Dublin, Jan. 13, 2025 (GLOBE NEWSWIRE) -- The "Bioprocess Optimization and Digital Bio-manufacturing: Global Markets" report has been added to ResearchAndMarkets.com's offering.
Over the last few years, the biopharmaceuticals market has witnessed tremendous growth. Innovation in the types of biological drug candidates has been remarkable. The expiration of patents of many blockbuster drugs has led to the rise of the biosimilars market, too. As a result, the biologic drug manufacturers who had been practicing age-old business models and traditional methods of biomanufacturing are now faced with numerous challenges. Improvement is required in process productivity in the form of production processes becoming faster and more cost-effective, and the processes also need to be GMP (good manufacturing practices)-compliant.
The U.S. Food and Drug Administration (FDA) launched the Process Analytical Technology (PAT) initiative in 2004 with an aim to imbibe quality in production processes by way of monitoring and controlling the processes in real-time. Sophisticated techniques of analysis, single-use technologies, and continuous processing are becoming popular as methods that can bring about efficiencies in the biomanufacturing processes, as well as save time and investments.
The biopharmaceutical market is rapidly adopting the "smart technologies" that define the industrial revolution 4.0 (or Industry 4.0). Though industrial control systems and automation have been part of the manufacturing platforms for quite some time, Industry 4.0 has brought about a new revolution by integrating the information technology and operational technology. The industrial internet of things (IIoT) streamlines the entire business operations of a company. Biopharmaceutical manufacturers can obtain several benefits by implementing IIoT in manufacturing, as it can drive process efficiencies; provide agility to the manufacturing and entire supply chain; provide tracking, visibility, and predictive maintenance; as well as save time in obtaining regulatory compliance.
The highly regulated nature of the biopharmaceutical industry, complemented by the complexity of biological production processes has delayed the entry of Industry 4.0 in this sector. Moreover, the need to transform legacy systems and obtain fresh validations for new ones or those processes requiring any modifications are additional obstacles. Nevertheless, the long-term merits offered by smart manufacturing and digitization in bioprocessing are driving this market.
There is heightened activity in the mergers and acquisitions among technology-driven companies, particularly single-use technologies and information technology companies. An increased number of collaborations and partnerships between private players, industry-government and industry-academic organizations are also fostering innovation and aiding the adoption of modern technologies for biomanufacturing. Another factor driving the bioprocess optimization and digital biomanufacturing market is the significant growth seen in contract manufacturing organizations, specifically in emerging countries. Countries in Asia-Pacific, including China, India, Singapore, and Korea, are witnessing rapid growth due to rising demands for automation and novel innovative technologies for improved manufacturing processes. The market forces of innovation and the need to implement PAT (Process Analytical Technology) in the bio/pharmaceutical processes are also driving this market.
The Global Bioprocess Optimization and Digital Bio-manufacturing Market was valued at USD 24.3 Billion in 2024, and is expected to reach USD 39.6 Billion by 2029, rising at a CAGR of 10.20%.
The report provides a comprehensive analysis of the bioprocess optimization and digital biomanufacturing market in a global context, including market forecasts and sales through the year 2029. Segmentation based on technology type includes manufacturing technologies (chromatography-based separation and purification, filtration, bioreactors, centrifugation), analytical and process control technologies (spectrophotometry, automation and industrial process control technologies, analytical chromatography, sensors and probes), and software (Industrial control and automation software, bioprocess optimization and data analytics software).
Segmentation based on application includes biomanufacturing process automation and control, flexible manufacturing, bioprocess optimization and process analytics, and others. By molecule type the market is segmented into monoclonal antibodies, vaccines, therapeutic proteins and peptides, and cell and gene therapies. The regional markets covered are North America, Europe, Asia-Pacific, and the Rest of the World (RoW).
The report discusses the critical issues impacting the adoption of digital biomanufacturing in pharmaceuticals, as well as emerging trends in digital biomanufacturing technologies. It also features new developments and new product launches in the global market. The report provides comprehensive profiles of market players in the industry. The report also covers mergers and acquisitions and any other collaborations or partnerships that occurred during the evaluation period of this report and which are expected to shape the industry.
