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市場調査レポート

バイオ医薬品製造受託市場:新規参入企業・サービス拡大・新興市場

Biopharmaceutical Contract Manufacturing 2015: Improving Markets, Services and Technologies

発行 HighTech Business Decisions, Inc. 商品コード 224990
出版日 ページ情報 英文 900 Pages; 260+ Charts & Tables
納期: 即日から翌営業日
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バイオ医薬品製造受託市場:新規参入企業・サービス拡大・新興市場 Biopharmaceutical Contract Manufacturing 2015: Improving Markets, Services and Technologies
出版日: 2014年10月31日 ページ情報: 英文 900 Pages; 260+ Charts & Tables
概要

当レポートでは、バイオ医薬品製造受託市場の現状と見通しについて調査分析し、バイオ医薬品製造の委託サイド(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、バイオ医薬品製造受託業者サイドの各種タイプ、提供可能な技術・サービス、製造能力、市場成長の見通しなどをまとめてお届けいたします。

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:バイオ医薬品製造受託業者
    • バイオ医薬品製造受託業者のタイプ
    • 主なバイオ医薬品製造受託業者
    • 産業の組織的変化
    • 技術とサービス
    • バイオ医薬品製造受託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
    • バイオ医薬品製造のアウトソーシング:製品技術別
    • 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
    • 社内のキャパシティ
    • アウトソースの必要条件
  • 産業推進因子
    • 需要と供給
  • 市場規模
  • 市場成長予測
  • バイオ医薬品製造受託市場の動向
    • 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
  • 回答者の企業背景
  • 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 バイオ医薬品製造受託業者

  • イントロダクション
  • 会社組織
  • 提供技術・キャパシティ
  • 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, the comprehensive 2014 industry study, provides the latest information on biomanufacturing strategies, markets, technologies, and needed outsourcing services so readers can make successful strategic decisions. The data and the analysis in this report are based on 73 in-depth interviews conducted with biomanufacturing directors at pharmaceutical and biotechnology companies and contractor companies worldwide. It is the most comprehensive 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 Strategies
    • 1.3.3. Outsourcing Budgets
    • 1.3.4. Change in CMO Pricing
    • 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

Chapter 3: 3.3 The Customers: Pharmaceutical and Biotechnology Companies

  • 3.3.1. Outsourced Biomanufacturing
  • 3.3.2. Outsourcing Biomanufacturing by Production Technology
  • 3.3.3. Examples of Contractors Used by Client Companies
  • 3.3.4. Customers' Future Outsourcing Expectations
  • 3.3.5. In-House Capacity
  • 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 Revenue
    • 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
  • 4.2. Respondent Company Backgrounds
    • 4.2.1. Respondents' Titles and Experience
    • 4.2.2. Locations and Sites
    • 4.2.2. Respondents' Biopharmaceutical Products on Market
    • 4.2.3. Respondents' Preclinical Products
    • 4.2.4. Respondents' Clinical and Commercial Products
    • 4.2.5. Respondents' Outsourced Products
  • 4.3. Biomanufacturing Needs
    • 4.3.1. Current and Forecast Tank Size Requirements
    • 4.3.2. Number of Outsourced Batches
    • 4.3.3. Current and Forecast Outsourced Demand
    • 4.3.4. Future Production Technology Requirements
  • 4.4. Biomanufacturing Strategies
    • 4.4.1. Outsource versus In-House Decision
    • 4.4.2. Early Clinical-Stage Programs
    • 4.4.3. Change in Project Scope to Separate Contracts

