17th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production

Table of Content

METHODOLOGY
Chapter 0: DEMOGRAPHICS
Introduction
0-1 Respondents’ Area of Involvement
0-2 Respondents Quali?cations
0-3Facility Locations
0-4Areas of Biopharmaceutical Manufacturing Operations
0-5 Production Operations, Phase of Development
0-6 Employees at Facility
0-7 Batches Run at Facility per Year
0-8 Single Use Bioreactor Capacity, In Use at Site
0-9 Stainless Steel Bioreactor Capacity, In Use at Site
Chapter 1: INTRODUCTION AND DISCUSSION
1-1Introduction:The Pharmaceutical and Biopharmaceutical Industries
1-2Current Status and Market Trends
1-3 Market Potential
1-4 Biopharmaceuticals and Biosimilars in the Pipeline
FDA Biopharmaceutical Approvals
1-5 Global Biopharmaceutical and Recombinant Protein/MAb Markets
Overall Health of the Biopharmaceutical Sector
U.S. Industry Leadership Continues
Biopharmaceuticals in the Rest-of-the-World
1-6 Biopharmaceutical Markets by Product Class
Monoclonal antibodies (mAbs) are the Leading Product Classes
1-7 Animal Derived Products and Biopharmaceuticals
Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
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
Introduction
Productivity and Cost Reductions
3-2 Budget Issues in 2018
Budget Change Comparisons
3-3 Operational Changes
3-4 New Bioprocessing Products Development Opportunities in 2018
Upstream New Product Areas of Need
Trends: Upstream New Product Areas of Need 2010-2018
Downstream New Product Areas of Need
Trends: Downstream New Product Areas of Need 2010-2018
Other New Product Areas of Need
Trends: Other General New Product Areas of Need 2010-2018
Innovations in Single-use/Disposable Equipment
Discussion of Needed Single-use Innovations
Other Areas for Innovation
New Product Development Areas:Biotherapeutic Developers vs. CMOs
New Product Development Areas:U.S. vs. Western Europe and ROW
3-5 Factors in Biomanufacturing Creating Improvements
Factors Improving Biomanufacturing Performance, 2010 - 2015
Factors Improving Biomanufacturing Performance, Biotherapeutic Developers vs. CMOs (2015 Data)
Factors Improving Biomanufacturing Performance, U.S. vs. Western Europe vs. ROW (2015 Data)
3-6 Cost-Cutting Actions & Development Timelines (2016 data)
Cost-Cutting Changes: Speci? c to Outsourcing (2016 data)
3-7 Average Cost per Gram Recombinant Protein
3-8 Assay Development
Biomanufacturing Assay Required; Biomanufacturers vs. CMOs (2016 data)
3-9 Perfusion Operations and Continuous Bioprocessing Operations Issues
Perfusion vs. Batch Fed Bioprocessing
3-10 Perfusion Operations and Continuous Bioprocessing Trends
Continuous Bioprocess and Process Intensi?cation
3-11 Discussion
Continuous Bioprocessing: Trends and Opportunities
Perfusion: Trends and Opportunities
3-12 Cell and Gene Therapy Platforms
Cell and Gene Therapy Manufacturing Advancements
Cell and Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure
3-13 Selecting Bioreactors in New Facilities (2017 data)
3-14 Discussion:Industry Trends and Issues
Industry Growth and Adaptation
Cost Cutting Trends
Trends in Assay Development
Trends in Speeding Development and Approval Timelines
Trends in Bioprocessing Industry Desires for Improved Products and Services
Chapter 4: CAPACITY UTILIZATION
4-1 Capacity Utilization Trends
Capacity Utilization De?nitions
Relevance of Capacity Utilization Capacity Utilization in Biomanufacturing, 2018
Capacity Utilization Changes Since 2004
Average Growth Rate in Capacity Utilization, 2006-2018
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
Mammalian Cell Culture
Estimated Bioreactor Capacity Distribution, Biotherapeutic Developers and CMOs
Biopharmaceutical Developers/Manufacturers as CMOs
Microbial Fermentation Capacity
Cell or Gene Therapy Capacity
Yeast Production Capacity (2016)
Insect Cells Production Capacity (2016)
4-5 Discussion: Capacity Trends
4-6 Range of Titers with mAb Production
Annual mAb Titer Changes, 2008-2018
4-7 Discussion: Capacity and Industry Trends
Capacity Utilization
Chapter 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS
5-1 Current Capacity Constraints
Respondents Experiencing No Capacity Constraints
Respondents’ Perception of Capacity Constraints, 2004-2018
Perception of Capacity Constraints:Biotherapeutic Developers vs. CMOs
Capacity Constraints:U.S. vs. Western European Biotherapeutic Developers & CMOs
5-2 Expected Capacity Constraints 210 Respondents’ Expectations of Capacity Constraints by 2023
Expected Capacity Constraints by 2023: Comparing 2004 through 2018 Data
Expected Capacity Constraints by 2023:CMOs vs. Biotherapeutic Developers
Expected Capacity Constraints by 2023:U.S. vs. Western Europe
5-3 Factors Impacting Future Production Capacity
Factors Creating Future Capacity Constraints
Factors Creating Future Capacity Constraints, 2008 vs. 2018
Factors Creating Future Capacity Constraints:Biotherapeutic Developers vs. CMOs
CMOs’ Capacity Bottleneck Projections, in Retrospect
Biotherapeutic Developers’ Capacity Bottleneck Projections, in Retrospect
Factors Creating Capacity Constraints: U.S. vs. Western European Respondents
5-4 Key Areas to Address to Avoid Future Capacity Constraints
Analysis of Areas to Avoid Capacity Constraints: Changing Perspectives, 2006-2018
Key areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs
Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
5-5 Discussion
Overall Capacity Constraints
Chapter 6: FUTURE CAPACITY EXPANSIONS
6-1 Planned Future Capacity Expansions
Planned Future Capacity Expansions, 2009-2023
Planned Future Capacity Expansions by 2023; CMOs vs. Biotherapeutic Developers
Planned Five-Year Capacity Expansions; U.S. vs. Western European Manufacturers
Planned Future Capacity Expansions of >100%
Chapter 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING
Why Outsource?
