2026 23rd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

Table of Contents

METHODOLOGY

CHAPTER 0: DEMOGRAPHICS

• KEY TAKEAWAYS
• 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
    • Analysis of Average Single-use Bioreactor Size
  • 0-9 STAINLESS STEEL BIOREACTOR CAPACITY IN USE AT SITE
    • Analysis of Average Stainless Steel Bioreactor Size

CHAPTER 1: INTRODUCTION AND DISCUSSION

• 1-1 SECTOR AND MARKET OVERVIEW
  • The Industry Continues to Mature
  • M&A Activities
  • “Biopharmaceutical:” - The Definition Used Here
  • Contract Manufacturing Trends
• 1-2 BIOPHARMACEUTICAL INDUSTRY STATUS AND MARKET TRENDS
  • U.S. Healthcare is Changing
  • Bioprocessing is Increasing Internationally
• 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
• 1-6 ANIMAL DERIVED PRODUCTS AND BIOPHARMACEUTICALS
  • Animal Derived Products and Biopharmaceuticals
  • Plant-based Biopharmaceutical Manufacturing
• 1-7 FUTURE TRENDS IN THE BIOPHARMACEUTICAL INDUSTRY
  • Future Trends in Biopharma
  • Conclusion

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE

• 2-1 2025 FDA Biopharmaceutical Approvals: Promising Year for Novel Biologics Driven by Innovation and Targeted Therapies
• 2-2 Recent Transactions Affecting the CDMO Landscape in 2025
• 2-3 Artificial Intelligence in Biopharmaceutical Development,Manufacturing, and Quality
• 2-4 Vein-to-Vein Manufacturing: Why Cell Therapy Requires a Patient-Centric Compliance Model
• 2-5 Can CDMOs Meet the Demand for Capacity in Peptide and Oligonucleotide Therapeutics Manufacturing?

CHAPTER 3: TRENDS AND EMERGING TECHNOLOGIES

• KEY TAKEAWAYS
  • 3-1 INDUSTRY TRENDS IN 2025
    • Background and Definitions
    • 3-2 BIOPROCESSING IMPROVEMENTS NEEDED IN 2026
      • 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
      • Operational Changes (2010 – 2012, 2022-2026)
      • Operational Changes: Biomanufacturers vs. CMOs
      • Operational Changes: U.S. vs. Western Europe
    • 3-4 BUDGET ISSUES IN 2026
      • Biomanufacturers’ Budget Shifts in 2026
      • Budget Change Comparisons (2009-2026)
    • 3-5 TOP BIOPROCESSING BUDGET EXPENDITURES
      • New Expenditures Focus Areas in 2026
      • Top New Bioprocessing Budget Expenditures (2020-2026)
    • 3-6 NEW BIOPROCESSING PRODUCTS DEVELOPMENT OPPORTUNITIES (2026)
      • Upstream New Product Areas of Interest, 2026
      • Trends: Upstream New Product Areas of Interest (2010-2026)
      • Downstream New Product Areas of Interest, 2026
      • Analysis Of Key Finding: Demand for New Product Development in
      • Upstream Bioprocessing
      • Trends: Downstream New Product Areas of Interest (2010-2026)
      • Other General New Product Areas of Interest, 2026
      • Trends: Other General New Product Areas of Interest (2010-2026)
      • 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, 2026
    • Factors Improving Biomanufacturing Performance (2010-2015, 2025-2026)
    • 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, 2026
    • Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2026)
    • Analysis of Key Finding: Some Good from the Pandemic. Cost per Gram in Biomanufacturing Proteins dropped 10% annually during COVID
  • 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)
    • Top Options for Bioreactor Platforms at Commercial Scale
    • Top Options for Bioreactor Platforms at Commercial Scale (2021-2024)
    • Largest Single-Use Bioreactor Capacity to Purchase in Next Two Years (2022, 2025-2025)
    • Largest Stainless Steel Bioreactor Capacity Purchase in ‘Next Two Years’,2022, 2025-2026
  • 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

• KEY TAKEAWAYS
• 4-1 CAPACITY UTILIZATION TRENDS
  • Capacity Utilization Definitions
  • Relevance of Capacity Utilization
  • Capacity Utilization in Other Industries, 2026: US Federal Reserve Board Comparisons
  • Capacity Utilization in Biomanufacturing by System, 2026
  • Capacity Utilization Changes (2006-2026)
  • Average Growth Rate in Capacity Utilization (2006-2026)
• 4-2 CAPACITY UTILIZATION: BIOMANUFACTURERS VS. CMOS
  • Capacity Utilization By System, Biomanufacturers vs. CMOs, 2026
• 4-3 CAPACITY UTILIZATION: U.S. VS. WESTERN EUROPEAN MANUFACTURERS
  • Capacity Utilization, By System, U.S. vs. Western Europe
  • Historical 14-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 Titer Ranges
  • Annual mAb Titer Changes (2008-2026)
• 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

