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年次報告書:バイオ医薬品の製造能力・生産分析

The 2019 16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

発行 BioPlan Associates, Inc. 商品コード 753440
出版日 ページ情報 英文 485 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1USD=109.13円で換算しております。
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年次報告書:バイオ医薬品の製造能力・生産分析 The 2019 16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production
出版日: 2019年04月30日 ページ情報: 英文 485 Pages
概要

当レポートでは、バイオ医薬品の開発業者・受託製造機関 (CMO) による製造能力・生産分析について取り上げ、最新の年次報告書について、体系的な情報を提供しています。

第1章 イントロダクション・考察

第2章 バイオプロセスの将来:専門家の見通し

  • 世界のバイオ医薬品CMOの製造能力分析
  • 微生物汚染の迅速な同定
  • バイオプロセスの進歩に対するサプライヤーの貢献
  • 製造 vs. 購買 (インソーシング vs. アウトソーシング) :原因、基準、結果
  • M&A
  • バイオ医薬品受託製造における中国の進歩

第3章 バイオ医薬品製造における新興の問題点

  • 産業動向
  • 予算問題
  • 運用上の変更点
  • 新しいバイオプロセス製品の開発の機会
  • バイオ製造を向上させる要因
  • 考察
  • 平均コスト
  • アッセイ開発、など

第4章 設備稼働率

  • 稼働率の動向
  • 稼働率:CMO vs.バイオ医薬品開発業者
  • 稼働率:米国 vs. 西欧のメーカー
  • 現在の総合生産能力、など

第5章 現在・将来の生産能力制約

  • 現在の生産能力制約
  • 将来の生産能力制約
  • 将来の生産能力に影響を与える要因
  • 将来の生産能力制約を避けるための主要分野
  • 考察

第6章 将来の生産能力拡大

  • 将来の生産能力拡大計画

第7章 バイオ医薬品製造のアウトソーシング動向

  • 現在のアウトソーシング:生産システム別
  • 将来のアウトソーシング
  • バイオ医薬品製造におけるアウトソーシング活動
  • アウトソーシングの重大問題
  • CMOの問題
  • バイオ医薬品製造の国際アウトソーシング (オフショアリング) における国の選択
  • オフショアリングの動向
  • CMO選択のアウトソーシングとオフショアリングの考察

第8章 バイオ医薬品製造におけるディスポーザブルと単回使用システム

  • ディスポーザブルと単回使用システムの利用
  • L&E
  • ディスポーザブルと単回使用システムの利用が増える理由
  • ディスポーザブルの利用を制限する要因
  • サプライヤーの基準設定機関への期待、など

第9章 下流の精製

  • 生産能力に対する下流プロセスの影響
  • 特定の精製ステップの制約
  • 下流の精製問題
  • mAbの精製能力の推定
  • 新しい下流プロセス技術、など

第10章 バイオ医薬品製造における品質問題、バッチ不良、PAT

第11章 バイオ医薬品製造における雇用、雇用成長、トレーニング

第12章 連続バイオプロセッシング

第13章 バイオ医薬品製造・ライフサイエンスに対するサプライヤー

目次
Product Code: 978-1-934106-36-5

The 2019 16th 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 report's 485 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

  • In-depth analysis of key data, capacity, production trends, and benchmarks
  • Budget trends and impact of current economic environment
  • 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 2025
  • Range of titers, 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
  • Much more...

Table of Contents

METHODOLOGY

CHAPTER 0: DEMOGRAPHICS

  • Introduction
    • 0-1. Respondents' Area of Involvement
    • 0-2. Respondents Qualifi cations
    • 0-3. Facility Locations
    • 0-4. Areas of Biopharmaceutical Manufacturing Operations
    • 0-5. Production Operations, Phase of Development
    • 0-6. Employees at Facility
    • 0-7. Batches Run at Facility per Year
    • 0-8. Single-Use Bioreactor Capacity In Use at Site
    • 0-9. Stainless Steel Bioreactor Capacity In Use at Site

CHAPTER 1: INTRODUCTION AND DISCUSSION

  • 1-1. Introduction: The Pharmaceutical and Biopharmaceutical Industries
  • 1-2. Current Status and Market Trends
  • 1-3. Market Potential
  • 1-4. Biopharmaceuticals and Biosimilars in the Pipeline
    • FDA Biopharmaceutical Approvals
  • 1-5. 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
  • 1-6. Biopharmaceutical Markets by Product Class
    • Monoclonal antibodies (mAbs) are the Leading Product Classes
  • 1-7. Animal Derived Products and Biopharmaceuticals
  • 1-8. Future Trends in the Biopharmaceutical Industry

