Home > Back to Publisher > Report Information
8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and ProductionBioPlan Associates, Inc.April 1, 2011 492 Pages - SKU: DFAQ6558536 |
The 2011 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations' current and projected future capacity and production. This year's 8th Annual Report and Survey of Biopharmaceutical Manufacturing shows the industry has returned to robust growth. Based on analysis of 352 global biomanufacturers' 2011 budgets, expect substantial investment in new technologies that:
|
- Overview
- Market Trends
- Market Potential
- Methodology
- CHAPTER 1:Introduction and Discussion
- Introduction
- The Biopharmaceutical Pipeline
- 1-1 U.S. and World Biopharmaceutical and Recombinant Protein/Mab Markets
- Biosimilars and Bio-betters
- BRIC Country Growth
- Expression Systems Today
- Biosimilars Are Expanding the Biopharmaceutical Industry
- 1-2 Expression Systems in Biopharmaceutical Manufacturing
- 1-3 Continuing Need for Production Improvements and Cost Containment
- Biotherapeutic Developers
- CMOs
- Industry Suppliers
- Government
- CHAPTER 2: 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 3:Emerging Issues in Biopharmaceutical Manufacturing
- 3-1 Budget Issues in 2011
- Budget Change Comparisons
- 3-2 Operational Changes in 2011
- Operational Changes: 2011 vs 2010
- Operational Changes: Biotherapeutic Developers vs CMOs
- Operational Changes: US vs Western Europe
- 3-3 New Product Development Opportunities in 2011
- New Product Development Focus, 2011 vs 2010
- New Product Development Areas: Biotherapeutic
- Developers vs CMO’s
- New Product Development Areas: Biotherapeutic US vs
- Western Europe and ROW
- 3-4 Factors in Biomanufacturing Creating Improvements
- Factors Improving Biomanufacturing Performance, 2011 vs 2010
- Factors Improving Biomanufacturing Performance, Biotherapeutic Developers vs CMOs
- Factors Improving Biomanufacturing Performance, US vs Western Europe, vs ROW
- 3-5 Cost-Cutting Actions & Development Timelines
- Cost-Cutting Changes: Specifi c to Outsourcing
- Activities Implemented to Speed Drug Development Timelines
- Activities Implemented to Speed Drug Development Timelines:
- Biomanufacturers vs. CMOs
- 3-6 Assay Development
- Biomanufacturing Assay Required; Biomanufacturers vs CMOs
- Biomanufacturing Assays Required: US vs Western Europe
- 3-7 Perfusion Operations Issues
- 3-8 Discussion: Industry Trends and Issues
- Budget Shifts
- Industry Growth and Adaptation
- Cost Cutting Trends
- Trends in Assay Development
- Trends in Speeding Drug Timelines
- CHAPTER 4: Capacity Utilization
- 4-1 Capacity Utilization Trends
- Capacity Utilization Defi nitions
- Relevance of Capacity Utilization
- Capacity Utilization in 2011
- Capacity Utilization Changes Since 2004
- Average Growth Rate in Capacity Utilization, 2006-2011
- 4-2 Capacity Utilization: CMOs vs. Biotherapeutic Developers
- 4-3 Capacity Utilization: US vs. Western European Manufacturers
- 4-4 Respondents’ Current Total Production Capacity
- Mammalian Cell Culture
- Estimated Bioreactor Capacity Distribution, Biotherapeutic Developers and CMOs
- Contract Manufacturing
- 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 Titres for MAb Production
- Annual Mab Titre Change, 2008-2011
- 4-7 Discussion: Capacity and Industry Trends
- Capacity Utilization
- CHAPTER 5: Current Capacity Constraints
- 5-1 Current Capacity Constraints
- Factors Creating Future Capacity Constraints
- Respondents Experiencing No Capacity Constraints
- Respondents’ Perception of Capacity Constraints, 2004-2011
- Perception of Capacity Constraints: Biotherapeutic Developers vs. CMOs
- Capacity Constraints: US vs. European Biotherapeutic Developers & CMOs
- 5-2 Expected Capacity Constraints
- Respondents’ Expectations of Capacity Constraints in the Next Five Years
