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20th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

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    Report

  • 520 Pages
  • April 2023
  • Region: Global
  • Bioplan Associates Inc
  • ID: 5118512

A Study of Biotherapeutic Developers and Contract Manufacturing Organizations

The 2023 20th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biomanufacturers and contract manufacturing organizations’ current and projected future capacity and production. This year’s annual report provides case study summaries highlighting a specific issue affecting the industry, an overview of the situation, and a discussion summary.

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.

Report 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 2028
  • 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

Key Highlights:

  • 207 Biopharma companies surveyed
  • 138 industry vendors and direct suppliers of materials
  • 25 Countries represented
  • 500+ Pages
  • 12 Chapters
  • 200+ Graphs and 20+ Tables
  • Subject Matter Experts providing analysis
  • Independent Sponsoring Organizations

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
M&A Activities
Pharmaceutical Industry Dependence on Biopharmaceuticals
Supply Chain Planning in Biopharma
1-2 Biopharmaceutical Industry Status and Market Trends
US Healthcare is Changing
Bioprocessing is Increasing Internationally
1-3 Pharma Industry is Shifting to Biopharmaceuticals
1-4 Global Biopharmaceutical Market Trends
Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
Growth in Biopharmaceutical Product Sales is Increasing the Demand for Bioprocessing
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
The Rise of Plant-based Biopharmaceutical Manufacturing
1-7 Future Trends in the Biopharmaceutical Industry

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE
2-1 2022 FDA Biopharmaceutical Approvals: Therapy Options Diversify as
Innovative Technologies Continue to Develop
2-2 Recent Transactions Affecting the CDMO Landscape
2-3 End-Of-Life Management for Single-Use Products in
Bioproduction: Users Perspective on End-of-Life Management for
Single-Use Products used in Bioproduction
2-4 China’s Position in Global Biomanufacturing: A Comparison of China’s
Emerging Position vs Established Regions’ Manufacturing Capacity and Production
2-5 Impact of COVID-19 on Bioprocessing Supply Chain, Hiring, and Inventory
2-6 AI: The Future of Biopharmaceuticals - Impacting Drug Discovery and Development in 2023

CHAPTER 3: EMERGING TECHNOLOGIES
3-1 Industry Trends in 2023
Introduction
3-2 Bioprocessing Innovations Needed in 2023
Bioprocessing Innovations Most Needed
Novel Bioprocessing Systems/Innovations
Novel Bioprocessing Systems/Innovations, Biomanufacturers vs. CMOs
3-3 Operational Changes in 2023
Operational Changes (2010-2012, 2022-2023)
Operational Changes: U.S. vs. Western Europe
3-4 Budget Issues in 2023
Budget Change Comparisons
Top Bioprocessing Budget Expenditures
Top Bioprocessing Budget Expenditures (2020-2023)
3-5 New Bioprocessing Products Development Opportunities in 2023
Trends: Upstream New Product Areas of Need (2010-2023)
Downstream New Product Areas of Need
Trends: Downstream New Product Areas of Interest (2010-2023)
Other General New Product Areas of Need
Trends: Other General New Product Areas of Need (2010-2023)
3-6 Innovations in Single use/Disposable Equipment
Other Areas for Innovation
New Product Development Areas: Biomanufacturers vs. CMOs
New Product Development Areas: U.S. vs. Western Europe and ROW
3-7 Cost-Cutting Actions & Development Timelines
Cost-Cutting Changes: Specific to Outsourcing
Factors Impacting Reduction in Cost of Goods
3-8 Average Cost per Gram Recombinant Protein
Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2023)
3-9 Assay Development
Assay Development (2019 data)
Biomanufacturing Assay Required; Biomanufacturers vs. CMOs (2019 data)
3-10 Selecting and Purchasing Commercial-Scale Bioreactors
Top Options for Bioreactor Platforms at Commercial Scale
Largest Stainless Steel Bioreactor Capacity Purchase in Next Two Years (2022 data)
Largest Single-Use Bioreactor Capacity Purchase in Next Two Years(2022 data)
3-11 Discussion: Industry Trends and Issues
Industry Growth and Adaptation
Cost Cutting Trends
Trends in Speeding Development and Approval Timelines
Discussion of Needed Single-use Innovations
Trends in Bioprocessing Industry Desires for Improved Products and Services

