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5th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

A Study of Biotherapeutic Developers and Contract Manufacturing Organizations, 2007

Publication Date   April 2008
Publisher   BioPlan Associates
Product Type   Report
Pages   184
ISBN Number   978-1-934106-09-9
Product Code   BPA009
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Summary


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This comprehensive look at the state of worldwide biopharmaceutical manufacturing provides the only on-going assessment of manufacturing capacity and production in this $80 billion global industry. You will find current, quantitative information from 434 worldwide biopharmaceutical developers and contract manufacturers, and over 120 suppliers to the industry. Covers year 2007.

Coverage includes:

  • In-depth analysis and summary of the key survey findings, trends and implications for industry-wide biomanufacturing capacity and biotherapeutic production
  • Comparison of production by biotherapeutic developers and contract manufacturing organizations
  • Current and future potential industry bottlenecks
  • Trend analysis in this 5th in a series of annual biopharmaceutical manufacturing industry evaluations
  • Projected capacity bottlenecks, and how they might be resolved
  • This edition includes the joint industry expertise from BioPlan Associates, and many industry consultants and experts

Overview

There are an estimated 10,000 large molecule biotechnology medicines in preclinical discovery or clinical trials around the world today. Over 2,000 of these are in clinical development . These biotherapeutic drugs target nearly 150 disease states and promise to bring better treatments to patients. However, if new biotherapeutics are to be made more accessible and affordable, most industry participants agree that improvements in performance and optimization of processes will be necessary. As the demand for production of biotherapeutics continues to grow, the question of whether current manufacturing capacity and production performance are sufficient to deal with the challenge becomes an important strategic issue.

Building new capacity and improving existing systems to meet the demand for new therapeutics, whether through in-house manufacturing or out-sourced contract manufacturing, has long-term cost implications. Designing new production facilities, bringing new capacity on line, and establishing new support services in these areas require accurate market knowledge, lead-time, large capital expenditures, and careful planning.

Both biopharmaceutical producers and contract manufacturers maintain a keen interest in the current and future status of industry capacity and trends. This report summarizes information obtained from worldwide biopharmaceutical manufacturers in late 2007. Its intent is to provide a quantitative assessment of industry capacity, production trends, and benchmarks. As an on-going benchmarking effort, it offers a view into current and future potential global industry bottlenecks.

Introduction

There are over 4,300 investigational new drugs of all types in clinical trials today, up from 3,106 in 2005. Biotechnology drugs now make up more than one-quarter of the FDA filings for approval, and over 40% of preclinical trials are now large molecule candidates.

The 2007-2008 pipeline for biotherapeutics continues to show strong evidence that planning for biologics manufacturing will continue to require strategic approaches to avoid potentially disruptive bottlenecks. Effective planning for biotherapeutic production is strategically important to every biotherapeutic developer, Contract Manufacturing Organization (CMO), and supplier to this industry. The long lead-time required to successfully launch a biotherapeutic requires pre-planning for capacity. This planning demands a new level of partnership between manufacturers and suppliers to develop new technologies that will keep pace with industry's need for capacity.

Strategic production decisions must be based on solid data, trend tracking, and effective benchmarking of capacity and production issues. This study provides an ongoing evaluation of the vital manufacturing trends shaping this industry.

US and World biopharmaceutical Markets

There is a wide range of estimates for the size of the world market for biopharmaceutical products. These commonly range from $40-$60 billion to $80 billion or more. Most of these discrepancies are due to differences in what is and is not included as a biopharmaceutical. An estimate of the total, comprehensive, world market for biopharmaceutical products, based on summing reported and estimated product revenue is about $93 billion. With the world pharmaceutical market in 2006 about $653 billion (as reported by IMS), biopharmaceuticals on the market today constitute <15% of the world pharmaceutical revenue.

For Recombinant Proteins, revenue increased ~15% from 2005 to 2006. The most significant growth in revenue was in Recombinant Monoclonal Antibodies, increasing from $12.5 to $19.5 billion or ~56%. Much of this growth is attributable to ramping-up of sales of new products approved in recent years. Non-recombinant vaccines, as a class, also experienced a significant increase, from an estimated $7.5 to $9.5 billion or ~27%. However, much of this growth is due to just a few newer products.

