AI-Driven Digital Biomanufacturing Market Size, Share & Forecast

According to a new market research report, the Digital Biomanufacturing Market is projected to reach USD 76.4 billion by 2035, growing from an estimated USD 23.4 billion in 2025, at a robust CAGR of 12.6% during the forecast period from 2025 to 2035.

The strong growth of the digital biomanufacturing market is primarily driven by the escalating demand for biologics, increasing capacity expansions of biopharmaceutical manufacturing plants, and the growing focus on continuous and data-driven bioprocessing. The rising production of monoclonal antibodies, vaccines, gene therapies, and cellular-based biologics is pushing manufacturers to adopt advanced digital technologies to improve efficiency, scalability, and regulatory compliance.

Growing Demand for Biologics Accelerates Digital Adoption

Biologics have become a cornerstone of modern therapeutics, particularly in oncology, immunology, rare diseases, and personalized medicine. Their complex manufacturing requirements necessitate real-time monitoring, advanced analytics, and process optimization—capabilities that digital biomanufacturing platforms provide effectively. Technologies such as digital twins, Manufacturing Execution Systems (MES), and Process Analytical Technology (PAT) enable manufacturers to optimize production workflows, reduce variability, and accelerate time-to-market while ensuring product quality and patient safety.

Capacity Expansions Drive Smart Manufacturing Investments

Leading biopharmaceutical companies are heavily investing in capacity expansion initiatives, with a strong emphasis on digital transformation. Rather than merely expanding physical infrastructure, companies are building intelligent, interconnected manufacturing ecosystems that leverage predictive maintenance, advanced analytics, and real-time quality monitoring. These digital strategies help reduce commissioning time, enhance operational flexibility, and improve overall equipment effectiveness (OEE), resulting in higher yields and lower production costs.

AI, Machine Learning, and Cloud Platforms Reshape Biomanufacturing

The integration of artificial intelligence (AI) and machine learning (ML) is emerging as a key trend in digital biomanufacturing. These technologies enable predictive quality control, autonomous process optimization, and proactive maintenance by analyzing large volumes of manufacturing data. In parallel, cloud-based manufacturing platforms are gaining traction due to their scalability, cost efficiency, and ability to support real-time collaboration across global manufacturing networks.

Bioprocessing 4.0 Creates New Growth Opportunities

The shift toward Bioprocessing 4.0, characterized by end-to-end digital connectivity and Industrial Internet of Things (IIoT) integration, is creating significant growth opportunities. Digital biomanufacturing solutions support automated monitoring, reduced manual intervention, enhanced process control, and improved compliance—making them essential for next-generation biopharmaceutical manufacturing.

Key Market Findings

By Offering: The software segment is expected to account for the largest share of the market in 2025, driven by the adoption of MES, digital twin platforms, and advanced analytics solutions.

By Functionality: Process optimization & analytics is projected to dominate the market due to its ability to improve yields, reduce costs, and minimize batch failures.

By Bioprocess: The upstream bioprocess segment is expected to hold the largest share, owing to the complexity and economic impact of cell culture operations.

By Application: Monoclonal antibodies are anticipated to represent the largest application segment in 2025, while gene-based biologics are expected to witness the fastest growth.

By End User: Biopharmaceutical companies are projected to dominate the market due to increasing adoption of digital technologies to scale biologics production.

North America Leads the Market

North America is expected to account for the largest share of the digital biomanufacturing market in 2025, supported by the presence of leading biopharmaceutical companies, advanced technological infrastructure, and favorable regulatory frameworks. However, the Asia-Pacific region is projected to register the fastest growth, driven by expanding biopharmaceutical manufacturing capacity and increasing government investments in biotechnology.

Key Players

Major companies operating in the global digital biomanufacturing market include GE Healthcare Technologies Inc., Siemens Xcelerator, Cytiva, ABB Ltd., Sanofi S.A., Emerson Electric Co., Honeywell International Inc., SAP SE, Schneider Electric SE, Dassault Systèmes, Oracle Corporation, and 3M, among others.

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