5th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity : Market Research Report

5th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity

Published by: BioPlan Associates, Inc.

Published: Apr. 1, 2008

Overview
Methodology
CHAPTER 1: Introduction and Discussion: Introduction; 1-1 U.S. and World Biopharmaceutical Markets; 1-2 Continuing Need for Production Improvements and Cost Containment
CHAPTER 2: Demographics: Respondents’ Area of Involvement; Respondents’ Titles; Respondents’ Facility Locations; Respondents’ Areas of Biopharmaceutical Manufacturing Operations; Respondents’ Production Operations, Phase of Development
CHAPTER 3: Capacity Utilization: 3-1 Changes in Capacity Utilization (2003-2007); 3-2 Capacity Utilization: CMOs vs. Biotherapeutic Developers; 3-3 Capacity Utilization: US vs. Western European Manufacturers; 3-4 Respondents’ Current Total Production Capacity; 3-5 Discussion: Current State of Capacity Utilization; 3-6 Range of Titres for MAb Production; 3-7 Discussion
CHAPTER 4: Current Capacity Constraints: 4-1 Current Capacity Constraints; 4-2 Expected Capacity Constraints4-7; 4-3 Factors Impacting Future Production Capacity; 4-4 Key Areas to Address to Avoid Future Capacity Constraints; 4-5 Discussion
CHAPTER 5: Future Capacity Expansions: 5-1 Planned Future Capacity Expansions; 5-2 Current Outsourcing, by Production System; 5-3 Future Outsourcing; 5-4 Critical Outsourcing Issues; 5-5 Discussion: Selecting a CMO
CHAPTER 6: Disposables and Single-Use Systems in Biopharmaceutical Manufacturing: 6-1 Use of Disposables and Single-Use Systems; 6-2 Reasons for Increasing Use of Disposables &; 6-3 Factors Restricting Use of Disposables; 6-4 Current Spending on Disposable Systems; 6-5 Scale of Use of Disposables; 6-6 Satisfaction with Vendors of Disposable and Single Use; 6-7 Discussion
CHAPTER 7: Downstream Purification: 7-1 Impact of Downstream Processing on Capacity; 7-2 Specific Purification Step Constraints; 7-3 Downstream Purification Issues Facing the Industry Today; 7-4 Areas Where Major Improvements will Occur in; 7-5 Problem Areas in Downstream Operations; 7-6 Microfiltration Problems in Biopharmaceutical; 7-7 Discussion
CHAPTER 8: Quality Issues, Batch Failures, and PAT in Biopharmaceutical Manufacturing: Introduction; 8-1 Process Analytical Technology; 8-2 Hurdles to Implementing Process Analytical Technology; 8-3 Batch Failure Frequency in Biopharmaceutical Manufacturing; 8-4 Primary Cause of Batch Failures, Percentages in; 8-5 Quality Problems Traced to Vendors in Biopharmaceutical Manufacturing
CHAPTER 9: Hiring, Employment Growth, and Training in Biopharmaceutical Manufacturing: Introduction; 9-1 Hiring in 2008; 9-2 Hiring in 2012; 9-3 Formal Education Requirements in Biopharmaceutical Workforce; 9-4 Training in Biopharmaceutical Manufacturing; 9-5 Discussion
CHAPTER 10: Suppliers to Biopharmaceutical Manufacturing and Life Sciences: Introduction; 10-1 Demographics; 10-2 Growth Rate of Sales by Suppliers; 10-3 Discussion: Industry Growth Rates; 10-4 Supplier Issues; 10-5 Discussion: Supplier Issues; 10-6 Sales Staff Training; 10-7 Vendor Business Longevity
Figures and Tables: Fig. 1.1 Current Worldwide Pipeline, Large Molecules, 2008; Fig. 2.1 Area of Involvement in Biopharmaceutical Manufacturing; Fig. 2.2 Respondents’ Job Responsibilities; Fig. 2.3 Facility Location; Fig. 2.4 Facility Location, by Region; Fig. 2.5 Biopharmaceutical Manufacturing Systems; Fig. 2.6 Phase of Development; Fig. 3.1 Capacity Utilization 2003-2007; Fig. 3.2 Capacity Utilization, CAGR 2003-2007; Fig. 3.3 Capacity Utilization, by System, Comparing CMOs vs Biotherapeutic Developers; Fig. 3.4 Capacity Utilization, by System, Comparing US vs Western European Biomanufacturers; Fig. 3.5 Current Production Capacity Distribution, Mammalian Cell Culture; Fig. 3.6 Estimated Bioreactor Capacity Distribution, by Biotherapeutic Developer (2006 vs 2010); Fig 3.7 Estimated Bioreactor Capacity Distribution, by Contract Manufacturing Organizations (CMO), 2006 vs 2010; Fig. 3.8 Current Production Capacity Distribution, Microbial Fermentation; Fig. 3.9 Current Production Capacity Distribution, Yeast Systems; Fig. 3.10 Current Production Capacity Distribution, Insect Systems; Fig 3.14 Range of Titers Being Obtained in MAb Production, Commercial vs Late-stage Clinical Scale Production; Fig. 4.1 Capacity Constraint, by Stage of Production; Fig. 4.2 Capacity Constraint, 2003 vs 2007; Fig. 4.3 Capacity Constraint, Biotherapeutic Developers vs CMOs; Fig. 4.4 Capacity Constraints, US vs. Europe; Fig. 4.5 Expectations of Capacity Constraints by 2012; Fig. 4.6 Five-year Projections for Capacity Constraints: 2003-2007; Fig. 4.7 Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs. CMOs; Fig. 4.8 Factors Creating Future Capacity Constraints; Fig. 4.9 Factors Creating Future Capacity Constraints, CMOs vs Biotherapeutic Developers; Fig. 4.10 Factors Creating Future Capacity Constraints, US vs Western European Biomanufacturers; Fig. 4-11 Key Areas to Address to Avoid Capacity Constraints; Fig. 4-12 Key Areas to Address to Avoid Capacity Constraints, 2005-2007; Fig. 4.13 Key Areas to Avoid Capacity Constraints, CMOs vs Biotherapeutic Developers; Fig. 4.14 Key Areas to Avoid Capacity Constraints, US vs W. European Biomanufactures; Fig. 5.1 Industry Average Planned Production Increase by 2012; Fig. 5.2 Planned Future