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Bioprocess Optimization and Digital Bio-manufacturing: Global Markets

  • ID: 4703998
  • Report
  • Region: Global
  • 438 Pages
  • BCC Research
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Report Scope

The biggest challenge for a biopharmaceutical company is to produce a high-quality product in a cost-effective manner. The need to harness the first-to-market advantage as well as meet the growing pressure to control costs from consumers, insurance companies and governments has led many biopharmaceutical manufacturers to resort to innovative methods of production. Implementation of process intensification (continuous manufacturing) and use of disposable technologies has significantly boosted the production productivities. Integration of statistical modeling with standard bioprocess optimization methods has also been a positive strategy in achieving the goals of faster production time and better process design.

There is a growing demand from the FDA and other regulatory authorities to comply with the stringent regulatory guidelines of quality and traceability. There is a humongous amount of data generated at every step of pharmaceutical manufacturing, including research and development, pilot plant and commercial manufacturing. Various automation systems at the company and at the contract manufacturing sites also generate large amounts of information. The resulting non-standard nomenclature and varying data structures complicate the communication systems, thereby delaying product release. Digital manufacturing (DM) is coming to transform pharmaceutical manufacturing in a big way. The connection between equipment, materials, and people brought about by IIoT as well as data analytics platforms are leading to more efficient and faster processes.

The new report on the topic “Bioprocess Optimization and Digital Biomanufacturing: Global Markets” 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. The report will analyze the market by segmenting it into the technologies and solutions that matter the most, namely Manufacturing Technologies, Analytical and Process Control Technologies, and Software. Each of these segments has been sub-divided into different types (as detailed later). This study surveys the bioprocess optimization and digital biomanufacturing market in all the geographic regions, including North America, Europe, and emerging markets. The emerging markets segment includes regions like India, China, Korea, Taiwan, Africa, Australia, New Zealand, Canada, Latin America, and more. The applications of digital biomanufacturing in bioprocess optimization, biomanufacturing, and flexible manufacturing have also been dealt with.

The report discusses the critical issues impacting the adoption of DM in pharmaceuticals, as well as emerging trends in DM technologies. It also features the new developments and new product launches in the global market.

The report provides relevant patent analysis and comprehensive profiles of market players in the industry. The industry structure chapter focuses on changing market trends, important manufacturers and suppliers, and their market shares and product offerings. The chapter also covers mergers and acquisitions and any other collaborations or partnerships that happened during the evaluation period of this report that is expected to shape the industry.

This new report elaborates on the strengths, weaknesses, threats, and opportunities of the global bioprocess optimization and DM market. Any regulatory changes or new initiatives are highlighted.

Excluded from this report are applications of digital manufacturing in other aspects of technology that are not related to pharmaceuticals. Additionally, the focus is on the biopharmaceutical market and not on small molecule drugs.

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.
Note: Product cover images may vary from those shown
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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
  • Market Overview
  • Market Revenue
  • Market Shares
  • Analytical and Process Control Technologies
  • Market Overview
  • Market Revenue
  • Market Shares
  • Software
  • Market Overview
  • Market Revenue
  • Market Shares

Chapter 5 Market Breakdown by Application

  • Case Studies
  • Market by Application
  • Market Overview
  • Market Revenue
  • Market Shares
  • Bioprocess Optimization and Process Analytics
  • Market Overview
  • Market Revenue
  • Market Shares
  • Biomanufacturing Process Automation and Control
  • Market Overview
  • Market Revenue
  • Market Shares
  • Flexible Manufacturing
  • Market Overview
  • Market Revenue
  • Market Shares
  • Other Applications
  • Market Overview
  • Market Revenue
  • Market Shares

