The global digital biomanufacturing market was valued at US$ 21.1 Bn in 2024. The market is projected to expand at a CAGR of 9.2% from 2025 to 2035, reaching a value of US$ 55.6 Bn by the end of 2035. Rise in demand for biologics, cell and gene therapies, and vaccines is prompting the adoption of advanced manufacturing technologies. Integration of artificial intelligence (AI), machine learning (ML), Internet of Things (IoT), and robotics is redefining traditional biomanufacturing workflows.
Analysts’ Viewpoint
Rapid advancements in digitalization across the pharmaceutical manufacturing ecosystem, combined with an increase in the production of complex biologics, are shaping the future of the digital biomanufacturing market. Implementation of manufacturing execution systems (MES), process analytical technologies (PAT), and digital twins is enabling real-time process control, improved quality assurance, and increased production efficiency. The convergence of automation, cloud technologies, and predictive analytics is expected to fuel the adoption of digital biomanufacturing platforms globally.
Digital Biomanufacturing Market Overview
Digital biomanufacturing refers to the integration of digital technologies to automate, monitor, and optimize biopharmaceutical production. The approach offers significant advantages such as enhanced process scalability, reduced costs, increased efficiency, and consistent product quality.
Key technologies—such as MES, PAT, data analytics software, and digital twins—form a digital ecosystem that enables smart decision-making, flexible manufacturing models, and rapid adaptation to market demand, particularly in the realm of personalized medicine.
Key Market Drivers
- Rising Demand for Biologics
Growing prevalence of chronic conditions, autoimmune diseases, and various forms of cancer has fueled the demand for monoclonal antibodies, gene therapies, and vaccines. The complexity and precision required in biologics production necessitate digital solutions for process optimization and scale-up. - Advancements in Digital Manufacturing Technologies
Integration of AI and machine learning for real-time insights, IoT-enabled sensors for predictive maintenance, and robotic automation to minimize human error are driving operational efficiency. Digital twins enable simulation and validation of processes before implementation, reducing risk and improving time-to-market. - Regulatory Support for Digitization
Regulatory agencies such as the U.S. FDA are increasingly endorsing the adoption of digital technologies in compliance with quality standards, thereby facilitating smoother approval pathways and fostering trust in digital biomanufacturing systems.
Market Segmentation
By Technology
- Manufacturing Execution System (MES)
- Process Analytical Technology (PAT)
- Data Analytics Software
- Digital Twins
By Deployment Type
- Cloud-based
- On-premises
By Biologic Type
- Vaccines
- Antibodies
- Cell and Gene Therapies
- Others
By Application
- Biomanufacturing Process Automation
- Remote Equipment Monitoring
- Digital Bioreactor Scaling
- Others
By End-user
- Biopharmaceutical Companies
- Contract Manufacturing Organizations (CMOs)
- Others
Regional Market Insights
North America held the dominant share of the global digital biomanufacturing market in 2024. This is attributed to the strong presence of leading biopharma companies, government support for digital transformation, and substantial investments in R&D.
The U.S. Food and Drug Administration’s (FDA) push for modernization and digital compliance is accelerating the integration of PAT, MES, and digital twins in manufacturing processes. Meanwhile, Asia Pacific is emerging as a lucrative market due to expanding biologics production in China, India, and Japan.
Competitive Landscape
Prominent players in the digital biomanufacturing market are focused on strategic collaborations, innovation, and portfolio expansion. Key companies include:
- Cytiva (Danaher Corporation)
- Eppendorf SE
- Sartorius AG
- Merck KGaA
- Aspen Technology Inc.
- Thermo Fisher Scientific Inc.
- ABB
- Siemens
- Dassault Systèmes
- Bruker
- Hamilton Company
- Genedata AG
- Körber AG
- Invert, Inc.
- AmpleLogic
- Kymanox Corporation
Key Developments
- In April 2025, Sartorius Stedim Biotech partnered with Tulip Interfaces to develop Biobrain Operate, a next-gen suite of digital applications for biopharma manufacturing.
- In January 2025, Cytiva announced a strategic collaboration with Cellular Origins to combine the Sefia platform and Constellation robotic platform, aiming to digitally transform cell and gene therapy manufacturing.
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