• KEY TAKEAWAYS
• 5-1 CURRENT CAPACITY CONSTRAINTS
  • Background & Definitions
  • Current Capacity Constraints
  • Respondents’ Perception of Capacity Constraints (2004-2026)
  • 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 (2031)
  • Expected Capacity Constraints Five-year Projections (2004-2026)
  • Expected Capacity Constraints in Five Years: Biomanufacturers vs. CMOs (2031).215
  • Expected Capacity Constraints in Five Years: U.S. vs. Western Europe (2031)
• 5-3 FACTORS IMPACTING FUTURE PRODUCTION CAPACITY
  • Factors Creating Future Capacity Constraints in Five Years (2031)
  • Factors Creating Future Capacity Constraints (2008-2026)
  • Factors Creating Future Capacity Constraints: Biomanufacturers vs. CMOs
  • CMO 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 CONSTRAINT
  • Areas to Avoid Capacity Constraints in 2026
  • Areas to Avoid Capacity Constraints: Changing Perspectives (2006-2026)
  • Key areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs.233
  • 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 (2009-2026)
  • Batch Failure Frequency Distribution (2009-2026)
  • Primary Cause of Batch Failures, Percentages of Failures
  • Primary Cause of Batch Failures, Percentages of Failures for Commercial Manufacturing (2009-2026)
  • Primary Cause of Batch Failures, Percentages of Failures for Clinical Scale Manufacture (2009-2026)
  • Improving Failure Rates
• 5-6 QUALITY PROBLEMS IN BIOMANUFACTURING ATTRIBUTED TO VENDORS
  • Global Quality Supply Management (2011-2013, 2022-2023) – 2023 Data
  • 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 and Artificial Intelligence to Address Capacity Constraints

CHAPTER 6: PLANNED FUTURE CAPACITY EXPANSIONS

• KEY TAKEAWAYS
• 6-1 PLANNED FUTURE CAPACITY EXPANSIONS
  • Background and Definitions
  • Industry Average Planned Production Increases, Five Years Estimates (2031)
  • Planned Future Capacity Expansions: Five Year Estimates (2009-2031)
  • 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 (2031)
• 6-3 PLANNED FUTURE CAPACITY EXPANSIONS FOR U.S. VS. WESTERN EUROPE, BY SYSTEM
  • Planned Future Capacity Expansions for U.S. vs. W. Europe Manufacturers, Five Year Estimates (2031)
• 6-4 PLANNED FUTURE CAPACITY EXPANSIONS
  • Biomanufacturing Capacity Under Active Construction in 2026
• 6-5 DISCUSSION: FUTURE OF CAPACITY EXPANSION TRENDS
  • Drivers of Platform-specific Capacity Expansion

CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING

• KEY TAKEAWAYS
• 7-1 BACKGROUND AND DEFINITIONS
  • Why Outsource?
  • Strategic Manufacturing Planning
  • Future Projections
• 7-2 CURRENT OUTSOURCING BY PRODUCTION SYSTEM
  • Facilities Currently Outsourcing Production by System (2026)
  • Facilities Currently Outsourcing No Production (All Production “In-house”) (2006-2026)
  • Historical Trends in Outsourcing Production
• 7-3 FUTURE OUTSOURCING
  • Biotherapeutic Developers’ Outsourcing, 5-Year Projections, by System (2031)
  • Five Year Projections for Biomanufacturers Outsourcing Some Production
• 7-4 OUTSOURCED ACTIVITIES IN BIOPHARMACEUTICAL MANUFACTURING
  • Biomanufacturers Outsourcing Some Activity Today, 2026
  • Comparison of Biomanufacturers’ Outsourcing, (2010-2026)
  • Increased Outsourced Activities, 24-Month Projections
  • Outsourcing Activities Projected at ‘Significantly Higher Levels’ (2010-2026)
  • Percentage of Activities Outsourced Today, 2026
  • Comparison of Outsourcing Activities (2010-2026)
  • Change in Average Spending on Outsourcing Activities
  • Change in Average Spending on Outsourcing by Facilities (2013-2026)
• 7-5 CRITICAL OUTSOURCING ISSUES
  • Key Attributes CMOs Must Deliver their Clients
  • Selecting a CMO, 2006-2018, 2025-2026
  • Proximity of CMOs to the Client
• 7-6 CMOS’ PROBLEMS WITH THEIR CLIENTS
  • CMOs Problems with Their Clients
• 7-7 COUNTRY SELECTIONS FOR INTERNATIONAL OUTSOURCING (OFFSHORING) OF BIOMANUFACTURING
  • U.S. BioSecure Act Impact on Offshoring (2025 data)
  • USA as Likely for INTERNATIONAL (non-US respondents) Outsourcing
  • Over Next Five Years
  • Possible” Selections for International Outsourcing (Offshoring) of
  • Biomanufacturing, Over Five Years (2016-2026)
  • 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
• 7-8 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 (2011-2026)
  • Five Year Projection for Average Percentages of Biomanufacturing International Outsourcing/Offshoring to Lower-Cost Regions (2011-2026)
  • Outsourcing to New Regions (2020 data)
• 7-9 DISCUSSION: OUTSOURCING AND OFFSHORING
  • Trends and Drivers of Outsourcing
  • Strategic Shifts in Outsourcing
  • Future Projections

