The 2025 22nd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most comprehensive, longest-running study of bioprocessing professionals. The 22nd Annual Report provides Key Takeaways for every chapter highlighting top trends, insights, and opportunities.
Key Highlights
- 203 Biopharma companies surveyed
- 116 industry vendors and direct suppliers of materials
- 21 Countries represented
- ~550 Pages
- 12 Chapters
- 200 Graphs and 20 Tables
- Subject Matter Experts providing analysis
- Independent Sponsoring Organizations
Report Coverage
- Compare 203 Biomanufacturers vs CMOs; U.S. vs. European & Global Biomanufacturing
- Comprehensive overview of biopharmaceutical manufacturing industry trends, technologies, and challenges
- Industry budget trends and impact of the current economic environment
- Downstream purification problems and issues
- Current and projected biopharmaceutical industry bottlenecks
- Capacity utilization and current production levels
- Capacity bottlenecks - what’s being done to resolve
- Biopharma production trends and Outsourcing trends
- International offshoring through 2030
- 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
Table of Contents
Methodology
Demographics
- Introduction
- Respondents’ Area of Involvement
- Respondents’ Qualifications
- Facility Locations
- Areas of Biopharmaceutical Manufacturing Operations
- Production Operations, Phase of Development
- Employees at Facility
- Batches Run at Facility per Year
- Single-Use Bioreactor Capacity in Use at Site
- Stainless Steel Bioreactor Capacity in Use at Site
Chapter 1: Introduction and Discussion
- 1-1 Sector and Market Overview
- The 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
- 1-6 Future Trends in the Biopharmaceutical Industry
- Future Trends in Biopharma
- Conclusion
Chapter 2: Future of Bioprocessing: Experts’ Perspective
- 2-1 2024 FDA Biopharmaceutical Approvals: Promising Year for Novel Biologics Driven by Innovation and Targeted Therapies
- 2-2 Recent Transactions Affecting the CDMO Landscape in 2024
- 2-3 The Waiting Game: A Bottom is Imminent for Bioprocessing in China With a Return to Growth Two Years Away
- 2-4 Future of Contract Fill-Finish: Post COVID Landscape
Chapter 3: Trends and Emerging Technologies
- 3-1 Industry Trends in 2025
- 3-2 Bioprocessing Improvements Needed in 2025
- Bioprocessing Improvements Most Needed
- Novel Bioprocessing Systems/Innovations
- Novel Bioprocessing Systems/Innovations, Biomanufacturers vs. CMOs
- 3-3 Operational Changes in Pre- and Post-COVID
- Operational Changes Due to Recent Global Economics, 2010-2025
- Operational Changes (2010 - 2012, 2022-2025)
- Operational Changes: Biomanufacturers vs. CMOs
- Operational Changes: U.S. vs. Western Europe
- 3-4 Budget Issues in 2025
- Biomanufacturers’ Budget Shifts in 2025
- Budget Change Comparisons (2009-2025)
- 3-5 Top Bioprocessing Budget Expenditures
- New Expenditure Focus Areas in 2025
- Top New Bioprocessing Budget Expenditures (2020-2025)
- 3-6 New Bioprocessing Products Development Opportunities (2025)
- Upstream New Product Areas of Interest
- Downstream New Product Areas of Interest
- Other General New Product Areas of Interest
- New Product Development Areas: Biomanufacturers vs. CMOs
- New Product Development Areas: U.S. vs. Western Europe and ROW
- 3-7 Factors in Biomanufacturing Creating Improvements
- Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements in 2025
- Factors Improving Biomanufacturing Performance (2010-2015, 2025)
- Factors Improving Biomanufacturing Performance, Biotherapeutic Developers vs. CMOs
- Factors Improving Biomanufacturing Performance, U.S. vs. Western Europe vs. ROW.
- 3-8 Cost-Cutting Actions & Development Timelines
- Cost-Cutting Changes: Actions Undertaken During 2011-2016, 2019-2024
- Cost-Cutting Changes: Specific to Outsourcing
- Factors Impacting Reduction in Cost of Goods (2020-2024)..
