16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

Date: April 1, 2019
Pages: 485
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US$ 1,950.00
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Publisher: BioPlan Associates, Inc.
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: 18B83BBCB7FEN
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16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
This report is the 16th in our annual evaluations of the state of the biopharmaceutical manufacturing 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.

This year, BioPlan Associates, Inc. surveyed 221 qualified and responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations in 24 countries; plus 120 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.

We continue to provide additional in-depth analysis of specific issues affecting the industry, including monographs in Chapter 2. These monographs cover the events and trends that will shape biopharmaceutical manufacturing over the next fi ve years. We also have included this year a chapter on Continuous Bioprocessing. Over the past few years, advances in technologies, expression systems, and single-use applications have increasingly made this segment an area of interest for innovation.

To ensure comprehensive global coverage, we partnered with world-wide organizations to ensure the most accurate overview of the worldwide biopharmaceutical industry. Our industry partners are cited in our acknowledgments section. In addition, to support this coverage, we also include acknowledgment of our media partners, whose assistance enabled us to reach the many high quality of respondents required in this quantitative analysis.
METHODOLOGY

CHAPTER 0: DEMOGRAPHICS

Introduction
  0-1 Respondents’ Area of Involvement
  0-2 Respondents Quali fi cations
  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
  0-9 Stainless Steel Bioreactor Capacity In Use at Site

CHAPTER 1: INTRODUCTION AND DISCUSSION

1-1 Introduction: The Pharmaceutical and Biopharmaceutical Industries
1-2 Current Status and Market Trends
1-3 Market Potential
1-4 Biopharmaceuticals and Biosimilars in the Pipeline
  FDA Biopharmaceutical Approvals
1-5 Global Biopharmaceutical and Recombinant Protein/MAb Markets
  Overall Health of the Biopharmaceutical Sector
  U.S. Industry Leadership Continues
  Biopharmaceuticals in the Rest of the World
1-6 Biopharmaceutical Markets by Product Class
  Monoclonal antibodies (mAbs) are the Leading Product Classes
1-7 Animal Derived Products and Biopharmaceuticals
1-8 Future Trends in the Biopharmaceutical Industry

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE

2-1 Worldwide Biopharmaceutical CMO Capacity Analysis
2-2 Rapid Identi fi cation of Microbial Contamination
2-3 Suppliers’ Contributions to Bioprocessing Advances
2-4 Make vs. Buy (In- vs. Outsourcing): Causes, criteria, and consequences
2-5 Mergers & Acquisitions
2-6 China’s Advances in Biopharmaceutical Contract Manufacturing

CHAPTER 3: EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING

3-1 Industry Trends in 2019
  Introduction
  Productivity and Cost Reductions
  Novel Bioprocessing Systems/Innovations
  Novel Bioprocessing Systems/Innovations – Biomanufacturers vs. CMOs
3-2 Budget Issues in 2019
  Budget Change Comparisons
3-3 Operational Changes
3-4 New Bioprocessing Products Development Opportunities in 2019
  Upstream New Product Areas of Need
  Downstream New Product Areas of Need
    Previous Year Areas Include:
  Other General New Product Areas of Need
  Innovations in Single-use/Disposable Equipment
  Discussion of Needed Single-use Innovations
  Other Areas for Innovation
  New Product Development Areas: Biotherapeutic Developers vs. CMOs
  New Product Development Areas: U.S. vs. Western Europe and ROW
3-5 Factors in Biomanufacturing Creating Improvements
  Factors Improving Biomanufacturing Performance, 2010 - 2015
  Factors Improving Biomanufacturing Performance, Biotherapeutic
  Developers vs. CMOs (2015 Data)
  Factors Improving Biomanufacturing Performance, U.S. vs. Western Europe vs. ROW (2015 Data)
3-6 Discussion
3-7 Cost-Cutting Actions & Development Timelines
  Cost-Cutting Changes Speci fi c to Outsourcing
3-8 Average Cost per Gram Recombinant Protein
3-9 Assay Development
  Biomanufacturing Assay Areas Required: Biomanufacturers vs. CMOs
3-10 Cell and Gene Therapy Platforms
  Cell and Gene Therapy Manufacturing Advancements (2018 data)
  Cell and Gene Therapy Manufacturing Improvements, Systems,
  Platforms and Infrastructure
3-11 Selecting Bioreactors in New Facilities
3-12 Discussion: Industry Trends and Issues
  Industry Growth and Adaptation
  Cost Cutting Trends
  Trends in Assay Development
  Trends in Speeding Development and Approval Timelines
  Trends in Bioprocessing Industry Desire for Improved Products and Services

