Digital Biomanufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (AI & IOMT Solutions, Process Analytical Technologies, Data Analytics Software, Others), By Application (Biomanufacturing Process Automation and Control, Bioprocess Optimization and Process Analytics, Flexible Manufacturing), By End User (Biotechnology & Pharmaceutical Companies, Academic & Research Institutions, Others), By Region and Competition, 2020-2030F

Market Overview

The Global Digital Biomanufacturing Market was valued at USD 2.24 billion in 2024 and is expected to reach USD 5.02 billion by 2030 with a CAGR of 14.40% during the forecast period. The major factors include rising automation processes in various industries, shifting toward digitalization and bio-manufacturing in the healthcare industry, and extensive development in technology, are curbing the market's growth. Digital Biomanufacturing refers to the use of digital technologies in manufacturing processes, for instance, computer-aided design (CAD) and computer-assisted machining (CAM). The application of these technologies assists in improving quality, efficacy, and safety standards. The other factors supporting the market’s growth are extensive research and development, increasing demand for biologics, rising emphasis on reduction in errors, cost and time, various investments by private as well public sectors, the growing number of collaborations between companies, and contract manufacturing organizations, particularly in emerging countries.

Key Market Drivers

Public Funding and National Biomanufacturing Strategies Accelerate Digital Adoption

Public investment and national strategies are a significant driver of the digital biomanufacturing market. Governments worldwide are investing heavily in strengthening domestic biomanufacturing capacities to ensure resilience, especially for biologics and vaccines. Initiatives include funding facility upgrades, workforce development, and digital platforms like process analytics, automation, and model-based control. For instance, the United States’ National Biotechnology and Biomanufacturing Initiative and similar programs in the EU and Asia-Pacific focus on supporting digitalization in biomanufacturing to accelerate scale-up and improve supply chain efficiency.

This driver is crucial because it reduces the risk for companies seeking to adopt expensive digital technologies. Shared pilot lines and national labs provide testing grounds for new digital workflows, allowing smaller firms to validate processes before scaling. Public funding also encourages partnerships between academia, industry, and government labs, fostering innovation in process optimization, digital twins, and real-time monitoring. Over time, these initiatives create a robust ecosystem where digital tools are widely adopted across biomanufacturing, enhancing efficiency, safety, and productivity.

Rising Demand for Complex Biologics Requires Scalable Digital Solutions

The surge in biologics, cell and gene therapies, and personalized medicines has increased the need for precise, scalable manufacturing. Regulatory agencies require stringent process control, traceability, and quality assurance. Digital biomanufacturing enables real-time monitoring, automated batch recording, and predictive analytics, helping manufacturers meet these regulatory requirements efficiently. Governments and public health agencies report rising approvals of biologics and advanced therapies, increasing the necessity for digitalized platforms to manage complex processes. Digital control systems minimize batch failures, shorten scale-up timelines, and ensure compliance with GMP standards. With an increasing pipeline of monoclonal antibodies, viral vectors, and protein therapeutics, manufacturers are compelled to adopt digital solutions to meet production demands, maintain quality, and accelerate time-to-market.

Download Free Sample Report

Key Market Challenges

Data Integration, Interoperability, and Regulatory Validation Challenges

Digital biomanufacturing relies on integrating diverse data sources such as sensors, MES, LIMS, and electronic batch records. Legacy equipment and proprietary software complicate integration, making system validation costly and time-consuming. Regulatory agencies expect auditable, traceable, and validated digital systems. Small and mid-sized manufacturers face high upfront costs to connect and validate digital platforms, which can slow adoption. Multinational operations further complicate matters, as harmonizing data standards across jurisdictions is necessary to comply with multiple regulators. The complexity of integration and validation presents a persistent challenge, slowing widespread adoption of fully digital manufacturing processes despite clear efficiency and quality benefits.

Workforce Skills Gap and Organizational Change

Digital biomanufacturing requires cross-disciplinary expertise in bioprocessing, data analytics, automation, and regulatory compliance. Many traditional manufacturing teams lack experience with continuous bioprocessing, process analytical technologies, and AI-assisted controls. Adopting digital workflows also requires cultural changes and new operational processes, including real-time data monitoring, digital batch records, and predictive maintenance. Workforce gaps increase project timelines and costs, especially for small biotech firms and CMOs. Governments are funding training programs, but scaling skilled personnel to meet rapid industry demand remains a challenge. Without targeted upskilling and organizational readiness, digital adoption can be delayed or underutilized.

