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生物医薬品の受託製造:2020年

Biopharmaceutical Contract Manufacturing 2020: New Demand and Expanded Services

出版日: | 発行: HighTech Business Decisions | ページ情報: 英文 700 Pages | 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=105.40円
生物医薬品の受託製造:2020年
出版日: 2020年08月31日
発行: HighTech Business Decisions
ページ情報: 英文 700 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

当レポートは、生物医薬品の製造受託業界における需要と供給の最新動向を調査したもので、市場の概要、クライアントの分析、製造受託業者の分析などを通じて、製造戦略、予算、アウトソーシングされる可能性のある製品の種類、受託業者の選択、新興市場での医薬品製造受託機関(CMO)の利用、次世代プロセスの動向などを明らかにします。

目次

第1章 エグゼクティブサマリー

  • イントロダクション
  • 市場の概要
  • 顧客ニーズの概要
  • 製造受託業者の能力

第2章 調査手法、定義、頭字語

  • 調査目的
  • 調査手法
  • 生物医薬品製造の定義
  • 箱ひげ図の定義
  • 頭字語

第3章 市場の概要

  • イントロダクション
  • サプライヤー:生物医薬品製造受託業者
    • 企業の種類
    • 主な企業
    • 業界の組織変化
    • 技術とサービス
    • 企業の能力
    • 買収と組織の変更
    • 収益
  • 顧客:製薬会社とバイオテクノロジー企業
    • フェーズ別の生物医薬品
    • アウトソーシングされたバイオマニュファクチャリング
    • クライアント企業が使用する受託業者の例
    • 顧客の将来的なアウトソーシングの見通し
    • アウトソーシングの要件
  • 業界の推進力
    • 需要と供給
  • 市場規模
    • 製造受託業者の収益ベースの市場規模見積もり
    • 技術別、サービスカテゴリー別の市場規模
  • 市場成長予測
  • 市場の動向
    • 業界の機会と課題
    • 業界全体の動向

第4章 クライアントの分析

  • イントロダクション
    • 調査の参加者
    • 回答者の役職と経験
    • 所在地
    • 上市されている生物医薬品
    • 前臨床段階の製品
    • 臨床研究のパイプライン
    • 臨床試験段階の製品と市販製品
    • アウトソーシングしている製品
  • バイオマニュファクチャリングのニーズ
    • 現在および予測されるタンクサイズの要件
    • アウトソーシングされたバッチの数
    • 現在および予測されるアウトソーシング需要
    • 将来の生産技術要件
    • 臨床パイプラインに入る新しい分子
  • バイオマニュファクチャリング戦略
    • アウトソーシングの決定の主な要因
    • アウトソーシングの決定に対する製品マージンの影響
    • バイオシミラーのアウトソーシング
    • 自社製造施設の拡張
  • バイオマニュファクチャリングのアウトソーシング
    • アウトソーシングと社内製造費
    • アウトソーシングサービスの変更
    • 欧州または北米での臨床使用のために原薬製造を中国にアウトソーシング
    • 中国での供給または再輸入を目的とした中国CMOの利用
    • 受託業者に求められる新しいサービス
    • 見つけるのが難しいサービス
  • 製造技術
    • 現在の発現レベル
    • 使用される宿主細胞系
    • 連続生産の未来
    • 第2世代のプロセストレンド
    • N-1灌流生産プロセス
    • 新しい製造技術を採用するためのプロセス
    • 長期的な商業規模またはコアテクノロジーへの変更
    • 革新的なバイオマニュファクチャリングへの最大の課題
  • 受託業者の選択
    • 受託業者選択の重要な基準
    • 促進プロジェクトの受託業者選択基準の変更
    • 受託業者の選択基準における「専門知識」の定義
    • 製造中に使用されるパフォーマンス基準
    • 契約維持の考慮に使用されるパフォーマンス基準
    • CMOが完全に統合されたサービスを持つことの重要性
    • CMOの数が多い国
    • 主なCMO
  • 受託業者の関係
    • 使用されたCMOの数
    • 優先ベンダーリスト
    • 製品フェーズ間のCMOの切り替え
    • 現在のCMOに変更
  • アウトソーシングの支出
    • アウトソーシングの予算
    • 技術別の予算
    • サービス別の予算
  • 今後の動向と期待
    • バイオマニュファクチャリングの課題
    • 業界と市場の長期的な動向
    • 細胞治療と遺伝子治療の課題と機会
    • 生物医薬品受託製造の未来

