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市場調査レポート

バイオ医薬品受託製造 (2017年):市場および製造能力の拡大と技術革新

Biopharmaceutical Contract Manufacturing 2017: Growing Markets, Capacities and Innovations

発行 HighTech Business Decisions 商品コード 224990
出版日 ページ情報 英文 900 Pages; 250+ Charts & Tables
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=110.37円で換算しております。
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バイオ医薬品受託製造 (2017年):市場および製造能力の拡大と技術革新 Biopharmaceutical Contract Manufacturing 2017: Growing Markets, Capacities and Innovations
出版日: 2017年05月31日 ページ情報: 英文 900 Pages; 250+ Charts & Tables
概要

当レポートでは、バイオ医薬品受託製造の市場を調査し、バイオ医薬品製造の委託企業 (顧客) の各種タイプ、バイオ医薬品製造のニーズ、バイオ医薬品製造の戦略、委託先業者の選定基準、アウトソーシング支出額、バイオ医薬品受託製造業者の各種タイプ、提供可能な技術・サービス、製造能力、バイオ医薬品受託製造の市場規模と成長の見通しなどをまとめています。

第1章 エグゼクティブサマリー

  • イントロダクション
  • 市場概要
  • 顧客のニーズ:サマリー
  • 受託業者の能力:サマリー

第2章 調査方法・定義・略語

第3章 市場概要

  • イントロダクション
  • サプライヤー:バイオ医薬品受託製造業者
    • バイオ医薬品受託製造業者のタイプ
    • 主なバイオ医薬品受託製造業者
    • 産業の組織的変化
    • 技術とサービス
    • バイオ医薬品受託製造業者のキャパシティ
    • 受託業者の収益
  • 顧客:医薬品・バイオテクノロジー企業
    • バイオ医薬品製造のアウトソーシング
    • 利用受託業者の例:クライアント企業別
    • 顧客による将来のアウトソーシング見通し
    • 社内能力の拡張
    • アウトソースの要件
  • 産業推進因子
    • 需要と供給
  • 市場規模
    • 市場規模推計:受託業者収益
    • 市場規模:技術・サービスカテゴリー別
  • 市場成長予測
  • バイオ医薬品受託製造市場の動向
    • 産業における機会と課題
    • 産業の総合的動向

第4章 医薬品・バイオテクノロジー企業:クライアント分析

  • イントロダクション
  • バイオ医薬品製造のニーズ
  • バイオ医薬品製造の戦略
  • バイオ医薬品製造のアウトソーシング
  • バイオ医薬品製造技術
  • 受託業者の選定
  • 受託業者との関係
  • アウトソーシングの支出額
  • 将来の動向・予測

第5章 バイオ医薬品受託製造業者

  • イントロダクション
  • 提供技術・能力
  • 製造技術
  • マーケティング
  • カスタマーリレーションズ
  • 業界と将来動向

付録

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目次

This 900-page report provides the latest information about the supply and demand for the outsource production of large-molecule drug substance. This report analyzes the biotechnology industry's biomanufacturing strategies, budgets, contractor relationships and new projects. This report also provides detailed analyses of typical batch sizes and product requirements by major production technology for both clinical and commercial production. In addition, this report highlights CMO capacity, current and projected utilization rates, and the use of proprietary expression systems. The data and the analysis in this report are based on 64 in-depth interviews conducted by Ph.D.-level analysts with both executives at biopharmaceutical and contractor companies worldwide. The analyses of their perspectives and insights allow readers to gain an understanding of the market and its future direction. This report includes over 250 summary data tables and charts, and is the most comprehensive and current industry report on biopharmaceutical contract manufacturing.

