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14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

This comprehensive look at the state of worldwide biopharmaceutical manufacturing provides the only on-going assessment of manufacturing capacity and production in this $20015 billion global industry. You will find current, quantitative information from 2273502 worldwide biopharmaceutical developers and contract manufacturers, and over 13185 direct suppliers to the industry. Coverage includes:

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 9th in a series of annual biopharmaceutical manufacturing industry evaluations. Projected capacity bottlenecks, and how they might be resolved. This edition includes the joint industry expertise from BioPlan Associates, and many industry consultants and experts


METHODOLOGY
CHAPTER 0: DEMOGRAPHICS
Introduction
0-1 Respondents’ Area of Involvement 0-2 Respondents Qualifi 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 Biopharmaceutical Industry
1-2 Current Status and Market Trends
1-3 Market Potential
1-4 Biopharmaceuticals and Biosimilars in the Pipeline
1-5 Biopharmaceutical Approvals Generic
1-6 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
1-7 Biopharmaceutical Markets by Product Class
mAbs are the Leading Product Classes
1-8 Biopharmaceutical Blockbusters
1-9 Commercial Product Expression Systems
1-10 Animal Derived Products and Biopharmaceuticals
1-11 Cost-Containment and Price Controls
1-12 Future Trends in the Biopharmaceutical Industry
1-13 Overview of Biopharmaceutical Market Trends
CHAPTER 2: Overview of Critical Issues in Bioprocessing
2-1 China’s Advances in Global Biopharma and Bioprocessing
2-2 I ndia’s Importance to the Global Biopharma Industry
2-3 Economic Models for Media and Buffer Prep Operations
2-4 Overview of Capacity Utilization and Capacity Trends among CMOs
2-5 Demand for Improved Downstream Bioprocessing Technologies
2-6 Cell Therapy and Gene Therapy Manufacturing Capacity Trends
2-7 Current and Future Trends in Biosimilars Manufacturing Costs
2-8 Bioprocessing Demands of Industry Suppliers are Evolving
CHAPTER 3: Emerging Issues in Biopharmaceutical Manufacturing
3-1 Industry Trends in 2017
Introduction
Productivity and Cost Reductions
3-2 Budget Issues in 2017
Budget Change Comparisons
3-3 Operational Changes
3-4 New Bioprocessing Products Development Opportunities in 2017
Upstream New Product Areas of Need
Trends: Upstream New Product Areas of Need 2010-2017
Downstream New Product Areas of Need
Trends: Downstream New Product Areas of Need 2010-2017
Other New Product Areas of Need
Trends: Other General New Product Areas of Need 2010-2017
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
3-9 Continuous Bioprocessing Operations Issues
Perfusion vs Batch Fed Bioprocessing
3-10 Discussion
3-11 Perfusion Operations and Continuous Bioprocessing Trends
Continuous Bioprocessing: Trends and Opportunities
3-12 Selecting Bioreactors in New Facilities
3-13 Supplier-End-User Technical Relationships
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 Defi nitions
Relevance of Capacity Utilization
Capacity Utilization in Biomanufacturing, 2017
Capacity Utilization Changes Since 2004
Average Growth Rate in Capacity Utilization, 2006-2017
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
Yeast Production Capacity
Insect Cells Production Capacity
4-5 Current State of Capacity Utilization
Future Capacity Issues
4-6 Range of Titers for mAb Production
Annual mAb Titer Change, 2008-2017
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, 2004-2017
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 2022
Expected Capacity Constraints by 2022: Comparing 2004 to 2017 Data
Expected Capacity Constraints by 2022: CMOs vs. Biotherapeutic Developers
Expected Capacity Constraints by 2022: U.S. vs. Western Europe
5-3 Factors Impacting Future Production Capacity
Factors Creating Future Capacity Constraints
Factors Creating Future Capacity Constraints, 2008 vs. 2017
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 199
5-4 Key Areas to Address to Avoid Future Capacity Constraints
Analysis of Areas to Avoid Capacity Constraints: Changing
Perspectives, 2006-2017
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, 2009-2022
Planned Future Capacity Expansions by 2022; 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?
