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19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

  • Report
  • 520 Pages
  • April 2022
  • Region: Global
  • Bioplan Associates Inc
  • ID: 5118512

This report’s ~500 pages of data-rich analysis will help improve your decision-making in biomanufacturing operations, with an in-depth analysis of capacity, production trends, benchmarks, and much more.

Coverage

  • In-depth analysis of key data, capacity, production trends, and benchmarks
  • Budget trends and impact of the current economic environment
  • Downstream purification problems and issues
  • Current and projected industry bottlenecks
  • Capacity utilization and current production levels
  • Capacity bottlenecks - what’s being done to resolve
  • Production trends and Outsourcing trends
  • International offshoring through 2027
  • Range of titers, growth
  • Disposables: Spending growth; downstream uses; L&E’s; reasons for increasing/ restricting; budget increases; vendor satisfaction
  • Batch failure rates & trends
  • Selecting a CMO - Problems & solutions
  • Quality management & PAT implementation
  • Hiring and employment growth
  • Supplier growth rates, and much more
  • Compare 140+ Biomanufacturers vs CMOs; U.S. vs. European & Global Biomanufacturing

Table of Contents

CHAPTER 0: DEMOGRAPHICS
Introduction
0-1 Respondents’ Area of Involvement
0-2 Respondents’ Qualifications
0-3 Facility Locations
0-4 Areas 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
1-1 Sector/Market Overview
“Biopharmaceutical:” The Definition Used Here
The Biopharma(ceutical) Industry is Losing its Core Identity
The Industry Continues to Mature
Pharmaceutical Industry Dependence on Biopharmaceuticals
1-2 Biopharmaceutical Industry Status and Market Trends
Bioprocessing is Increasing in Developing Countries
1-3 Pharma Industry is Shifting to Biopharmaceuticals
1-4 Global Biopharmaceutical Market Trends
Overall Health of the Biopharmaceutical Sector
U.S. Industry Leadership Continues
Biopharmaceuticals in the Rest-of-the-World
Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
1-5 Biopharmaceutical Markets by Product Class
Monoclonal Antibodies (mAbs) are the Leading Product Class
1-6 Animal Derived Products and Biopharmaceuticals
1-7 Future Trends in the Biopharmaceutical Industry

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE
2-1 Case Study: Expanding Production Capacity for High Producing mAb Processes
2-2 Case Study: A Raw Material Issue Derails PPQ and
Causes a Two-Year Process Delay
2-3 Case Study: Overcoming Materials Supply Challenges
2-4 Case Study: Selecting the Right Facility Design and Technology to Support AAV Production at Scale
2-5 Case Study: Tech Options to Improve Low-Producing Biotherapeutic Processes.
2-6 Case Study: Bridging the Cell and Gene Therapy Technology Gap
2-7 Case Study: Implementation of a Continuous Technology Strategy to
Support Therapeutic Protein Production
2-8 Case Study: Build or Buy Decision for Cell and Gene Therapy Companies
That Must Be Experts in Multiple Technologies
2-9 Case Study: Scale-Up Challenges of E. Coli Protein Production Process
2-10 Case Study: Increased Bioburden Excursions in an Aging Facility
2-11 Case Study: Navigating and Making Better
Technology Decisions
2-12 Getting to Yes: How Major Changes at Phase Can Make an Unapprovable Product Approvable
2-13 Lower Operational Cost by Reducing
GMP Sampling

