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17th Annual Report and Survey on Biopharmaceutical Manufacturing Capacity and Production

  • ID: 5118512
  • Report
  • April 2020
  • Region: Global
  • 522 Pages
  • Bioplan Associates Inc

The 2020 17th 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 522 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. Trend analysis in this 17th in a series of annual biopharmaceutical manufacturing industry evaluations. This edition includes the joint industry expertise of the publisher, and many industry consultants and experts.

Note: Product cover images may vary from those shown

METHODOLOGY

CHAPTER 0: DEMOGRAPHICS
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
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

  • Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

1-8 Future Trends in the Biopharmaceutical Industry
1-9 Future Biopharmaceutical Market Trends

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS’ PERSPECTIVE
2-1 Cell and Gene Therapy – Future of Bioprocessing
2-2 Continuous Processing – Present and Future Challenges
2-3 China and Asia’s position in Global Bioproduction
2-4 Intersection of Biopharma and Small Pharma: Small Molecule Manufacturing Lessons for a New Industry
2-5 Upstream and Downstream Biologics Manufacturing: Mapping the Future Challenges and Trends
2-6 Suppliers’ Contributions to Bioprocessing Advances
2-7 Contract Manufacturing’s Contributions to Bioprocessing Advances
2-8 Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board
2-9 China’s Advances in Global Biopharma and Bioprocessing: A 10-year Projection on Need for Quality Improvements

CHAPTER 3: EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING
3-1 Industry Trends in 2018

  • Introduction
  • Productivity and Cost Reductions

3-2 Budget Issues in 2018

  • Budget Change Comparisons

3-3 Operational Changes
3-4 New Bioprocessing Products Development Opportunities in 2018

  • Upstream New Product Areas of Need
  • Trends: Upstream New Product Areas of Need 2010-2018
  • Downstream New Product Areas of Need
  • Trends: Downstream New Product Areas of Need 2010-2018
  • Other New Product Areas of Need
  • Trends: Other General New Product Areas of Need 2010-2018
  • 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 Cost-Cutting Actions & Development Timelines (2016 data)

  • Cost-Cutting Changes: Specifi c to Outsourcing (2016 data)

3-7 Average Cost per Gram Recombinant Protein
3-8 Assay Development

  • Biomanufacturing Assay Required; Biomanufacturers vs. CMOs (2016 data)

3-9 Perfusion Operations and Continuous Bioprocessing Operations Issues

  • Perfusion vs. Batch Fed Bioprocessing

3-10 Perfusion Operations and Continuous Bioprocessing Trends

  • Continuous Bioprocess and Process Intensification

3-11 Discussion

  • Continuous Bioprocessing: Trends and Opportunities
  • Perfusion: Trends and Opportunities

3-12 Cell and Gene Therapy Platforms

  • Cell and Gene Therapy Manufacturing Advancements
  • Cell and Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure

3-13 Selecting Bioreactors in New Facilities (2017 data)

3-14 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 Desires for Improved Products and Services

CHAPTER 4: CAPACITY UTILIZATION
4-1 Capacity Utilization Trends

  • Capacity Utilization Definitions
  • Relevance of Capacity Utilization Capacity Utilization in Biomanufacturing, 2018
  • Capacity Utilization Changes Since 2004
  • Average Growth Rate in Capacity Utilization, 2006-2018

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
  • Yeast Production Capacity (2016)
  • Insect Cells Production Capacity (2016)

4-5 Discussion: Capacity Trends
4-6 Range of Titers with mAb Production

  • Annual mAb Titer Changes, 2008-2018

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, 2004-2018
  • Perception of Capacity Constraints: Biotherapeutic Developers vs. CMOs
  • Capacity Constraints: U.S. vs. Western European Biotherapeutic Developers & CMOs

5-2 Expected Capacity Constraints 210 Respondents’ Expectations of Capacity Constraints by 2023

  • Expected Capacity Constraints by 2023: Comparing 2004 through 2018 Data
  • Expected Capacity Constraints by 2023:CMOs vs. Biotherapeutic Developers
  • Expected Capacity Constraints by 2023:U.S. vs. Western Europe

