6th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

Published by: BioPlan Associates, Inc.

Published: Apr. 1, 2009 - 259 Pages

Table of Contents

Overview

Methodology

CHAPTER 1:

Introduction and Discussion

Introduction

1-1 U.S. and World Biopharmaceutical Markets

Expression Systems in Biopharmaceutical Manufacturing

World Markets for Biopharmaceuticals

1-2 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 2009

3-2 Expression Systems in Biopharmaceutical Manufacturing

Selection and Royalty Issues in Expression Systems

Expectations of Alternatives to Current Expression Systems

3-3 Cell line/clone production strain selection process

3-4 Current Expression System Issues

Critical Expression System Concerns

COMMENTS & CONCERNS REGARDING EXPRESSION SYSTEMS

Cell Line Optimization

Cold Chain Management Strategies in BioProduction

3-5 Discussion: Industry Trends and Issues

Summary

CHAPTER 4:

Capacity Utilization

4-1 Capacity Utilization Trends

Capacity Utilization Definitions

Relevance of Capacity Utilization

Capacity Utilization in 2008

Capacity Utilization Changes Since 2003

Average Growth Rate in Capacity Utilization, 2005-2008

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

Microbial Fermentation Capacity

Yeast Production Capacity

Insect Cells Production Capacity

4-5 Discussion: Current State of Capacity Utilization

Summary of Capacity Issues

4-6 Range of Titres for MAb Production

Annual Mab Titre Change, 2007-2008

4-7 Discussion: Capacity and Industry Trends

Capacity Utilization

Capacity Utilization--Microbial & Other

CHAPTER 5:

Current Capacity Constraints

5-1 Current Capacity Constraints

Respondents Experiencing No Capacity Constraints

Respondents’ Perception of Capacity Constraints, 2003-2008

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 2013: Comparing 2003 to 2008 Data

Expected Capacity Constraints by 2013: CMOs vs. Biotherapeutic Developers

Expected Capacity Constraints by 2013: U.S. vs Western Europe

5-3 Factors Impacting Future Production Capacity

Factors Creating Future Capacity Constraints

Factors Creating Future Capacity Constraints, 2007 vs 2008

Factors Creating Future Capacity Constraints: CMOs vs. Biotherapeutic Developers

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, 2005-2008

Key Areas to Address to Avoid Capacity Constraints: CMOs vs. Biotherapeutic Developers

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, 2008 vs. 2013

Planned Future Capacity Expansions by 2013, 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

7-1 Current Outsourcing, by Production System

Summary of Findings:

Facilities Currently Outsourcing No Production(All Production “In-house”), 2005-2008

7-2 Future Outsourcing

Biotherapeutic Developers’ Outsourcing, 2013 Projections, by System

Biotherapeutic Developers Outsourcing Some Production in 2013

7-3 Critical Outsourcing Issues

Selecting a CMO: 2008

Selecting a CMO, 2005-2008

Difficulty in Finding a CMO with Available Capacity

Country Selections for International Outsourcing of Biomanufacturing

US vs Western European Respondents’ Outsourcing Destinations

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: 2005-2008

Disposable Use by Stage of Production/Application

Newly Introduced Disposable Applications

Downstream Operations That Are Currently 100% Disposable

Leachables and Extractables

Use of Disposables: CMOs vs. Biotherapeutic Developers

8-2 Reasons for Increasing Use of Disposables & Single-Use Systems

Reasons for Increased Use of Disposables, 2005 through 2008

Reasons for Increased Use of Disposables, 2008 vs. 2007: CMOs vs. Biotherapeutic Developers

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 2005-2008

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, 2007-2008

Top Reasons for Not Increasing the Use of Disposables: US vs. European Respondents

Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developer vs CMO

8-4 Current Spending on Disposable Systems

Annual Growth Rate in Spending on Single-use Components 2007-2008

Spending on Disposable Systems, 2006-2008

Current Spending on Disposables: CMO’s vs. Biotherapeutic Developers

8-5 Scale of use in Disposable Devices

Switching from Disposables to Fixed Systems in Late Stage Biopharmaceutical Manufacturing

Disposable Bioreactor Attributes

Waste Disposal of Single-use Devices

Single-Use Waste Disposal, U.S. vs Western Europe

8-6 Satisfaction with Vendors of Disposables for Biopharmaceutical Manufacturing

8-8 Discussion

CHAPTER 9: Downstream Purification

9-1 Impact of Downstream Processing on Capacity

Impact of Downstream Processing on Capacity, US vs. Western European Biomanufacturers

Impact of Downstream Processing on Capacity, Biopharmaceutical Developers vs. CMOs