CHAPTER 3: EMERGING TECHNOLOGIES
Industry Trends in 2022
Introduction
3-1 Bioprocessing Innovations Needed in 2022
Bioprocessing Innovations Most Needed
Novel Bioprocessing Systems/Innovations
Novel Bioprocessing Systems/Innovations, Biomanufacturers vs. CMOs
3-2 Operational Changes in 2022
Operational Changes: 2010 - 2012, 2022
Operational Changes: Biotherapeutic Developers vs. CMOs
Operational Changes: U.S. vs. Western Europe
3-3 Budget Issues in 2022
Budget Change Comparisons
Top Bioprocessing Budget Expenditures
3-4 New Bioprocessing Products Development Opportunities in 2022
Upstream New Product Areas of Interest
Trends: Upstream New Product Areas of Need 2010-2022
Downstream New Product Areas of Need
Trends: Downstream New Product Areas of Interest, 2010-2022
Other General New Product Areas of Need
Trends: Other General New Product Areas of Need 2010-2022
Innovations in Single-use/Disposable Equipment .
Innovations in Continuous Bioprocessing .
Other Areas for Innovation
New Product Development Areas: Biomanufacturers vs. CMOs
New Product Development Areas: U.S. vs. Western Europe and ROW
3-5 Cost-Cutting Actions & Development Timelines
Cost-Cutting Changes: Specific to Outsourcing
Factors Impacting Reduction in Cost of Goods
3-6 Average Cost per Gram Recombinant Protein
3-7 Assay Development
Biomanufacturing Assay Required; Biomanufacturers vs. CMOs
3-8 Selecting and Purchasing Commercial-Scale Bioreactors
Largest Stainless Steel Bioreactor Capacity Purchase in Two Years (2024)
Largest Single-Use Bioreactor Capacity Purchase in Two Years (2024)
3-9 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
Discussion of Needed Single-use Innovations

CHAPTER 4: CAPACITY UTILIZATION.
4-1 Capacity Utilization Trends
Capacity Utilization Definitions
Relevance of Capacity Utilization
Capacity Utilization in Biomanufacturing, 2022
Capacity Utilization Changes, 2006-2022
Average Growth Rate in Capacity Utilization, 2006-2022
4-2 Capacity Utilization: Biomanufacturers vs. CMOs
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
The Largest Capacity Facilities
Biopharmaceutical Capacity Expansions Continue
Biopharmaceutical Developers/Manufacturers as CMOs
Major CMOs in Terms of Facilities and Capacity
Microbial Fermentation Capacity
Cell and Gene Therapy Capacity
4-5 Range of Titers with mAb Production
Annual mAb Titer Changes, 2008-2022
4-6 Discussion: Capacity and Industry Trends
Capacity Utilization
Over Capacity Trends

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS AND QUALITY FACTORS
5-1 Current Capacity Constraints
Respondents Experiencing No Capacity Constraints
Respondents’ Perception of Capacity Constraints, 2004-2022
Perception of Capacity Constraints: Biomanufacturers vs. CMOs
Capacity Constraints: U.S. vs. Western European Biotherapeutic
Developers & CMOs
5-2 Expected Capacity Constraints
5-3 Factors Impacting Future Production Capacity
Factors Creating Future Capacity Constraints, 2008-2022
Factors Creating Future Capacity Constraints: Biomanufacturers vs. CMOs
CMO 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, 2006-2022
Key areas to Address to Avoid Capacity Constraints;
Biomanufacturers vs. CMOs
Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
5-5 Batch Failures in Biopharmaceutical Manufacturing
Primary Cause of Batch Failures, Percentages of Failures
5-6 Automation Implementation
Demand for Automation
Automation Implementation
Comparison of Implementation Plans 2009-2013, 2022
5-7 Quality Problems in Biomanufacturing Attributed to Vendors
Quality Problems Traced to Vendors
Global Quality Supply Management
Global Quality Supply Management, 2011-2013, 2022
Global Quality Supply Management Biotherapeutic Developers vs. CMOs
U.S. vs. W. Europe Global Quality Supply Management
Addressing Supply Chain Security
5-8 Discussion: Industry Trends
Overall Capacity Constraints

CHAPTER 6: FUTURE CAPACITY EXPANSIONS
6-1 Planned Future Capacity Expansions
Planned Future Capacity Expansions, 2009-2027
Planned Future Capacity Expansions by 2027: CMOs vs. Biotherapeutic
Developers
Planned Five-Year Capacity Expansion: U.S. vs. Western European
Manufacturers
Planned Future Capacity Expansions

