Biopharmaceutical Process Analytical Technology Market– Forecast (2024-2030)

Overview

The Biopharmaceutical Process Analytical Technology market size is forecast to reach USD 9,485.82 million by 2030, after growing at a CAGR of 14.53% during the forecast period 2024-2030. Biopharmaceutical process analytical technology represents an important part of biopharmaceutical manufacturing, emphasizing the implementation of advanced technologies for monitoring and controlling the drug manufacturing process. 
The Biopharmaceutical Process Analytical Technology (PAT) Market is growing in both drug development & manufacturing and drug discovery applications due to increasing demand for efficient, high-quality, and cost-effective drug production. In drug development and manufacturing, PAT enables real-time monitoring and control of critical process parameters, ensuring consistent product quality, reducing waste, and complying with regulatory requirements.

Report Coverage

The report “Biopharmaceutical Process Analytical Technology Market– Forecast (2024-2030)”, by IndustryARC, covers an in-depth analysis of the following segments of Biopharmaceutical Process Analytical Technology.

By Product: Analyzer, Sample, Sensors and Probes, and Software

By Mode: Line Measurement, Inline Measurement, Offline Measurement, Online Measurement

By Technology: Capillary electrophoresis, Liquid Chromatography, Particle Size Analysis, Spectroscopy

By Application: Drug Development & Manufacturing, Drug Discovery

By End User: Academic Institutions & Research Institutions, Biopharmaceuticals, Contract Research Organization (CRO)

By Geography:  Americas, APAC, Europe, Middle East and Africa

Key Takeaways

•  The UK biopharmaceutical process analysis technology market is a rapidly growing sector with a CAGR of 14.63% during the forecast period, driven by increasing demand for biopharmaceutical products, advancements in analytical technologies, and a growing emphasis on quality control and regulatory compliance in the biopharmaceutical industry. For instance, in 2022, the biopharma industry made up 68% of the life sciences sector's overall revenue in the UK. The biopharmaceutical industry is a research-intensive one, accounting for 23 of the top 100 global R&D spenders. 

•   On June 21, 2023, Thermo Fisher Scientific Inc., a global leader in scientific services, announced the completion of its acquisition of MarqMetrix, a privately owned company specializing in Raman-based spectroscopy solutions for inline measurement.

•    In Asia Pacific Region China Occupied a major share in 2023. The biopharmaceutical process analytical technology (PAT) market in China is anticipated to experience rapid growth, driven by the increasing demand for high-quality pharmaceutical products and the government's focus on promoting innovation in the biopharmaceutical industry. For instance, a 5-billion yuan ($700 million) healthcare fund has been raised by Shenzhen's government and Fosun Pharma one of China's largest pharmaceutical companies to invest in new companies and discoveries in cellular biology, genetics, and other biomedical sectors. The adoption of PAT in China is driven by the government's initiatives to promote innovation in the biopharmaceutical sector and streamline manufacturing processes. 

By Product - Segment Analysis

Analyzers dominate the market, accounting for 36% of total revenue in 2023. This is likely due to the critical role analyzers play in real-time monitoring and ensuring product quality in biopharmaceutical production processes.  Biopharmaceutical Process Analytical Technology (PAT) products consist of analyzers that can assess both physical and chemical parameters of processes, aiming to enhance process control. On January 04, 2024, The acquisition of Tornado Spectral Systems Inc. by Bruker enhances the biopharmaceutical Process Analytical Technology (PAT) market, particularly in the analyzer product segment. Tornado’s patented High-Throughput Virtual Slit (HTVS™) technology is a game-changer, enabling the measurement of high-quality spectra even in challenging Raman analyses. Their portfolio, which includes the HyperFlux™ PRO Plus, Process Guardian™, and SuperFlux™, offers superior performance compared to traditional Raman spectrometers, facilitating more accurate chemical identification and quantification in complex mixtures and at low concentrations.

By Mode - Segment Analysis

In 2023, the biopharmaceutical Process Analytical Technology (PAT) market by measurement mode reveals a dominance of inline measurement, which constitutes 40% of the total market share. This is likely due to the increasing adoption of real-time monitoring technologies, allowing for continuous and immediate control of critical quality attributes during the manufacturing process. Recent advancements in PAT are facilitating the greater integration of in-line instruments for real-time measurements in the continuous manufacturing (CM) of oral solid dosage (OSD) drugs. 
The widespread adoption of PAT is essential during the development phase to enhance understanding of both the product and the manufacturing process. In-line measurement devices offer continuous concentration measurements without delays, enabling immediate detection of changes in process conditions without consuming the measurable sample. 