Table of Contents

Chapter 1: EXECUTIVE SUMMARY

  • 1.1 Introduction
  • 1.2 Market Overview
    • 1.2.1 Introduction
    • 1.2.2 Industry Drivers
    • 1.2.3 Market Size
  • 1.3 Summary of Customer Needs
    • 1.3.1 Products
    • 1.3.2 Outsourcing Budgets
    • 1.3.3 Change in CMO Pricing
    • 1.3.4 CMO Response to Capacity Shortfall
    • 1.3.5 Industry Trends and Observations
  • 1.4 Summary of Contractors' Capabilities
    • 1.4.1 Annual Revenue Ranges
    • 1.4.2 Technology Capabilities
    • 1.4.3 Capacity
    • 1.4.4 Expectations for the Future of the Industry

Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS

  • 2.1 Research Objectives
  • 2.2 Research Methodology
  • 2.3 Definition of Biopharmaceutical Manufacturing
  • 2.4 Box-and-Whiskers Plot Definition
  • 2.5 Acronyms

Chapter 3: BIOPHARMACEUTICAL CONTRACT MANUFACTURING: MARKET OVERVIEW

  • 3.1 Introduction
  • 3.2 Suppliers: The Contract Biomanufacturers
    • 3.2.1 Types of Contract Biomanufacturing Companies
    • 3.2.2 Major Players: Contract Biomanufacturing Companies
    • 3.2.3 Organizational Changes in the Industry
    • 3.2.4 Technologies and Services
    • 3.2.5 Contract Biomanufacturers' Capacities
    • 3.2.6 Contractor Revenues
  • 3.3 The Customers: Pharmaceutical and Biotechnology Companies
    • 3.3.1 Respondents' Biopharmaceuticals by Phase
    • 3.3.2 Outsourced Biomanufacturing
    • 3.3.3 Examples of Contractors Used by Client Companies
    • 3.3.4 Customers' Future Outsourcing Expectations
    • 3.3.5 In-House Capacity Expansion
    • 3.3.6 Outsource Requirements
  • 3.4 Industry Drivers
    • 3.4.1 Supply and Demand
  • 3.5 Market Size
    • 3.5.1 Estimates of Market Size Based on Contractor Revenues
    • 3.5.2 Market Size by Technology and Service Categories
  • 3.6 Market Growth Forecasts
  • 3.7 Trends in the Biopharmaceutical Contract Mfg. Market
    • 3.7.1 Industry Opportunities and Challenges
    • 3.7.2 Overall Industry Trends

Chapter 4: PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES: CLIENT ANALYSIS

  • 4.1 Introduction
    • 4.1.1 Study Participants
    • 4.1.2 Respondents' Titles and Experience
    • 4.1.3 Locations and Sites
    • 4.1.4 Respondents' Biopharmaceutical Products on the Market
    • 4.1.5 Respondents' Preclinical Products
    • 4.1.6 Respondents' Clinical and Commercial Products
    • 4.1.7 Respondents' Outsourced Products
  • 4.2 Biomanufacturing Needs
    • 4.2.1 Current and Forecasted Tank Size Requirements
    • 4.2.2 Number of Outsourced Batches
    • 4.2.3 Current and Forecasted Outsourced Demand
    • 4.2.4 Future Production Technology Requirements
    • 4.2.5 New Molecules Entering Clinical Pipeline
  • 4.3 Biomanufacturing Strategies
    • 4.3.1 Outsource versus In-House Decision
    • 4.3.2 Deviation from Outsourcing Strategy
    • 4.3.3 When Decision is Made to Expand Internal Capacity
    • 4.3.4 Estimate of Future Outsourcing Requirements
  • 4.4 Outsourcing Biomanufacturing
    • 4.4.1 Outsourcing vs. In-House Manufacturing Spending
    • 4.4.2 Current and Anticipated Needs for Outsourced Services
    • 4.4.3 Change in CMO Pricing
    • 4.4.4 External Funding
    • 4.4.5 CMO Response to Capacity Shortfall
    • 4.4.6 China Market Strategy
    • 4.4.7 Use of China CMO for Export Purposes
    • 4.4.8 New Services Sought in a Contractor
    • 4.4.9 Companion Diagnostics
  • 4.5 Manufacturing Technologies
    • 4.5.1 Current Expression Levels
    • 4.5.2 Projects Requiring Continuous Manufacturing
    • 4.5.3 Molecules Requiring Continuous Manufacturing
    • 4.5.4 Range of Bioreactor Scale
    • 4.5.5 Biggest Challenges to Innovative Biomanufacturing
    • 4.5.6 New Technologies for Complex Molecules
  • 4.6 Contractor Selection
    • 4.6.1 Essential Characteristics Sought in a Contractor
    • 4.6.2 Commercial-Phase CMO Differentiation
    • 4.6.3 Change in Commercial-Phase CMO Differentiation
    • 4.6.4 Clinical-Phase CMO Differentiation
    • 4.6.5 Consideration of CMO New in the Industry
    • 4.6.6 Importance for Services to be Co-Located
    • 4.6.7 Services Difficult to Find
  • 4.7 Contractor Relationships
    • 4.7.1 Favorite Contractors
    • 4.7.2 Top CMOs for Operational Excellence, Price and Overall Reputation
    • 4.7.3 Number of CMOs Utilized
  • 4.8 Outsource Spending
    • 4.8.1 Outsourcing Budgets
    • 4.8.2 Outsourcing Budgets by Technology
    • 4.8.3 Outsourcing Budgets by Service
  • 4.9 Future Trends and Expectations
    • 4.9.1 Microbial Fermentation Trends
    • 4.9.2 Challenges for Biomanufacturing
    • 4.9.3 Long-Term Industry and Market Trends
    • 4.9.4 Future of Biopharmaceutical Contract Manufacturing