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”),
2006-2022
7-2 Future Outsourcing
Biotherapeutic Developers’ Outsourcing, 5-Year (2027) Projections, by System
Biotherapeutic Developers Outsourcing Some Production in 2027
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
Comparison of Biomanufacturers’ Outsourcing, (2010-2022)
Increased Outsourced Activities, 24-month Projections
Outsourcing Activities Projected at ‘Significantly Higher Levels,’ Comparison of 2010-2022 Trends
Average Percentage of Activities Outsourced Today, 2022
Comparison of Outsourcing Activities, 2010-2022
Change in Spending on Outsourcing Activities
7-4 Critical Outsourcing Issues
Selecting a CMO: (2018 data)
Selecting a CMO (2022 update)
Changes in Critical Issues when Considering a CMO
7-5 CMOs’ Problems with Their Clients
7-6 Country Selections for International Outsourcing (Offshoring) of Biomanufacturing
Country Selections for International Outsourcing (Offshoring) of
Biomanufacturing, Over Five Years (2016-2022)
U.S. vs. Western European Respondents’ Outsourcing Destinations
Western European Respondents’ Outsourcing Destinations
7-7 Offshoring Trends
5-Year Projection for Biomanufacturing International Outsourcing/Offshoring
5-Year Projection for Biomanufacturing International Outsourcing/Offshoring (2011-2022)
5-Year Projection for Average Percentages of Biomanufacturing International
Outsourcing/Offshoring (2011-2022)
Outsourcing to New Regions (2020 data)
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: 2006-2022
Average Annual Growth Rate for Disposables: Market Penetration/Usage
16-Year Average Growth in Disposable Applications, Percentage-Point Gains
Disposable Use by Stage of Production/Application
Use of Disposables: CMOs vs. Biotherapeutic Developers
8-2 Leachables and Extractables
8-3 Reasons for Increasing Use of Disposables & Single-Use Systems
Single Most Critical Reason for Increasing the Use of Disposables (2018)
8-4 Factors That May Restrict Use of Disposables
Most Critical Reasons for Restricting Use of Disposables
Most Important Reasons for Not Increasing Use of Disposables, 2008-2019
Most Important Reasons for Restricting Use of Disposables:
Biotherapeutic Developers vs. CMOs
Top Reasons for Not Increasing the Use of Disposables: U.S. vs.
Western Europe
Cell-Culture Problems due to Single-Use Devices
Cell-Culture Problems due to Single-use Devices, 2022 vs. 2021
Recycling of Disposables
8-5 Single-Use Adoption Issues
Single-Use Adoption Issues (2018)
Single-use Adoption Factors, U.S. vs. Western Europe (2018 data)
8-6 Need for Single-use Sensors, and Bioreactor Attributes
Single-Use Sensor Technologies (2012-2017, 2019) Data
8-7 Satisfaction with Single-Use Device Vendors
Single-Use Attribute Importance Analysis
Single-Use Suppliers’ Delivery Problems, 2013-2022
8-8 Single-Use Operations and Trends
Percentage of Unit Operations that are Single-Use
Distribution of Responses
8-9 Discussion: Single-use Bioprocessing
Single-use Advantages
Growth in the Use of Single-use Systems
Downstream Single-use Systems Usage
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
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 Specific Purification Step Constraints
Changes in Impact on Capacity of Purification Steps, 2008-2022
Specific Purification Step Constraints, U.S. vs. Western European
Biomanufacturers
9-3 Downstream Purification Issues
Protein A and Alternatives
Changes in Perception of Protein A and Alternatives
Protein A Downstream Purification Issues, U.S. vs. Western Europe
9-4 mAb Purification Capacity Estimates
Upstream Production Titer vs. Max Capacity
9-5 New Downstream Processing Technologies
New Downstream Processing Solutions; 2010-2022
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 Industry Trends
Upstream Expression Titer Trends and Impact on Downstream Operations
Downstream Processing Solutions
CHAPTER 10: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING
Introduction
No Substitute for on-the-job Training
10-1 Hiring Trends
Trends in New Hires, by Area; 2008-2022
10-2 Hiring in 2027: 5-year Trends
10-3 Hiring Challenges Today
Hiring Difficulties; 2010-2022
U.S. and Western Europe Hiring Difficulties
10-4 Training in Biopharmaceutical Manufacturing
Changes in Training for New Manufacturing Employees, 2009-2018
10-5 Discussion: Training Industry Trends
Options Developing for Bioprocessing Training
Continued Growth in Biopharmaceutical Manufacturing Jobs