CHAPTER 2: FUTURE OF BIOPROCESSING: EXPERTS' PERSPECTIVE

  • 2-1. Worldwide Biopharmaceutical CMO Capacity Analysis
  • 2-2. Rapid Identifi cation of Microbial Contamination
  • 2-3. Suppliers' Contributions to Bioprocessing Advances
  • 2-4. Make vs. Buy (In- vs. Outsourcing): Causes, criteria, and consequences
  • 2-5. Mergers & Acquisitions
  • 2-6. China's Advances in Biopharmaceutical Contract Manufacturing

CHAPTER 3: EMERGING ISSUES IN BIOPHARMACEUTICAL MANUFACTURING

  • 3-1. Industry Trends in 2019
    • Introduction
    • Productivity and Cost Reductions
    • Novel Bioprocessing Systems/Innovations
    • Novel Bioprocessing Systems/Innovations - Biomanufacturers vs. CMOs
  • 3-2. Budget Issues in 2019
    • Budget Change Comparisons
  • 3-3. Operational Changes
  • 3-4. New Bioprocessing Products Development Opportunities in 2019
    • Upstream New Product Areas of Need
    • Downstream New Product Areas of Need
    • Previous Year Areas Include:
    • Other General New Product Areas of Need
    • Innovations in Single-use/Disposable Equipment
    • Discussion of Needed Single-use Innovations
    • Other Areas for Innovation
    • New Product Development Areas: Biotherapeutic Developers vs. CMOs
    • New Product Development Areas: U.S. vs. Western Europe and 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. Discussion
    • 3-7 Cost-Cutting Actions & Development Timelines
    • Cost-Cutting Changes Specifi c to Outsourcing
  • 3-8. Average Cost per Gram Recombinant Protein
  • 3-9. Assay Development
    • Biomanufacturing Assay Areas Required: Biomanufacturers vs. CMOs
  • 3-10. Cell and Gene Therapy Platforms
    • Cell and Gene Therapy Manufacturing Advancements (2018 data)
    • Cell and Gene Therapy Manufacturing Improvements, Systems,
    • Platforms and Infrastructure
  • 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 Desire for Improved Products and Services

CHAPTER 4: CAPACITY UTILIZATION

  • 4-1. Capacity Utilization Trends
    • Capacity Utilization Defi nitions
    • Relevance of Capacity Utilization
    • Capacity Utilization in Biomanufacturing, 2019
    • Capacity Utilization Changes Since 2004
    • Average Growth Rate in Capacity Utilization, 2006-2019
  • 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
    • Cell or Gene Therapy Capacity
  • 4-5. Discussion: Capacity Trends
  • 4-6. Range of Titers with mAb Production
    • Annual mAb Titer Changes, 2008-2019
  • 4-7. Discussion: Capacity and Industry Trends
    • Capacity Utilization

CHAPTER 5: CURRENT AND FUTURE CAPACITY CONSTRAINTS

  • 5-1. Current Capacity Constraints
    • Respondents Experiencing No Capacity Constraints
    • Respondents' Perception of Capacity Constraints, 2004-2019
    • 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 2024
    • Expected Capacity Constraints by 2024: Comparing 2004 to 2019 Data
    • Expected Capacity Constraints by 2024: Biotherapeutic Developers vs. CMOs
    • Expected Capacity Constraints by 2024: U.S. vs. Western Europe
  • 5-3. Factors Impacting Future Production Capacity
    • Factors Creating Future Capacity Constraints
    • Factors Creating Future Capacity Constraints, 2008 - 2019
    • Factors Creating Future Capacity Constraints: Biotherapeutic Developers vs. CMOs
    • CMO 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, 2006-2019
    • Key areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs
    • Key Areas to Address to Avoid Capacity Constraints: U.S. vs. Western Europe
  • 5-5. Discussion
    • Overall Capacity Constraints

CHAPTER 6: FUTURE CAPACITY EXPANSIONS

  • 6-1. Planned Future Capacity Expansions
    • Planned Future Capacity Expansions, 2009-2024
    • Planned Future Capacity Expansions by 2024: CMOs vs. Biotherapeutic Developers
    • Planned Five-Year Capacity Expansion: U.S. vs. Western European Manufacturers
    • Planned Future Capacity Expansions of >100%

