Bioprocess Monitoring

Global Bioprocess Monitoring Market to Reach US$5.8 Billion by 2030

The global market for Bioprocess Monitoring estimated at US$3.5 Billion in the year 2024, is expected to reach US$5.8 Billion by 2030, growing at a CAGR of 8.4% over the analysis period 2024-2030. Bioprocess Monitoring Reagents & Kits, one of the segments analyzed in the report, is expected to record a 8.5% CAGR and reach US$4.0 Billion by the end of the analysis period. Growth in the Bioprocess Monitoring Instruments segment is estimated at 7.5% CAGR over the analysis period.

The U.S. Market is Estimated at US$1.2 Billion While China is Forecast to Grow at 10.7% CAGR

The Bioprocess Monitoring market in the U.S. is estimated at US$1.2 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$736.4 Million by the year 2030 trailing a CAGR of 10.7% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 6.7% and 7.8% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 7.1% CAGR.

Global Bioprocess Monitoring Market – Key Trends & Drivers Summarized

Why Is Bioprocess Monitoring Essential for the Future of Biopharmaceutical Manufacturing?

Bioprocess monitoring has become a critical component in biopharmaceutical production, ensuring efficiency, product quality, and regulatory compliance in drug manufacturing. As the demand for biologics, including monoclonal antibodies, vaccines, cell therapies, and gene therapies, continues to rise, precise real-time monitoring of bioprocesses is essential for optimizing yields and reducing batch failures. Bioprocess monitoring involves tracking critical parameters such as pH, dissolved oxygen, temperature, glucose levels, cell viability, and metabolite concentrations, enabling manufacturers to maintain consistency in bioproduction.

With the transition toward single-use bioprocessing systems and continuous manufacturing models, real-time data acquisition and process control have become increasingly important. Regulatory bodies such as the FDA and EMA are emphasizing process analytical technology (PAT) and Quality by Design (QbD) approaches, driving the adoption of advanced bioprocess monitoring solutions. Additionally, the integration of artificial intelligence (AI) and machine learning (ML) into bioprocess monitoring is transforming the industry by enabling predictive analytics and automated process optimization. As biopharma companies seek to enhance efficiency, reduce operational costs, and accelerate time-to-market, the role of bioprocess monitoring in ensuring consistent product quality and regulatory compliance continues to grow.

How Are Technological Innovations Enhancing Bioprocess Monitoring?

Rapid advancements in sensor technology, automation, and data analytics are revolutionizing bioprocess monitoring, allowing for real-time control of complex biological systems. One of the most significant innovations in this space is the development of miniaturized, non-invasive, and in-line sensors that provide continuous monitoring of bioreactors without disrupting the cell culture environment. These advanced sensors, including Raman spectroscopy, near-infrared (NIR) spectroscopy, and biosensors, enable precise measurement of key bioprocess parameters with minimal sample handling, reducing contamination risks and improving process efficiency.

Another breakthrough in bioprocess monitoring is the integration of AI-driven predictive analytics, which allows manufacturers to anticipate deviations and optimize process conditions before issues arise. Cloud-based monitoring platforms and digital twins are also transforming biomanufacturing, enabling remote access to real-time process data and virtual modeling of bioreactors for enhanced decision-making. Additionally, automation and robotics are improving process consistency by eliminating manual interventions, reducing variability, and increasing throughput. The expansion of single-use bioprocessing technologies has further driven the need for real-time monitoring solutions, ensuring that disposable systems maintain reproducibility and compliance in large-scale bioproduction.

Which Market Trends Are Driving Growth in the Bioprocess Monitoring Industry?

The growing adoption of biologics, personalized medicine, and biosimilars is one of the most significant trends driving the bioprocess monitoring market. As pharmaceutical companies shift toward the production of high-value biologics and cell-based therapies, maintaining precise control over bioprocess conditions has become increasingly important to ensure therapeutic efficacy and regulatory approval. Additionally, the rise of single-use bioprocessing systems and modular manufacturing facilities has fueled demand for portable and disposable monitoring solutions that integrate seamlessly with flexible production workflows.

Another key trend shaping the market is the increasing reliance on data-driven biomanufacturing. Real-time analytics, cloud computing, and AI-powered process control are transforming how biopharma companies manage production, enabling proactive decision-making and reducing downtime. The emergence of continuous bioprocessing is further accelerating demand for in-line monitoring technologies that can track cell growth, metabolic activity, and process deviations in real-time. Additionally, the push for cost-effective biomanufacturing in emerging markets is driving investments in advanced monitoring solutions to improve scalability and production efficiency. As the pharmaceutical industry embraces digitalization and automation, bioprocess monitoring is becoming a fundamental enabler of next-generation biomanufacturing.

What Are the Key Growth Drivers Shaping the Future of the Bioprocess Monitoring Market?

The growth in the bioprocess monitoring market is driven by several key factors, including the increasing demand for biologics, advancements in sensor technology, and the adoption of Industry 4.0 practices in biomanufacturing. One of the primary growth drivers is the expanding pipeline of monoclonal antibodies, gene therapies, and recombinant proteins, which require precise process control to ensure batch-to-batch consistency and regulatory compliance. As regulatory agencies impose stricter quality standards, pharmaceutical companies are investing heavily in bioprocess monitoring solutions to maintain Good Manufacturing Practices (GMP) and prevent product failures.

Another crucial driver shaping the market is the rapid expansion of contract development and manufacturing organizations (CDMOs), which are leveraging advanced bioprocess monitoring to enhance production efficiency and meet the growing demand for outsourced biologics manufacturing. The integration of AI, big data analytics, and digital twins in bioprocessing is also accelerating market growth, providing manufacturers with real-time insights into process optimization and predictive maintenance. Furthermore, the increasing adoption of continuous manufacturing is driving demand for robust, in-line monitoring solutions that enable seamless process control and higher production yields. As the pharmaceutical industry continues to innovate and optimize biomanufacturing processes, the demand for bioprocess monitoring technologies will continue to rise, shaping the future of precision-driven biologics production.

SCOPE OF STUDY:

The report analyzes the Bioprocess Monitoring market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Offering (Bioprocess Monitoring Reagents & Kits, Bioprocess Monitoring Instruments, Bioprocess Monitoring Software); Application (Host Cell Residual DNA / Protein Quantitation Application, Mycoplasma Detection Application, Viral Titer Determination Application, Adventitious Virus Testing Application, Other Applications); End-Use (Pharma & Biotech Companies End-Use, CROs & CMOs End-Use, Academic & Research Institutes End-Use)q

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 58 Featured) -

• Agilent Technologies
• Applied Biological Materials Inc.
• Bio-Rad Laboratories, Inc.
• Bio-Techne
• Bruker
• Danaher Corporation
• Eppendorf AG
• F. Hoffmann-La Roche AG
• GE Healthcare
• Hamilton Company
• Lonza Group Ltd.
• Maravai Life Sciences
• Nova Biomedical
• PerkinElmer
• Qiagen NV
• Sartorius AG
• Shimadzu Corporation
• Thermo Fisher Scientific, Inc.
• Waters Corporation

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