Strategic Manufacturing Planning
Future Projections
7-1 Current Outsourcing by Production System
Facilities Currently Outsourcing No Production (All Production “In-house”), 2006-2017
7-2 Future Outsourcing
Biotherapeutic Developers’ Outsourcing, 2022 Projections, by System
Biotherapeutic Developers Outsourcing Some Production in 2022
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
Comparison of Biomanufacturers’ Outsourcing, (2010-2017)
Increased Outsourced Activities, 24-month Projections
Outsourcing Activities Projected at ‘Signifi cantly Higher Levels’, Comparison of 2010-2017 Trends
Average Percentage of Activities Outsourced Today
Comparison of Outsourcing Activities, 2010-2017
Change in Spending on Outsourcing Activities
7-4 Critical Outsourcing Issues
Selecting a CMO: 2017
Selecting a CMO, 2006-2017
Changes in Critical Issues when Considering a CMO, 2008-2017
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: 2006-2017
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, 2015 vs 2016
8-3 Reasons for Increasing Use of Disposables & Single-Use Systems
Reasons for Increased Use of Disposables, 2006 through 2015
Reasons for Increased Use of Disposables: Biotherapeutic
Developers vs. CMOs
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, 2008-2017
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 Standards Setting for Disposable, Single-use Systems
Standardizing Single-use Designs
Standardization Factors, 2013-2015
Suppliers’ Expectations for Standards Setting Bodies
8-6 Budgets for Disposable Systems
8-7 Need for Single-use Sensors, and Bioreactor Attributes
Single-Use Adoption Issues
Single-use Adoption Factors, U.S. vs Western Europe
Single-Use Sensor Technologies
8-8 Recycling and Disposal of Single-use Plastics
Waste Disposal of Single-use Devices
Meeting Respondents’ Demands for Recycling
8-9 Satisfaction with Single-use Device Vendors
Single-Use Attribute Importance Analysis
Single-use Suppliers’ Delivery Problems, 2013-2017
8-10 Single Use Operations and Trends
Percentage of Unit Operations that are Single-Use
Distribution of Responses
8-11 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 Purifi cation
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 Specifi c Purifi cation Step Constraints
Changes in Impact on Capacity of Purifi cation Steps, 2008-2017
Specifi c Purifi cation Step Constraints, U.S. vs. Western European
Biomanufacturers
9-3 Downstream Purifi cation Issues
Protein A and Alternatives
Changes in Perception of Protein A and Alternatives
Protein A Downstream Purifi cation Issues, U.S. vs. Western Europe
9-4 mAb Purifi cation Capacity Estimates
Upstream Production Titer vs. Max Capacity
9-5 New Downstream Processing Technologies
New Downstream Processing Solutions; 2010 – 2017
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 Hurdles to Implementing Process Analytical Technology
Trends in PAT, 2008-2017
PAT Adoption Will Increase
10-2 Batch Failure Frequency in Biopharmaceutical Manufacturing
10-3 Primary Cause of Batch Failures, Percentages of Failures
10-4 Quality Problems in BioManufacturing Attributed to Vendors
10-5 Automation Implementation
Comparison of Implementation Plans 2009 - 2013
10-6 Quality Initiative Implementation
Comparison of Quality Initiative Implementation, 2009 - 2017
10-7 Global Quality Supply Management
Quality Supply Management-U.S. vs. W. Europe
10-8 Discussion
Hurdles Hindering Implementation of PAT
Batch Failures Due to Single-Use Adoption or Continued Stainless Steel Use?
