Market Research

2024 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

Best Price Guarantee Length Publisher Published Date SKU
from $2,450 505 Pages BioPlan Associates, Inc. April, 2024 DFAQ18928063
Best Price Guarantee
Price from $2,450
Length 505 Pages
Publisher BioPlan Associates, Inc.
Published Date April, 2024
SKU DFAQ18928063

2024 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production


Comprehensive overview of biopharmaceutical manufacturing industry trends, technologies, and challenges, with responses from 220 Biopharma companies, 179 industry vendors and direct suppliers of materials, and 23 Countries represented.

500 Pages, 12 Chapters, 200+ Graphs and 20+ Tables, and Subject Matter Experts providing analysis.


METHODOLOGY
CHAPTER 0: DEMOGRAPHICS
Introduction
0-1 Respondents’ Area of Involvement
0-2 Respondents’ Qualifications/DD>
0-3 Facility Locations/DD>
0-4 Areas of Biopharmaceutical Manufacturing Operations/DD>
0-5 Production Operations, Phase of Development/DD>
0-6 Employees at Facility /DD>
0-7 Batches Run at Facility per Year /DD>
0-8 Single-Use Bioreactor Capacity in Use at Site/DD>
0-9 Stainless Steel Bioreactor Capacity in Use at Site
CHAPTER 1: INTRODUCTION AND DISCUSSION
1-1 Sector and Market Overview
The Biopharma(ceutical) Industry is Losing its Core Identity
M&A Activities
Contract Manufacturing Trends
1-2 Biopharmaceutical Industry Status and Market Trends
U.S. Healthcare is Changing
1-3 Pharma Industry is Shifting to Biopharmaceuticals
Pharmaceutical Industry Dependence on Biopharmaceuticals
1-4 Global Biopharmaceutical Market Trends
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
Monoclonals are a Costly Treatment
Animal Derived Products and Biopharmaceuticals
Plant-based Biopharmaceutical Manufacturing
1-6 Future Trends in the Biopharmaceutical Industry
Future Trends in Biopharma
Conclusion
CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE
2-1 2023 FDA Biopharmaceutical Approvals: Promising Year for Novel Biologics Driven by Innovation and Targeted Therapies
2-2 China’s Position in Global BioManufacturing: A Comparison of China’s Emerging Position vs Established Regions’ Manufacturing Capacity and Production
2-3 Gene-modified Cell Therapies: A Brief Overview of the Field’s Most Advanced Modality
2-4 Design Principles and Solutions to Purification Challenges of Asymmetric Fc-Containing Bispecific Antibodies
2-5 CRISPR-based Treatment: Capabilities and Challenges
CHAPTER 3: TRENDS AND EMERGING TECHNOLOGIES
3-1 Industry Trends in 2024
Introduction
3-2 Bioprocessing Improvements Needed in 2024
Bioprocessing Improvements Most Needed
Novel Bioprocessing Systems/Innovations
Novel Bioprocessing Systems/Innovations, Biomanufacturers vs. CMOs
3-3 Operational Changes in 2024
Operational Changes (2010 – 2012, 2022-2024)
Operational Changes: Biomanufacturers vs. CMOs
Operational Changes: U.S. vs. Western Europe
3-4 Budget Issues in 2024
Budget Change Comparisons (2009-2024)
3-5 Top Bioprocessing Budget Expenditures
Top New Bioprocessing Budget Expenditures (2020-2024)
3-6 New Bioprocessing Products Development Opportunities (2024)
Upstream New Product Areas of Interest
Trends: Upstream New Product Areas of Interest (2010-2024)
Downstream New Product Areas of Interest
Trends: Downstream New Product Areas of Interest (2010-2024)
Other General New Product Areas of Interest
Trends: Other General New Product Areas of Interest (2010-2024)
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 (2020-2024)
3-8 Average Cost per Gram Recombinant Protein
Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2024)
3-9 Assay Development
Biomanufacturing Assay Areas Required; Biomanufacturers vs. CMOs
Biomanufacturing Assay Areas Required, U.S. vs Western Europe
3-10 Selecting and Purchasing Commercial-Scale Bioreactors
Largest Commercial-Scale Bioreactor Expected in Next Two Years (2022 data)
Top Options for Bioreactor Platforms at Commercial Scale
Largest Stainless Steel Bioreactor Capacity Purchase in Next Two Years (2024) (2022 data)