CHAPTER 4: CAPACITY UTILIZATION

4-1 Capacity Utilization Trends
  Capacity Utilization De fi nitions
  Relevance of Capacity Utilization
  Capacity Utilization in Biomanufacturing, 2019
  Capacity Utilization Changes Since 2004
  Average Growth Rate in Capacity Utilization, 2006-2019
4-2 Capacity Utilization: CMOs vs. Biotherapeutic Developers
4-3 Capacity Utilization: U.S. vs. Western European Manufacturers
4-4 Respondents’ Current Total Production Capacity
  Mammalian Cell Culture
  Estimated Bioreactor Capacity Distribution, Biotherapeutic Developers and CMOs
  Biopharmaceutical Developers/Manufacturers as CMOs
  Microbial Fermentation Capacity
  Cell or Gene Therapy Capacity
4-5 Discussion: Capacity Trends
4-6 Range of Titers with mAb Production
  Annual mAb Titer Changes, 2008-2019
4-7 Discussion: Capacity and Industry Trends
  Capacity Utilization

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS

5-1 Current Capacity Constraints
  Respondents Experiencing No Capacity Constraints
  Respondents’ Perception of Capacity Constraints, 2004-2019
  Perception of Capacity Constraints: Biotherapeutic Developers vs. CMOs
  Capacity Constraints: U.S. vs. Western European Biotherapeutic
  Developers & CMOs
5-2 Expected Capacity Constraints
  Respondents’ Expectations of Capacity Constraints by 2024
  Expected Capacity Constraints by 2024: Comparing 2004 to 2019 Data
  Expected Capacity Constraints by 2024: Biotherapeutic Developers vs. CMOs
  Expected Capacity Constraints by 2024: U.S. vs. Western Europe
5-3 Factors Impacting Future Production Capacity
  Factors Creating Future Capacity Constraints
  Factors Creating Future Capacity Constraints, 2008 - 2019
  Factors Creating Future Capacity Constraints: Biotherapeutic
  Developers vs. CMOs
  CMO Capacity Bottleneck Projections, in Retrospect
  Biotherapeutic Developers’ Capacity Bottleneck Projections, in Retrospect
  Factors Creating Capacity Constraints: U.S. vs. Western European Respondents
5-4 Key Areas to Address to Avoid Future Capacity Constraints
  Analysis of Areas to Avoid Capacity Constraints: Changing Perspectives, 2006-2019
  Key areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs
  Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
5-5 Discussion
  Overall Capacity Constraints

CHAPTER 6: FUTURE CAPACITY EXPANSIONS

6-1 Planned Future Capacity Expansions
  Planned Future Capacity Expansions, 2009-2024
  Planned Future Capacity Expansions by 2024: CMOs vs. Biotherapeutic Developers
  Planned Five-Year Capacity Expansion: U.S. vs. Western European Manufacturers
  Planned Future Capacity Expansions of >100%

CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING

  Why Outsource?
  Relating Outsourcing to Workforce Reduction
  Strategic Manufacturing Planning
  Future Projections
7-1 Current Outsourcing by Production System
  Facilities Currently Outsourcing No Production (All Production “In-house”), 2006-2019
7-2 Future Outsourcing
  Biotherapeutic Developers’ Outsourcing, 5-Year/2024 Projections, by System
  Biotherapeutic Developers Outsourcing Some Production in 2024
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
  Comparison of Biomanufacturers’ Outsourcing, (2010-2019)
  Increased Outsourced Activities, 24-month Projections
  Outsourcing Activities Projected at “Signi fi cantly Higher Levels”, Comparison of 2010-2019 Trends
  Average Percentage of Activities Outsourced Today
  Comparison of Outsourcing Activities, 2010-2019
  Change in Spending on Outsourcing Activities
7-4 Critical Outsourcing Issues
  Selecting a CMO: (2018 data)
  Selecting a CMO, 2006-2018
  Changes in Critical Issues when Considering a CMO, 2006-2018
7-5 CMOs’ Problems with Their Clients
7-6 Country Selections for International Outsourcing (Off-shoring) of Biomanufacturing
  U.S. vs. Western European Respondents’ Outsourcing Destinations
  Western European Respondents’ Outsourcing Destinations
  5-Year Projection for Biomanufacturing International Outsourcing/Off-shoring
7-7 Offshoring Trends
  5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Off-shoring
7-8 Discussion of Outsourcing and Offshoring
  Selecting a CMO