CHAPTER 8: DISPOSABLES AND SINGLE-USE SYSTEMS IN BIOPHARMACEUTICAL MANUFACTURING

• KEY TAKEAWAYS
• 8-1 USE OF DISPOSABLES AND SINGLE-USE SYSTEMS
  • Background and Definitions
  • Disposables Applications in Biopharmaceutical Manufacturing
  • Trends in Disposable Applications (2006-2026)
  • Average Annual Growth Rate for Disposables: 20 Years of Market Penetration and Usage
  • 20-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
• 8-4 FACTORS THAT MAY RESTRICT USE OF DISPOSABLES
  • Factors that May Restrict Use of Disposables, 2026
  • Most Important Factors That May Restrict Use of Disposables (2006-2015, 2025-2026)
  • Cell-Culture Problems due to Single-Use Devices (2021 vs. 2022)
  • 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 (2023-2026)
• 8-6 NEED FOR SINGLE-USE SENSORS, AND BIOREACTOR ATTRIBUTES
  • Single-Use Sensor Technologies (2012-2017, 2019, 2026)
• 8-7 SATISFACTION WITH SINGLE-USE DEVICE VENDORS (2008-2026)
  • Single-Use Product Vendor Satisfaction Factors (2008-2026)
  • Single-Use Attribute Importance Analysis
  • Single-Use Suppliers’ Issues (2013-2026)
• 8-8 SINGLE-USE OPERATIONS AND TRENDS
  • Percentage of Unit Operations that are Single-Use (2014-2026)
  • 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

• KEY TAKEAWAYS
• 9-1 IMPACT OF DOWNSTREAM PROCESSING ON CAPACITY
  • Background and Definitions
  • 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
  • Background on Purification Processes in DSP
  • Changes in Impact on Capacity of Purification Steps (2008-2026)
  • 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)
• 9-4 MAB PURIFICATION CAPACITY ESTIMATES
  • Upstream Production Titer vs. Max Capacity
  • Over-building of DSP Capacity to Handle Available Bioreactor Capacity
• 9-5 NEW DOWNSTREAM PROCESSING TECHNOLOGIES
  • New Downstream Processing Solutions (2010-2026)
  • 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, 2025-2026)
• 9-7 FILL FINISH TRENDS
  • Background and Definitions
  • Fill-Finish Trends (2025)
  • Recent Industry Trends
  • New Technology Implementation in Fill-Finish
  • Outsourcing Fill/Finish
• 9-8 DSP Yield in Primary Process
• 9-9 DISCUSSION: INDUSTRY TRENDS
  • Downstream Processing Solutions
  • Artificial Intelligence
  • Continuous Downstream Bioprocessing
  • Single-use systems
  • Membrane-based Filtration

CHAPTER 10: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

• KEY TAKEAWAYS
• Background and Definitions
• 10-1 HIRING TRENDS
  • New Hires in Biopharmaceutical Manufacturing, 2026
  • Trends in New Hires, by Area (2008-2026)
• 10-2 FIVE YEAR TRENDS IN HIRING (2031)
  • New Hires in Biopharmaceutical Manufacturing in Five Years (2031)
• 10-3 HIRING CHALLENGES TODAY
  • Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2026
  • Hiring Difficulties (2010-2026)
  • U.S. and Western Europe Hiring Difficulties
• 10-4 TRAINING IN BIOPHARMACEUTICAL MANUFACTURING
• 10-5 DISCUSSION: STRATEGIES FOR SUCCESSFUL EMPLOYMENT GROWTH
  • Root Causes of the Persistent Talent Gap
  • Rapid Technology Evolution
  • Multidisciplinary Skillset
  • Insufficient Hands-On Training
  • Supply–Demand Mismatch
  • Retention Challenges
  • Strategic Training
  • Attractive Career Paths

CHAPTER 11: NEW METHODS: CONTINUOUS AND PROCESS INTENSIFICATION, CELL AND GENE THERAPIES

• KEY TAKEAWAYS
• INTRODUCTION TO INNOVATIVE BIOPROCESSING
• Background and Definitions
• Benefits of Cell and Gene Therapies
• Benefits of Continuous Bioprocessing and Perfusion
• 11-1 FUTURE ADOPTION OF CONTINUOUS BIOPROCESSING AND PROCESS INTENSIFICATION
  • Future of Continuous Bioprocessing in 2026
  • Future of Continuous Bioprocessing (2018-2025)
• 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
  • Comparison of Implementation Plans (2009-2013, 2022-2026)
  • The Role of Automation in Supporting Continuous Bioprocessing
  • Factor Inhibiting Greater Automation (2026)
• 11-4 ARTIFICIAL INTELLIGENCE (AI) ACTIVITIES
  • Artificial Intelligence in Biomanufacturing
  • Activities Considered Using Artificial Intelligence (AI) in the Next 2 Years (2028)
  • Challenges in Implementation of Artificial Intelligence (2026)
  • Activities Using Artificial Intelligence (AI) Today vs in the Next 2 Years (2028)
• 11-5 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)
• 11-6 DISCUSSION: FUTURE OF BIOMANUFACTURING
  • Looking Ahead: Industry Considerations and Strategic Imperatives