Relating Outsourcing to Workforce Reduction
Strategic Manufacturing Planning
Future Projections
7-1 Current Outsourcing by Production System
Facilities Currently Outsourcing No Production (All Production ?In-house?), 2006-2018
7-2 Future Outsourcing
Biotherapeutic Developers’ Outsourcing, 2023 Projections, by System
Biotherapeutic Developers Outsourcing Some Production in 2023
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
Comparison of Biomanufacturers’ Outsourcing, (2010-2018)
Increased Outsourced Activities, 24-month Projections
Outsourcing Activities Projected at ?Signi?cantly Higher Levels’, Comparison of 2010-2018 Trends
Average Percentage of Activities Outsourced Today
Comparison of Outsourcing Activities, 2010-2018
Change in Spending on Outsourcing Activities
7-4 Critical Outsourcing Issues
Selecting a CMO:2018
Selecting a CMO, 2006-2018
Changes in Critical Issues when Considering a CMO, 2006-2018
7-5 CMOs’ Problems with Their Clients
7-6 Country Selections for International Outsourcing (Off-shoring) of Biomanufacturing
U.S. vs. Western European Respondents’ Outsourcing Destinations
Western European Respondents’ Outsourcing Destinations
5-Year Projection for Biomanufacturing International Outsourcing/Off-shoring
7-7 Offshoring Trends
5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Off-shoring
7-8 Discussion of Outsourcing and Offshoring
Selecting a CMO
Chapter 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING
8-1 Use of Disposables and Single-Use Systems
Disposables Applications in Biopharmaceutical Manufacturing
Trends in Disposable Applications: 2006-2018
Annual Growth Rate for Disposables Market Penetration/Usage
10-year Growth in Disposables Applications, Percentage-point Gains
Disposable Use by Stage of Production/Application
Use of Disposables:CMOs vs. Biotherapeutic Developers
8-2 Leachables and Extractables
Paying for L&E Testing, 2018 vs. 2016
8-3 Reasons for Increasing Use of Disposables & Single-Use Systems 326
Reasons for Increased Use of Disposables, 2006 through 2015
Single Most Critical Reason for Increasing the Use of Disposables
8-4 Factors That May Restrict Use of Disposables
Factors That May Restrict Use of Disposables: Trends 2006-2015
Factors that May Restrict Use of Disposables: CMO’s vs. Biotherapeutic Developers
Most Critical Reasons for Restricting Use of Disposables
Most Important Reasons for Not Increasing Use of Disposables, 2008-2018
Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developer vs. CMO
Top Reasons for Not Increasing the Use of Disposables: U.S. vs. Western Europe Respondents
8-5 Suppliers’ Expectations for Standards Setting Bodies
8-6 Need for Single-use Sensors, and Bioreactor Attributes
Single-Use Adoption Issues
Single-use Adoption Factors, U.S. vs. Western Europe
8-7 Satisfaction with Single-use Device Vendors
Single-Use Attribute Importance Analysis
Single-use Suppliers’ Delivery Problems, 2013-2018
8-8 Single Use Operations and Trends
Percentage of Unit Operations that are Single-Use
Distribution of Responses
8-9 Discussion of Single-use Bioprocessing
Single-use Advantages
Growth in the Use of Single-use Systems
Downstream Single-use Systems Use
CMOs’ Use of Single-use Equipment
Downstream Bottlenecks Persist
Modular:The Next Trend after Single-Use
Single-use Equipment Sourcing, Quality Issues, and L&E Testing
Chapter 9: DOWNSTREAM PURIFICATION
9-1 Impact of Downstream Processing on Capacity
Impact of Downstream Processing on Capacity, Biopharmaceutical Developers vs. CMOs
Impact of Downstream Processing on Capacity, U.S. vs. Western European Biomanufacturers
9-2 Speci?c Puri?cation Step Constraints
Changes in Impact on Capacity of Puri?cation Steps, 2008-2018
Speci?c Puri?cation Step Constraints, U.S. vs. Western European Biomanufacturers
9-3 Downstream Puri?cation Issues
Protein A and Alternatives
Changes in Perception of Protein A and Alternatives
Protein A Downstream Puri?cation Issues, U.S. vs. Western Europe
9-4 mAb Puri?cation Capacity Estimates
Upstream Production Titer vs. Max Capacity
9-5 New Downstream Processing Technologies
New Downstream Processing Solutions; 2010 – 2018
New Downstream Processing Technologies; Biotherapeutic Developers vs. CMOs
New Downstream Processing Technologies; U.S. vs. Western Europe
9-6 Improvements to Downstream Operations
Comparison of New Downstream Technology Implementation; Biomanufacturers vs. CMOs
Comparison of New Downstream Technology Investigations; U.S. vs. W. Europe vs. ROW
9-7 Discussion
Upstream Expression Titer Trends and Impact on Downstream Operations
Downstream Processing Solutions
Chapter 10: QUALITY ISSUES, BATCH FAILURES, AND PAT IN BIOPHARMACEUTICAL MANUFACTURING
10-1 Quality Initiative Implementation
Comparison of Quality Initiative Implementation, 2009 - 2018
Quality Initiatives Are Becoming Commonplace and the New Industry Norm
Challenges to Implementing PAT, QbD and other Quality Initiatives
10-2 Hurdles to Implementing Process Analytical Technology
Trends in PAT, 2008-2018
PAT Adoption Will Increase
10-3 Batch Failure Frequency in Biopharmaceutical Manufacturing
10-4 Primary Cause of Batch Failures, Percentages of Failures
Quality Problems Traced to Vendors
Process Information Needs and Value Drive Automation
10-5 Quality Problems in BioManufacturing Attributed to Vendors
10-6 Discussion
Supply Management Issues with Single-Use Systems
Chapter 11: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING
Introduction
No Substitute for on-the-job Training
11-1 Hiring Trends
Trends in New Hires, by Area; 2008 – 2018
11-2 Hiring in 2023: 5-year Trends
11-3 Hiring Challenges Today
Hiring Dif?culties; 2010 - 2018
11-4 Training in Biopharmaceutical Manufacturing
Changes in Training for New Manufacturing Employees, 2009-2018
11-5 Intersection of Biopharma and Small Pharma
Large-molecule Biomanufacturing Bene? tting from Small-molecule Experienc
11-6 Discussion
Options Developing for Bioprocessing Training
Continued Growth in Biopharmaceutical Manufacturing Jobs
Chapter 12: New Methods: Continuous and Process Intensification, Cell and Gen
Introduction
12-1 PerfusionAreas of Involvement
12-2 Trends in Fill-Finish and Related Bioprocessing Capacity
Analysis of US and European In-house Capacity and Capacity Utilization (2017 data)
Challenges in Estimating Fill-Finish Capacity
12-3 Current Fill-Finish Trends
Recent Industry Trends
Future Fill and Finish Trends
Suppliers’ Innovation Trends
Industry Capacity Data
New Technology Implementation in Fill-Finish (2017 data)
12-4 Discussion
Chapter 13: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES
Introduction
13-1 Demographics
Areas of Involvement
Location of Vendor Sales
Respondents’ Primary Job
13-2 Growth Rate of Sales by Suppliers
Average Industry Growth Rate, By Segment
Vendor Sales Growth Rates, by Industry Segment, 2007 to 2018
Supplier Annual Sales, Distribution
13-3 Discussion of Vendor and Industry Growth
13-4 Budget Issues and Problems Faced by Industry Suppliers