Chapter 5: BIOPHARMACEUTICAL CONTRACT MANUFACTURERS

  • 5.1 Introduction
    • 5.1.1 Study Participants
    • 5.1.2 Types of Suppliers
    • 5.1.3 Locations
    • 5.1.4 Regulatory Inspections and Status
    • 5.1.5 Acquisitions and Organizational Changes
    • 5.1.6 Revenues
  • 5.2 Technologies and Capacities Offered
    • 5.2.1 Number of cGMP Phase III and Commercial Products
    • 5.2.2 Production Technologies
    • 5.2.3 Business Mix by Service Category
    • 5.2.4 Contract Manufacturers' Current Capacities
    • 5.2.5 Contract Manufacturers' Expansion Plans
  • 5.3 Manufacturing Technologies
    • 5.3.1 Expression Yields and Batch Success Rates
    • 5.3.2 Number of Batches Run per Tank
    • 5.3.3 Investment in Technology Over Past Five Years
    • 5.3.4 Investment Plans: Next Five Years
    • 5.3.5 Expression Technologies for Non-Standard Format Antibodies
    • 5.3.6 Production Scale
    • 5.3.7 Single-Use Capacity Mix
    • 5.3.8 Importance of Drug Substance and Drug Product Capability
    • 5.3.9 Biosimilar Projects
    • 5.3.10 Biosimilar Strategy
  • 5.4 Marketing
    • 5.4.1 Request-for-Proposals Received
    • 5.4.2 Request-for-Proposals Requiring Single-Use vs. Stainless Steel Bioreactors
    • 5.4.3 Request-for-Proposals Outside Standard Platform
    • 5.4.4 Request-for-Proposals Leading to Contract
    • 5.4.5 Revenue Spent on Research and Development
    • 5.4.6 Metrics Used to Benchmark Business Performance
    • 5.4.7 How to Measure Customer Satisfaction
  • 5.5 Customer Relationship
    • 5.5.1 Clients Served
    • 5.5.2 Bookings
    • 5.5.3 Offerings to Clients to Help Manage Schedule or Capacity
    • 5.5.4 Differentiation from Other CMOs
    • 5.5.5 Contractor vs. Client Relationship Changes
    • 5.5.6 Characteristics of the Customer Base
    • 5.5.7 Portion of Business by World Regions
  • 5.6 Industry and Future Trends
    • 5.6.1 Observation of Change in Demand for Outsourcing Services
    • 5.6.2 Expectation of Industry Growth
    • 5.6.3 Price Changes for Biopharmaceutical Production
    • 5.6.4 Regulatory Challenges
    • 5.6.5 Changes and Trends for the Future of the Biopharmaceutical Contract Manufacturing Industry