- Expected Capacity Constraints by 2015: Comparing 2004 to 2011 Data
- Expected Capacity Constraints by 2015: CMOs vs. Biotherapeutic Developers
- Expected Capacity Constraints by 2015: US vs. Western Europe
- 5-3 Factors Impacting Future Production Capacity
- Factors Creating Future Capacity Constraints
- Factors Creating Future Capacity Constraints, 2008 vs. 2011
- Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs CMOs
- CMO’s Capacity Bottleneck Projections, in Retrospect
- Biotherapeutic Capacity Bottleneck Projections, in Retrospect
- Factors Creating Capacity Constraints: US vs. Western European Respondents
- 5-4 Key Areas to Address to Avoid Future Capacity Constraints
- Avoiding Capacity Constraints
- Analysis of Areas to Avoid Capacity Constraints: Changing Perspectives, 2006-2011
- General Comments for Reducing Capacity Constraints
- Key Areas to Address to Avoid Capacity Constraints: U.S. vs Western Europe
- 5-5 Discussion
- CHAPTER 6:Future Capacity Expansions
- 6-1 Planned Future Capacity Expansions
- Planned Future Capacity Expansions, 2009 vs. 2015
- Planned Future Capacity Expansions by 2015;
- CMOs vs. Biotherapeutic Developers
- Planned Five-Year Capacity Expansions; US 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
- New Outsourcing Process & Risk Analysis
- Future Projections
- Collaborative Outsourcing
- 7-1 Current Outsourcing, by Production System
- Summary of Findings:
- Facilities Currently Outsourcing No Production (All Production “In-house”), 2006-2011
- 7-2 Future Outsourcing
- Biotherapeutic Developers’ Outsourcing, 2015 Projections, by System
- Biotherapeutic Developers Outsourcing Some Production in 2015
- 7-3 Outsourced Activities in Biopharmaceutical Manufacturing
- Comparison of Biomanufacturers’ Outsourcing, (2010-2011)
- Increased Outsourced Activities, 24-month Projections
- Outsourcing Activities Projected at ‘Signifi cantly Higher Levels’, Comparison of 2010 vs 2011 Trends
- Average Percentage of Activities Outsourced Today Comparison of outsourcing activities, 2010 vs 2011
- 7-4 Critical Outsourcing Issues
- Selecting a CMO: 2011
- Selecting a CMO, 2006-2011
- Changes in Critical Issues when Considering a CMO, 2008-2011
- CMOs’ Problems with Clients
- CMOs’ Problems with Clients, Trends
- 7-5 Country Selections for International Outsourcing of Biomanufacturing
- US vs Western European Respondents’ Outsourcing Destinations
- Western European Respondents’ Outsourcing Destinations
- 5-Year Projection for Biomanufacturing International Outsourcing/Off-shoring
- 5-Year Projection for Biomanufacturing International Outsourcing/Off-shoring
- Respondent Comments:
- 7-6 Discussion
- 1. Global situation for outsourcing
- 2. Trends to cut costs
- 3. Role of new technologies with impact on outsourcing
- 4. Competitive Situation with Impact on outsourcing
- 5. Trends to form consortiums around outsourcing options
- 6. Future of biologics mfg outsourcing
- 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: 2006-2011
- Annual Growth Rate for Disposables Market Penetration / Usage
- 6-year Growth in Disposables Applications, Percentage-point Gains
- Disposable Use by Stage of Production/Application
- Growth in the use of disposable systems
- Newly Introduced Disposable Applications
- Leachables and Extractables
- Cost Conscious L&E Testing
- Use of Disposables: CMOs vs. Biotherapeutic Developers
- 8-2 Reasons for Increasing Use of Disposables & Single-Use Systems
- Reasons for Increased Use of Disposables, 2006 through 2011
- Summarizing trends:
- 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 2006-2011
- 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, 2008-2011
- Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developer vs.CMO
- Top Reasons for Not Increasing the Use of Disposables: US vs.
