Process Analytical Technology Market: Opportunities and Challenges in a Rapidly Evolving Industry
Discover key market drivers, challenges, and product insights shaping the future of the PAT market
VANCOUVER, BC, CANADA, June 6, 2024 /EINPresswire.com/ -- The global Process Analytical Technology (PAT) market size was USD 3.18 Billion in 2022 and is expected to register a rapid revenue CAGR of 12.6 % during the forecast period. The global pharmaceutical industry is experiencing significant growth in the adoption of Process Analytical Technology (PAT), a key factor driving market revenue. PAT is increasingly essential for measuring the effectiveness of Active Pharmaceutical Ingredients (APIs), ensuring compliance with quality standards set by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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Essential Role of PAT in Quality Control
PAT is crucial in maintaining high standards in pharmaceutical manufacturing processes, particularly through techniques like Statistical Process Control (SPC), Continuous Process Verification (CPV), and Quality by Design (QbD). These methods are mandated by global regulatory bodies to ensure the quality and performance of pharmaceutical products post-manufacture.
Market Drivers: Cell and Gene Therapy, Infectious Diseases
The deployment of PAT in cell and gene therapy, particularly through Multivariate Data Analysis (MVDA), is a significant market driver. Clinical laboratories worldwide rely on PAT to analyze treatments for diseases such as cancer, infections, heart disease, and diabetes. According to the World Health Organization (WHO), cancer led to nearly 10 million deaths in 2020, highlighting the critical need for advanced analytical technologies.
Additionally, the prevalence of infectious diseases drives the demand for PAT. The Centers for Disease Control and Prevention (CDC) reported significant flu impacts in 2021-2022, with 9 million cases and 100,000 hospitalizations, emphasizing the need for effective vaccine development and clinical trials facilitated by PAT.
Innovations in PAT Technology
Emerging innovations are enhancing PAT’s capabilities. In October 2023, Telescope Innovations Corp launched Direct Inject Liquid Chromatography (DILC), automating chemical reaction analysis. Such advancements are pivotal in maintaining the purity, efficacy, and selectivity of pharmaceutical products.
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Market Challenges: Cost and Skilled Workforce Shortages
However, the high cost of deploying PAT systems poses a challenge. Pharmaceutical manufacturers often hesitate to invest in expensive software and instruments, seeking to reduce operational expenses. Furthermore, a lack of skilled professionals in the industry exacerbates the issue. According to the International Monetary Fund (IMF), a substantial portion of the global youth population faces a skills deficit.
Product Insights: Analyzers Lead the Market
The PAT market is segmented into analyzers, sensors and probes, samplers, and software and services. Analyzers dominate the market, largely due to their widespread use in real-time parameter analysis, such as temperature and pressure monitoring. Regulatory requirements further boost their adoption by laboratories and contract organizations.
Sensors and Probes Show Moderate Growth
The sensors and probes segment is also growing, driven by the need to capture accurate data in pharmaceutical manufacturing. The World Health Organization (WHO) reports that cardiovascular diseases cause 17.9 million deaths annually, underscoring the importance of precise data in medical treatments.
Technique Insights: Spectroscopy and Chromatography
Among PAT techniques, spectroscopy holds a significant market share. Innovations like trinamiX’s NIR spectrometer, launched in October 2023, demonstrate the technology’s critical role in cancer detection and other medical applications. Chromatography is also vital, ensuring the safety of pharmaceuticals by analyzing compounds for contaminants and aiding in vaccine development.
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Process Analytical Technology (PAT) Top Companies and Competitive Landscape
The global PAT market is fairly fragmented with many large and medium-sized players accounting for majority of market revenue. Major players are deploying various strategies, entering into mergers & acquisitions, strategic agreements & contracts, developing, evaluating, and introducing PAT solutions in the market.
Thermo Fisher Scientific Inc.
Agilent Technologies
Danaher Corporation
Waters Corporation
Bruker
PerkinElmer Inc
ZEISS Group
Mettler Toledo
SHIMADZU CORPORATION
Sartorius AG
Process Insights, Inc
Merck KGaA
Verum Analytics, LLC
Hamilton Company
Emerson Electric Co.
Bio-Techne Corporation
InProcess-LSP
Hovione
NECI
Cornerstone Controls, Inc.
Endress+Hauser Group Services AG
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Process Analytical Technology (PAT) Latest Industry News
On 24 October 2023, LumaCyte launched new PAT instrument Radiance. The state-of-the-art real-time platform Radiance employs a label-free, single-cell methodology for quantitatively characterizing innate cellular responses. The new PAT technology utilizes Laser Force Cytolog (LFC), which accurately measures nuanced phenotypic changes solely based on the inherent biophysical and biochemical properties of cells in response to their environment or treatment.
On 21 June 2021, Thermo Fisher Scientific completed the acquisition of MarqMetrix to enhance its Analytical Technology (PAT) product portfolio. MarqMetrix offers advanced and purposeful in-line Process Analytical Technology (PAT), providing customers with a streamlined approach to achieving precise and accurate measurements across various manufacturing processes.
On 17 June 2022, Merck Life Science and Agilent Technologies joined forces to introduce recent development in PAT, such as real time monitoring and automated process control, of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
Process Analytical Technology (PAT) Market Segment Analysis
For the purpose of this report, Emergen Research has segmented the global PAT market on the basis of product, techniques, monitoring, end-use, and region:
Product Outlook (Revenue, USD Billion; 2019-2032)
Analyzers
Sensors and Probes
Samplers
Software and Services
Technique Outlook (Revenue, USD Billion; 2019-2032)
Spectroscopy
Chromatography
Particle Size Analysis
Electrophoresis
Others
Monitoring Outlook (Revenue, USD Billion; 2019-2032)
On line
In line
At line
Off line
End-Use Outlook (Revenue, USD Billion; 2019-2032)
Pharmaceutical and Biotechnology
Contract Research Organization (CRO)
Contract Manufacturing Organizations (CMOs)
Contract Development and Manufacturing Organizations (CDMOs)
Regional Outlook (Revenue, USD Billion; 2019–2032)
North America
U.S.
Canada
Europe
Germany
France
UK
Italy
Spain
Benelux
Russia
Rest of Europe
Asia Pacific
China
Japan
South Korea
India
ASEAN Countries
Oceania
Rest of APAC
Latin America
Brazil
Mexico
Rest of LATAM
Middle East & Africa
GCC Countries
Israel
Turkey
South Africa
Rest of Middle East & Africa
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