Appendix A: Write-Ups of Interviews with 41 Pharmaceutical and Biotechnology Company BioManufacturing Directors Worldwide, Unnamed and Edited for Confidentiality

Appendix B: Directory of Biopharmaceutical Contract Manufacturers

Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company Respondents

Appendix D: Interview Guide for Biopharmaceutical Contract Manufacturers

LIST OF TABLES

Chapter 1

  • 1.3-1 Observed CMO Response to Capacity Shortfall
  • 1.3-2 Willingness to Accept Implemented CMO Changes
  • 1.3-3 User' Opinions on Future of the Industry
  • 1.4-1 Future Trends Noted by CMO Respondents

Chapter 2

  • 2.2-1 Market Research Steps
  • 2.5-1 List of Acronyms

Chapter 3

  • 3.2-1 CMOs Preferred by Respondents
  • 3.2-2 Examples of Changes or Events in the CMO Industry: Past Two Years
  • 3.2-3 Industry Revenue Mix by Technology Categories
  • 3.2-4 Biopharmaceutical Contract Manufacturing Industry Capacity Estimates
  • 3.2-5 Examples of New Capacity for Biopharmaceutical Contract Manufacturing
  • 3.3-1 Examples of Contract Biomanufacturers and their Client Companies
  • 3.3-2 Examples of Pharmaceutical/Biotechnology Companies Building Capacity
  • 3.3-3 Outsourced Volumes by Technology
  • 3.3-4 Estimates of Needs for Outsourced Volumes for the Worldwide Industry
  • 3.4-1 Outsourced Manufacturing Capacity vs. Needs: Mammalian Cell Culture
  • 3.4-2 Outsourced Manufacturing Capacity vs. Needs: Microbial Fermentation
  • 3.5-1 Worldwide 2016 Market Size for Contract Biomanufacturing: Revenues
  • 3.5-2 2016 Market Size by Technology Category: US$
  • 3.5-3 2016 Market Size by Service Category: US$
  • 3.6-1 Worldwide 2017 Market Size for Contract Biomanufacturing
  • 3.7-1 Major Biopharmaceutical Contract Manufacturing Industry Trends

