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12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

The 2015 12th 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. The report contains the industry's definitive, quantitative analysis and includes 12 years of biopharma trends as well as a review of current opportunities and in-depth coverage by 8 subject matter experts of critical issues affecting the industry.

This report's 468 pages of data-rich analysis is spread over 13 chapters containing more than 200 graphs and charts. The study will help improve your decision-making in biomanufacturing operations, with in-depth analysis of capacity, production trends, benchmarks, and much more:

  • Biosimilars pipeline in development
  • In-depth analysis of key data, capacity, production trends, and benchmarks
  • Budget trends and impact of current economic environment
  • Expression system advances
  • Downstream purification problems and issues
  • Current and projected industry bottlenecks
  • Capacity utilization and current production levels
  • How capacity bottlenecks are being resolved
  • Production trends and implications for industry
  • Outsourcing trends
  • International offshoring through 2017
  • Range of titres, growth
  • Disposables: Spending growth; downstream uses; L&E's; reasons for increasing/ restricting; vendor satisfaction
  • Disposables: Compare innovators vs CMOs & US vs Europe
  • Batch failure rates & trends
  • Selecting a CMO — Problems & solutions
  • Quality management & PAT implementation
  • Fill-finish trends and innovations
  • Hiring and employment growth
  • Supplier growth rates
  • Much more...
Compare 237 biotherapeutic developers vs CMOs; US vs European & Global Biomanufacturing. Also includes data from a survey of 164 suppliers to the industry.


Methodology
CHAPTER 0: Demographics
Respondents’ Area of Involvement
Respondents’ Titles
Respondents’ Facility Locations
Respondents’ Areas of Biopharmaceutical Manufacturing Operations
Respondents’ Production Operations, Phase of Development
Employees at Facility
Batches Run at Facility per Year
CHAPTER 1: INTRODUCTION AND DISCUSSION
1-1 INTRODUCTION: THE BIOPHARMACEUTICAL INDUSTRY
1-2 Some Biopharmaceutical Market Trends
1-3 Market Potential
1-4 Biopharmaceutical R&D Pipelines
1-5 Biosimilars Are a Large Part of the Pipeline
1-6 U.S. AND WORLD 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 Protein A Resins Continue to Serve Monoclonal Antibodies Manufacture Well, While Incremental Improvements Continue
2-2 Biosimilars: Review of Progress in 2014
2-3 Bioassays: A Critical and Commonly Outsourced Part of Biopharmaceutical Development
2-4 Facility Contamination: Behavioral-Based Intervention
2-5 Alternatives to Protein A
2-6 The Use of Membrane Chromatography throughout a Product’s Life Cycle
2-7 Continuous Bioprocessing and Perfusion: Single-use Technology Aiding to Increase Adoption
2-8 Bioprocessing Equipment and Service Supplier Mergers and Acquisitions, 2014
2-9 The Bioprocessing Equipment Supply Chain: Materials in Single-use Products are the Weakest Link
CHAPTER 3: Emerging Issues in Biopharmaceutical Manufacturing
3-1 Industry Trends in 2015
Productivity and Innovation
3-2 Budget Issues in 2015
Budget Change Comparisons
3-3 Operational Changes
3-4 New Bioprocessing Products Development Opportunities in 2015
Innovations in Single-use/Disposable Equipment
Discussion of Needed Single-use Innovations
Other Areas for Innovation
New Product Development Focus, From 2010 to 2015
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
Factors Improving Biomanufacturing Performance, U.S. vs. Western
Europe vs. ROW
3-6 Cost-Cutting Actions & Development Timelines
Cost-Cutting Changes: Specifi c to Outsourcing
3-7 Assay Development
3-8 Perfusion Operations Issues
Discussion
Selecting Bioreactors in New Facilities
3-9 Discussion: Perfusion Operations and Continuous Bioprocessing Trends
Continuous Bioprocessing: Trends and Opportunities
3-10 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, 2015
Capacity Utilization Changes Since 2004
Average Growth Rate in Capacity Utilization, 2006-2015
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 Discussion: Current State of Capacity Utilization
Future Capacity Issues
4-6 Range of Titers for MAb Production
Annual Mab Titer Change, 2008-2015
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, 2004-2015
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 2020
Expected Capacity Constraints by 2020: Comparing 2004 to 2015 Data
Expected Capacity Constraints by 2020: CMOs vs. Biotherapeutic Developers
Expected Capacity Constraints by 2020: U.S. vs. Western Europe
5-3 Factors Impacting Future Production Capacity
Factors Creating Future Capacity Constraints
Factors Creating Future Capacity Constraints, 2008 vs. 2015
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 190
5-4 Key Areas to Address to Avoid Future Capacity Constraints
Analysis of Areas to Avoid Capacity Constraints: Changing Perspectives, 2006-2015
Key areas to Address to Avoid Capacity Constraints;
Biomanufacturers vs. CMOs: 2015 vs. Recent Years
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, 2009-2020
Planned Future Capacity Expansions by 2020; 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?