Budget Challenges in 2018
Vendor Average Budget Changes for 2009 -2018
Vendor Pricing Changes
Future Price Changes
Supplier Budget Issues
13-5 Cost Cutting Actions by Vendors
Cost Cutting Actions, By Segment
13-6 Problems Clients Have with Their Vendors
13-7 Vendor Expansion Plans
Biopharma Vendor Business Trends, 2010 vs. 2018
13-8 New Technology Areas in Development by Vendors
Suppliers’ Development of Innovative Technologies
Suppliers’ R&D Spending/Budgets for New Products/Services
13-9 Sales Staff Training 502 Days of Training Provided
Areas where Training May Help Sales Staff Perform, Trends 2010 - 2018
Clients’ Demands on Vendors
13-10 Biopharma Vendors’ Financial Outlook for 2018
13-11 Discussion of Biopharma Suppliers
Bioprocessing Vendors Will See Continued Market Growth
Single-use Systems Are Increasingly Driving Sales
Trends Favor Increased Vendor Sales
Vendors are Offering More Services, Going for Larger Sales
Biopharma Suppliers in Emerging Regions
FIGURES
Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 to 2018
Fig 0.2: Respondents’ Job Responsibilities, 2011 – 2018
Fig 0.3: Facility Location
Fig 0.4: Facility Location, by Region
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2018) Trends
Fig 0.6: Phase of Development of Surveyed Respondents, 2006-2018
Fig 0.7: Phase of Development of Surveyed Respondents, (U.S. vs Western Europe)
Fig 0.8: Distribution of Employees at Facility, and Organization
Fig 0.9: Distribution of Total Batches Run at Facility Last Year, by Scale of Production
Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity
Fig 0.11: Distribution of Largest STAINLESS Bioreactor Capacity
Fig 1.1: Number of Biosimilars in the U.S. Pipeline by Launchable Dates
Fig 1.2: Biosimilars Launchable Dates by Sum of Current Reference Products Sales ($millions)
Fig 1.3: FDA Approvals of New Biopharmaceutical Products 1982-2017
Fig 2.1: Cell Therapy, Gene Therapy, Gene Modi?ed Cell Therapy De?nitions
Fig 2.2: The Personalized Cell Therapy Challenge: A Race Against Time
Fig 2.3: Typical Lentivirus and AAV Process
Fig 2.4: High-Throughput Analytics
Fig 2.5: Focus on de?ning the operation model and ensuring stakeholder alignment can enable the move to an improved performance stage – the future stage
Fig 2.6: Changing the way culture is viewed
Fig 2.7: Example of an operational work? ow diagram for an upstream process
Fig 2.8: The triangle of pharmaceutical facility design
Fig 2.9: The QbD principles as laid out by ICH Q8 and Q11 as an enabler for a speedy and systematic development approach those results in a control strategy
Fig 2.10: Biopharma Bene? tting from Pharma Experience
Fig 2.11: Where Large Molecule BioFacilities Are Hiring From
Fig 2.12: Entry points and starting materials to CDMOs
Fig 2.13: Bene?ts of Disposables for CDMOs
Fig 2.14: Global Bioprocessing Operations Concentration (By Facility Index)
Fig 2.15: Distribution of Worldwide Capacity by Size Ranges
Fig 2.16: China Respondents’ Job Responsibilities
Fig 2.17: China Biopharmaceutical Facility Type
Fig 2.18:Top “Strength” Attributes Required for China’s Biologics Companies to Expand Globally
Fig 2.19: Top Attributes Chinese Companies Need to Compete Globally
Fig 2.20: What China Biopharma Needs to Compete Globally as a Biopharma Center in 10 Years
Fig 2.21: Chinese Bioprocessing Facilities: Primary Objectives for Biologics Production – 2016 vs 2026
Fig 3.1: SINGLE most important biomanufacturing trend or operational area, 2014-2018
Fig 3.2: Biomanufacturers’ Budget Shifts in 2018
Fig 3.3: Approximate Average Change in Biomanufacturers’ Budgets for 2018
Fig 3.4: Average Biomanufacturers’ Budget Change, 2009-2018
Fig 3.5: New Product Development-Upstream Focus Areas
Fig 3.6: New Product Development-Upstream Focus Areas (2010-2018)
Fig 3.7: New Product Development-Downstream Focus Areas
Fig 3.8: New Product Development-Downstream Focus Areas (2010-2018)
Fig 3.9: New Product Development – General Focus Areas
Fig 3.10: New Product Development – General Focus Areas, 2010-2018
Fig 3.11: New Product Development Areas of Interest: Biotherapeutic Developers vs. CMO’s
Fig 3.12: New Product Development Areas of Interest: U.S. vs. Western Europe and ROW
Fig 3.13: Factors in Biomanufacturing Performance Creating “Signi? cant” or “Some” Improvements
Fig 3.14: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2016
Fig 3.15: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2018
Fig 3.16: Biomanufacturing Assay ?Areas’ Urgently Requiring New, Improved Testing Methods, 2011 -2015, 2018
Fig 3.17: Biomanufacturing Assay ?Areas’ Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs (2016 data)
Fig 3.18: Perfusion Operations Issues: Perfusion vs. Batch-Fed Processes (2016 data)
Fig 3.19: Perfusion Operations Issues: Comparison 2010 - 2016 (2016 data)
Fig 3.20: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing
Fig 3.21: Facilities Evaluating CBP Technologies Over Next 12 months (Upstream vs. Downstream), 2016-2018
Fig 3.22: Continuous Bioprocessing and Process Intensi?cation
Fig 3.23: Future Cell and Gene Therapy Platforms
Fig 3.24: Cell and Gene Therapy Manufacturing Advancements in 5 Years (2023) to Avoid Bottlenecks
Fig 3.25: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure
Fig 3.26: Likelihood of Implementing Bioreactor, by Type (2017 data)
Fig 3.27: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2017
Fig 4.1: Capacity Utilization, By System
Fig 4.2: Capacity Utilization, By System, 2004-2018
Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2018
Fig 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs. CMOs
Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe
Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2018
Fig 4.8: Current Production Capacity Distribution, Microbial Fermentation
Fig 4.9: Current Production Capacity Distribution, Cell or Gene Therapy
Fig 4.10: Range of Titres for mAbs Obtained at Various Production Scales, Distribution
Fig 4.11: Average mAb Titre Trend 2008-2017
Fig 5.1: Capacity Constraints, by Stage of Production
Fig 5.2: Capacity Constraints, 2004 through 2018 ...205
Fig 5.3: Capacity Constraints Trends, 2004-2018
Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs ..208
Fig 5.5: Capacity Constraints, US vs. Western Europe .209
Fig 5.6: Expectations of Capacity Constraints; by Stage of Production; Five-year Projections
Fig 5.7: Expectations of Capacity Constraints: Five-year Projections Made in 2004-2018
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2023 (Trend Line)
Fig 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs. CMOs
Fig 5.10: Five-year Projections for Capacity Constraints:U.S. vs. Western Europe
Fig 5.11: Factors Creating Future Capacity Constraints, in 5 years
Fig 5.12A: Factors Creating Future Capacity Constraints, 2008-2018
Fig 5.12B: Factors Creating Future Capacity Constraints, 2008-2018
Fig 5.13: Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs
Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western European Biomanufacturers