CHAPTER 12: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND LIFE SCIENCES

• KEY TAKEAWAYS
• 12-1 DEMOGRAPHICS
  • Background and Definitions
  • 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
  • Average Industry Growth Rate, By Segment (2007-2026)
  • Supplier Annual Sales, Distribution
• 12-3 BUDGET ISSUES AND PROBLEMS FACED BY INDUSTRY SUPPLIERS
  • Budget planning requires long-term projections for sales, segment growth and other trends
  • Budget Challenges in 2026
  • Vendor Average Pricing Changes
  • Vendor Projected 2026 Pricing Changes
• 12-4 PROBLEMS CLIENTS HAVE WITH THEIR VENDORS
  • Quality of Business Relationships with Suppliers
  • Quality of Business Relationships with Clients
  • Supplier Values:
  • Facility / Customer Values:
  • CMOs Problems with Their Clients (2018 data)
  • 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 (2010-2026)
• 12-6 VENDORS’ PRODUCTS AND SERVICES
  • New Technology Areas in Development by Vendors
  • Suppliers’ R&D Spending/Budgets for New Products/Services
• 12-7 SALES STAFF TRAINING
  • Areas where Training May Help Sales Staff Perform, Trends (2010-2026)
  • Client Demands of Vendors, Service and Support (2012-2026)
• 12-8 BIOPHARMA VENDORS’ FINANCIAL OUTLOOK FOR 2026
• 12-9 CMO PRICING CHANGES FOR BIOPHARMACEUTICAL SERVICES
• 12-10 DISCUSSION: BIOPHARMA SUPPLIERS
  • Vendor and Industry Growth
  • Biopharma Suppliers in Emerging Regions