CHAPTER 7: OUTSOURCING TRENDS IN BIOPHARMACEUTICAL MANUFACTURING

  • Why Outsource?
  • Relating Outsourcing to Workforce Reduction
  • Strategic Manufacturing Planning
  • Future Projections
  • 7-1. Current Outsourcing by Production System
    • Facilities Currently Outsourcing No Production (All Production “In-house”), 2006-2019
  • 7-2. Future Outsourcing
    • Biotherapeutic Developers' Outsourcing, 5-Year/2024 Projections, by System
    • Biotherapeutic Developers Outsourcing Some Production in 2024
  • 7-3. Outsourced Activities in Biopharmaceutical Manufacturing
    • Comparison of Biomanufacturers' Outsourcing, (2010-2019)
    • Increased Outsourced Activities, 24-month Projections
    • Outsourcing Activities Projected at “Signifi cantly Higher Levels”, Comparison of 2010-2019 Trends
    • Average Percentage of Activities Outsourced Today
    • Comparison of Outsourcing Activities, 2010-2019
    • Change in Spending on Outsourcing Activities
  • 7-4. Critical Outsourcing Issues
    • Selecting a CMO: (2018 data)
    • Selecting a CMO, 2006-2018
    • Changes in Critical Issues when Considering a CMO, 2006-2018
  • 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
  • 7-7. Offshoring Trends
    • 5-Year Projection for Percentages of Biomanufacturing International Outsourcing/Off-shoring
  • 7-8. Discussion of Outsourcing and Offshoring
    • Selecting a CMO

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: 2006-2019
    • Average Annual Growth Rate for Disposables: Market Penetration/Usage
    • 13-Year Average Growth in Disposable 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, 2018, vs. 2016-2009
  • 8-3. Reasons for Increasing Use of Disposables & Single-Use Systems
    • Single Most Critical Reason for Increasing the Use of Disposables (2018 data)
  • 8-4. Factors That May Restrict Use of Disposables
    • Most Critical Reasons for Restricting Use of Disposables
    • Most Important Reasons for Not Increasing Use of Disposables, 2008-2019
    • Most Important Reasons for Restricting Use of Disposables: Biotherapeutic Developers vs. CMOs
    • Top Reasons for Not Increasing the Use of Disposables: U.S. vs. Western Europe
  • 8-5. Suppliers' Expectations for Standards Setting Bodies
  • 8-6. Need for Single-use Sensors, and Bioreactor Attributes
    • Single-Use Adoption Issues (2018 data)
    • Single-use Adoption Factors, U.S. vs. Western Europe (2018 data)
    • Single-Use Sensor Technologies (2012-2017, 2019) Data
  • 8-7. Satisfaction with Single-Use Device Vendors
    • Single-Use Attribute Importance Analysis
    • Single-Use Suppliers' Delivery Problems, 2013-2019
  • 8-8. Single Use Operations and Trends
    • Percentage of Unit Operations that Are Single-Use
    • Distribution of Responses
  • 8-9. Discussion of Single-use Bioprocessing
    • Single-use Advantages
    • Growth in the Use of Single-use Systems
    • Downstream Single-use Systems Usage
    • 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

CHAPTER 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. Specifi c Purifi cation Step Constraints
    • Changes in Impact on Capacity of Purifi cation Steps, 2008-2019
    • Specifi c Purifi cation Step Constraints, U.S. vs. Western European Biomanufacturers
  • 9-3. Downstream Purifi cation Issues
    • Protein A and Alternatives (2017 data)
    • Changes in Perception of Protein A and Alternatives
    • Protein A Downstream Purifi cation Issues, U.S. vs. Western Europe (2017 data)
  • 9-4. mAb Purifi cation Capacity Estimates
    • Upstream Production Titer vs. Max Capacity
  • 9-5. New Downstream Processing Technologies
    • New Downstream Processing Solutions; 2010 - 2019
    • 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
    • Upstream Expression Titer Trends and Impact on Downstream Operations
    • Downstream Processing Solutions

CHAPTER 10: QUALITY ISSUES, BATCH FAILURES, AND PAT IN BIOPHARMACEUTICAL MANUFACTURING

  • 10-1. Quality Initiative Implementation
    • Comparison of Quality Initiative Implementation, 2009 - 2018
    • Quality Initiatives Are Becoming Commonplace and the New Industry Norm
    • Challenges to Implementing PAT, QbD and other Quality Initiatives
  • 10-2. Hurdles to Implementing Process Analytical Technology
    • Trends in PAT, 2008-2019
    • PAT Adoption Will Increase
  • 10-3. Batch Failure Frequency in Biopharmaceutical Manufacturing
  • 10-4. Primary Cause of Batch Failures, Percentages of Failures
    • Quality Problems Traced to Vendors
    • Process Information Needs and Value Drive Automation
  • 10-5. Quality Problems in BioManufacturing Attributed to Vendors
  • 10-6. Discussion
    • Supply Management Issues with Single-Use Systems