Critical Outsourcing Operations
Relating Outsourcing to Workforce Reduction
Strategic Manufacturing Planning
Future Projections
7-1 Current Outsourcing by Production System
Summary of Findings:
Facilities Currently Outsourcing No Production (All Production “In-house”), 2006-2015
7-2 Future Outsourcing
Biotherapeutic Developers’ Outsourcing, 2020 Projections, by System
Biotherapeutic Developers Outsourcing Some Production in 2020
7-3 Outsourced Activities in Biopharmaceutical Manufacturing
Comparison of Biomanufacturers’ Outsourcing, (2010-2020)
Increased Outsourced Activities, 24-month Projections
Outsourcing Activities Projected at ‘Signifi cantly Higher Levels’, Comparison of 2010-2015 Trends
Average Percentage of Activities Outsourced Today
Comparison of Outsourcing Activities, 2010-2015
Change in Spending on Outsourcing Activities
7-4 Critical Outsourcing Issues
Selecting a CMO: 2015
Selecting a CMO, 2006-2015
Changes in Critical Issues when Considering a CMO, 2006-2015
CMOs’ Problems with Clients
7-5 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
5-Year Projection for Percentages of Biomanufacturing International
Outsourcing/Off-shoring
Some respondent comments
7-6 Discussion:
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: 2006-2015
Annual Growth Rate for Disposables Market Penetration / Usage
9-year Growth in Disposables Applications, Percentage-point Gains
Disposable Use by Stage of Production/Application
Use of Disposables: CMOs vs. Biotherapeutic Developers
Leachables and Extractables
Paying for L&E Testing
8-2 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
8-3 Factors That May Restrict Use of Disposables
Factors That May Restrict Use of Disposables: Trends 2006-2015
Factors that May Restrict Use of Disposables: CMOs vs. Biotherapeutic
Developers
Most Critical Reasons for Restricting Use of Disposables
Most Important Reasons for Not Increasing Use of Disposables, 2008-2015
Most Important Reasons for Restricting Use of Disposables: Biotherapeutic
Developer vs. CMO
Top Reasons for Not Increasing the Use of Disposables: U.S. vs. European
Respondents
8-4 Standards Setting for Disposable,
Single-use Systems
Standardizing Single-use Designs
Standardization Factors, 2013-2015
Suppliers’ Expectations for Standards Setting Bodies
8-5 Budgets for Disposable Systems
Annual Growth Rate in Budgets for Single-use Components 2007-2013
8-6 Disposable Adoption Issues, 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
8-7 Recycling and Disposal of Single-use Plastics
Waste Disposal of Single-use Devices
Meeting Respondents’ Demands for Recycling
8-8 Satisfaction with Vendors of Disposables for Biopharmaceutical
Manufacturing
Single-Use Attribute Importance Analysis
Percentage of Unit Operations that are Single-use
Distribution of Responses
8-9 Discussion
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, 2008-2015
Specifi c Purifi cation Step Constraints, U.S. vs. Western European
Biomanufacturers
9-3 Downstream Purifi cation Issues Facing the Industry Today
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; Current Upstream Production
Titer vs. Max Capacity
9-5 New Downstream Processing Technologies
New Downstream Processing Solutions; 2010 – 2015
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
Introduction
10-1 Hurdles to Implementing Process Analytical Technology, 2008-2015
PAT Adoption Will Increase
10-2 Batch Failure Frequency in Biopharmaceutical Manufacturing
10-3 Primary Cause of Batch Failures and Percentages of Failures
10-4 Quality Problems in Biopharmaceutical Manufacturing
Attributed to Vendors
10-5 Automation Implementation
Comparison of Implementation Plans 2009 - 2013
10-6 Quality Initiative Implementation
Comparison of Quality Initiative Implementation, 2009 - 2015
10-7 Global Quality Supply Management
Quality Supply Management-US 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
11-2 Hiring in 2020: 5-year Trends
11-3 Hiring Challenges Today
Hiring Diffi culties; 2010 - 2015
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, 2009-2015
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 Aseptic Bioprocessing Capacity
An Analysis of US and European In-house Capacity and
Capacity Utilization
Problems in Estimating Capacity
Current Fill-Finish Trends
Recent Industry Trends
Future Fill and Finish Trends
Suppliers’ Innovation Trends