Chapter 6 Market Breakdown by Region

  • Market by Region
  • Global Market Overview
  • Market Revenue
  • Market Shares
  • Manufacturing Technologies
  • Market Overview
  • Market Revenue
  • Market Shares
  • Bioreactors
  • Chromatography-based Separation and Purification Techniques
  • Filtration
  • Centrifugation
  • Analytical and Process Control Technologies
  • Market Overview
  • Market Revenue
  • Market Shares
  • Sensors and Probes
  • Automation and Industrial Process Control Technologies
  • Analytical Chromatography
  • Spectrophotometry
  • Software
  • Market Overview
  • Market Revenue
  • Market Shares
  • 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 Bv
  • Bio-Rad Laboratories Inc.
  • Bruker Corp.
  • Danaher Corp.
  • Emerson Electric Co.
  • Eppendorf Ag
  • Endress+Hauser Ag
  • GEA Group
  • GE Healthcare Life Sciences
  • Hamilton Co.
  • Hitachi High-Technologies Corp.
  • Honeywell International Inc.
  • Jasco Inc.
  • Knauer Wissenschaftliche Geräte Gmbh
  • Koki Holdings Co. Ltd. (Formerly Hitachi Koki Co. Ltd.)
  • Mettler-Toledo Gmbh
  • 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.
  • Sartorius Stedium Biotech Gmbh
  • SAP Se
  • Schneider Electric Sa
  • Shimadzu Corp.
  • Siemens Ag
  • Sparta Systems Inc.
  • Spectris Plc
  • Thermo Fisher Scientific Inc.
  • Tosoh Bioscience Llc
  • Waters Corp.
  • Werum It Solutions Gmbh
  • Yokagawa Electric Corp.