CHAPTER 11: HIRING, EMPLOYMENT GROWTH, AND TRAINING IN BIOPHARMACEUTICAL MANUFACTURING

  • Introduction
  • No Substitute for on-the-job Training
  • 11-1. Hiring Trends
    • Trends in New Hires, by Area; 2008 - 2019
  • 11-2. Hiring in 2024: 5-year Trends
  • 11-3. Hiring Challenges Today
    • Hiring Diffi culties; 2010 - 2019
  • 11-4. Training in Biopharmaceutical Manufacturing
    • Changes in Training for New Manufacturing Employees, 2009-2018
  • 11-5. Discussion
    • Options Developing for Bioprocessing Training
    • Continued Growth in Biopharmaceutical Manufacturing Jobs

CHAPTER 12: CONTINUOUS BIOPROCESSING

  • Introduction
  • Adoption of Continuous Bioprocessing
  • Implementation of Continuous Bioprocessing
  • Continuous Processing - Present and Future Challenges
  • Continuous Bioprocess and Process Intensifi cation
  • 12-1. Perfusion Operations and Continuous Bioprocessing Operations Issues Perfusion vs. Batch Fed Bioprocessing (2018 data)
  • 12-2. Perfusion Operations and Continuous Bioprocessing Trends
  • 12-3. Discussion
    • Continuous Bioprocessing: Trends and Opportunities
    • Perfusion: Progress in Adoption

CHAPTER 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 - 2019
    • 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 2018
    • Vendor Average Budget Changes for 2009 -2018
    • Vendor Pricing Changes
    • Past Year and Expected Price Changes (2009-2019)
    • 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 - 2019
  • 13-8. New Technology Areas in Development by Vendors
    • Suppliers' Development of Innovative Technologies
    • Suppliers' R&D Spending/Budgets for New Products/Services
  • 13-9. Sales Staff Training
    • Days of Training Provided by Suppliers
    • Areas where Training May Help Sales Staff Perform, Trends 2010 - 2019
    • Clients' Demands on Vendors
  • 13-10. Biopharma Vendors' Financial Outlook for 2019
  • 13-11. CMO Pricing Changes for Biopharmaceutical Services
  • 13-12. Discussion of Biopharma Suppliers
    • Bioprocessing Vendors Will See Continued Market Growth
    • Single-use Systems Continue to Drive Sales
    • Trends Favor Increased Vendor Sales
    • Vendors are Offering More Services, Going for Larger Sales
    • Biopharma Suppliers in Emerging Regions