- European Respondents
- 8-4 Standards Setting for Disposable, Single-use Systems
- Design and Engineering Standards Settings
- Leachables and Extractables Standards Settings
- Component Manufacturing Control (Quality) Standards Settings
- Organizations from Which End Users Expect Standards Settings
- 8-5 Current Budgets for Disposable Systems
- Budgets for Disposable Systems, 2007-2011
- Annual Growth Rate in Budgets for Single-use Components 2007-2011 298
- Data Findings, CAGR
- Current Budget for Disposables: CMO’s vs. Biotherapeutic Developers
- 8-7 Disposable Bioreactor Attributes
- Waste Disposal of Single-use Devices (2010 Data)
- Comments in 2010 regarding Waste Disposal Issues:
- Comments in 2009 regarding Waste Disposal Issues:
- 8-8 Satisfaction with Vendors of Disposables for Biopharmaceutical Manufacturing
- 8-9 Discussion
- The Expanding Use of Single-use Devices
- Current Markets
- Safety Concerns with Disposables
- Summary
- 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, US vs. Western European Biomanufacturers
- 9-2 Specifi c Purifi cation Step Constraints
- Changes in Impact on Capacity of Purifi cation Steps, 2008-2011
- Specifi c Purifi cation Step Constraints, US 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, US vs Western Europe
- 9-4 Problems in Downstream Purifi cation
- 9-5 New Downstream Processing Technologies
- New Downstream Processing Solutions; 2010 - 2011
- New Downstream Processing Technologies; Biotherapeutic Developers vs. CMOs
- New Downstream Processing Technologies; US vs Western Europe
- 9-6 Improvements to Downstream Operations
- Comparison of New Downstream Technology Investigations; Biomanufacturers vs CMOs
- Comparison of New Downstream Technology Investigations; US vs W. Europe vs ROW
- 9-7 Discussion
- CHAPTER 10: Quality Issues, Batch Failures, and PAT in Biopharmaceutical Manufacturing
- Introduction
- 10-1 Process Analytical Technology(2010 Data)
- PAT Initiatives for Existing Processes (2010 Data)
- 10-2 Hurdles to Implementing Process Analytical
- Technology, 2008-2011
- PAT Adoption Will Increase
- 10-3 Batch Failure Frequency in Biopharmaceutical Manufacturing
- 10-4 Primary Cause of Batch Failures and Percentages of Failures
- 10-5 Quality Problems Traced to Vendors in Biopharmaceutical
- Manufacturing
- 10-6 Automation Implementation
- Comparison of Implementation Plans 2009 - 2011
- 10-7 Quality Initiative Implementation
- Comparison of Quality Initiative Implementation, 2009 - 2011
- 10-9 Global Quality Supply Management
- Global Quality Supply Management
- US vs W. European Global Quality Supply Management
- 10-10 Effect Of Cost-Cutting on Overall Quality Operations
- CMOs Impact of Cost Cutting on Quality Manufacturing
- US vs Western European Impact of Cost Cutting on
- Quality Manufacturing
- 10-11 Discussion
- CHAPTER 11: Hiring, Employment Growth, and Training in Biopharmaceutical Manufacturing
- Introduction
- 11-1 Hiring in 2011
- 11-2 Hiring in 2015
- 11-3 Hiring Challenges Today
- Hiring Diffi culties; 2010 vs 2011
- Hiring Diffi culties: US vs Western Europe
- 11-4 Training in Biopharmaceutical Manufacturing
- Changes in Training for New Manufacturing Employees, 2009-2011
- 11-5 Global Initiatives
- CHAPTER 12:Suppliers to Biopharmaceutical Manufacturing and Life Sciences
- Introduction
- 12-1 Demographics
- Areas of Involvement
- Location of Vendor Sales
- Respondents’ Primary Job
- 12-2 Growth Rate of Sales by Suppliers
- Average Industry Growth Rate, Distribution
- Average Industry Growth Rate, By Segment
- Vendor Sales Growth Rate, by Industry Segment, 2007 to 2011
- Overall Vendor Sales Growth, 2007-2011
- Vendor Annual Sales, Distribution
- 12-3 Discussion: Industry Growth Rates
- 12-4 Budget Issues and Problems Faced by Industry Supplier
- Budget Challenges in 2011
- Vendor Average Budget Changes for 2009 -2011
- Vendor Pricing Changes
- Future Price Changes for 2012
- CMO Price Changes
- Average CMO Pricing Shift, 2010-2011
- 12-5 Cost Cutting Actions by Vendors
- Cost Cutting Actions, By Segment
- 12-6 Problems Faced by Vendors
- Problems Faced by Vendors’ Clients