CHAPTER 4: CAPACITY UTILIZATION
4-1 Capacity Utilization Trends
Capacity Utilization Definitions
Relevance of Capacity Utilization
Capacity Utilization in Biomanufacturing, 2023
Capacity Utilization in Biomanufacturing, By System, 2023
Capacity Utilization Changes (2006-2023)
Average Growth Rate in Capacity Utilization (2006-2023)
4-2 Capacity Utilization: Biomanufacturers vs. CMOs
4-3 Capacity Utilization: U.S. vs. Western European Biomanufacturers
4-4 Respondents’ Current Total Production Capacity
Mammalian Cell Culture
Estimated Bioreactor Capacity Distribution, Biotherapeutic Developers and CMOs Largest Capacity Facilities
Biopharmaceutical Capacity Expansions Continue
Biopharmaceutical Developers/Manufacturers as CMOs
Major CMOs in Terms of Facilities and Capacity
Microbial Fermentation Capacity
Cell Therapy Capacity
Gene Therapy Capacity
4-5 Range of Titers with mAb Production
Annual mAb Titer Changes (2008-2023)
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 (2004-2023)
Perception of Capacity Constraints: Biomanufacturers vs. CMOs
Capacity Constraints: U.S. vs. Western European Biomanufacturers & CMOs
5-2 Expected Capacity Constraints
Respondents’ Expectations of Capacity Constraints by 2028
Expected Capacity Constraints by 2028 (2004-2023)
Expected Capacity Constraints by 2028: Biomanufacturers vs. CMOs
Expected Capacity Constraints by 2028: U.S. vs. Western Europe
5-3 Factors Impacting Future Production Capacity
Factors Creating Future Capacity Constraints
Factors Creating Future Capacity Constraints (2008-2023)
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(2006-2023)
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
Average Time Between Batch Failures (2009-2023)
Batch Failure Frequency Distribution (2009-2023)
Primary Cause of Batch Failures, Percentages of Failures
5-6 Automation Implementation
Demand for Automation
Automation Implementation
Comparison of Implementation Plans (2009-2013, 2022-2023)
5-7 Quality Problems in Biomanufacturing Attributed to Vendors
Global Quality Supply Management
Global Quality Supply Management (2011-2013, 2022-2023)
Global Quality Supply Management: Biomanufacturers vs. CMOs
Global Quality Supply Management: U.S. vs. W. Europe
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 (2009-2028)
Planned Future Capacity Expansions: Biomanufacturers vs. CMOs, by 2028
Planned Five-Year Capacity Expansion: U.S. vs. Western European
Biomanufacturers
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”)(2006-2023)
7-2 Future Outsourcing
Biotherapeutic Developers’ Outsourcing, 5-Year (2028) Projections, by System
Biomanufacturers Outsourcing Some Production in 2028
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
Comparison of Biomanufacturers’ Outsourcing (2010-2023)
Increased Outsourced Activities, 24-Month Projections
Outsourcing Activities Projected at ‘Significantly Higher Levels’ (2010-2023)
Average Percentage of Activities Outsourced Today, 2023
Comparison of Outsourcing Activities (2010-2023)
Change in Spending on Outsourcing Activities
7-4 CMOs’ Problems with Their Clients
7-5 Country Selections for International Outsourcing (Offshoring)of Biomanufacturing
Country Selections for International Outsourcing (Offshoring) of
Biomanufacturing, Over Five Years (2016-2023)
U.S. vs. Western European Respondents’ Outsourcing Destinations
7-6 Offshoring Trends
5-Year Projection for Biomanufacturing International Outsourcing/Offshoring
5-Year Projection for Biomanufacturing International Outsourcing/Offshoring(2011-2023)
5-Year Projection for Average Percentages of Biomanufacturing International