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

8-1 Use of Disposables and Single-Use Systems
  Disposables Applications in Biopharmaceutical Manufacturing
  Trends in Disposable Applications: 2006-2019
  Average Annual Growth Rate for Disposables: Market Penetration/Usage
  13-Year Average Growth in Disposable Applications, Percentage-Point Gains
  Disposable Use by Stage of Production/Application
  Use of Disposables: CMOs vs. Biotherapeutic Developers
8-2 Leachables and Extractables
  Paying for L&E Testing, 2018, vs. 2016-2009
8-3 Reasons for Increasing Use of Disposables & Single-Use Systems
  Single Most Critical Reason for Increasing the Use of Disposables (2018 data)
8-4 Factors That May Restrict Use of Disposables
  Most Critical Reasons for Restricting Use of Disposables
  Most Important Reasons for Not Increasing Use of Disposables, 2008-2019
  Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developers vs. CMOs
  Top Reasons for Not Increasing the Use of Disposables: U.S. vs. Western Europe
8-5 Suppliers’ Expectations for Standards Setting Bodies
8-6 Need for Single-use Sensors, and Bioreactor Attributes
  Single-Use Adoption Issues (2018 data)
  Single-use Adoption Factors, U.S. vs. Western Europe (2018 data)
  Single-Use Sensor Technologies (2012-2017, 2019) Data
8-7 Satisfaction with Single-Use Device Vendors
  Single-Use Attribute Importance Analysis
  Single-Use Suppliers’ Delivery Problems, 2013-2019
8-8 Single Use Operations and Trends
  Percentage of Unit Operations that Are Single-Use
  Distribution of Responses
8-9 Discussion of 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
  Downstream Bottlenecks Persist
  Modular: The Next Trend after Single-Use?
  Single-use Equipment Sourcing, Quality Issues, and L&E Testing

CHAPTER 9: DOWNSTREAM PURIFICATION

9-1 Impact of Downstream Processing on Capacity
  Impact of Downstream Processing on Capacity, Biopharmaceutical Developers vs. CMOs
  Impact of Downstream Processing on Capacity, U.S. vs. Western European Biomanufacturers
9-2 Speci fi c Puri fi cation Step Constraints
  Changes in Impact on Capacity of Puri fi cation Steps, 2008-2019
  Speci fi c Puri fi cation Step Constraints, U.S. vs. Western European Biomanufacturers
9-3 Downstream Puri fi cation Issues
  Protein A and Alternatives (2017 data)
  Changes in Perception of Protein A and Alternatives
  Protein A Downstream Puri fi cation Issues, U.S. vs. Western Europe (2017 data)
9-4 mAb Puri fi cation Capacity Estimates
  Upstream Production Titer vs. Max Capacity
9-5 New Downstream Processing Technologies
  New Downstream Processing Solutions; 2010 – 2019
  New Downstream Processing Technologies; Biotherapeutic Developers vs. CMOs
  New Downstream Processing Technologies: U.S. vs. Western Europe
9-6 Improvements to Downstream Operations
  Comparison of New Downstream Technology Implementation; Biomanufacturers vs. CMOs
  Comparison of New Downstream Technology Investigations; U.S. vs. W. Europe vs. ROW
9-7 Discussion
  Upstream Expression Titer Trends and Impact on Downstream Operations
  Downstream Processing Solutions

