디지털 바이오제조 시장 규모, 점유율, 예측, 동향 분석 : 제공별(소프트웨어/하드웨어), 기능별(제품 설계, 분석, 자동화), 용도별(단일클론항체, 단백질, 백신), 바이오프로세스별 세계 예측(-2035년)

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 2035

According to the 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 2035,' the digital biomanufacturing market is projected to reach $76.4 billion by 2035, at a CAGR of 12.6% during the forecast period 2025-2035. The report provides an in-depth analysis of the global digital biomanufacturing market across five major regions, emphasizing the current market trends, market sizes, recent developments, and forecasts till 2035.

Following extensive secondary and primary research and an in-depth analysis of the market scenario, the report conducts the impact analysis of the key industry drivers, restraints, opportunities, and challenges. The growth of this market is driven by the escalating demand for biologics, capacity expansions of biopharmaceutical plants by key players, increased focus on continuous bioprocessing, rising need for process optimization in biomanufacturing, and the growing emphasis on quality standards and regulatory compliance. Moreover, the integration of artificial intelligence and machine learning, cloud-based manufacturing platforms, digital twin technology adoption, and the shift towards Bioprocessing 4.0 are expected to support the market's growth.

However, the market's growth faces notable challenges including the high cost of technology deployment, complex development and manufacturing processes of biopharmaceuticals, integration challenges with legacy systems, and concerns about data security and intellectual property protection.

The key players operating in the 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 Inc. (U.S.), Schneider Electric SE (France), Dassault Systemes (France), Oracle Corporation (U.S.), and 3M (U.S.).

The digital biomanufacturing market is segmented by offering (software and hardware), functionality (product design, process optimization & analytics, automation & control, real-time quality monitoring and compliance, supply chain and operations management, and other functionalities), bioprocess (upstream bioprocess and downstream bioprocess), application (monoclonal antibodies, recombinant hormones/proteins, vaccines, cellular-based biologics, gene-based biologics, biosimilars, industrial biotech, and other applications), end user (biopharmaceutical companies, academic and research institutes, CDMOs & CROs, food and industrial biotech companies, and other end users), and geography. The study also evaluates industry competitors and analyzes the market at the country level.

The software segment is projected to account for the largest market share of 58% in 2025. The dominance of this segment is primarily attributed to its fundamental role as the core intelligence layer driving process optimization, data analytics, and real-time decision-making across all biomanufacturing processes. This includes sophisticated process analytical technology (PAT) systems, advanced data analysis software, manufacturing execution systems (MES), and cutting-edge digital twin platforms that create virtual replicas of bioprocessing operations. The segment's growth is further accelerated by the continuous evolution of artificial intelligence and machine learning capabilities embedded within these platforms, transitioning from simple monitoring systems to intelligent platforms capable of predictive analytics, autonomous process adjustments, and cognitive decision-making. The software segment is also expected to register significant growth during the forecast period, driven by increasing adoption of cloud-based solutions and advanced analytics capabilities.

The process optimization & analytics segment is expected to dominate the digital biomanufacturing market in 2025. This segment's leadership reflects the critical need for continuous improvement in biomanufacturing processes, where even minor optimizations can result in significant cost savings, yield improvements, and quality enhancements. Process optimization & analytics encompasses advanced statistical process control, design of experiments (DoE), multivariate data analysis, and machine learning-powered optimization algorithms that continuously analyze process parameters to identify opportunities for improvement. These systems integrate data from multiple sources across the bioprocessing workflow to provide comprehensive insights into process performance, enabling manufacturers to achieve higher product yields, reduce batch-to-batch variability, and minimize production costs while maintaining regulatory compliance. However, the supply chain & operations management segment is projected to register the highest CAGR of 16.5% during the forecast period, driven by the increasing recognition of the importance of end-to-end visibility and coordination across global biopharmaceutical operations.

The upstream bioprocess segment is expected to account for the largest share of the digital biomanufacturing market in 2025. The upstream segment's dominance is due to its fundamental role as the foundation of all biomanufacturing operations and its significant impact on overall process economics. Upstream processes directly influence product yield, quality, and consistency, making optimization in this area particularly valuable. The complexity of cell culture processes, with their numerous interdependent variables including pH, dissolved oxygen, temperature, nutrient levels, and metabolite concentrations, creates substantial opportunities for digital optimization. Advanced process analytical technology, real-time monitoring systems, and AI-powered control algorithms can significantly improve cell productivity, reduce contamination risks, and optimize media consumption, driving the widespread adoption of digital solutions in upstream bioprocessing.