5-3 Factors Impacting Future Production Capacity

  • Factors Creating Future Capacity Constraints
  • Factors Creating Future Capacity Constraints, 2008 vs. 2018
  • Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs
  • CMOs’ 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, 2006-2018
  • 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, 2009-2023
  • Planned Future Capacity Expansions by 2023; CMOs vs. Biotherapeutic Developers
  • Planned Five-Year Capacity Expansions; 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”), 2006-2018

7-2 Future Outsourcing

  • Biotherapeutic Developers’ Outsourcing, 2023 Projections, by System
  • Biotherapeutic Developers Outsourcing Some Production in 2023

7-3 Outsourced Activities in Biopharmaceutical Manufacturing

  • Comparison of Biomanufacturers’ Outsourcing, (2010-2018)
  • Increased Outsourced Activities, 24-month Projections
  • Outsourcing Activities Projected at ‘Significantly Higher Levels’, Comparison of 2010-2018 Trends
  • Average Percentage of Activities Outsourced Today
  • Comparison of Outsourcing Activities, 2010-2018
  • Change in Spending on Outsourcing Activities

7-4 Critical Outsourcing Issues

  • Selecting a CMO:2018
  • 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
7-8 5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Off-shoring

  • 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: 2006-2018
  • Annual Growth Rate for Disposables Market Penetration/Usage
  • 10-year Growth in Disposables 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

8-3 Reasons for Increasing Use of Disposables & Single-Use Systems 326

  • Reasons for Increased Use of Disposables, 2006 through 2015
  • 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: Trends 2006-2015
  • Factors that May Restrict Use of Disposables: CMO’s vs. Biotherapeutic Developers
  • Most Critical Reasons for Restricting Use of Disposables
  • Most Important Reasons for Not Increasing Use of Disposables, 2008-2018
  • Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developer vs. CMO
  • Top Reasons for Not Increasing the Use of Disposables: U.S. vs. Western Europe Respondents

8-5 Suppliers’ Expectations for Standards Setting Bodies
8-6 Need for Single-use Sensors, and Bioreactor Attributes

  • Single-Use Adoption Issues
  • Single-use Adoption Factors, U.S. vs. Western Europe

8-7 Satisfaction with Single-use Device Vendors

  • Single-Use Attribute Importance Analysis
  • Single-use Suppliers’ Delivery Problems, 2013-2018

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 Use
  • 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 Specific Purification Step Constraints

  • Changes in Impact on Capacity of Purification Steps, 2008-2018
  • Specific Purification Step Constraints, U.S. vs. Western European Biomanufacturers

9-3 Downstream Purification Issues

  • Protein A and Alternatives
  • Changes in Perception of Protein A and Alternatives
  • Protein A Downstream Purification Issues, U.S. vs. Western Europe

9-4 mAb Purification Capacity Estimates

  • Upstream Production Titer vs. Max Capacity

9-5 New Downstream Processing Technologies

  • New Downstream Processing Solutions; 2010 – 2018
  • 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, 2008-2018
  • 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 – 2018

11-2 Hiring in 2023: 5-year Trends
11-3 Hiring Challenges Today

  • Hiring Difficulties; 2010 - 2018

11-4 Training in Biopharmaceutical Manufacturing

  • Changes in Training for New Manufacturing Employees, 2009-2018

11-5 Intersection of Biopharma and Small Pharma

  • Large-molecule Biomanufacturing Benefitting from Small-molecule Experience

11-6 Discussion

  • Options Developing for Bioprocessing Training
  • Continued Growth in Biopharmaceutical Manufacturing Jobs

CHAPTER 12: New Methods: Continuous and Process Intensification, Cell and Gen

  • Introduction

12-1 PerfusionAreas of Involvement
12-2 Trends in Fill-Finish and Related Bioprocessing Capacity

  • Analysis of US and European In-house Capacity and Capacity Utilization (2017 data)
  • Challenges in Estimating Fill-Finish Capacity

12-3 Current Fill-Finish Trends

  • Recent Industry Trends
  • Future Fill and Finish Trends
  • Suppliers’ Innovation Trends
  • Industry Capacity Data
  • New Technology Implementation in Fill-Finish (2017 data)

