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13th Annual Report and Survey Biopharmaceutical Manufacturing Capacity and Production

  • ID: 3820763
  • April 2016
  • Region: Global
  • 492 Pages
  • Bioplan Associates Inc
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This report’s 492 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.

Coverage:

- 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 2021
- Range of titres, growth
- Disposables: Spending growth; downstream uses; L&E’s; reasons for increasing/ restricting; budget increases; vendor satisfaction
- Disposables: Compare innovators vs CMOs & US vs Europe
- Batch failure rates & trends
- Selecting a CMO — Problems & solutions
- Quality management & PAT implementation
- Hiring and employment growth
- Supplier growth rates

Note: Product cover images may vary from those shown
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0: Demographics
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
- Employees at Facility
- Batches Run at Facility per Year

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 in the Pipeline
1.6 Biopharmaceutical Approvals Generic
1.7 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
1.8 Biopharmaceutical Markets by Product Class
- mAbs are the Leading Product Classes
1.9 Biopharmaceutical Blockbusters
1.10  Commercial Product Expression Systems
1.11  Animal Derived Products and Biopharmaceuticals
1.12  Cost-containment and Price Controls
1.13  Future Trends in the Biopharmaceutical Industry
1.14  Overview of Biopharmaceutical Market Trends

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:  Cost Effective Manufacturing Creating Pressures for 
Mainstream Biologics
2.3 Training:  From Startup to Market Production - A GxP Training 
Philosophy for Success
2.4 Facility Planning, Design and Engineering - The Changing 
Environment - Flexibility is a Key Attribute
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 Mergers and Acquisitions in the 
Pharmaceutical Industry, 2015
2.9 The Bioprocessing Equipment Supply Chain:  Materials in Single-use
Products are the Weakest Link
2.10  Trends in Aseptic Bioprocessing Capacity for the Fill and Finish of 
Recombinant Biologics: An Analysis of US and European In-house
Capacity and Capacity Utilization

3: Emerging Issues in Biopharmaceutical Manufacturing
3.1 Industry Trends in 2015  Productivity and Innovation
3.2 Budget Issues in 2016  Budget Change Comparisons 
3.3 Operational Changes
3.4 New Bioprocessing Products Development Opportunities in 2016  Innovations in Single-use/Disposable Equipment
- Discussion of Needed Single-use Innovations
- Other Areas for Innovation
- New Product Development Focus, From 2010 to 2016
- New Product Development Areas:  Biotherapeutic Developers vs. CMOs
- New Product Development Areas:  U.S. vs. Western Europe vs. 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
- Cost.Cutting Changes: Specific to Outsourcing
3.7 Assay Development
3.8 Continuous Bioprocessing Operations Issues
3.9 Discussion
3.10 Perfusion Operations and Continuous Bioprocessing Trends
- Continuous Bioprocessing: Trends and Opportunities
3.11 Selecting Bioreactors in New Facilities
3.12 Discussion:  Industry Trends and Issues 
- Industry Growth and Adaptation
- Cost Cutting Trends 
- Trends in Assay Development
- Trends in Speeding Development and Approval Timelines
- Trends in Bioprocessing Industry Desires for Improved Products and Services

4.1 Capacity Utilization Trends
- Capacity Utilization Definitions
- Relevance of Capacity Utilization
- Capacity Utilization in Biomanufacturing, 2016
- Capacity Utilization Changes Since 2004 
Average Growth Rate in Capacity Utilization, 2006-2016
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, 2008-2016
4.7 Discussion: Capacity and Industry Trends
- Capacity Utilization

5: Current and Future Capacity Constraints
5.1 Current Capacity Constraints
- Respondents Experiencing No Capacity Constraints
- Respondents’ Perception of Capacity Constraints, 2004-2016
- 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 2021
- Expected Capacity Constraints by 2021: Comparing 2004 to 2016 Data
- Expected Capacity Constraints by 2021:  CMOs vs. Biotherapeutic Developers 
- Expected Capacity Constraints by 2021:  U.S. vs. Western Europe
5.3 Factors Impacting Future Production Capacity
- Factors Creating Future Capacity Constraints
- Factors Creating Future Capacity Constraints, 2008 vs. 2016
- 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, 2006-2016
- Key areas to Address to Avoid Capacity Constraints; Biotherapeutic
- Developers vs. CMOs: 2016 vs. Recent Years
- Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
5.5 Discussion
- Overall Capacity Constraints

