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 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 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 for BCC Research 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 have 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 are expected to shape the industry.
BCC Research’s 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.
– 91 data tables and 30 additional tables
– An overview of the global markets for bioprocess optimization and digital bio-manufacturing (DM)
– Evaluation of 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.
Table of Contents
Chapter 1 Introduction
Chapter 2 Summary and Highlights
Chapter 3 Market and Technology Background
Chapter 4 Market Breakdown by Technology Type
Chapter 5 Market Breakdown by Application
Chapter 6 Market Breakdown by Region
Chapter 7 Industry Structure
Chapter 8 Patent Review/ New Developments
Chapter 9 New Developments/ Regulatory Aspects
Chapter 10 Critical Issues in Adopting Digital Biomanufacturing
Chapter 11 Emerging Trends in Digital Biomanufacturing
Chapter 12 Analysis of Market Opportunities
Chapter 13 Company Profiles
AB SCIEX LLC
AGILENT TECHNOLOGIES INC.
ALVA LAVAL AB
APPLIED MATERIALS INC.
APPLIKON BIOTECHNOLOGY BV
BIO-RAD LABORATORIES INC.
EMERSON ELECTRIC CO.
GE Healthcare Life Sciences
HITACHI HIGH-TECHNOLOGIES CORP.
HONEYWELL INTERNATIONAL INC.
KNAUER WISSENSCHAFTLICHE GERÄTE GMBH
KOKI HOLDINGS CO. LTD. (FORMERLY HITACHI KOKI CO. LTD.)
ORACLE INTERNATIONAL CORP.
Chapter 14 Appendix: Acronyms, Abbreviations and Glossary
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