Largest Single-Use Bioreactor Capacity Purchase in Next Two Years (2024) (2022 data)
3-11 Discussion: Industry Trends and Issues
Cost Cutting Trends
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 Other Industries, 2024: US Federal Reserve Board Comparisons
Capacity Utilization in Biomanufacturing, 2024
Capacity Utilization in Biomanufacturing, By System, 2024
Capacity Utilization Changes (2006-2024)
Average Growth Rate in Capacity Utilization (2006-2024)
4-2 Capacity Utilization: Biomanufacturers vs. CMOs
4-3 Capacity Utilization: U.S. vs. Western European Manufacturers
Historical 12-year US vs EU Trends in Capacity Utilization
Availability of CMO/CDMO Capacity
4-4 Respondents’ Current Total Production Capacity
Mammalian Cell Culture Capacity
Microbial Fermentation Capacity
Cell Therapy Capacity
Gene Therapy Capacity
4-5 Global Bioreactor Capacity
The Largest Capacity Facilities
Biopharmaceutical Capacity Expansions Continue
Biopharmaceutical Developers/Manufacturers as CMOs
Major CMOs in Terms of Facilities and Capacity
4-6 Range of Titers with mAb Production
Annual mAb Titer Changes (2008-2024)
4-7 DISCUSSION: CAPACITY AND INDUSTRY TRENDS
The Risks of Biomanufacturers Seeking to become a CMO
Future Capacity Trends
CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS AND QUALITY FACTORS
5-1 Current Capacity Constraints
Introduction
Current Capacity Constraints
Respondents Experiencing No Capacity Constraints (2004-2024)
Respondents’ Perception of Capacity Constraints (2004-2024)
Differences in Capacity Constraints: Biomanufacturers vs. CMOs
Capacity Constraints: U.S. vs. Western European Biomanufacturers & CMOs
5-2 Expected Capacity Constraints
Respondents’ Expectations of Capacity Constraints in Five Years (2029)
Expected Capacity Constraints Five-year Projections (2004-2024)
Expected Capacity Constraints in Five Years: Biomanufacturers vs. CMOs (2029)
Expected Capacity Constraints in Five Years: U.S. vs. Western Europe (2029)
5-3 Factors Impacting Future Production Capacity
Factors Creating Future Capacity Constraints in Five Years (2029)
Factors Creating Future Capacity Constraints (2008-2024)
CMO Capacity Bottleneck Projections, in Retrospect
Biomanufacturers’ Capacity Bottleneck Projections, in Retrospect
Factors Creating Capacity Constraints: U.S. vs. Western Europe Respondents
5-4 Key Areas to Address to Avoid Future Capacity Constraints
Areas to Avoid Capacity Constraints: Changing Perspectives (2006-2024)
Key areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs 223
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 (2009-2024)
Batch Failure Frequency Distribution (2009-2024)
Improving Failure Rates
Primary Cause of Batch Failures, Percentages of Failures
5-6 Automation Implementation
Demand for Automation
Automation Implementation
Comparison of Implementation Plans (2009-2013, 2022-2024)
5-7 Quality Problems in Biomanufacturing Attributed to Vendors
Global Quality Supply Management (2023)
Global Quality Supply Management (2011-2013, 2022-2023)
Global Quality Supply Management Biomanufacturers vs. CMOs (2023)
U.S. vs. W. Europe Global Quality Supply Management (2023)
Addressing Supply Chain Security
5-8 Discussion: Industry Trends
Automation
Single-use Systems
Skilled Staff
CHAPTER 6: PLANNED FUTURE CAPACITY EXPANSIONS
6-1 Planned Future Capacity Expansions
Industry Average Planned Production Increases, Five Years Estimates (2029)
Planned Future Capacity Expansions: Five Year Estimates (2009-2029)
6-2 Planned Future Capacity Expansions for Biomanufacturers vs CMOs, by System
Planned Future Capacity Expansions for Biomanufacturers vs. CMOs, Five Year Estimates (2029)
6-3 Planned Future Capacity Expansions for U.S. vs. Western Europe, by System
Planned Future Capacity Expansions for U.S. vs. Western European
Manufacturers, Five Year Estimates (2029)
6-4 Planned Future Capacity Expansions of >100%, by Systems
Planned Future Capacity Expansions of >100%, by Systems
6-5 Planned Future Global Capacity Expansions
CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING
Introduction
Why Outsource?