Key Market Trends

Modular, Digital-Native Facilities and Plug-and-Play Manufacturing

A growing trend is the adoption of modular, flexible, and digital-native manufacturing facilities. These setups use single-use bioreactors, standardized automation modules, and cloud-connected control layers, allowing rapid scale-up and adaptation for different products. Governments and industry bodies are supporting modular plant deployment for pandemic preparedness and regional production flexibility. These facilities reduce capital risk, shorten project timelines, and enable distributed manufacturing. The modular design ensures standardized interfaces and validates digital layers, easing integration challenges and fostering a more scalable digital biomanufacturing ecosystem.

AI, Digital Twins, and Predictive Quality Control

The use of AI and digital twins is transforming process control in biomanufacturing. Digital twins simulate real-world processes to predict deviations, optimize media feeds, and enhance batch consistency. These predictive models reduce cycle times, minimize failures, and strengthen compliance with regulatory expectations. Public agencies and regulatory authorities are increasingly receptive to model-driven process validation, enabling manufacturers to leverage AI for both operational efficiency and quality assurance. Adoption of AI-driven control, coupled with real-time analytics, represents a durable trend that is reshaping the landscape of digital biomanufacturing, improving productivity and supporting the scale-up of complex biologics and personalized therapies.

Segmental Insights

Technology Insights

Based on Technology, Process Analytical Technologies (PAT) currently hold the largest market share. PAT includes real-time monitoring tools, sensors, and analytical systems that allow manufacturers to continuously assess critical process parameters during bioproduction. These technologies help maintain consistent product quality, improve process efficiency, and reduce batch failures — all of which are essential in biologics and advanced therapy manufacturing. Government and regulatory support significantly contributes to the adoption of PAT. The U.S. Food and Drug Administration (FDA) encourages the use of PAT as part of its Process Analytical Technology Guidance for Industry, recognizing that real-time monitoring improves process understanding and product safety. Similar initiatives in Europe and Asia, including the European Medicines Agency (EMA) and China’s regulatory frameworks, promote PAT implementation to ensure quality by design (QbD) principles.

Download Free Sample Report

Regional Insights

Based on the region, North America currently dominates the global digital biomanufacturing market due to its advanced healthcare infrastructure, strong regulatory frameworks, and significant public and private investments in biotechnology. The region is home to many biopharmaceutical companies, contract manufacturing organizations (CMOs), and academic research institutions that are early adopters of digital technologies, including process analytical technologies (PAT), automation, and AI-driven process control. Government initiatives play a key role in sustaining this leadership. In the United States, programs such as the National Biotechnology and Biomanufacturing Initiative have directed substantial funding toward modernizing facilities, expanding digital process capabilities, and developing skilled workforce programs. Public funding reduces the financial risks associated with implementing capital-intensive digital systems and encourages both startups and established companies to adopt advanced digital platforms for process monitoring, predictive analytics, and model-based control.

Recent Developments

• In January 2025, Sartorius signed a research and development agreement with McMaster University to open Sartorius Bioprocess Automation Lab with an aim to advance biomanufacturing capabilities in Canada.
• In December 2024, DataHow signed a technology integration agreement with Eppendorf to integrate DataHowLab analytical solution with Eppendorf's cloud-based platform, BioNsight® cloud to improve the management of bioprocess data.

Key Market Players

• Agilent Technologies, Inc.
• Danaher Corporation
• Donaldson Company, Inc.
• SAP SE
• Honeywell International Inc.
• Emerson Electric Company
• Siemens Healthineers AG
• Atos SE
• GE Healthcare
• e-matica srl

Report Scope:

In this report, the Global Digital Biomanufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Digital Biomanufacturing Market, By Technology:

o   AI & IOMT Solutions

o   Process Analytical Technologies

o   Data Analytics Software

o   Others

• Digital Biomanufacturing Market, By Application:

o   Biomanufacturing Process Automation and Control

o   Bioprocess Optimization and Process Analytics

o   Flexible Manufacturing

• Digital Biomanufacturing Market, By End User:

o   Biotechnology & Pharmaceutical Companies

o   Academic & Research Institutions

o   Others

• Digital Biomanufacturing Market, By Region:

o   North America

§  United States

§  Mexico

§  Canada

o   Europe

§  France

§  Germany

§  United Kingdom

§  Italy

§  Spain

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Japan

§  Australia

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East and Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Digital Biomanufacturing Market.

Available Customizations:

Global Digital Biomanufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Global Digital Biomanufacturing Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]