List of Figures

• Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing (2010-2026)
• Fig 0.2: Respondents’ Job Responsibilities (2011-2026)
• Fig 0.3: Facility Location, 2026
• Fig 0.4: Facility Location, by Region, 2026
• Fig 0.5: Biopharmaceutical Manufacturing Systems, Trends (2007-2026)
• Fig 0.6: Phase of Development of Surveyed Respondents (2006-2026)
• Fig 0.7: Phase of Development of Surveyed Respondents, U.S. vs. Western Europe (2026)
• Fig 0.8: Distribution of Employees at Facility and Organization, 2026
• Fig 0.9: Distribution of Total Batches Run at Facility in Past 12 Months, by Scale of Production (2026)
• Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity (2017-2026)
• Fig 0.11: Average SINGLE-USE Bioreactor Volume (Liters) (2017-2026)
• Fig 0.12: Distribution of Largest STAINLESS Bioreactor Capacity (2017-2026)
• Fig 0.13: Average ‘Largest’ Stainless Steel Capacity (L) (2017-2026)
• 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 1982 (1982-2025)
• Fig 2.2: Number of Facilities, both Recombinant and Synthetic (SPPS), Peptide Therapeutics, All Scales, 2026, Percent
• Fig 2.3: Global Capacity for Synthetic (SPPS), Commercial-scale Peptide Therapeutics, 2026, Percent
• Fig 2.4: Factors Creating Future Capacity Constraints, Biomanufacturers vs. CMOs, 2026, Percent
• Fig 3.1: SINGLE Most Important Biomanufacturing Trend or Operational Area (2014-2026)
• Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (2018-2026)
• Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (Biomanufacturers vs. CMOs), 2026
• Fig 3.4: Operational Changes Due to Recent Global Economics, 2026
• Fig 3.5: Operational Changes Due to Recent Global Economics (2010 - 2012, 2022-2026)
• Fig 3.6: Operational Changes Due to Recent Global Economics; Biomanufacturers vs. CMOs, 2026
• Fig 3.7: Operational Changes Due to Recent Global Economics; U.S. vs. Western Europe, 2026
• Fig 3.8: Biomanufacturers’ Budget Shifts, 2026
• Fig 3.9: Approximate Average Change in Biomanufacturers’ Budgets, 2026
• Fig 3.10: Average Biomanufacturers’ Budget Changes (2009-2026)
• Fig 3.11: New Expenditures Focus Areas, 2026
• Fig 3.12: New Expenditures Focus Areas (2020-2026)
• Fig 3.13: New Product Development-Upstream Focus Areas, 2026
• Fig 3.14: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2026)
• Fig 3.15: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2026
• Fig 3.16: New Product Development – Downstream Focus Areas (2010-2026)
• Fig 3.17: New Product Development – General Focus Areas, Biomanufacturers & CMOs, 2026
• Fig 3.18: New Product Development – General Focus Areas (2010-2026)
• Fig 3.19: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs, 2026
• Fig 3.20: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe vs. ROW, 2026
• Fig 3.21: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements, 2026
• Fig 3.22: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements (2010-2015, 2025-2026)
• Fig 3.23: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements: Biomanufacturers vs. CMOs, 2026
• Fig 3.24: Factors in Biomanufacturing Performance Creating “Significant” or “Some” Improvements: US vs. Western Europe vs. ROW, 2026
• Fig 3.25: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months”Comparing (2011-2016, 2019-2024)
• Fig 3.26: Cost-Cutting Changes, Outsourced Jobs, by Segment, (2011-2016, 2019-2024)
• Fig 3.27: Factors That Will Have the Greatest Impact on REDUCING YOUR COST OF GOODS for Biotherapeutic Products (2020-2024)
• Fig 3.28: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2026
• Fig 3.29: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein (2017-2026)
• Fig 3.30: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods (2011-2015, 2018-2019, 2024, 2026)
• Fig 3.31: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs, 2026
• Fig 3.32: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; US vs. Western Europe, 2026
• Fig 3.33: Largest Commercial-Scale Bioreactor Expected in the Next Two Years (2028)
• Fig 3.34: Top Options for Bioreactor Platforms at Commercial Scale, 2024
• Fig 3.35: Top Options for Bioreactor Platforms at Commercial Scale (2021-2024)
• Fig 3.36: Distribution of Largest Single-Use Bioreactor Capacity to Purchase in Next Two Years (2022, 2025-2026)
• Fig 3.37: Distribution of Largest Stainless Steel Bioreactor Capacity to Purchase in Next Two Years (2022, 2025-2026)
• Fig 4.1: Capacity Utilization, By System, 2026
• Fig 4.2: Capacity Utilization, By System (2006-2026)
• Fig 4.3: Change in Capacity Utilization, CAGR (2006-2026)
• Fig 4.4: Capacity Utilization, By System, Biomanufacturers vs. CMOs, 2026
• Fig 4.5: Availability of CMO/CDMO Capacity (2024-2026)
• Fig 4.6: Capacity Utilization, By System, U.S. vs. Western Europe, 2026
• Fig 4.7: Western European vs. US Biomanufacturers’ Average Capacity Utilization (2012-2026)
• Fig 4.8: Current Production Capacity Distribution, Mammalian Cell Culture, 2026
• Fig 4.9: Production Capacity Distribution, Mammalian Cell Culture (2010-2026)
• Fig 4.10: Current Production Capacity Distribution, Microbial Fermentation, 2026
• Fig 4.11: Current Production Capacity Distribution, Microbial Fermentation (2010-2026)
• Fig 4.12: Current Production Capacity Distribution, Cell Therapy, 2026
• Fig 4.13: Production Capacity Distribution, Cell Therapy (2020-2026)
• Fig 4.14: Current Production Capacity Distribution, Gene Therapy, 2026
• Fig 4.15: Production Capacity Distribution, Gene Therapy (2020-2026)
• Fig 4.16: Bioprocessing Concentration, Capacity Data, 2026
• Fig 4.17: Range of Titers for mAbs Obtained at Various Production Scales, Distribution, 2026
• Fig 4.18: Average mAb Titer Trend (2008-2026)
• Fig 5.1: Capacity Constraints, by Stage of Production, 2026
• Fig 5.2: Capacity Constraints ‘Today’ (2004-2026)
• Fig 5.3: Capacity Constraints Trends (2004-2026)
• Fig 5.4: Capacity Constraints, Biomanufacturers vs. CMOs, 2026
• Fig 5.5: Capacity Constraints, U.S. vs. Western Europe, 2026
• Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections (by 2031)
• Fig 5.7: Expectations of Capacity Constraints: Five-year Projections (2004-2026)
• Fig 5.8: Expectations of Capacity Constraints: Five-year Projections (Trend Line) (2004-2026)
• Fig 5.9: Five-year Projections for Capacity Constraints: Biomanufacturers vs. CMOs (2031)
• Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe (2031)
• Fig 5.11: Factors Creating Future Capacity Constraints in Five Years (2031)
• Fig 5.12A: Factors Creating Future Capacity Constraints in Five Years (2008-2026)