第5章 生物医薬品受託製造業者

  • イントロダクション
    • 調査の参加者
    • サプライヤーの種類
    • 所在地
    • 買収と組織変更
    • 生産される製品の種類
    • 収益
  • 提供される技術と生産能力
    • 生産技術
    • サービスカテゴリー別のビジネスミックス
    • 委託製造業者の現在の能力
    • 委託製造業者のプロジェクト
    • 委託製造業者の拡張計画
  • 製造技術
    • 発現の歩留まりとバッチ成功率
    • タンク1台あたりの年間バッチ数
    • バッチサイズとダウンストリーム収量
    • 生産規模
    • 組換えタンパク質生産に使用される微生物発酵能力
    • 単回使用設備のキャパシティミックス
    • 連続製造プロセス
    • 今後5年間の投資計画
    • 施設の拡張または売却時に考慮される要素
  • マーケティング
    • 提案依頼書
    • 単回使用とステンレス鋼のバイオリアクターを必要とする提案依頼書
    • 標準プラットフォーム外の提案依頼書
    • 契約につながる提案依頼書
    • 顧客満足度の測定に使用される指標
    • 顧客維持の最も重要な指標
    • 哺乳類細胞培養製造のトップ競合企業
    • 新興市場戦略
    • 迅速審査プロジェクトの経験
  • 顧客関係
    • サービスを提供しているクライアント
    • 商業契約
    • サービス料以外の取り決め
    • 顧客基盤の特徴
    • 地域別の事業比率
  • 業界と将来の動向
    • アウトソーシングサービスの需要の変化の観察
    • 業界の成長期待
    • 技術面の課題
    • 将来の成長のための新しいビジネスエリア
    • 細胞および遺伝子治療の課題と機会
    • 生物医薬品製造受託業の将来の変化と動向

生物医薬品製造受託業者の要覧

図表

LIST OF TABLES

Chapter 1

  • 1.3-1 Reasons for Expanding Manufacturing Facility
  • 1.3-2 New CMO Services Sought
  • 1.3-3 Different Aspects of Integrated Continuous Manufacturing
  • 1.3-4 Reasons for Change in Number of CMOs Utilized
  • 1.3-5 Clients' Cell and Gene Therapy Outlook
  • 1.3-6 Clients' 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 User Mentioned Top CMOs
  • 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 And Forecasts in Tank Liters
  • 3.2-5 CMO Recent and Anticipated Organization Changes
  • 3.3-1 Examples of Contract Biomanufacturers and their Client Companies
  • 3.3-2 Outsourced Volumes by Technology
  • 3.3-3 Estimates of Needs for Outsourced Volumes for the Worldwide Industry
  • 3.4-1 Biopharmaceutical Outsourced Manufacturing Capacity versus Needs: Mammalian Cell Culture
  • 3.4-2 Biopharmaceutical Outsourced Manufacturing Capacity versus Needs: Microbial Fermentation
  • 3.5-1 Worldwide 2019 Market Size for Contract Biomanufacturing: Revenues
  • 3.5-2 2019 Market Size by Technology Category
  • 3.5-3 2019 Market Size by Service Category
  • 3.6-1 Worldwide 2020 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 Outsourced Preclinical Products
  • 4.1-8 Number of Products Produced Using Mammalian Cell Culture
  • 4.1-9 Number of Products Produced Using Microbial Fermentation