Outsourcing/Offshoring (2011-2023)
Outsourcing to New Regions (2020 data)
7-7 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 (2006-2023)
Average Annual Growth Rate for Disposables: Market Penetration/Usage
17-Year Average Growth in Disposable Applications, Percentage-Point Gains
Disposable Use by Stage of Production/Application
Use of Disposables: Biomanufacturers vs. CMOs
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 data)
8-4 Factors That May Restrict Use of Disposables
Most Critical Reasons for Restricting Use of Disposables (2019 data)
Most Important Reasons for Not Increasing Use of Disposables (2008-2019)
Top Reasons for Not Increasing the Use of Disposables: U.S. vs. Western Europe (2019
Cell-Culture Problems due to Single-Use Devices (2022)
Cell-Culture Problems due to Single-Use Devices (2022 vs. 2021)
Recycling of Disposables (2020)
8-5 Single-Use Adoption Issues
Single-Use Adoption Issues (2018 data)
Single-use Adoption Factors, U.S. vs. Western Europe (2018 data)
8-6 Single-Use Failure Issues
Single-use Failures
Average Weeks Between Failures of Single-use Devices
8-7 Need for Single-use Sensors, and Bioreactor Attributes
Single-Use Sensor Technologies (2012-2017, 2019 data)
8-8 Satisfaction with Single-Use Device Vendors
Single-Use Attribute Importance Analysis
Single-Use Suppliers’ Delivery Problems (2013-2023)
8-9 Single-Use Operations and Trends
Percentage of Unit Operations that are Single-Use
Percentage of Single-Use Device Usage in Biomanufacturing
8-10 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
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, Biomanufacturers 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 (2008-2023)
9-3 Downstream Purification Issues
Protein A and Alternatives (2022 data)
Changes in Perception of Protein A and Alternatives (2009-2017, 2020-2022)
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 (2010-2023)
New Downstream Processing Technologies: Biomanufacturers vs. CMOs
New Downstream Processing Technologies: U.S. vs. Western Europe
9-6 Improvements to Downstream Operations
Improving Downstream Operations (2019 data)
Comparison of New Downstream Technology Implementation: Biomanufacturers vs. CMOs (2019 data)
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 (2008-2023)
10-2 Hiring in 2028: Five-year Trends
10-3 Hiring Challenges Today
Hiring Difficulties (2010-2023)
U.S. and Western Europe Hiring Difficulties
10-4 Training in Biopharmaceutical Manufacturing
Skills or Hands-On Training Required in New Hires in GMP Bioprocessing
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
11-1 Continuous Bioprocessing and Process Intensification
Perfusion vs. Batch Fed Bioprocessing (2021-2023)
11-2 Perfusion Operations and Continuous Bioprocessing Operational Issues
Perfusion Operation Issues (2010-2016, 2020 data)
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
Future Cell and Gene Therapy Platforms (2019 data)
Cell and Gene Therapy Manufacturing Advancements (2018 data)
Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure
Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2023)
Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure
Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2023)
Cell and Gene Therapy GMP and Commercial Manufacturing
Cell and Gene Therapy GMP and Commercial Manufacturing (2020-2023)
Cell and Gene Therapy Capacity Plans for In-House Bioprocessing Facilities
Cellular and Gene Therapies Commercial Manufacturing Scales (2021 data)
11-4 Discussion
Continuous Bioprocessing and Perfusion Trends
Implementation of Continuous Bioprocessing
Perfusion: Progress in Adoption

CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES
12-1 Demographics
Areas of Involvement
Location of Vendor Sales
Biopharmaceutical Adjacent Industries and Supplier Impact: Alternative Proteins
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 2023
Vendor Average Pricing Changes
12-4 Problems Clients Have with Their Vendors
Quality of Business Relationships with Suppliers
Quality of Business Relationships with Clients
Quality Problems Traced to Vendors
12-5 Impacts of COVID-19 on Suppliers’ Activities
Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in COVID-Related Factors (2021-2023)
Biopharma Vendor Business Trends
Biopharma Vendor Business Trends (2010-2023)
12-6 Vendors’ Products and Services
New Technology Areas in Development by Vendors
2023 Other New Technology Areas in Development
2022 Other New Technology Areas in Development
Suppliers’ R&D Spending/Budgets for New Products/Services
Average Annual Suppliers’ R&D Spending/Budgets for New Products/Services (2017-2023)
12-7 Sales Staff Training
Days of Training Provided by Suppliers (2021 data)
Areas where Training May Help Sales Staff Perform, Trends (2010-2023)
Clients’ Demands on Vendors
12-8 Biopharma Vendors’ Financial Outlook for 2023
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
Biopharma Supplier Growth

List of Figures
Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing (2010-2023)
Fig 0.2: Respondents’ Job Responsibilities (2011-2023)
Fig 0.3: Facility Location, 2023
Fig 0.4: Facility Location, by Region
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2023) Trends
Fig 0.6: Phase of Development of Surveyed Respondents (2006-2023)
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 in Past 12 Months, by Scale of Production
Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity, 2023
Fig 0.11: Distribution of Largest STAINLESS Bioreactor Capacity, 2023
Fig 1.1: Percentage of Total Market Revenue: Top 50 Biopharmaceutical Products
Fig 2.1: Numbers of Recombinant and Non-Recombinant Biopharmaceuticals Approved by FDA Since 1981
Fig 2.3: Current Disposal Method for Single-Use Assemblies at End User Facilities
Fig 2.4: Preferred Method of Disposal of Single-Use Assemblies
Fig 2.5: Selected Areas--Single Most Important Biomanufacturing Trend or Operational Area Industry Must Focus Efforts (China, US, W. Europe, and ROW)
Fig 2.6: Average Cost per Gram for PRIMARY Recombinant Protein(by region, 2022 - 2023)
Fig 2.7: Capacity Utilization, By System (China), 2023 vs. 2022
Fig 2.8: Selected Areas: Percent Expecting “Some” Increase in Budgets for 2023 (Global)
Fig 2.9: Selected Cost-Cutting Changes: Actions in “Past 12 Months” (Global), 2023
Fig 2.10: Estimated Percentage of Facilities’ Unit Operations that are “Single-Use”(Global), 2023
Fig 2.11: Change in Spending on Outsourcing for R&D or Manufacturing, Next 12 Months (Global)
Fig 2.12: End User (Biomanufacturer) Facility Changes in Ordering for Bioprocess Supplies and Consumables (Past 12 Mo)
Fig 2.13: Changes in Orders in Past 2-6 Months (Suppliers’ Perceptions in mid-2022)
Fig 2.14: Expected Competition Among Suppliers to Reduce Prices and Expenditures
Fig 2.15: Forecast for Competition (Suppliers’ Perspective)
Fig 2.16: Industry Comparative (Perceived) Average Lead Times End-users vs Suppliers for Consumables and Services (Weeks)
Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area Industry Must Focus Effort (2014-2023)
Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months, 2023
Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months(Biomanufacturers vs. CMOs), 2023
Fig 3.4: Operational Changes Due to Recent Global Economics, 2023
Fig 3.5: Operational Changes Due to Recent Global Economics(2010 - 2012, 2022-2023)
Fig 3.6: Operational Changes Due to Recent Global Economics; Biomanufacturers vs. CMOs, 2023
Fig 3.7: Operational Changes Due to Recent Global Economics; U.S. vs. Western Europe, 2023
Fig 3.8: Biomanufacturers’ Budget Shifts, 2023
Fig 3.9: Approximate Average Change in Biomanufacturers’ Budgets, 2023
Fig 3.10: Average Biomanufacturers’ Budget Changes (2009-2023)
Fig 3.11: New Bioprocessing Expenditures Focus Areas in the Past Year, 2023
Fig 3.12: Top NEW Bioprocessing Expenditure Focus Areas in Past Year (2020-2023)
Fig 3.13: New Product Development-Upstream Focus Areas, 2023
Fig 3.14: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2023)
Fig 3.15: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2023
Fig 3.16: New Product Development-Downstream Focus Areas (2010-2023)
Fig 3.17: New Product Development - General Focus Areas, Biomanufacturers & CMOs, 2023