• Fig 5.12B: Factors Creating Future Capacity Constraints in Five Years (2008-2026)
• Fig 5.13: Factors Creating Future Capacity Constraints: Biomanufacturers vs. CMOs, 2026.224
• Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western Europe Biomanufacturers, 2026
• Fig 5.15: Key Areas to Address to Avoid Capacity Constraints, 2026
• Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints (2006-2026)
• Fig 5.16B: Key areas to Address to Avoid Capacity Constraints (2006-2026)
• Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biomanufacturers vs. CMOs, 2026
• Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe, 2026
• Fig 5.19: Average Time (weeks) Between Batch Failures (2009-2026)
• Fig 5.20: Batch Failure Frequency Distribution (2009-2026)
• Fig 5.21: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2026
• Fig 5.22: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing (Commercial Manufacture) (2009-2026)
• Fig 5.23: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing (“Clinical” Scale) (2009-2026)
• Fig 5.24: Global Quality Supply Management (2011-2013, 2022-2023)
• Fig 5.25: Global Quality Supply Management, Biomanufacturers vs. CMOs, 2023
• Fig 5.26: Global Quality Supply Management (U.S. vs. W. Europe), 2023
• Fig 5.27: Addressing Supply Chain Security (2023-2026)
• Fig 6.1: Industry Average Planned Production Increase: Five Year Estimates (2031)
• Fig 6.2: Planned Future Capacity Expansion: Five Year Estimates (2009–2031)
• Fig 6.3: Percentage of Respondents Projecting Production Increases over 100%: Five Year Trend (2031)
• Fig 6.4: Average Planned Future Capacity Expansion: Five-Year Estimates, Biomanufacturers vs. CMOs, by 2031
• Fig 6.5: Average Planned Future Capacity Expansion: Five-Year Estimates, U.S. vs. Western Europe, by 2031
• Fig 7.1: Current Percent Production Outsourced; by System, 2026
• Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production (2006-2026)
• Fig 7.3: Current Percent Respondents Outsourcing up to 50% of Production, by System, 2009-2026
• Fig 7.4: Biomanufacturers’ Outsourcing, Five Year Projections, by System (2031)
• Fig 7.5: Five-year Projections: % Biotherapeutic Manufacturers Planning to Outsource at Least Some Production; Projections made 2007-2026
• Fig 7.6: Biomanufacturers Outsourcing Some Activity Today, 2026
• Fig 7.7A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today (2010-2026)
• Fig 7.7B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today (2010-2026)
• Fig 7.8: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years (2026)
• Fig 7.9A: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, Trends (2010-2026)
• Fig 7.9B: Outsourcing Activities Projected to be Done at ‘Significantly Higher Levels’ in 2 Years, Trends (2010-2026)
• Fig 7.10: Estimated Average Percentage of Activity Outsourced, by Facilities Today, 2026
• Fig 7.11A: Estimated Average Percent of Activity Outsourced by Facilities (2010-2026)
• Fig 7.11B: Estimated Average Percent of Activity Outsourced by Facilities (2010-2026)
• Fig 7.12: Change in Spending on Outsourcing for R&D or Manufacturing, Next 12 months (2012-2026)
• Fig 7.13: Average Change in Outsourcing Spending by Facilities, (2013-2026), with 2-year moving average
• Fig 7.14: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, 2026
• Fig 7.15: ‘Very Important’ Issues for Considering Outsourcing to CMOs, Percentage Point Shifts Over Time (2006-2018, 2025-2026)
• Fig 7.16: U.S. BioSecure Act INFLUENCE Choice of Commercial-scale Contract Manufacturers (CMOs) or Outsourcing Vendors, 2025
• Fig 7.17: Percent Indicating USA as Likely or Strong Likely Selection for INTERNATIONAL (non-US respondents) Outsourcing Over Next Five Years, 2009-2026 (targeting 2031)
• Fig 7.18: Country Selections for International Outsourcing/Capacity Expansion Over Next Five Years, 2031
• Fig 7.19A: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2026)
• Fig 7.19B: Country Selections for “Possible” International Outsourcing/Capacity Expansion Over Next Five Years (2016-2026)
• Fig 7.20A: U.S. Respondents Considering International Country as “Possible”International Outsourcing Destination, over Next Five Years (2009-2026)
• Fig 7.20B: U.S. Respondents Considering International Country as “Possible”International Outsourcing Destination, over Next Five Years (2009-2026)
• Fig 7.21: U.S. Respondents Considering Country as “Strong likelihood” or “Likelihood” as Outsourced Capacity Destination, Next Five Years (2031)
• Fig 7.22A: Western European Respondents Considering Country as “Possible”Outsourcing Destination, Next Five Years, (2009-2026)
• Fig 7.22B: Western European Respondents Considering Country as “Possible”Outsourcing Destination, Next Five Years, (2009-2026)
• Fig 7.23: Western European Respondents Considering Country as ‘Strong likelihood’ or ‘Likelihood’ as Outsourced Capacity Destination, over Next Five Years (2031)
• Fig 7.24: Percent of Biomanufacturing Operations Offshored (International Outsourcing) to Lower-Cost Regions Within Five Years (2031)
• Fig 7.25: Percent of Biomanufacturers Performing at Least “Some” International Outsourcing/Offshoring to Lower-Cost Regions Over Next Five Years (2011-2026)
• Fig 7.26: Estimated Average Percentage of Operations to be Done as International Outsourcing/ Offshoring to Lower-Cost Regions During Next Five Years (2011-2026)
• Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture, 2026
• Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2026)
• Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture (2006-2026)
• Fig 8.3: Average Annual Growth Rate, Disposables (2006-2026)
• Fig 8.4: 20-Year Percentage-Point Increase in First Usage of Disposables (2006-2026)
• Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture (R&D–Commercial), 2026
• Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing: Biomanufacturers vs. CMOs, 2026
• Fig 8.7: Reasons for Increasing Use of Disposable System Components, 2026
• Fig 8.8: Reasons for Increasing Use of Disposable System Components, 2006-2015, 2026
• Fig 8.9: Reasons for Restricting Use of Disposables, 2026
• Fig 8.10: Factors Restricting Use of Disposables (2006-2015, 2025-2026)
• Fig 8.11: Time Since Facility’s Last Failure of Single-use Devices and Equipment, 2026
• Fig 8.12: Average Weeks Before Failure of Single-use Devices and Equipment (2023-2026)
• Fig 8.13: Need for Improved Single-Use Sensors, 2012-2017, 2019, 2026