9-2 Specific Purification Step Constraints

Specific Purification Step Constraints, US vs. Western European Biomanufacturers

9-3 Downstream Purification Issues Facing the Industry Today

Protein A and Alternatives

Protein A Downstream Purification Issues, US vs Western Europe

Downstream Purification and Productivity

Downstream Purification and Productivity, US vs Western Europe

9-4 Emerging Problems in Downstream Purification

9-5 Areas Where Major Improvements Will Occur in Downstream Processing

Membrane Technology Opinions

Moving Bed Technology Opinions

Development of MAb Fragments Opinions

9-6 Microfiltration Problems in Biopharmaceutical Downstream Processing

Filtration Factors in 2008

Filtration Factors in 2007

Filtration Factors in 2006

Filtration Factors in 2005:

9-7 Discussion

CHAPTER 10:

Quality Issues, Batch Failures, and PAT in Biopharmaceutical Manufacturing

Introduction

10-1 Process Analytical Technology

10-2 Hurdles to Implementing Process Analytical Technology

10-3 Batch Failure Frequency in Biopharmaceutical Manufacturing

10-4 Primary Cause of Batch Failures and Percentages of Failures

Batch Failure Rates, by Type of Manufacturing

10-5 Quality Problems Traced to Vendors in Biopharmaceutical Manufacturing

10-6 Automation Implementation

10-7 Automation Impact on Production

10-8 “Quality By Design” Initiative Implementation

Quality Initiatives, Current and Within-the-Year

CHAPTER 11:

Hiring, Employment Growth, and Training in Biopharmaceutical Manufacturing

Introduction

11-1 Hiring in 2009

11-2 Hiring in 2013

11-3 Formal Education Requirements in Biopharmaceutical Workforce

Level of Biopharmaceutical Workforce Education, 2006 vs. 2011 Estimate

11-4 Training in Biopharmaceutical Manufacturing

Manufacturing Areas Where Additional Training is Required

11-5 Discussion

CHAPTER 12:

Suppliers to Biopharmaceutical Manufacturing and Life Sciences

Introduction

12-1 Demographics

Areas of Involvement

Vendors’ Years in Biopharmaceuticals Business

Location of Vendor Sales

Comparison of Vendors’ Export Business

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, 2006 to 2008

Overall Vendor Sales Growth, 2006-2008

Vendor Annual Sales, Distribution

12-3 Discussion: Industry Growth Rates

12-4 Budget Issues and Problems Faced by Industry Supplier

Budget Challenges in 2009

Problems Faced by Vendors

Vendors were asked about the problems they face when selling to biopharmaceutical manufacturers. The top three:

Sales Reps’ Problems

Problems of Vendors in US and in Europe

Problems Faced by Vendors’ Clients

12-5 Discussion: Supplier Issues

12-6 Sales Staff Training

Days of Training Provided

Areas Where More Training Needed, Sales Staff vs. All Staff

FIGURES AND TABLES:

Fig. 1.1 Current Worldwide Pipeline & Launched Products, Large Molecules, 2009 . 4

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, 2006-2008

Fig. 2.6 Phase of Development of Surveyed Respondents

Fig. 2.7 Distribution of Employees at Facility, and Organization

Fig. 2.8: Distribution of Total Batches Run at Facility Last Year, by Scale of Production

Fig. 3.1 Biomanufacturers’ Budget Shifts in 2009

Fig. 3.2 Approximate Average Change in Biomanufacturers’ Budgets for 2009

Fig. 3.3 Expression Systems: Royalty & Selection Issues

Fig. 3.4 Expression Systems: Alternatives and Opinions

Fig. 3.5 Cell Line Selection Factors

Fig. 3.6 Most Critical Expression System Issues

Fig. 3.7 Methods used to optimize cell lines

Fig. 3.8 Cold Chain Management Considerations

Fig. 4.1 Capacity Utilization, By System, 2008

Fig. 4.2 Capacity Utilization, By System, 2003-2008

Fig. 4.3 Change in Capacity Utilization, CAGR, 2005-2008

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

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 Forecast (2003-2010)

Fig. 4.13 Estimated Microbial Fermentation Capacity Forecast (2003-2009)

Fig. 4.14 Range of Titres for Mabs Obtained at Various Production Scales; Commercial vs Late-stage Clinical Scale Production

Fig. 4.15 Annual Average Mab Titre Increase, 2007-2008

Fig. 5.1 Capacity Constraints, by Stage of Production

Fig. 5.2 Capacity Constraints, 2003 through 2008

Fig. 5.3 Capacity Constraints, Biotherapeutic Developers vs CMOs

Fig. 5.4 Capacity Constraints, US vs. Europe

Fig. 5.5 Expectations of Capacity Constraints; by Stage of Production; Five-year Projections