- 3-9 Average Cost per Gram Recombinant Protein
- Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2025
- Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2025)
- 3-10 Assay Development
- Biomanufacturing Assay Areas Required; Biomanufacturers vs. CMOs
- Biomanufacturing Assay Areas Required, U.S. vs Western Europe
- 3-11 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
- Top Options for Bioreactor Platforms at Commercial Scale (2021-2024)
- Largest Stainless Steel Bioreactor Capacity Purchase in Next Two Years, 2025 vs. 2022
- Largest Stainless Steel Bioreactor Capacity Purchase in ‘Next Two Years’, 2025 vs. 2022
- Largest Single-Use Bioreactor Capacity Purchase in Next Two Years 2025 vs. 2022
- 3-12 Discussion: Industry Trends and Issues
- Industry Growth and Adaptation
- Cost Cutting Trends
- Discussion of Cost per Gram
- Discussion of Maturity of Single-Use
Chapter 4: Capacity Utilization
- 4-1 Capacity Utilization Trends
- Capacity Utilization Definitions
- Relevance of Capacity Utilization
- Capacity Utilization in Other Industries, 2025: US Federal Reserve Board Comparisons
- Capacity Utilization in Biomanufacturing, By System, 2025
- Capacity Utilization Changes (2006-2025)
- Average Growth Rate in Capacity Utilization (2006-2025)
- 4-2 Capacity Utilization: Biomanufacturers vs. CMOs
- 4-3 Capacity Utilization: U.S. vs. Western European Manufacturers
- Historical 13-year US vs EU Trends in Capacity Utilization
- 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
- Distribution of mAb Tier Ranges
- Annual mAb Titer Changes (2008-2025)
- 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’ Perception of Capacity Constraints (2004-2025)
- 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 (2030)
- Expected Capacity Constraints Five-year Projections (2004-2025)
- Expected Capacity Constraints in Five Years: Biomanufacturers vs. CMOs (2030)
- Expected Capacity Constraints in Five Years: U.S. vs. Western Europe
- 5-3 Factors Impacting Future Production Capacity
- Factors Creating Future Capacity Constraints in Five Years (2030)
- Factors Creating Future Capacity Constraints (2008-2025)
- 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 in 2025
- Areas to Avoid Capacity Constraints: Changing Perspectives (2006-2025)
- 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
- Background and Definitions
- Average Time Between Batch Failures (2009-2025)
- Batch Failure Frequency Distribution (2009-2025)
- Primary Cause of Batch Failures, Percentages of Failures
- Primary Cause of Batch Failures, Percentages of Failures for Commercial Manufacturing (2009-2025)
- Primary Cause of Batch Failures, Percentages of Failures for Clinical Scale Manufacture (2009-2025)
- Improving Failure Rates
- 5-6 Quality Problems in Biomanufacturing Attributed to Vendors
- 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 Post Pandemic
- 5-7 Discussion: Industry Trends
- Mitigation Strategies for Financial Constraints in Biomanufacturing
- Automation to Address Capacity Constraints..
Chapter 6: Planned Future Capacity Expansions
- 6-1 Planned Future Capacity Expansions
- Industry Average Planned Production Increases, Five Years Estimates (2030)
- Planned Future Capacity Expansions: Five Year Estimates (2009-2030)
- Planned Future Capacity Expansions of >100%, by Systems
- 6-2 Planned Future Capacity Expansions for Biomanufacturers vs CMOs, by System
- Planned Future Capacity Expansions for Biomanufacturers vs. CMOs, Five Year Estimates (2030)
- 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 (2030)
- 6-4 Planned Future Capacity Expansions
- Greenfield Project
- Brownfield Project
- Biomanufacturing Capacity Under Active Construction in 2025
- 6-5 Discussion: Future of Capacity Expansion Trends
- Drivers Of Platform- Specific Capacity Expansion
- Regional Differences Influence Capacity Growth In Gene Therapy
Chapter 7: Outsourcing Trends in Biopharmaceutical Manufacturing
- Why Outsource?
- Strategic Manufacturing Planning
- Future Projections
- 7-1 Current Outsourcing by Production System
- Facilities Currently Outsourcing Production by System (2025)
- Facilities Currently Outsourcing No Production (All Production “In-house”) (2006-2025)
- 7-2 Future Outsourcing
- Biotherapeutic Developers’ Outsourcing, 5-Year Projections, by System (2030)
- Five Year Projections for Biomanufacturers Outsourcing Some Production
- 7-3 Outsourced Activities in Biopharmaceutical Manufacturing
- Biomanufacturers Outsourcing Some Activity Today, 2025
- Comparison of Biomanufacturers’ Outsourcing, (2010-2025)
- Increased Outsourced Activities, 24-Month Projections
- Outsourcing Activities Projected at ‘Significantly Higher Levels’ (2010-2025)
- Average Percentage of Activities Outsourced Today, 2025
- Comparison of Outsourcing Activities (2010-2025)
- Change in Average Spending on Outsourcing Activities
- Change in Average Spending on Outsourcing by Facilities (2013-2025)
- 7-4 Critical Outsourcing Issues
- Selecting a CMO: 2025
- Proximity of CMOs to the Client
- Selecting a CMO, 2006-2018, 2025
- 7-5 CMOs’ Problems with Their Clients
- 7-6 Country Selections for International Outsourcing (Offshoring) of Biomanufacturing
- U.S. BioSecure Act Impact on Offshoring
- USA as Likely for INTERNATIONAL (non-US respondents) Outsourcing Over Next Five Years
- Country Selections for International Outsourcing (Offshoring) of Biomanufacturing, Over Five Years (2016-2025)
- U.S.-based Companies “Possible” Outsourcing Destinations
- U.S.-based Companies “Likely” Outsourcing Destinations
- W. European - based Companies “Possible” Outsourcing Destinations
- W. European - based Companies “Likely” Outsourcing Destinations
- 7-7 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 (2011-2025)
- Five Year Projection for Average Percentages of Biomanufacturing International
- Outsourcing/Offshoring to Lower-Cost Regions (2011-2025)
- Outsourcing to New Regions (2020 data)
- 7-8 Discussion of Outsourcing and Offshoring
- Trends and Drivers of Outsourcing
- 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 (2006-2025)
- Average Annual Growth Rate for Disposables: Market Penetration/Usage
- 19-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
- Factors that May Restrict Use of Disposables, 2025
- Most Important Factors That May Restrict Use of Disposables (2006-2015, 2025)
- Cell-Culture Problems due to Single-Use Devices (2022 vs. 2021)
- Recycling of Disposables (2020)
- 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, 2023-2025
- 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 (2008-2025)
- Single-Use Attribute Importance Analysis
- Single-Use Suppliers’ Issues (2013-2025)
- 8-8 Single-Use Operations and Trends
- Percentage of Unit Operations that are Single-Use (2014-2025)
- 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 (2008-2025)
- 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 (2010-2025)
- New Downstream Processing Technologies; Biomanufacturers vs. CMOs
- New Downstream Processing Technologies: U.S. vs. Western Europe
- 9-6 Improvements to Downstream Operations
- Drivers of Downstream Processing Bottlenecks
- Improving Downstream Operations (2011-2019, 2025)
- 9-7 Fill Finish Trends
- Background & Definitions
Current Fill-Finish Trends
Recent Industry Trends.
