19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
The 2022 19th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations’ current and projected future capacity and production. This report’s ~500 pages of data-rich analysis will help improve your decision-making in biomanufacturing operations, with in-depth analysis of capacity, production trends, benchmarks, and much more.
In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic production. Comparison of production by biotherapeutic developers and contract manufacturing organizations. Current and future potential industry bottlenecks. Trend analysis in this 19th in a series of annual biopharmaceutical manufacturing industry evaluations. This edition includes the joint industry expertise from BioPlan Associates, and many industry consultants and experts.
- METHODOLOGY
- 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
- 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 toSupport 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 3 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: 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 .77
- 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) ..190
- 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) Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
- 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, 2009-2022
- 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
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