Fig 3.18: New Product Development - General Focus Areas (2010-2023)
Fig 3.19: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs, 2023
Fig 3.20: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe vs. ROW, 2023
Fig 3.21: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing (2011-2016, 2019-2023)
Fig 3.22: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography(2011-2016, 2019-2023)
Fig 3.23: Factors That Will Have the Greatest Impact on Reducing Your Cost of Goods for Biotherapeutic Products, 2023
Fig 3.24: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2023
Fig 3.25: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein(2017-2023)
Fig 3.26: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods (2011-2015, 2018-2019) (2019 data)
Fig 3.27: Largest Commercial-Scale Bioreactor Expected in the Next Two Years(2024) (2022 data)
Fig 3.28: Top Options for Bioreactor Platforms at Commercial Scale Manufacturing, 2023
Fig 3.29: Distribution of Largest Stainless Steel Bioreactor Capacity Next Two Years(2022 data)
Fig 3.30: Distribution of Largest SINGLE-USE Bioreactor Capacity Next Two Years(2022 data)
Fig 4.1: Capacity Utilization, By System, 2023
Fig 4.2: Capacity Utilization, By System (2006-2023)
Fig 4.3: Change in Capacity Utilization, CAGR (2006-2023)
Fig 4.4: Capacity Utilization, By System, Biomanufacturers vs. CMOs
Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe
Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture, 2023
Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture (2010-2023)
Fig 4.8: Bioprocessing Concentration, Capacity Data, 2023
Fig 4.9: Current Production Capacity Distribution, Microbial Fermentation, 2023
Fig 4.10: Current Production Capacity Distribution, Cell Therapy, 2023
Fig 4.11: Production Capacity Distribution, Cell Therapy (2020-2023)
Fig 4.12: Current Production Capacity Distribution, Gene Therapy, 2023
Fig 4.13: Production Capacity Distribution, Gene Therapy (2020-2023)
Fig 4.14: Range of Titers for mAbs Obtained at Various Production Scales, Distribution
Fig 4.15: Average mAb Titer Trend (2008-2023)
Fig 5.1: Capacity Constraints, by Stage of Production, 2023
Fig 5.2: Capacity Constraints (2004-2023)
Fig 5.3: Capacity Constraints Trends (2004-2023)
Fig 5.4: Capacity Constraints, Biomanufacturers vs. CMOs, 2023
Fig 5.5: Capacity Constraints, U.S. vs. Western Europe, 2023
Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections (by 2028)
Fig 5.7: Expectations of Capacity Constraints: Five-year Projections (2004-2023)
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections (Trend Line)(2004-2023)
Fig 5.9: Five-year Projections for Capacity Constraints: Biomanufacturers vs. CMOs (2028)
Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe (2028)
Fig 5.11: Factors Creating Future Capacity Constraints in Five Years, by 2028
Fig 5.12A: Factors Creating Future Capacity Constraints (2008-2023)
Fig 5.12B: Factors Creating Future Capacity Constraints (2008-2023)
Fig 5.13: Factors Creating Future Capacity Constraints: Biomanufacturers vs. CMOs, 2023199
Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western Europe Biomanufacturers, 2023
Fig 5.15: Key Areas to Address to Avoid Capacity Constraints, 2023
Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints (2006-2023)
Fig 5.16B: Key areas to Address to Avoid Capacity Constraints (2006-2023)
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biomanufacturers Developers vs. CMOs, 2023
Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe, 2023
Fig 5.19: Average Time (weeks) Between Batch Failures (2009-2023)
Fig 5.20: Batch Failure Frequency Distribution (2009-2023)
Fig 5.21: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2023
Fig 5.22: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing(“Commercial Manufacture”) (2009-2023)
Fig 5.23: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing(“Clinical” Scale) (2009-2023)
Fig 5.24: Automation Technologies Implemented/to be Implemented in 2023
Fig 5.25: Automation Technologies to be Implemented; Comparing(2009 - 2013, 2022-2023)
Fig 5.26: Global Quality Supply Management, 2023
Fig 5.27: Global Quality Supply Management (2011-2013, 2022-2023)
Fig 5.28: Global Quality Supply Management, Biomanufacturers vs. CMOs, 2023
Fig 5.29: Global Quality Supply Management (U.S. vs. W. Europe), 2023
Fig 5.30: Addressing Supply Chain Security, 2023
Fig 6.1: Industry Average Planned Production Increase by 2028
Fig 6.2: Planned Future Capacity Expansion: Five-Year Estimates (2009-2028)