Capacity Expansion: 5-year Estimates, 2008 through 2012; Fig. 5.3 Planned Future Capacity Expansion: 5-year Estimates, 2008 through 2012; Biotherapeutic Developers vs CMOs; Fig. 5.4 Planned Future Capacity Expansion: 5-year Estimates, 2008 through 2012; US vs Western Europe; Fig. 5.5 Percent of Respondents Projecting Production Increases of over 100% by 2012; Fig. 5.6 Current Percentage Production Outsourced by System, 2007; Fig. 5.7 Percent Biotherapeutic Developers Outsourcing NO production, 2007 vs 2006 vs 2005; Fig. 5.8 Future Outsourcing: Percent Production Outsourced in 2012, by System; Fig. 5.9 Five-year Projections: Percent Biotherapeutic Developers Planning to Outsource at Least Some Production, 2012 vs 2011; Fig. 5.10 Issues of Greatest Importance when Considering Outsourcing Biopharmaceutical Manufacturing; Fig. 5.11 Critical Issues When Selecting a CMO, 2005-2007; Fig. 5.12 Difficulties in Finding CMOs with Available Capacity; Fig. 6.1 Usage of Disposables in Biomanufacturing, Any Stage, 2005-2007; Fig. 6.2 Disposables’ Increased Market Penetration: Percentage Point Market Gain, 2006-2007; Fig. 6.3 Usage of Disposables in Biomanufacturing, by Stage of Manufacturing, Early R&D through Commercial Production; Fig. 6.4 Newly Introduced Disposables, Past 12 Months; Fig. 6.5 Percent of Respondents where Downstream Operations are 100% Disposable, by Application; Fig. 6.6 Perceptions and Opinions on Leachables and Extractables: Testing, Validation, Costs; Fig. 6.7 Usage of Disposables in Biomanufacturing, CMOs vs Biotherapeutic Developers; Fig. 6.8 Reasons for Increasing Use of Disposable System Components; Fig. 6.9 Reasons for Increasing Use of Disposable System Components, 2005-2007; Fig. 6.10 Reasons for Increasing Use of Disposable System Components, CMOs vs Biotherapeutic Developers; Fig. 6.11 Most Critical Reason for Increasing Use of Disposables; Fig. 6.12 Reasons for Restricting Use of Disposables; Fig. 6.13 Reasons for Restricting Use of Disposables: 2006 vs 2007; Fig. 6.14 Reasons for Restricting Use of Disposables: CMOs vs Biotherapeutic Developers; Fig. 6.15 Most Critical Reason for Not Increasing Use of Disposables; Fig. 6.16 Most Critical Reasons for Not Increasing Use of Disposables: US vs Western Europe; Fig. 6.17 Average Spending on Single-use Disposable System Components; Fig. 6.18 Average Spending on Disposable System Components: 2006 vs 2007; Fig. 6.19 Average Spending on Disposable System Components: CMO’s vs. Biotherapeutic Developers; Fig. 6.20 Annual Growth Rate in Spending on Disposable System Components; Fig. 6.21 Expected Budgetary Increases for Disposables Over Next 12 Months; Fig. 6.22 Rejecting Disposable Devices, Based on Scale of Production; Fig 6.23 Switching from Disposables to Fixed Systems in Late-stage Biomanufacturing; Fig. 6.24 Satisfaction with Vendors of Disposables for Biopharmaceutical Manufacturing; Fig. 7.1 Impact of Downstream Processing on Overall Capacity; Fig. 7.2 Impact of Downstream Processing on Overall Capacity, US vs Western European Biomanufacturers; Fig. 7.3 Impact of Downstream Processing on Overall Capacity, Biopharmaceutical Developers vs CMOs; Fig. 7.4 Impact of Purification Steps on Overall Capacity; Fig. 7.5 Impact of Purification Steps on Overall Capacity: US vs Western European Biomanufacturers; Fig. 7.6 Downstream Purification Issues Affecting Biopharmaceutical Production; Fig. 7.7 Areas Where Major Improvements in Purification Processes May Occur in the Next Five Years (2012); Fig. 7.8 Problem Areas in Downstream Operations; Fig 7.9 Problems Involving Microfiltration Steps in Biopharmaceutical Manufacturing; Fig. 8.1 Implementation of Process Analytical Technology (PAT): New vs Existing Biomanufacturing Processes; Fig. 8.2 Hurdles Hindering Implementation of PAT; Fig. 8.3 Batch Failure Frequency; Fig. 8.4 Primary Causes of Batch Failures, by Facility Capacity; Fig. 8.5 Quality Problems Traced to Vendors; Fig. 9.1 New Hires in Biopharmaceutical Manufacturing, 2008; Fig. 9.2 New Hires in Biopharmaceutical Manufacturing, 2012; Fig. 9.3 Comparison of Percent of Workforce with Specific Education Levels (2006 Data); Fig. 9.4 Training Time for New Operations/Manufacturing Employees; Fig. 9.5 Areas Where “Very high” or “High” Need for Additional Training is Require; Fig. 10.1 Primary Products or Services Area; Fig. 10.2 Geographic Locations in which Vendors Currently Actively Sell Products or Services; Fig. 10.3 Respondents’ Primary Job Function; Fig. 10.4 Biopharmaceutical Supply Market Segment Sales Growth; Fig. 10.5 Average Industry Growth Rate, By Segment; Fig. 10.6 Supplier Segment Growth Rate, 2006 vs. 2007; Fig. 10.7 Problems Faced by Suppliers to Biopharmaceutical Manufacturers and CMOs; Fig. 10.8 Days of Sales Staff Training Provided; Fig. 10.9 Areas Where Training May Help Sales Staff Perform Better; Fig. 10.10 Vendor Business Longevity
Tables: Table 1.1 Biologics (Large Molecule), Worldwide, through February 2008; Table 1.2 Summary All Therapeutics vs Biologics (Large Molecule), Worldwide, through February 2008; Table 1.3 Worldwide Pipeline, Large Molecules, by Therapeutic Area, 2008; Table 1.4 Worldwide Biopharmaceutical Revenue by Product Class; Table 1.5 Biopharmaceutical Blockbusters: >$1 billion revenue in 2006, and Expression Systems/Host Cells; Table 1.6 Biopharmaceutical World Markets - Products and Revenue, by Class