Chapter 4

  • 4.1-1 Respondent Pharmaceutical and Biotechnology Companies
  • 4.1-2 Respondents' Titles by Segment
  • 4.1-3 Respondent Locations
  • 4.1-4 Respondents' Bulk Biopharmaceutical Manufacturing Sites
  • 4.1-5 Respondents' Fill-and-Finish Biopharmaceutical Manufacturing Sites
  • 4.1-6 Respondents' Preclinical Products
  • 4.1-7 Respondents' Preclinical Products Requiring Outsourcing
  • 4.1-8 Number of Products Produced Using Mammalian Cell Culture
  • 4.1-9 Number of Products Produced Using Microbial Fermentation
  • 4.1-10 Types of Respondents' Products by Production Technology
  • 4.1-11 Outsourced Products by Phase by Year
  • 4.1-12 Number of Products Outsourced by Tank Size Needs in 2017: Mammalian Cell Culture
  • 4.1-13 Number of Products Outsourced by Tank Size Needs in 2017: Microbial Fermentation
  • 4.2-1 Tank Size Distribution for Outsourced Products: Mammalian Cell Culture
  • 4.2-2 Tank Size Distribution for Outsourced Products: Microbial Fermentation
  • 4.2-3 Outsource Batches per Project: Mammalian Cell Culture
  • 4.2-4 Outsource Batches per Project: Microbial Fermentation
  • 4.2-5 Outsource Demand by Phase: Mammalian Cell Culture
  • 4.2-6 Outsource Demand by Phase: Microbial Fermentation
  • 4.2-7 Expected Changes in Technologies Used
  • 4.2-8 Molecule Class Mix Entering Clinical Pipeline
  • 4.3-1 Drivers for Companies Who Outsource 100% GMP Manufacturing
  • 4.3-2 Drivers for Companies Who Outsource Some GMP Manufacturing
  • 4.3-3 Deviation from Outsourcing Strategy
  • 4.3-4 Decision Points to Add Internal Capacity
  • 4.3-5 Considerations for Estimating Future Outsourcing Requirements
  • 4.3-6 Future Outsourcing Trends
  • 4.4-1 Spending Mix by Production Source and Technology
  • 4.4-2 Services Currently Outsourced
  • 4.4-3 Services To Be Outsourced
  • 4.4-4 No Plans to Outsource Services
  • 4.4-5 Change in Outsourced Service by Number of Products
  • 4.4-6 Reasons for Pricing Change for CMO Biopharmaceutical Services
  • 4.4-7 External Funding Observations
  • 4.4-8 Observed CMO Response to Capacity Shortfall
  • 4.4-9 Willingness to Accept Implemented CMO Changes
  • 4.4-10 China Market Strategy and Drivers
  • 4.4-11 Considerations for Use of Chinese CMO for Export Purposes
  • 4.4-12 New CMO Services Sought
  • 4.4-13 Companion Diagnostics by Segment
  • 4.5-1 Expression Levels Reported by Respondents in Grams per Liter
  • 4.5-2 Expression Levels Reported for Mammalian mAb Products
  • 4.5-3 Summary of Comments Related to the Use of Continuous Manufacturing
  • 4.5-4 Required Bioreactor Scales in Liters
  • 4.5-5 Innovative Biomanufacturing: Challenges and Actions
  • 4.5-6 Development of Manufacturing Technologies for Complex Molecules
  • 4.6-1 Essential Characteristics for Choosing a CMO
  • 4.6-2 Weighted Characteristics by Respondent Segment
  • 4.6-3 Main Differentiators Among Commercial-Phase CMOs
  • 4.6-4 Observations Regarding Contract Manufacturing Industry Changes
  • 4.6-5 Main Differentiators Among Clinical-Phase CMOs
  • 4.6-6 Criteria for Using a New CMO without Manufacturing History
  • 4.6-7 Reasons for Importance Rating of Service Co-Location
  • 4.6-8 Services Difficult to Find
  • 4.7-1 Contract Manufacturers Preferred by Respondents
  • 4.7-2 Top CMOs for Operational Excellence, Price and Overall Reputation
  • 4.7-3 Reasons for Change in Number of CMOs Utilized
  • 4.8-1 Expenditures on Outsourcing of Biopharmaceutical Production
  • 4.8-2 Spending Mix by Technology: 2017 and 2019
  • 4.8-3 Weighted Averages: Outsourcing Budget by Services in 2017
  • 4.8-4 Weighted Averages: Outsourcing Budget by Services in 2019
  • 4.9-1 Microbial Fermentation Trends
  • 4.9-2 Capacity Constraints and Challenges
  • 4.9-3 Near-Term Challenges for the Biopharmaceutical Manufacturing Industry
  • 4.9-4 Future Trends in Biopharmaceutical Manufacturing
  • 4.9-5 Future Expectations of the Biopharmaceutical Manufacturing Industry