CHAPTER 11: NEW METHODS: CONTINUOUS AND PROCESS INTENSIFICATION, CELL AND GENE THERAPIES
Introduction to Continuous Processing
Adoption of Continuous Bioprocessing
Implementation of Continuous Bioprocessing
11-1 Continuous Bioprocessing and Process Intensification
Perfusion vs. Batch Fed Bioprocessing, 2021 vs. 2022
11-2 Perfusion Operations and Continuous Bioprocessing Operational Issues
Perfusion vs. Batch Fed Bioprocessing
Evaluating or Considering CBP technologies (Upstream) Over the Next 12 Months
Evaluating or Considering CBP technologies (Downstream) Over the Next 12 Months
11-3 Cell and Gene Therapy Platforms
Cell and Gene Therapy Manufacturing Advancements (2018 data)
Cell and Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure
Cell and Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2022)
Cell and Gene Therapy GMP and Commercial Manufacturing
Cell and Gene Therapy GMP and Commercial Manufacturing (2020-2022)
Cell and Gene Therapy Capacity Plans for In-House Bioprocessing Facilities
Cellular and Gene Therapies Commercial Manufacturing Scales
11-4 Discussion
Continuous Bioprocessing and Perfusion Trends
Perfusion: Progress in Adoption

CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES
Introduction
12-1 Demographics
Areas of Involvement
Location of Vendor Sales
Respondents’ Primary Job
12-2 Growth Rate of Sales by Suppliers
Average Industry Growth Rate, By Segment
Supplier Annual Sales, Distribution
12-3 Budget Issues and Problems Faced by Industry Suppliers
Budget Challenges in 2022
Vendor Average Pricing Changes
12-4 Problems Clients Have with Their Vendors
Problems Faced by Vendors’ Clients
Quality Problems Traced to Vendors
12-5 Impacts of Covid-19 on Suppliers’ Activities
Impact of COVID-19 Pandemic on Vendors, Inflation (2022 vs. 2021)
Biopharma Vendor Business Trends
Biopharma Vendor Business Trends, 2010-2022
12-6 New Technology Areas in Development by Vendors
Suppliers’ R&D Spending/Budgets for New Products/Services
12-7 Sales Staff Training
Days of Training Provided by Suppliers
Areas where Training May Help Sales Staff Perform, Trends 2010-2022
Clients’ Demands on Vendors
12-8 Biopharma Vendors’ Financial Outlook for 2021
12-9 CMO Pricing Changes for Biopharmaceutical Services .
12-10 Discussion: Biopharma Suppliers
Vendor and Industry Growth
Bioprocessing Vendors Will See Continued Market Growth
Single-use Systems Continue to Drive 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 - 2022
Fig 0.2: Respondents’ Job Responsibilities, 2011-2022 .
Fig 0.3: Facility Location, 2022 .
Fig 0.4: Facility Location, by Region .
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2022) Trends
Fig 0.6: Phase of Development of Surveyed Respondents, 2006-2022 .
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 2.1 Continuous Manufacturing Concept: Transition from Batch to Continuous .
Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area, 2014-2022 .
Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (2022)
Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (2022) (Biomanufacturers vs. CMOs)
Fig 3.4: Operational Changes Due to Recent Global Economics (2022) .
Fig 3.5: Operational Changes Due to Recent Global Economics, 2010 - 2012, 2022 .
Fig 3.6: Operational Changes Due to Recent Global Economics; Biotherapeutic Developers vs. CMOs
Fig 3.7: Operational Changes Due to Recent Global Economics; U.S. vs. Western Europe
Fig 3.8: Biomanufacturers’ Budget Shifts, 2022 .
Fig 3.9: Approximate Average Change in Biomanufacturers’ Budgets (2022)
Fig 3.10: Average Biomanufacturers’ Budget Change, 2009-2022
Fig 3.11: New Expenditures Focus Areas (2022) .
Fig 3.12: New Product Development-Upstream Focus Areas, 2022
Fig 3.13: Upstream New Product Development Areas Cited Where Suppliers Should
Focus Development Efforts (2010-2022) .
Fig 3.14: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2022
Fig 3.15: New Product Development-Downstream Focus Areas (2010-2022) .
Fig 3.16: New Product Development - General Focus Areas, Biomanufacturers & CMOs, 2022 .
Fig 3.17: New Product Development - General Focus Areas, 2010-2022 .
Fig 3.18: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs
Fig 3.19: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe and ROW .
Fig 3.20: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2016, 2019-2022
Fig 3.21: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography (2011-2016, 2019-2022)
Fig 3.22: Factors That Will Have the Greatest Impact on Reducing Your Cost of Goods for Biotherapeutic Products .
Fig 3.23: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2022