12-4 Discussion

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 to 2018
  • 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
  • Future Price Changes
  • 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 vs. 2018

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 502 Days of Training Provided

  • Areas where Training May Help Sales Staff Perform, Trends 2010 - 2018
  • Clients’ Demands on Vendors

13-10 Biopharma Vendors’ Financial Outlook for 2018
13-11 Discussion of Biopharma Suppliers

  • Bioprocessing Vendors Will See Continued Market Growth
  • Single-use Systems Are Increasingly Driving Sales  
  • Trends Favor Increased Vendor Sales
  • Vendors are Offering More Services, Going for Larger Sales
  • Biopharma Suppliers in Emerging Regions

FIGURES
Figure 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 to 2018
Figure 0.2: Respondents’ Job Responsibilities, 2011 – 2018
Figure 0.3: Facility Location
Figure 0.4: Facility Location, by Region
Figure 0.5: Biopharmaceutical Manufacturing Systems, (2007-2018) Trends
Figure 0.6: Phase of Development of Surveyed Respondents, 2006-2018
Figure 0.7: Phase of Development of Surveyed Respondents, (U.S. vs Western Europe)
Figure 0.8: Distribution of Employees at Facility, and Organization
Figure 0.9: Distribution of Total Batches Run at Facility Last Year, by Scale of Production
Figure 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity
Figure 0.11: Distribution of Largest STAINLESS Bioreactor Capacity
Figure 1.1: Number of Biosimilars in the U.S. Pipeline by Launchable Dates
Figure 1.2: Biosimilars Launchable Dates by Sum of Current Reference Products Sales ($millions)
Figure 1.3: FDA Approvals of New Biopharmaceutical Products 1982-2017
Figure 2.1: Cell Therapy, Gene Therapy, Gene Modified Cell Therapy Definitions
Figure 2.2: The Personalized Cell Therapy Challenge: A Race Against Time
Figure 2.3: Typical Lentivirus and AAV Process
Figure 2.4: High-Throughput Analytics
Figure 2.5: Focus on defining the operation model and ensuring stakeholder alignment can enable the move to an improved performance stage – the future stage
Figure 2.6: Changing the way culture is viewed
Figure 2.7: Example of an operational workfl ow diagram for an upstream process
Figure 2.8: The triangle of pharmaceutical facility design
Figure 2.9: The QbD principles as laid out by ICH Q8 and Q11 as an enabler for a speedy and systematic development approach those results in a control strategy
Figure 2.10: Biopharma Benefi tting from Pharma Experience
Figure 2.11: Where Large Molecule BioFacilities Are Hiring From
Figure 2.12: Entry points and starting materials to CDMOs
Figure 2.13: Benefits of Disposables for CDMOs
Figure 2.14: Global Bioprocessing Operations Concentration (By Facility Index)
Figure 2.15: Distribution of Worldwide Capacity by Size Ranges
Figure 2.16: China Respondents’ Job Responsibilities
Figure 2.17: China Biopharmaceutical Facility Type
Figure 2.18: Top “Strength” Attributes Required for China’s Biologics Companies to Expand Globally
Figure 2.19: Top Attributes Chinese Companies Need to Compete Globally
Figure 2.20: What China Biopharma Needs to Compete Globally as a Biopharma Center in 10 Years
Figure 2.21: Chinese Bioprocessing Facilities: Primary Objectives for Biologics Production – 2016 vs 2026
Figure 3.1: SINGLE most important biomanufacturing trend or operational area, 2014-2018
Figure 3.2: Biomanufacturers’ Budget Shifts in 2018
Figure 3.3: Approximate Average Change in Biomanufacturers’ Budgets for 2018
Figure 3.4: Average Biomanufacturers’ Budget Change, 2009-2018
Figure 3.5: New Product Development-Upstream Focus Areas
Figure 3.6: New Product Development-Upstream Focus Areas (2010-2018)
Figure 3.7: New Product Development-Downstream Focus Areas
Figure 3.8: New Product Development-Downstream Focus Areas (2010-2018)
Figure 3.9: New Product Development – General Focus Areas
Figure 3.10: New Product Development – General Focus Areas, 2010-2018
Figure 3.11: New Product Development Areas of Interest: Biotherapeutic Developers vs. CMO’s
Figure 3.12: New Product Development Areas of Interest: U.S. vs. Western Europe and ROW
Figure 3.13: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements
Figure 3.14: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2016