Chapter 5

  • 5.1-1 Respondents from Companies Offering Contract Biomanufacturing Services
  • 5.1-2 Types of Biopharmaceutical Contract Manufacturing Organizations
  • 5.1-3 Contract Biomanufacturers: Headquarter Locations
  • 5.1-4 Examples of Company Changes in Contract Biomanufacturing
  • 5.1-5 Organization Changes Over Last Two Years
  • 5.1-6 Contract Biomanufacturers' Revenue in 2016 (US$)
  • 5.2-1 Phase III and Commercial cGMP Products Manufactured
  • 5.2-2 Business Mix by Production Technology and Year
  • 5.2-3 Business Mix by Production Technology and Respondent Segment: 2017
  • 5.2-4 Business Mix by Service and Production Category and Year
  • 5.2-5 Business Mix by Service and Production Category by Respondent Segment
  • 5.2-6 Mammalian Cell Culture Capacity at 17 Respondents' Facilities in 2017
  • 5.2-7 Microbial Fermentation Capacity at 14 Respondents' Facilities in 2017
  • 5.2-8 New Capacity Expected: 2017 to 2022
  • 5.3-1 Contractor Yields and Success Rates
  • 5.3-2 Number of Batches Run per Tank
  • 5.3-3 Investment in Technology Over Past Five Years
  • 5.3-4 Investment in New Technology
  • 5.3-5 Expected Bioreactor Scale in Demand
  • 5.3-6 Percentage of Single-Use Technologies at Respondent Sites
  • 5.3-7 Advantage of Drug Substance and Drug Product Capability
  • 5.3-8 Biosimilar Strategies
  • 5.4-1 Number of RFPs Received per Month
  • 5.4-2 Percent of RFPs Split by Stage of Project
  • 5.4-3 Percent of RFPs Split by Bioreactor Type
  • 5.4-4 RFPs Received Not Within Standard Platform
  • 5.4-5 RFP Success Rate
  • 5.4-6 Areas of Investment
  • 5.4-7 Benchmarking Metrics
  • 5.4-8 How Customer Satisfaction is Measured
  • 5.5-1 Number of Clients in 2016
  • 5.5-2 Offerings to Clients to Manage Schedule
  • 5.5-3 Factors CMOs' Clients Use to Differentiate Them
  • 5.5-4 Observed Contractor and Client Relationship Changes
  • 5.5-5 Business Mix by Customer Base by Respondent Segment
  • 5.5-6 Simple and Weighted Business Mix by Customer Base
  • 5.5-7 Types of Customers Served and Number of Products
  • 5.5-8 Average Percentage of International Clients
  • 5.5-9 Business Mix by World Region by Respondent Segment
  • 5.5-10 Simple and Weighted Business Mix by World Region
  • 5.6-1 Observations for Demand Increase Over Last 12 Months
  • 5.6-2 Average Expectations of Growth: Next Twelve Months
  • 5.6-3 Average Expectations of Growth: Next Three Years
  • 5.6-4 Areas Impacted by Price Pressures
  • 5.6-5 Regulatory Challenges
  • 5.6-6 Industry Prospects and Trends Noted by Contractor Respondents

LIST OF FIGURES

Chapter 1

  • 1.2-A Outsourcing Demand vs. Contract Biomanufacturers' Capacity: Mammalian
  • 1.2-B Outsourcing Demand vs. Contract Biomanufacturers' Capacity: Microbial
  • 1.2-C Worldwide Biopharmaceutical Contract Manufacturing Market Forecast
  • 1.3-A Respondents' Biopharmaceutical Products by Phase and Technology
  • 1.3-B Respondents' Preclinical Products
  • 1.3-C Respondents' Expected Change in Biopharmaceutical Outsourcing Budgets
  • 1.3-D Price Change for CMO Biopharmaceutical Services
  • 1.4-A Contract Biomanufacturers' Annual Revenue Ranges in 2016
  • 1.4-B Technology Comparisons: Weighted Business Mix in 2017
  • 1.4-C Worldwide Biopharmaceutical Contract Manufacturing Industry Capacity

Chapter 2

  • 2.4-A Explanation of Box-and-Whiskers Plot

Chapter 3

  • 3.2-A Worldwide Biopharmaceutical Contract Manufacturing Industry Capacity
  • 3.2-B Biopharmaceutical CMO Average Revenue in 2016
  • 3.3-A Respondents' Biopharmaceutical Products by Phase
  • 3.3-B Production Source Mix
  • 3.3-C Outsourced Products by Phase in 2017
  • 3.3-D Outsourced Production Spending by Respondent Segment
  • 3.3-E Outsourced Products by Phase by Year
  • 3.3-F Trends Indicated by Number of Products Outsourced or to be Outsourced
  • 3.4-A Outsourcing Demand versus Contract Capacity: 2017 to 2022: Mammalian
  • 3.4-B Outsourcing Demand versus Contract Capacity: 2017 to 2022: Microbial
  • 3.6-A Worldwide Biopharmaceutical Contract Manufacturing Market Forecast