Fig 3.24: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods, 2011-2015, 2018-2019
Fig 3.25: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs (2019 data)
Fig 3.26: Largest Commercial-Scale Bioreactor Expected in the Next 2 Years (2024)
Fig 3.27: Top Options for Bioreactor Platforms at Commercial Scale
Fig 3.28: Distribution of Largest Stainless Steel Bioreactor Capacity (Next 2 Years)
Fig 3.29: Distribution of Largest Single-use Bioreactor Capacity (Next 2 Years) .
Fig 4.1: Capacity Utilization, By System, 2022 .
Fig 4.2: Capacity Utilization, By System, 2006-2022
Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2022 .
Fig 4.4: Capacity Utilization, By System, Biomanufacturers vs. CMOs, 2022
Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe, 2022
Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2010-2022
Fig 4.8: Bioprocessing Concentration, Capacity Data, 2022 .
Fig 4.9: Current Production Capacity Distribution, Microbial Fermentation .
Fig 4.10: Current Production Capacity Distribution, Cell Therapy
Fig 4.11: Current Production Capacity Distribution, Gene Therapy .
Fig 4.12: Range of Titers for mAbs Obtained at Various Production Scales, Distribution
Fig 4.13: Average mAb Titer Trend 2008-2022
Fig 5.1: Capacity Constraints, by Stage of Production .
Fig 5.2: Capacity Constraints, 2004-2022
Fig 5.3: Capacity Constraints Trends, 2004-2022
Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs
Fig 5.5: Capacity Constraints, U.S. vs. Western Europe
Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections .
Fig 5.7: Expectations of Capacity Constraints: Five-year Projections, 2004 thru 2022
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections, 2004 thru 2022 (Trend Line)
Fig 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs. CMOs (2027) .
Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe (2027)
Fig 5.11: Factors Creating Future Capacity Constraints in Five Years (by 2027) .
Fig 5.12A: Factors Creating Future Capacity Constraints, 2008-2022 .
Fig 5.12B: Factors Creating Future Capacity Constraints, 2008-2022 .
Fig 5.13: Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs
Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western Europe Biomanufacturers .
Fig 5.15: Key Areas to Address to Avoid Capacity Constraints (2022)
Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints; 2006-2022
Fig 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2022
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biomanufacturers Developers vs. CMOs
Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe
Fig 5.19: Batch Failure Frequency Distribution, 2009-2022 .
Fig 5.20: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2022 .
Fig 5.21: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009-2022 (“Commercial Manufacture”) .
Fig 5.22: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009-2022 (“Clinical” Scale)
Fig 5.23: Automation Technologies Implemented, or to be Implemented in 2022 .
Fig 5.24: Automation Technologies to be Implemented; Comparing 2009 - 2013, 2022 .
Fig 5.25: Quality Problems Traced to Vendors; 2008-2018
Fig 5.26: Global Quality Supply Management, 2022
Fig 5.27: Global Quality Supply Management, 2011-2013, 2022 .
Fig 5.28: Global Quality Supply Management (Biomanufacturers vs. CMOs) .
Fig 5.29: Global Quality Supply Management (U.S. vs. W. Europe)
Fig 5.30: Addressing Supply Chain Security (2022) .
Fig 6.1: Industry Average Planned Production Increase by 2027
Fig 6.2: Planned Future Capacity Expansion: Five-Year Estimates, 2009-2027
Fig 6.3: Planned Future Capacity Expansion: Five-year Estimates: Biotherapeutic Developers vs. CMOs, by 2027 .
Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates: U.S. vs. Western Europe, by 2027.
Fig 6.5: Percentage of Respondents Projecting Production Increases over 100% by 2027: 5-year Trend
Fig 7.1: Current Percent Production Outsourced; by System, 2022 .
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2022
Fig 7.3: Biotherapeutic Developers’ Outsourcing, 5-year (2027) Projections, by System
Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 20012-2022
Fig 7.5: Biomanufacturers Outsourcing Some Activity Today (2022) .
Fig 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010-2022
Fig 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010-2022
Fig 7.7: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years .
Fig 7.8A: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, 2010-2022 Trends
Fig 7.8B: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, 2010-2022 Trends