Fig 5.15: Key areas to Address to Avoid Capacity Constraints
Fig 5.16A: Key areas to Address to Avoid Capacity Constraints; 2006-2018
Fig 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2018
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs
Fig 5.18: Key areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe
Fig 6.1: Industry Average Planned Production Increase by 2023
Fig 6.2: Planned Future Capacity Expansion: 5-year Estimates, 2009 - 2023
Fig 6.3: Planned Future Capacity Expansion: 5-year Estimates; Biotherapeutic Developers vs. CMOs
Fig 6.4: Planned Future Capacity Expansion: 5-year Estimates; U.S. vs. Western Europe
Fig 6.5: Percent of Respondents Projecting Production Increases of over 100% by 2023; 5-year Trend
Fig 7.1: Current Percent Production Outsourced; by System
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2018
Fig 7.3: Future Outsourcing: Percent Production Outsourced; by System, by 2023
Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2018
Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today
Fig 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 – 2018
Fig 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 – 2018
Fig 7.7: Outsourcing Activities Projected to be Done at ?Signi? cantly Higher Levels’ in 2 Years
Fig 7.8A: Outsourcing Activities Projected to be Done at ?Signi? cantly Higher Levels’ in 2 Years, 2010 - 2018 Trends
Fig 7.8B: Outsourcing Activities Projected to be Done at ?Signi? cantly Higher Levels’ in 2 Years, 2010 - 2018 Trends
Fig 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today
Fig 7.10A: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2018
Fig 7.10B: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2018
Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012 - 2018
Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations
Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2006-2018
Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2018, Percentage Point Differences
Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2018
Fig 7.16: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2018; 2010-2013
Fig 7.17: Country Selections as Destination for International Outsourcing of BioManufacturing (All Respondents)
Fig 7.18A: Percent U.S. Respondents Considering Country as ?Possible’ Outsourcing Destination, next ?ve years
Fig 7.18B:Percent U.S. Respondents Considering Country as ?Possible’ Outsourcing Destination, next ?ve years
Fig 7.19: Percent U.S. Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination, next ?ve years
Fig 7.20: Percent Western European Respondents Considering Country as ?Possible’ Outsourcing Destination
Fig 7.21: Percent European Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination
Fig 7.22: Percent of Biomanufacturing Operations Off-shored (International Outsourcing) within 5 Years
Fig 7.23: Percent Biomanufacturers Performing at Least “Some” International Outsourcing/Off-shoring during Next 5 Years (2011-2018)
Fig 7.24: Estimated % Operations Done as International Outsourcing/Off-shoring during Next 5 Years (2011-2018)
Fig 8.1: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture
Fig 8.2A: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture; 2006-2018
Fig 8.2B: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture; 2006-2018
Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2018
Fig 8.4: 10-Year Percentage-Point Change in First-Usage of Disposables, 2006-2018
Fig 8.5: Usage of Disposables in Biomanufacturing, by Stage of Manufacture (R&D - Commercial)
Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing; Biotherapeutic Developer vs. CMO
Fig 8.7: Value of Useable Leachables and Extractables Data (2016 Data)
Fig 8.8: Reasons for Increasing Use of Disposable System Components in 2015 (data from 2015)
Fig 8.9: Reasons for Increasing Use of Disposable System Components, 2006-2015
Fig 8.10: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2018
Fig 8.11: Reasons for Restricting Use of Disposables (2015 Data)
Fig 8.12: Factors Restricting Use of Disposables, 2006-2015 (2015 Data)
Fig 8.13: Top Reasons for Not Increasing Use of Disposables, 2018
Fig 8.14: Top Reasons for Not Increasing Use of Disposables, 2008-2018
Fig 8.15: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developer vs. CMO
Fig 8.16: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe
Fig 8.17: Suppliers’ Perception of Organizations Responsible for Establishing Standards for Single-use Devices (2017 data)
Fig 8.18:Single-use / Disposable Device Adoption Factors
Fig 8.19:Single-use / Disposable Device Adoption Factors; U.S. vs. Western Europe
Fig 8.20:Need for

List of Figures

0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 - 2020 ........3 Fig 0.2: Respondents’ Job Responsibilities, 2011-2020 ...........................................................5 Fig 0.3: Facility Location ...........................................................................................................6 Fig 0.4: Facility Location, by Region .........................................................................................7 Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2020) Trends ..............................9 Fig 0.6: Phase of Development of Surveyed Respondents, 2006-2020 .................................11 Fig 0.7: Phase of Development of Surveyed Respondents (U.S. vs. Western Europe) ..........12 Fig 0.8: Distribution of Employees at Facility, and Organization ............................................13 Fig 0.9: Distribution of Total Batches Run at Facility Last Year, by Scale of Production ........15 Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity .........................................16 Fig 0.11: Distribution of Largest STAINLESS Bioreactor Capacity ...........................................18 Fig 2.1: Long-term Effects of Covid-19 on Bioprocessing ......................................................53 Fig 2.2: Key Fears and Resolutions in Bioprocessing Post Covid-19 .....................................53 Fig 2.3: “New Normal” in Bioprocessing Post Covid-19 .........................................................54 Fig 2.4: FDA Approvals of New Biopharmaceutical Products 1982-2019 ..............................58 Fig 2.5: Regions of Approval Recipient Companies ...............................................................62 Fig 2.6: Leading Countries of Approval Recipient Companies ..............................................62 Fig 2.7A: Xcellerex XDR 2000L reactor .....................................................................................64 Fig 2.7B: Xcellerex XDUO 1000L mixer ....................................................................................64 Fig 2.8: Pall Allegro STR 50, Allegro STR 200, Allegro STR 500, Allegro STR 1000, and Allegro STR 2000 bioreactor .................................................65 Fig 2.9: The Pall iCELLis? 