Fig 6.3: Planned Future Capacity Expansion: Five-year Estimates: Biomanufacturers vs. CMOs, by 2028
Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates: U.S. vs. Western Europe, by 2028
Fig 6.5: Percentage of Respondents Projecting Production Increases over 100% by 2028 (5-year Trend)
Fig 7.1: Current Percent Production Outsourced; by System, 2023
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production (2006-2023)
Fig 7.3: Biotherapeutic Developers’ Outsourcing, Five Year (2028) Projections, by System, 2023
Fig 7.4: Five Year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2023
Fig 7.5: Biomanufacturers Outsourcing Some Activity Today, 2023
Fig 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today(2010-2023)
Fig 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today(2010-2023)
Fig 7.7: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, 2023
Fig 7.8A: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, Trends (2010-2023)
Fig 7.8B: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, Trends (2010-2023)
Fig 7.9: Estimated Average Percentage of Activity Outsourced, by Facilities Today, 2023
Fig 7.10A: Estimated Average Percent of Activity Outsourced, by Facilities (2010-2023)
Fig 7.10B: Estimated Average Percent of Activity Outsourced, by Facilities(2010-2023)
Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, Next 12 months (2012-2023)
Fig 7.11A: Percent Indicating USA as Likely or Strong Likely Selection for INTERNATIONAL (non-US respondents) Outsourcing Over Next Five Years, 2009-2023 (targeting 2028)
Fig 7.12: Country Selections for International Outsourcing/Capacity Expansion Over Next Five Years, 2028
Fig 7.13A: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2023)
Fig 7.13B: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2023)
Fig 7.14A: U.S. Respondents Considering International Country as “Possible” Outsourcing Destination, over Next Five Years (2009-2023)
Fig 7.14B: U.S. Respondents Considering International Country as “Possible” Outsourcing Destination, over Next Five Years (2009-2023)
Fig 7.15: U.S. Respondents Considering Country as “Strong likelihood” or“ Likelihood” as Outsourced Capacity Destination, Next Five Years (2028), 2023
Fig 7.16A: Western European Respondents Considering Country as “Possible” Outsourcing Destination, Next Five Years, (2009-2023)
Fig 7.16B: Western European Respondents Considering Country as “Possible” Outsourcing Destination, Next Five Years, (2009-2023)
Fig 7.17: Western European Respondents Considering Country as ‘Strong likelihood’ or ‘Likelihood’ as Outsourced Capacity Destination, over Next Five Years (2028), 2023
Fig 7.18: Percent of Biomanufacturing Operations Offshored(International Outsourcing) within Five Years (2028), 2023
Fig 7.19: Biomanufacturers Performing at Least “Some” International Outsourcing/Offshoring Over Next Five Years (2011-2023)
Fig 7.20: Estimated Average Percentage of Operations to be Done as International Outsourcing/Offshoring during Next Five Years (2011-2023)
Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture, 2023
Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2023)
Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2023)
Fig 8.3: Average Annual Growth Rate, Disposables (2006-2023)
Fig 8.4: 17-Year Percentage-Point Increase in First Usage of Disposables (2006-2023)
Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture(R&D-Commercial), 2023
Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing: Biomanufacturers vs. CMOs, 2023
Fig 8.7: Cell Culture Problems Due to Single-Use Devices (2022 vs. 2021)
Fig 8.8: Single-use Recycling; Respondents’ Desires for Disposal vs. Actual Disposal Process (2020 data)
Fig 8.9: Percent of Respondents Indicating Single-use Failures by Time and SUS Type, 2023
Fig 8.10: Average Weeks Before Failure of SUS Devices, 2023
Fig 8.11: Need for Improved Single-Use Sensors (2012-2017, 2019) (2019 data)
Fig 8.12: Single-Use Product Vendor Satisfaction Factors (2008-2023)
Fig 8.13: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction, 2023
Fig 8.14: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction (2013-2023)
Fig 8.15: Estimated Percentage of Facilities’ Unit Operations that are “Single-Use” (2014-2023)
Fig 8.16: Distribution of Responses, % Single-Use Devices in Biomanufacturing,2023
Fig 9.1: Impact of Downstream Processing on Overall Capacity (2008-2023)
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
Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at ‘Significant’ or ‘Severe’ Constraints (2008-2023)
Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe
Fig 9.7: Issues Regarding Protein A Usage (2022 data)
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 (2022 data)
Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses(2014 -2016, 2018-2023)
Fig 9.11: Bioreactor Output at which DOWNSTREAM Purification Train Becomes Bottlenecked (2014-2016, 2018-2023)
Fig 9.12: New Downstream Processing Solution, 2023
Fig 9.13A: New Downstream Processing Solutions Comparison (2010-2023)
Fig 9.13B: New Downstream Processing Solutions Comparison (2010-2023)
Fig 9.14: New Downstream Processing Solutions: Biomanufacturers vs. CMOs, 2023
Fig 9.15: New Downstream Processing Solutions: U.S. vs. Western Europe, 2023
Fig 9.16: Improving Downstream Operations, 2011-2019 (2019 data)
Fig 10.1: New Hires in Biopharmaceutical Manufacturing, 2023
Fig 10.2: Estimated Hiring, by Area (2008-2023)
Fig 10.3: New Hires in Biopharmaceutical Manufacturing in Five Years (2028)
Fig 10.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2023
Fig 10.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations(2010-2023)
Fig 10.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations(2010-2023)
Fig 10.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe, 2023
Fig 10.7: Skills or Hands-On Training Required in NEW HIRES in GMP Bioprocessing
Fig 11.1: Future of Continuous Bioprocessing and Process Intensification, 2023
Fig 11.2: Future of Continuous Bioprocessing and Process Intensification (2021-2023)
Fig 11.3: Perfusion Operations Issues (2010 - 2016, 2020, 2023)
Fig 11.4: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing, 2023
Fig 11.5: Facilities Evaluating CBP Technologies Over the Next 12 Months (Upstream)(2016-2023)
Fig 11.6: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream)(2016-2023)
Fig 11.7: Future Cell and Gene Therapy Platforms (2019 data)
Fig 11.8: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure, Cell Therapy, 2023
Fig 11.9: Most Needed Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019 - 2023)
Fig 11.10: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure, Gene Therapy, 2023
Fig 11.11: Most Needed Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2023)
Fig 11.12: Cell and Gene Therapy Plans for GMP and Commercial Manufacturing, 2023
Fig 11.13: Cell and Gene Therapy Plans for GMP and Commercial Manufacturing(2020-2023)
Fig 11.14: Cell and Gene Therapy Capacity Plans for In-House Bioprocessing Facilities Next Five Years (2028)
Fig 11.15: Commercial Manufacturing of Cell Therapies (2021)
Fig 11.16: 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 (2010-2023)
Fig 12.3A: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2023)
Fig 12.3B: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2023)
Fig 12.4: Vendor Respondents’ Primary Job Function
Fig 12.5: Average Annual Vendor Sales Growth Rate (2007-2023)
Fig 12.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution, 2023
Fig 12.7: Average Annual Vendor Segment Sales Growth Rates, 2023
Fig 12.8: Average Annual Vendor Sales Growth Rate, by Segment (2007-2023)
Fig 12.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment % (2012-2023)
Fig 12.10: Vendors’ Average Budget Change, 2023
Fig 12.11: Vendors’ Average Budget Change, Summary (2009-2023)
Fig 12.12: Vendors’ Average Pricing Changes, Last Year (2023 data)
Fig 12.13: Vendors’ Average Pricing Changes (2009-2022 Actual and 2023 projected)
Fig 12.14: Factors to Measure The ‘Quality’ of Business Relationships with Suppliers, 2023-2022
Fig 12.15: Factors Important in Measuring the ‘Quality’ of Business Relationships, Suppliers Perspective vs. Facility Perspective, 2023
Fig 12.16: Impact of COVID-19 Pandemic on Vendors, 2023
Fig 12.17: Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in COVID-Related Factors (2023-2021)
Fig 12.18: Biopharma Business and Marketing Plans, 2023
Fig 12.19: Biopharma Business and Marketing Plans (2010-2023)
Fig 12.20A: Top New Technologies or New Product Development Areas(2011-2023)
Fig 12.20B: Top New Technologies or New Product Development Areas(2011-2023)
Fig 12.21: R&D Spending/Budgets for New Products/Services, 2023
Fig 12.22: Approximate Average Annual R&D Spending/Budget for New Products/Services (2017-2023)
Fig 12.23: Areas Where Training is Considered as Needed, All Vendor Respondents (2010-2023)
Fig 12.24: Client Demands of Vendors, Service and Support (2012-2023)
Fig 12.25: Vendors Views of Financial (Sales) Outlook for Next Year (2011-2023)
Fig 12.26: Average CMOs Service Price Shifts over the Past 12 Months, 2023
Fig 12.27: CMOs Service Price Shifts Over Past 12 Months, Distribution, 2023