Fig 7.9: Estimated Average Percentage of Activity Outsourced, by Facilities Today (2022)
Fig 7.10A: Estimated Average Percent of Activity Outsourced, by Facilities, 2010-2022
Fig 7.10B: Estimated Average Percent of Activity Outsourced, by Facilities, 2010-2022
Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, next 12 months, 2012-2022
Fig 7.12: ‘Very Important’ Issues for Considering Outsourcing to CMOs, Trends 2006-2018
Fig 7.13: ‘Very Important’ Issues for Considering Outsourcing to CMOs, Percentage Point Shifts Over Time, 2006-2018
Fig 7.14: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2010-2013; 2018
Fig 7.15: Country Selections for International Outsourcing/Capacity Expansion Over Next Five Years (2027) .
Fig 7.16: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2022) .
Fig 7.17A: U.S. Respondents Considering International Country as “Possible” Outsourcing Destination, over Next Five Years, 2009-2022
Fig 7.17B: U.S. Respondents Considering International Country as “Possible” Outsourcing Destination, over Next Five Years, 2009-2022
Fig 7.18: U.S. Respondents Considering Country as “Strong likelihood” or “Likelihood” as Outsourced Capacity Destination, Next Five Years, (2027) .
Fig 7.19A: Western European Respondents Considering Country as “Possible” Outsourcing Destination, Next Five Years, (2009-2022)
Fig 7.19B: Western European Respondents Considering Country as “Possible” Outsourcing Destination, Next Five Years, (2009-2022)
Fig 7.20: Western European Respondents Considering Country as ‘Strong likelihood’ or ‘Likelihood’ as Outsourced Capacity Destination, over Next Five Years, (2027)
Fig 7.21: Percent of Biomanufacturing Operations Offshored (International Outsourcing) within 5 Years (2027) .
Fig 7.22: Biomanufacturers Performing at Least “Some” International Outsourcing/Offshoring during Next Five Years (2011-2022) .
Fig 7.23: Estimated Average Percentage of Operations to be Done as International Outsourcing/Offshoring during Next Five Years (2011-2022) .
Fig 7.24 Factors Considered MOST IMPORTANT for Outsourcing to New Regions, such as China, India, and Brazil, 2020 .
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: 2006-2022 .
Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2022 .
Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2022 .
Fig 8.4: 16-Year Percentage-Point Increase in First Usage of Disposables, 2006-2022
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 Developers vs. CMOs
Fig 8.7: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2018
Fig 8.8: Top Reasons for Not Increasing Use of Disposables (2019 data)
Fig 8.9A: Top Reasons for Not Increasing Use of Disposables, 2008-2019 .
Fig 8.9B: Top Reasons for Not Increasing Use of Disposables, 2008-2019 .
Fig 8.10: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developers vs. CMOs (2019 data)
Fig 8.11: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe (2019 data)
Fig 8.12: Cell Culture Problems Due to Single-use Devices .
Fig 8.13: Cell Culture Problems Due to Single-use Devices, 2022 vs. 2021
Fig 8.14: Single-use Recycling; Respondents’ Desires for Disposal vs. Actual Disposal Process (2020 data)
Fig 8.15: Single use / Disposable Device Adoption Factors (2018 data) .
Fig 8.16: Single-use / Disposable Device Adoption Factors; U.S. vs. Western Europe (2018 data)
Fig 8.17: Need for Improved Single-use Sensors, 2012-2017, 2019 (2019 data)
Fig 8.18: Single-use Product Vendor Satisfaction Factors, 2008-2022
Fig 8.19: Importance of Single-use Product Attributes vs. Level of Vendor Satisfaction (2022) .
Fig 8.20: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction, 2013-2022
Fig 8.21: Estimated Percentage of Facilities’ Unit Operations that Are “Single-use” (2014-2022) .
Fig 8.22: Distribution of Responses, % Single-use Devices in Biomanufacturing
Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2022
Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biotherapeutic Developers vs. CMOs
Fig 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe
Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps (2022) .
Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at ‘Significant’ or ‘Severe’ Constraints, 2008-2022
Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe .
Fig 9.7: Issues Regarding Protein A Usage (2022)
Fig 9.8: Issues Regarding Protein A Usage, 2009-2017, 2020-2022 .
Fig 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe
Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses, 2014 -2016, 2018-2022 Data)