Strategic Manufacturing Planning
Future Projections
7-1 Current Outsourcing by Production System
Facilities Currently Outsourcing No Production (All Production “In-house”) (2006-2024)
Historical Trends in Outsourcing Production
7-2 Future Outsourcing
Biotherapeutic Developers’ Outsourcing, 5-Year Projections, by System (2029)
Five Year Projections for Biomanufacturers Outsourcing Some Production
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
Comparison of Biomanufacturers’ Outsourcing, (2010-2024)
Increased Outsourced Activities, 24-Month Projections
Outsourcing Activities Projected at ‘Significantly Higher Levels’ (2010-2024)
Average Percentage of Activities Outsourced Today, 2024
Comparison of Outsourcing Activities (2010-2024)
Change in Average Spending on Outsourcing Activities
Average Change in Outsourcing Spending by Facilities (2013-2024)
7-4 CMOs’ Problems with Their Clients
CMOs Problems with Their Clients (2018 data)
7-5 Country Selections for International Outsourcing (Offshoring) of Biomanufacturing
Country Selections for International Outsourcing (Offshoring) of
Biomanufacturing, Over Five Years (2016-2024)
U.S.-based Companies Capacity Expansion Destinations
U.S.-based Companies Outsourcing Destinations
W. European – based Companies Capacity Expansion Destinations
W. European – based Companies Outsourcing Destinations
7-6 Offshoring Trends to Lower-Cost Regions
5-Year Projection for Biomanufacturing International Outsourcing /Offshoring to Lower-Cost Regions
Five Year Projection for Biomanufacturing International Outsourcing/Offshoring to Lower-Cost Regions (2011-2024)
Five Year Projection for Average Percentages of Biomanufacturing International Outsourcing/Offshoring to Lower-Cost Regions (2011-2024)
Outsourcing to New Regions (2020 data)
7-7 Discussion of Outsourcing and Offshoring
Strategic Shifts in Outsourcing
Future Projections
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 (2006-2024)
Average Annual Growth Rate for Disposables: Market Penetration/Usage
18-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
Issues Related to Leachables and Extractables (2018 data)
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)
Cell-Culture Problems due to Single-Use Devices (2022 vs. 2021)
8-5 Single-Use Adoption Issues
Evolution of SUS Adoption
Single-use Failures by Timeframe and SUS Type
Average Weeks Before Failures of Single-use Devices, 2023 vs 2024
8-6 Need for Single-use Sensors, and Bioreactor Attributes
Single-Use Sensor Technologies (2012-2017, 2019)
8-7 Satisfaction with Single-Use Device Vendors (2008-2024)
Single-Use Attribute Importance Analysis
Single-Use Suppliers’ Issues (2013-2024)
8-8 Single-Use Operations and Trends
Percentage of Unit Operations that are Single-Use (2014-2024)
Percentage of Single-Use Device Usage in Biomanufacturing
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
Modular: The Next Trend after Single-Use?
Single-use Equipment Sourcing, Quality Issues, and L&E Testing
CHAPTER 9: DOWNSTREAM PURIFICATION
9-1 Impact of Downstream Processing on Capacity
Impact of Downstream Processing on Overall 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 (2008-2024)
Specific Purification Step Constraints, U.S. vs. Western European
Biomanufacturers
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 (2022 data)
9-4 mAb Purification Capacity Estimates
Upstream Production Titer vs. Max Capacity
9-5 New Downstream Processing Technologies
New Downstream Processing Solutions (2010-2024)
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)
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
Industry Overview
10-1 Hiring Trends
Trends in New Hires, by Area (2008-2024)
10-2 Five Year Trends in Hiring (2029)
10-3 Hiring Challenges Today
Hiring Difficulties (2010-2024)
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: Strategies For Successful Employment Growth
Educational Programs
Strategic Trainings
Attractive Career Paths
CHAPTER 11: NEW METHODS: CONTINUOUS AND PROCESS INTENSIFICATION, CELL AND GENE THERAPIES
Introduction to Innovative Bioprocessing
Advanced Therapies
Improved, Continuous Bioprocessing
11-1 Future Adoption of Continuous Bioprocessing and Process Intensification
Future of Continuous Bioprocessing (2021-2024)
11-2 Perfusion Operations and Continuous Bioprocessing Operational Issues
Perfusion Operation Issues (2010-2016, 2020, 2023-2024)
Perfusion vs. Batch Fed Bioprocessing – Areas of Much Bigger Concern