Chapter 4: 4.5 Outsourcing Biomanufacturing

  • 4.5.1. Percentage Outsourced and Expected to Be Outsourced
  • 4.5.2. Current and Anticipated Needs for Outsourced Services
  • 4.5.3. Change in CMO Pricing
  • 4.5.4. Budgetary Considerations for Engineering Runs
  • 4.5.5. New Services Sought in a Contractor
  • 4.6. Biomanufacturing Technologies
    • 4.6.1. Current Expression Levels
    • 4.6.2. Commercially Available Proprietary Expression System
    • 4.6.3. Ideal Bioreactor Size
    • 4.6.4. Use of Chemically-Defined Media
  • 4.7. Contractor Selection
    • 4.7.1. Primary Screening Criteria
    • 4.7.2. Number of CMOs Contacted
    • 4.7.3. CMO Repeat Business
    • 4.7.4. Essential Characteristics Sought in a Contractor
    • 4.7.5. Suggestions for New CMO
    • 4.7.6. Importance for Services to be at Same Location
    • 4.7.7. Fill-and-Finish Capability at Site
    • 4.7.8. Production at Location Product Marketed
    • 4.7.9. Clinical-Phase CMO Differentiation
    • 4.7.10. CMO Customer-Facing Organization Skills
  • 4.8. Contractor Relationships
    • 4.8.1. Favorite Contractors
    • 4.8.2. Describing Flexibility and Ease of Use with a Contractor
    • 4.8.3. Client Expectation Regarding Failed Batch Runs
    • 4.8.4. Expectation of Initial Payment to Secure Slot
  • 4.9. Outsource Spending
    • 4.9.1. Outsourcing Budgets
    • 4.9.2. Outsourcing Budgets by Technology
    • 4.9.3. Outsourcing Budgets by Service
  • 4.10. Future Trends and Expectations
    • 4.10.1. Opinion on Strategic Partnerships
    • 4.10.2. Interest in Strategic Development/Manufacturing Partnership
    • 4.10.3. Long-Term Industry and Market Trends

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. Company Organization
    • 5.2.1. Ratio of Business Development to Program Management
    • 5.2.2. Ratio of Quality to Manufacturing
    • 5.2.3. GMP Manufacturing Staff Activities
    • 5.2.4. Education Level of GMP Manufacturing Operators
    • 5.2.5. Technical Staff Turnover Rate
  • 5.3. Technologies and Capacities Offered
    • 5.3.1. Number of cGMP Phase III and Commercial Products
    • 5.3.2. Technologies Offered
    • 5.3.3. Percentage of Business by Service Category
    • 5.3.4. Contract Manufacturers' Current Capacities
    • 5.3.5. Contract Manufacturers' Expansion Plans
  • 5.4. Manufacturing Technologies
    • 5.4.1. Expression Yields and Batch Success Rates
    • 5.4.2. Number of Batches Run per Tank
    • 5.4.3. Investment in New Technologies
    • 5.4.4. Effect of Disruptive Technologies on Manufacturing
    • 5.4.5. Single-Use Capability
    • 5.4.6. Full Lot Release Testing Capability
    • 5.4.7. Analytical, Bioassay, Formulation, Stability Capabilities
    • 5.4.8. Quality by Design
    • 5.4.9. Advantage of Drug Substance and Drug Product Capability
    • 5.4.10. Use of Platform Technologies
    • 5.4.11. Electronic Access to Data

Chapter 5: 5.5 Marketing and Customer Relationships

  • 5.5.1. Request for Proposals
  • 5.5.2. Clients Served
  • 5.5.3. Number of Phase II/III and Commercial Contracts
  • 5.5.4. Revenue Spent on Business Development and Proposals
  • 5.5.5. Portion of Fully Integrated Projects
  • 5.5.6. Typical Contract Guarantees
  • 5.5.7. Number of MBR Reviews Done by Clients
  • 5.5.8. Characteristics of the Customer Base
  • 5.5.9. Proportion of Business by World Regions
  • 5.5.10. Reasons for Winning Business
  • 5.5.11. Metrics Used to Benchmark Business Performance
  • 5.6. Industry and Future Trends
    • 5.6.1. Contractor Change in Demand for Outsource Services
    • 5.6.2. Expectation of Industry Growth
    • 5.6.3. Price Changes for Biopharmaceutical Production
    • 5.6.4. Regulatory Challenges
    • 5.6.5. Expectations for the Biopharmaceutical Contract Manufacturing Industry

Appendix A: Write-Ups of Interviews with 50 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

  • 1.3-2: Users' 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: Contractors Manufacturers Preferred by Respondents
  • 3.2-2: Examples of Changes or Events in the CMO Industry: Past Two Years
  • 3.2-3: Major Contract Biomanufacturing 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: Estimates of Totaled Needs for Outsourced Volumes by Respondents
  • 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 2013 Market Size for Contract Biomanufacturing: Revenues
  • 3.5-2: Market Size by Technology Category: US$
  • 3.5-3: Market Size by Service Category: US$
  • 3.6-1: Worldwide 2014 Market Size for Contract Biomanufacturing
  • 3.7-1: Major Biopharmaceutical Contract Manufacturing Industry Trends