List of Tables
Table 0.1: Areas of Biopharmaceutical Manufacturing Operations
Table 1.1 Number of Biopharmaceutical Products Currently Approved in U.S. and European Markets
Table 1.2 Global Market for Top 50 Biopharma Products in (2021-2022, $USD Million)
Table 1.3 Top 50 Biopharmaceutical Products Vs. Total Market Size (%) $mm
Table 1.4 Bioprocess Related Industry Expenditures on Manufacture of Biotherapeutics (estimated $USD, billions)
Table 1.5 Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2023
Table 2.1 Biopharmaceuticals Approved by FDA, 2022
Table 2.2 Mergers and Acquisitions, 2022
Table 3.1 Areas of Significant Projected Budget Percentage Changes for Biomanufacturing (2011-2023)
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, 2023
Table 4.4: Regional Distribution of Total Worldwide Average Capacity*
Table 4.5: Bioprocessing CMOs, Their Number of Facilities Worldwide and Estimated Total Capacity*
Table 4.6 Compound Annual Change in mAb Titers (2008-2023)
Table 5.1 Severe or Significant Capacity Constraints, by Stage of Production (2009-2023)
Table 5.2 Severe and Significant Capacity Constraints Today, U.S. vs. W. Europe(2010-2023)
Table 5.3: Average Rates of Failure, by Primary Cause, and Phase of Manufacture(2017-2023)
Table 6.1 Western European Biomanufacturers’ Five-Year Projected Increases(2008-2023)
Table 6.2 U.S. Biomanufacturers’ Five-Year Projected Increases (2008-2023)
Table 7.1 Respondents Reporting No Outsourced Production(i.e., all in-house manufacturing) (2009-2023)
Table 7.2 Respondents Outsourcing up to 50% of Production, Mammalian and Microbial Systems (2009-2023)
Table 7.3 Respondents Outsourcing Over 50% of Production, Mammalian and Microbial Cell Systems (2009-2023)
Table 7.4 Plant and Insect Cells, (All Production “In-house”) (2015-2023)
Table 7.5 Average Change in Spending on Outsourcing Activities (2013-2023)
Table 7.6 Percent of U.S.-based Respondents Indicating Country as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2009-2023)
Table 7.7 Percent of European-based Respondents Indicating International Countries as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2011-2023)
Table 9.1 Percent of Biomanufacturers vs. CMO Facilities experiencing “Serious” or “Some” Capacity Problems due to Downstream Processing (2008-2023)
Table 9.2 Percent of U.S. vs. Western Europe Facilities Experiencing ‘Serious’ Capacity Problems due to Downstream Processing (2009-2023)
Table 9.3 Percent U.S. vs. Western Europe Facilities Not Expecting to see Bottlenecks due to Downstream Processing (2008-2023)
Table 9.4 Upstream Production Titer vs. Max Capacity (2018-2023)
Table 12.1 Average Vendor Sales and Technical Training Days (2011-2013, 2019-2021)