Evaluating or Considering CBP technologies (Upstream)
Over the Next 12 Months (2016-2024)
Evaluating or Considering CBP technologies (Downstream)
Over the Next 12 Months (2016-2024)
11-3 Cell and Gene Therapy Platforms
Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2024)
Gene Therapy Manufacturing Improvements, Systems, Platforms,
and Infrastructure (2019-2024)
Advanced Therapy (Cell or Gene Therapy) GMP and Commercial
Manufacturing (2020-2024)
Cell Therapy Capacity Plans for In-House Bioprocessing Facilities:
Five Year Estimates (2023-2024)
Cellular Therapies Commercial Manufacturing Scales (2021)
Gene Therapy Vectors and Products Commercial Manufacturing Scales (2021)
11-4 Discussion
Continuous Bioprocessing and Perfusion Trends
Cell & Gene Therapy Manufacturing
CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES
Introduction
12-1 Demographics
Areas of Involvement
Location of Vendor Sales
Vendor / Supplier 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 2024
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 (2018 data)
12-5 Impacts of COVID-19 on Suppliers’ Activities
Biopharma Industry’s Response to COVID on Bioprocessing-Related Business (2023 data)
Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in COVID-Related Factors (2021-2023)
Post COVID Impact on Suppliers: Permanent Changes on Business Operations
Biopharma Vendor Business Trends
Biopharma Vendor Business Trends (2010-2024)
12-6 Vendors’ Products and Services
New Technology Areas in Development by Vendors
Suppliers’ R&D Spending/Budgets for New Products/Services
Average Annual Suppliers’ R&D Spending/Budgets for New Products/Services (2017-2022)
12-7 Sales Staff Training
Days of Training Provided by Suppliers (2021 data)
Areas where Training May Help Sales Staff Perform, Trends (2010-2024)
Clients’ Demands on Vendors
12-8 Biopharma Vendors’ Financial Outlook for 2024
12-9 CMO Pricing Changes for Biopharmaceutical Services
12-10 Discussion: Biopharma Suppliers
Vendor and Industry Growth
Trends Favor Increased Vendor Sales
Vendors are Offering More Services
Biopharma Suppliers in Emerging Regions
FIGURES
Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing (2010-2024)
Fig 0.2: Respondents’ Job Responsibilities (2011-2024)
Fig 0.3: Facility Location, 2024
Fig 0.4: Facility Location, by Region, 2024
Fig 0.5: Biopharmaceutical Manufacturing Systems, Trends (2007-2024)
Fig 0.6: Phase of Development of Surveyed Respondents (2006-2024)
Fig 0.7: Phase of Development of Surveyed Respondents, U.S. vs. Western Europe (2024)13
Fig 0.8: Distribution of Employees at Facility, and Organization, 2024
Fig 0.9: Distribution of Total Batches Run at Facility in Past 12 Months, by Scale of Production (2024)
Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity, 2024
Fig 0.11: L Average SINGLE-USE Bioreactor Volume (2017-2024)
Fig 0.12: Distribution of Largest STAINLESS Bioreactor Capacity, 2024
Fig 1.1: Top 50 Biopharmaceutical Products, Percentage of Total Market Revenue
Fig 2.1: Numbers of Recombinant and Non-Recombinant Biopharmaceuticals Approved by FDA Since 1981
Fig 2.2: Selected Areas--Single Most Important Biomanufacturing Trend or Operational Area Industry Must Focus Efforts (China, US, W. Europe, and ROW), 2024
Fig 2.3: Average Cost per Gram for PRIMARY Recombinant Protein (by region, 2022 – 2024)
Fig 2.4: Capacity Utilization, By System (China), 2022-2024
Fig 2.5: Selected Areas: Percent Expecting “Some” Increase in Budgets for 2024 (Global)
Fig 2.6: Selected Cost-Cutting Changes: Actions in “Past 12 Months” (Global), 2024
Fig 2.7: Estimated Percentage of Facilities’ Unit Operations that are “Single-Use” (Global), 2024
Fig 2.8: Change in Spending on Outsourcing for R&D or Manufacturing, Next 12 Months (Global)
Fig 2.9: EMA and FDA Approved Gene-Modified Cell Therapies - aka Ex-Vivo Gene Therapies- by Year of Approval And DP (Manufacturer)
Fig 2.10: Overview of Common bsAb MoA (5)
Fig 2.11: Designs of asymmetric Fc based bsAbs
Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area (2014-2024)
Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (2018-2024)
Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (Biomanufacturers vs. CMOs), 2024
Fig 3.4: Operational Changes Due to Recent Global Economics, 2024
Fig 3.5: Operational Changes Due to Recent Global Economics (2010 - 2012, 2022-2024)
Fig 3.6: Operational Changes Due to Recent Global Economics; Biomanufacturers vs.CMOs, 2024
Fig 3.7: Operational Changes Due to Recent Global Economics; U.S. vs. Western Europe, 2024