6: Future Capacity Expansions
6.1 Planned Future Capacity Expansions
- Planned Future Capacity Expansions, 2009-2021
- Planned Future Capacity Expansions by 2021; CMOs vs. Biotherapeutic
- Developers
- Planned Five-Year Capacity Expansions; U.S. vs. Western European
- Manufacturers
- Planned Future Capacity Expansions of >100%

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”), 2006-2016
7.2 Future Outsourcing
- Biotherapeutic Developers’ Outsourcing, 2021 Projections, by System
- Biotherapeutic Developers Outsourcing Some Production in 2021
7.3 Outsourced Activities in Biopharmaceutical Manufacturing
- Comparison of Biomanufacturers’ Outsourcing, (2010-2016)
- Increased Outsourced Activities, 24-month Projections 
- Outsourcing Activities Projected at ‘Significantly Higher Levels’ Comparison of 2010-2016 Trends
- Average Percentage of Activities Outsourced Today
- Comparison of Outsourcing Activities, 2010-2016
- Change in Spending on Outsourcing Activities
7.4 Critical Outsourcing Issues
- Selecting a CMO:  2016
- Selecting a CMO, 2006-2016
- Changes in Critical Issues when Considering a CMO, 2008-2016
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
7.7Offshoring  Trends
- 5-Year Projection for Percentages of Biomanufacturing International
- Outsourcing/Off-shoring
7.8 Discussion of Outsourcing and Offshoring: 
- Selecting a CMO

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: 2006-2016
- 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 (2015 data)
- 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 (2015 data)
- Most Critical Reasons for Restricting Use of Disposables
- Most Important Reasons for Not Increasing Use of Disposables, 2008-2016
- 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
8.9 Satisfaction with Single-use Device Vendors 
- Single-Use Attribute Importance Analysis
- Single-use Suppliers’ Delivery Problems, 2013-2016 
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

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, 2008-2016
- 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 
- Current Upstream Production Titer vs. Max Capacity
9.5 New Downstream Processing Technologies
- New Downstream Processing Solutions; 2010 - 2016
- 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

10: Quality Issues, Batch Failures, and PAT in Biopharmaceutical 
- Manufacturing
- Introduction
10.1 Hurdles to Implementing Process Analytical Technology
- Trends in PAT, 2008-2016
- PAT Adoption Will Increase
10.2 Batch Failure Frequency in Biopharmaceutical Manufacturing
10.3 Primary Cause of Batch Failures, Percentages of Failures
- 2016 Results included:
- 2015 results included:
10.4 Quality Problems in BioManufacturing Attributed to Vendors
10.5 Automation Implementation
- Comparison of Implementation Plans 2009 - 2013
10.6Quality Initiative Implementation
- Initiating quality initiatives requires substantial organizational resources and commitment. 
- Comparison of Quality Initiative Implementation, 2009 - 2016
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

11:  Hiring, Employment Growth, and Training in Biopharmaceutical Manufacturing
- Introduction
11.1 Hiring  Trends
- Trends in New Hires, by Area; 2008 - 2016
11.2 Hiring in 2021: 5-year Trends
11.3 Hiring Challenges Today
- Hiring Difficulties; 2010 - 2016
- Hiring Difficulties: 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, 2009-2016
11-5 Discussion 
- Options Developing for Bioprocessing Training
- Continued Growth in Biopharmaceutical Manufacturing Jobs

12: Fill and Finish
- Introduction
12.1 Demographics
- Areas of Involvement
- Geographic Location, Facilities
12.2Trends 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:

