Global Process Analytical Technology market was valued at US$ 2,638.9 in 2021 and is expected to reach US$ 7,828.0 million by 2030. Furthermore, the market is expected to grow at a CAGR of 13.2% during the forecast period.
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The development of new, cutting-edge, and dependable technologies is being driven by the industry’s expanding need for process analytical technology. The cost of produced pharmaceuticals is growing, and regulators are paying more attention. PAT is crucial in guaranteeing the efficacy and security of pharmaceutical products. It is employed to ascertain the identity, structure, identity, and potency of medicines.
PAT also aids in spotting possible issues, such as contamination or foreign matter, in drug production procedures. Global market research reports on process analytical technology indicate that contamination levels can be detected as low as 0.1 parts per million. This can result in significant cost and time savings throughout production.
Market Dynamics
Driving Factors
Growing R&D Expenditure: Due to the high capital and operating expenses associated with implementing these solutions, the growth of the global market for process analytical technology is dependent on R&D spending. Spending on health and medical R&D increased in the United States by 38% between 2013 and 2018, according to Research America. Additionally, the market is being strengthened by rising emerging economies’ greater government investment in the pharmaceutical industry.
Focus on Robust Automation: The requirement for speedy and precise results grows along with the rate of medication development. Because of this, drug process laboratories must use reliable automation. The market for process analytical technology is anticipated to increase as a result of the use of robotics, factory automation, and data analytics to speed up and optimize sample processing, assay creation, and MAID operations.
Investment by Governments: Following FDA approval, many well-known contract manufacturing organizations, including Agilent Technologies, have been concentrating more and more on the application of constant manufacturing for biologics production. Continuous manufacturing can benefit from real-time process monitoring during the production of pharmaceuticals. National Resilience had additionally secured US$ 625 million in series D financing.
Precision Medicine: It is becoming possible to give patients more specialized therapies as technologies advance. With the help of drug process analytical data, this precision medicine strategy may identify patient profiles and forecast how they will react to different therapies. Manufacturers can create better pharmaceuticals by comprehending how a drug affects various groups.
Transformation to Lab-on-Demand: Due to space or legal restrictions, many businesses cannot convert their discovery labs into manufacturing lines. Instead, they use services that offer on-demand access to dedicated lab space, sometimes known as lab-on-demand (LOD). Firms can outsource all or a portion of their R&D workflow using LOD solutions, chemical purification, synthesis, sample testing, and characterization.
Restraints
High Cost: PAT implementation involves a number of technical and budgetary hurdles. PAT implementation costs depend on a variety of factors, including alterations to the current infrastructure, adoption of new technology, ongoing maintenance of hardware and software, and staff training. In order to remove operational obstacles in pharmaceutical manufacturing, PAT is crucial. As a result, everyone in technical staff and high management must be knowledgeable about PAT. This will call for a large investment in training and development. The Coalition of State Bioscience Institutes discovered that the easiest functional responsibilities to perform were continuous assembling processes.
Lack of skilled technical experts: The lack of abilities to control the biopharmaceutical production processes, particularly in the areas of designing, information investigation, and cycle improvement, remains a challenge and restrains the market for process analytical technology.
Competitive Landscape
According to Astute Analytica, some of the notable companies in the global market for process analytical technology include Thermo Fisher Scientific, Inc. Agilent Technologies, Inc. (U.S.), PerkinElmer, Inc. (U.S.), Danaher Corporation (U.S.), ABB Ltd, Bruker Corporation (U.S.), and Shimadzu Corporation. In 2021, the leading 5 companies accounted for about 30% of the global market.
These businesses are primarily focused on creating cutting-edge technologies that enhance the pharmaceutical industry’s quality control and diagnostic procedures. These businesses mostly sell mass spectrometers, flow cytometry equipment, and tools for biochemical analysis.
Thermo Fisher is one of the industry’s top suppliers of process analytical technology. It provides a variety of options, such as nuclear magnetic resonance, gas chromatography-tandem mass spectrometry, optical detection, and liquid chromatography-mass spectrometry (LC-MS) (NMR). The business is renowned for providing unequivocal assurance of product quality and assisting manufacturers in avoiding pricey recalls.
Players use alliances and acquisitions as tools to enhance their products. In order to work together on projects, some big businesses have formed alliances with other businesses or paid hefty prices for promised smaller businesses with innovative technology. For instance, Danhar purchased GE Healthcare’s biopharma division in March 2022. Additionally, Thermo Fisher purchased Max Analytical Technologies in March 2022. As it enables the sharing of experience and promotes quicker advancement, this kind of teamwork might be crucial for innovation.
Segmentation Summary
Offering Analysis
In 2021, the product segment held a share of 84.4% of the global industry. PAT makes use of many tools, including fixed-reason sensors and spectroscopic and chromatographic compositional analyzers. Process analytical technology (PAT) is an essential tool for implementing quality by design (QbD) and enabling efficient monitoring of process variables while producing finished pharmaceutical goods of the highest caliber. Manufacturing scientists can create, monitor, and control processes using a collection of tools called process sensors.
Technique Analysis
In 2021, the spectroscopy segment accounted for the maximum share of 55.6% and will project the highest growth rate of 13.7% during 2022-2030.
It makes sense to use spectroscopic technology to track a distillation operation since it is effective at determining the composition of gas-phase samples. While other spectroscopic methods can be used to track distillation, mass spectrometry (MS) offers a number of benefits. Just a few of them are quick response times, improved selectivity and sensitivity, and the ability to manage a variety of sample pressures while simultaneously monitoring numerous species. The chromatography approach, on the other hand, enables the online separation and measurement of a mixture’s constituent parts during a chemical reaction.
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Regional Analysis
North America had the maximum market share of 43.8% in 2021 due to the presence of numerous pharmaceutical businesses. In 2020, 49% of all pharmaceutical sales were made in North America. According to IQVIA (MIDAS April 2021), 63.7% of new medications launched between 2015 and 2020 were sold in the United States, compared to 17.4% in Europe.
Asia Pacific is likely to rise at a higher CAGR from 2022 to 2030. Due to government laws and growing industrialization, with the exception of Japan, practically all of Asia was a latecomer to these upheavals.
Segmentation Outline
By Offering
- Products
-
- Analyzers
- Sensors and probes
- Samplers
- Monitors
- Services
By Measurement
- Online
- In-line
- At-line
- Off-line
By Technique
- Spectroscopy
-
- Molecular
- Atomic
- Mass
- Chromatography
- Liquid chromatography (LC)
- Gas chromatography (GC)
- Capillary Electrophoresis
- Particle Size Analysis
By Applications
- Hydroformylations
- Hydrogenation Reactions
- Lithiation and Organolithium Reactions
- Fluorinations and Fluorine Chemistry
- Grignard Reactions
- Others
By End User
- Pharmaceutical Manufacturers
- Biopharmaceutical Manufacturers
- Contract Research and Manufacturing Organizations
- Others
By Region
- North America
-
- The U.S.
- Canada
- Mexico
- Europe
- Western Europe
-
-
- The UK
- Germany
- France
- Italy
- Spain
- Rest of Western Europe
-
- Eastern Europe
- Poland
- Russia
- Rest of Eastern Europe
- Asia Pacific
- China
- India
- Japan
- Australia & New Zealand
- ASEAN
- Rest of Asia Pacific
- Middle East & Africa (MEA)
- UAE
- Saudi Arabia
- South Africa
- Rest of MEA
- South America
- Argentina
- Brazil
- Rest of South America
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