Biopharmaceutical revenue is increasing at an annual rate in the range of ~15%, roughly twice the rate of the pharmaceutical industry. Thus, it is valid to claim that biopharmaceuticals are the fastest-growing sector of the pharmaceutical industry.

The U.S. constitutes the largest market for biopharmaceuticals, as it does for most pharmaceuticals. It accounts for just under half of all pharmaceutical sales worldwide.

As reported by IMS for 2006, global pharmaceutical sales were ~$653 billion, with North America accounting for $290.1 billion or 45% of global pharmaceutical revenue. Presuming a comparable 45% of biopharmaceutical sales are in the U.S., current U.S. annual biopharmaceutical sales would be about $42 billion.

However, biopharmaceutical sales, relative to other pharmaceutical (drug) sales, are disproportionately higher in the U.S. (and, to a lesser extent, in Europe and other affluent major markets). When considering that biopharmaceuticals are relatively expensive and that most biopharmaceuticals are developed and manufactured in the U.S, combined with the fact that many major products are only marketed the U.S.and other major markets, the U.S. accounts for more than 50% of current worldwide biopharmaceutical sales, probably in the range of $50 billion/year.

The markets for biopharmaceuticals in lesser-developed countries, e.g., India and China, are rapidly growing. Much of this involves locally-produced biogeneric versions of products originally developed by Western innovators. The majority of these products at present are, at best, in the tens of millions of dollars range. However, with growing affluence, sales of biopharmaceuticals are likely increasing faster in many lesserdeveloped than in the major, affluent markets.

The CHO cell blockbusters clearly dominate those with the highest sales, including five of the six (83%) with revenue over $3 billion/year. Factors contributing to CHO/ mammalian cell expression dominating the products with the most total sales include: manufacture with these technologies being more expensive than with microbial systems, with mammalian cell systems more complex and generally providing higher production yields, resulting in more expensive products; and most of the CHO/ mammalian expressed products are monoclonal antibodies requiring relatively high and frequently repeated doses (large amounts of protein), meaning patients consume relatively large amounts of protein (e.g., tens of milligrams rather than micrograms per relatively frequent dose).

A number of observations may be made. For example, the total world market for vaccines, with over 163 products, including 63 currently approved in the U.S., is about the same size as the markets for erythropoietin (EPO) products; cancer monoclonal antibodies; and tumor necrosis factor (TNF) antibodies. Other than vaccines, each of these product classes is dominated by a few blockbusters.

