Bioprocess Automation and Control Software Market Set for Explosive Growth to US$ 13.59 Billion by 2032, Led by North America's 42.8% Market Share

The Bioprocess Automation and Control Software Market reached US$4.96 billion in 2024 and is expected to reach US$13.59 billion by 2032, growing at a CAGR of 13.7% during the forecast period of 2025-2032.

Market growth is driven by the expanding biopharmaceutical industry, rising demand for biologics, biosimilars, and personalized medicines, along with the need for enhanced manufacturing efficiency, product consistency, and regulatory compliance. Advancements in automation technologies such as AI, IoT, and machine learning for predictive maintenance and real-time analytics, coupled with increasing investments in biomanufacturing infrastructure, are accelerating expansion.

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Key Industry Developments

United States:
✅ January 2026: Cytiva launched an advanced AI-integrated bioprocess control software upgrade. This enhances real-time monitoring and predictive analytics for upstream and downstream processes. It boosts yield efficiency by 20% in biologics manufacturing.

✅ December 2025: Rockwell Automation introduced Bioprocess Optimizer 5.0, a cloud-based control platform. The software features IoT connectivity for seamless single-use bioreactor integration. It supports scalable automation in biopharmaceutical production.

✅ November 2025: Thermo Fisher Scientific unveiled DeltaV BioPrime software suite. This incorporates digital twins for virtual bioprocess simulation and control. It improves process development and regulatory compliance in US facilities.

Key Mergers and Acquisitions:
✅ Siemens AG strengthened its bioprocess automation capabilities by acquiring U.S.-based R&D scientific software company Dotmatics for $5.1 billion in April 2025, expanding AI-powered product lifecycle management under the Xcelerator platform for life sciences.

✅ Aspen Technology enhanced its automation solutions, including bioprocess control, through the acquisition of Cosmic Robotics in May 2025, integrating advanced robotics for sophisticated process integration.

✅ The Bundy Group reported nine automation transactions in June 2025, signaling continued consolidation in the bioprocess automation sector to boost capabilities and market presence.

✅ Repligen bolstered its bioprocessing analytics portfolio with the March 2025 acquisition of 908 Devices' desktop PAT technologies for real-time upstream process monitoring and control.

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

Strategic Leadership Analysis: Top 5 Players in Bioprocess Automation and Control Software Market 2026
-Thermo Fisher Scientific Inc.: Launched the 5L DynaDrive single-use bioreactor, enabling bench-scale productivity, scalability, and efficiency with reduced environmental impact to streamline bioprocessing workflows.​

-Merck KGaA: Introduced the Bio4C Software Suite as part of the BioContinuum Platform, integrating process control, analytics, and plant-level automation for holistic biomanufacturing oversight and Bioprocessing 4.0 capabilities.​

-Sartorius AG: Advanced the Biobrain Automation Platform with recipe operations via BioPAT MFCS, PAT integration, and SCADA/MES connectivity to simplify bioprocess control, ensure compliance, and support continuous processing.​

-Cytiva (Danaher Corporation): Released X-platform bioreactors with Figurate automation software, offering ergonomic improvements, scalable production, and simplified supply chain for efficient single-use upstream bioprocessing.​

-Emerson Electric Co.: Enhanced DeltaV automation system, including DeltaV Discovery and PK Controller, for seamless R&D-to-manufacturing transitions, scalable data transfer, and integrated PAT monitoring in bioprocess control.​

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Market Drivers and Key Trends:
-Biopharma Expansion: Surging demand for biologics, biosimilars, and cell/gene therapies drives adoption of automation software for scalable, precise manufacturing processes.

-Industry 4.0 Integration: Real-time analytics, AI optimization, and digital twins enhance process control in bioreactors, fermentation, and purification workflows.

-Efficiency Optimization: Continuous manufacturing and cloud-based MES-SCADA systems reduce variability, boost productivity, and ensure regulatory compliance.

-Digital Transformation: North America's 40% market dominance reflects heavy investments in smart bioprocessing amid biologics production growth.​

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 Acceleration" fuels AI-integrated platforms for real-time bioprocess optimization; cloud-native MES-SCADA systems and continuous manufacturing subsidies enable seamless scaling for cell/gene therapy workflows. Single-use bioreactor expansions with predictive analytics offer de-risked pathways for ESG-aligned biopharma scaling.

-Challenges: Legacy integration hurdles from mismatched protocols inflate validation timelines, while AI analytics talent gaps demand rapid upskilling. Success requires interoperability mastery across bioreactor vendors and stringent GMP data compliance.

-Strategic Verdict: AI-driven upstream control and predictive downstream analytics stand as prime 2026 growth levers.​

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Market Segmentation Analysis:
-By Software Type: Bioprocess Control Software Leads Efficiency
Bioprocess Control Software dominates at 40% share in 2024, enabling real-time monitoring and automation of fermentation and cell culture for consistent yields.​
Data Management and Analytics Software holds 25%, integrating big data for predictive insights.​
Quality Management Software (QMS) and Laboratory Information Management Systems (LIMS) claim 15% and 10%, ensuring compliance and lab workflows, while Manufacturing Execution Systems take 10%, streamlining production.​

-By Deployment: On-Premises Retains Security Preference
On-Premises leads with 45% share, preferred for data security and customization in regulated environments.​
Cloud-Based follows at 35%, offering scalability and remote access.​
Hybrid models capture 20%, blending security with flexibility.​

-By Application: Upstream Processing Drives Growth
Upstream Processing commands 35% share, focusing on cell culture and fermentation scale-up.​
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
Biopharmaceutical and Pharmaceutical Companies lead with 50% share, fueling biologics demand.​
Contract Manufacturing Organizations (CMOs) take 25%, supporting outsourced production.​
Academic and Research Institutes hold 10%, Food and Beverage Industry 10%, and Others 5%.​

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