Chapter 14 Appendix: Acronyms, Abbreviations and Glossary

List of Tables
Summary Table: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Region, Through 2023
Table 1: List of Biologics Produced in E. coli
Table 2: List of Biologics Produced in Mammalian Cells
Table 3: Popular Types of Bioreactors Used for Cell Culture Processes
Table 4: Differences Between Industrial Control Systems
Table 5: Features of Different Sensor Types
Table 6: Features of Different Sensor Types Based on Spectroscopy
Table 7: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Type, Through 2023
Table 8: Global Market Shares of Bioprocess Optimization and Digital Biomanufacturing, by Type, 2017
Table 9: Global Market for Manufacturing Technologies, by Type, Through 2023
Table 10: Global Market Shares of Manufacturing Technologies, by Type, 2017
Table 11: Global Market for Analytical and Process Control Technologies, by Type, Through 2023
Table 12: Global Market Shares of Analytical and Process Control Technologies, by Type, 2017
Table 13: Global Market for Software, by Type, Through 2023
Table 14: Global Market Shares of Software, by Type, 2017
Table 15: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Application, Through 2023
Table 16: Global Market Shares of Bioprocess Optimization and Digital Biomanufacturing, by Application, 2017
Table 17: Global Market for Bioprocess Optimization and Process Analytics, by Region, Through 2023
Table 18: Global Market Shares of Bioprocess Optimization, by Region, 2017
Table 19: Global Market for Biomanufacturing Process Automation and Control, by Region, Through 2023
Table 20: Global Market Shares of Biomanufacturing Process Automation and Control, by Region, 2017
Table 21: Global Market for Flexible Manufacturing, by Region, Through 2023
Table 22: Global Market Shares of Flexible Manufacturing, by Region, 2017
Table 23: Global Market for Other Applications, by Region, Through 2023
Table 24: Global Market Shares of Other Applications, by Region, 2017
Table 25: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Region, Through 2023
Table 26: Global Market Shares of Bioprocess Optimization and Digital Biomanufacturing, by Region, 2017
Table 27: Global Market for Manufacturing Technologies, by Region, Through 2023
Table 28: Global Market Shares of Manufacturing Technologies, by Region, 2017
Table 29: Global Market for Bioreactors, by Region, Through 2023
Table 30: Global Market for Chromatography-based Separation and Purification Techniques, by Region, Through 2023
Table 31: Global Market for Filtration, by Region, Through 2023
Table 32: Global Market for Centrifugation, by Region, Through 2023
Table 33: Global Market for Analytical and Process Control Technologies, by Region, Through 2023
Table 34: Global Market Shares of Analytical and Process Control Technologies, by Region, 2017
Table 35: Global Market for Sensors and Probes, by Region, Through 2023
Table 36: Global Market for Automation and Industrial Process Control Technologies, by Region, Through 2023
Table 37: Global Market for Analytical Chromatography, by Region, Through 2023
Table 38: Global Market for Spectrophotometry, by Region, Through 2023
Table 39: Global Market for Software, by Region, Through 2023
Table 40: Global Market Shares of Software, by Region, 2017
Table 41: Global Market for Bioprocess Optimization and Data Analytics Software, by Region, Through 2023
Table 42: Global Market for Industrial Control and Automation Software, by Region, Through 2023
Table 43: Global Market for Other Software, by Region, Through 2023
Table 44: Mergers and Acquisitions in the Bioprocess Optimization and Digital Biomanufacturing Market, 2016 Through July 2018
Table 45: Collaborations and Partnerships in the Bioprocess Optimization and Digital Biomanufacturing Market, 2016 Through July 2018
Table 46: Leading Manufacturers/Suppliers of Bioreactors, 2017
Table 47: Global Market Shares of Leading Manufacturers/Suppliers of Bioreactors, 2017
Table 48: Leading Manufacturers/Suppliers of Chromatography-based Separation and Purification Techniques, 2017
Table 49: Global Market Shares of Leading Manufacturers/Suppliers of Chromatography- based Separation and Purification Techniques, 2017
Table 50: Leading Manufacturers/Suppliers of Filtration, 2017
Table 51: Global Market Shares of Leading Manufacturers/Suppliers of Filtration, 2017
Table 52: Leading Manufacturers/Suppliers of Centrifugation, 2017
Table 53: Global Market Shares of Leading Manufacturers/Suppliers of Centrifugation, 2017
Table 54: Leading Manufacturers/Suppliers of Sensors and Probes, 2017
Table 55: Global Market Shares of Leading Manufacturers/Suppliers of Sensors and Probes, 2017
Table 56: Leading Manufacturers/Suppliers of Analytical Chromatography, 2017
Table 57: Global Market Shares of Leading Manufacturers/Suppliers of Analytical Chromatography, 2017
Table 58: Leading Manufacturers/Suppliers of Spectrophotometry, 2017
Table 59: Global Market Shares of Leading Manufacturers/Suppliers of Spectrophotometry, 2017
Table 60: Leading Manufacturers/Suppliers of Automation and Industrial Control Systems, 2017
Table 61: Global Market Shares of Leading Manufacturers/Suppliers of Automation and Industrial Control Systems, 2017
Table 62: Leading Manufacturers/Suppliers of Bioprocess Optimization and Data Analytics Software, 2017