Fig 9.11: Bioreactor Output at which DOWNSTREAM Purification Train Becomes Bottlenecked (2014-2016, 2018-2022 Data)
Fig 9.12: New Downstream Processing Solutions, 2022
Fig 9.13A: New Downstream Processing Solutions Comparison: 2010-2022
Fig 9.13B: New Downstream Processing Solutions Comparison: 2010-2022
Fig 9.14: New Downstream Processing Solutions: Biotherapeutic Developers vs. CMOs (2022) .
Fig 9.15: New Downstream Processing Solutions: U.S. vs. Western Europe (2022)
Fig 9.16: Improving Downstream Operations, 2011-2019 (2019 data)
Fig 9.17: Improving Downstream Operations: Biotherapeutic Developers vs. CMOs (2019 data).
Fig 9.18: Improving Downstream Operations (U.S. vs. Western Europe vs. ROW) (2019 data).
Fig 10.1: New Hires in Biopharmaceutical Manufacturing (2022)
Fig 10.2: Estimated Hiring, by Area, 2008-2022 .
Fig 10.3: New Hires in Biopharmaceutical Manufacturing in Five Years (2027)
Fig 10.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations
Fig 10.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations; 2010-2022
Fig 10.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations; 2010-2022
Fig 10.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe
Fig 10.7: Training for New Operations/Manufacturing Employees (2018 data) .
Fig 10.8: Average Annual Changes in Training for New Operations/Manufacturing Employees, 2009-2018
Fig 11.1: Future of Continuous Bioprocessing and Process Intensification (2022)
Fig 11.2: Future of Continuous Bioprocessing and Process Intensification, 2021 vs. 2022 .
Fig 11.3: Perfusion Operations Issues: Comparison 2010 - 2016, 2020 (2020 data)
Fig 11.4: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing (2022).
Fig 11.5: Facilities Evaluating CBP Technologies Over the Next 12 Months (Upstream), 2016-2022
Fig 11.6: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream), 2016-2022 .
Fig 11.7: Future Cell and Gene Therapy Platforms (2019 data) .
Fig 11.8: Cell and Gene Therapy Manufacturing Advancements in 5 Years (2023) to Avoid Bottlenecks (2018 data).
Fig 11.9: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2022) .
Fig 11.10: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019 - 2022) .
Fig 11.11: Cell and Gene Therapy Plans for GMP and Commercial Manufacturing (2022).
Fig 11.12: Cell and Gene Therapy Plans for GMP and Commercial Manufacturing (2020-2022) .
Fig 11.13: Cell and Gene Therapy Capacity Plans for In-House Bioprocessing Facilities Next Five Years (2025)
Fig 11.14: Commercial Manufacturing of Cell Therapies (2021)
Fig 11.15: Commercial Manufacturing of Gene Therapy Vectors and Products (2021)
Fig 12.1: Area of Biopharmaceutical Involvement, Vendor
Fig 12.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010-2022
Fig 12.3A: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008-2022.
Fig 12.3B: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008-2022.
Fig 12.4: Respondents’ Primary Job Function, 2022
Fig 12.5: Average Annual Vendor Sales Growth Rate, 2007-2022 .
Fig 12.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
Fig 12.7: Average Annual Vendor Segment Sales Growth Rates, 2022 .
Fig 12.8: Average Annual Vendor Sales Growth Rate, 2007-2022, by Segment .
Fig 12.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2022 .
Fig 12.10: Vendors’ Average Budget Change, 2022
Fig 12.11: Vendors’ Average Budget Change for 2009-2022, Summary .
Fig 12.12: Vendors’ Average Pricing Changes, Last Year .
Fig 12.13: Vendors’ Average Pricing Changes, 2009-2021 Actual and 2022 projected
Fig 12.14: Factors to Measure The ‘Quality’ of Business Relationships with Suppliers
Fig 12.15: (See Fig 5.25: Quality Problems Traced to Vendors; 2008-2018): Quality Problems Traced to Vendors (2018 data) .
Fig 12.16: Impact of COVID-19 Pandemic on Vendors, 2022
Fig 12.17: Impact of COVID-19 Pandemic on Vendors, INCREASED 2022 vs. 2021
Fig 12.18: Biopharma Business and Marketing Plans, 2022
Fig 12.19: Biopharma Business and Marketing Plans, 2010-2022 .
Fig 12.20A: Top New Technologies or New Product Development Areas (2011-2022) .
Fig 12.20B: Top New Technologies or New Product Development Areas (2011-2022) .
Fig 12.21: R&D Spending/Budgets for New Products/Services, 2022 .
Fig 12.22: Days of Sales Staff Training Provided (2021 data)
Fig 12.23: Areas Where Training is Considered as Needed; 2010-2022 .
Fig 12.24: Client Demands of Vendors, Service and Support, 2012-2022 .
Fig 12.25: Vendors Views of Financial (Sales) Outlook for Next Year, 2011-2022 .
Fig 12.26: Average CMOs Service Price Shifts over the Past 12 Months, 2022 .
Fig 12.27: CMOs Service Price Shifts Over Past 12 Months, Distribution