CHAPTER 10: QUALITY ISSUES, BATCH FAILURES, AND PAT IN BIOPHARMACEUTICAL MANUFACTURING

10-1 Quality Initiative Implementation
  Comparison of Quality Initiative Implementation, 2009 - 2018
  Quality Initiatives Are Becoming Commonplace and the New Industry Norm
  Challenges to Implementing PAT, QbD and other Quality Initiatives
10-2 Hurdles to Implementing Process Analytical Technology
  Trends in PAT, 2008-2019
  PAT Adoption Will Increase
10-3 Batch Failure Frequency in Biopharmaceutical Manufacturing
10-4 Primary Cause of Batch Failures, Percentages of Failures
  Quality Problems Traced to Vendors
  Process Information Needs and Value Drive Automation
10-5 Quality Problems in BioManufacturing Attributed to Vendors
10-6 Discussion
  Supply Management Issues with Single-Use Systems

CHAPTER 11: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

  Introduction
  No Substitute for on-the-job Training
11-1 Hiring Trends
  Trends in New Hires, by Area; 2008 – 2019
11-2 Hiring in 2024: 5-year Trends
11-3 Hiring Challenges Today
  Hiring Dif fi culties; 2010 - 2019
11-4 Training in Biopharmaceutical Manufacturing
  Changes in Training for New Manufacturing Employees, 2009-2018
11-5 Discussion
  Options Developing for Bioprocessing Training
  Continued Growth in Biopharmaceutical Manufacturing Jobs

CHAPTER 12: CONTINUOUS BIOPROCESSING

  Introduction
  Adoption of Continuous Bioprocessing
  Implementation of Continuous Bioprocessing
  Continuous Processing – Present and Future Challenges
  Continuous Bioprocess and Process Intensi fi cation
12-1 Perfusion Operations and Continuous Bioprocessing Operations Issues
  Perfusion vs. Batch Fed Bioprocessing (2018 data)
12-2 Perfusion Operations and Continuous Bioprocessing Trends
12-3 Discussion
  Continuous Bioprocessing: Trends and Opportunities
  Perfusion: Progress in Adoption

CHAPTER 13: SUPPLIERS TO BIOPHARMACEUTICAL MANUFACTURING AND

  LIFE SCIENCES
  Introduction
13-1 Demographics
  Areas of Involvement
  Location of Vendor Sales
  Respondents’ Primary Job
13-2 Growth Rate of Sales by Suppliers
  Average Industry Growth Rate, By Segment
  Vendor Sales Growth Rates, by Industry Segment, 2007 - 2019
  Supplier Annual Sales, Distribution
13-3 Discussion of Vendor and Industry Growth
13-4 Budget Issues and Problems Faced by Industry Suppliers
  Budget Challenges in 2018
  Vendor Average Budget Changes for 2009 -2018
  Vendor Pricing Changes
  Past Year and Expected Price Changes (2009-2019)
  Supplier Budget Issues
13-5 Cost Cutting Actions by Vendors
  Cost Cutting Actions, By Segment
13-6 Problems Clients Have with Their Vendors
13-7 Vendor Expansion Plans
  Biopharma Vendor Business Trends, 2010 - 2019
13-8 New Technology Areas in Development by Vendors
  Suppliers’ Development of Innovative Technologies
  Suppliers’ R&D Spending/Budgets for New Products/Services
13-9 Sales Staff Training
  Days of Training Provided by Suppliers
  Areas where Training May Help Sales Staff Perform, Trends 2010 - 2019
  Clients’ Demands on Vendors
13-10 Biopharma Vendors’ Financial Outlook for 2019
13-11 CMO Pricing Changes for Biopharmaceutical Services
13-12 Discussion of Biopharma Suppliers
  Bioprocessing Vendors Will See Continued Market Growth
  Single-use Systems Continue to Drive Sales
  Trends Favor Increased Vendor Sales
  Vendors are Offering More Services, Going for Larger Sales
  Biopharma Suppliers in Emerging Regions