Chapter 4

  • 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 2020 Mammalian Cell Culture
  • 4.1-13 Number of Products Outsourced by Tank Size Needs in 2020 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 Outsourced Batches per Project: Mammalian Cell Culture
  • 4.2-4 Outsourced Batches per Project: Microbial Fermentation
  • 4.2-5 Outsourced Demand by Phase: Mammalian Cell Culture
  • 4.2-6 Outsourced Demand by Phase: Microbial Fermentation
  • 4.2-7 Expected Changes in Technologies and Product Types Used
  • 4.2-8 Technology and Product Types Not Used by Respondents
  • 4.2-9 Molecule Class Mix Entering Clinical Pipeline
  • 4.3-1 Drivers and Factors for Companies Who Outsource 100% GMP Manufacturing
  • 4.3-2 Drivers for Companies Who Outsource Some GMP Manufacturing
  • 4.3-3 How Product Margin Affects Outsourcing Decision
  • 4.3-4 Reasons for Whether Biosimilars Are Better Outsourcing Candidates
  • 4.3-5 Reasons for Expanding Manufacturing Facility
  • 4.4-1 Spending Mix by Production Source and Technology
  • 4.4-2 Expected Changes in Services Used
  • 4.4-3 Services Not Used by Respondents
  • 4.4-4 Considerations for Outsourcing Drug Substance Manufacturing to China
  • 4.4-5 Strategy of Outsourcing to China by Respondent Segment
  • 4.4-6 New CMO Services Sought
  • 4.4-7 Services Difficult to Find
  • 4.5-1 Expression Levels Reported by Respondents by Production Technology
  • 4.5-2 Expression Levels Reported for mAbs
  • 4.5-3 Expression Levels Reported for Fc Fusion and Bispecific Molecules
  • 4.5-4 Changes to Host Cell Systems
  • 4.5-5 Different Aspects of Integrated Continuous Manufacturing
  • 4.5-6 Areas of Second-Generation Processes
  • 4.5-7 Reasons for Considering N-1 Perfusion Production Processes
  • 4.5-8 Process for Adopting New Manufacturing Technologies
  • 4.5-9 Changes to Commercial Scale and Core Technologies
  • 4.5-10 Innovative Biomanufacturing: Challenges and Actions
  • 4.6-1 Key Criteria for Choosing a CMO
  • 4.6-2 Key Criteria for Choosing a CMO: Clinical
  • 4.6-3 Key Criteria for Choosing a CMO: Commercial
  • 4.6-4 Weighted Criteria by Respondent Segment
  • 4.6-5 Criteria Change for Expedited Project

Chapter 4

  • 4.6-6 Definition of Expertise
  • 4.6-7 Reasons for Importance Rating of Service Co-Location
  • 4.6-8 Top Countries for CMO Location
  • 4.6-9 Top CMOs in the Industry: Mammalian Manufacturing
  • 4.6-10 Top CMOs in the Industry: Microbial Manufacturing
  • 4.6-11 Top CMOs in the Industry: Viral Vector Manufacturing
  • 4.7-1 Number of CMOs Utilized
  • 4.7-2 Reasons for Change in Number of CMOs Utilized
  • 4.7-3 Number of CMOs on Preferred Vendor List
  • 4.7-4 Preferred Vendor List Criteria
  • 4.7-5 Rationale for Switching CMOs Between Product Phases
  • 4.7-6 Reasons to Change Current CMO
  • 4.8-1 Expenditures on Outsourcing of Biopharmaceutical Production
  • 4.8-2 Spending Mix by Technology: 2020 and 2022
  • 4.8-3 Weighted Averages: Outsourcing Budget by Services in 2020
  • 4.8-4 Weighted Averages: Outsourcing Budget by Services in 2022
  • 4.9-1 Biomanufacturing and Business Challenges
  • 4.9-2 Future Trends in Biopharmaceutical Manufacturing
  • 4.9-3 Cell and Gene Therapy Challenges and Opportunities
  • 4.9-4 Future Expectations of the Biopharmaceutical Manufacturing Industry

