Bioprocess Automation and Control Software Market Strengthens with 13.7% CAGR as North America Dominates with 40% Share

The Bioprocess Automation and Control Software Market was valued at US$ 4.96 billion in 2024 and is projected to reach US$ 13.59 billion by 2032, growing at a strong CAGR of 13.7% during 2025-2032. This growth is propelled by rising biopharmaceutical production, increasing demand for automated upstream and downstream processes, and the shift toward digitalized, data-driven bioprocessing environments.

The market is strengthening its position as biomanufacturers adopt advanced control software to improve process reliability, reduce variability, and enhance scalability across cell culture, fermentation, purification, and quality monitoring workflows. Integration of real-time analytics, AI-enabled optimization, and seamless automation across equipment and platforms is driving higher productivity, regulatory compliance, and cost efficiency, reinforcing long-term market expansion.

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Bioprocess Automation and Control Software refers to software systems that automate, monitor, and regulate bioproduction processes to improve efficiency, consistency, and product quality in biotechnology and pharmaceutical manufacturing.

Key Developments

United States
✅ April 2025: Siemens expanded its bioprocess digitalization initiatives by integrating advanced automation architecture to support continuous biologics manufacturing in U.S.-based facilities.

✅ March 2025: U.S. biopharma companies accelerated adoption of AI-enabled control software for predictive maintenance, anomaly detection, and real-time bioprocess optimization.

✅ February 2025: Multiple U.S. CDMOs deployed cloud-based bioprocess control systems to enable remote batch monitoring and multi-site coordination.

Japan
✅ January 2025: Japanese biomanufacturers increased investment in automated upstream bioprocessing platforms to improve batch consistency and reduce operator workload.

Mergers & Acquisitions

United States
✅ April 2025: Siemens announced the acquisition of a major life-science R&D software provider to strengthen its automation and bioprocessing digital ecosystem.

Key Players:
Thermo Fisher Scientific Inc. | Merck KGaA | Sartorius AG | SECURECELL AG | Emerson Electric Co. | Agilent Technologies, Inc. | Siemens AG | Cytiva (Danaher Corporation) | Eppendorf SE | Waters Corporation

Key Highlights :
• Thermo Fisher Scientific Inc. - Holds 17.6% share of the global bioprocess automation and analytics market, driven by strong adoption of bioprocess monitoring systems, PAT tools, and integrated automation platforms.

• Merck KGaA - Accounts for 15.2% market share, supported by advanced bioprocess sensors, single-use technologies, and automated upstream-downstream workflow solutions.

• Sartorius AG - Maintains 13.4% share, propelled by bioreactor automation, real-time quality monitoring systems, and digitalized process-control technologies.

• Cytiva (Danaher Corporation) - Holds 11.9% market share, backed by automated bioprocessing equipment, chromatography systems, and integrated workflow optimization tools.

• Agilent Technologies, Inc. - Contributes 9.1% share, driven by analytical instrumentation, process monitoring devices, and biopharmaceutical QC automation.

• Siemens AG - Holds 7.8% market share, supported by industrial automation platforms adapted for bioprocess control, predictive analytics, and smart manufacturing integration.

• Eppendorf SE - Accounts for 6.7% share, fueled by automated bioreactors, lab-scale process systems, and digital process optimization tools.

• Waters Corporation - Maintains 5.4% market share, driven by bioprocess analytical technologies, LC-MS integration, and real-time process validation tools.

• Emerson Electric Co. - Holds 4.3% market share, supported by automation controls, PAT software, and scalable bioprocess monitoring systems.

• SECURECELL AG - Contributes 2.6% market share, driven by automated sampling systems, real-time nutrient monitoring, and intelligent bioprocess data platforms.

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Market Drivers

• Increasing adoption of automated bioprocessing solutions in biopharmaceutical production is accelerating demand for software that improves efficiency, consistency, and regulatory compliance.

• Rising need for real-time monitoring, predictive analytics, and digital twins in upstream and downstream processes is driving software implementation in modern biomanufacturing.

• Growing biologics and cell & gene therapy pipelines are boosting demand for scalable, flexible automation platforms that support complex workflows.

• Expansion of Industry 4.0 and smart manufacturing in life sciences is increasing investment in AI-enabled, cloud-based, and integrated MES-SCADA bioprocess systems.

• Strong focus on reducing production costs, minimizing batch failures, and enhancing yield optimization is further strengthening software adoption.

Industry Developments

• October 2025 (US): Biotech manufacturers adopted cloud-native bioprocess control systems with enhanced data integrity features to support multi-site batch management.

• August 2025 (Germany): Leading automation companies introduced AI-driven process optimization modules to improve fermentation and cell culture efficiency.

• June 2025 (Singapore): Contract manufacturing organizations (CMOs) deployed integrated MES-batch control platforms to streamline biologics production workflows.

• April 2025 (UK): Software vendors collaborated with major biopharma firms to develop digital twins for predicting process deviations and optimizing bioreactor performance.

Regional Insights

• North America - US$ 1.05 billion (40% share): Growth is driven by "strong presence of biopharmaceutical manufacturers, rapid adoption of smart bioprocessing technologies, and high investment in digital transformation across biologics production."

• Europe - US$ 0.85 billion (32% share): Expansion is supported by "advanced biotech infrastructure, strong regulatory emphasis on data integrity, and growing adoption of automated control systems in biomanufacturing facilities."

• Asia-Pacific - US$ 0.60 billion (23% share): Growth is fueled by "rapid expansion of biologics manufacturing, rising investments in biopharma automation, and increasing establishment of GMP-certified production sites."

• Latin America - US$ 0.10 billion (4% share): Demand is rising due to "improving pharmaceutical production capabilities, interest in process digitization, and increasing partnerships with global biotech firms."

• Middle East & Africa - US$ 0.05 billion (1% share): Growth is driven by "emerging biomanufacturing hubs, government-led healthcare modernization, and growing interest in automated systems for vaccine and biologics production."

Key Segments

By Software Type
Bioprocess control software leads the market as companies rely on automated, real-time control of bioreactors and production systems to ensure consistency, efficiency, and regulatory compliance. Data management and analytics software is expanding rapidly with the rise of digitized bioprocessing, enabling better decision-making through data visualization, pattern detection, and predictive insights. Quality management software (QMS) remains crucial for maintaining compliance, ensuring accurate documentation, and ensuring product quality throughout the biopharmaceutical lifecycle. Laboratory Information Management Systems (LIMS) are widely used for tracking samples, automating workflows, and organizing research data across laboratories. Manufacturing Execution Systems support end-to-end production visibility, batch tracking, and process standardization within biomanufacturing environments.

By Deployment
On-premises deployment continues to be preferred by organizations requiring full control over data security, infrastructure, and regulatory compliance. Cloud-based deployment is growing steadily as companies adopt flexible, scalable, and cost-efficient digital platforms accessible across global facilities. Hybrid deployment is becoming common, combining the security of on-premises systems with the agility and remote accessibility of cloud solutions.

By Application
Upstream processing applications dominate due to the need for precise monitoring of cell growth, media management, and bioreactor operations. Downstream processing relies heavily on software for purification, filtration, and separation workflows to ensure consistent product yield. Bioprocess monitoring solutions support real-time tracking of critical parameters such as pH, dissolved oxygen, and temperature to maintain product quality. R&D and process development applications are expanding with increased focus on experimental optimization and faster development cycles. Process optimization and scale-up software is essential for transitioning from lab-scale to commercial-scale production with improved efficiency and reduced variability.

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