Fig 3.8: Biomanufacturers’ Budget Shifts, 2024
Fig 3.9: Approximate Average Change in Biomanufacturers’ Budgets, 2024
Fig 3.10: Average Biomanufacturers’ Budget Changes (2009-2024)
Fig 3.11: New Expenditures Focus Areas, 2024
Fig 3.12: New Expenditures Focus Areas (2020-2024)
Fig 3.13: New Product Development-Upstream Focus Areas, 2024
Fig 3.14: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2024)
Fig 3.15: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2024
Fig 3.16: New Product Development – Downstream Focus Areas (2010-2024)
Fig 3.17: New Product Development – General Focus Areas, Biomanufacturers & CMOs, 2024
Fig 3.18: New Product Development – General Focus Areas (2010-2024)
Fig 3.19: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs, 2024
Fig 3.20: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe vs. ROW, 2024
Fig 3.21: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing (2011-2016, 2019-2024)
Fig 3.22: Cost-Cutting Changes, Outsourced Jobs, by Segment, (2011-2016, 2019-2024)
Fig 3.23: Factors That Will Have the Greatest Impact on REDUCING YOUR COST OF GOODS for Biotherapeutic Products (2020-2024)
Fig 3.24: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2024
Fig 3.25: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2024)
Fig 3.26: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods (2011-2015, 2018-2019, 2024)
Fig 3.27: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs, 2024
Fig 3.28: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; US vs. Western Europe, 2024
Fig 3.29: Largest Commercial-Scale Bioreactor Expected in the Next Two Years (2024) (2022 data)
Fig 3.30: Top Options for Bioreactor Platforms at Commercial Scale, 2024
Fig 3.31: Top Options for Bioreactor Platforms at Commercial Scale (2021-2024)
Fig 3.32: Distribution of Largest Stainless Steel Bioreactor Capacity Next Two Years(2024) (2022 data)
Fig 3.33: Distribution of Largest SINGLE-USE Bioreactor Capacity Next Two Years (2024)
Fig 4.1: Capacity Utilization, By System, 2024
Fig 4.2: Capacity Utilization, By System (2006-2024)
Fig 4.3: Change in Capacity Utilization, CAGR (2006-2024)
Fig 4.4: Capacity Utilization, By System, Biomanufacturers vs. CMOs, 2024
Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe, 2024
Fig 4.6: Western European vs US Biomanufacturers’ Average Capacity Utilization (2012-2024)
Fig 4.7: Availability of CMO/CDMO Capacity, 2024
Fig 4.8: Current Production Capacity Distribution, Mammalian Cell Culture, 2024
Fig 4.9: Production Capacity Distribution, Mammalian Cell Culture (2010-2024)
Fig 4.10: Current Production Capacity Distribution, Microbial Fermentation, 2024
Fig 4.11 Current Production Capacity Distribution, Microbial Fermentation (2010-2024)
Fig 4.12: Current Production Capacity Distribution, Cell Therapy, 2024
Fig 4.13: Production Capacity Distribution, Cell Therapy (2020-2024)
Fig 4.14: Current Production Capacity Distribution, Gene Therapy, 2024
Fig 4.15: Production Capacity Distribution, Gene Therapy (2010-2024)
Fig 4.16: Bioprocessing Concentration, Capacity Data, 2024
Fig 4.17: Range of Titers for mAbs Obtained at Various Production Scales, Distribution, 2024
Fig 4.18: Average mAb Titer Trend (2008-2024)
Fig 5.1: Capacity Constraints, by Stage of Production, 2024
Fig 5.2: Capacity Constraints ‘Today’ (2004-2024)
Fig 5.3: Capacity Constraints Trends (2004-2024)
Fig 5.4: Capacity Constraints, Biomanufacturers vs. CMOs, 2024
Fig 5.5: Capacity Constraints, U.S. vs. Western Europe, 2024
Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections (by 2029)
Fig 5.7: Expectations of Capacity Constraints: Five-year Projections (2004-2024)
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections (Trend Line) (2004-2024)
Fig 5.9: Five-year Projections for Capacity Constraints: Biomanufacturers vs. CMOs (2029)
Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe (2029)
Fig 5.11: Factors Creating Future Capacity Constraints in Five Years (2029)
Fig 5.12A: Factors Creating Future Capacity Constraints in Five Years (2008-2024)
Fig 5.12B: Factors Creating Future Capacity Constraints in Five Years (2008-2024)
Fig 5.13: Factors Creating Future Capacity Constraints:Biomanufacturers vs. CMOs, 2024
Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western Europe Biomanufacturers, 2024
Fig 5.15: Key Areas to Address to Avoid Capacity Constraints, 2024
Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints (2006-2024)
