제23회 바이오의약품 제조능력 및 생산에 관한 연차 보고서 및 조사(2026년)

METHODOLOGY

This report is the 23rd in our annual evaluations of the state of the biopharmaceutical manufacturing (bioprocessing) industry. The strength of this study’s methodology remains in its breadth of coverage, which yields a composite view from the respondents closest to the industry, its 23-year longevity, industry familiarity and high response rates. These permit a consistent approach which delivers reliable data and analysis.

Note, “biopharmaceutical” here refers to the classic biotechnology-grounded definition: involving manufacture of pharmaceuticals using biotechnology/bioprocessing. The term does not refer to the entire pharmaceutical industry or just those parts considered innovative, with “biopharmaceutical” now simply commonly substituted where “pharmaceutical” or “drug” were formerly used.

This year, BioPlan Associates, Inc. surveyed 300 qualified and responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations in 21 countries plus 121 industry vendors and direct suppliers of materials, services, and equipment to this industry segment. Using a web-based survey tool, we obtained and evaluated information including regarding respondents’ current capacity, production, novel technology adoption, human resources, quality, and outsourcing issues. We also assessed respondents’ projected reasons for bottlenecks, and their perception of how these bottlenecks might be resolved.

This year, we continue to include new questions and chapters, including Artificial Intelligence Use and Applications, Continuous Bioprocessing and Process Intensification (Chapter 11.) Over the past few years, advances in technologies, platforms, expression systems, and single-use applications have increasingly made the bioprocessing segment an area of interest for such innovation.

We continue to partner with worldwide media and membership organizations to ensure a high response rate, and the most accurate overview of the worldwide biopharmaceutical industry and its bioprocessing sector. Our industry partners are cited in our acknowledgments section. In addition, to supporting this coverage, we also acknowledge our media partners, whose assistance enables us to reach the many high-quality respondents required for this quantitative survey and analysis.

Further information on methodology, breakouts on specific segments, and data from earlier surveys may be requested by contacting us at the address below. Thank you for your participation and interest in this important research.

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