Digital Biomanufacturing

Global Digital Biomanufacturing Market to Reach US$39.1 Billion by 2030

The global market for Digital Biomanufacturing estimated at US$18.2 Billion in the year 2024, is expected to reach US$39.1 Billion by 2030, growing at a CAGR of 13.6% over the analysis period 2024-2030. Software Offering, one of the segments analyzed in the report, is expected to record a 15.1% CAGR and reach US$29.7 Billion by the end of the analysis period. Growth in the Hardware Offering segment is estimated at 9.6% CAGR over the analysis period.

The U.S. Market is Estimated at US$5.0 Billion While China is Forecast to Grow at 18.5% CAGR

The Digital Biomanufacturing market in the U.S. is estimated at US$5.0 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$8.4 Billion by the year 2030 trailing a CAGR of 18.5% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 9.8% and 12.3% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 10.8% CAGR.

Global Digital Biomanufacturing Market – Key Trends & Drivers Summarized

What Is Driving the Shift Toward Digitalization in Biomanufacturing?

Digital biomanufacturing represents the integration of data-driven technologies into biological production systems to enhance efficiency, flexibility, and quality across biopharmaceutical and biotech manufacturing processes. Traditionally reliant on batch-based, manual procedures, the biomanufacturing industry is now embracing digital tools such as advanced process control, predictive analytics, artificial intelligence, and machine learning to modernize and optimize operations. These technologies allow real-time monitoring, dynamic control of process parameters, and automated decision-making, which ultimately improves yield, reduces variability, and accelerates product release.

The push toward digitalization is particularly significant in the context of personalized medicine, gene therapies, and biosimilars, where production timelines and quality control are critical. In these high-stakes applications, digital tools ensure that manufacturing can adapt quickly to changing batch sizes, product types, and regulatory expectations. The ability to capture, model, and act on large datasets throughout upstream and downstream processes marks a critical turning point in transitioning biomanufacturing from reactive to predictive and adaptive operations.

How Are Advanced Technologies Powering the Digital Biomanufacturing Revolution?

The backbone of digital biomanufacturing lies in technologies like process analytical technology (PAT), digital twins, cloud computing, and AI-enabled bioprocess control systems. PAT tools enable continuous, in-line measurement of key quality attributes, allowing process parameters to be dynamically adjusted during production rather than relying on post-batch testing. Digital twins—virtual replicas of physical bioprocesses—can simulate scenarios, predict outcomes, and optimize system performance before implementation, reducing risks and minimizing costly downtime.

Machine learning algorithms are being applied to bioprocess data to forecast cell growth, product titers, and contamination risks, enabling preemptive interventions. Cloud-based platforms and edge computing facilitate real-time data sharing across facilities, making global collaboration and centralized control more accessible. Robotics and smart sensors are also enabling automation of tasks such as media preparation, cell line development, and purification, contributing to increased reproducibility, scalability, and compliance. These advancements are not just technological upgrades—they’re transforming how biologics are produced, validated, and distributed globally.

Which Applications and Stakeholders Are Driving Market Adoption?

The adoption of digital biomanufacturing is being spearheaded by biopharmaceutical companies, contract development and manufacturing organizations (CDMOs), and biotech startups seeking to accelerate development timelines and maintain regulatory compliance. Monoclonal antibodies, cell and gene therapies, and recombinant proteins are key product categories benefiting from digital transformation due to their complexity and high value. Continuous manufacturing systems for vaccines and biosimilars are also leveraging digital tools to optimize throughput and consistency.

Regulatory agencies are increasingly recognizing the benefits of digitalization in enhancing traceability and enabling real-time quality assurance. This has led to growing support for initiatives such as real-time release testing (RTRT) and Quality by Design (QbD), which are more readily implemented with digital infrastructure. Academic research centers and technology vendors are collaborating to build flexible, modular biomanufacturing platforms tailored to small-batch, high-mix production. As a result, the entire value chain—from upstream fermentation and cell culture to downstream purification and fill-finish operations—is undergoing a digital transformation.

What Are the Key Growth Drivers Accelerating Digital Biomanufacturing Adoption?

The growth in the digital biomanufacturing market is driven by several factors, including the increasing demand for flexible, scalable biologics production platforms and the rising complexity of advanced therapies such as cell and gene treatments. The growing emphasis on process efficiency, cost reduction, and batch consistency is encouraging manufacturers to deploy AI-powered predictive control systems and smart analytics tools. The adoption of single-use technologies and modular production setups is also creating favorable conditions for digital integration, as these platforms are inherently adaptable and data-centric.

End-use trends such as the shift to personalized therapies, the need for rapid vaccine development, and the expansion of biologics pipelines are accelerating investment in digital infrastructure. In parallel, regulatory support for continuous manufacturing, real-time data sharing, and QbD practices is pushing biomanufacturers to embrace digital tools that enhance transparency and product quality. With increasing pressure to reduce time-to-market, meet global demand variability, and improve operational resilience, digital biomanufacturing is rapidly becoming a cornerstone of next-generation pharmaceutical production strategies.

SCOPE OF STUDY:

The report analyzes the Digital Biomanufacturing market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Offering (Software Offering, Hardware Offering); Functionality (Product Design Functionality, Process Optimization & Analytics Functionality, Automation & Control Functionality, Other Functionalities); Application (Monoclonal Antibodies Application, Recombinant Hormones / Proteins Application, Vaccines Application, Cellular-based Biologics Application, Gene-based Biologics Application); End-Use (Biopharma Companies End-Use, Academic & Research Institutes End-Use, CDMOs & CROs End-Use)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 41 Featured) -

• 3M Company
• ABB Ltd
• Agilent Technologies Inc.
• Aspen Technology Inc.
• Atos SE
• Cytiva (Danaher Corporation)
• Dassault Systèmes SE
• Emerson Electric Co.
• Eppendorf AG
• FUJIFILM Diosynth Biotechnologies
• GE HealthCare Technologies Inc.
• Honeywell International Inc.
• Immersciobio GmbH
• Körber AG
• Merck KGaA
• Sartorius AG
• Samsung Biologics Co. Ltd.
• Sanofi SA
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc.

AI INTEGRATIONS
We`re transforming market and competitive intelligence with validated expert content and AI tools.

Instead of following the general norm of querying LLMs and Industry-specific SLMs, we built repositories of content curated from domain experts worldwide including video transcripts, blogs, search engines research, and massive amounts of enterprise, product/service, and market data.

TARIFF IMPACT FACTOR
Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by increasing the Cost of Goods Sold (COGS), reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks. The Publisher uses digital controls protecting against copying and printing is restricted to one full copy to be used at the same location.

The latest version of Adobe Acrobat Reader is required to view the report. Upon ordering an electronic version, the Publisher will provide a link to download the purchased report.

Prior to fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.