Industry Capacity Data
12-3 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 2015
Supplier Annual Sales, Distribution
13-3 Discussion
13-4 Budget Issues and Problems Faced by Industry Supplier
Budget Challenges in 2015
Vendor Average Budget Changes for 2009 -2015
Vendor Pricing Changes
Future Price Changes
13-5 Cost Cutting Actions by Vendors
Cost Cutting Actions, By Segment
13-6 Problems Clients Have With Their Vendors
Vendor Expansion Plans
Biopharma Vendor Business Trends, 2010 vs 2015
Top New Technology Areas in Development by Vendors
13-7 Discussion: Supplier Budget Issues
13-8 Sales Staff Training
Days of Training Provided
Areas where Training May Help Sales Staff Perform, Trends 2010 - 2015
Clients’ Demands on Vendors
Biopharma Vendors’ Outlook for 2015
13-9 Discussion
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
FIGURES
Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 to 2015
Fig 0.2: Respondents’ Job Responsibilities, 2011 - 2015
Fig 0.3: Facility Location
Fig 0.4: Facility Location, by Region
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2015) Trends
Fig 0.6: Phase of Development of Surveyed Respondents
Fig 0.7: Phase of Development of Surveyed Respondents, 2015 (US 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 1.1: Investigational Drugs: Large Molecule (Protein Therapeutics), Worldwide, 2010 - 2015
Fig 1.2: Current Worldwide Pipeline & Launched Products, Large Molecules, January 2015
Fig 1.3: Current Worldwide Pipeline & Launched Products, Large Molecules, January 2015
Fig 2.1: Scanned Excerpt from an FDA Form 483
Fig 2.2: Antibody binding capacities on two prototype mixed mode membranes from Natrix Separations.
Fig 2.3: Example of chromatographic like separation achieved on a mixed mode membrane from Natrix Separations.
Fig 3.1: SINGLE most important biomanufacturing trend or operational area, 2014-2015
Fig 3.2: Biomanufacturers’ Budget Shifts in 2015
Fig 3.3: Approximate Average Change in Biomanufacturers’ Budgets for 2015
Fig 3.4: Average Biomanufacturers’ Budget Change, 2009-2015
Fig 3.5: New Product Development Focus Areas
Fig 3.6: New Product Development Areas of Interest: 2010 - 2015
Fig 3.7: New Product Development Areas of Interest: Biotherapeutic Developers vs CMOs
Fig 3.8: New Product Development Areas of Interest: US vs Western Europe and ROW
Fig 3.9: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements
Fig 3.10: Factors in Biomanufacturing Performance Creating “Signifi cant” or Some” Improvements: 2010 - 2015
Fig 3.11: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: Biomanufacturers vs. CMOs
Fig 3.12: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: U.S. vs Western Europe vs. Rest of World
Fig 3.13: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2015
Fig 3.14: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography
Fig 3.15: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods, 2011 -2015
Fig 3.16: Perfusion Operations Issues: Perfusion vs. Batch-Fed Processes (2014 data)
Fig 3.17: Perfusion Operations Issues: Comparison 2010 - 2014
Fig 3.18: Likelihood of Implementing bioreactor, by type (2014 data)
Fig 3.19: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2014
Fig 4.1: Capacity Utilization, By System
Fig 4.2: Capacity Utilization, By System, 2004-2015
Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2015
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, 2011-2015
Fig 4.8: Current Production Capacity Distribution, Microbial Fermentation
Fig 4.9: Current Production Capacity Distribution, Yeast
Fig 4.10: Current Production Capacity Distribution, Insect Cells
Fig 4.11: Mammalian Cell Culture Capacity Estimates 2003-2014
Fig 4.12: Microbial Fermentation Capacity Estimates 2003-2014
Fig 4.13: Range of Titres for Mabs Obtained at Various Production Scales, Distribution
Fig 4.14: Average Mab Titre Trend 2008-2015
Fig 5.1: Capacity Constraints, by Stage of Production
Fig 5.2: Capacity Constraints, 2004 through 2015
Fig 5.3: Capacity Constraints Trends, 2004-2015
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 2004-2015 ..177
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2020 (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 5.12: Factors Creating Future Capacity Constraints, 2008-2015
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 5.16: Key areas to Address to Avoid Capacity Constraints; 2006-2015