Fig. 5.6 Expectations of Capacity Constraints: Five-year Projections Made in 2003-2008

Fig. 5.7 Five-year Projections for Capacity Constraints: Biotherapeutic Developers vs CMOs

Fig. 5.8 Five-year Projections for Capacity Constraints: US vs Western Europe

Fig. 5.9 Factors Creating Future Capacity Constraints

Fig. 5.10 Factors Creating Future Capacity Constraints, 2007-2008

Fig. 5.11 Factors Creating Future Capacity Constraints, CMOs vs Biotherapeutic Developers

Fig. 5.12 Factors Creating Future Capacity Constraints, US vs Western European Biomanufacturers

Fig. 5.13 Key Areas to Address to Avoid Capacity Constraints

Fig. 5.14 Key areas to Address to Avoid Capacity Constraints; 2005-2008

Fig. 5.15 Key areas to Address to Avoid Capacity Constraints (Biomanufacturers vs CMOs)

Fig. 5.16 Key areas to Address to Avoid Capacity Constraints (U.S. vs Western Europe)

Fig. 6.1 Industry Average Planned Production Increase by 2013

Fig. 6.2 Planned Future Capacity Expansion: 5-year Estimates, 2009 through 2013

Fig. 6.3 Planned Future Capacity Expansion: 5-year Estimates; Biotherapeutic Developers vs CMOs

Fig. 6.4 Planned Future Capacity Expansion: 5-year Estimates, 2009 through 2013, US vs Western Europe

Fig. 6.5 Percent of Respondents Projecting Production Increases of over 100% by 2013

Fig. 7.1 Current Percent Production Outsourced; by System, 2008

Fig. 7.2 Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2005-2008

Fig. 7.3 Future Outsourcing: Percent Production Outsourced; by System, in 2013

Fig. 7.4 Five-year Projections: Percent Biotherapeutic Developers Planning to Outsource at Least Some Production, 2011, 2012, 2013 Studies

Fig. 7.5 Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations

Fig. 7.6 Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2005-2008

Fig. 7.7 Difficulty Finding a CMO with Available Capacity

Fig. 7.8 Country Selections as Destination for International Outsourcing of BioManufacturing (All Respondents)

Fig. 7.9 Percent U.S. Respondents Considering Outsourcing Biomanufacturing, at any level of interest (Possible, Likely, or Very Likely), by Country

Fig. 7.10 Percent Western European Respondents Considering Outsourcing Biomanufacturing , by Countries

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

Fig. 8.3 Average Annual Growth Rate, Disposables, 2005-2008

Fig. 8.4 Percentage-Point Increase in Usage of Disposables, 2005-2008

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 Percent of Downstream Operations 100% Disposable, by Application

Fig. 8.8 Current Issues: Leachables and Extractables in Disposable Devices

Fig. 8.9 Usage of Disposables in Biopharmaceutical Manufacturing; Biotherapeutic Developer vs CMO

Fig. 8.10 Reasons for Increasing Use of Disposable System Components

Fig. 8.11 Reasons for Increasing Use of Disposable System Components, 2005-2008

Fig. 8.12 Reasons for Increasing Use of Disposable System Components, Biotherapeutic Developers vs CMOs

Fig. 8.13 Most Critical Reason for Increasing Use of Disposables

Fig. 8.14 Reasons for Restricting Use of Disposables

Fig. 8.15 Factors Restricting Use of Disposables, 2005-2008

Fig. 8.16 Factors Restricting Use of Disposables, Biotherapeutic Developer vs CMO

Fig. 8.17 Top Reasons for Not Increasing Use of Disposables, 2008

Fig. 8.18 Top Reasons for Not Increasing Use of Disposables, 2007-2008

Fig. 8.19 Top Reasons for Not Increasing Use of Disposables, U.S. vs Western Europe

Fig. 8.20 Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developer vs CMO

Fig. 8.21 Average Spending Per Facility, Single-use Disposable System Components

Fig. 8.22 Growth Rate from 2007 to 2008 in Spending on Single-use / Disposable System Components

Fig. 8.23 Average Spending Per Facility, Single-use Disposable System Components, 2006 vs 2008

Fig. 8.24 Average Spending Per Facility, Disposable Systems; Biotherapeutic Developers vs CMOs

Fig. 8.25 Interim Use of Disposables in Biopharmaceutical Manufacturing, 2008 vs 2007

Fig. 8.26 Disposable Bioreactor Attributes Considered “Very Important”