Chapter- 4

  • 4.1-1: Respondent Pharmaceutical and Biotechnology Companies
  • 4.2-1: Respondents' Titles by Segment
  • 4.2-2: Respondent Locations
  • 4.2-3: Respondents' Bulk Biopharmaceutical Manufacturing Sites
  • 4.2-4: Respondents' Fill-and-Finish Biopharmaceutical Manufacturing Sites
  • 4.2-5: Respondents' Preclinical Products
  • 4.2-6: Number of Products Produced Using Mammalian Technologies
  • 4.2-7: Number of Products Produced Using Microbial Technologies
  • 4.2-8: Types of Respondents' Products by Production Technology
  • 4.2-9: Outsourced Products by Phase by Year
  • 4.2-10: Number of Products Outsourced by Tank Size Needs in 2014: Mammalian Cell Culture
  • 4.2-11: Number of Products Outsourced by Tank Size Needs in 2014: Microbial Fermentation

Chapter- 4

  • 4.3-1: Tank Size Distribution for Outsourced Products: Mammalian Cell Culture
  • 4.3-2: Tank Size Distribution for Outsourced Products: Microbial Fermentation
  • 4.3-3: Outsource Batches per Project: Mammalian Cell Culture
  • 4.3-4: Outsource Batches per Project: Microbial Fermentation
  • 4.3-5: Outsource Demand by Phase
  • 4.3-6: Expected Changes in Technologies Used
  • 4.4-1: Drivers for Companies Who Outsource 100% GMP Manufacturing
  • 4.4-2: Drivers for Companies Who Outsource Some GMP Manufacturing
  • 4.4-3: Respondents' Outsourcing of Clinical-Stage Programs
  • 4.4-4: Separate Outsourced Services
  • 4.5-1: Outsource Budget Allocated by Production Technology
  • 4.5-2: Services Currently Outsourced
  • 4.5-3: Services Planned Outsourced
  • 4.5-4: No Plans to Outsource Services
  • 4.5-5: Summary of Service Categories Based on Number of Products
  • 4.5-6: Reasons for Pricing Change for CMO Biopharmaceutical Services
  • 4.5-7: Budget Considerations by Respondent Segment
  • 4.5-8: New CMO Services Sought
  • 4.6-1: Expression Levels Reported by Respondents in Grams per Liter
  • 4.6-2: Expression Levels Reported for Mammalian mAb Products
  • 4.6-3: Proprietary Expression System Used
  • 4.6-4: Reason for Choosing Proprietary Expression System
  • 4.6-5: Ideal Bioreactor Size (L)
  • 4.7-1: Criteria for Initial Selection of CMO
  • 4.7-2: Number of CMOs by Selection Step
  • 4.7-3: Essential Characteristics for Choosing a CMO
  • 4.7-4: Weighted Characteristics Distributed By Respondent Segment
  • 4.7-5: Criteria for Using a New CMO without Manufacturing History
  • 4.7-6: Reasons Regarding CMOs Having All Services in One Location
  • 4.7-7: Reasons for Selection of Bulk Production CMO without F&F Capability
  • 4.7-8: Production Location at Sites Where Product Marketed
  • 4.7-9: Factors that Differentiate Clinical-Phase CMOs
  • 4.7-10: Skills Needed by CMOs Customer-Facing Organization
  • 4.8-1: Contract Manufacturers Preferred by Respondents
  • 4.8-2: Examples of CMO Flexibility and Ease of Use
  • 4.8-3: Initial Payment to Secure Manufacturing Slot
  • 4.9-1: Expenditures on Outsourcing of Biopharmaceutical Production: 2014
  • 4.9-2: Expenditures on Outsourcing of Biopharmaceutical Production: 2016
  • 4.9-3: Average Percentage of Budgets Spent on Each Technology: 2014 and 2016
  • 4.9-4: Weighted Average Percentage of Budgets Spent on Each Technology
  • 4.9-5: Simple Average: Percentages of Budgets by Service Expected in 2014
  • 4.9-6: Simple Average: Percentages of Budgets by Service Expected in 2016
  • 4.9-7: Weighted Average: Percentages of Budgets by Service Expected in 2014
  • 4.9-8: Weighted Average: Percentages of Budgets by Service Expected in 2016