- Vendor Expansion Plans for 2011
- Biopharma Vendor Business Trends, 2010 vs 2011
- Top New Technology Areas in Development by Vendors
- Other NPD activities:
- 12-6 Discussion: Supplier Issues
- 12-7 Sales Staff Training
- Days of Training Provided
- Areas where Training May Help Sales Staff Perform
- Areas where Training May Help Sales Staff Perform, Trends 2010 vs 2011
- FIGURES AND TABLES:
- Fig 1.1: FDA Approvals of New Biopharmaceutical Products 1982-2010
- Fig 1.2: Investigational Drugs: Large Molecule (Protein Therapeutics), Worldwide, March 2011 vs March 2010
- Fig 1.3: Current Worldwide Pipeline & Launched Products, Large Molecules, March 2011
- Fig 2.1: Area of Involvement in Biopharmaceutical Manufacturing
- Fig 2.2: Area of Involvement in Biopharmaceutical Manufacturing, 2010 vs 2011 25
- Fig 2.3: Respondents’ Job Responsibilities
- Fig 2.4: Facility Location
- Fig 2.5: Facility Location, by Region
- Fig 2.6: Biopharmaceutical Manufacturing Systems, (2007-2011) Trends
- Fig 2.7: Phase of Development of Surveyed Respondents
- Fig 2.8: Distribution of Employees at Facility, and Organization
- Fig 2.9: Distribution of Total Batches Run at Facility Last Year, by Scale of Production
- Fig 3.1: Biomanufacturers’ Budget Shifts for 2011
- Fig 3.2: Approximate Average Change in Biomanufacturers’ Budgets for 2011
- Fig 3.3: Approximate Average Change in Biomanufacturers’ Budgets for 2011
- Fig 3.4: Operational Changes Due to Recent Global Economics
- Fig 3.5: Operational Changes Due to Recent Global Economics, 2011 vs 2010
- Fig 3.6: Operational Changes Due to Recent Global Economics; Biotherapeutic developers vs CMO’s
- Fig 3.7: Operational Changes Due to Recent Global Economics; US vs Western Europe
- Fig 3.8: New Product Development Focus Areas
- Fig 3.9: New Product Development Focus Areas, 2011 vs 2010
- Fig 3.10: New Product Development Areas of Interest: Biotherapeutic Developers vs CMO’s
- Fig 3.11: New Product Development Areas of Interest: US vs Western Europe and ROW
- Fig 3.12: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements
- Fig 3.13: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: 2011 vs 2010
- Fig 3.14: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: Biomanufacturers Vs CMOs
- Fig 3.15: Factors in Biomanufacturing Performance Creating “Signifi cant” or “Some” Improvements: US Vs Western Europe Vs Rest of World
- Fig 3.16: Cost-Cutting Changes: Actions Undertaken During Past 12 Months
- Fig 3.17: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography
- Fig 3.18: Activities Implemented to Speed Drug Development Timelines
- Fig 3.19: Activities Implemented to Speed Drug Development Timelines; Biomanufacturers vs CMOs
- Fig 3.20: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods
- Fig 3.21: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs CMOs
- Fig 3.22: Biomanufacturing Assay ‘Areas’ Urgently Requiring New, Improved Testing Methods; US vs Western Europe
- Fig 3.23: Perfusion Operations Issues: Perfusion vs Batch-Fed Processes (Note: 2010 Data)
- Fig 4.1: Capacity Utilization, By System, 2011
- Fig 4.2: Capacity Utilization, By System, 2004-2011
- Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2011
- Fig 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs CMOs
- Fig 4.5: Capacity Utilization By System, US vs. Western Europe
- Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
- Fig 4.7: Estimated Bioreactor Capacity Distribution, by Biotherapeutic Developer (2006 vs 2010)
- Fig 4.8: Estimated Bioreactor Capacity Distribution, by Contract Manufacturing Organizations (CMO), 2006, vs 2010, vs 2011
- Fig 4.9: Current Production Capacity Distribution, Microbial Fermentation
- Fig 4.10: Current Production Capacity Distribution, Yeast
- Fig 4.11: Current Production Capacity Distribution, Insect Cells
- Fig 4.12: Mammalian Cell Culture Capacity Estimates 2003-2011
- Fig 4.13: Microbial Fermentation Capacity Estimates 2003-2011
- Fig 4.14: Range of Titres for Mabs Obtained at Various Production Scales, Distribution
- Fig 4.15: Annual Average Mab Titre Increase, 2008-2011