FIGURES

Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 to 2019
Fig 0.2: Respondents’ Job Responsibilities, 2011 – 2019
Fig 0.3: Facility Location
Fig 0.4: Facility Location, by Region
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2019) Trends
Fig 0.6: Phase of Development of Surveyed Respondents, 2006-2019
Fig 0.7: Phase of Development of Surveyed Respondents (U.S. vs. Western Europe)
Fig 0.8: Distribution of Employees at Facility, and Organization
Fig 0.9: Distribution of Total Batches Run at Facility Last Year, by Scale of Production
Fig 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity
Fig 0.11: Distribution of Largest STAINLESS Bioreactor Capacity
Fig 1.1: U.S. Biosimilars Launchable Dates 2012-2014 by Current Cumulative Reference Product Sales ($Millions)
Fig 1.2: U.S. Biosimilars Launchable Dates 2012-2014 by Current Cumulative Reference Product Sales ($Millions)
Fig 1.3: Number of FDA Approvals of New Biopharmaceutical Products 1982-2018
Fig 2.1: Total CMO Facilities and Capacity by Bioprocessing Capacity Scales
Fig 2.2: Distribution of All and CMO Facilities by Facility Capacity Ranges
Fig 2.3: The 10-C criteria for make-or-buy decisions
Fig 2.4: A scenario-based approach
Fig 2.5: A make-or-buy decision tree
Fig 2.6: Integration of services in the CDMO value chain
Fig 3.1: SINGLE most important biomanufacturing trend or operational area, 2014-2019
Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months
Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (Biomanufacturers vs. CMOs)
Fig 3.4: Biomanufacturers’ Budget Shifts in 2019
Fig 3.5: Approximate Average Change in Biomanufacturers’ Budgets for 2019
Fig 3.6: Average Biomanufacturers’ Budget Change, 2009-2019
Fig 3.7: New Product Development-Upstream Focus Areas
Fig 3.8: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2019)
Fig 3.9: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2019
Fig 3.10: New Product Development-Downstream Focus Areas (2010-2019)
Fig 3.11: New Product Development – General Focus Areas, Biomanufacturers & CMOs, 2019
Fig 3.12: New Product Development – General Focus Areas, 2010-2019
Fig 3.13: Top 10 New Product Development Areas of Interest: Biomanufacturers vs. CMOs
Fig 3.14: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe and ROW
Fig 3.15: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2016, 2019
Fig 3.16: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography (2011-2016, 2019)
Fig 3.17: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2019
Fig 3.18: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods, 2011 -2015, 2018-2019
Fig 3.19: Biomanufacturing Assay “Areas” Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs (2019 data)
Fig 3.20: Future Cell and Gene Therapy Platforms, 2019
Fig 3.21: Cell and Gene Therapy Manufacturing Advancements in 5 Years (2023) to Avoid Bottlenecks
Fig 3.22: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure
Fig 3.23: Likelihood of Implementing Bioreactor, by Type, 2017
Fig 3.24: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2017
Fig 4.1: Capacity Utilization, By System
Fig 4.2: Capacity Utilization, By System, 2004-2019
Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2019
Fig 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs. CMOs, 2019
Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe, 2019
Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2019
Fig 4.8: Bioprocessing Concentration, Capacity Data, 2019
Fig 4.9: Current Production Capacity Distribution, Microbial Fermentation
Fig 4.10: Current Production Capacity Distribution, Cell or Gene Therapy
Fig 4.11: Range of Titers for mAbs Obtained at Various Production Scales, 2019 Distribution
Fig 4.12: Average mAb Titer Trend 2008-2019
Fig 5.1: Capacity Constraints, by Stage of Production
Fig 5.2: Capacity Constraints, 2004 -2019
Fig 5.3: Capacity Constraints Trends, 2004-2019
Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs
Fig 5.5: Capacity Constraints, U.S. vs. Western Europe
Fig 5.6: Expectations of Capacity Constraints by Stage of Production: Five-year Projections
Fig 5.7: Expectations of Capacity Constraints: Five-year Projections Made in 2004-2019
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2024 (Trend Line)
Fig 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs. CMOs
Fig 5.10: Five-year Projections for Capacity Constraints: U.S. vs. Western Europe
Fig 5.11: Factors Creating Future Capacity Constraints in Five Years