Quality Problems Traced to Vendors
Process Information Needs and Value Drive Automation
Quality Initiatives Are Becoming Commonplace and the New Industry Norm
Challenges to Implementing PAT, QbD and other Quality Initiatives
Supply Management Issues with Single-Use Systems
CHAPTER 11: Hiring, Employment Growth, and Training in Biopharmaceutical Manufacturing
Introduction
11-1 Hiring Trends
Trends in New Hires, by Area; 2008 - 2017
11-2 Hiring in 2022: 5-year Trends
11-3 Hiring Challenges Today
Hiring Diffi culties; 2010 - 2017
Hiring Diffi culties: U.S. vs. Western Europe
U.S. vs. Western Europe Hiring Trends
11-4 Training in Biopharmaceutical Manufacturing
Changes in Training for New Manufacturing Employees, 2009 - 2017
11-5 Discussion
Options Developing for Bioprocessing Training
Continued Growth in Biopharmaceutical Manufacturing Jobs
CHAPTER 12: Fill and Finish
Introduction
12-1 Demographics
Areas of Involvement
Geographic Location, Facilities
12-2 Trends in Fill-Finish and Related Bioprocessing Capacity
Analysis of US and European In-house Capacity and Capacity Utilization
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
12-4 Discussion
Voice of Industry
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 2017
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 2017
Vendor Average Budget Changes for 2009 - 2017
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 - 2017
13-8 New Technology Areas in Development by Vendors
Suppliers’ Development of Innovative Technologies
Suppliers’ R&D Budget Spending for Innovative Technologies
13-9 Sales Staff Training
Days of Training Provided
Areas where Training May Help Sales Staff Perform, Trends
2010 - 2017
Clients’ Demands on Vendors
13-10 Biopharma Vendors’ Financial Outlook for 2017
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
Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 to 2017
Fig 0.2: Respondents’ Job Responsibilities, 2011 – 2017
Fig 0.3: Facility Location
Fig 0.4: Facility Location, by Region
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2017) Trends
Fig 0.6: Phase of Development of Surveyed Respondents
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: Number of Biosimilars in the U.S. Pipeline by Launchable Dates
Fig 1.2: Biosimilars Launchable Dates by Sum of Current Reference Products Sales ($millions)
Fig 1.3: FDA Approvals of New Biopharmaceutical Products 1982-2016
Fig 2.1: China Respondents’ Job Responsibilities
Fig 2.2: China Biopharmaceutical Facility Type
Fig 2.3: Top “Strength” Attributes Required for China’s Biologics Companies to Expand Globally
Fig 2.4: Top Attributes Chinese Companies Need to Compete Globally
Fig 2.5: What China Biopharma Needs to Compete Globally as a Biopharma Center in 10 Years
Fig 2.6: Chinese Bioprocessing Facilities: Primary Objectives for Biologics Production – 2016 vs 2026
Fig 2.7: Respondents’ Job Responsibilities
Fig 2.8: Biopharmaceutical Facility Type
Fig 2.9: Top “Strength” Attributes Required for India’s Biologics Companies to Expand Globally
Fig 2.10: Top Attributes Indian Companies Need to Compete Globally
Fig 2.11: What India Biopharma Needs to Compete Globally as a Biopharma Center in 10 Years
Fig 2.12: Indian Bioprocessing Facilities: Primary Objectives for Biologics Production – 2016 vs 2026
Fig 2.13: Biosimilars in the Pipeline Targeting Specifi c Reference and Classes of Products
Fig 2.14: Summary of Lowest Facility Manufacturing Cost Estimates*
Fig 2.15: Future of Biomanufacturing; System Requirements
Fig 2.16: Suppliers’ Type of Service Valued Most
Fig 2.17: How Can Suppliers Work More Effectively with Customers
Fig 3.1: SINGLE most important biomanufacturing trend or operational area, 2014-2017
Fig 3.2: Biomanufacturers’ Budget Shifts in 2017
Fig 3.3: Approximate Average Change in Biomanufacturers’ Budgets for 2017
Fig 3.4: Average Biomanufacturers’ Budget Change, 2009-2017
Fig 3.5: New Product Development-Upstream Focus Areas
Fig 3.6: New Product Development-Upstream Focus Areas (2010-2017)
Fig 3.7: New Product Development-Downstream Focus Areas
Fig 3.8: New Product Development-Downstream Focus Areas (2010-2017)
Fig 3.9: New Product Development – General Focus Areas
Fig 3.10: New Product Development – General Focus Areas, 2010-2017