FIGURE

  • Fig 0.1: Area of Primary Involvement in Biopharmaceutical Manufacturing, 2010 to 2019
  • Fig 0.2: Respondents' Job Responsibilities, 2011 -- 2019
  • Fig 0.3: Facility Location
  • Fig 0.4: Facility Location, by Region
  • Fig 0.5: Biopharmaceutical Manufacturing Systems, (2007-2019) Trends
  • Fig 0.6: Phase of Development of Surveyed Respondents, 2006-2019
  • 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 0.10: Distribution of Largest SINGLE-USE Bioreactor Capacity
  • Fig 0.11: Distribution of Largest STAINLESS Bioreactor Capacity
  • Fig 1.1: U.S. Biosimilars Launchable Dates 2012-2014 by Current Cumulative Reference Product Sales ($Millions)
  • Fig 1.2: U.S. Biosimilars Launchable Dates 2012-2014 by Current Cumulative Reference Product Sales ($Millions)
  • Fig 1.3: Number of FDA Approvals of New Biopharmaceutical Products 1982-2018
  • Fig 2.1: Total CMO Facilities and Capacity by Bioprocessing Capacity Scales
  • Fig 2.2: Distribution of All and CMO Facilities by Facility Capacity Ranges
  • Fig 2.3: The 10-C criteria for make-or-buy decisions
  • Fig 2.4: A scenario-based approach
  • Fig 2.5: A make-or-buy decision tree
  • Fig 2.6: Integration of services in the CDMO value chain
  • Fig 3.1: SINGLE most important biomanufacturing trend or operational area, 2014-2019
  • Fig 3.2: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months
  • Fig 3.3: Novel Bioprocessing Systems/Innovations to Evaluate in Next 12 Months (Biomanufacturers vs. CMOs)
  • Fig 3.4: Biomanufacturers' Budget Shifts in 2019
  • Fig 3.5: Approximate Average Change in Biomanufacturers' Budgets for 2019
  • Fig 3.6: Average Biomanufacturers' Budget Change, 2009-2019
  • Fig 3.7: New Product Development-Upstream Focus Areas
  • Fig 3.8: Upstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts (2010-2019)
  • Fig 3.9: Downstream New Product Development Areas Cited Where Suppliers Should Focus Development Efforts, 2019
  • Fig 3.10: New Product Development-Downstream Focus Areas (2010-2019)
  • Fig 3.11: New Product Development -- General Focus Areas, Biomanufacturers & CMOs, 2019
  • Fig 3.12: New Product Development -- General Focus Areas, 2010-2019
  • Fig 3.13: Top 10 New Product Development Areas of Interest: Biomanufacturers vs CMOs
  • Fig 3.14: Top 10 New Product Development Areas of Interest: U.S. vs. Western Europe and ROW
  • Fig 3.15: Cost-Cutting Changes: Actions Undertaken During "Past 12 Months" Comparing 2011-2016, 2019
  • Fig 3.16: Cost-Cutting Changes, Outsourced Jobs, by Segment, and Geography (2011-2016, 2019)
  • Fig 3.17: Distribution, Average Cost per Gram for PRIMARY Recombinant Protein, 2019
  • Fig 3.18: Biomanufacturing Assay "Areas" Urgently Requiring New, Improved Testing Methods, 2011 -2015, 2018-2019
  • Fig 3.19: Biomanufacturing Assay "Areas" Urgently Requiring New, Improved Testing Methods; Biomanufacturers vs. CMOs (2019 data)
  • Fig 3.20: Future Cell and Gene Therapy Platforms, 2019
  • Fig 3.21: Cell and Gene Therapy Manufacturing Advancements in 5 Years (2023) to Avoid Bottlenecks
  • Fig 3.22: Most Needed Cell & Gene Therapy Manufacturing Improvements, Systems, Platforms and Infrastructure
  • Fig 3.23: Likelihood of Implementing Bioreactor, by Type, 2017
  • Fig 3.24: Likelihood of Implementing Single-use Bioreactors, Clinical Scale, 2012-2017
  • Fig 4.1: Capacity Utilization, By System
  • Fig 4.2: Capacity Utilization, By System, 2004-2019
  • Fig 4.3: Change in Capacity Utilization, CAGR, 2006-2019
  • Fig 4.4: Capacity Utilization, By System, Biotherapeutic Developer vs. CMOs, 2019
  • Fig 4.5: Capacity Utilization, By System, U.S. vs. Western Europe, 2019
  • Fig 4.6: Current Production Capacity Distribution, Mammalian Cell Culture
  • Fig 4.7: Production Capacity Distribution, Mammalian Cell Culture, 2011-2019
  • Fig 4.8: Bioprocessing Concentration, Capacity Data, 2019
  • Fig 4.9: Current Production Capacity Distribution, Microbial Fermentation
  • Fig 4.10: Current Production Capacity Distribution, Cell or Gene Therapy
  • Fig 4.11: Range of Titers for mAbs Obtained at Various Production Scales, 2019 Distribution
  • Fig 4.12: Average mAb Titer Trend 2008-2019
  • Fig 5.1: Capacity Constraints, by Stage of Production
  • Fig 5.2: Capacity Constraints, 2004 -2019
  • Fig 5.3: Capacity Constraints Trends, 2004-2019
  • Fig 5.4: Capacity Constraints, Biotherapeutic Developers vs. CMOs
  • Fig 5.5: Capacity Constraints, U.S. 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 2004-2019
  • Fig 5.8: Expectations of Capacity Constraints: Five-year Projections Made in 2004 thru 2024 (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 in Five Years
  • Fig 5.12A: Factors Creating Future Capacity Constraints, 2008-2019
  • Fig 5.12B: Factors Creating Future Capacity Constraints, 2008-2018
  • 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 5.16A: Key Areas to Address to Avoid Capacity Constraints; 2006-2019