By Technology- Segment Analysis    

In the biopharmaceutical Process Analytical Technology (PAT) market, liquid chromatography holds the largest share at 40% in 2023, highlighting its indispensable role in separating, identifying, and quantifying biomolecules during drug development and manufacturing. This technology is widely used for its precision in analyzing complex biological compounds, particularly in protein purification, ensuring that biologics meet stringent quality standards. Liquid chromatography's ability to handle a variety of sample types and its proven accuracy make it the preferred choice for ensuring product purity and consistency across the biopharmaceutical industry.

In a recent development, researchers at Roche Diagnostics GmbH unveiled a new approach to liquid chromatography aimed at enhancing PAT in biopharmaceutical processing, as detailed in their publication in the Journal of Chromatography on June 24, 2024. While existing spectroscopic techniques provide speed, they often fall short in selectivity and sensitivity, and traditional offline methods, like ultrahigh-performance liquid chromatography (UHPLC), are too slow for real-time applications. This underscores the demand for advanced LC solutions that can effectively meet the rigorous requirements of biopharmaceutical processes.

The novel online LC setup developed by Roche facilitates real-time monitoring of critical product quality attributes during time-sensitive purification operations. By employing fast, specialized analytical methods, this innovative solution achieves sampling cycle times of just 1.30 to 2.35 minutes, all while maintaining the ability to resolve and quantify relevant product variants accurately. 

By Application-Segment Analysis

The Drug Development & Manufacturing a major share of 70% in 2023. The demand for PAT tools has grown dramatically due to the drug manufacturing industry's adoption of Quality by Design concepts. These concepts emphasize integrating quality into the process rather than depending entirely on end-product testing. PAT makes it possible to monitor important quality aspects in real time while a product is being produced, guaranteeing that it continuously meets the necessary criteria. According to the IQVIA, the U.S. spent $568 billion on medicines in 2021, with $260 billion on biologics (46% of total medicine spending), highlighting the increasing reliance on biologics, which are complex and expensive to manufacture. This surge in biologics spending drives the need for Biopharmaceutical Process Analytical Technology (PAT) to optimize production.

 By End User – Segment Analysis

Biopharmaceuticals occupied a dominant position in the Biopharmaceutical Process Analytical Technology market in 2023. Companies in the biopharmaceutical industry are working to launch innovative treatments faster in an increasingly competitive market. Biopharmaceutical process analysis technology facilitates faster decision-making, simplifying the development process and accelerating the R&D to manufacturing transition. For instance, Pharmaceutical Research and Manufacturers of America, the $276 billion global R&D investment by biopharmaceutical companies across 4,191 firms in 2021. The robust biopharmaceutical industry driving the biopharmaceutical process analysis technology market.

By Geography - Segment Analysis

The American region in the Biopharmaceutical Process Analytical Technology market is anticipated to hold a major share with a CAGR of 14.89% during the forecast period (2024-2030).   

The United States has a significant portion of the worldwide biopharmaceutical revenue, making it the largest biopharmaceutical market in the world. Due to this leadership role, there is a greater need for sophisticated process analysis technologies, which are essential for creating and producing novel treatments, such as biologics and biosimilars. In the biopharmaceutical industry, the United States invests some of the most in research and development. As a result of their constant innovation and product development, pharmaceutical and biotechnology industries must use modern process analysis tools to ensure product quality and streamline research and development processes.

For instance, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), the significant achievement of the U.S. biopharmaceutical industry, exceeding $800 billion in direct output in 2022, highlights the sector's vital role in the economy and underscores the escalating demand for innovative therapies and products. This substantial financial output drives the biopharmaceutical process analysis technology market, as companies are compelled to adopt advanced analytical tools to enhance manufacturing efficiency, ensure product quality, and comply with stringent regulatory standards. 

Drivers – Biopharmaceutical Process Analytical Technology Market

•    Increasing demand for biopharmaceuticals biologics

Biologics are transforming the modern healthcare. For example, 2024 has already shown to be a crucial year for the biologics industry, as seen by a dramatic increase in FDA approvals. The FDA approved 9 novel biologics in the first quarter alone, which is a significant increase from the 5 that were approved in the same period in 2023. This increase in approvals ushers in a new age in healthcare, highlighting the quick advancements and increased attention being paid to biologics in medical therapy.