New Technology Implementation in Fill-Finish
Outsourcing Fill/Finish
- Background & Definitions
- 9-7 Discussion: Industry Trends
- Downstream Processing Solutions
Chapter 10: Hiring, Employment Growth, and Training in Biopharmaceutical Manufacturing
- 10-1 Hiring Trends
- New Hires in Biopharmaceutical Manufacturing, 2025
- Trends in New Hires, by Area (2008-2025)
- 10-2 Five Year Trends in Hiring (2030)
- 10-3 Hiring Challenges Today
- Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2025
- Hiring Difficulties (2010-2025)
- 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
- Root Causes of the Persistent Talent Gap
- Strategic Trainings
- Attractive Career Paths
Chapter 11: New Methods: Continuous and Process Intensification, Cell and Gene Therapies
- 11-1 Future Adoption of Continuous Bioprocessing and Process Intensification
- Future of Continuous Bioprocessing in 2025
- Future of Continuous Bioprocessing (2021-2025)
- 11-2 Perfusion Operations and Continuous Bioprocessing Operational Issues
- Perfusion vs. Batch Fed Bioprocessing - Areas of Much Bigger Concern
- Perfusion Operation Issues (2010-2014, 2016, 2020, 2023-2025)
- Evaluating or Considering CBP technologies (Upstream) Over the Next 12 Months (2016-2025)
- Evaluating or Considering CBP technologies (Downstream) Over the Next 12 Months (2016-2025)
- Continuous Bioprocessing and Perfusion Trends
- 11-3 Automation Implementation
- Demand for Automation
- Automation Technologies Implemented/to be Implemented
- Comparison of Implementation Plans (2009-2013, 2022-2025)
- The Role of Automation in Supporting Continuous Bioprocessing ..
- 11-4 Cell and Gene Therapy Platforms
- Cell and Gene Therapy Manufacturing: A Catalyst for Innovation
- Cell and Gene Therapy Manufacturing Trends
- Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2025)
- Gene Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2025)
- Advanced Therapy (Cell or Gene Therapy) GMP and Commercial Manufacturing (2020-2025)
- Cell Therapy Capacity Plans for In-House Bioprocessing Facilities: Five Year Estimates (2023-2025)
- Cell Therapies Commercial Manufacturing Scales (2021)
- Gene Therapy Vectors and Products Commercial Manufacturing Scales (2021)
- 11-5 Discussion: Future of Biomanufacturing
- Looking Ahead: Industry Considerations and Strategic Imperatives.
Chapter 12: Suppliers to Biopharmaceutical Manufacturing and Life Sciences
- 12-1 Demographics
- Areas of Involvement
- Location of Vendor Sales
- Vendor / Supplier Respondents’ Primary Job
- 12-2 Growth Rate of Sales by Suppliers
- Average Annual Vendor Sales Growth Rate
- Distribution of Growth Rates
- Average Industry Growth Rate, By Segment
- 12-3 Budget Issues and Problems Faced by Industry Suppliers
- Budget Challenges in 2025
- 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
- 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 (2010-2025)
- 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 (2017-2025)
- 12-7 Sales Staff Training
- Days of Training Provided by Suppliers (2021 data)
- Areas where Training May Help Sales Staff Perform, Trends (2010-2025)
- Client Demands of Vendors, Service and Support (2012-2025)
- 12-8 Biopharma Vendors’ Financial Outlook for 2025
- 12-9 CMO Pricing Changes for Biopharmaceutical Services
- 12-10 Discussion: Biopharma Suppliers
- Vendor and Industry Growth
- Vendors are Offering More Services
- Biopharma Suppliers in Emerging Regions
