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

Published Apr 01, 2026
Length 573 Pages
SKU # DFAQ21477000

Description

2026 23rd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations’ current and projected future capacity and production. This report’s 570+ pages of data-rich analysis will help improve your decision-making in biomanufacturing operations, with in-depth analysis of capacity, production trends, benchmarks, and much more.

In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic production. Comparison of production by biotherapeutic developers and contract manufacturing organizations. Current and future potential industry bottlenecks. 23 years of trend analysis; part of a series of annual biopharmaceutical manufacturing industry evaluations. This edition includes the joint industry expertise from BioPlan Associates, and many industry consultants and experts.

Table of Contents

573 Pages
METHODOLOGY
CHAPTER 0: DEMOGRAPHICS
KEY TAKEAWAYS
INTRODUCTION
0-1 RESPONDENTS’ AREA OF INVOLVEMENT0-2 RESPONDENTS’ QUALIFICATIONS0-3 FACILITY LOCATIONS0-4 AREAS OF BIOPHARMACEUTICAL MANUFACTURING OPERATIONS0-5 PRODUCTION OPERATIONS, PHASE OF DEVELOPMENT0-6 EMPLOYEES AT FACILITY0-7 BATCHES RUN AT FACILITY PER YEAR0-8 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
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
©2026 BIOPLAN ASSOCIATES, INC. • NO UNAUTHORIZED REPRODUCTION PERMITTED • ALL RIGHTS RESERVED xiii
TABLE OF CONTENTS / FIGURES AND TABLES
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.249
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
FIGURES AND TABLES
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).13
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
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)
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