  • Fig 5.16B: Key areas to Address to Avoid Capacity Constraints; 2006-2019
  • 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 2024
  • Fig 6.2: Planned Future Capacity Expansion: Five-Year Estimates, 2009--2024
  • Fig 6.3: Planned Future Capacity Expansion: Five-year Estimates: Biotherapeutic Developers vs. CMOs
  • Fig 6.4: Planned Future Capacity Expansion: Five-Year Estimates: U.S. vs. Western Europe
  • Fig 6.5: Percentage of Respondents Projecting Production Increases over 100% by 2024: Five-year Trend
  • Fig 7.1: Current Percent Production Outsourced; by System
  • Fig 7.2: Biopharmaceutical Manufacturing Facilities Outsourcing NO Production, 2006-2019
  • Fig 7.3: Future Outsourcing: Percent Production Outsourced; by 2024, by System
  • Fig 7.4: Five-year Projections: % Biotherapeutic Developers Planning to Outsource at Least Some Production; Projections made 2007-2019
  • Fig 7.5: Percent of Biomanufacturers Outsourcing at Least Some Activity Today
  • Fig 7.6A: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 -- 2019
  • Fig 7.6B: Percent of Biomanufacturers Outsourcing at Least Some Activity Today, 2010 -- 2019
  • Fig 7.7: Outsourcing Activities Projected to be Done at "Signifi cantly Higher Levels" in 2 Years
  • Fig 7.8A: Outsourcing Activities Projected to be Done at "Signifi cantly Higher Levels" in 2 Years, 2010 - 2019 Trends
  • Fig 7.8B: Outsourcing Activities Projected to be Done at "Signifi cantly Higher Levels" in 2 Years, 2010 - 2019 Trends
  • Fig 7.9: Current Outsourcing: Average Percentage of Activity Outsourced Today
  • Fig 7.10A: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2019
  • Fig 7.10B: Estimated Average Percent of Activity Outsourced by Facilities, 2010 thru 2019
  • Fig 7.11: Change in Spending on Outsourcing for R&D or Manufacturing, 2012 - 2019
  • Fig 7.12: Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations
  • Fig 7.13: Important Outsourcing Issues: BioManufacturing by Contract Manufacturing Organizations, Trends 2006-2018
  • Fig 7.14: Important Outsourcing Issues: Response Shifts Over Time 2006-2018, Percentage Point Differences
  • Fig 7.15: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2018
  • Fig 7.16: Most Common Mistakes Biopharmaceutical Sponsors Make with their CMOs, 2010-2013; 2018
  • Fig 7.17: Country Selections as Destination for International Outsourcing of BioManufacturing (All Respondents), in the next fi ve years, 2024
  • Fig 7.18A: Percent U.S. Respondents Considering Country as "Possible" Outsourcing Destination, next fi ve years, 2024
  • Fig 7.18B: Percent U.S. Respondents Considering Country as "Possible" Outsourcing Destination, next fi ve years, 2024
  • Fig 7.19: Percent U.S. Respondents Considering Country as "Strong Likelihood" or "Likelihood" as Outsourced Capacity Destination, next fi ve years, 2024
  • Fig 7.20: Percent Western European Respondents Considering Country as "Possible" Outsourcing Destination, next fi ve years, 2024
  • Fig 7.21: Percent 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 (2024)
  • Fig 7.23: Percent Biomanufacturers Performing at Least "Some" International Outsourcing/Off-shoring during Next 5 Years (2011-2019)
  • Fig 7.24: Estimated % Operations Done as International Outsourcing/Off-shoring during Next 5 Years (2011-2019)
  • Fig 8.1: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture
  • Fig 8.2A: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2019
  • Fig 8.2B: Usage of Disposables in Biopharmaceutical Manufacturing, Any Stage of R&D or Manufacture: 2006-2019
  • Fig 8.3: Average Annual Growth Rate, Disposables, 2006-2019
  • Fig 8.4: 13-Year Percentage-Point Change in First Usage of Disposables, 2006-2019
  • 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 Developers vs. CMOs
  • Fig 8.7: Willingness to Pay for Useable Leachables and Extractables Data (2018 Data)
  • Fig 8.8: Single Most Critical Reason for Increasing Use of Disposables, 2009 - 2018
  • Fig 8.9: Top Reasons for Not Increasing Use of Disposables, 2019
  • Fig 8.10A: Top Reasons for Not Increasing Use of Disposables, 2008-2019
  • Fig 8.10B: Top Reasons for Not Increasing Use of Disposables, 2008-2019
  • Fig 8.11: Top Reasons for Not Increasing Use of Disposables, Biotherapeutic Developers vs. CMOs
  • Fig 8.12: Top Reasons for Not Increasing Use of Disposables, U.S. vs. Western Europe
  • Fig 8.13: Suppliers' Perception of Organizations Responsible for Establishing Standards for Single-use Devices (2017 data)
  • Fig 8.14: Single-use / Disposable Device Adoption Factors (2018 data)
  • Fig 8.15: Single-use / Disposable Device Adoption Factors; U.S. vs. Western Europe, 2018 data
  • Fig 8.16: Need for Improved Single-Use Sensors, 2012-2017, 2019
  • Fig 8.17: Single-Use Product Vendor Satisfaction Factors, 2008-2019
  • Fig 8.18: Importance of Single-Use Product Attributes vs. Level of Vendor Satisfaction