Fig 5.17: Key Areas to Address to Avoid Capacity Constraints; Biomanufacturers 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 2020
Fig 6.2: Planned Future Capacity Expansion: 5-year Estimates, 2009 through 2020
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 ..213
Fig 6.5: Percent of Respondents Projecting Production Increases of over 100% by 2020; 5-year Trend
Fig 7.1: Current Percent Production Outsourced; by System, 2015
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2015
Fig 7.3: Future Outsourcing: Percent Production Outsourced; by System, in 2020
Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2015
Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today
Fig 7.6: Percent of Biomanufacturers Outsourcing at Least Some Activity, 2010 - 2015
Fig 7.7: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ Next 2 Years
Fig 7.8: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years, 2010 - 2015 Trends
Fig 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today
Fig 7.10: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2015
Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012 - 2015
Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations
Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2006-2015
Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2015, 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
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” of the following as International Outsourcing/Off-shoring during Next 5 Years
Fig 7.23: Estimated % Operations Done as International Outsourcing/Off-shoring during Next 5 Years
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; 2006-2015
Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2015
Fig 8.4: 9-Year Percentage-Point Change in First-Usage of Disposables, 2006-2015
Fig 8.5: Usage of Disposables in Biopharmaceutical Manufacturing, by Stage of Manufacture (R&D Through Commercial Manufacture)
Fig 8.6: Usage of Disposables in Biopharmaceutical Manufacturing; Biotherapeutic Developer vs. CMO
Fig 8.7: Value of Useable Leachables and Extractables Data
Fig 8.8: Reasons for Increasing Use of Disposable System Components in 2015
Fig 8.9: Reasons for Increasing Use of Disposable System Components, 2006-2015
Fig 8.10: Reasons for Increasing Use of Disposable System Components, Biotherapeutic Developers vs. CMOs
Fig 8.11: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2015
Fig 8.12: Reasons for Restricting Use of Disposables
Fig 8.13: Factors Restricting Use of Disposables, 2006-2015
Fig 8.14: Factors Restricting Use of Disposables, Biotherapeutic Developer vs. CMO
Fig 8.15: Top Reasons for Not Increasing Use of Disposables, 2015
Fig 8.16: Top Reasons for Not Increasing Use of Disposables, 2008-2015
Fig 8.17: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developer vs. CMO
Fig 8.18: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe
Fig 8.19: Single-use/Disposables Standardization Factors
Fig 8.20: Single-use/Disposables Standardization Factors, 2013-2015
Fig 8.21: Single-use / Disposable Device Adoption Factors
Fig 8.22: Single-use / Disposable Device Adoption Factors; U.S. vs Western Europe
Fig 8.23: Need for Improved Single-Use Sensors, 2012-2015
Fig 8.24: Single-use Product Vendor Satisfaction Factors, 2008 - 2015
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
Fig 8.27: Estimated Percentage of Facilities’ Unit Operations That Are “Single-use” (2014 vs 2015)
Fig 8.28: Distribution of Responses, % Single-use Devices in Biomanufacturing
Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2015
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 - 2015
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 - 2015
Fig 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe
Fig 9.10: mAb Operations: Current Upstream mAb Production Titer (Distribution of Responses)
Fig 9.11: Bioreactor Yield at which DOWNSTREAM mAb Purifi cation Train Becomes Bottlenecked
Fig 9.12: New Downstream Processing Solutions
Fig 9.13: New Downstream Processing Solutions Comparison 2010-2015
Fig 9.14: New Downstream Processing Solutions; Biotherapeutic Dev. vs. CMO
Fig 9.15: New Downstream Processing Solutions; U.S. vs. Western Europe
Fig 9.16: Improving Downstream Operations, 2011 - 2015
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 - 2015)
Fig 10.2: Batch Failure Frequency Distribution, 2009 - 2015