For example, AMTAGVI, a new biologic for advanced melanoma, represents the innovative therapies emerging in 2024 and is offering targeted treatment options where conventional therapies like PD-1 blocking antibodies have been inadequate. CASGEVY provides new hope to patients suffering from ß-thalassemia, a blood condition that traditionally required lifelong blood transfusions. Established immune globulin medicines, such as GAMMAGARD LIQUID (human immunoglobulin G) and HYQVIA (human immunoglobulin G + hyaluronidase) represent a significant advancement in the management of this chronic disease. The growing production capacity of biotechnology and pharmaceutical businesses to produce next-generation biologics is driving the industry. 

•    Regulatory Bodies Worldwide, Endorse The Use Of PAT To Ensure Drug Quality And Manufacturing Efficiency

Several regulatory guidance documents relevant to PAT are available, including the FDA’s 2015 draft guidance document “Development and Submission of Near Infrared Analytical Procedures,” as well as the FDA’s 2004 guidance for industry on PAT. There are other pertinent advice publications in Europe. In Japan, the Sakura Bloom example for RTRT registration from 2014 offers guidance on what should be included in the Common Technical Document's pharmaceutical development section when a drug product is created utilizing aspects of the quality by design technique, which applies PAT. In order to guarantee production efficiency, increase real-time monitoring of pharmaceutical processes, and improve medication quality, the biopharmaceutical PAT industry is heavily influenced by this regulatory backing.

The strategies toward continuous manufacturing in biopharmaceuticals are significantly increasing the market for Process Analytical Technology (PAT). This is because PAT is perceived as the main enabler for a robust control strategy with continuous manufacturing because process analytical technology can aid in implementing continuous manufacturing throughout the entire life cycle. Analytical integration into the process is essential for continuous production. As a result, process analytical technology may greatly improve the continuous production process's design, analysis, and control. 

Challenges – Biopharmaceutical Process Analytical Technology Market

•    High Implementation Costs And Limited Standardization

High implementation costs can be a significant barrier to the adoption of Biopharmaceutical Process PAT in many organizations. PAT systems often require sophisticated and expensive equipment, such as high-resolution sensors, spectrometers, and analytical instruments. These upfront costs of purchasing and installing PAT systems can be substantial, especially for organizations with large-scale manufacturing facilities.
Furthermore, analyzing and interpreting the data generated by PAT systems requires specialized skills and software, which can also contribute to costs. Additionally, ongoing costs for maintenance, calibration, and compliance with regulatory standards may deter smaller companies or those with limited budgets from adopting PAT solutions, potentially slowing down market growth.

The limited standardization of PAT is also a challenge in the biopharmaceutical industry. The absence of common standards can impede collaboration between biopharmaceutical companies, and research institutions, limiting knowledge sharing and hindering innovation. For instance, while there are guidelines and frameworks like the FDA's PAT guidance and ICH Q8, the implementation can vary significantly between companies and regions. Existing guiding rules state that companies must obtain more regulatory approval for their process analytical technology applications at every stage of their life cycle. This is difficult, and it is exacerbated by the disparities in the needs of various regulatory organizations. Certain changes to the scope of the European Medicines Agency advice necessitate regulatory notification and approval before a model update can be applied. This lack of standardization might result in discrepancies in how PAT is applied and understood, making it difficult to establish uniform quality across the sector in the short term.

Market Landscape

In 2023, the top ten players in the Biopharmaceutical Process Analytical Technology market share accounted for 81.49% of the share. Major players in the Biopharmaceutical Process Analytical Technology market are ABB, Thermo Fisher Scientific Inc., Emerson Electric, Merck KGaA, Mettler-Toledo International Inc., Danaher Corporation, Waters Corporation, Carl Zeiss AG, Sartorius AG, and Hamilton Company.

Developments:

•    In November 2023, Emerson launched the Rosemount Analytical Solutions, offering advanced process control and automation technologies specifically designed for biopharmaceutical industries.
•   Merck introduced the Mobius® Power MIX single-use mixer, enhancing upstream bioprocessing with improved process control and monitoring On August 2023.
•   In June 2022, Danaher partnered with Lonza to develop next-generation cell culture technologies, focusing on improving biopharmaceutical production yields and analytical capabilities.
   

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