Content


  • 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
    • Mammalian Cell Culture
    • Estimated Bioreactor Capacity Distribution, Biotherapeutic
    • Developers and CMOs
    • Microbial Fermentation
    • Yeast Production
    • Insect Cells
    • 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
    • Respondents' Perception of Capacity Constraints
    • Respondents' Perception of Capacity Constraints, 2003-2007
    • Perception of Capacity Constraints in 2007:
    • CMOs vs. Biotherapeutic Developers
    • Perception of Capacity Constraints in 2007: US vs. European
    • Biotherapeutic Developers & CMOs
    • 4-2 Expected Capacity Constraints4-7
    • Respondents' Expectations of Capacity Constraints by 2012
    • Expected Capacity Constraints by 2012: 2003 to 2007 Data
    • Expected Capacity Constraints by 2012:
    • CMO vs. Biotherapeutic Developer
    • 4-3 Factors Impacting Future Production Capacity
    • Factors Creating Future Capacity Constraints
    • Factors Creating Future Capacity Constraints:
    • CMOs vs. Biotherapeutic Developers
    • Factors Creating Capacity Constraints:
    • US vs. European Respondents
    • 4-4 Key Areas to Address to Avoid Future Capacity Constraints
    • Analysis of Areas to Avoid; Changing Perspectives, 2005-2007
    • Key Areas to Address to Avoid Capacity Constraints: CMOs
    • vs. Biotherapeutic Developers
    • Key Areas to Address to Avoid Capacity Constraints:
    • US vs. European Respondents
    • 4-5 Discussion
  • Chapter 5: Future Capacity Expansions
    • 5-1 Planned Future Capacity Expansions
    • Planned Future Capacity Expansions, 2008 vs. 2012
    • Planned Future Capacity Expansions by 2012, CMOs vs
    • Biotherapeutic Developers
    • Planned Capacity Expansions by 2012: US vs. Western European
    • Manufacturers
    • Planned Future Capacity Expansions of >100%
    • 5-2 Current Outsourcing, by Production System
    • Facilities Currently Outsourcing No Production, 2005-2007
    • 5-3 Future Outsourcing
    • Biotherapeutic Developers' Outsourcing, 2012 Projections, by
    • System
    • Biotherapeutic Developers' Outsourcing Some Production in 2012
    • 5-4 Critical Outsourcing Issues
    • Selecting a CMO: 2007
    • Selecting a CMO, 2005-2007
    • Difficulty in Finding a CMO with Available Capacity
    • 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
    • Use of Disposables, 2007 vs. 20066
    • Annual Growth Rates for Disposables
    • Disposable Use by Stage of Production/Application
    • Newly Introduced Disposable Applications
    • Downstream Operations that are now 100% Disposable
    • Leachables and Extractables
    • Use of Disposables: CMOs vs. Biotherapeutic Developers
    • 6-2 Reasons for Increasing Use of Disposables &
    • Single-Use Systems
    • Reasons for Increased Use of Disposables,
    • 2005 through 2007
    • Reasons for Increased Use of Disposables,
    • 2007 vs. 2006 CMOs vs. Biotherapeutic Developers
    • Single Most Critical Reason for Increasing Use Disposables
    • 6-3 Factors Restricting Use of Disposables
    • Reasons for Restricting Usage of Disposables
    • Reasons for Restricting Expanded Use of Disposables:
    • 2006 vs. 2007
    • Reasons for Restricting Expanded Use of Disposables:
    • CMO's vs. Biotherapeutic Developers
    • Most Critical Reasons for Restricting Use of Disposables
    • Most Critical Reasons for Restricting Use of Disposables:
    • US vs. European Respondents
    • 6-4 Current Spending on Disposable Systems
    • Spending on Disposable Systems, 2006-2007
    • Current Spending on Disposables: CMO's vs. Biotherapeutic
    • Developers
    • Growth in Spending on Disposable Systems, 2006-2007
    • Budget Increase for Disposable and Single use Components
    • in Biopharmaceutical Manufacturing
    • 6-5 Scale of Use of Disposables
    • Switching from Disposables in Late Stage Biopharmaceutical
    • Manufacturing
    • 6-6 Satisfaction with Vendors of Disposable and Single Use
    • Components for Biopharmaceutical Manufacturing
    • 6-7 Discussion
  • Chapter 7: Downstream Purification
    • 7-1 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
    • 7-2 Specific Purification Step Constraints
    • Specific Purification Step Constraints, US vs. Western
    • European Biomanufacturers
    • 7-3 Downstream Purification Issues Facing the Industry Today
    • 7-4 Areas Where Major Improvements will Occur in
    • Downstream Processing
    • Membrane Technology: Opinions
    • Moving Bed Technology: Opinions
    • 7-5 Problem Areas in Downstream Operations
    • 7-6 Microfiltration Problems in Biopharmaceutical
    • Downstream Processing
    • 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
    • Biopharmaceutical Manufacturing
    • 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
    • Level of Biopharmaceutical Workforce Education,
    • 2006 vs. 2011 Estimate
    • 9-4 Training in Biopharmaceutical Manufacturing
    • Additional Training Needed
    • 9-5 Discussion
  • Chapter 10: Suppliers to Biopharmaceutical
    • Manufacturing and Life Sciences
    • Introduction
    • 10-1 Demographics
    • Areas of Involvement
    • Location of Vendor Sales
    • Respondents' Primary Job
    • 10-2 Growth Rate of Sales by Suppliers
    • Average Industry Growth Rate, Distribution
    • Average Industry Growth Rate, By Segment
    • Industry Growth Rate, 2006 vs. 2007
    • 10-3 Discussion: Industry Growth Rates
    • 10-4 Supplier Issues
    • Problems Faced by Suppliers
    • Problems Faced by Vendors' Clients
    • 10-5 Discussion: Supplier Issues
    • 10-6 Sales Staff Training
    • Days of Training Provided
    • Areas Where More Training Needed, Sales Staff vs. All Staff
    • 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 EducationLevels (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