The monoclonal antibodies segment is expected to account for the largest share of 33% of the digital biomanufacturing market in 2025. The large share of this segment is attributed to the established manufacturing infrastructure, well-understood production processes, and significant commercial value of these products. The complex multi-step production process of monoclonal antibodies, involving cell line development, upstream cell culture, downstream purification, formulation, and fill-finish operations, creates numerous opportunities for digital optimization. The high value and large production volumes of monoclonal antibodies justify substantial investments in advanced digital technologies that can improve yields, reduce production costs, and ensure consistent product quality. However, the gene-based biologics segment is experiencing the fastest growth at a CAGR of 17.9% during the forecast period, as this emerging therapeutic modality gains regulatory approval and commercial traction, with the FDA anticipating approval of 10 to 20 cell and gene therapy products per year by 2025.

The biopharmaceutical companies segment is expected to account for the largest share of the digital biomanufacturing market in 2025. The increasing preference for biopharmaceuticals, growing research in personalized medicines, and supportive initiatives for the adoption of biopharmaceuticals are supporting the segment's largest market share. Biopharmaceuticals are typically complex and costlier than conventional drugs to manufacture, leading biomanufacturing industries to deploy digital solutions to reduce errors and scale up production processes. The increasing number of biopharmaceutical companies along with the gradually increasing adoption of digital technologies in these companies contributes to the segment's dominance, with approximately 55% of companies having incorporated digital technologies in their workflows.

An in-depth geographic analysis of the industry provides detailed qualitative and quantitative insights into the five major regions (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) and the coverage of major countries in each region.

North America is expected to account for the largest share of 38% of the digital biomanufacturing market in 2025. The large share of this region is attributed to the presence of leading biopharmaceutical companies, advanced technological infrastructure, substantial R&D investments, and a supportive regulatory environment. The United States, in particular, hosts numerous biotechnology hubs and maintains a leadership position in biologics development and manufacturing. North America's established biopharmaceutical ecosystem includes major companies with extensive manufacturing networks, well-developed supply chains, and significant financial resources for technology adoption. The region's regulatory framework, led by the FDA, has been progressive in encouraging the adoption of advanced manufacturing technologies and providing guidance on digital technologies in biomanufacturing.

However, Asia-Pacific is projected to register the highest CAGR of 16.0% during the forecast period across the overall digital biomanufacturing market. This growth is fueled by the rapidly expanding biopharmaceutical sectors in countries such as China, India, Japan, and South Korea. The region's growth is driven by increasing government investments in biotechnology, growing domestic demand for biologics, expanding manufacturing capacity, and the presence of cost-effective contract development and manufacturing organizations (CDMOs). Rising government initiatives aimed at digitization, growing demand for cost-effective automation solutions, expanding biopharmaceutical manufacturing infrastructure, and increasing focus on operational efficiency in densely populated countries are driving market expansion. The region's booming biotechnology sector, expanding research and development activities, growing skilled workforce, increasing foreign direct investments in the life sciences sector, and supportive regulatory frameworks for digital technology adoption are creating a conducive environment for market growth.

Key Questions Answered in the Report

• What is the current revenue generated by the digital biomanufacturing market globally?
• At what rate is the global digital biomanufacturing demand projected to grow for the next 10 years?
• What are the historical market sizes and growth rates of the global digital biomanufacturing market?
• What are the major factors impacting the growth of this market at the regional and country levels? What are the major opportunities for existing players and new entrants in the market?
• Which segments in terms of offering, functionality, bioprocess, application, and end user are expected to create major traction for the manufacturers in this market?
• What are the key geographical trends in this market? Which regions/countries are expected to offer significant growth opportunities for the companies operating in the global digital biomanufacturing market?
• Who are the major players in the global digital biomanufacturing market? What are their specific product offerings in this market?
• What are the recent strategic developments in the global digital biomanufacturing market? What are the impacts of these strategic developments on the market?

Scope of the Report

Digital Biomanufacturing Market Assessment-by Offering

• Software
  • Process Analytical Technology
  • Data Analysis Software
  • Manufacturing Execution System
  • Digital Twin Platforms
• Hardware
• Services

Digital Biomanufacturing Market Assessment-by Functionality

• Product Design
• Process Optimization & Analytics
• Automation & Control
• Real-Time Quality Monitoring and Compliance
• Supply Chain and Operations Management
• Other Functionalities

Digital Biomanufacturing Market Assessment-by Bioprocess

• Upstream Bioprocess
• Downstream Bioprocess

Digital Biomanufacturing Market Assessment-by Application

• Monoclonal Antibodies
• Recombinant Hormones/Proteins
• Vaccines
• Cellular-based Biologics
• Gene-based Biologics
• Biosimilars
• Industrial Biotech
• Other Applications

Digital Biomanufacturing Market Assessment-by End User

• Biopharmaceutical Companies
• Academic and Research Institutes
• CDMOs & CROs
• Food and Industrial Biotech Companies
• Other End Users