TABLES
Table 1.1 Number of Biopharmaceutical Products in U.S. and European Markets
Table 1.2 Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2022
Table 3.1 Areas of Significant Projected Budget Percentage Increases for Biomanufacturing, 2022 and Past Years .
Table 3.2 Average Cost per Gram Recombinant Protein .
Table 4.1 Western European Biomanufacturers’ Average Capacity Utilization .
Table 4.2 U.S. Biomanufacturers’ Average Capacity Utilization
Table 4.3 Leading Biopharma Company Capacity Estimates .
Table 4.4: Regional Distribution of Total Worldwide*
Table 4.5 Bioprocessing CMOs, Their Number of Facilities Worldwide and Estimated Total Capacity*.
Table 4.6 Compound Annual Change in mAb Titers, 2008-2022
Table 5.1 Severe or Significant Capacity Constraints, by Stage of Production, 2009-2022 .
Table 5.2 Severe and Significant Capacity Constraints Today, U.S. vs. W. Europe, 2010-2022
Table 6.1 Western European Biomanufacturers’ Five-Year Projected Increases
Table 6.2 U.S. Biomanufacturers’ Five-Year Projected Increases .
Table 7.1 Respondents Reporting No Outsourced Production (i.e., all in-house manufacturing), 2009-2022
Table 7.2 Respondents Outsourcing up to 50% of Production, Mammalian and Microbial Systems, 2009-2
Table 7.3 Respondents Outsourcing Over 50% of Production, Mammalian and Microbial Cell Systems, 2009-2022 .
Table 7.4 Plant and Insect Cells, (All Production “In-house”), 2015-2022
Table 7.5 Non-U.S. Respondents indicating U.S. as ‘Strong likelihood’ or ‘Likelihood’ Outsourcing destination
Table 7.6 Percent of U.S.-based Respondents Indicating Country as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination, 2009-2022
Table 7.7 Percent of European-based Respondents Indicating International Countries as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination, 2011-2022
Table 9.1 Percent experiencing “Serious” or “Some” capacity problems due to downstream processing 2008-2022
Table 9.2 Percent U.S. vs. Western Europe facilities experiencing ‘Serious’ capacity problems due to downstream processing, 2009-2022
Table 9.3 Percent U.S. vs. Western Europe facilities not expecting to see bottlenecks due to downstream processing, 2008-2022
Table 9.4 Upstream Production Titer vs. Max Capacity, 2022 Data
Table 12.1 Average Vendor Sales and Technical Training Days, 2011-2013, 2019-2021 .

Samples

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