Figure 3.15: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2018
Figure 3.16: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods, 2011 -2015, 2018
Figure 3.17: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs (2016 data)
Figure 3.18: Perfusion Operations Issues: Perfusion vs. Batch-Fed Processes (2016 data)
Figure 3.19: Perfusion Operations Issues: Comparison 2010 - 2016 (2016 data)
Figure 3.20: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing
Figure 3.21: Facilities Evaluating CBP Technologies Over Next 12 months (Upstream vs. Downstream), 2016-2018
Figure 3.22: Continuous Bioprocessing and Process Intensification
Figure 3.23: Future Cell and Gene Therapy Platforms
Figure 3.24: Cell and Gene Therapy Manufacturing Advancements in 5 Years (2023) to Avoid Bottlenecks
Figure 3.25: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure
Figure 3.26: Likelihood of Implementing Bioreactor, by Type (2017 data)
Figure 3.27: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2017
Figure 4.1: Capacity Utilization, By System
Figure 4.2: Capacity Utilization, By System, 2004-2018
Figure 4.3: Change in Capacity Utilization, CAGR, 2006-2018
Figure 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs. CMOs
Figure 4.5: Capacity Utilization, By System, U.S. vs. Western Europe
Figure 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
Figure 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2018
Figure 4.8: Current Production Capacity Distribution, Microbial Fermentation
Figure 4.9: Current Production Capacity Distribution, Cell or Gene Therapy
Figure 4.10: Range of Titres for mAbs Obtained at Various Production Scales, Distribution
Figure 4.11: Average mAb Titre Trend 2008-2017
Figure 5.1: Capacity Constraints, by Stage of Production
Figure 5.2: Capacity Constraints, 2004 through 2018 ...205
Figure 5.3: Capacity Constraints Trends, 2004-2018
Figure 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs ..208
Figure 5.5: Capacity Constraints, US vs. Western Europe .209
Figure 5.6: Expectations of Capacity Constraints; by Stage of Production; Five-year Projections
Figure 5.7: Expectations of Capacity Constraints: Five-year Projections Made in 2004-2018
Figure 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2023 (Trend Line)
Figure 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs. CMOs
Figure 5.10: Five-year Projections for Capacity Constraints:U.S. vs. Western Europe
Figure 5.11: Factors Creating Future Capacity Constraints, in 5 years
Figure 5.12A: Factors Creating Future Capacity Constraints, 2008-2018
Figure 5.12B: Factors Creating Future Capacity Constraints, 2008-2018
Figure 5.13: Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs
Figure 5.14: Factors Creating Future Capacity Constraints, U.S. vs. Western European Biomanufacturers
Figure 5.15: Key areas to Address to Avoid Capacity Constraints
Figure 5.16A: Key areas to Address to Avoid Capacity Constraints; 2006-2018
Figure 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2018
Figure 5.17: Key Areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs
Figure 5.18: Key areas to Address to Avoid Capacity Constraints; U.S. vs. Western Europe
Figure 6.1: Industry Average Planned Production Increase by 2023
Figure 6.2: Planned Future Capacity Expansion: 5-year Estimates, 2009 - 2023
Figure 6.3: Planned Future Capacity Expansion: 5-year Estimates; Biotherapeutic Developers vs. CMOs
Figure 6.4: Planned Future Capacity Expansion: 5-year Estimates; U.S. vs. Western Europe
Figure 6.5: Percent of Respondents Projecting Production Increases of over 100% by 2023; 5-year Trend
Figure 7.1: Current Percent Production Outsourced; by System
Figure 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2018
Figure 7.3: Future Outsourcing: Percent Production Outsourced; by System, by 2023
Figure 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2018
Figure 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today
 Figure 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 – 2018
Figure 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 – 2018
Figure 7.7: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years
Figure 7.8A: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years, 2010 - 2018 Trends
Figure 7.8B: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years, 2010 - 2018 Trends