  • Fig 8.19: Percentage Point Gap between Importance of SUS Product Attributes and Level of Satisfaction, 2013-2019
  • Fig 8.20: Estimated Percentage of Facilities' Unit Operations that Are "Single-Use" (2014 - 2019)
  • Fig 8.21: Distribution of Responses, % Single-Use Devices in Biomanufacturing
  • Fig 9.1: Impact of Downstream Processing on Overall Capacity, 2008-2019
  • 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 -- 2019
  • Fig 9.6: Impact on Capacity of Purifi cation Steps, U.S. vs. Western Europe
  • Fig 9.7: Issues Regarding Protein A Usage (2017 data)
  • Fig 9.8: Issues Regarding Protein A Usage, 2009 - 2017
  • Fig 9.9: Issues Regarding Protein A Usage; U.S. vs. Western Europe
  • Fig 9.10: mAb Operations: Upstream Production Titer (Distribution of Responses, 2014 -2016, 2018-2019 Data)
  • Fig 9.11: Bioreactor Yield at which DOWNSTREAM Purifi cation Train Becomes Bottlenecked
  • Fig 9.12: New Downstream Processing Solutions, 2019
  • Fig 9.13A: New Downstream Processing Solutions Comparison 2010-2019
  • Fig 9.13B: New Downstream Processing Solutions Comparison 2010-2019
  • Fig 9.14: New Downstream Processing Solutions; Biotherapeutic Dev. vs. CMOs
  • Fig 9.15: New Downstream Processing Solutions; U.S. vs. Western Europe
  • Fig 9.16: Improving Downstream Operations, 2011 - 2019
  • 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: Quality Initiative Implemented Currently, or within Next 12 Months (2018 DATA)
  • Fig 10.2: Quality Initiative to be Implemented in "Next 12 Months," Comparing 2009 - 2018
  • Fig 10.3: Hurdles Hindering Implementation of PAT (2008 -- 2019)
  • Fig 10.4: Batch Failure Frequency Distribution, 2009 -- 2019
  • Fig 10.5: Average Rates of Failure, by Primary Cause, and Phase of Manufacture
  • Fig 10.6: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2019 (Commercial Manufacture)
  • Fig 10.7: Average Rates of Failure, by Primary Cause, and Phase of Manufacturing 2009 - 2019 ("Clinical" Scale)
  • Fig 10.8: Quality Problems Traced to Vendors; 2008 -- 2018
  • Fig 11.1: New Hires in Biopharmaceutical Manufacturing (2019)
  • Fig 11.2: Estimated Hiring, by Area, 2008-2019
  • Fig 11.3: New Hires in Biopharmaceutical Manufacturing (2024)
  • 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 -- 2019
  • 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 (2018 data)
  • Fig 11.8: Average Annual Changes in Training for New Operations/Manufacturing Employees, 2009 -- 2018
  • Fig 12.1: Changing the way culture is viewed
  • Fig 12.2: Example of an operational workfl ow diagram for an upstream process
  • Fig 12.3: Triangle of Pharmaceutical Facility Design
  • Fig 12.4: The QbD principles as laid out by ICH Q8 and Q11
  • Fig 12.5: Future of Continuous Bioprocessing and Process Intensifi cation
  • Fig 12.6: Perfusion Operations Issues: Comparison 2010 - 2016 (2016 data)
  • Fig 12.7: Concerns Over Perfusion Processes vs. Batch-fed Processes in Bioprocessing
  • Fig 12.8: Facilities Evaluating CBP Technologies Over Next 12 months (Upstream vs. Downstream), 2016-2019
  • Fig 13.1: Area of Biopharmaceutical Involvement, Vendor
  • Fig 13.2: Area of Biopharmaceutical Involvement, Vendor Comparison 2010 to 2019
  • Fig 13.3: In Which Geographic Regions/Countries Does Your Company Currently Actively Sell, 2008 - 2019
  • Fig 13.4: Respondents' Primary Job Function
  • Fig 13.5: Average Annual Vendor Sales Growth Rate, 2007 - 2019
  • Fig 13.6: Biopharmaceutical Supply Market Segment Sales Growth Distribution
  • Fig 13.7: Average Annual Vendor Segment Sales Growth Rates, 2019
  • Fig 13.8: Average Annual Vendor Sales Growth Rate, 2007 - 2019, by Segment
  • Fig 13.9: Vendors' Approx. Annual Sales to Biopharmaceutical Segment %, 2012-2019 TABLES
  • Fig 13.10: Vendors' Average Budget Change, 2019
  • Fig 13.11: Vendors' Average Budget Change for 2009 - 2019, Summary
  • Fig 13.12: Vendors' Average Pricing Changes
  • Fig 13.13: Vendors' Average Pricing Changes, 2009-2018 Actual and 2019 projected
  • Fig 13.14: Actions undertaken to reduce overall costs, prior 12 months, 2011-2017
  • Fig 13.15: Actions undertaken to reduce overall costs in past 12 months, By Segment (2017 data)
  • Fig 13.16: (See Fig 10.8; recap): Quality Problems Traced to Vendors (2008-2018)
  • Fig 13.17: Biopharma Business and Marketing Plans, 2019
  • Fig 13.18: Biopharma Business and Marketing Plans, 2010-2019
  • 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: Plans for Launching Signifi cant, Truly Novel Bioprocessing Advances (2017 data)
  • Fig 13.21: R&D Spending/Budgets for New Products/Services, 2019
  • Fig 13.22: Areas Where Training is Considered as Needed; 2010 -- 2019
  • Fig 13.23: Client Demands of Vendors, Service and Support, 2012 - 2019
  • Fig 13.24: Vendors Views of Financial (Sales) Outlook for Next Year, 2011-2019
  • Fig 13.25: Average CMOs Service Price Shifts in 2019
  • Fig 13.26: CMOs Service Price Shifts in 2019, Distribution