• Fig 8.14: Single-Use Product Vendor Satisfaction Factors (2008-2026)
• Fig 8.15: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction, 2026
• Fig 8.16: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction (2013-2026)
• Fig 8.17: Estimated Percentage of Facilities’ Unit Operations that Are “Single-Use”(2014-2026)
• Fig 8.18: Distribution of Responses, % Single-Use Devices in Biomanufacturing, 2026
• Fig 9.1: Impact of Downstream Processing on Overall Capacity (2008-2026)
• Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biomanufacturers vs. CMOs, 2026
• Fig 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe, 2026
• Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps, 2026
• Fig 9.5: Impact on Capacity of Purification Steps: Experiencing at ‘Significant’ or ‘Severe’ Constraints (2008-2026)
• Fig 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe, 2026
• Fig 9.7: Issues Regarding Protein A Usage (2022)
• Fig 9.8: Issues Regarding Protein A Usage (2009-2017, 2020-2022)
• Fig 9.9: mAb Operations: Upstream Production Titer (Distribution of Responses (2014 -2016, 2018-2026)
• Fig 9.10: Bioreactor Output at which DOWNSTREAM Purification Train Becomes Bottlenecked (2014-2016, 2018-2026)
• Fig 9.11: New Downstream Processing Solutions, 2026
• Fig 9.12A: New Downstream Processing Solutions Comparison (2010-2026)
• Fig 9.12B: New Downstream Processing Solutions Comparison (2010-2026)
• Fig 9.13: New Downstream Processing Solutions: Biomanufacturers vs. CMOs, 2026
• Fig 9.14: New Downstream Processing Solutions: U.S. vs. Western Europe, 2026
• Fig 9.15: Improving Downstream Operations, (2011-2019, 2025-2026)
• Fig 9.16: Most Important Fill-Finish Trends (2015-2017, 2025)
• Fig 9.17: Novel Fill-Finish Technology Implementation Plans within 24 Months (2015-2017, 2025)
• Fig 9.18: Average Downstream Processing (DSP) Yield
• Fig 9.19: Percent Point Change in DSP Yield - Past 2 Years vs Today
• Fig 10.1: New Hires in Biopharmaceutical Manufacturing, 2026
• Fig 10.2: Estimated % of Hiring in Biopharmaceutical Manufacturing, by Operational Area, (2008-2026)
• Fig 10.3: New Hires in Biopharmaceutical Manufacturing in Five Years (2031)
• Fig 10.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, 2026
• Fig 10.5A: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2026)
• Fig 10.5B: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations (2010-2026)
• Fig 10.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe, 2026
• Fig 10.7: Skills or Hands-On Training Required in NEW HIRES in GMP Bioprocessing (2023-2026)
• Fig 11.1: Future of Continuous Bioprocessing and Process Intensification, 2026
• Fig 11.2: Future of Continuous Bioprocessing and Process Intensification (2018-2025)
• Fig 11.3: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing, 2025
• Fig 11.4: Perfusion Operations Issues (2011 – 2014, 2016, 2020, 2023-2025)
• Fig 11.5: Facilities Evaluating CBP Technologies Over the Next 12 Months (Upstream) (2016-2025)
• Fig 11.6: Facilities Evaluating CBP Technologies Over Next 12 months (Downstream) (2016-2025)
• Fig 11.7: Automation Technologies Implemented/to be Implemented in 2026
• Fig 11.8: Automation Technologies to be Implemented; Comparing (2009 - 2013, 2022-2026)
• Fig 11.9: Most Common Factors Inhibiting Greater AUTOMATION of your Facility’s Bioprocessing Today, 2026
• Fig 11.10: Bioprocessing Activities Using AI in Next 2 Years (2028)
• Fig 11.11: Biggest Problems/Hurdles to Facility’s Implementing Artificial Intelligence (AI) tools in Bioprocessing, 2026
• Fig 11.12: Respondents Currently Using or Considering Artificial Intelligence (AI) Application/Approaches at Bioprocessing Facility: TODAY vs 2 YEARS:
• Fig 11.13: Most Needed Cell Therapy Manufacturing Improvements, Systems, Platforms, and Infrastructure (2019-2025)
• Fig 11.14: Most Needed Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure (2019-2025)
• Fig 11.15: Cell or Gene Therapy Plans for GMP and Commercial Manufacturing (2020-2025)
• Fig 11.16: Cell Therapy Capacity Plans for In-House Bioprocessing Facilities Next Five Years (2030)
• Fig 12.1: Area of Biopharmaceutical Involvement, Vendor, 2026
• Fig 12.2: Area of Biopharmaceutical Involvement, Vendor (2010-2026)
• Fig 12.3A: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2026)
• Fig 12.3B: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell (2008-2026)
• Fig 12.4: Vendor Respondents’ Primary Job Function, 2026
• Fig 12.5: Average Annual Vendor Sales Growth Rate (2007-2026)
• Fig 12.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution, 2026
• Fig 12.7: Average Annual Vendor Segment Sales Growth Rates, 2026
• Fig 12.8: Average Annual Vendor Sales Growth Rate, by Segment (2007-2026)
• Fig 12.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment % (2012-2026)
• Fig 12.10: Vendors’ Average Budget Change, 2026
• Fig 12.11: Vendors’ Average Budget Change, Summary (2009-2026)
• Fig 12.12: Vendors’ Average Pricing Changes, Last Year (2026)
• Fig 12.13: Vendors’ Average Pricing Changes, 2009-2025 Actual and 2026 Projected
• Fig 12.14: ‘Most Important’ Factors to Measure The ‘Quality’ of Business Relationships with Suppliers, BIOMANUFACTURERS’ PERSPECTIVE (2022-2026)
• Fig 12.15: ‘Most Important’ Factors to Measure The ‘Quality’ of Business Relationships with Suppliers, SUPPLIERS vs. FACILITIES (2022-2026)
• Fig 12.16: Impact of COVID-19 Pandemic on Vendors, Percent Indicating an INCREASE in COVID- Related Factors (2021-2023)
• Fig 12.17: Permanent Changes caused by Pandemic on Your Business Operations (2024 vs 2025)
• Fig 12.18: Biopharma Business and Marketing Plans, 2026
• Fig 12.19: Biopharma Business and Marketing Plans (2010-2026)
• Fig 12.20A: Top New Technologies or New Product Development Areas (2011-2026)
• Fig 12.20B: Top New Technologies or New Product Development Areas (2011-2026)
• Fig 12.20C: Top New Technologies or New Product Development Areas (2011-2026)
• Fig 12.21: R&D Spending/Budgets for New Products/Services, 2026
• Fig 12.22: Approximate Average Annual R&D Spending/Budget for New Products/Services (2017-2026)
• Fig 12.23: Areas Where Training is Considered as Needed or Very Much Needed, All Vendor Respondents (2010-2026)
• Fig 12.24: Client Demands of Vendors, Service and Support (2012-2026)
• Fig 12.25: Vendors Views of Financial (Sales) Outlook for Next Year (2011-2026)
• Fig 12.26: Average CMOs Service Price Shifts over the “Past 12 Mo.(2010-2012, 2018-2026)
• Fig 12.27: CMOs Service Price Shifts Over Past 12 Months, Distribution, 2026

