DUBLIN–(BUSINESS WIRE)–The “17th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production” report has been added to ResearchAndMarkets.com’s offering.
The 2020 17th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations’ current and projected future capacity and production.
This report’s 522 pages of data-rich analysis will help improve your decision-making in biomanufacturing operations, with in-depth analysis of capacity, production trends, benchmarks, and much more.
In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic production. Comparison of production by biotherapeutic developers and contract manufacturing organizations. Current and future potential industry bottlenecks. Trend analysis in this 17th in a series of annual biopharmaceutical manufacturing industry evaluations. This edition includes the joint industry expertise of the publisher, and many industry consultants and experts.
Key Topics Covered:
CHAPTER 1: INTRODUCTION AND DISCUSSION
1-1 Introduction: The Pharmaceutical and Biopharmaceutical Industries
1-2 Current Status and Market Trends
1-3 Market Potential
1-4 Biopharmaceuticals and Biosimilars in the Pipeline
1-5 Global Biopharmaceutical and Recombinant Protein/MAb Markets
1-6 Biopharmaceutical Markets by Product Class
1-7 Animal Derived Products and Biopharmaceuticals
1-8 Future Trends in the Biopharmaceutical Industry
1-9 Future Biopharmaceutical Market Trends
CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE
2-1 Cell and Gene Therapy – Future of Bioprocessing
2-2 Continuous Processing – Present and Future Challenges
2-3 China and Asia’s position in Global Bioproduction
2-4 Intersection of Biopharma and Small Pharma: Small Molecule Manufacturing Lessons for a New Industry
2-5 Upstream and Downstream Biologics Manufacturing: Mapping the Future Challenges and Trends
2-6 Suppliers’ Contributions to Bioprocessing Advances
2-7 Contract Manufacturing’s Contributions to Bioprocessing Advances
2-8 Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board
2-9 China’s Advances in Global Biopharma and Bioprocessing: A 10-year Projection on Need for Quality Improvements
CHAPTER 3: EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING
3-1 Industry Trends in 2018
3-2 Budget Issues in 2018
3-3 Operational Changes
3-4 New Bioprocessing Products Development Opportunities in 2018
3-5 Factors in Biomanufacturing Creating Improvements
3-6 Cost-Cutting Actions & Development Timelines (2016 data)
3-7 Average Cost per Gram Recombinant Protein
3-8 Assay Development
3-9 Perfusion Operations and Continuous Bioprocessing Operations Issues
3-10 Perfusion Operations and Continuous Bioprocessing Trends
3-11 Discussion
3-12 Cell and Gene Therapy Platforms
3-13 Selecting Bioreactors in New Facilities (2017 data)
3-14 Discussion: Industry Trends and Issues
CHAPTER 4: CAPACITY UTILIZATION
4-1 Capacity Utilization Trends
4-2 Capacity Utilization: CMOs vs. Biotherapeutic Developers
4-3 Capacity Utilization: U.S. vs. Western European Manufacturers
4-4 Respondents’ Current Total Production Capacity
4-5 Discussion: Capacity Trends
4-6 Range of Titers with mAb Production
4-7 Discussion: Capacity and Industry Trends
CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS
5-1 Current Capacity Constraints
5-2 Expected Capacity Constraints 210 Respondents’ Expectations of Capacity Constraints by 2023
5-3 Factors Impacting Future Production Capacity
5-4 Key Areas to Address to Avoid Future Capacity Constraints
5-5 Discussion
CHAPTER 6: FUTURE CAPACITY EXPANSIONS
6-1 Planned Future Capacity Expansions
CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING
7-1 Current Outsourcing by Production System
7-2 Future Outsourcing
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
7-4 Critical Outsourcing Issues
7-5 CMOs’ Problems with Their Clients
7-6 Country Selections for International Outsourcing (Off-shoring) of Biomanufacturing
7-7 Offshoring Trends
7-8 5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Off-shoring
CHAPTER 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING
8-1 Use of Disposables and Single-Use Systems
8-2 Leachables and Extractables
8-3 Reasons for Increasing Use of Disposables & Single-Use Systems 326
8-4 Factors That May Restrict Use of Disposables
8-5 Suppliers’ Expectations for Standards Setting Bodies
8-6 Need for Single-use Sensors, and Bioreactor Attributes
8-7 Satisfaction with Single-use Device Vendors
8-8 Single Use Operations and Trends
8-9 Discussion of Single-use Bioprocessing
CHAPTER 9: DOWNSTREAM PURIFICATION
9-1 Impact of Downstream Processing on Capacity
9-2 Specic Purication Step Constraints
9-3 Downstream Purication Issues
9-4 mAb Purication Capacity Estimates
9-5 New Downstream Processing Technologies
9-6 Improvements to Downstream Operations
9-7 Discussion
CHAPTER 10: QUALITY ISSUES, BATCH FAILURES, AND PAT IN BIOPHARMACEUTICAL MANUFACTURING
10-1 Quality Initiative Implementation
10-2 Hurdles to Implementing Process Analytical Technology
10-3 Batch Failure Frequency in Biopharmaceutical Manufacturing
10-4 Primary Cause of Batch Failures, Percentages of Failures
10-5 Quality Problems in BioManufacturing Attributed to Vendors
10-6 Discussion
CHAPTER 11: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING
11-1 Hiring Trends
11-2 Hiring in 2023: 5-year Trends
11-3 Hiring Challenges Today
11-4 Training in Biopharmaceutical Manufacturing
11-5 Intersection of Biopharma and Small Pharma
11-6 Discussion
CHAPTER 12: New Methods: Continuous and Process Intensification, Cell and Gen
12-1 PerfusionAreas of Involvement
12-2 Trends in Fill-Finish and Related Bioprocessing Capacity
12-3 Current Fill-Finish Trends
12-4 Discussion
CHAPTER 13: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES
13-1 Demographics
13-2 Growth Rate of Sales by Suppliers
13-3 Discussion of Vendor and Industry Growth
13-4 Budget Issues and Problems Faced by Industry Suppliers
13-5 Cost Cutting Actions by Vendors
13-6 Problems Clients Have with Their Vendors
13-7 Vendor Expansion Plans
13-8 New Technology Areas in Development by Vendors
13-9 Sales Staff Training 502 Days of Training Provided
13-10 Biopharma Vendors’ Financial Outlook for 2018
13-11 Discussion of Biopharma Suppliers
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