Chapter 4

  • 4.1-A Respondent Segment by Number of Biomanufacturing Sites
  • 4.1-B Summary of Respondents' Bulk and Fill-and-Finish Biopharmaceutical Manufacturing Sites
  • 4.1-C Number of Biopharmaceutical Products on the Market
  • 4.1-D Respondents' Preclinical Products
  • 4.1-E Respondents' Preclinical Products Requiring Outsourcing
  • 4.1-F Change in Number of Preclinical Products Requiring Outsourcing
  • 4.1-G Respondents' Biopharmaceutical Products by Phase and Technology
  • 4.1-H Respondents' Biopharmaceutical Product Mix by Phase
  • 4.1-I Respondents' Biopharmaceutical Products by Technology and Company Type
  • 4.1-J Respondents' Biopharmaceutical Products Sourcing Mix
  • 4.1-K Outsourced Products by Phase in 2017
  • 4.1-L Outsourced Products by Phase by Year
  • 4.1-M Tanks Sizes Required for Outsourced Mammalian Cell Culture Products
  • 4.1-N Tanks Sizes Required for Outsourced Microbial Fermentation Products
  • 4.2-A Tanks Size Mix for Outsourced Products: Mammalian Cell Culture
  • 4.2-B Tanks Size Mix for Outsourced Products: Microbial Fermentation
  • 4.2-C Outsource Batches per Project: Mammalian Cell Culture
  • 4.2-D Outsource Batches per Project: Microbial Fermentation
  • 4.2-E Summation of Outsourced Volumes Required by Respondents
  • 4.2-F Technology Usage Patterns Top 6 Mentions
  • 4.2-G Molecule Class Mix Entering Clinical Pipeline
  • 4.3-A Respondents' Outsourcing Strategies
  • 4.3-B Deviation from Outsourcing Strategy
  • 4.3-C Decision Time Frame in Advance of Capacity Expansion
  • 4.4-A Outsourced Production Spending by Respondent Segment
  • 4.4-B Outsourced Spending Mix by Technology: 2017
  • 4.4-C Expected Changes in Outsourced Spending
  • 4.4-D Price Change for CMO Biopharmaceutical Services
  • 4.4-E Distribution of Price Increase for CMO Biopharmaceutical Services
  • 4.4-F Observed Change in External Funding
  • 4.4-G China Market Strategy
  • 4.4-H China Market Strategy-Local Manufacturing vs. Import Path
  • 4.4-I Use of Chinese CMO for Export Purposes
  • 4.4-J Developing Companion Diagnostics
  • 4.5-A Mammalian Cell Culture Titers
  • 4.5-B Microbial Fermentation Yields
  • 4.5-C Future Projects Requiring Continuous Manufacturing
  • 4.5-D Molecules Requiring Continuous Manufacturing
  • 4.5-E Mammalian Cell Culture Bioreactor Scale-Commercial Phase
  • 4.5-F Mammalian Cell Culture Bioreactor Scale-Clinical Phase
  • 4.5-G Microbial Fermentation Bioreactor Scale-Commercial Phase
  • 4.5-H Microbial Fermentation Bioreactor Scale-Clinical Phase
  • 4.5-I Major Areas that Present Challenges to Innovative Biomanufacturing
  • 4.5-J Availability of Technology for Development and Manufacture of Complex Molecules
  • 4.6-A Top Criteria for Selecting a CMO
  • 4.6-B Top 5 Weighted Characteristics by Respondent Segment
  • 4.6-C Changes in Main Differentiators that Set Commercial-Phase CMOs Apart
  • 4.6-D Importance for CMO to Have All Services Co-Located
  • 4.6-E Importance for CMO to Have All Services Co-Located by Respondent Segment
  • 4.7-A Change in Number of CMOs Utilized
  • 4.8-A Respondents' Expected Change in Outsourcing Budgets: 2017 to 2019
  • 4.8-B Weighted Averages: Outsourcing Budget by Services: 2017 and 2019
  • 4.9-A Microbial Fermentation Trends
  • 4.9-B Challenges for Biomanufacturing
  • 4.9-C Opinion on Future Success of Biopharmaceutical Manufacturing