List of Tables

• Table 0.1: Areas of Biopharmaceutical Manufacturing Operations (2018-2026)
• Table 1.1: Worldwide Revenue of Biopharmaceuticals ($USD billions)
• Table 1.2: Number of Biopharmaceutical Products in U.S. and European Markets, 2025-2026
• Table 1.3: Global Market for Top 50 Biopharma Products in (2024-2025, $USD Million)
• Table 1.4: Top 50 Biopharmaceutical Products vs Total Market Size (%) $million
• 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 2025
• Table 2.1: Biopharmaceuticals Approved by FDA, 2025
• Table 2.2: Biopharmaceuticals Approved by FDA in 2026 (Till May’2026)
• Table 2.3: Facility Takeovers Involving CDMOs
• Table 2.4: M&A Transactions Involving CDMOs
• Table 3.1A: Areas of Significant Projected Budget Percentage Increases for Biomanufacturing (2011-2026)
• Table 3.1B: Areas of Significant Projected Budget Percentage Increases for Biomanufacturing (2011-2026)
• Table 4.1: Regional Distribution of Total Worldwide Average Capacity*
• Table 4.2: Leading Biopharma Company Capacity Estimates, 2026
• Table 4.3: Bioprocessing CMOs, Their Number of Facilities Worldwide and Estimated Total Capacity*
• Table 4.4: Compound Annual Change in mAb Titers (2008-2026)
• Table 5.1: Severe or Significant Capacity Constraints, by Stage of Production (2009-2026)
• Table 5.2: Severe and Significant Capacity Constraints Today, U.S. vs. W. Europe (2010-2026)
• Table 5.3: Average Rates of Failure, by Primary Cause, and Phase of Manufacture (2017-2026)
• Table 6.1: U.S. Biomanufacturers’ Five-Year Projected Capacity Increases, by System (2008-2026)
• Table 6.2: Western European Biomanufacturers’ Five-Year Projected Capacity Increases, by System (2008-2026)
• Table 7.1: Percentage of U.S.-based Respondents Indicating Country as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2009-2026)
• Table 7.2: Percent of Western European-based Respondents Indicating International Countries as a ‘Strong likelihood’ or ‘Likelihood’ as Outsourcing Destination (2011-2026)
• Table 9.1: Percent of Biomanufacturers vs. CMO Facilities Experiencing “Serious” or “Some” Capacity Problems due to Downstream Processing (2008-2026)
• Table 9.2: Percent of U.S. vs. Western Europe Facilities Experiencing ‘Serious’ Capacity Problems due to Downstream Processing (2009-2026)
• Table 9.3: Percent U.S. vs. Western Europe Facilities Not Expecting to see Bottlenecks due to Downstream Processing (2008-2026)
• Table 9.4: Upstream Production Titer vs. Max Capacity (2018-2026)
• Table 12.1: Average Vendor Sales and Technical Training Days (2011-2013, 2019-2021)