Fig 5.12A: Factors Creating Future Capacity Constraints, 2008-2019
Fig 5.12B: Factors Creating Future Capacity Constraints, 2008-2018
Fig 5.13: Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs
Fig 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western European Biomanufacturers
Fig 5.15: Key Areas to Address to Avoid Capacity Constraints
Fig 5.16A: Key Areas to Address to Avoid Capacity Constraints; 2006-2019
Fig 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2019
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs
Fig 5.18: Key Areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe
Fig 6.1: Industry Average Planned Production Increase by 2024
Fig 6.2: Planned Future Capacity Expansion: Five-Year Estimates, 2009–2024
Fig 6.3: Planned Future Capacity Expansion: Five-year Estimates: Biotherapeutic Developers vs. CMOs
Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates: U.S. vs. Western Europe
Fig 6.5: Percentage of Respondents Projecting Production Increases over 100% by 2024: Five-year Trend
Fig 7.1: Current Percent Production Outsourced; by System
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2019
Fig 7.3: Future Outsourcing: Percent Production Outsourced; by 2024, by System
Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2019
Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today
Fig 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 – 2019
Fig 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 – 2019
Fig 7.7: Outsourcing Activities Projected to be Done at “Signi fi cantly Higher Levels” in 2 Years
Fig 7.8A: Outsourcing Activities Projected to be Done at “Signi fi cantly Higher Levels” in 2 Years, 2010 - 2019 Trends
Fig 7.8B: Outsourcing Activities Projected to be Done at “Signi fi cantly Higher Levels” in 2 Years, 2010 - 2019 Trends
Fig 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today
Fig 7.10A: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2019
Fig 7.10B: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2019
Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012 - 2019
Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations
Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2006-2018
Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2018, Percentage Point Differences
Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2018
Fig 7.16: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2010-2013; 2018
Fig 7.17: Country Selections as Destination for International Outsourcing of BioManufacturing (All Respondents), in the next fi ve years, 2024
Fig 7.18A: Percent U.S. Respondents Considering Country as “Possible” Outsourcing Destination, next fi ve years, 2024
Fig 7.18B: Percent U.S. Respondents Considering Country as “Possible” Outsourcing Destination, next fi ve years, 2024
Fig 7.19: Percent U.S. Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination, next fi ve years, 2024
Fig 7.20: Percent Western European Respondents Considering Country as “Possible” Outsourcing Destination, next fi ve years, 2024
Fig 7.21: Percent European Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination
Fig 7.22: Percent of Biomanufacturing Operations Off-shored (International Outsourcing) within 5 Years (2024)
Fig 7.23: Percent Biomanufacturers Performing at Least “Some” International Outsourcing/Off-shoring during Next 5 Years (2011-2019)
Fig 7.24: Estimated % Operations Done as International Outsourcing/Off-shoring during Next 5 Years (2011-2019)
Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture
Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2019
Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2019
Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2019
Fig 8.4: 13-Year Percentage-Point Change in First Usage of Disposables, 2006-2019
Fig 8.5: Usage of Disposables in Biomanufacturing by Stage of Manufacture (R&D–Commercial)
Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing: Biotherapeutic Developers vs. CMOs
Fig 8.7: Willingness to Pay for Useable Leachables and Extractables Data (2018 Data)
Fig 8.8: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2018
Fig 8.9: Top Reasons for Not Increasing Use of Disposables, 2019
Fig 8.10A: Top Reasons for Not Increasing Use of Disposables, 2008-2019
Fig 8.10B: Top Reasons for Not Increasing Use of Disposables, 2008-2019
Fig 8.11: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developers vs. CMOs
Fig 8.12: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe
Fig 8.13: Suppliers’ Perception of Organizations Responsible for Establishing Standards for Single-use Devices (2017 data)
Fig 8.14: Single-use/Disposable Device Adoption Factors (2018 data)
Fig 8.15: Single-use/Disposable Device Adoption Factors; U.S. vs. Western Europe, 2018 data
Fig 8.16: Need for Improved Single-Use Sensors, 2012-2017, 2019
Fig 8.17: Single-Use Product Vendor Satisfaction Factors, 2008-2019
Fig 8.18: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction
Fig 8.19: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction, 2013-2019
Fig 8.20: Estimated Percentage of Facilities’ Unit Operations that Are “Single-Use” (2014 - 2019)
Fig 8.21: Distribution of Responses, % Single-Use Devices in Biomanufacturing
Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2019
Fig 9.2: Impact of Downstream Processing on Overall Capacity; Biotherapeutic Developers vs. CMOs
Fig 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe
Fig 9.4: Impact on Capacity of Depth, Chromatography and UF Puri fi cation Steps
Fig 9.5: Impact on Capacity of Puri fi cation Steps: Experiencing at “Signi fi cant” or “Severe” Constraints, 2008 – 2019
Fig 9.6: Impact on Capacity of Puri fi cation Steps, U.S. vs. Western Europe
Fig 9.7: Issues Regarding Protein A Usage (2017 data)
Fig 9.8: Issues Regarding Protein A Usage, 2009 - 2017
Fig 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe
Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses, 2014 -2016, 2018-2019 Data)
Fig 9.11: Bioreactor Yield at which DOWNSTREAM Puri fi cation Train Becomes Bottlenecked
Fig 9.12: New Downstream Processing Solutions, 2019
Fig 9.13A: New Downstream Processing Solutions Comparison 2010-2019
Fig 9.13B: New Downstream Processing Solutions Comparison 2010-2019
Fig 9.14: New Downstream Processing Solutions; Biotherapeutic Dev. vs. CMOs
Fig 9.15: New Downstream Processing Solutions; U.S. vs. Western Europe
Fig 9.16: Improving Downstream Operations, 2011 - 2019
Fig 9.17: Improving Downstream Operations; Biomanufacturers vs. CMOs
Fig 9.18: Improving Downstream Operations (U.S. vs. Western Europe vs. ROW)
Fig 10.1: Quality Initiative Implemented Currently, or within Next 12 Months (2018 DATA)
Fig 10.2: Quality Initiative to be Implemented in “Next 12 Months,” Comparing 2009 - 2018
Fig 10.3: Hurdles Hindering Implementation of PAT (2008 – 2019)
Fig 10.4: Batch Failure Frequency Distribution, 2009 – 2019
Fig 10.5: Average Rates of Failure, by Primary Cause, and Phase of Manufacture
Fig 10.6: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2019 (Commercial Manufacture)
Fig 10.7: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2019 (“Clinical” Scale)
Fig 10.8: Quality Problems Traced to Vendors; 2008 – 2018
Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2019)
Fig 11.2: Estimated Hiring, by Area, 2008-2019
Fig 11.3: New Hires in Biopharmaceutical Manufacturing (2024)
Fig 11.4: Areas Where Hiring Dif fi culties Exist in Biopharmaceutical Operations
Fig 11.5: Areas Where Hiring Dif fi culties Exist in Biopharmaceutical Operations; 2010 – 2019
Fig 11.6: Areas Where Hiring Dif fi culties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe
Fig 11.7: Training for New Operations/Manufacturing Employees (2018 data)
Fig 11.8: Average Annual Changes in Training for New Operations/Manufacturing Employees, 2009 – 2018
Fig 12.1: Changing the way culture is viewed
Fig 12.2: Example of an operational work fl ow diagram for an upstream process
Fig 12.3: Triangle of Pharmaceutical Facility Design
Fig 12.4: The QbD principles as laid out by ICH Q8 and Q11
Fig 12.5: Future of Continuous Bioprocessing and Process Intensi fi cation
Fig 12.6: Perfusion Operations Issues: Comparison 2010 - 2016 (2016 data)
Fig 12.7: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing
Fig 12.8: Facilities Evaluating CBP Technologies Over Next 12 months (Upstream vs. Downstream), 2016-2019
Fig 13.1: Area of Biopharmaceutical Involvement, Vendor
Fig 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010 to 2019
Fig 13.3: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008 - 2019
Fig 13.4: Respondents’ Primary Job Function
Fig 13.5: Average Annual Vendor Sales Growth Rate, 2007 - 2019
Fig 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
Fig 13.7: Average Annual Vendor Segment Sales Growth Rates, 2019
Fig 13.8: Average Annual Vendor Sales Growth Rate, 2007 - 2019, by Segment
Fig 13.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2019