Table 63: Global Market Shares of Leading Manufacturers/Suppliers of Bioprocess Optimization and Data Analytics Software, 2017
Table 64: Leading Manufacturers/Suppliers of Automation and Industrial Control Software, 2017
Table 65: Global Market Shares of Leading Manufacturers/Suppliers of Automation and Industrial Control Software, 2017
Table 66: Leading Manufacturers/Suppliers of Other Software, 2017
Table 67: Global Market Shares of Leading Manufacturers/Suppliers of Other Software, 2017
Table 68: Basic Aspects of Patents
Table 69: Representative U.S. Patents on Chromatography-Related Technologies, 2016 Through Aug. 7, 2018
Table 70: U.S. Patents Issued on Bioprocess Optimization and Digital Biomanufacturing, by Year, 2016 Through Aug. 7, 2018
Table 71: U.S. Patents Issued on Bioprocess Optimization and Digital Biomanufacturing, by Category, 2016 Through Aug. 7, 2018
Table 72: U.S. Patents Issued on Bioprocess Optimization and Digital Biomanufacturing, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 73: U.S. Patents Issued on Manufacturing Technologies, by Type, 2016 Through Aug. 7, 2018
Table 74: U.S. Patents Issued on Bioreactors, by Year, 2016 Through Aug. 7, 2018
Table 75: U.S. Patents Issued on Bioreactors, by Company, 2016 Through Aug. 7, 2018
Table 76: U.S. Patents Issued on Bioreactors, by Assignee Country, 2016 Through Aug. 7, 2018
Table 77: U.S. Patents Issued on Bioreactors, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 78: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Year, 2016 Through Aug. 7, 2018
Table 79: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Company, 2016 Through Aug. 7, 2018
Table 80: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Assignee Country, 2016 Through Aug. 7, 2018
Table 81: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 82: U.S. Patents Issued on Filtration, by Year, 2016 Through Aug. 7, 2018
Table 83: U.S. Patents Issued on Filtration, by Company, 2016 Through Aug. 7, 2018
Table 84: U.S. Patents Issued on Filtration, by Assignee Country, 2016 Through Aug. 7, 2018
Table 85: U.S. Patents Issued on Filtration, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 86: U.S. Patents Issued on Centrifugation, by Year, 2016 Through Aug. 7, 2018
Table 87: U.S. Patents Issued on Centrifugation, by Company, 2016 Through Aug. 7, 2018
Table 88: U.S. Patents Issued on Centrifugation, by Assignee Country, 2016 Through Aug. 7, 2018
Table 89: U.S. Patents Issued on Centrifugation, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 90: U.S. Patents Issued on Automation and Process Control Technologies, by Type, 2016 Through Aug. 7, 2018
Table 91: U.S. Patents Issued on Sensors and Probes, by Year, 2016 Through Aug. 7, 2018
Table 92: U.S. Patents Issued on Sensors and Probes, by Company, 2016 Through Aug. 7, 2018
Table 93: U.S. Patents Issued on Sensors and Probes, by Assignee Country, 2016 Through Aug. 7, 2018
Table 94: U.S. Patents Issued on Sensors and Probes, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 95: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Year, 2016 Through Aug. 7, 2018
Table 96: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Company, 2016 Through Aug. 7, 2018
Table 97: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Assignee Country, 2016 Through Aug. 7, 2018
Table 98: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 99: U.S. Patents Issued on Analytical Chromatography, by Year, 2016 Through Aug. 7, 2018
Table 100: U.S. Patents Issued on Analytical Chromatography, by Company, 2016 Through Aug. 7, 2018
Table 101: U.S. Patents Issued on Analytical Chromatography, by Assignee Country, 2016 Through Aug. 7, 2018
Table 102: U.S. Patents Issued on Analytical Chromatography, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 103: U.S. Patents Issued on Spectrophotometry, by Year, 2016 Through Aug. 7, 2018
Table 104: U.S. Patents Issued on Spectrophotometry, by Company, 2016 Through Aug. 7, 2018
Table 105: U.S. Patents Issued on Spectrophotometry, by Assignee Country, 2016 Through Aug. 7, 2018
Table 106: U.S. Patents Issued on Spectrophotometry, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 107: U.S. Patents Issued on Software, by Type, 2016 Through Aug. 7, 2018
Table 108: U.S. Patents Issued on Software, by Year, 2016 Through Aug. 7, 2018
Table 109: U.S. Patents Issued on Software, by Company, 2016 Through Aug. 7, 2018
Table 110: U.S. Patents Issued on Software, by Assignee Country, 2016 Through Aug. 7, 2018
Table 111: U.S. Patents Issued on Software, by Type of Assignee, 2016 Through Aug. 7, 2018
Table 112: New Product Developments in Manufacturing Technologies, 2016 Through July 2018
Table 113: New Product Developments in Analytical and Process Control Technologies, 2016 Through July 2018
Table 114: New Product Developments in Software, 2016 Through July 2018
Table 115: List of Regulatory Guidelines Related to Biopharmaceutical Manufacturing
Table 116: Functionalities Required to be Validated in SCADA and ERP Systems
Table 117: Warning Letters Issued In lieu of Data Integrity Issues, 2016 Through July 2018
Table 118: Examples of Continuous Processing Developments
Table 119: Acronyms/Abbreviations Used in Bioprocess Optimization and Digital Biomanufacturing
Table 120: Glossary of Terms Used in Bioprocess Optimization and Digital Biomanufacturing