Chapter 5

  • 5.1-A Length of Time in CMO Business
  • 5.1-B Number of CMO Respondent Sites
  • 5.1-C Number of FDA or EMA Inspections
  • 5.1-D Inspections Associated with New or Approved BLA
  • 5.1-E Contract Biomanufacturers' Annual Revenue Ranges in 2016
  • 5.1-F Contract Biomanufacturers' Expected Revenue Change: 2016 to 2017
  • 5.2-A Average Number of Phase III and Commercial Products
  • 5.2-B Technology Comparisons: Business Mix by Respondent Segment: 2017
  • 5.2-C Technology Comparisons: Weighted Business Mix: 2017
  • 5.2-D Service Category Comparisons: Business Mix by Respondent Segment
  • 5.2-E Production Category Comparisons: Business Mix by Respondent Segment
  • 5.2-F Weighted Business Mix by Service and Production Category: 2017
  • 5.2-G Mammalian Cell Culture Capacity Utilization Rates: 2017/2019
  • 5.2-H Microbial Fermentation Capacity Utilization Rates: 2017/2019
  • 5.2-I Additional Mammalian Cell Culture Capacity by Year
  • 5.2-J Additional Microbial Fermentation Capacity by Year
  • 5.2-K Summary of Current and Future Capacity at Surveyed Contractor Facilities
  • 5.3-A Expression Yields by Technology and Respondent Segment
  • 5.3-B Average Number of Batches Run per Tank
  • 5.3-C Expression Technology Implementation for Non-Standard Format Antibodies
  • 5.3-D Distribution of Scale for Mammalian Cell Culture: Clinical Phase
  • 5.3-E Distribution of Scale for Mammalian Cell Culture: Commercial Phase
  • 5.3-F Distribution of Scale for Microbial Fermentation: Clinical Phase
  • 5.3-G Distribution of Scale for Microbial Fermentation: Commercial Phase
  • 5.3-H Distribution of Single-Use Technologies by Respondent Type
  • 5.3-I Importance of Drug Substance and Drug Product Capability
  • 5.3-J Change in Importance of Drug Substance and Drug Product Capability
  • 5.3-K Percent of Business Related to Biosimilar Projects
  • 5.3-L Change in Percentage of Business for Biosimilar Projects
  • 5.3-M Biosimilar Strategy
  • 5.4-A Average Number of RFPs Received per Month
  • 5.4-B Percent of Respondents Whose RFPs Specify Requirements
  • 5.4-C RFP Success Rate
  • 5.4-D Percent of Revenue Invested in R&D
  • 5.4-E Change in R&D Investment from 2016
  • 5.4-F Customer Loyalty Survey Implementation
  • 5.5-A Distribution of Number of Clients Served in 2016
  • 5.5-B Percent of Respondents Fully Booked in 2016
  • 5.5-C Production Technology Fully Booked in 2016
  • 5.5-D Length of Time Manufacturing Plant Booked Out
  • 5.5-E Business Mix by Customer Base by Respondent Segment
  • 5.5-F Simple and Weighted Business Mix by Customer Base Comparison
  • 5.5-G Business Mix by World Region by Customer Segment
  • 5.5-H Simple and Weighted Business Mix by World Region Comparison
  • 5.6-A Change in Demand for Outsourced Services Over Last 12 Months
  • 5.6-B Expectations of Industry Growth: Twelve Months and Three Years
  • 5.6-C Price Expectations in 2017
    • 5.6-D Distribution of Expected Price Change
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