TABLES

Table 0.1 Areas of Biopharmaceutical Manufacturing Operations
Table 1.1 Recently Announced CMO SUS-based Commercial Scale Expansions & New Facilities
Table 1.2 FDA Biopharmaceutical Approvals, 2018
Table 1.3 Number of Biopharmaceutical Products in U.S. and European Markets*
Table 1.4 Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2018
Table 2.1 Total and CMO Facilities Bioprocessing Capacity Scales
Table 2.2 Regional Distribution of Bioprocessing and CMO Facilities, Total & Average Capacity
Table 2.3 Major US W. European Bioprocessing CMOs, # Facilities and Estimated Capacity*
Table 2.4 Some Recently Announced CMO SUS-based Commercial Scale Expansions & New Facilities
Table 2.5 Constructs and Contracts for Manufacturing
Table 2.6 Recent M&A activities
Table 2.7 Service offerings and value chains of selected CDMOs
Table 3.1 Areas of Signi fi cant Projected Budget Percentage Increases for Biomanufacturing, 2019 and Past Years
Fig 13.10: Vendors’ Average Budget Change, 2019
Fig 13.11: Vendors’ Average Budget Change for 2009 - 2019, Summary
Fig 13.12: Vendors’ Average Pricing Changes
Fig 13.13: Vendors’ Average Pricing Changes, 2009-2018 Actual and 2019 projected
Fig 13.14: Actions undertaken to reduce overall costs, prior 12 months, 2011-2017
Fig 13.15: Actions undertaken to reduce overall costs in past 12 months, By Segment (2017 data)
Fig 13.16: (See Fig 10.8; recap): Quality Problems Traced to Vendors (2008-2018)
Fig 13.17: Biopharma Business and Marketing Plans, 2019
Fig 13.18: Biopharma Business and Marketing Plans, 2010-2019
Fig 13.19A: Top New Technologies or New Product Development Areas
Fig 13.19B: Top New Technologies or New Product Development Areas
Fig 13.20: Plans for Launching Signi fi cant, Truly Novel Bioprocessing Advances (2017 data)
Fig 13.21: R&D Spending/Budgets for New Products/Services, 2019
Fig 13.22: Areas Where Training is Considered as Needed; 2010 – 2019
Fig 13.23: Client Demands of Vendors, Service and Support, 2012 - 2019
Fig 13.24: Vendors Views of Financial (Sales) Outlook for Next Year, 2011-2019
Fig 13.25: Average CMOs Service Price Shifts in 2019
Fig 13.26: CMOs Service Price Shifts in 2019, Distribution
Table 4.1 Western European Biomanufacturers’ Average Capacity Utilization
Table 4.2 U.S. Biomanufacturers’ Average Capacity Utilization
Table 4.3 Leading Biopharma Company Capacity
Table 4.4 Compound Annual Change in Mab Titer, 2008-2019
Table 5.1 Severe or Signi fi cant Capacity Constraints, by Stage of Production, 2009-2019
Table 5.2 Severe and Signi fi cant Capacity Constraints Today, U.S. vs. W. Europe, 2010-2019
Table 6.1 Western European Biomanufacturers’ Five-Year Projected Increases
Table 6.2 U.S. Biomanufacturers’ Five-Year Projected Increases
Table 7.1 Respondents Reporting No Outsourced Production (i.e., all in-house manufacturing), 2009-2019
Table 7.2 Respondents Outsourcing up to 50% of Production, Mammalian and Microbial Systems, 2009-2019
Table 7.3 Respondents Outsourcing Over 50% of Production, Mammalian and Microbial Cell Systems, 2009-2019
Table 7.4 Plant and Insect Cells, 2015-2019
Table 7.5 Percent of U.S.-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2009-2019
Table 7.6 Percent of European-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2011-2019
Table 9.1 Percent experiencing “Serious” or “Some” capacity problems due to downstream processing 2008-2019
Table 9.2 Percent U.S. vs. Western Europe facilities experiencing “Serious” capacity problems due to downstream processing, 2009-2019
Table 9.3 Percent U.S. vs. Western Europe facilities not expecting to see bottlenecks due to downstream processing, 2008-2018
Table 9.4 Upstream Production Titer vs. Max Capacity, 2019 Data
Table 13.1 Selected “Other” New Technology Areas in Development
Table 13.2 Average Vendor Sales and Technical Training Days, 2011 – 2013, 2019
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16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
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