Chapter- 4

  • 4.10-1: Benefits and Challenges of Production Networks or Alliances
  • 4.10-2: Consideration for Co-Investing in a CMO
  • 4.10-3: Long-Term Industry Trends

Chapter- 5

  • 5.1-1: Respondents from Companies Offering Contract Biomanufacturing Services
  • 5.1-2: Types of Biopharmaceutical Contract Manufacturers
  • 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: 2013 Revenues for Contract Biomanufacturers in US$M
  • 5.2-1: Technical Staff Turnover Rate
  • 5.2-2: Incentive Programs Provided to Retain GMP Manufacturing Staff
  • 5.3-1: Phase III and Commercial cGMP Products Manufactured
  • 5.3-2: Business Mix by Production Technology and Year
  • 5.3-3: Business Mix in 2014 by Production Technology and Contractor Segment
  • 5.3-4: Averaged Percentages of Business from Biopharmaceutical Services
  • 5.3-5: 2014 Averaged Percentages of Business from Biopharmaceutical Services By Company Type
  • 5.3-6: Mammalian Cell Culture Capacity at 19 Respondents' Facilities in 2014
  • 5.3-7: Microbial Fermentation Capacity at 13 Respondents' Facilities in 2014
  • 5.3-8: New Capacity Expected: 2015 to 2019
  • 5.4-1: Contractor Yields and Success Rates
  • 5.4-2: Number of Batches Run per Tank
  • 5.4-3: New Technology Investments
  • 5.4-4: Disruptive Technologies in Biopharmaceutical Manufacturing
  • 5.4-5: Percentage of Single-Use at Respondent Sites
  • 5.4-6: Advantages and Disadvantages of Single-Use Bioreactors
  • 5.4-7: Analytic Testing Capability
  • 5.4-8: Analytic Technology Capability
  • 5.4-9: Bioassay Capability
  • 5.4-10: Formulation Capability
  • 5.4-11: Stability Capability
  • 5.4-12: Advantage of Drug Substance and Drug Product Capability
  • 5.4-13: Time and Cost Savings Through Use of Platform Technology
  • 5.5-1: Number of Request for Proposals Received per Month
  • 5.5-2: RFP Proposal Success Rate
  • 5.5-3: Number of Clients in 2013
  • 5.5-4: Number of Phase II/III and Commercial Contracts
  • 5.5-5: Percent of Revenue Spent on Business Development and Proposals

Chapter- 5

  • 5.5-6: Percent of Fully Integrated Projects Awarded
  • 5.5-7: Typical Contract Guarantees
  • 5.5-8: Number of MBR Reviews Done by Clients
  • 5.5-9: Simple Average Percent of Business by Segment: Customer Base
  • 5.5-10: Simple and Weighted Average Percent of Business: Customer Base
  • 5.5-11: Types of Customers Served and Number of Products
  • 5.5-12: Average Percentage of International Clients
  • 5.5-13: Simple Average Percent of Business by Segment: World Regions
  • 5.5-14: Simple and Weighted Average Percent of Business: World Regions
  • 5.5-15: Reasons Why Chosen by Client
  • 5.5-16: Top Benchmarking Metrics
  • 5.6-1: Reasons 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: Reasons for Price Changes Observed by Contractors
  • 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: Size of Worldwide Biopharmaceutical Contract Manufacturing Market
  • 1.3-A: Number of Respondents' Biopharmaceutical Products by Phase
  • 1.3-B: Respondents' Preclinical Products by Company Type
  • 1.3-C: Respondents Outsourcing Strategies
  • 1.3-D: Respondents' Expected Change in Biopharmaceutical Outsourcing Budgets
  • 1.3-E: Price Change for CMO Biopharmaceutical Services
  • 1.4-A: Contract Biomanufacturers' Annual Revenue Ranges in 2013
  • 1.4-B: Technology Comparisons: Average Weighted Percentage of Business 2014
  • 1.4-C: Worldwide Biopharmaceutical Contract Manufacturing Capacity