Report Scope
- 69 data tables and 61 additional tables
- Analyses of trends in the global market for bioprocess optimization and digital bio-manufacturing, with market revenue data for 2021-2023, estimates for 2024, forecasts for 2025, and projected CAGRs through 2029
- Estimates of the market size and revenue growth prospects of the global market, along with a market share analysis by technology, application, drug molecule type and region
- Facts and figures pertaining to the market dynamics, technical advances, regulations and the impact of macroeconomic factors
- Insights derived from the Porter's Five Forces model, as well as global supply chain and PESTLE analyses
- Analysis of patents, emerging trends, and new developments
- Analysis of the industry structure, including companies' market shares, strategic alliances, M&A activity and a venture funding outlook
- Overview of sustainability trends and ESG developments, with emphasis on consumer attitudes, and ESG scores and practices of leading companies
- Profiles of the market leaders, including:
- Agilent Technologies
- Agilitech
- Bio-Rad Laboratories
- Bruker
- Clean Biologics
- Danaher
- Emerson Electric
- Eppendorf
- Korber
- Merck
- Sartorius
- Shimadzu
- Thermo Fisher Scientific
- Univercells Technologies
- Waters
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 180 |
| Forecast Period | 2024 - 2029 |
| Estimated Market Value (USD) in 2024 | $24.3 Billion |
| Forecasted Market Value (USD) by 2029 | $39.6 Billion |
| Compound Annual Growth Rate | 10.2% |
| Regions Covered | Global |
Key Topics Covered:
Chapter 1 Introduction
- Market Outlook
- Scope of Report
- Market Summary
Chapter 2 Market Overview
- Technology Background
- Biologics Manufacturing Process
- Upstream Processing
- Cell Harvesting and Clarification
- Downstream Processing
- Bioprocess Optimization
- Industry 4.0 - Digital Biomanufacturing
Chapter 3 Market Dynamics
- Market Drivers
- Growing Aging Population
- Increasing Prevalence of Chronic Diseases
- Unprecedented Rise in Demand for Biopharmaceuticals
- Growing Number of Product Launches
- Increasing Number of Contract Manufacturing Organizations (CMOs)
- Market Restraints
- Lack of Skilled Labor
- High Cost of Equipment
- Unharmonized Smart Manufacturing Standards
- Market Opportunities
- Favorable Government Programs
- Advances in Sensor Technology
- Process Analytical Technology Initiatives
- Market Challenges
- Technical Issues and the Threat of Cyberattacks
- Regulatory Landscape
- Good Automation Manufacturing Practices (GAMP)
- Instrumentation, Systems, and Automation (ISA) Society-88 and 95 Standards
Chapter 4 Emerging Technologies and Developments
- Emerging Trends and Technologies
- Continuous Bioprocessing
- Continuous Cell Retention Technologies
- Continuous Chromatography
- Single-Use Technologies
Chapter 5 Market Segmentation Analysis
- Market Analysis by Technology
- Manufacturing Technologies
- Analytical and Process Control Technologies
- Software
- Market Analysis by Application
- Biomanufacturing Process Automation and Control
- Flexible Manufacturing
- Bioprocess Optimization and Process Analytics
- Other Applications
- Market Analysis by Molecule Type
- Monoclonal Antibodies (mAbs)
- Therapeutic Proteins and Peptides
- Vaccines
- Cell and Gene Therapies
- Market Analysis by Region
Chapter 6 Competitive Intelligence
- Ranking of Leading Players
- Key Strategies Adopted by Players
- Collaborations and Partnerships
- Expansion
- Acquisitions
- New Product Launches
Chapter 7 Sustainability in the Bioprocess Optimization and Digital Biomanufacturing Market: An ESG Perspective
- ESG Practices in the Industry
- Companies' ESG Risk Ratings
Company Profiles
- Agilent Technologies
- Agilitech
- Bio-Rad Laboratories
- Bruker
- Clean Biologics
- Danaher
- Emerson Electric
- Eppendorf
- Korber
- Merck
- Sartorius
- Shimadzu
- Thermo Fisher Scientific
- Univercells Technologies
- Waters
For more information about this report visit https://www.researchandmarkets.com/r/x6x869
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