Digital Biomanufacturing Market Assessment-by Geography

• North America
  • U.S.
  • Canada
• Europe
  • U.K.
  • Germany
  • France
  • Italy
  • Spain
  • Switzerland
  • Denmark
  • Ireland
  • Belgium
  • Rest of Europe
• Asia-Pacific
  • China
  • India
  • Japan
  • South Korea
  • Australia
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • South Africa
  • Rest of Middle East & Africa

TABLE OF CONTENTS

1 Introduction

• 1.1. Market Definition & Scope
• 1.2. Market Ecosystem
• 1.3. Currency & Limitations

2 Research Methodology

• 2.1. Research Approach
• 2.2. Data Collection & Validation
  • 2.2.1. Secondary Research
  • 2.2.2. Primary Research
• 2.3. Market Assessment
  • 2.3.1. Market Size Estimation
  • 2.3.2. Bottom-Up Approach
  • 2.3.3. Top-Down Approach
  • 2.3.4. Growth forecast
• 2.4. Assumptions for the Study

3 Executive Summary

• 3.1. Overview
• 3.2. Segmental Analysis
  • 3.2.1. Market Analysis, by Offering
  • 3.2.2. Market Analysis, by Functionality
  • 3.2.3. Market Analysis, by Bioprocess
  • 3.2.4. Market Analysis, by Application
  • 3.2.5. Market Analysis, by End-User
• 3.3. Regional Analysis
• 3.4. Competitive Analysis

4 Market Insights

• 4.1. Overview
• 4.2. Factors Affecting Market Growth
  • 4.2.1. Drivers
    • 4.2.1.1. Growing Demand for Biologics
    • 4.2.1.2. Capacity Expansions of Biopharmaceutical Plants by Key Players
    • 4.2.1.3. Increased Need for Process Optimization
    • 4.2.1.4. Increased Focus on Quality Standards & Regulatory Compliance
    • 4.2.1.5. Strong R&D Pipeline for Biopharmaceuticals
    • 4.2.1.6. Rising Focus on Continuous Bioprocessing
  • 4.2.2. Restraints
    • 4.2.2.1. High Cost of Technology Deployment
    • 4.2.2.2. Complex Development and Manufacturing Process of Biopharmaceuticals
  • 4.2.3. Opportunities
    • 4.2.3.1. Introduction of Industry 4.0
    • 4.2.3.2. Availability of Advanced Data Analysis Tools
    • 4.2.3.3. Shift Towards Bioprocessing 4.0
  • 4.2.4. Challenges
    • 4.2.4.1. Complexities In Process Analytical Technology (Pat) Implementation
  • 4.2.5. Trends
    • 4.2.5.1. Integration of Artificial Intelligence and Machine Learning
    • 4.2.5.2. Cloud-Based Manufacturing Platforms
    • 4.2.5.3. Advanced Process Control and Automation

5 Digital Biomanufacturing Market Assessment - by Offering

• 5.1. Overview
• 5.2. Software
  • 5.2.1. Process Analytical Technology (Pat)
  • 5.2.2. Data Analysis Software
  • 5.2.3. Manufacturing Execution System (Mes)
  • 5.2.4. Digital Twin Platforms
• 5.3. Hardware
• 5.4. Services

6 Digital Biomanufacturing Market Assessment - by Functionality

• 6.1. Overview
• 6.2. Product Design
• 6.3. Process Optimization & Analytics
• 6.4. Automation & Control
• 6.5. Real-Time Quality Monitoring & Compliance
• 6.6. Supply Chain & Operations Management
• 6.7. Others (Predictive Maintenance, Sustainability Dashboards)

7 Digital Biomanufacturing Market Assessment - by Bioprocess

• 7.1. Overview
• 7.2. Upstream Bioprocessing
• 7.3. Downstream Bioprocessing

8 Digital Biomanufacturing Market Assessment - by Application

• 8.1. Overview
• 8.2. Monoclonal Antibodies (Mabs)
• 8.3. Recombinant Hormones/Proteins
• 8.4. Vaccines
• 8.5. Cellular-Based Biologics
• 8.6. Gene-Based Biologics
• 8.7. Biosimilars
• 8.8. Industrial Biotech (Enzymes, Bio-Based Chemicals, Food & Feed Ingredients)
• 8.9. Others (Blood Products, Peptides, Oligonucleotides)

9 Digital Biomanufacturing Market Assessment - by End-User

• 9.1. Overview
• 9.2. Biopharmaceutical Companies
• 9.3. Academic and Research Institutes
• 9.4. CDMOs & CROs
• 9.5. Food & Industrial Biotech Companies
• 9.6. Others (Government Labs, Consortia, and Non-Profit Organizations)