Chapter- 2

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

Chapter- 3

  • 3.2-A: Worldwide Biopharmaceutical Contract Manufacturing Capacity
  • 3.3-A: Number of Products Outsourced versus Produced In-House
  • 3.3-B: Outsourced Products by Development Stage in 2014
  • 3.3-C: Percentage of Respondents' Portfolio Outsourced by Production Technology
  • 3.3-D: Tank Sizes Required for Outsourced Mammalian Cell Culture Products
  • 3.3-E: Tank Sizes Required for Outsourced Microbial Fermentation Products
  • 3.3-F: Simple Averaged Expected Percentages of Overall Outsourced Production
  • 3.3-G: Trends by Number of Products Outsourced by Phase
  • 3.3-H: Trends by Number of Products Outsourced by Technology
  • 3.4-A: Outsourcing Demand versus Contract Capacity: 2014 to 2019: Mammalian
  • 3.4-B: Outsourcing Demand versus Contract Capacity: 2014 to 2019: Microbial
  • 3.6-A: Size of the Worldwide Biopharmaceutical Contract Manufacturing in US$B

Chapter- 4

  • 4.2-A: Percentage of Respondents by Number of Biomanufacturing Sites
  • 4.2-B: Number of Bulk and Fill-and-Finish Biopharmaceutical Manufacturing Sites
  • 4.2-C: Number of Biopharmaceutical Products on Market
  • 4.2-D: Respondents' Preclinical Products
  • 4.2-E: Respondents' Biopharmaceutical Products by Technology and Phase
  • 4.2-F: Respondents' 155 Biopharmaceutical Products by Phase
  • 4.2-G: Respondents' 155 Biopharmaceutical Products by Company Type
  • 4.2-H: Number of Products Outsourced versus Produced In-House
  • 4.2-I: Outsourced Products by Phase in 2014
  • 4.2-J: Outsourced Products by Phase by Year

Chapter- 4

  • 4.2-K: Tanks Sizes Required for Outsourced Microbial Fermentation Products
  • 4.2-L: Tanks Sizes Required for Outsourced Mammalian Cell Culture Products
  • 4.3-A: Percent of Tanks Size for Outsourced Products: Mammalian Cell Culture
  • 4.3-B: Percent of Tanks Size for Outsourced Products: Microbial Fermentation
  • 4.3-C: Outsource Batches per Project: Mammalian Cell Culture
  • 4.3-D: Outsource Batches per Project: Microbial Fermentation
  • 4.3-E: Summation of Outsourced Volumes Required by Respondents
  • 4.3-F: Technology Usage Patterns Top 6 Mentions
  • 4.4-A: Respondents' Outsourcing Strategies
  • 4.4-B: Respondents' Outsourcing of Clinical-Stage Programs
  • 4.4-C: Number of Outsourced Clinical-Phase Programs
  • 4.4-D: Project Scope Changes
  • 4.5-A: Average Percentages of Outsourced Production
  • 4.5-B: Average Percentages of Outsourced Budget: 2014
  • 4.5-C: Numbers of Respondents Increasing, Decreasing, or Keeping the Same Outsourcing Percentage
  • 4.5-D: Price Change for CMO Biopharmaceutical Services
  • 4.5-E: Budget Considerations for Engineering Runs
  • 4.6-A: Expression Levels by Phase and Technology
  • 4.6-B: Use of Proprietary Expression Systems
  • 4.6-C: Pricing Agreements for Proprietary Expression Systems
  • 4.6-D: Fees Paid for Proprietary Expression Systems
  • 4.6-E: Preferred Pricing Agreement for Proprietary Expression Systems
  • 4.6-F: Average Ideal Bioreactor Size by Respondent Segment
  • 4.6-G: Average Ideal Bioreactor Size Distribution
  • 4.6-H: Average Use of Chemically-Defined Media
  • 4.6-I: Distribution of Use of Chemically-Defined Media
  • 4.7-A: Top 5 Criteria for Initial Selection of CMO
  • 4.7-B: Average Number of CMOs by Selection Step
  • 4.7-C: Average Percentage of CMO Repeat Awards
  • 4.7-D: Distribution of Percentage of CMO Repeat Awards
  • 4.7-E: Top Criteria for Selecting a CMO
  • 4.7-F: Top 5 Weighted Characteristics by Respondent Segment
  • 4.7-G: Importance for CMO to Have All Services at Same Location
  • 4.7-H: Importance for CMO to Have All Services at Same Location: Segment
  • 4.7-I: Selection of Bulk Production CMO without Fill-and-Finish Capability
  • 4.7-J: Importance of Having Production Location at Sites Product Marketed
  • 4.8-A: Top Attributes of Flexible CMOs
  • 4.8-B: Financial Responsibility for Non-Negligent Batch Failures
  • 4.8-C: Distribution of Initial Payment to Secure Manufacturing Slot
  • 4.9-A: Respondents' Expected Change in Outsourcing Budgets: 2014 to 2016
  • 4.9-B: Simple Average Percentage of Budgets Spent on Each Technology
  • 4.9-C: Weighted Average Percentage of Budgets Spent on Each Technology
  • 4.9-C: Simple Averages: Percentages of Budgets by Service: 2014 and 2016
  • 4.9-D: Weighted Averages: Percentages of Budgets by Service: 2014 and 2016