Abstract

This report is the fifth in our annual evaluations of the state of the biopharmaceutical manufacturing industry. The strength of the methodology remains in its breadth of coverage, which yields a composite view from the respondents closest to the industry. This year, BioPlan Associates, Inc. surveyed 434 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations in 39 countries around the world. The survey methodology also, separately, provided data from an additional 126 direct suppliers of materials, services and equipment to this industry segment. Using a web-based survey tool, we obtained and evaluated information regarding respondents' current capacity, production, novel technology adoption, human resources, and outsourcing issues. We assessed respondents' projected reasons for bottlenecks, and their perception of how these bottlenecks might be resolved. This year, we brought in experts from the industry to provide in-depth analysis of the events shaping the past year, and the trends that will shape biopharmaceutical manufacturing in 2008-2013.

Our subject matter experts include: Eileen Bartholomew, Senior Consultant, PharmaBioSource, Inc. Geoff Hodge, Vice President, Technology, Xcellerex Beth H. Junker, PhD, Senior Director, Bioprocess Research and Development, Merck Research Laboratories Vladimir Kostyukovsky, Senior Director, Manufacturing, Artisan Pharma Inc. Sean P. McKee, Senior Consultant, PharmaBioSource, Inc. Mark J. Stramaglia, Senior Product Manager, Invitrogen Corporation Scott Wheelwright, President and Founder, Strategic Manufacturing Worldwide William B. Wiederseim, President & CEO, PharmaBioSource, Inc.

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5th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity

Table of Contents

Abstract