TABLE

  • Table 0.1: Areas of Biopharmaceutical Manufacturing Operations
  • Table 1.1: Recently Announced CMO SUS-based Commercial Scale Expansions & New Facilities
  • Table 1.2: FDA Biopharmaceutical Approvals, 2018
  • Table 1.3: Number of Biopharmaceutical Products in U.S. and European Markets*
  • Table 1.4: Summary of Worldwide Biopharmaceutical Revenue Growth by Product Class, 2007 and 2018
  • Table 2.1: Total and CMO Facilities Bioprocessing Capacity Scales
  • Table 2.2: Regional Distribution of Bioprocessing and CMO Facilities, Total & Average Capacity
  • Table 2.3: Major US W. European Bioprocessing CMOs, # Facilities and Estimated Capacity*
  • Table 2.4: Some Recently Announced CMO SUS-based Commercial Scale Expansions & New Facilities
  • Table 2.5: Constructs and Contracts for Manufacturing
  • Table 2.6: Recent M&A activities
  • Table 2.7: Service offerings and value chains of selected CDMOs
  • Table 3.1: Areas of Signifi cant Projected Budget Percentage Increases for Biomanufacturing, 2019 and Past Years
  • Table 4.1: Western European Biomanufacturers' Average Capacity Utilization
  • Table 4.2: U.S. Biomanufacturers' Average Capacity Utilization
  • Table 4.3: Leading Biopharma Company Capacity
  • Table 4.4: Compound Annual Change in Mab Titer, 2008-2019
  • Table 5.1: Severe or Signifi cant Capacity Constraints, by Stage of Production, 2009-2019
  • Table 5.2: Severe and Signifi cant Capacity Constraints Today, U.S. vs. W. Europe, 2010-2019
  • Table 6.1: Western European Biomanufacturers' Five-Year Projected Increases
  • Table 6.2: U.S. Biomanufacturers' Five-Year Projected Increases
  • Table 7.1: Respondents Reporting No Outsourced Production (i.e., all in-house manufacturing), 2009-2019
  • Table 7.2: Respondents Outsourcing up to 50% of Production, Mammalian and Microbial Systems, 2009-2019
  • Table 7.3: Respondents Outsourcing Over 50% of Production, Mammalian and Microbial Cell Systems, 2009-2019
  • Table 7.4: Plant and Insect Cells, 2015-2019
  • Table 7.5: Percent of U.S.-based Respondents Indicating Country as a "Strong Likelihood" or "Likelihood" as Outsourcing Destination, 2009-2019
  • Table 7.6: Percent of European-based Respondents Indicating Country as a "Strong Likelihood" or "Likelihood" as Outsourcing Destination, 2011-2019
  • Table 9.1: Percent experiencing "Serious" or "Some" capacity problems due to downstream processing 2008-2019
  • Table 9.2: Percent U.S. vs. Western Europe facilities experiencing "Serious" capacity problems due to downstream processing, 2009-2019
  • Table 9.3: Percent U.S. vs. Western Europe facilities not expecting to see bottlenecks due to downstream processing, 2008-2018
  • Table 9.4: Upstream Production Titer vs. Max Capacity, 2019 Data
  • Table 13.1: Selected "Other" New Technology Areas in Development
  • Table 13.2: Average Vendor Sales and Technical Training Days, 2011 -- 2013, 2019
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