Fig 3.11: New Product Development Areas of Interest: Biotherapeutic Developers vs CMO’s
Fig 3.12: New Product Development Areas of Interest: U.S. vs Western Europe and ROW
Fig 3.13: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: US Vs Western Europe Vs Rest of World (2015 Data)
Fig 3.14: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2016
Fig 3.15: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2017
Fig 3.16: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods, 2011 -2015
Fig 3.17: Perfusion Operations Issues: Perfusion vs. Batch-Fed Processes (2016 data)
Fig 3.18: Perfusion Operations Issues: Comparison 2010 - 2016 (2016 data)
Fig 3.19: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing
Fig 3.20: Continuous Bioprocessing Technologies Evaluation, 2016-2017
Fig 3.21: Likelihood of Implementing Bioreactor, by Type
Fig 3.22: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2017
Fig 3.23: Areas having dedicated, F/T staff engineers or technicians working directly with the vendors, 2016-2017
Fig 4.1: Capacity Utilization, By System
Fig 4.2: Capacity Utilization, By System, 2004-2017
Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2017
Fig 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs. CMOs
Fig 4.5: Capacity Utilization, By System, U.S. vs Western Europe
Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2017
Fig 4.8: Current Production Capacity Distribution, Microbial Fermentation
Fig 4.9: Mammalian Cell Culture Capacity Estimates 2003-2016
Fig 4.10: Microbial Fermentation Capacity Estimates 2003-2016
Fig 4.11: Range of Titres for Mabs Obtained at Various Production Scales, Distribution
Fig 4.12: Average Mab Titre Trend 2008-2017
Fig 5.1: Capacity Constraints, by Stage of Production
Fig 5.2: Capacity Constraints, 2004 through 2017
Fig 5.3: Capacity Constraints Trends, 2004-2017
Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs
Fig 5.5: Capacity Constraints, US 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 2004-2017
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2022 (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
Fig 5.12A: Factors Creating Future Capacity Constraints, 2008-2017
Fig 5.12B: Factors Creating Future Capacity Constraints, 2008-2017
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; 2006-2017
Fig 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2017
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 2022
Fig 6.2: Planned Future Capacity Expansion: 5-year Estimates, 2009 - 2022
Fig 6.3: Planned Future Capacity Expansion: 5-year Estimates; Biotherapeutic Developers vs. CMOs
Fig 6.4: Planned Future Capacity Expansion: 5-year Estimates; U.S. vs. Western Europe ..220
Fig 6.5: Percent of Respondents Projecting Production Increases of over 100% by 2022; 5-year Trend
Fig 7.1: Current Percent Production Outsourced; by System
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2017
Fig 7.3: Future Outsourcing: Percent Production Outsourced; by System, in 2022
Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2017
Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today
Fig 7.6: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 – 2017
Fig 7.7: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years
Fig 7.8: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years, 2010 - 2017 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 2017
Fig 7.10B: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2017
Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012 - 2017
Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations
Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2006-2017
Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2017, Percentage Point Differences
Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2010-2013
Fig 7.16: Country Selections as Destination for International Outsourcing of BioManufacturing (All Respondents)
Fig 7.17: Percent U.S. Respondents Considering Country as ‘Possible’ Outsourcing Destination
Fig 7.18: Percent U.S. Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination
Fig 7.19: Percent Western European Respondents Considering Country as ‘Possible’ Outsourcing Destination
Fig 7.20: Percent European Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination
Fig 7.21: Percent of Biomanufacturing Operations Off-shored (International Outsourcing) within 5 Years
Fig 7.22: Percent Biomanufacturers Performing at Least “Some” International Outsourcing/Off-shoring during Next 5 Years (2011-2017)
Fig 7.23: Estimated % Operations Done as International Outsourcing/Off-shoring during Next 5 Years (2011-2017)
Fig 8.1: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture
Fig 8.2: Usage of Disposables in Biopharmaceutical manufacturing, any Stage of R&D or Manufacture; 2006-2017
Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2017
Fig 8.4: 10-Year Percentage-Point Change in First-Usage of Disposables, 2006-2017
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 Developer vs. CMO
Fig 8.7: Value of Useable Leachables and Extractables Data (2016 Data)
Fig 8.8: Reasons for Increasing Use of Disposable System Components in 2015 (data from 2015)
Fig 8.9: Reasons for Increasing Use of Disposable System Components, 2006-2015
Fig 8.10: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2017
Fig 8.11: Reasons for Restricting Use of Disposables (2015 Data)
Fig 8.12: Factors Restricting Use of Disposables, 2006-2015 (2015 Data)
Fig 8.13: Top Reasons for Not Increasing Use of Disposables, 2017
Fig 8.14: Top Reasons for Not Increasing Use of Disposables, 2008-2017
Fig 8.15: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developer vs. CMO
Fig 8.16: Top Reasons for Not Increasing Use of Disposables, U.S. vs Western Europe
Fig 8.17: Single-use/Disposables Standardization Factors (2015 Data)
Fig 8.18: Single-use/Disposables Standardization Factors, 2013 - 2015
Fig 8.19: Suppliers’ Perception of Organizations Responsible for Establishing Standards for Single-use Devices
Fig 8.20: Single-use / Disposable Device Adoption Factors
Fig 8.21: Single-use / Disposable Device Adoption Factors; U.S. vs Western Europe
Fig 8.22: Need for Improved Single-Use Sensors, 2012-2017
Fig 8.23: Single-use Recycling; Respondents’ Desires for Disposal vs. Actual Disposal Process (2016 data)
Fig 8.24: Single-use Product Vendor Satisfaction Factors, 2008 - 2017
Fig 8.25: Importance of Single-use Product Attributes vs. Level of Vendor Satisfaction
Fig 8.26: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction, 2013-2017
Fig 8.27: Estimated Percentage of Facilities’ Unit Operations that are “Single-use” (2014 - 2017)
Fig 8.28: Distribution of Responses, % Single-use Devices in Biomanufacturing
Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2017
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 Purifi cation Steps
Fig 9.5: Impact on Capacity of Purifi cation Steps: Experiencing at “Signifi cant” or “Severe” Constraints, 2008 - 2017
Fig 9.6: Impact on Capacity of Purifi cation Steps, U.S. vs. Western Europe
Fig 9.7: Issues Regarding Protein A Usage
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, 2016 Data)
Fig 9.11: Bioreactor Yield at which DOWNSTREAM Purifi cation Train Becomes Bottlenecked (2016 Data)
Fig 9.12: New Downstream Processing Solutions
Fig 9.13: New Downstream Processing Solutions Comparison 2010-2017
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 - 2017
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: Hurdles Hindering Implementation of PAT (2008 – 2017)
Fig 10.2: Batch Failure Frequency Distribution, 2009 – 2017
Fig 10.3: Average Rates of Failure, by Primary Cause, and Phase of Manufacture
Fig 10.4: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2017 (Commercial Manufacture)
Fig 10.5: Average Rates Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2017 (“Clinical” Scale)
Fig 10.6: Quality Problems Traced to Vendors; 2008 – 2017
Fig 10.7: Quality Initiative Implemented Currently, or within Next 12 Months
Fig 10.8: Quality Initiative to be Implemented in “Next 12 Months,” Comparing 2009 - 2017
Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2017)
Fig 11.2: Estimated Hiring, by Area, 2008-2017
Fig 11.3: New Hires in Biopharmaceutical Manufacturing (2022)
Fig 11.4: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations
Fig 11.5: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations; 2010 - 2017
Fig 11.6: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe
Fig 11.7: Training for New Operations/Manufacturing Employees
Fig 11.8: Average Annual Changes in Training for New Operations/Manufacturing Employees, 2009 – 2017
Fig 12.1: Fill-Finish Operation Type
Fig 12.2: Fill-Finish Operation Location
Fig 12.3: Fill-Finish Capacity Utilization Averages, 2015-2017
Fig 12.4: Most Important Trends in Fill-Finish, 2015-2017
Fig 12.5: Novel Fill-Finish Technology Implementation Plans within 24 Months, 2015 vs 2017
Fig 13.1: Area of Biopharmaceutical Involvement, Vendor
Fig 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010 to 2017
Fig 13.3: Geographic Locations in which Vendors Currently Actively Sell Products or Services, 2008 - 2017
Fig 13.4: Respondents’ Primary Job Function
Fig 13.5: Average Annual Vendor Sales Growth Rate, 2007 - 2017
Fig 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
Fig 13.7: Average Annual Vendor Segment Sales Growth Rates, 2017
Fig 13.8: Average Annual Vendor Sales Growth Rate, 2007 - 2017, by Segment
Fig 13.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2017
Fig 13.10: Vendors’ Average Budget Change for 2017
Fig 13.11: Vendors’ Average Budget Change for 2009 - 2017, Summary
Fig 13.12: Vendors’ Average Pricing Changes
Fig 13.13: Vendors’ Average Pricing Changes, 2009-2016 Actual and 2017 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
Fig 13.16: (See
Fig 10.6; recap): Quality Problems Traced to Vendors
Fig 13.17: Biopharma Business and Marketing Plans, 2017
Fig 13.18: Biopharma Business and Marketing Plans, 2010-2017
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 Signifi cant, Truly Novel Bioprocessing Advances
Fig 13.21: R&D Spending/Budget for New Products/Services
Fig 13.22: Areas Where Training May Help Sales Staff Perform Better; 2010 – 2017
Fig 13.23: Client Demands of Vendors, Service and Support, 2012 - 2017
Fig 13.24: Vendors’ Optimism; Financial Performance 2011-2016, and Projected
TABLES
Table 1.1 FDA Biopharmaceutical Approvals, 2016
Table 1.2 Number of Products in U.S. and European Markets*
Table 1.3 Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2016
Table 1.4 Blockbuster Biopharmaceutical Products*
Table 1.5 Expression Systems/Host Cells for U.S./EU-Marketed Cultured Biopharmaceuticals
Table 2.1 Average Annual Total Costs for In-house Buffer Prep, by Liter Production
Table 2.2 Downstream Operations Causing Greatest Problems
Table 3.1 Areas of Signifi cant Projected Budget Percentage Increases for Biomanufacturing, Past Years
Table 4.1 Western European Biomanufacturers’ Average Capacity Utilization
Table 4.2 U.S. Biomanufacturers’ Average Capacity Utilization
Table 4.3 Distribution of Mammalian Cell Culture Capacity, Product Manufacturers
Table 4.4 Compound Annual Change in Mab Titre, 2008-2017
Table 5.1 “Severe” or “Signifi cant” Capacity Constraints, by Stage of Production, 2009-2017
Table 5.2 “Severe” or “Signifi cant” Capacity Constraints today, W. Europe v. U.S., 2010-2017
Table 6.1 Western European Biomanufacturers’ 5-year projected increases
Table 6.2 U.S. Biomanufacturers’ 5-year projected increases
Table 7.1 Respondents Reporting No outsourced production (i.e., all in-house manufacturing), 2009-2017
Table 7.2 Respondents Outsourcing up to 50% of Production, Mammalian and Microbial Systems, 2009-2017
Table 7.3 Respondents Outsourcing Over 50% of Production, Mammalian and Microbial Cell Systems, 2009-2017
Table 7.4 Percent of U.S.-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2009-2017
Table 7.5 Percent of European-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2011-2017
Table 9.1 Percent experiencing “Serious” or “Some” capacity problems due to downstream processing 2008-2017
Table 9.2 Percent U.S. vs. Western Europe facilities experiencing “Serious” capacity problems due to downstream processing, 2009-2017
Table 9.3 Percent U.S. vs. Western Europe facilities not expecting to see bottlenecks due to downstream processing, 2008-2017
Table 9.4 Upstream Production Titer vs. Max Capacity, 2016 Data
Table 10.1 Batch Failures, Average Weeks per Failure, per Facility, 2008-2017
Table 13.1 Selected “Other” New Technology Areas in Development
Table 13.2 Average Vendor Sales and Technical Training Days, 2011 - 2013

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