List of Figures
Summary Figure: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Region, 2016-2023
Figure 1: A Typical Biopharmaceutical Manufacturing Process
Figure 2: Steps and Layers in Industrial Internet of Things
Figure 3: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Type, 2016-2023
Figure 4: Global Market Shares of Bioprocess Optimization and Digital Biomanufacturing, by Type, 2017
Figure 5: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Type, 2016-2023
Figure 6: Global Market Shares of Manufacturing Technologies, by Type, 2017
Figure 7: Global Market for Analytical and Process Control Technologies, by Type, 2016-2023
Figure 8: Global Market Shares of Analytical and Process Control Technologies, by Type, 2017
Figure 9: Global Market for Software, by Type, 2016-2023
Figure 10: Global Market Shares of Software, by Type, 2017
Figure 11: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Application, 2016-2023
Figure 12: Global Market Shares of Bioprocess Optimization and Digital Biomanufacturing, by Application, 2017
Figure 13: Global Market for Bioprocess Optimization and Process Analytics, by Region, 2016-2023
Figure 14: Global Market Shares of Manufacturing Technologies, by Type, 2017
Figure 15: Global Market for Biomanufacturing Process Automation and Control, by Region, 2016-2023
Figure 16: Global Market Shares of Biomanufacturing Process Automation and Control, by Region, 2017
Figure 17: Global Market for Flexible Manufacturing, by Region, 2016-2023
Figure 18: Global Market Shares of Flexible Manufacturing, by Region, 2017
Figure 19: Global Market for Other Applications, by Region, 2016-2023
Figure 20: Global Market Shares of Other Applications, by Region, 2017
Figure 21: Global Market for Bioprocess Optimization and Digital Biomanufacturing, by Region, 2016-2023
Figure 22: Global Market Shares of Bioprocess Optimization and Digital Biomanufacturing, by Region, 2017
Figure 23: Global Market for Manufacturing Technologies, by Region, 2016-2023
Figure 24: Global Market Shares of Manufacturing Technologies, by Region, 2017
Figure 25: Global Market for Bioreactors, by Region, 2016-2023
Figure 26: Global Market for Chromatography-based Separation and Purification Techniques, by Region, 2016-2023
Figure 27: Global Market for Filtration, by Region, 2016-2023
Figure 28: Global Market for Centrifugation, by Region, 2016-2023
Figure 29: Global Market for Analytical and Process Control Technologies, by Region, 2016-2023
Figure 30: Global Market Shares of Analytical and Process Control Technologies, by Region, 2017
Figure 31: Global Market for Sensors and Probes, by Region, 2016-2023
Figure 32: Global Market for Automation and Industrial Process Control Technologies, by Region, 2016-2023
Figure 33: Global Market for Analytical Chromatography, by Region, 2016-2023
Figure 34: Global Market for Spectrophotometry, by Region, 2016-2023
Figure 35: Global Market for Software, by Region, 2016-2023
Figure 36: Global Market Shares of Software, by Region, 2017
Figure 37: Global Market for Bioprocess Optimization and Data Analytics Software, by Region, 2016-2023
Figure 38: Global Market for Industrial Control and Automation Software, by Region, 2016-2023
Figure 39: Global Market for Other Software, by Region, 2016-2023
Figure 40: Global Market Shares of Leading Manufacturers/Suppliers of Bioreactors, 2017
Figure 41: Global Market Shares of Leading Manufacturers/Suppliers of Chromatography- based Separation and Purification Techniques, 2017
Figure 42: Global Market Shares of Leading Manufacturers/Suppliers of Filtration, 2017
Figure 43: Global Market Shares of Leading Manufacturers/Suppliers of Centrifugation, 2017
Figure 44: Global Market Shares of Leading Manufacturers/Suppliers of Sensors and Probes, 2017
Figure 45: Global Market Shares of Leading Manufacturers/Suppliers of Analytical Chromatography, 2017
Figure 46: Global Market Shares of Leading Manufacturers/Suppliers of Spectrophotometry, 2017
Figure 47: Global Market Shares of Leading Manufacturers/Suppliers of Automation and Industrial Control Systems, 2017
Figure 48: Global Market Shares of Leading Manufacturers/Suppliers of Bioprocess Optimization and Data Analytics Software, 2017
Figure 49: Global Market Shares of Leading Manufacturers/Suppliers of Automation and Industrial Control Software, 2017
