Digital Biomanufacturing Market Size Expected to Surpass USD 55.6 Billion by 2035 with 9.2% CAGR - TMR

Digital Biomanufacturing Market Size and Outlook 2035

The global digital biomanufacturing market was valued at US$ 21.1 Bn in 2024 and is projected to reach US$ 55.6 Bn by 2035, expanding at an impressive CAGR of 9.2% from 2025 to 2035. The market is gaining strong momentum as biotechnology companies and pharmaceutical manufacturers accelerate the transition toward data-driven, automated, and AI-enabled production systems. Advancements in digital twins, process analytical technologies (PAT), and smart bioreactors are transforming the efficiency, scalability, and quality of biologics production worldwide.

Growing demand for personalized medicine, cell & gene therapies, and high-throughput biologics manufacturing is further driving adoption of digital solutions that optimize process control, reduce downtime, and enhance regulatory compliance.

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Market Overview

Digital biomanufacturing integrates data analytics, automation, AI/ML, IoT sensors, cloud platforms, and digital twins into bioprocessing operations. It enables real-time monitoring, predictive optimization, and intelligent decision-making to improve yields, reduce batch failures, and ensure consistent product quality.

The market growth is fueled by:
• Rising complexity of biologics and biosimilars production.
• Shift toward continuous and intensified bioprocessing.
• Integration of real-time data systems to meet global regulatory standards (FDA, EMA).
• Increasing adoption of robotics and advanced automation in bioprocessing facilities.

As the biotech industry moves toward Industry 4.0, digital biomanufacturing is emerging as the backbone of next-generation production systems, enhancing agility and reducing costs across both upstream and downstream processes.

Market Description

Biomanufacturing traditionally involves complex, multi-step biological processes prone to variability. Digital biomanufacturing addresses these challenges by enabling data-driven process control, smart workflow automation, and simulation-based optimization.

Key components include:
• Digital twins for bioprocess simulation
• AI-driven process optimization
• IoT-enabled bioreactors and sensors
• Cloud-based manufacturing execution systems (MES)
• Advanced PAT tools
• Robotics for aseptic operations

This digital shift supports scalable production of monoclonal antibodies, vaccines, mRNA therapeutics, cell therapies, and recombinant proteins. Moreover, pharma companies are leveraging advanced analytics to accelerate tech transfer, streamline facility operations, and ensure high consistency across global sites.

With rising therapeutic demand and supply chain pressures, digitally empowered biomanufacturing is becoming essential for global competitiveness.

Analysis of Key Players in the Digital Biomanufacturing Market

Leading players are investing heavily in digital process technologies, automation platforms, predictive analytics, and bioprocessing software to enhance flexibility and productivity. Strategic collaborations between biotech firms, automation companies, and software developers are shaping the competitive landscape.

Prominent companies include:
• Cytiva (Danaher Corporation)
• Eppendorf SE
• Sartorius AG
• Merck KGaA
• Aspen Technology Inc
• Körber AG
• AmpleLogic
• Siemens
• Thermo Fisher Scientific Inc.
• ABB
• Bruker
• Hamilton Company
• Dassault Systèmes
• Kymanox Corporation
• Invert, Inc.
• Genedata AG
Each of these players is profiled based on financial status, technological expertise, automation capabilities, product portfolio, and recent growth strategies.

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Key Developments in the Market

• In April 2025, Sartorius Stedim Biotech inked a collaboration with Tulip Interfaces with an aim to accelerate digital transformation in biopharmaceutical manufacturing. In accordance with the partnership's terms, the companies are combining their respective capabilities to develop Biobrain Operate, a next-generation suite of digital manufacturing applications that will interface directly with Sartorius Stedim Biotech process equipment.

• In January 2025, Cytiva announced that it entered into a partnership with Cellular Origins to transform the manufacturing processes of cell therapies. Under the terms of the agreement, Cytiva's automated Sefia platform and Cellular Origin's automated robotic platform, Constellation, are to be combined to form a seamless interface, providing complete digital interconnection, including quality control systems, fully remote digital controls, and analytics. The combined system is poised to provide cell and gene therapy manufacturers the ability to scale production to industrial levels without changing the process used during discovery phases or clinical trials.

Key Player Strategies

• AI & Machine Learning Integration: Enhancing predictive maintenance, yield optimization, and anomaly detection.
• Automation & Robotics: Streamlining upstream cell culture and downstream purification.
• Cloud-first Manufacturing Models: Supporting remote monitoring and multi-site operations.
• Collaborative Innovation: Partnerships between software vendors, biotech companies, and academic institutions.
• Modular Facility Designs: Enabling flexible, scalable, and rapid deployment of bioprocessing units.

Market Challenges

• High initial investment for automation and digital transformation.
• Skill gaps in data science and bioprocess engineering.
• Cybersecurity risks associated with cloud-connected systems.
• Integration complexities across legacy equipment and new digital platforms.

Market Opportunities

• Increasing demand for mRNA vaccines and cell & gene therapies.
• Rapid expansion of modular and continuous bioprocessing facilities.
• Adoption of digital twins for R&D and manufacturing scalability.
• Growing use of AR/VR solutions for training and virtual facility management.
• Rising government support for biotech infrastructure modernization.

Market Segmentations
By Technology

• Digital Twin
• IoT & Sensors
• Manufacturing Execution Systems (MES)
• Automation & Robotics
• AI/ML Platforms
• Advanced Analytics
• Cloud Computing
• Cyber-physical Systems

By Application

• Bioprocess Monitoring & Control
• Predictive Maintenance
• Process Optimization
• Tech Transfer & Scale-up
• Quality Management
• Supply Chain & Facility Management

By End User

• Biopharmaceutical Companies
• CDMOs & CROs
• Research Institutes
• Academic Laboratories
• Industrial Biotech Facilities

By Region

• North America: Leading adoption driven by biotech investments and strong digital infrastructure.
• Europe: Growing focus on advanced analytics and automation in biologics production.
• Asia-Pacific: Fastest growth due to expanding biopharma manufacturing and government support.
• Latin America & MEA: Emerging adoption with increasing digitalization initiatives.

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Why Buy This Report?

• Comprehensive analysis of digital transformation in biomanufacturing.
• Detailed segmentation covering technologies, applications, and end users.
• In-depth competitive benchmarking and strategic insights.
• Forecast-driven intelligence for long-term planning.
• Evaluation of emerging technologies shaping next-gen bioprocessing.

Conclusion

The digital biomanufacturing market is advancing rapidly as companies transition toward smart, automated, and highly efficient production systems. With rising pressure to deliver high-quality biologics at scale, digital solutions-powered by AI, automation, and real-time analytics-are becoming indispensable. Though challenges such as high investment and skill shortages persist, the continued evolution of digital twins, PAT tools, and intelligent bioprocessing is unlocking transformative opportunities across the global biopharmaceutical landscape.

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