500+ system ................................................................................65 Fig 2.10: Repligen’s XCell ATF? Single-use System ................................................................67 Fig 2.11: Novasep BioSC? Pilot ...............................................................................................68 Fig 2.12: Amsphere...................................................................................................................68 Fig 2.13: Eshmuno? CP-FT Resin ............................................................................................69 Fig 2.14: CIMmultus? columns available with 1.3?m, 2?m, and 6?m channels .....................69 Fig 2.15: Repligen OPUS? Pre-packed Columns .....................................................................70 Fig 2.16: JSR Chromassette modules .......................................................................................71 Fig 2.17: Natrix membrane technology .....................................................................................71 Fig 2.18: Cytiva ?KTA? ready Single-use Systems .................................................................72 Fig 2.19: Cytiva ?KTATM ready and ?KTA ready XL .................................................................72 Fig 2.20: TangenX? SIUS? Single-use TFF Cassettes ...........................................................73 Fig 2.21: TangenX? SIUS? Gamma TFF cassettes ................................................................73 Fig 2.22: Cadence? Single-Pass TFF System and Module .....................................................74 Fig 2.23: Pellicon Capsule and Pellicon Cassette ....................................................................75 Fig 2.24: Planova? BioEX Virus Removal Filters and Planova? VFC System ........................76 Fig 2.25: FlexFactory.................................................................................................................77 Fig 2.26: BioContinuum? Buffer Delivery Platform ..................................................................77 Fig 2.27: Customer perspective................................................................................................83 Fig 2.28: CDMO Selection Criteria ............................................................................................83 Fig 2.29: Number of Biosimilars in the U.S. Pipeline by Launchable Dates .............................89 Fig 2.30: Biosimilars Launchable Dates by Sum of Current Reference Products Sales ($millions) .........................................................................................................89 Fig 2.31: The Biosimilars Pipeline by Phases of Development, 2013 and 2020 .......................90 Fig 2.32: Current Major Market vs. Other/International Market Biosimilar Pipelines .................90 Fig 2.33: Number of Companies Involved with Biosimilars by Their Location, 2013 and 2020 ...........................................................................................................91 Fig 2.34: Break-Down of WuXi Biologics Deals in 20185 .........................................................96 Fig 2.35: IND Application to the U.S. from China .....................................................................98 Fig 2.36: Drug Projects Applying for IND in the U.S./China8 ...................................................98 Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area, 2014-2020 ...............................................................................................................105 Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (2020) ..........................................................................................................107 Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (Biomanufacturers vs. CMOs) .....................................................................109 Fig 3.4: Biomanufacturers’ Budget Shifts in 2020 .................................................................111 Fig 3.5: Approximate Average Change in Biomanufacturers’ Budgets (2020) ....................112 Fig 3.6: Average Biomanufacturers’ Budget Change, 2009-2020 ........................................115 Fig 3.7. New Expenditures Focus Areas ...............................................................................116 Fig 3.8: New Product Development-Upstream Focus Areas, 2020 ......................................120 Fig 3.9: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2020) .....................................................122
Fig 3.10: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2020 ................................................................124 Fig 3.11: New Product Development-Downstream Focus Areas (2010-2020) .......................126 Fig 3.12: New Product Development – General Focus Areas, Biomanufacturers & CMOs, 2020 ............................................................................128 Fig 3.13: New Product Development – General Focus Areas, 2010-2020 .............................130 Fig 3.14: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs ....................................................................................135 Fig 3.15: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe and ROW .........................................................................137 Fig 3.16: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2016, 2019-2020 ..........................................................................139 Fig 3.17: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography (2011-2016, 2019-2020) ..........................................................................................141 Fig 3.18: Factors that will have the greatest impact on reducing your cost of goods for biotherapeutic products ..........................................................................142 Fig 3.19: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2020 ....144 Fig 3.20: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods, 2011 -2015, 2018-2019 ...............................................146 Fig 3.21: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs (2019 data) ....................................148 Fig 3.22: Likelihood of Implementing Bioreactor, by Type, 2017 ...........................................151 Fig 3.23: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2017 ....152 Fig 3.24: Largest Commercial-Scale Bioreactor Expected in the Next 2 Years (2022) ..........153 Fig 4.1: Capacity Utilization, By System, 2020 .....................................................................162 Fig 4.2: Capacity Utilization, By System, 2004-2020 ............................................................163 Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2020 .................................................164 Fig 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs. CMOs, 2020 .........166 Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe, 