- Fig 5.1: Capacity Constraints, by Stage of Production
- Fig 5.2: Capacity Constraints, 2004 through 2011
- Fig 5.3: Capacity Constraints Trends, 2004-2011
- Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs CMOs
- Fig 5.5: Capacity Constraints, US vs. 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 2004-2011
- Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004-2011 (Trend Line)
- Fig 5.9: Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs CMOs
- Fig 5.10: Five-year Projections for Capacity Constraints: US vs Western Europe
- Fig 5.11: Factors Creating Future Capacity Constraints
- FIG 5.12: Factors Creating Future Capacity Constraints, 2008-2011
- Fig 5.13: Factors Creating Future Capacity Constraints, CMOs vs Biotherapeutic Developers
- Fig 5.14: Factors Creating Future Capacity Constraints, US 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; 2006-2011
- 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 2015
- Fig 6.2: Planned Future Capacity Expansion: 5-year Estimates, 2009 through 2015
- Fig 6.3: Planned Future Capacity Expansion: 5-year Estimates, 2009 - 2015 (Trend Line)
- Fig 6.4: Planned Future Capacity Expansion: 5-year Estimates; Biotherapeutic Developers vs CMOs
- Fig 6.5: Planned Future Capacity Expansion: 5-year Estimates, 2009 - 2015, US vs Western Europe
- Fig 6.6: Percent of Respondents Projecting Production Increases of over 100% by 2015; 4-year Trend
- Fig 7.1: Current Percent Production Outsourced; by System, 2009
- Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2011
- Fig 7.3: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2011 (Trend Line
- Fig 7.4: Future Outsourcing: Percent Production Outsourced; by System, in 2015
- Fig 7.5: Five-year Projections: Percent Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2011
- Fig 7.6: Percent of Biomanufacturers Outsourcing at Least Some Activity Today
- Fig 7.7: Percent of Biomanufacturers Outsourcing at Least Some Activity, (2010-2011)
- Fig 7.8: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years
- Fig 7.9: Outsourcing Activities Projected to be Done at ‘Signifi cantly Higher Levels’ in 2 Years, 2010 vs 2011 Trend
- Fig 7.10: Current Outsourcing: Average Percentage of Activity Outsourced Today
- Fig 7.11: Current Outsourcing: Average Percentage of Activity Outsourced, 2010-2011
- Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations
- Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2005-2009
- Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2008-2011, Percentage Point Differences
- Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs
- Fig 7.16: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs
- Fig 7.17: Country Selections as Destination for International Outsourcing of BioManufacturing (All Respondents)
- Fig 7.18: Percent U.S. Respondents Considering Country as ‘Possible’ Outsourcing Destination
- Fig 7.19: Percent U.S. Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination
- Fig 7.20: Percent Western European Respondents Considering Country as “Strong Likelihood” or “Likelihood” as Outsourced Capacity Destination
- Fig 7.22: Percent of Biomanufacturing Operations Off-shored (International Outsourcing) within 5 Years.
- 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; 2006-2011
- Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2011
- Fig 8.4: 6-Year Percentage-Point Change in First-Usage of Disposables, 2006-2011
- Fig 8.5: Usage of Disposables in Biopharmaceutical manufacturing, by Stage of Manufacture (R&D through Commercial Manufacture)
- Fig 8.6: Newly Introduced Disposables, Past 12 Months
- Fig 8.7: Current Issues: Leachables and Extractables in Disposable Devices
- Fig 8.8: Usage of Disposables in Biopharmaceutical Manufacturing; Biotherapeutic Developer vs CMO
- Fig 8.9: Reasons for Increasing Use of Disposable System Components in 2011
- Fig 8.10: Reasons for Increasing Use of Disposables 2006-2011
- Fig 8.11: Reasons for Increasing Use of Disposable System Components, Biotherapeutic Developers vs CMOs
- Fig 8.12: Most Critical Reason for Increasing Use of Disposables
- Fig 8.13: Reasons for Restricting Use of Disposables