Figure 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today
Figure 7.10A: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2018
Figure 7.10B: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2018
Figure 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012 - 2018
Figure 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations
Figure 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2006-2018
Figure 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2018, Percentage Point Differences
Figure 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2018
Figure 7.16: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2018; 2010-2013
Figure 7.17: Country Selections as Destination for International Outsourcing of BioManufacturing (All Respondents)
Figure 7.18A: Percent U.S. Respondents Considering Country as ‘Possible’ Outsourcing Destination, next five years
Figure 7.18B:Percent U.S. Respondents Considering Country as ‘Possible’ Outsourcing Destination, next five years
Figure 7.19: Percent U.S. Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination, next five years
Figure 7.20: Percent Western European Respondents Considering Country as ‘Possible’ Outsourcing Destination
Figure 7.21: Percent European Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination
Figure 7.22: Percent of Biomanufacturing Operations Off-shored (International Outsourcing) within 5 Years
Figure 7.23: Percent Biomanufacturers Performing at Least “Some” International Outsourcing/Off-shoring during Next 5 Years (2011-2018)
Figure 7.24: Estimated % Operations Done as International Outsourcing/Off-shoring during Next 5 Years (2011-2018)
Figure 8.1: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture
Figure 8.2A: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture; 2006-2018
Figure 8.2B: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture; 2006-2018
Figure 8.3: Average Annual Growth Rate, Disposables, 2006-2018
Figure 8.4: 10-Year Percentage-Point Change in First-Usage of Disposables, 2006-2018
Figure 8.5: Usage of Disposables in Biomanufacturing, by Stage of Manufacture (R&D - Commercial)
Figure 8.6: Usage of Disposables in Biopharmaceutical Manufacturing; Biotherapeutic Developer vs. CMO
Figure 8.7: Value of Useable Leachables and Extractables Data (2016 Data)
Figure 8.8: Reasons for Increasing Use of Disposable System Components in 2015 (data from 2015)
Figure 8.9: Reasons for Increasing Use of Disposable System Components, 2006-2015
Figure 8.10: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2018
Figure 8.11: Reasons for Restricting Use of Disposables (2015 Data)
Figure 8.12: Factors Restricting Use of Disposables, 2006-2015 (2015 Data)
Figure 8.13: Top Reasons for Not Increasing Use of Disposables, 2018
Figure 8.14: Top Reasons for Not Increasing Use of Disposables, 2008-2018
Figure 8.15: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developer vs. CMO
Figure 8.16: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe
Figure 8.17: Suppliers’ Perception of Organizations Responsible for Establishing Standards for Single-use Devices (2017 data)
Figure 8.18: Single-use / Disposable Device Adoption Factors
Figure 8.19: Single-use / Disposable Device Adoption Factors; U.S. vs. Western Europe
Figure 8.20: Need for Improved Single-Use Sensors, 2012-2017
Figure 8.21: Single-use Product Vendor Satisfaction Factors, 2008 - 2018
Figure 8.22: Importance of Single-use Product Attributes vs. Level of Vendor Satisfaction
Figure 8.23: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction, 2013-2018
Figure 8.24: Estimated Percentage of Facilities’ Unit Operations that are “Single-use” (2014 vs. 2018)
Figure 8.25: Distribution of Responses, % Single-use Devices in Biomanufacturing
Figure 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2018
Figure 9.2: Impact of Downstream Processing on Overall Capacity; Biotherapeutic Developers vs. CMOs
Figure 9.3: Impact of Downstream Processing on Overall Capacity; U.S. vs. Western Europe
Figure 9.4: Impact on Capacity of Depth, Chromatography and UF Purification Steps
Figure 9.5: Impact on Capacity of Purification Steps: Experiencing at “Significant” or “Severe” Constraints, 2008-2018
Figure 9.6: Impact on Capacity of Purification Steps, U.S. vs. Western Europe
Figure 9.7: Issues Regarding Protein A Usage