Fig 5.16B: Key areas to Address to Avoid Capacity Constraints (2006-2024)
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs, 2024
Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe, 2024
Fig 5.19: Average Time (weeks) Between Batch Failures (2009-2024)
Fig 5.20: Batch Failure Frequency Distribution (2009-2024)
Fig 5.21: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2024
Fig 5.22: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing (Commercial Manufacture) (2009-2024)
Fig 5.23: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing (“Clinical” Scale) (2009-2024)
Fig 5.24: Automation Technologies Implemented/to be Implemented in 2024
Fig 5.25: Automation Technologies to be Implemented; Comparing (2009 - 2013, 2022-2024)
Fig 5.26: Global Quality Supply Management (2011-2013, 2022-2023)
Fig 5.27: Global Quality Supply Management, Biomanufacturers vs. CMOs, 2023
Fig 5.28: Global Quality Supply Management (U.S. vs. W. Europe), 2023
Fig 5.29: Addressing Supply Chain Security (2023-2024)
Fig 6.1: Industry Average Planned Production Increase: Five Year Estimates (2029)
Fig 6.2: Planned Future Capacity Expansion: Five Year Estimates (2009–2029)
Fig 6.3: Planned Future Capacity Expansions: Five Year Estimates, Biomanufacturers vs. CMOs, by 2029
Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates, U.S. vs. Western Europe, by 2029
Fig 6.5: Percentage of Respondents Projecting Production Increases over 100%: Five Year Trend (2029)
Fig 7.1: Current Percent Production Outsourced; by System, 2024
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production (2006-2024)
Fig 7.3: Current Percent Respondents Outsourcing up to 50% of Production, by System, 2009-2024
Fig 7.4: Biomanufacturers’ Outsourcing, Five Year Projections, by System (2029)
Fig 7.5: Five Year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2024
Fig 7.6: Biomanufacturers Outsourcing Some Activity Today, 2024
Fig 7.7A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today (2010-2024)
Fig 7.7B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today (2010-2024)
Fig 7.8: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years (2024)
Fig 7.9A: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’in 2 Years, Trends (2010-2024)
Fig 7.9B: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’in 2 Years, Trends (2010-2024)
Fig 7.10: Estimated Average Percentage of Activity Outsourced, by Facilities Today, 2024
Fig 7.11A: Estimated Average Percent of Activity Outsourced, by Facilities (2010-2024)
Fig 7.11B: Estimated Average Percent of Activity Outsourced, by Facilities (2010-2024)
Fig 7.12: Change in Spending on Outsourcing for R&D or Manufacturing, Next 12 months (2012-2024)
Fig 7.13: Average Change in Outsourcing Spending by Facilities (2013-2024)
Fig 7.14: Percent Indicating USA as Likely or Strong Likely Selection for INTERNATIONAL (non-US respondents) Outsourcing Over Next Five Years, 2009-2024 (targeting 2029)
Fig 7.15: Country Selections for International Outsourcing/Capacity Expansion Over Next Five Years, 2029
Fig 7.16A: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2024)
Fig 7.16B: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2024)
Fig 7.17A: U.S. Respondents Considering International Country as “Possible” International Outsourcing Destination, over Next Five Years (2009-2024)
Fig 7.17B: U.S. Respondents Considering International Country as “Possible” International Outsourcing Destination, over Next Five Years (2009-2024)
Fig 7.18: U.S. Respondents Considering Country as “Strong likelihood” or “Likelihood” as Outsourced Capacity Destination, Next Five Years (2029)
Fig 7.19A: Western European Respondents Considering Country as “Possible” Outsourcing Destination, Next Five Years, (2009-2024)
Fig 7.19B: Western European Respondents Considering Country as “Possible” Outsourcing Destination, Next Five Years, (2009-2024
Fig 7.20: Western European Respondents Considering Country as ‘Strong likelihood’ or ‘Likelihood’ as Outsourced Capacity Destination, over Next Five Years (2029)
Fig 7.21: Percent of Biomanufacturing Operations Offshored (International Outsourcing) to Lower-Cost Regions Within Five Years (2029)
Fig 7.22: Biomanufacturers Performing at Least “Some” International Outsourcing/Offshoring Over Next Five Years (2011-2024)
Fig 7.23: Estimated Average Percentage of Operations to be Done as International Outsourcing/Offshoring to Lower-Cost Regions During Next Five Years (2011-2024)
Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture, 2024
Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2024)
Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2024)
Fig 8.3: Average Annual Growth Rate, Disposables (2006-2024)
Fig 8.4: 18-Year Percentage-Point Increase in First Usage of Disposables (2006-2024)
Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture (R&D–Commercial), 2024
Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing: Biomanufacturers vs. CMOs, 2024
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: Time Since Facility’s Last Failure of Single-use Devices and Equipment, 2024
Fig 8.10: Average Weeks Before Failures of Single-use Devices and Equipment (2023-2024)
Fig 8.11: Need for Improved Single-Use Sensors (2012-2017, 2019) (2019 data)
Fig 8.12: Single-Use Product Vendor Satisfaction Factors (2008-2024)
Fig 8.13: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction, 2024349
Fig 8.14: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction (2013-2024)
Fig 8.15: Estimated Percentage of Facilities’ Unit Operations that Are “Single-Use” (2014-2024)
Fig 8.16: Distribution of Responses, % Single-Use Devices in Biomanufacturing, 2024
Fig 9.1: Impact of Downstream Processing on Overall Capacity (2008-2024)
Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biomanufacturers vs. CMOs, 2024
Fig 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe, 2024
Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps, 2024
Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at ‘Significant’ or ‘Severe’Constraints (2008-2024)
Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe, 2024
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 (2022)
Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses (2014 -2016, 2018-2024)
Fig 9.11: Bioreactor Output at which DOWNSTREAM Purification Train BecomesBottlenecked (2014-2016, 2018-2024)
Fig 9.12: New Downstream Processing Solutions, 2024
Fig 9.13A: New Downstream Processing Solutions Comparison (2010-2024)
Fig 9.13B: New Downstream Processing Solutions Comparison (2010-2024)
Fig 9.14: New Downstream Processing Solutions: Biomanufacturers vs. CMOs, 2024
Fig 9.15: New Downstream Processing Solutions: U.S. vs. Western Europe, 2024
Fig 9.16: Improving Downstream Operations, 2011-2019 (2019 data)
Fig 10.1: New Hires in Biopharmaceutical Manufacturing, 2024
Fig 10.2: Estimated Hiring, by Area (2008-2024)
Fig 10.3: New Hires in Biopharmaceutical Manufacturing in Five Years (2029)
Fig 10.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2024
Fig 10.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2024)410
Fig 10.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2024)411
Fig 10.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe, 2024
Fig 10.7: Skills or Hands-On Training Required in NEW HIRES in GMP Bioprocessing (2023 vs. 2024)
Fig 11.1: Future of Continuous Bioprocessing and Process Intensification, 2024
Fig 11.2: Future of Continuous Bioprocessing and Process Intensification (2021-2024)
Fig 11.3: Perfusion Operations Issues (2010 – 2016, 2020, 2023-2024)
Fig 11.4: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing, 2024
Fig 11.5: Facilities Evaluating CBP Technologies Over the Next 12 Months (Upstream) (2016-2024)
Fig 11.6: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream) (2016-2024)
Fig 11.7: Most Needed Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2024)
Fig 11.8: Most Needed Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure (2019-2024)
Fig 11.9: Cell or Gene Therapy Plans for GMP and Commercial Manufacturing (2020-2024)439
Fig 11.10: Cell Therapy Capacity Plans for In-House Bioprocessing Facilities Next Five Years (2029)
Fig 11.11: Commercial Manufacturing of Cell Therapies (2021)
Fig 11.12: Commercial Manufacturing of Gene Therapy Vectors and Products (2021)
Fig 12.1: Area of Biopharmaceutical Involvement, Vendor, 2024
Fig 12.2: Area of Biopharmaceutical Involvement, Vendor (2010-2024)
Fig 12.3A: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2024)
Fig 12.3B: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2024)
Fig 12.4: Vendor Respondents’ Primary Job Function, 2024
Fig 12.5: Average Annual Vendor Sales Growth Rate (2007-2024)
Fig 12.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution, 2024
Fig 12.7: Average Annual Vendor Segment Sales Growth Rates, 2024
Fig 12.8: Average Annual Vendor Sales Growth Rate, by Segment (2007-2024)
Fig 12.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment % (2012-2024)