Figure 50: Global Market Shares of Leading Manufacturers/Suppliers of Other Software, 2017
Figure 51: U.S. Patents Issued on Bioprocess Optimization and Digital Biomanufacturing Technologies, by Year, 2016 Through Aug. 7, 2018
Figure 52: U.S. Patents Issued on Bioprocess Optimization and Digital Biomanufacturing, by Category, 2016 Through Aug. 7, 2018
Figure 53: U.S. Patents Issued on Bioprocess Optimization and Digital Biomanufacturing, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 54: U.S. Patents Issued on Manufacturing Technologies, by Type, 2016 Through Aug. 7, 2018
Figure 55: U.S. Patents Share Issued on Bioreactors, by Year, 2016 Through Aug. 7, 2018
Figure 56: U.S. Patents Issued on Bioreactors, by Company, 2016 Through Aug. 7 2018
Figure 57: U.S. Patents Issued on Bioreactors, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 58: U.S. Patents Issued on Bioreactors, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 59: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Year, 2016 Through Aug. 7, 2018
Figure 60: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Company, 2016 Through Aug. 7, 2018
Figure 61: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 62: U.S. Patents Issued on Chromatography-based Separation and Purification Techniques, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 63: U.S. Patents Issued on Filtration, by Year, 2016 Through Aug. 7, 2018
Figure 64: U.S. Patents Issued on Filtration, by Company, 2016 Through Aug. 7, 2018
Figure 65: U.S. Patents Issued on Filtration, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 66: U.S. Patents Issued on Filtration, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 67: U.S. Patents Issued on Centrifugation, by Year, 2016 Through Aug. 7, 2018
Figure 68: U.S. Patents Issued on Centrifugation, by Company, 2016 Through Aug. 7, 2018
Figure 69: U.S. Patents Issued on Centrifugation, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 70: U.S. Patents Issued on Centrifugation, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 71: U.S. Patents Issued on Automation and Process Control Technologies, by Type, 2016 Through Aug. 7, 2018
Figure 72: U.S. Patents Issued on Sensors and Probes, by Year, 2016 Through Aug. 7, 2018
Figure 73: U.S. Patents Issued on Sensors and Probes, by Company, 2016 Through Aug. 7, 2018
Figure 74: U.S. Patents Issued on Sensors and Probes, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 75: U.S. Patents Issued on Sensors and Probes, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 76: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Year, 2016 Through Aug. 7, 2018
Figure 77: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Company, 2016 Through Aug. 7, 2018
Figure 78: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 79: U.S. Patents Issued on Automation and Industrial Process Control Technologies, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 80: U.S. Patents Issued on Analytical Chromatography, by Year, 2016 Through Aug. 7, 2018
Figure 81: U.S. Patents Issued on Analytical Chromatography, by Company, 2016 Through Aug. 7, 2018
Figure 82: U.S. Patents Issued on Analytical Chromatography, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 83: U.S. Patents Issued on Analytical Chromatography, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 84: U.S. Patents Issued on Spectrophotometry, by Year, 2016 Through Aug. 7, 2018
Figure 85: U.S. Patents Issued on Spectrophotometry, by Company, 2016 Through Aug. 7, 2018
Figure 86: U.S. Patents Issued on Spectrophotometry, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 87: U.S. Patents Issued on Spectrophotometry, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 88: U.S. Patents Issued on Software, by Type, 2016 Through Aug. 7, 2018
Figure 89: U.S. Patents Issued on Software, by Year, 2016 Through Aug. 7, 2018
Figure 90: U.S. Patents Issued on Software, by Company, 2016 Through Aug. 7, 2018
Figure 91: U.S. Patents Issued on Software, by Assignee Country, 2016 Through Aug. 7, 2018
Figure 92: U.S. Patents Issued on Software, by Type of Assignee, 2016 Through Aug. 7, 2018
Figure 93: SWOT Analysis of the Bioprocess Optimization and Digital Biomanufacturing Market

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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.

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