10 Digital Biomanufacturing Market Assessment-by Geography

• 10.1. Overview
• 10.2. North America
  • 10.2.1. U.S.
  • 10.2.2. Canada
• 10.3. Europe
  • 10.3.1. Germany
  • 10.3.2. France
  • 10.3.3. U.K.
  • 10.3.4. Italy
  • 10.3.5. Spain
  • 10.3.6. Switzerland
  • 10.3.7. Denmark
  • 10.3.8. Ireland
  • 10.3.9. Belgium
  • 10.3.10. Rest of Europe (RoE)
• 10.4. Asia-Pacific
  • 10.4.1. Japan
  • 10.4.2. China
  • 10.4.3. India
  • 10.4.4. South Korea
  • 10.4.5. Australia
  • 10.4.6. Rest of Asia-Pacific
• 10.5. Latin America
  • 10.5.1. Brazil
  • 10.5.2. Mexico
  • 10.5.3. Rest of Latin America (RoLATAM)
• 10.6. Middle East & Africa

11 Competitive Landscape

• 11.1. Overview
• 11.2. Key Growth Strategies
• 11.3. Competitive Benchmarking
• 11.4. Competitive Dashboard
  • 11.4.1. Industry Leaders
  • 11.4.2. Market Differentiators
  • 11.4.3. Vanguards
  • 11.4.4. Emerging Companies
• 11.5. Market Share/Position Analysis

12 Company Profiles

• 12.1. GE Healthcare Technologies, Inc.
  • 12.1.1. Company Overview
  • 12.1.2. Business Description
  • 12.1.3. Financial Overview
  • 12.1.4. Product Portfolio
  • 12.1.5. SWOT Analysis
• 12.2. Siemens Xcelerator
  • 12.2.1. Company Overview
  • 12.2.2. Business Description
  • 12.2.3. Financial Overview
  • 12.2.4. Product Portfolio
  • 12.2.5. SWOT Analysis
• 12.3. Cytiva
  • 12.3.1. Company Overview
  • 12.3.2. Business Description
  • 12.3.3. Financial Overview
  • 12.3.4. Product Portfolio
  • 12.3.5. SWOT Analysis
• 12.4. ABB Ltd.
  • 12.4.1. Company Overview
  • 12.4.2. Business Description
  • 12.4.3. Financial Overview
  • 12.4.4. Product Portfolio
  • 12.4.5. SWOT Analysis
• 12.5. Sanofi S.A.
  • 12.5.1. Company Overview
  • 12.5.2. Business Description
  • 12.5.3. Financial Overview
  • 12.5.4. Product Portfolio
  • 12.5.5. SWOT Analysis
• 12.6. Emerson Electric Co.
  • 12.6.1. Company Overview
  • 12.6.2. Business Description
  • 12.6.3. Financial Overview
  • 12.6.4. Product Portfolio
  • 12.6.5. SWOT Analysis
• 12.7. Honeywell International, Inc.
  • 12.7.1. Company Overview
  • 12.7.2. Business Description
  • 12.7.3. Financial Overview
  • 12.7.4. Product Portfolio
  • 12.7.5. SWOT Analysis
• 12.8. SAP SE
  • 12.8.1. Company Overview
  • 12.8.2. Business Description
  • 12.8.3. Financial Overview
  • 12.8.4. Product Portfolio
  • 12.8.5. SWOT Analysis
• 12.9. Ovo Biomanufacturing Ltd.
  • 12.9.1. Company Overview
  • 12.9.2. Business Description
  • 12.9.3. Financial Overview
  • 12.9.4. Product Portfolio
  • 12.9.5. SWOT Analysis
• 12.10. Schneider Electric SE
  • 12.10.1. Company Overview
  • 12.10.2. Business Description
  • 12.10.3. Financial Overview
  • 12.10.4. Product Portfolio
  • 12.10.5. SWOT Analysis
• 12.11. Dassault Systemes
  • 12.11.1. Company Overview
  • 12.11.2. Business Description
  • 12.11.3. Financial Overview
  • 12.11.4. Product Portfolio
  • 12.11.5. SWOT Analysis
• 12.12. Oracle Corporation
  • 12.12.1. Company Overview
  • 12.12.2. Business Description
  • 12.12.3. Financial Overview
  • 12.12.4. Product Portfolio
  • 12.12.5. SWOT Analysis
• 12.13. 3M
  • 12.13.1. Company Overview
  • 12.13.2. Business Description
  • 12.13.3. Financial Overview
  • 12.13.4. Product Portfolio
  • 12.13.5. SWOT Analysis

13 Appendix

• 13.1. Available Customization
• 13.2. Related Reports