Fig 12.10: Vendors’ Average Budget Change, 2024
Fig 12.11: Vendors’ Average Budget Change, Summary (2009-2024)
Fig 12.12: Vendors’ Average Pricing Changes, Last Year (2024 data)
Fig 12.13: Vendors’ Average Pricing Changes (2009-2023 Actual and 2024 projected)
Fig 12.14: ‘Most Important’ Factors to Measure The ‘Quality’ of Business Relationships with Suppliers, 2022-2024
Fig 12.15: Factors Important in Measuring the ‘Quality’ of Business Relationships, Suppliers Perspective vs. Facility Perspective, 2024
Fig 12.16: Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in COVID-Related Factors (2023-2021)
Fig 12.17: Post COVID Impact on Suppliers: Permanent Changes caused by Pandemic on Your Business Operations, 2024
Fig 12.18: Biopharma Business and Marketing Plans, 2024
Fig 12.19: Biopharma Business and Marketing Plans (2010-2024)
Fig 12.20A: Top New Technologies or New Product Development Areas (2011-2024)
Fig 12.20B: Top New Technologies or New Product Development Areas (2011-2024)
Fig 12.21: R&D Spending/Budgets for New Products/Services, 2024
Fig 12.22: Approximate Average Annual R&D Spending/Budget for New Products/Services (2017-2024)
Fig 12.23: Areas Where Training is Considered as Needed, All Vendor Respondents (2010-2024)
Fig 12.24: Client Demands of Vendors, Service and Support (2012-2024)
Fig 12.25: Vendors Views of Financial (Sales) Outlook for Next Year (2011-2024)
Fig 12.26: Average CMOs Service Price Shifts over the Past 12 Months, 2024
Fig 12.27: CMOs Service Price Shifts Over Past 12 Months, Distribution, 2024
TABLES
Table 0.1: Areas of Biopharmaceutical Manufacturing Operations (2018-2024)
Table 1.1 Worldwide Revenue of Biopharmaceuticals ($USD billions)
Table 1.2 Number of Biopharmaceutical Products in U.S. and European Markets, 2023/2024
Table 1.3 Global Market for Top 50 Biopharma Products in (2022-2023, $USD Million)
Table 1.4 Top 50 Biopharmaceutical Products Vs. Total Market Size (%) $mm
Table 1.5 Bioprocess Related Industry Expenditures on Manufacture of Biotherapeutics (estimated $USD, billions)
Table 1.6 Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2024
Table 2.1: Biopharmaceuticals Approved by FDA, 2023
Table 2.2: Biopharmaceuticals Approved by FDA in 2024 (till 10 June’24)
Table 2.3: All FDA/ EMA Approved or Pre-Registered In-Vivo Gene Therapies and Their Manufacturers
Table 2.4: All FDA/ EMA Approved or Pre-Registered Gene-Modified Cell Therapies and Their Manufacturers
Table 2.5: Approved bsAb (1)
Table 2.6: Approaches Enforcing HC Heterodimer Formation
Table 2.7: Approaches Minimizing HC-LC Mispairing
Table 2.8: Purification Strategies To Eliminate Product Related Impurities (40)
Table 3.1 Areas of Significant Projected Budget Percentage Increases for Biomanufacturing(2011-2024)
Table 4.1 Leading Biopharma Company Capacity Estimates, 2024
Table 4.2: Regional Distribution of Total Worldwide Average Capacity*
Table 4.3: Bioprocessing CMOs, Their Number of Facilities Worldwide and Estimated Total Capacity*
Table 4.4 Compound Annual Change in mAb Titers (2008-2024)
Table 5.1 Severe or Significant Capacity Constraints, by Stage of Production (2009-2024)
Table 5.2: Severe and Significant Capacity Constraints Today, U.S. vs. W. Europe (2010-2024)
Table 5.3: Average Rates of Failure, by Primary Cause, and Phase of Manufacture (2017-2024)
Table 6.1: U.S. Biomanufacturers’ Five-Year Projected Capacity Increases, by System (2008-2024)
Table 6.2: Western European Biomanufacturers’ Five-Year Projected Capacity Increases, by System (2008-2024)
Table 6.3: Future Capacity Expansions Coming Online in the Next 24 Months
Table 7.1: Percentage of U.S.-based Respondents Indicating Country as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2009-2024)
Table 7.2 Percent of Western European-based Respondents Indicating International Countries as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2011-2024)
Table 9.1 Percent of Biomanufacturers vs. CMO Facilities experiencing “Serious” or “Some” Capacity Problems due to Downstream Processing (2008-2024)
Table 9.2 Percent of U.S. vs. Western Europe Facilities Experiencing ‘Serious’ Capacity Problems due to Downstream Processing (2009-2024)
Table 9.3 Percent U.S. vs. Western Europe Facilities Not Expecting to see Bottlenecks due to Downstream Processing (2008-2024)
Table 9.4 Upstream Production Titer vs. Max Capacity (2018-2024)
Table 12.1 Average Vendor Sales and Technical Training Days (2011-2013, 2019-2021)

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