Figure 9.8: Issues Regarding Protein A Usage, 2009 - 2017
Figure 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe
Figure 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses, 2014 -2016, 2018 Data)
Figure 9.11: Bioreactor Yield at which DOWNSTREAM Purification Train Becomes Bottlenecked
Figure 9.12: New Downstream Processing Solutions
Figure 9.13: New Downstream Processing Solutions Comparison 2010-2018
Figure 9.14: New Downstream Processing Solutions; Biotherapeutic Dev. vs. CMOs
Figure 9.15: New Downstream Processing Solutions; U.S. vs. Western Europe
Figure 9.16: Improving Downstream Operations, 2011 - 2018
Figure 9.17: Improving Downstream Operations; Biomanufacturers vs. CMOs
Figure 9.18: Improving Downstream Operations (U.S. vs. Western Europe vs. ROW)
Figure 10.1: Quality Initiative Implemented Currently, or within Next 12 Months
Figure 10.2: Quality Initiative to be Implemented in “Next 12 Months,” Comparing 2009 - 2018
Figure 10.3: Hurdles Hindering Implementation of PAT (2008 – 2018)
Figure 10.4: Batch Failure Frequency Distribution, 2009 – 2018
Figure 10.5: Average Rates of Failure, by Primary Cause, and Phase of Manufacture
Figure 10.6: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2018 (Commercial Manufacture)
Figure 10.7: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2018 (“Clinical” Scale)
Figure 10.8: Quality Problems Traced to Vendors; 2008 – 2018
Figure 11.1: New Hires in Biopharmaceutical Manufacturing (2018)
Figure 11.2: Estimated Hiring, by Area, 2008-2018
Figure 11.3: New Hires in Biopharmaceutical Manufacturing (2023)
Figure 11.4: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations
Figure 11.5: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations; 2010 - 2018
Figure 11.6: Areas Where Hiring Difficulties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe
Figure 11.7: Training for New Operations/Manufacturing Employees
Figure 11.8: Average Annual Changes in Training for New Operations/Manufacturing Employees, 2009 – 2018
Figure 11.9: Areas Where Large Molecule BioFacilities Are Hiring Consultants, Staff
Figure 11.10: Areas Where Large-molecule Biomanufacturing Could Benefit from Small-molecule Pharma Experience
Figure 12.1: Fill-Finish Operation Type
Figure 12.2: Fill-Finish Capacity Utilization Averages, 2015-2017
Figure 12.3: Most Important Trends in Fill-Finish, 2015-2017
Figure 12.4: Novel Fill-Finish Technology Implementation Plans within 24 Months, 2015 -2017
Figure 13.1: Area of Biopharmaceutical Involvement, Vendor
Figure 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010 to 2018
Figure 13.3: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008 - 2018
Figure 13.4: Respondents’ Primary Job Function
Figure 13.5: Average Annual Vendor Sales Growth Rate, 2007 - 2018
Figure 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
Figure 13.7: Average Annual Vendor Segment Sales Growth Rates, 2018
Figure 13.8: Average Annual Vendor Sales Growth Rate, 2007 - 2018, by Segment
Figure 13.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2018
Figure 13.10: Vendors’ Average Budget Change for 2018 479
Figure 13.11: Vendors’ Average Budget Change for 2009 - 2018, Summary
Figure 13.12: Vendors’ Average Pricing Changes
Figure 13.13: Vendors’ Average Pricing Changes, 2009-2017 Actual and 2018 projected
Figure 13.14: Actions undertaken to reduce overall costs, prior 12 months, 2011-2017
Figure 13.15: Actions undertaken to reduce overall costs in past 12 months, By Segment
Figure 13.16: (See Figure 10.8; recap): Quality Problems Traced to Vendors
Figure 13.17: Biopharma Business and Marketing Plans, 2018
Figure 13.18: Biopharma Business and Marketing Plans, 2010-2018
Figure 13.19A: Top New Technologies or New Product Development Areas
Figure 13.19B: Top New Technologies or New Product Development Areas
Figure 13.20: Plans for Launching Signifi cant, Truly Novel Bioprocessing Advances
Figure 13.21: R&D Spending/Budgets for New Products/Services
Figure 13.22: Areas Where Training is Considered as Needed; 2010 – 2018
Figure 13.23: Client Demands of Vendors, Service and Support, 2012 - 2018
Figure 13.24: Vendors’ Optimism; Financial Performance 2011-2017, and Projected Performance in 2018

Note: Product cover images may vary from those shown
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