Digital Biomanufacturing Market

Digital Biomanufacturing Market Analysis

The Digital Biomanufacturing Market size is estimated at USD 23.88 billion in 2025, and is expected to reach USD 41.34 billion by 2030, at a CAGR of 11.6% during the forecast period (2025-2030).

The major factors driving the market are the growing adoption of digital biomanufacturing, increasing biologics and biosimilar approvals, and growing demand for biologics, including vaccines, monoclonal antibodies, and gene therapies. Biopharmaceutical manufacturing involves complex and time-consuming processes for the production of high-quality biologics. Hence, to make biomanufacturing time and cost-efficient, pharmaceutical companies are adopting digital biomanufacturing to automate processes and reduce overall human errors in production. Thus, the growing adoption of digital biomanufacturing is expected to drive the market during the forecast period. For instance, in February 2024, Amgen, a biotechnology company, opened a digitally advanced biomanufacturing facility in Ohio, United States. This facility features the latest tech in assembly and final product packaging. According to a release from the local development council, the Columbus Region, this facility is expected to tackle the final manufacturing step for US injectables. Hence, the increasing adoption of digital biomanufacturing is expected to drive the market during the forecast period. Also, the increasing approvals of biologics and biosimilars increase the demand for digital biomanufacturing technologies to improve the manufacturing process by reducing the cost and time, which will drive the market during the forecast period. For instance, in November 2023, the US Food and Drug Administration (FDA) approved the Ixchiq, the first vaccine to prevent the mosquito-borne virus chikungunya. It was approved for use in adults aged 18 years and older. In December 2023, the FDA approved the Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Casgevy is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy. Hence, the approval of biological and biosimilar products increases the demand for digital biomanufacturing technologies to improve biological products' yield and reduce human manufacturing errors. Hence, the growing adoption of digital biomanufacturing technologies and increasing approval of biologics and biosimilar products are expected to drive the market during the forecast period. However, the lack of skilled professionals to implement digital biomanufacturing solutions is expected to restrain the market during the forecast period.

Digital Biomanufacturing Market Trends

The Process Analytical Technologies Segment is Expected to Show Significant Growth During the Forecast Period

Process analytical technologies ensure quality in biopharmaceutical manufacturing by monitoring and controlling processes in real-time. It utilizes analytical tools to develop manufacturing processes accommodating material and equipment variability. By using this technology, critical process parameters (CPPs) impacting essential quality attributes (CQAs) are identified to develop analytical methods for real-time monitoring biopharmaceutical manufacturing. The increasing expansion of process analytical laboratories to optimize biomanufacturing is expected to drive the market during the forecast period.

For instance, in March 2023, the Cell and Gene Therapy Catapult (CGT Catapult) reported opening a new laboratory in Stevenage, United Kingdom. This process analytical technologies laboratory is expected to provide an analytically and digitally enabled space for cell and gene therapy developers to ensure the quality of the products is controlled and retained as they prepare to scale up production. Hence, such expansion is expected to increase the accessibility of digital biomanufacturing solutions and drive the market during the forecast period. Also, the increasing demand for the quality of biological products is expected to increase the adoption of process analytical technologies for continuous monitoring of biopharmaceutical manufacturing, which will ultimately drive the market during the forecast period.

For instance, according to an article published in the Wiley Journal in April 2022, the implementation of continuous manufacturing for biological processes producing protein-based drug molecules, such as monoclonal antibodies (mAbs), is facing several new hurdles. However, the improved process understanding through better predictive capabilities enabled by process analytical technologies is solving this problem efficiently to improve the overall production of monoclonal antibodies production. Hence, the increasing adoption of PAT to improve the overall quality of biological products is expected to drive the market during the forecast period.

North America is Expected to Hold the Largest Share of the Market During the Forecast Period

The geographical analysis of the digital biomanufacturing market shows that North America holds a significant market share in the global market. This is due to the increasing investments in the biopharmaceutical industries and the expansion of biopharmaceutical manufacturing facilities in the region.

The increasing expansion of biopharmaceutical manufacturing facilities increases the utilization of digital biomanufacturing solutions for the cost and time-efficient manufacturing of biological products, which will ultimately drive the market during the forecast period.

For instance, in March 2023, the Canadian government planned to invest CAD 80.5 million (USD 59 million) in the Canadian Critical Drug Initiative to boost drug research, commercialization, and manufacturing in the Alberta province. Applied Pharmaceutical Innovation, in partnership with the Li Ka Shing Applied Virology Institute at the University of Alberta, planned to establish a new 40,000-square-foot manufacturing facility in Edmonton with the support of this fund provided by the government. Hence, such expansion increases the adoption of digital biomanufacturing solutions, which will drive the market during the forecast period.

Also, the growing strategic activities, such as the launch of new biomanufacturing solutions, are expected to increase accessibility and drive the market during the forecast period. For instance, in April 2024, SAP SE, a business technology company, launched AI advancements in its supply chain solutions, unleashing a transformative wave of productivity, efficiency, and precision in biomanufacturing. By utilizing AI-powered analysis of up-to-the-minute data, biopharmaceutical companies may leverage their data to enhance decision-making throughout supply chains, optimize product creation, and enhance industrial efficiency. Hence, such digital solutions are expected to increase the accessibility and adoption of digital biomanufacturing solutions, further driving the market during the forecast period.

Hence, the increasing government investments and growing strategic activities are expected to drive the market during the forecast period in North America.

Digital Biomanufacturing Industry Overview

The digital biomanufacturing market is fragmented due to the presence of several companies operating globally and regionally. With the increasing adoption of digital biomanufacturing solutions worldwide, companies focus more on new software launches with advanced technologies. Some of the keys include Getinge (Applikon Biotechnology BV), Danaher Cooperation (Cytiva), Schneider Electric (AVEVA and AVEVA), GE HealthCare, and Siemens.

Digital Biomanufacturing Market Leaders

Digital Biomanufacturing Market News

• June 2024: The Syntegon subsidiary Pharmatec reported the launch of its new modular bioprocessing platform (MBP). Developed to address the current challenges in biopharmaceutical production, the MBP is a highly flexible, fully digitally integrated, and automated solution for biological drug substances.
• March 2024: Novel Bio, next-generation biomanufacturing technology for plasmid DNA for use in genetic medicines, reported a partnership with Culture Biosciences to accelerate the development of scalable fermentation processes for the proprietary NBx Platform for plasmid DNA production.