Press release
Bioprocess Automation and Control Software Market Set for Explosive Growth to USD 13.59 Billion by 2032, Led by North America's 42.8% Market Share | Key Players - Thermo Fisher Scientific Inc., Sartorius AG, Cytiva
Market growth is driven by surging demand for biologics and cell/gene therapies, rising adoption of Industry 4.0 in biomanufacturing, and the need for efficient, scalable production processes. Advancements in AI-driven process control, expanding single-use bioreactor systems, growing investments in continuous manufacturing, and increased regulatory emphasis on data integrity are further accelerating market expansion.
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Key Industry Developments
United States:
✅ January 2026: Cytiva launched an advanced AI-integrated bioprocess control software upgrade, enhancing real-time monitoring and predictive analytics for upstream and downstream processes to boost yield efficiency by 20% in biologics manufacturing.
✅ December 2025: Rockwell Automation introduced Bioprocess Optimizer 5.0, a cloud-based control platform with IoT connectivity for seamless single-use bioreactor integration.
✅ November 2025: Thermo Fisher Scientific unveiled DeltaV BioPrime software suite, incorporating digital twins for virtual bioprocess simulation and control.
Asia Pacific / Japan:
✅ January 2026: FUJIFILM Diosynth Biotechnologies debuted a Japan-centric bioprocess automation module within their global platform, optimized for high-density mammalian cell cultures.
✅ November 2025: Sartorius Japan released BioPAT MFCS advanced version with edge computing for real-time bioprocess analytics in APAC facilities.
✅ October 2025: Yokogawa Electric Corporation rolled out CENTUM VP R7.01 for biopharma, featuring hybrid AI-human oversight for precise fermentation control in Japanese plants.
Strategic Mergers and Acquisitions:
✅ Siemens AG acquired U.S.-based R&D scientific software company Dotmatics for $5.1 billion in April 2025, bolstering its Life Sciences portfolio and expanding AI-powered product lifecycle management under the Xcelerator platform for bioprocess automation.
✅ Aspen Technology completed the acquisition of Cosmic Robotics in May 2025, integrating advanced robotics into its automation solutions to strengthen capabilities in bioprocess control and related sectors.
✅ The Bundy Group reported nine automation transactions in June 2025, reflecting ongoing consolidation and strategic acquisitions to enhance capabilities and market presence in bioprocess automation.
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
Strategic Leadership Report: Top 5 Players in Bioprocess Automation and Control Software Market 2026
-Thermo Fisher Scientific Inc.: Deployed the Thermo Scientific TruBio Bioprocess Control Software on the DeltaV Distributed Control Platform, enabling seamless integration of multiple vessels for streamlined process control and data management from research to production scales with enhanced user interfaces and scalability.
-Sartorius AG: Advanced the Sartorius Biostat STR® single-use bioreactor system with integrated automation software featuring real-time process analytics and predictive control algorithms, optimizing upstream bioprocessing efficiency and ensuring robust scale-up for biopharmaceutical production.
-Merck KGaA: Launched Mobius® Automation Solutions with enhanced Process Information Management System (PIMS), providing unified data integration and advanced PAT tools for real-time monitoring and control in single-use bioprocessing workflows.
-Cytiva (Danaher Corporation): Introduced the ÄKTATM process systems with upgraded UNICORNTM control software version 8.0, delivering AI-driven optimization features for chromatography automation, improved method transferability, and comprehensive data integrity for downstream purification.
-Emerson Electric Co.: Expanded the DeltaVTM BioPharma Software Suite with hybrid cloud connectivity and model-predictive control modules tailored for bioprocesses, facilitating predictive maintenance, batch analytics, and seamless integration across upstream and downstream operations.
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Market Drivers and Key Trends:
-Biopharma Surge: Escalating demand for biologics, biosimilars, and personalized medicines fuels adoption of automation software for precise, scalable manufacturing processes.
-Efficiency Gains: Continuous biomanufacturing techniques, backed by advanced control systems like Sartorius BioBrain, optimize workflows and boost real-time decision-making.
-Tech Advancements: Integration of AI, machine learning, and cloud-based platforms enables predictive analytics, remote monitoring, and regulatory compliance in complex bioprocesses.
-Regulatory Pressures: Stringent GMP standards and data integrity requirements drive investment in compliant automation to ensure product consistency and audit readiness.
Regional Insights:
-North America: 42.8% (Largest share, driven by advanced healthcare infrastructure and strong R&D in biopharmaceuticals).
-Asia Pacific: 25% (Fastest growing, fueled by biomanufacturing expansion in China, India, and Japan).
-Europe: 20% (Supported by mature biotech sectors and steady automation adoption).
Market Opportunities & Challenges: Bioprocess Automation and Control Software Market 2026
-Opportunities: A "Digital Twin Surge" accelerates adoption, with AI-integrated platforms forecasting a 13.7% CAGR through integrated MES-SCADA systems for biologics scaling. Cloud-native solutions and Industry 4.0 subsidies for cell/gene therapy workflows enable low-risk entry for precision-focused biopharma investors.
-Challenges: High upfront integration costs linger from "2025 Validation Bottlenecks," while talent shortages in AI process analytics demand reskilling. Success hinges on mastering vendor interoperability across fragmented bioreactor ecosystems.
-Strategic Verdict: AI-optimized upstream control and predictive downstream analytics emerge as core 2026 growth drivers.
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Market Segmentation Analysis:
-By Software Type: Bioprocess Control Software Leads Process Efficiency
Bioprocess Control Software dominates at 40% share in 2024, enabling real-time monitoring and automation of fermentation and cell culture processes for consistent yields.
Data Management and Analytics Software holds 25%, integrating big data for predictive insights and optimization.
Quality Management Software (QMS) and Laboratory Information Management Systems (LIMS) claim 15% and 10%, ensuring compliance and lab workflows.
Manufacturing Execution Systems take 10%, streamlining production execution.
-By Deployment: On-Premises Retains Control Preference
On-Premises leads with 45% share, preferred for data security and customization in regulated biopharma environments.
Cloud-Based follows at 35%, offering scalability and remote access for agile operations.
Hybrid models capture 20%, blending security with flexibility.
-By Application: Upstream Processing Drives Biomanufacturing Growth
Upstream Processing commands 35% share, focusing on cell culture and fermentation scale-up in biologics production.
Downstream Processing holds 25%, handling purification and formulation.
Bioprocess Monitoring, R&D and Process Development, and Process Optimization and Scale-Up split 20%, 15%, and 5%, supporting analytics and innovation.
-By End-User: Biopharmaceutical Companies Dominate Demand
Biopharmaceutical and Pharmaceutical Companies lead with 50% share, fueling demand for high-volume biologics like vaccines and monoclonal antibodies.
Contract Manufacturing Organizations (CMOs) take 25%, supporting outsourced production.
Academic and Research Institutes hold 10%, Food and Beverage Industry 10%, and Others 5% for specialized applications.
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