2020 ............................168 Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture ........................170 Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2020 ..................172 Fig 4.8: Bioprocessing Concentration, Capacity Data, 2020 ...............................................173 Fig 4.9: Current Production Capacity Distribution, Microbial Fermentation .........................185 Fig 4.10: Current Production Capacity Distribution, Cell or Gene Therapy ............................187 Fig 4.11: Range of Titers for mAbs Obtained at Various Production Scales, Distribution ......190 Fig 4.12: Average mAb Titer Trend 2008-2020 ......................................................................191 Fig 5.1: Capacity Constraints, by Stage of Production .........................................................201 Fig 5.2: Capacity Constraints, 2004-2020 ............................................................................203 Fig 5.3: Capacity Constraints Trends, 2004-2020 ................................................................204 Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs ..................................206 Fig 5.5: Capacity Constraints, U.S. vs. Western Europe ......................................................207 Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections ...............................................................................................209 Fig 5.7: Expectations of Capacity Constraints: Five-year Projections Made in 2004-2020 ..211 Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2025 (Trend Line) ....................................................................................212
Fig 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs. CMOs (2025) ...................................................................................214 Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe (2025) ..215 Fig 5.11: Factors Creating Future Capacity Constraints in Five Years (by 2025) ...................217 Fig 5.12A: Factors Creating Future Capacity Constraints, 2008-2020 .....................................219 Fig 5.12B: Factors Creating Future Capacity Constraints, 2008-2020 .....................................219 Fig 5.13: Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs ..............................................................................................222 Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western European Biomanufacturers ....................................................................................226 Fig 5.15: Key Areas to Address to Avoid Capacity Constraints .............................................228 Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints; 2006-2019 ..........................230 Fig 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2020 ..........................231 Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs ..............................................................................................233 Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe ....235 Fig 6.1: Industry Average Planned Production Increase by 2025 ........................................244 Fig 6.2: Planned Future Capacity Expansion: Five-Year Estimates, 2009–2025 ..................245 Fig 6.3: Planned Future Capacity Expansion: Five-year Estimates: Biotherapeutic Developers vs. CMOs ......................................................................246 Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates: U.S. vs. Western Europe ..........................................................................................248 Fig 6.5: Percentage of Respondents Projecting Production Increases over 100% by 2025: Five-year Trend .......................................................................249 Fig 7.1: Current Percent Production Outsourced; by System ..............................................257 Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2020 ......................................................................................259 Fig 7.3: Future Outsourcing: Percent Production Outsourced; by 2025, by System ............261 Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2020 ......................263 Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today ...............265 Fig 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010-2020 .......................................................................................267 Fig 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010-2020 ....................................................................................................268 Fig 7.7: Outsourcing Activities Projected to be Done at “Significantly Higher Levels” in 2 Years ....................................................................................................270 Fig 7.8A: Outsourcing Activities Projected to be Done at “Significantly Higher Levels” in 2 Years, 2010-2020 Trends .....................................................................272 Fig 7.8B: Outsourcing Activities Projected to be Done at “Significantly Higher Levels” in 2 Years, 2010-2020 Trends .....................................................................273 Fig 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today ..............275 Fig 7.10A: Estimated Average Percent of Activity Outsourced by Facilities, 2010-2020 .........276 Fig 7.10B: Estimated Average Percent of Activity Outsourced by Facilities, 2010-2019 .........277 Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012-2020 .........279 Fig 7.12: Outsourcing Issues: Biomanufacturing by Contract Manufacturing Organizations (2018 data) .......................................................................................281 Fig 7.13: Important Outsourcing Issues: Biomanufacturing by Contract Manufacturing Organizations, Trends 2006-2018 ...................................................283 Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2018, Percentage Point Differences ..................................................................................285 Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with t heir CMOs, 2018 ......................................................................................................287 Fig 7.16: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2010-2013; 2018 ..........................................................................................288 Fig 7.17: Country Selections as Destination for International Outsourcing of Biomanufacturing (All Respondents), in the Next Five Years (2025) .......................291 Fig 7.18A: Percent U.S. Respondents Considering Country as “Possible” Outsourcing Destination, over Next Five Years (2025) ............................................293 Fig 7.18B: Percent U.S. Respondents Considering Country as ?Possible’ Outsourcing Destination, over Next Five Years (2025) ............................................294 Fig 7.19: Percent U.S. Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination, Next Five Years, 2024 ..............295 Fig 7.20A: Percent Western European Respondents Considering Country as “Possible” Outsourcing Destination, Next Five Years (2025) ....................................................298 Fig 7.20B: Percent Western European Respondents Considering Country as ?Possible’ Outsourcing Destination, Next Five Years (2025) ....................................................299 Fig 7.21: Percent European Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination, over Next Five Years (2025) ....300 Fig 7.22: Percent of Biomanufacturing Operations Off-shored (International Outsourcing) within 5 Years (2025) .........................................................................302 Fig 7.23: Percent Biomanufacturers Performing at Least “Some” International Outsourcing/Off-shoring during Next 5 Years (2011-2020) .....................................304 Fig 7.24: Estimated % Operations Done as International Outsourcing/Off-shoring during Next 5 Years (2011-2020) .............................................................................306 Fig 7.25 Factors Considered MOST IMPORTANT for Outsourcing to New Regions, such as China, India, and Brazil ..............................................................................307 Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture ................................................................................................317 Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2020 .............................................................................319 Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2020 .............................................................................320 Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2020 .........................................322 Fig 8.4: 14-Year Percentage-Point Change in First Usage of Disposables, 2006-2020 .......324 Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture (R&D–Commercial) ..................................................................................................326 Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing: Biotherapeutic Developers vs. CMOs ..............................................................................................328 Fig 8.7: Willingness to Pay for Useable Leachables and Extractables Data (2018 Data) ....330 Fig 8.8: Single Most Critical Reason for Increasing Use of Disposables, 2009- 2018 .........332 Fig 8.9: Top Reasons for Not Increasing Use of Disposables, 2019 ....................................334 Fig 8.10A: Top Reasons for Not Increasing Use of Disposables, 2008-2019 ...........................336 Fig 8.10B: Top Reasons for Not Increasing Use of Disposables, 2008-2019 ...........................337
Fig 8.11: Single-use Recycling; Respondents’ Desires for Disposal vs. Actual Disposal Process .....................................................................................................338 Fig 8.12: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developers vs. CMOs (2019 data) ..........................................................................340 Fig 8.13: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe (2019 data) ......................................................................342 Fig 8.14: Suppliers’ Perception of Organizations Responsible for Establishing Standards for Single-use Devices (2017 data) ........................................................344 Fig 8.15: Single use / Disposable Device Adoption Factors (2018 data) ...............................345 Fig 8.16: Single use / Disposable Device Adoption Factors; U.S. vs. Western Europe (2018 data) ......................................................................346 Fig 8.17: Need for Improved Single-Use Sensors, 2012-2017, 2019 (2019 data) .................348 Fig 8.18: Single-Use Product Vendor Satisfaction Factors, 2008-2020 ..................................350 Fig 8.19: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction .......352 Fig 8.20: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction, 2013-2020.......................................................................354 Fig 8.21: Estimated Percentage of Facilities’ Unit Operations that Are “Single-Use” (2014-2020) ........................................................................................356 Fig 8.22: Distribution of Responses, % Single-Use Devices in Biomanufacturing .................357 Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2020 ......................371 Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biotherapeutic Developers vs. CMOs ..............................................................................................372 Fig 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe ..........................................................................................374 Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps ............376 Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at “Significant” or “Severe” Constraints, 2008-2020 .............................................................................378 Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe .......................379 Fig 9.7: Issues Regarding Protein A Usage ..........................................................................380 Fig 9.8: Issues Regarding Protein A Usage, 2009-2017, 2020 ............................................382 Fig 9.9: Issues Regarding Protein A Usage: U.S. vs. Western Europe ................................383 Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses, 2014 -2016, 2018-2020 Data) ..................................................................................385 Fig 9.11: Bioreactor Yield at Which DOWNSTREAM Purification Train Becomes Bottlenecked ............................................................................................386 Fig 9.12: New Downstream Processing Solutions, 2020 ........................................................388 Fig 9.13A: New Downstream Processing Solutions Comparison: 2010-2020 ..........................390 Fig 9.13B: New Downstream Processing Solutions Comparison: 2010-2020 ..........................391 Fig 9.14: New Downstream Processing Solutions: Biotherapeutic Developers vs. CMOs (2020) ...................................................................................393 Fig 9.15: New Downstream Processing Solutions: U.S. vs. Western Europe .........................395 Fig 9.16: Improving Downstream Operations, 2011-2019 (2019 data) ..................................397 Fig 9.17: Improving Downstream Operations: Biomanufacturers vs. CMOs (2019 data) ......399 Fig 9.18: Improving Downstream Operations (U.S. vs. Western Europe vs. ROW) (2019 data)...............................................................................................................401