Chapter- 4

  • 4.10-A: Interest in Production Networks or Alliances
  • 4.10-B: Interest in Production Networks or Alliances by Respondent Segment
  • 4.10-C: Interest in Co-Investment in a CMO
  • 4.10-D: Interest in Co-Investment in a CMO by Respondent Segment

Chapter- 5

  • 5.1-A: Year Respondent Company Entered into CMO Business
  • 5.1-B: Number of CMO Respondent Sites
  • 5.1-C: Number of FDA or EMA Inspections
  • 5.1-D: Contract Biomanufacturers' Annual Revenue Ranges in US$ in 2013
  • 5.2-A: Ratio of Business Development to Project Management Employees
  • 5.2-B: Ratio of Quality to Manufacturing Employees
  • 5.2-C: GMP Manufacturing Staff Performing GMP Support Activities
  • 5.2-D: GMP Manufacturing Staff Performing GMP Support Activities by Segment
  • 5.2-E: Education Level of GMP Manufacturing Operators
  • 5.2-F: Percentage of GMP Manufacturing Operators Education Level
  • 5.2-G: Distribution of Technical Staff Turnover Rate
  • 5.3-A: Average Number of Phase III and Commercial Products
  • 5.3-B: Technology Comparisons: Average Percentage of Business: 2014
  • 5.3-C: Technology Comparisons: Average Weighted Percentage of Business: 2014
  • 5.3-D: Service Category Comparisons: Average Percentage of Business: 2014
  • 5.3-E: Production Category Comparisons: Average Percentage of Business: 2014
  • 5.3-F: Average Percentage of Revenue from Each Service Category: Weighted
  • 5.3-G: Individual Mammalian Cell Culture Capacity Utilization Rates: 2014/2016
  • 5.3-H: Individual Microbial Fermentation Capacity Utilization Rates: 2014/2016
  • 5.3-I: Additional Mammalian Cell Culture Capacity by Year
  • 5.3-J: Additional Microbial Fermentation Capacity by Year
  • 5.2-K: Summary of Current and Future Capacity at Surveyed Contractor Facilities
  • 5.4-A: Expression Yields by Technology and Contractor Size
  • 5.4-B: Average Number of Batches Run per Tank
  • 5.4-C: Distribution of Single-Use Percentages at Respondent Sites
  • 5.4-D: Full Lot Release Testing Capability
  • 5.4-E: Analytical, Bioassay, Formulation and Stability Capabilities
  • 5.4-F: Analytic Capability
  • 5.4-G: QbD Principles Applied to Development
  • 5.4-H: Advantage of Drug Substance and Drug Product Capability
  • 5.4-I: Platform Technology Usage by CMOs
  • 5.4-J: Electronic Data Access and Raw Data Access
  • 5.5-A: Average Number of RFPs Received Each Month
  • 5.5-B: Average Percentage of RFP Proposal Success Rates
  • 5.5-C: Distribution of Clients Served in 2013

Chapter- 5

  • 5.5-D: Distribution of Phase II/III and Commercial Contracts
  • 5.5-E: Distribution of Revenue Spent on Business Development and Proposals
  • 5.5-F: Distribution of Fully Integrated Projects Awarded
  • 5.5-G: Distribution of MBR Reviews Done by Clients
  • 5.5-H: Simple Average Percent of Business by Segment: Customer Base
  • 5.5-I: Simple and Weighted Average Percent of Business: Customer Base
  • 5.5-J: Simple Average Percent of Business by Segment: World Regions
  • 5.5-K: Simple and Weighted Average Percent of Business: World Regions
  • 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 Changes Observed by Contractors
  • 5.6-D: Price Changes Observed by Contractor Segment
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