Digital Biomanufacturing Market Size, Share, Forecast, & Trends Analysis by Offering (Software Hardware), Functionality (Product Design, Analytics, Automation), Application (MAB, Protein, Vaccine), and Bioprocess

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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) Bioprocess-Global Forecast to 2031

The digital biomanufacturing market is projected to reach $50.89 billion by 2031, at a CAGR of 13.3% from 2024 to 2031.

Succeeding extensive secondary and primary research and in-depth analysis of the market scenario, the report comprises the analysis of key industry drivers, restraints, challenges, and opportunities. The growth of the digital biomanufacturing market is driven by growing demand for biologics, capacity expansions of biopharmaceutical plants by key players, increased need for process optimization, increased 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 and the complex development and manufacturing process of biopharmaceuticals are restraining the growth of this market.

Furthermore, the introduction of industry 4.0 technologies, availability of advanced data analysis tools, and shift towards bioprocessing 4.0 are expected to generate market growth opportunities. However, complexities in process analytical technology (PAT) implementation for downstream processes and intensive capital requirements for biopharmaceutical production are major challenges in the digital biomanufacturing market.

The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry in the past three to four years. The key players operating in the digital biomanufacturing market are GE Healthcare Technologies Inc. (U.S.), Siemens Xcelerator (Subsidiary of Siemens) (Germany), Cytiva (a 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.).

Among all the offerings studied in this report, the software segment is expected to account for the largest share of 74.4% of the digital biomanufacturing market. The rising demand for process optimization coupled with the advantages of software in designing, planning, and manufacturing of drugs or biologics support the large share of this segment.

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. Process optimization and analytics help in improving the manufacturing process by streamlining operating procedures. This involves real-time monitoring and analysis of the activities, which helps the organization in finding bugs in the process or deciding the area of improvement. Moreover, this helps in increasing the efficiency of manufacturing equipment and makes the biomanufacturing process efficient.

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. Downstream bioprocesses are considered a complex process in nature that requires continuous monitoring. Digital biomanufacturing software helps in improving and maintaining the workflow of these bioprocesses. This also improves the quality of products. Moreover, the use of predictive technology in the software helps reduce the future complexities associated with downstream bioprocesses, which results in reducing extra costs or future loss. Such factors are driving the growth of the market.

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 availability of funding for monoclonal antibody research and development, approvals for monoclonal antibodies, and increasing production capacity of monoclonal antibody manufacturing plants are contributing to the largest share of the segment.

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. Initiatives focused on improving the adoption of biopharmaceuticals, patent expiration of biologics, and increasing awareness of biopharmaceuticals among physicians are supporting the largest share of the market.

An in-depth analysis of the geographical scenario of the digital biomanufacturing printing market provides detailed qualitative and quantitative insights into the five major geographies (North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa) along with the coverage of major countries in each region. Among all the geographies studied in this report, in 2024, North America is expected to account for the largest share of the digital biomanufacturing market. The largest share is attributed to the developed healthcare industry & infrastructure, the presence of major key players, and supportive initiatives focused on improving the adoption of biopharmaceuticals.

Scope of the Report:

Digital Biomanufacturing Market Assessment-by Offering

Software
- by Type
Process Analytical Technologies
Data Analysis Software
Manufacturing Execution Systems
Digital Twin
- by Deployment
Cloud-based
On-premise
Hardware

Digital Biomanufacturing Market Assessment-by Functionality

Product Design
Process Optimization & Analytics
Automation & Control
Other Functionalities

Note: Other functionalities include Quality management, predictive maintenance, and data storage.

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

Digital Biomanufacturing Market Assessment-by End User

Biopharmaceutical Companies
Academic and Research Institutes
CDMO &CROs

Digital Biomanufacturing Market Assessment -by Geography

North America
U.S.
Canada
Europe
Germany
France
U.K
Italy
Spain
Switzerland
Denmark
Ireland
Belgium
Rest of Europe (RoE)
Asia-Pacific (APAC)
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific (RoAPAC)
Latin America
Brazil
Mexico
Rest of Latin America
Middle East & Africa

Product Code: MRHC - 1041288

1. Introduction

1.1. Market Definition & Scope
1.2. Market Ecosystem
1.3. Currency and Limitations
1.4. Key Stakeholders

2. Research Methodology

2.1. Research Approach
2.2. Process of Data Collection & Validation
- 2.2.1. Secondary Research
- 2.2.2. Primary Research/Interviews with Key Opinion Leaders from the Industry
2.3. Market Sizing and Forecasting
- 2.3.1. Market Size Estimation Approach
- 2.3.2. Growth Forecast Approach
- 2.3.3. Market Share Analysis
2.4. Assumptions for the Study

3. Executive Summary

4. Market Insights

4.1. Overview
4.2. Drivers
- 4.2.1. Growing Demand for Biologics
- 4.2.2. Capacity Expansions of Biopharmaceutical Plants by Key Players
- 4.2.3. Increased Need for Process Optimization
- 4.2.4. Increased Focus On Quality Standards & Regulatory Compliance
- 4.2.5. Strong R&D Pipeline for Biopharmaceuticals
- 4.2.6. Rising Focus on Continuous Bioprocessing
4.3. Restraints
- 4.3.1. High Cost of Technology Deployment
- 4.3.2. Complex Development and Manufacturing Process of Biopharmaceuticals
4.4. Opportunities
- 4.4.1. Introduction of Industry 4.0
- 4.4.2. Availability of Advanced Data Analysis Tools
- 4.4.3. Shift Towards Bioprocessing 4.0
4.5. Challenges
- 4.5.1. Complexities in Process Analytical Technology (PAT) Implementation for Downstream Processes.
- 4.5.2. Intensive Capital Requirements for Biopharmaceuticals Production
4.6. Factor Analysis
4.7. Trends
- 4.7.1. Digital Twin Technology
- 4.7.2. Integration of Artificial Intelligence (AI) & Machine Learning (ML)
4.8. Regulatory Analysis
4.9. Pricing Analysis
4.10. Porter's Five Force Analysis

5. Digital Biomanufacturing Market Assessment-by Offering

5.1. Overview
5.2. Software
- 5.2.1. By Type
  - 5.2.1.1. Process Analytical Technology
  - 5.2.1.2. Data Analysis Software
  - 5.2.1.3. Manufacturing Execution System
  - 5.2.1.4. Digital Twin
- 5.2.2. By Deployment
  - 5.2.2.1. Cloud-based
  - 5.2.2.2. On-Premises
5.3. Hardware

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. Other Functionalities

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
8.3. Recombinant Hormones/Proteins
8.4. Vaccines
8.5. Cellular-based Biologics
8.6. Gene-based Biologics

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

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 (RoAPAC)
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. Competition Analysis

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 Analysis/Market Ranking, by Key Players (2023)

12. Company Profiles (Company Overview, Financial Overview, Product Portfolio, Strategic Developments, and SWOT Analysis)

12.1. GE Healthcare Technologies, Inc.
12.2. Siemens Xcelerator (subsidiary of Siemens)
12.3. Cytiva (subsidiary of Danaher Corporation)
12.4. ABB Ltd. (Sweden)
12.5. Sanofi S.A.
12.6. Emerson Electric Co.
12.7. Honeywell International, Inc.
12.8. SAP SE
12.9. OVO Biomanufacturing Ltd.
12.10. Schneider Electric SE
12.11. Dassault Systemes
12.12. Oracle Corporation
12.13. 3M

(Note: SWOT analysis of the top 5 companies will be provided.)

13. Appendix

13.1. Available Customization
13.2. Related Reports