Fig 10.3: Average Rates of Failure, by Primary Cause, and Scale of Manufacture
Fig 10.4: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2015 (Commercial Manufacture)
Fig 10.5: Average Rates Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2015 (“Clinical” Scale)
Fig 10.6: Quality Problems Traced to Vendors; 2008 – 2015
Fig 10.7: Quality Initiatives Implemented Currently, or within Next 12 Months
Fig 10.8: Quality Initiative to be Implemented in “Next 12 Months,” Comparing 2009 - 2015
Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2015)
Fig 11.2: New Hires in Biopharmaceutical Manufacturing (2020)
Fig 11.3: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations
Fig 11.4: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations; 2010 - 2015
Fig 11.5: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations, U.S. vs. Western Europe
Fig 11.6: Training for New Operations/Manufacturing Employees
Fig 11.7: Changes in Training for New Operations/Manufacturing Employees, 2009 - 2015
Fig 12.1: Fill-Finish Operation Type
Fig 12.2: Fill-Finish Operation Location
Fig 12.3: Fill-Finish Capacity Utilization Averages (12th Annual Report data)
Fig 12.4: Most Important Trends in Fill-Finish
Fig 12.5: Novel Fill-Finish Technologies; Implementation Plans within 2 Years
Fig 13.1: Area of Biopharmaceutical Involvement, Vendor
Fig 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010 to 2015
Fig 13.3: Geographic Locations in which Vendors Currently Actively Sell Products or Services, 2008 - 2015
Fig 13.4: Respondents’ Primary Job Function
Fig 13.5: Average Annual Vendor Sales Growth Rate, 2007 - 2015
Fig 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
Fig 13.7: Average Annual Vendor Segment Sales Growth Rates, 2015
Fig 13.8: Average Annual Vendor Sales Growth Rate, 2007 - 2015, by Segment
Fig 13.9: Vendors’ Approx Annual Sales to Biopharmaceutical Segment %
Fig 13.10: Vendors’ Average Budget Change for 2015
Fig 13.11: Vendors’ Average Budget Change for 2009 - 2015, Summary
Fig 13.12: Vendors’ Average Pricing Changes (2015 responses)
Fig 13.13: Vendors’ Average Pricing Changes, 2009-2014 Actual and 2015 projected
Fig 13.14: Actions undertaken to reduce overall costs, prior 12 months, 2011 – 2015
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, 2015
Fig 13.18: Biopharma Business and Marketing Plans, 2010-2015
Fig 13.19: Top New Technologies or New Product Development Areas
Fig 13.20: Areas Where Training May Help Sales Staff Perform Better; 2010 – 2015
Fig 13.21: Client Demands of Vendors, Service and Support, 2012 - 2015
Fig 13.22: Vendors’ Optimism; Financial Performance 2011-2014, and Projected Performance in 2015
TABLES
Table: 1.1 Biologics (Large Molecule), Worldwide, through January 2015
Table 1.2: Worldwide Pipeline, Large Molecules, 2008-2015
Table 1.3: Number of Products in U.S. and European Markets*
Table 1.4: Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2014
Table 1.5: Blockbuster Biopharmaceutical Products*
Table 1.6: Expression Systems/Host Cells for U.S./EU-Marketed Cultured Biopharmaceuticals
Table 3.1: Areas of Signifi cant Projected Budget Percentage Increases for Biomanufacturing, Past Years:
Table 4.1: Distribution of Mammalian Cell Culture Capacity, Product Manufacturers
Table 4.2: Compound Annual Change in Mab Titre, 2008-2015
Table 7.1: Percent of U.S.-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2009-2014
Table 7.2: Percent of European-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2011-2014
Table 8.1: Suppliers’ Expectations for Who Should be Setting Standards for SUS
Table 9.1: Percent experiencing “Serious” or “Some” capacity problems due to downstream processing 2008-2015
Table 9.2: Percent U.S. vs. Western Europe facilities experiencing “Serious” capacity problems due to downstream processing, 2009-2015
Table 9.3: Percent U.S. vs. Western Europe facilities not expecting to see bottlenecks due to downstream processing, 2008-2015
Table 9.4: Current Upstream Production Titer vs. Max Capacity
Table 10.1: Batch Failures, Average Weeks Between Failures, per Facility, 2008-2015
Table 11.1 Percentage New Hires, by Area; 2008 – 2015
Table 13.1: Selected “Other” Responses, New Technology Areas in Development
Table 13.2: Average Vendor Sales and Technical Training Days, 2011 - 2013

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