Chapter 5

  • 5.1-1 Respondent Contract Manufacturing Companies
  • 5.1-2 Types of Biopharmaceutical Contract Manufacturing Organizations
  • 5.1-3 Contract Biomanufacturers: Headquarter Locations
  • 5.1-4 Examples of Company Changes at CMOs: Past Two Years
  • 5.1-5 Organization Changes Over Last Two Years and Anticipated Changes
  • 5.1-6 Contract Biomanufacturers' Revenue in 2019
  • 5.1-7 Drivers for Expected Revenue Change
  • 5.2-1 Business Mix by Production Technology and Year
  • 5.2-2 Business Mix by Production Technology and Respondent Segment: 2020
  • 5.2-3 Business Mix by Service and Production Category and Year
  • 5.2-4 Business Mix by Service and Production Category by Respondent Segment
  • 5.2-5 Mammalian Cell Culture Capacity at 14 Respondents' Facilities in 2020
  • 5.2-6 Mammalian Cell Culture Utilization Rates
  • 5.2-7 Microbial Fermentation Capacity at 10 Respondents' Facilities in 2020
  • 5.2-8 Microbial Fermentation Utilization Rages
  • 5.2-9 Contract Manufacturers' 2019 Projects by Production Technology
  • 5.2-10 New Capacity Expected: 2021 to 2024
  • 5.3-1 Contractor Yields and Success Rates
  • 5.3-2 Annual Batches per Tank
  • 5.3-3 Batch Size and Downstream Yield

Chapter 5

  • 5.3-4 Expected Bioreactor Scale in Demand
  • 5.3-5 Percentage of Single-Use Production Capacity at Respondent Sites
  • 5.3-6 Continuous Manufacturing Process Implementation by Segment
  • 5.3-7 Investments in New Technology by Area
  • 5.3-8 Expansion Considerations
  • 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 Customer Satisfaction Metrics
  • 5.4-7 Top Mammalian Cell Culture Manufacturing Competitors
  • 5.4-8 Ways to Increase Marketing Effort in Emerging Markets
  • 5.4-9 Reasons Chosen for Expedited Pathway Projects
  • 5.5-1 Number of Customers in 2019
  • 5.5-2 Number of Commercial Contracts in 2019
  • 5.5-3 Customer Mix by Respondent Segment
  • 5.5-4 Simple and Weighted Revenue Mix by Customer Type
  • 5.5-5 Number of Products by Customer Type
  • 5.5-6 International Customer Mix
  • 5.5-7 Business Mix by World Region by Respondent Segment
  • 5.5-8 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 Current Challenges
  • 5.6-5 New Business Areas for Future Growth
  • 5.6-6 Cell and Gene Therapy Opportunities and Challenges
  • 5.6-7 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 Future of Fully Integrated Continuous Manufacturing
  • 1.3-E Average Number of CMOs Utilized
  • 1.3-F Change in Number of CMOs Utilized
  • 1.4-A Contract Biomanufacturers' Annual Revenue Ranges in 2019
  • 1.4-B Technology Comparisons: Weighted Business Mix in 2020
  • 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 Trend
  • 3.3-A Respondents' Biopharmaceutical Products by Phase
  • 3.3-B Production Source Mix
  • 3.3-C Outsourced Products by Phase
  • 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 Biomanufacturers' Capacity Mammalian Cell Culture
  • 3.4-B Outsourcing Demand versus Contract Biomanufacturers' Capacity Microbial Fermentation
  • 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 Outsourced Preclinical Products
  • 4.1-F Change in Number of Outsourced Preclinical Products: 2019 to 2020
  • 4.1-G Distribution of Percent of Microbially Produced Clinical Pipeline