- Fig 8.14: Factors Restricting Use of Disposables, 2006-2011
- Fig 8.15: Factors Restricting Use of Disposables in Biotherapeutic Developer vs CMO
- Fig 8.16: Top Reasons for Not Increasing Use of Disposables, 2011
- Fig 8.17: Top Reasons for Not Increasing Use of Disposables, 2008-2011
- Fig 8.18: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developer vs CMO
- Fig 8.19: Top Reasons for Not Increasing Use of Disposables, U.S. vs Western Europe
- Fig 8.20: Standards Setting for Design and Engineering; Organizations Expected to Set Standards
- Fig 8.21: Standards Setting for Design Leachables and Extractables; Organizations Expected to Set Standards
- Fig 8.22: Standards Setting for Component Manufacturing Control (Quality); Organizations Expected to Set Standards
- Fig 8.23: Standards Setting for Component Manufacturing Control (Quality); Organizations Expected to Set Standards
- Fig 8.24: Average Budget Per Facility, Single-use Disposable System Components
- Fig 8.25: Average Budget, Single-use Disposable System Components, 2007 vs 2010
- Fig 8.26: CAGR: Growth Rate in Budget on Single-use / Disposable System Components 2007-2011 (by device)
- Fig 8.27: Average Disposables Budget Per Facility, Disposable Systems; Biotherapeutic Developers vs CMOs
- Fig 8.28: Disposable Bioreactor Attributes Considered “Very Important”
- Fig 8.29: Disposable Bioreactor Attributes Considered “Very Important”, 2010 vs 2011
- Fig 8.30: Impact of Waste Disposal for Disposables (Note: 2010 data)
- Fig 8.31: Single-Use Product Vendor Satisfaction Factors
- Fig 9.1: Impact of Downstream Processing on Overall Capacity
- 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 - 2011
- 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 -2011
- Fig 9.9: Issues Regarding Protein A Usage; US vs. Western Europe
- Fig 9.10: Problem Areas in Downstream Operations, 2007 vs 2009 (Data from 2010 Study)
- Fig 9.11: New Downstream Processing Solutions in 2010
- Fig 9.12: New Downstream Processing Solutions; 2010 - 2011
- Fig 9.13: New Downstream Processing Solutions in 2010; Biotherapeutic Dev. vs CMO
- Fig 9.14: New Downstream Processing Solutions in 2011; US vs. Western Europe
- Fig 9.15: Improving Downstream Operations
- Fig 9.16: Improving Downstream Operations; Biomanufacturers vs CMOs
- Fig 9.17: Improving Downstream Operations (US Vs Western Europe Vs ROW)
- Fig 10.1: Implementation of Process Analytical Technology (PAT) for New Biomanufacturing Processes, 2009 vs 2010 (2010 Data)
- Fig 10.2: Hurdles Hindering Implementation of PAT (2008 - 2011)
- Fig 10.3: Batch Failure Frequency Distribution, 2009 - 2011
- Fig 10.4: Average Rates of Failure, by Primary Cause, and Phase of Manufacture, 2011
- Fig 10.5: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2011 (Commercial Manufacture)
- Fig 10.6: Quality problems traced to vendors
- Fig 10.7: Automation Technologies Implemented, or to be Implemented in 2011
- Fig 10.8: Automation Technologies to be Implemented; Comparing 2009 - 2011
- Fig 10.9: Quality Initiative Implemented Currently, or within Next 12 Months
- Fig 10.10: Quality Initiative to be Implemented in “Next 12 Months”, Comparing 2009 - 2011
- Fig 10.11: Global Quality Supply Management
- Fig 10.12: Global Quality Supply Management (Biomanufacturers vs CMOs)
- Fig 10.13: Global Quality Supply Management (US vs W. Europe)
- Fig 10.14: Cost Cutting Impact on Quality
- Fig 10.15: Cost Cutting Impact on Quality (Biomanufacturers Vs CMOs)
- Fig 10.16: Cost Cutting Impact on Quality (US vs Western Europe)
- Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2011)
- Fig 11.2: New Hires in Biopharmaceutical Manufacturing (2015)
- 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 vs 2011
- Fig 11.5: Areas Where Hiring Diffi culties Exist in Biopharmaceutical Operations, US vs. Western Europe
- Fig 11.6: Training for New Operations/Manufacturing Employees
- Fig 11.7: Changes in Training for New Operations/Manufacturing Employees
- Fig 11.8: Global Health Interest
- Fig 12.1: Area of Biopharmaceutical Involvement, Vendor
- Fig 12.2: Area of Biopharmaceutical Involvement, Vendors, 2011 vs 2010