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 2016
- 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 2016
- Vendor Average Budget Changes for 2009 -2016
- 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 2016
13.8 New Technology Areas in Development by Vendors
13.9 Sales Staff Training
- Days of Training Provided 
- Areas where Training May Help Sales Staff Perform, Trends 2010 - 2016
- Clients’ Demands on Vendors
13.10 Biopharma Vendors’ Financial Outlook for 2016
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 2016
Fig 0.2: Respondents’ Job Responsibilities, 2011 - 2016
Fig 0.3: Facility Location
Fig 0.4: Facility Location, by Region
Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2016) Trends
Fig 0.6: Phase of Development of Surveyed Respondents (2006-2016) Trends
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 1.1: Investigational Drugs: Large Molecule (Protein Therapeutics), Worldwide, 2010 - 2015
Fig 1.2: Worldwide Pipeline & Launched Products, Large Molecules, January 2015
Fig 1.3: Current Worldwide Pipeline & Launched Products, Large Molecules, January 2015
Fig 1.4: Number of Biosimilars in the U.S. Pipeline by Launchable Dates
Fig 1.5: Biosimilars Launchable Dates by Sum of Current Reference Products Sales ($millions)
Fig 1.6: FDA Approvals of New Biopharmaceutical Products 1982-2015
Fig 2.1: A GxP Training Philosophy for Success 
Fig 2.2: Trends in FDA Key Compliance Themes
Fig 2.3: Antibody binding capacities on two prototype mixed mode membranes from Natrix Separations.
Fig 2.4: Example of chromatographic like separation achieved on a mixed mode membrane from Natrix Separations. (updated for this year’s edition)
Fig 3.1: Single most important biomanufacturing trend or operational area, 2014-2016 
Fig 3.2: Biomanufacturers’ Budget Shifts in 2016
Fig 3.3: Approximate Average Change in Biomanufacturers’ Budgets for 2016
Fig 3.4: Average Biomanufacturers’ Budget Change, 2009-2016
Fig 3.5: New Product Development Focus Areas
Fig 3.6: New Product Development Areas of Interest: 2010 - 2016
Fig 3.7: New Product Development Areas of Interest: Biotherapeutic Developers vs CMOs
Fig 3.8: New Product Development Areas of Interest: U.S. vs. Western Europe vs. ROW
Fig 3.9: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: 2010 - 2015 (Data from 2015)
Fig 3.10: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: Biomanufacturers vs CMOs (2015 Data)
Fig 3.11: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: U.S. vs. Western Europe vs. Rest of World (2015 Data)
Fig 3.12: Cost-Cutting Changes: Actions Undertaken During “Past 12 Months” Comparing 2011-2016
Fig 3.13: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography (2011-2016)
Fig 3.14: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods, 2011-2015 (2015 Data)
Fig 3.15: Perfusion Operations Issues: Perfusion vs. Batch-Fed Processes
Fig 3.16: Perfusion Operations Issues: Comparison 2010 - 2016 
Fig 3.17: Continuous Bioprocessing Technologies Evaluation, Next 12 Months
Fig 3.18: Likelihood of Implementing bioreactor, by type 
Fig 3.19: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2016 
Fig 4.1: Capacity Utilization, By System
Fig 4.2: Capacity Utilization, By System, 2004-2016
Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2016
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, 2011-2016
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 2003-2015
Fig 4.12 Microbial Fermentation Capacity Estimates 2003-2015
Fig 4.13: Range of Titres for Mabs Obtained at Various Production Scales, Distribution
Fig 4.14: Average Mab Titre Trend 2008-2016
Fig 5.1: Capacity Constraints, by Stage of Production
Fig 5.2: Capacity Constraints, 2004 through 2016
Fig 5.3: Capacity Constraints Trends, 2004-2016
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 2004-2016
Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2021 (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, 2008-2016
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; 2006-2016 
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 2021
Fig 6.2: Planned Future Capacity Expansion: 5-year Estimates, 2009 through 2021
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
Fig 6.5: Percent of Respondents Projecting Production Increases of over 100% by 2021; 5-year Trend
Fig 7.1: Current Percent Production Outsourced; by System
Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production,  2006-2016
Fig 7.3: Future Outsourcing: Percent Production Outsourced; by System, in 2021
Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2016
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 - 2016
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 - 2016 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 2016
Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012 - 2016
Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations .255
Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2006-2016
Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2016, 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 (2011-2016)
Fig 7.23: Estimated % Operations Done as International Outsourcing/Off-shoringduring Next 5 Years (2011-2016)
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; 2006-2016
Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2016
Fig 8.4: 10-Year Percentage-Point Change in First-Usage of Disposables, 2006-2016
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
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 - 2016
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, 2016
Fig 8.14: Top Reasons for Not Increasing Use of Disposables, 2008-2016
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 (2015 data)
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, 2012-2016
Fig 8.23: Single-use Recycling; Respondents’ Desires for Disposal vs. Actual Disposal Process
Fig 8.24: Single-use Product Vendor Satisfaction Factors, 2008 - 2016
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, 2013-2016
Fig 8.27: Estimated Percentage of Facilities’ Unit Operations that are “Single-use” (2014-2016)
Fig 8.28: Distribution of Responses, % Single-use Devices in Biomanufacturing
Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2016
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 357
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 - 2016
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 - 2016
Fig 9.9: Issues Regarding Protein A Usage; U.S. Vs. Western Europe
Fig 9.10: mAb Operations: Current Upstream Production Titer (Distribution of Responses)
Fig 9.11: Bioreactor Yield at which DOWNSTREAM Purifi cation Train Becomes  Bottlenecked
Fig 9.12: New Downstream Processing Solutions
Fig 9.13: New Downstream Processing Solutions Comparison 2010-2016
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 - 2016
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 - 2016) 
Fig 10.2: Batch Failure Frequency Distribution, 2009 - 2016
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 - 2016 (Commercial Manufacture)
Fig 10.5: Average Rates Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2016 (“Clinical” Scale)
Fig 10.6: Quality Problems Traced to Vendors; 2008 - 2016
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 - 2016
Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2016)
Fig 11.2: Estimated Hiring, by Area, 2008-2016
Fig 11.3: New Hires in Biopharmaceutical Manufacturing (2021)
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 - 2016
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 - 2016
Fig 12.1: Fill-Finish Operation Type 
Fig 12.2: Fill-Finish Operation Location
Fig 12.3: Fill-Finish Capacity Utilization Averages, 2015-2016
Fig 12.4: Most Important Trends in Fill-Finish, 2015-2016
Fig 12.5: Novel Fill-Finish Technology Implementation Plans within 24 Months, 2015 vs 2016
Fig 13.1: Area of Biopharmaceutical Involvement, Vendor
Fig 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010 to 2016
Fig 13.3: Geographic Locations in which Vendors Currently Actively Sell Products or Services, 2008 - 2016 
Fig 13.4: Respondents’ Primary Job Function
Fig 13.5: Average Annual Vendor Sales Growth Rate, 2007 - 2016
Fig 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
Fig 13.7: Average Annual Vendor Segment Sales Growth Rates, 2016
Fig 13.8: Average Annual Vendor Sales Growth Rate, 2007 - 2016, by Segment
Fig 13.9: Vendors’ Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2016
Fig 13.10: Vendors’ Average Budget Change for 2016
Fig 13.11: Vendors’ Average Budget Change for 2009 - 2016, Summary
Fig 13.12: Vendors’ Average Pricing Changes (2015 responses)
Fig 13.13: Vendors’ Average Pricing Changes, 2009-2015 Actual and 2016 projected
Fig 13.14: Actions undertaken to reduce overall costs, prior 12 months, 2011 - 2016
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, 2016
Fig 13.18: Biopharma Business and Marketing Plans, 2010-2016
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: Areas Where Training May Help Sales Staff Perform Better; 2010 - 2016
Fig 13.21: Client Demands of Vendors, Service and Support, 2012 - 2016
Fig 13.22: Vendors’ Optimism; Financial Performance 2011-2014, and Projected Performance in 2016