Chapter 4

  • 4.1-H Respondents' Biopharmaceutical Products by Phase and Technology
  • 4.1-I Respondents' Biopharmaceutical Product Mix by Phase
  • 4.1-J Respondents' Biopharmaceutical Products by Technology and Company Type
  • 4.1-K Respondents' Biopharmaceutical Products Sourcing Mix
  • 4.1-L Outsourced Products by Phase
  • 4.1-M Outsourced Products by Phase by Year
  • 4.1-N Tanks Sizes Required for Outsourced Mammalian Cell Culture Products
  • 4.1-O 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 Outsourced Batches per Project: Mammalian Cell Culture
  • 4.2-D Outsourced 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 Drivers for Companies Who Outsource 100% GMP Manufacturing
  • 4.3-B Product Margin Effect on Outsourcing Decision
  • 4.3-C Whether Biosimilars Are Better Outsourcing Candidates
  • 4.4-A Outsourced Production Spending by Respondent Segment
  • 4.4-B Outsourced Spending Mix by Technology: 2020
  • 4.4-C Expected Changes in Outsourced Spending
  • 4.4-D Top 6 Services with Increased Usage
  • 4.4-E Consideration for Outsourcing Drug Substance Manufacturing to China for Clinical Studies
  • 4.4-F Strategy of Outsourcing Manufacturing to China
  • 4.5-A Mammalian Cell Culture Titers
  • 4.5-B Microbial Fermentation Yields
  • 4.5-C Host Cell Systems Used
  • 4.5-D Changes to Host Cell Systems
  • 4.5-E Future of Fully Integrated Continuous Manufacturing
  • 4.5-F Second-Generation Process Trend
  • 4.5-G Consideration for N-1 Perfusion Production Processes
  • 4.5-H Major Areas that Present Challenges to Innovative Biomanufacturing
  • 4.6-A Top Criteria for Selecting a CMO
  • 4.6-B Top 4 Weighted Criteria by Respondent Segment
  • 4.6-C Change in CMO Selection Criteria for Expedited Project
  • 4.6-D CMO Manufacturing Performance Criteria
  • 4.6-E CMO Retention Consideration by Percent of Respondents
  • 4.6-F Mix of CMO Retention Considerations
  • 4.6-G Importance for CMO to Have All Services Co-Located
  • 4.6-H Importance for CMO to Have All Services Co-Located by Respondent Segment

Chapter 4

  • 4.7-A Average Number of CMOs Utilized
  • 4.7-B Change in Number of CMOs Utilized
  • 4.7-C Preferred Vendor List
  • 4.7-D Number of CMOs on Preferred Vendor List
  • 4.7-E Frequency of Preferred Vendor List Update
  • 4.7-F Switching of CMOs Between Product Phases
  • 4.7-G Product Phase Where CMO Switch Typically Happens
  • 4.8-A Respondents' Expected Change in Outsourcing Budgets: 2020 to 2022
  • 4.8-B Weighted Averages: Outsourcing Budget by Services: 2020 and 2022
  • 4.9-A 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 CMO Product Categories
  • 5.1-D Contract Biomanufacturers' Annual Revenue Distribution in 2019
  • 5.1-E Contract Biomanufacturers' Revenue Change from 2 Years Ago
  • 5.1-F Contract Biomanufacturers' Expected Revenue Change in 2020
  • 5.1-G Contract Biomanufacturers' Expected Revenue Change: 2019 to 2020
  • 5.2-A Technology Comparisons-Business Mix by Respondent Segment: 2020
  • 5.2-B Technology Comparisons-Weighted Business Mix: 2020
  • 5.2-C Service Category Comparisons-Business Mix by Respondent Segment
  • 5.2-D Production Category Comparisons-Business Mix by Respondent Segment
  • 5.2-E Weighted Business Mix by Service and Production Category: 2020
  • 5.2-F Mammalian Cell Culture Utilization Rates
  • 5.2-G Microbial Fermentation Utilization Rates
  • 5.2-H Additional Mammalian Cell Culture Capacity by Year
  • 5.2-I 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 Distribution of Scale in Demand for Mammalian Cell Culture
  • 5.3-D Distribution of Scale in Demand for Microbial Fermentation
  • 5.3-E Expected Change of Microbial Fermentation Production Capacity Used for Recombinant Protein Production
  • 5.3-F Distribution of Microbial Fermentation Production Capacity Used for Recombinant Protein Production
  • 5.3-G Distribution of Single-Use Production Capacity by Respondent Type
  • 5.3-H Continuous Manufacturing Process Implementation
  • 5.3-I Areas of Continuous Manufacturing Process
  • 5.3-J Investment in New Technology
  • 5.3-K Drivers for Expansion