Fig. 8.27 Impact of Waste Disposal for Disposables

Fig. 8.28 Select Comments Regarding Waste Disposal for Disposables; U.S. vs Western Europe

Fig. 8.29 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; U.S. vs Western Europe

Fig. 9.3 Impact of Downstream Processing on Overall Capacity; Biotherapeutic Developers vs CMOs

Fig. 9.4 Impact on Capacity of Purification Steps

Fig. 9.5 Impact on Capacity of Purification Steps, U.S., vs Western Europe

Fig. 9.6 Issues Regarding Protein A Usage

Fig. 9.7 Issues Regarding Protein A Usage; US vs. Western Europe

Fig. 9.8 Issues Regarding Downstream Processing & Productivity

Fig. 9.9 Issues Regarding Downstream Purification Productivity; US vs. Western Europe

Fig. 9.10 Problem Areas in Downstream Operations, 2007 vs 2008

Fig. 9.11 Areas of improvement for purification processes by 2013

Fig. 9.12 Problems Involving Microfiltration Steps in Biopharmaceutical Manufacturing

Fig. 10.1 Implementation of Process Analytical Technology (PAT): New vs Existing Biomanufacturing Processes

Fig. 10.2 Hurdles Hindering Implementation of PAT

Fig. 10.3 Batch Failure Frequency

Fig. 10.4 Batch Failures by Primary Causes, for Large Capacity (>1000L), Commercial Manufacturing Facilities

Fig. 10.5 Batch Failures, Primary Cause, by Type of Manufacture (Clinical vs Commercial Production)

Fig. 10.6 Quality problems traced to vendors

Fig. 10.7 Automation Technologies Implemented, or to be Implemented in 2009

Fig. 10.8 Automation technologies, once fully implemented, that will have greatest impact on production efficiency

Fig. 10.9 Quality Initiative Implementation Problems

Fig. 10.10 Quality Initiative to be Implemented in Next 12 Months

Fig. 11.1 New Hires in Biopharmaceutical Manufacturing (2009)

Fig. 11.2 New Hires in Biopharmaceutical Manufacturing (2013)

Fig. 11.3 Comparison of Percent of Workforce with Specific Education Levels (2006 Data)

Fig. 11.4 Training for New Operations/Manufacturing Employees

Fig. 11.5 Manufacturing Areas Where Additional Training is Required, 2007 vs 2008

Fig. 12.1 Area of Biopharmaceutical Involvement, Vendor

Fig. 12.2 Vendors’ Years in Business Supplying Biopharmaceutical Industry

Fig. 12.3 Geographic Locations in which Vendors Currently Actively Sell Products or Services

Fig. 12.4 Geographic Sales Regions, US Respondents

Fig. 12.5 Geographic Sales Regions, W. European Respondents

Fig. 12.6 Respondents’ Primary Job Function

Fig. 12.7 Biopharmaceutical Supply Market Segment Sales Growth Distribution

Fig. 12.8 Average Annual Vendor Segment Sales Growth Rates, 2008

Fig. 12.9 Average Annual Vendor Sales Growth Rate, 2006 - 2008, by Segment

Fig. 12.10 Average Annual, Vendor Sales Growth Rate, 2006 - 2008

Fig. 12.11 Vendors’ Approx Annual Sales to Biopharmaceutical Segment %

Fig. 12.12 Vendors’ Average Budget Change for 2009

Fig. 12.13 Vendors’ Average Budget Change for 2009, Summary

Fig. 12.14 Problems Faced by All Suppliers

Fig. 12.15 Problems Faced: Sales Reps Only

Fig. 12.16 Problems Faced by Suppliers; U.S. vs Western Europe

Fig. 12.17 Days of Sales Staff Training Provided

Fig. 12.18 Areas Where Training May Help Sales Staff Perform Better

TABLES

Table 1.1 Biologics (Large Molecule), Worldwide, through March 2009

Table 1.2 Summary All Therapeutics vs Biologics (Large Molecule), Worldwide, through March 2009

Table 1.3 Worldwide Pipeline, Large Molecules, 2009

Table 1.4 Worldwide Biopharmaceutical Revenue by Product Class, 2008 estimates

Table 1.5 Biopharmaceutical Blockbusters: >$1 billion revenue in 2006, and Expression Systems/Host Cells

Table 1.6 Expression Systems/Hosts for U.S./EU Recombinant Products

Table 1.7 Biopharmaceutical World Markets - Products and Revenue, by Class(2006-2007 Data)

Table 7.1 Percent of US-based Respondents Indicating Country as Likely Outsourcing Destination

Abstract

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