Tables:

Table 1.1 Biopharmaceutical Approvals Generic, 2015
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 2015 
Table 1.4 Blockbuster Biopharmaceutical Products*
Table 1.5 Expression Systems/Host Cells for U.S./EU-Marketed Cultured Biopharmaceuticals
Table 2.1 Factors involved in facility decision-making
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, 2008-2016
Table 5.1 “Severe” or “Signifi cant” Capacity Constraints, by Stage of Production, 2009-2016
Table 5.2 “Severe” or “Signifi cant” Capacity Constraints today, W. Europe vs. U.S., 2010-2016 
Table 7.1 Mammalian and Microbial Cell Systems, No outsourced production (i.e., all in-house manufacturing)
Table 7.2 Mammalian and Microbial Cell Systems, outsourced up to half of production
Table 7.3 Mammalian and Microbial Cell Systems, outsourced more than half of production
Table 7.4 Percent of U.S.-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2009-2016
Table 7.5 Percent of European-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2011-2016
Table 9.1 Percent experiencing “Serious” or “Some” capacity problems due to downstream processing 2008-2016
Table 9.2 Percent U.S. vs. Western Europe facilities experiencing “Serious” capacity problems due to downstream processing, 2009-2016
Table 9.3 Percent U.S. vs. Western Europe facilities not expecting to see bottlenecks due to downstream processing, 2008-2016
Table 9.4 Current Upstream Production Titer vs. Max Capacity
Table 10.1 Batch Failures, Average Weeks per Failure, per Facility, 2008-2016
Table 13.1 Selected “Other” Responses, New Technology Areas in Development
Table 13.2 Average Vendor Sales and Technical Training Days, 2011 - 2013

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown

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