Chapter 5

  • 5.4-A Average Number of RFPs Received per Month
  • 5.4-B RFP Success Rate
  • 5.4-C Most Reliable Indicator to Predict Repeat Business
  • 5.4-D Emerging Market Strategy
  • 5.4-E Experience with Expedited Pathway Projects
  • 5.5-A Distribution of Total Customers in 2019
  • 5.5-B Distribution of New Customers in 2019
  • 5.5-C Distribution of Number of Commercial Contracts in 2019
  • 5.5-D Non-Fee-for-Service Arrangements
  • 5.5-E Business Mix by Customer Base by Respondent Segment
  • 5.5-F Simple and Weighted Revenue 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 Outsourcing Services Over Last 12 Months
  • 5.6-B Expectations of Industry Growth: Twelve Months and Three Years
  • 5.6-C Growth Rate Comparison
目次

This 700-page report provides the latest information about the supply and demand for outsourced biopharmaceutical production. This report analyzes the biotechnology industry's biomanufacturing strategies, budgets, types of products likely to be outsourced, contractor selection, use of emerging-market CMOs, and next-generation process trends. This report also provides detailed analyses of typical batch sizes and product requirements by major process technology for both clinical and commercial production. In addition, this report highlights CMO capacity, expression titers and yields, batch throughput, capacity utilization rates, and the use of proprietary expression systems. The data and the analysis in this report are based on 54 in-depth interviews conducted by Ph.D.-level analysts with executives at both biotechnology 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 260 summary data tables and charts , and 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 Budgets
    • 1.3.3 Expansion of In-House Manufacturing Facility
    • 1.3.4 New Services Sought in a Contractor
    • 1.3.5 Future of Continuous Manufacturing
    • 1.3.6 Change in Number of CMOs Utilized
    • 1.3.7 Challenges and Opportunities for Cell and Gene Therapy
    • 1.3.8 Industry Trends and Observations
  • 1.4 Summary of Contractors' Capabilities
    • 1.4.1 Annual Revenue Ranges
    • 1.4.2 Technology Capabilities
    • 1.4.3 Biopharmaceutical Contract Manufacturing 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 Acquisition and Organization Changes
    • 3.2.7 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 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' Microbially Produced Clinical Pipeline
    • 4.1.7 Respondents' Clinical and Commercial Products
    • 4.1.8 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 Top Factors in Outsourcing Decision
    • 4.3.2 Product Margin Effect on Outsourcing Decision
    • 4.3.3 Outsourcing of Biosimilars
    • 4.3.4 Expansion of In-House Manufacturing Facility
  • 4.4 Outsourcing Biomanufacturing
    • 4.4.1 Outsourcing versus In-House Manufacturing Spending
    • 4.4.2 Changes to Outsourced Services
    • 4.4.3 Outsourcing Drug Substance Manufacturing to China for Clinical Use in Europe or North America
    • 4.4.4 Use of China CMO for China Supply or Re-Import
    • 4.4.5 New Services Sought in a Contractor
    • 4.4.6 Services Difficult to Find
  • 4.5 Manufacturing Technologies
    • 4.5.1 Current Expression Levels
    • 4.5.2 Host Cell Systems Used
    • 4.5.3 Future of Continuous Manufacturing
    • 4.5.4 Second-Generation Process Trend
    • 4.5.5 N-1 Perfusion Production Processes
    • 4.5.6 Process for Adopting New Manufacturing Technologies
    • 4.5.7 Changes to Long-Term Commercial Scale or Core Technologies
    • 4.5.8 Biggest Challenges to Innovative Biomanufacturing