Fig 10.1: Quality Initiative Implemented Currently, or within Next 12 Months (2018 DATA) ...409 Fig 10.2: Quality Initiative to be Implemented in “Next 12 Months,” Comparing 2009-2018 (2018 data) ............................................................................................411 Fig 10.3: Hurdles Hindering Implementation of PAT (2008-2019) (2019 data) ......................414 Fig 10.4: Batch Failure Frequency Distribution, 2009-2020 ...................................................418 Fig 10.5: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2020 .....420 Fig 10.6: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009-2020 (Commercial Manufacture) ....................................................................423 Fig 10.7: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009-2020 (“Clinical” Scale) ....................................................................................424 Fig 10.8: Quality Problems Traced to Vendors; 2008 – 2018 .................................................428 Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2020) ..........................................433 Fig 11.2: Estimated Hiring, by Area, 2008-2019 .....................................................................435 Fig 11.3: New Hires in Biopharmaceutical Manufacturing (2025) ..........................................436 Fig 11.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations ..................438 Fig 11.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations; 2010-2020 ................................................................................................................440 Fig 11.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations; 2010-2020 ................................................................................................................441 Fig 11.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe ..........................................................................................443 Fig 11.7: Training for New Operations/Manufacturing Employees (2018 data) .....................445 Fig 11.8: Average Annual Changes in Training for New Operations/Manufacturing Employees, 2009-2018 ............................................................................................446 Fig 12.1: Changing the way culture is viewed ........................................................................452 Fig 12.2: Example of an operational workflow diagram for an upstream process .................453 Fig 12.3: Triangle of Pharmaceutical Facility Design ..............................................................455 Fig 12.4: The QbD principles as laid out by ICH Q8 and Q11 ...............................................456 Fig 12.5: Future of Continuous Bioprocessing and Process Intensification ...........................458 Fig 12.6: Perfusion Operations Issues: Comparison 2010 - 2016 (2016 data) .......................461 Fig 12.7: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing ...463 Fig 12.8: Facilities Evaluating CBP Technologies Over Next 12 months (Upstream), 2016-2020 ................................................................................................................465 Fig 12.9: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream), 2016-2020 ................................................................................................................466 Fig 12.10: Future Cell and Gene Therapy Platforms (2019 data) .............................................470 Fig 12.11: Cell and Gene Therapy Manufacturing Advancements in 5 Years (2023) to Avoid Bottlenecks (2018 data) .................................................................471 Fig 12.12: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure....................................................................................472 Fig 12.13: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019 vs. 2020) ..........................................................473 Fig 12.14: Cell and Gene Therapy Plans for GMP and Commercial Manufacturing ................475 Fig 12.15: Cell and Gene Therapy Capacity Plans for In-House Bioprocessing Facilities Next Five Years (2025) ..............................................................................476 Fig 13.1: Area of Biopharmaceutical Involvement, Vendor ....................................................480 Fig 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010-2020 ..............481 Fig 13.3: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008-2020...........................................................................................483 Fig 13.4: Respondents’ Primary Job Function ........................................................................484 Fig 13.5: Average Annual Vendor Sales Growth Rate, 2007-2020 .........................................485 Fig 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution ..................486 Fig 13.7: Average Annual Vendor Segment Sales Growth Rates, 2020 .................................487 Fig 13.8: Average Annual Vendor Sales Growth Rate, 2007-2020, by Segment ...................488 Fig 13.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2020 .....490 Fig 13.10: Vendors’ Average Budget Change, 2020 ................................................................493 Fig 13.11: Vendors’ Average Budget Change for 2009-2020, Summary .................................494 Fig 13.12: Vendors’ Average Pricing Changes, Last Year .................................................... Fig 13.13: Vendors’ Average Pricing Changes, 2009-2019 Actual and 2020 projected ..........496 Fig 13.14: Actions undertaken to reduce overall costs, prior 12 months, 2011-2017 (2017 data)...............................................................................................................499 Fig 13.15: Actions undertaken to reduce overall costs in past 12 months, By Segment (2017 data)...............................................................................................................500 Fig 13.16: (See Fig 10.8; recap): Quality Problems Traced to Vendors (2018 data) ...............502 Fig 13.17: Biopharma Business and Marketing Plans, 2020 ....................................................504 Fig 13.18: Biopharma Business and Marketing Plans, 2010-2020 ...........................................506 Fig 13.19A: Top New Technologies or New Product Development Areas .................................508 Fig 13.19B: Top New Technologies or New Product Development Areas .................................509 Fig 13.20: Plans for Launching Significant, Truly Novel Bioprocessing Advances (2017 data)...............................................................................................................511 Fig 13.21: R&D Spending/Budgets for New Products/Services, 2020 .....................................512 Fig 13.22: Days of Sales Staff Training Provi