Dublin, Dec. 11, 2018 (GLOBE NEWSWIRE) -- The "Bioprocess Optimization and Digital Bio-manufacturing: Global Markets" report has been added to ResearchAndMarkets.com's offering.
This 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 2023.
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 report includes:
- 91 data tables and 30 additional tables
- An overview of the global markets for bioprocess optimization and digital bio-manufacturing (DM)
- Evaluation of the role of process analytical technologies (PAT) in DM
- A look into the new developments, new product launches and regulatory aspects in the global market
- Discussion about critical issues impacting the adoption of DM in pharmaceuticals as well as emerging trends in DM technologies
- Detailed analysis of industry 4.0 in DM
- Comprehensive profiles of market players in the industry, including Agilent Technologies, Thermo Fisher Scientific Inc., Waters Corp., Shimadzu Corp., Sartorius Stedium Biotech GmbH, GE Healthcare, and ABB Ltd.
Key Topics Covered
Chapter 1 Introduction
- Study Goals and Objectives
- Reasons for Doing This Study
- Scope of Report
- Information Sources
- Methodology
- Geographic Breakdown
- Analyst's Credentials
- Custom Research
- Related Reports
Chapter 2 Summary and Highlights
- Key Findings of the Report
Chapter 3 Market and Technology Background
- Biologics Manufacturing Process
- Upstream Processing
- Cell Harvesting and Clarification
- Downstream Processing
- Bioprocess Optimization
- Design of Experiments (DoE)
- Response Surface Methodology (RSM)
- Cost Estimation in Biomanufacturing Process Design
- Risk Assessment
- Industry 4.0-Digital Biomanufacturing
- Some Aspects of Digital Biomanufacturing
- Role of Process Analytical Technology in Digital Biomanufacturing
- Multivariate Tools for Design, Data Acquisition and Analysis
- Process Analyzers
- Process Control Tools
- Continuous Improvement and Knowledge Management Tools
Chapter 4 Market Breakdown by Technology Type
- Market by Type
- Market Overview
- Market Revenue
- Market Shares
- Manufacturing Technologies
- Analytical and Process Control Technologies
- Software
Chapter 5 Market Breakdown by Application
- Case Studies
- Market by Application
- Bioprocess Optimization and Process Analytics
- Biomanufacturing Process Automation and Control
- Flexible Manufacturing
- Other Applications
Chapter 6 Market Breakdown by Region
- Market by Region
- Global Market Overview
- Market Revenue
- Market Shares
- Manufacturing Technologies
- Bioreactors
- Chromatography-based Separation and Purification Techniques
- Filtration
- Centrifugation
- Analytical and Process Control Technologies
- Sensors and Probes
- Automation and Industrial Process Control Technologies
- Analytical Chromatography
- Spectrophotometry
- Software
- Bioprocess Optimization and Data Analytics Software
- Industrial Control and Automation Software
- Other Software
Chapter 7 Industry Structure
- Industry Trends
- Mergers and Acquisitions
- Collaborations and Partnerships
- Digitalized Supply Chain
- Inventory Management
- Leading Manufacturers/Suppliers of Bioprocess Optimization and Digital Biomanufacturing
- Manufacturing Technologies
- Analytical and Process Control Technologies
- Software
Chapter 8 Patent Review/ New Developments
- Patents on Bioprocess Optimization and Digital Biomanufacturing
- Patent Analysis
- Patents by Year
- Patents by Category
- Patents by Type of Assignee
- Patents on Manufacturing Technologies by Type
- Bioreactors
- Chromatography-based Separation and Purification Techniques
- Filtration
- Centrifugation
- Patents on Analytical and Process Control Technologies by Type
- Sensors and Probes
- Automation and Industrial Process Control Technologies
- Analytical Chromatography
- Spectrophotometry
- Patents on Software Related to Bioprocess Optimization and Digital Biomanufacturing
- Patents by Type
- Patents by Year
- Patents by Company
- Patents by Assignee Country
- Patents by Type of Assignee
Chapter 9 New Developments/ Regulatory Aspects
- New Developments
- New Developments in Manufacturing Technologies
- New Developments in Analytical and Process Control Technologies
- New Developments in Software
- Regulatory Aspects
- FDA's Quality Metrics Program
- Guidelines Related to Analytical Method Validation: General Concepts
- Guidelines Related to Downstream Processing: General Concepts
- Guidelines Related to Single-Use Technologies
- Guidelines Related to Data Integrity
- Good Automation Manufacturing Practices (GAMP)
- Instrumentation, Systems, and Automation (ISA) Society-88 and 95 Standards
Chapter 10 Critical Issues in Adopting Digital Biomanufacturing
- Regulatory Constraints
- Issues with Disposable Technologies
- Process Scalability Issues
- Challenges in Continuous Bioprocessing
- Lack of Standards and Guidelines
- Technological Challenges at Upstream Processing Stages
- Technological Challenges at Downstream Processing Stages
- Scaling-up of Chromatography
- Integration of Different Unit Operations
- Lack of Knowledge and Examples in the Industry
- Issues in Implementation of PAT in Biological Processes
- Cyber Security
Chapter 11 Emerging Trends in Digital Biomanufacturing
- Continuous Bioprocessing
- Continuous Cell Retention Technologies
- Continuous Chromatography
- Single-use Technologies
- Automation
- Acquisition of Finesse Solutions by Thermo Fisher Scientific
- GE Healthcare Invests in Zenith Technologies
- Sartorius Stedium Introduces New BIOSTAT STR Bioreactors
- Data Integrity
- Process Analytical Technologies and Smart Sensors
- Real-time Analytics Solutions
Chapter 12 Analysis of Market Opportunities
- Strengths of Bioprocess Optimization and Digital Biomanufacturing Market
- Rising Incidence of Diseases
- Growing Market for Biopharmaceuticals
- New Product Launches
- Need for Regulatory Compliance
- Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs)
- Drive to Reduce Cost and Improve Process Productivity
- Mergers and Acquisitions
- Challenges of Bioprocess Optimization and Digital Biomanufacturing Market
- Lack of Skilled Labor
- Cost of Equipment
- Interoperability Challenges
- Unharmonized Smart Manufacturing Standards
- Opportunities for Bioprocess Optimization and Digital Biomanufacturing Market
- Favorable Government Initiatives
- Emerging Markets
- Advances in Sensor Technology
- Process Analytical Technology Initiative
- Threats to the Bioprocess Optimization and Digital Biomanufacturing Market
- Technical Issues and Cyber Threats
Chapter 13 Company Profiles
- 3M Co.
- ABB Group
- AB Sciex LLC
- Agilent Technologies Inc.
- Alertenterprise
- Alva Laval AB
- Applied Materials Inc.
- Applikon Biotechnology B.V.
- Bio-Rad Laboratories Inc.
- Danaher Corp.
- Emerson Electric Co.
- Eppendorf AG
- Endress+Hauser AG
- GEA Group
- GE Healthcare Life Sciences
- Hitachi High-Technologies Corp.
- Microsoft Corp.
- Milliporesigma
- Novasep Inc.
- Oracle International Corp.
- Pall Corp.
- Parker Hannifin Corp.
- Pendotech
- Perkinelmer Inc.
- Phenomenex Inc.
- PSC Biotech Corp.
- Purolite Corp.
- Repligen Corp.
- Rockwell Automation Inc.
- Thermo Fisher Scientific Inc.
- Tosoh Bioscience LLC
- Waters Corp.
- Werum It Solutions Gmbh
- Yokagawa Electric Corp.
- and more...
For more information about this report visit https://www.researchandmarkets.com/research/bvzzx3/the_global_market?w=12