- Fig 12.3: Geographic Locations in which Vendors Currently Actively Sell Products or Services
- Fig 12.4: Respondents’ Primary Job Function
- Fig 12.5: Biopharmaceutical Supply Market Segment Sales Growth Distribution
- Fig 12.6: Average Annual Vendor Segment Sales Growth Rates, 2011
- Fig 12.7: Average Annual Vendor Sales Growth Rate, 2007 - 2011, by Segment
- Fig 12.8: Average Annual, Vendor Sales Growth Rate, 2007 - 2011
- Fig 12.9: Average Annual Vendor Sales Trend Line, 2007 - 2011, by Segment
- Fig 12.10: Vendors’ Approx Annual Sales to Biopharmaceutical Segment %
- Fig 12.11: Vendors’ Average Budget Change for 2011
- Fig 12.12: Vendors’ Average Budget Change for 2009 - 2011, Summary
- Fig 12.13: Vendors’ Average Pricing Changes in 2011
- Fig 12.14: Vendors’ Average Pricing Changes, 2009 Actual - 2012 Projected
- Fig 12.15: CMOs Service Price Shifts in 2011, Distribution
- Fig 12.16: Average CMOs Service Price Shifts in 2010
- Fig 12.17: Average CMOs Service Price Shifts 2010 vs 2011
- Fig 12.18: Actions undertaken to reduce overall costs, past 12 months
- Fig 12.19: Actions undertaken to reduce overall costs in past 12 months, By Segment
- Fig 12.20: Problems Faced by All Suppliers
- Fig 12.21 (Fig 10.6 Recap): Biomanufacturers’ and CMOs Quality Problems Traced to Vendors
- Fig 12.22: Biopharma Business and Marketing Plans, 2011
- Fig 12.23: Biopharma Business and Marketing Plans, 2010 vs 2011
- FIG 12.24: Top New Technologies or New Product Development Areas
- Fig 12.25: Days of Sales Staff Training Provided
- FIG 12.26: Areas Where Training May Help Sales Staff Perform Better; All Respondents vs Sales Reps Only
- FIG 12.27: Areas Where Training May Help Sales Staff Perform Better; 2010 vs 2011
- TABLES
- Table 1.1: Biologics (Large Molecule), Worldwide, through March 2011
- Table 1.2: Summary All Therapeutics vs Biologics (Large Molecule), Worldwide, through March 2011 (Comparing 2008-2010)
- Table 1.3: Worldwide Pipeline, Large Molecules, 2011
- Table 1.4: Summary of Worldwide Biopharmaceutical Revenue by Product Class, 2007 and 2010 estimates
- Table 1.5: Biopharmaceutical Blockbusters: >$1 billion revenue, and Expression Systems/Host Cells (2010 vs 2009)
- Table 1.6: Biopharmaceutical Markets ñ Products and Revenue by Class
- Table 1.7: Monoclonal Antibody Therapeutic Products Revenue & Approvals
- Table 1.7: Expression Systems/Host Cells for U.S./EU-Marketed Cultured Biopharmaceuticals
- Table 3.1: Areas of Signifi cant Projected Budget Increases for Biomanufacturing, Past Three Years:
- Table 4.1: Distribution of Mammalian Cell Culture Capacity in 2011, Product Manufacturers
- Table 4.2: Distribution of Mammalian Cell Culture Capacity Among Contract Manufacturing Organizations (CMOs), 2011 data
- Table 4.3: Compound Annual Change in Mab Titre, 2008-2011
- Table 7.1: Percent of US-based Respondents Indicating Country as a “Strong Likelihood” or “Likelihood” as Outsourcing Destination, 2009-2011
- Table 9.1: Percent experiencing ‘Serious’ or ‘Some’ capacity problems due to downstream processing 2008-2011
- Table 9.2: Percent US vs Western Europe facilities experiencing ‘Serious’ capacity problems due to downstream processing, 2009-2011
- Table 9.3: Percent US vs Western Europe facilities experiencing ‘No Downstream Bottlenecks’ due to downstream processing, 2008-2011
- Table 10-1: Batch Failures, Average Weeks per Failure, per Facility, 2008-2011
- Table 12-1: Average Industry Growth Rate, 2007 -2011
- Table 12.2: Top 14 Areas of biopharma R&D and New Product Development
- Table 12-3: Average Vendor Sales and Technical Training Days, 2010 - 2011
Related Markets
- Biotechnology
- Research & Development
- Pharmaceuticals
- Manufacturing, Packaging & Detailing
- Biopharmaceuticals
Biopharmaceuticals Reports
- Research Report on Chinese Bio-pharmaceutical Industry, 2012
- Regulatory Intelligence on Biologics Recalls – Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes
- Biologics Market in Brazil
- Global Biosimilars Market Forecast to 2015
- Biosimilars: Current Situation & Future Prospects, Worldwide