Chapter 4:

  • 4.6 Contractor Selection
    • 4.6.1 Key Criteria in Contractor Selection
    • 4.6.2 Contractor Selection Criteria Change for Expedited Project
    • 4.6.3 Definition of "Expertise" in Contractor Selection Criteria
    • 4.6.4 Performance Criteria Used During Manufacturing
    • 4.6.5 Performance Criteria Used for Retention Consideration
    • 4.6.6 Importance for CMO to Have Fully Integrated Services
    • 4.6.7 Top Countries for CMO Location
    • 4.6.8 Top CMOs
  • 4.7 Contractor Relationships
    • 4.7.1 Number of CMOs Utilized
    • 4.7.2 Preferred Vendor List
    • 4.7.3 Switching CMOs Between Product Phases
    • 4.7.4 Change to Current CMO
  • 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 Challenges for Biomanufacturing
    • 4.9.2 Long-Term Industry and Market Trends
    • 4.9.3 Challenges and Opportunities for Cell and Gene Therapy
    • 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 Acquisitions and Organizational Changes
    • 5.1.5 Types of Products Produced
    • 5.1.6 Revenues: 2019
    • 5.1.7 Revenues: Expected Change in 2020
  • 5.2 Technologies and Capacities Offered
    • 5.2.1 Production Technologies
    • 5.2.2 Business Mix by Service Category
    • 5.2.3 Contract Manufacturers' Current Capacities
    • 5.2.4 Contract Manufacturers' 2019 Projects
    • 5.2.5 Contract Manufacturers' Expansion Plans

Chapter 5:

  • 5.3 Manufacturing Technologies
    • 5.3.1 Expression Yields and Batch Success Rates
    • 5.3.2 Annual Batches Run per Tank
    • 5.3.3 Batch Size and Downstream Yields
    • 5.3.4 Production Scale
    • 5.3.5 Microbial Fermentation Capacity Used for Recombinant Protein Production
    • 5.3.6 Single-Use Capacity Mix
    • 5.3.7 Continuous Manufacturing Process
    • 5.3.8 Investment Plans: Next Five Years
    • 5.3.9 Factors Considered When Expanding or Selling Facility
  • 5.4 Marketing
    • 5.4.1 Request-for-Proposals Received
    • 5.4.2 Request-for-Proposals Requiring Single-Use versus Stainless Steel Bioreactors
    • 5.4.3 Request-for-Proposals Outside Standard Platform
    • 5.4.4 Request-for-Proposals Leading to Contract
    • 5.4.5 Metrics Used to Measure Customer Satisfaction
    • 5.4.6 Most Important Indicator for Repeat Business
    • 5.4.7 Top Competitors for Mammalian Cell Culture Manufacturing
    • 5.4.8 Emerging Market Strategy
    • 5.4.9 Experience with Expedited Pathway Projects
  • 5.5 Customer Relationship
    • 5.5.1 Clients Served
    • 5.5.2 Commercial Contracts
    • 5.5.3 Non-Fee-for-Service Arrangements
    • 5.5.4 Characteristics of the Customer Base
    • 5.5.5 Proportion 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 Industry Growth Expectations
    • 5.6.3 Technology Challenges
    • 5.6.4 New Business Areas for Future Growth
    • 5.6.5 Challenges and Opportunities for Cell and Gene Therapies
    • 5.6.6 Changes and Trends for the Future of the Biopharmaceutical Contract Manufacturing Industry

Directory of Biopharmaceutical Contract Manufacturers

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