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Meticulous Research®—a leading global market research company, published a research report titled ‘Digital Biomanufacturing Market Size, Share, Forecast, & Trends Analysis by Offering (Software, [PAT, MES, Digital Twin] Hardware) Functionality (Product Design, Analytics, Automation) Application (MAB, Protein, Vaccine), and Bioprocess - Global Forecast to 2031.’
According to this latest publication from Meticulous Research®, the global digital biomanufacturing market is projected to reach $50.89 billion by 2031 at a CAGR of 13.3% from 2024 to 2031. The growth of this market can be attributed to various factors such as, growing demand for biologics, capacity expansions of biopharmaceutical plants by key players, increased need for process optimization, growing focus on quality standards & regulatory compliance, strong R&D pipeline for biopharmaceuticals, and rising focus on continuous bioprocessing. However, the high cost of technology deployment, complex development, and manufacturing process of biopharmaceuticals are restraining the market growth.
Furthermore, the introduction of industry 4.0, availability of advanced data analysis tools, and shift towards bioprocessing 4.0 are expected to offer growth opportunities. However, complexities in process analytical technology (PAT), implementation for downstream processes, and intensive capital requirements for biopharmaceuticals production are major challenges for market growth.
Key Players
The key players operating in the global digital biomanufacturing market are GE Healthcare Technologies Inc. (U.S.), Siemens Xcelerator (subsidiary of Siemens) (Germany), Cytiva (subsidiary of Danaher Corporation) (U.S.), ABB Ltd. (Switzerland), Sanofi S.A. (France), Emerson Electric co. (U.S.), Honeywell International, Inc. (U.S.), SAP SE (Germany), OVO Biomanufacturing. (U.S.), Schneider Electric SE (France), Dassault Systems (France), Oracle Corporation (U.S.), and 3M (U.S.).
Digital Biomanufacturing Market: Future Outlook
The global digital biomanufacturing market is segmented by Offering (Software [by Type {Process Analytical Technology, Data Analysis Software, Manufacturing Execution System, and Digital Twin}, by Deployment {Cloud-based and On-premise}, Hardware), by Functionality (Product Design, Process Optimization & Analytics, Automation & Control, and Other Functionality), by Bioprocess (Upstream Bioprocess and Downstream Bioprocess), by Application (Monoclonal Antibodies, Recombinant Hormones/Proteins, Vaccines, Cellular-based Biologics, and Gene-based Biologics), by End-user (Biopharmaceutical Companies, Academic and Research Institutes, and CDMOs & CROs), and Geography. The study also evaluates industry competitors and analyzes the market at the global and regional levels.
Among all the offerings studied in this report, in 2024, the software segment is expected to account for the largest share of 74.4% of the digital biomanufacturing market. The growing need for process optimization in the biomanufacturing industry is driving up demand for software. Software deployment aids in evaluating product and process quality through real-time monitoring, data management, and predictive outcomes. It streamlines biomanufacturing processes, leading many key players to integrate software into their workflows.
Among all the functionalities studied in this report, in 2024, the process optimization & analytics segment is expected to account for the largest share of the digital biomanufacturing market. The largest share of the segment is attributed to the benefits offered by process optimization & analytics such as improved sustainability, reduced wastage, risk management, reduced cost, and increased process efficiency. Analytics also offer real-time monitoring of the manufacturing process, allowing for the early detection of errors. By identifying issues at an early stage, these errors can be addressed before they disrupt production. This capability helps save costs, time, and resources for the end user, leading to increased adoption.
Among all the bioprocesses studied in this report, in 2024, the downstream bioprocess segment is expected to account for the largest share of the digital biomanufacturing market. The downstream process determines the overall product quality and purity. Digitalization enhances downstream biomanufacturing by eliminating bottlenecks through the integration of automated systems, continuous processing, and increased throughput screening. As a result, manufacturers are increasingly adopting digital biomanufacturing solutions to uphold product quality by implementing rigorous quality control procedures during the downstream process.
Among all the applications studied in this report, in 2024, the monoclonal antibodies segment is expected to account for the largest share of 48.6% of the digital biomanufacturing market. The largest share of the segment is attributed to the increasing focus on monoclonal antibodies manufacturing, introduction of Bioprocessing 4.0, rising biopharmaceutical industry, increasing government focus on monoclonal antibodies development, increasing capacity expansion by key players, and rising approvals for monoclonal antibodies. Rising prevalence of cancer is also increasing the demand for targeted therapy, thereby raising the demand for monoclonal antibodies. To ensure faster and higher-quality production of antibodies, biopharmaceutical companies are employing digital biomanufacturing technologies such as sensors and Manufacturing Execution Systems (MES) to enhance the manufacturing process.
Among all the end users studied in this report, in 2024, the biopharmaceutical companies segment is expected to account for the largest share of the digital biomanufacturing market. Biopharmaceutical companies are integrating digital biomanufacturing solutions in the workflow to optimize resource use, improve product quality, scalability, cost reduction, and adherence with quality control standards. Digital biomanufacturing solutions enable automated data collection throughout the manufacturing process, which is subsequently used in the regulatory approval process. The segment's large market share is attributed to the expanding number of biopharmaceutical companies, rising demand for biologics, an increase in biologics approvals, and growing investments in biologics development and manufacturing.
Geographic Review
This research report analyzes major geographic regions and provides a comprehensive analysis of the market in North America (U.S. and Canada), Europe (Germany, France, U.K., Italy, Spain, Switzerland, Denmark, Ireland, Belgium, and Rest of Europe), Asia-Pacific (Japan, China, India, Australia, South Korea, and Rest of Asia-Pacific), Latin America (Brazil, Mexico, and Rest of Latin America), and the Middle East & Africa.
Among all the geographies studied in this report, Asia-Pacific is slated to register the highest CAGR of 15.1% of the market. The growth of the region is attributed to a growing pharmaceutical market, increasing R&D expenditures by biopharmaceutical companies, and favorable regulatory policies. The number of new biopharmaceutical companies in China is steadily increasing. According to data released by the Chinese president at the World Health Assembly in 2020, over 140 new biotech companies emerged in China between 2010 and 2020, bringing the total number of active biopharmaceutical companies in the country to over 500. To further expand the presence of biopharmaceutical companies in China, the government is focusing on increasing the production capacities of biopharmaceuticals within the country. Such developments are contributing to digital biomanufacturing market growth in Asia-Pacific.
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