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生物医薬品製造受託:ベストプラクティスと価格設定の分析

Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2019

発行 HighTech Business Decisions 商品コード 206945
出版日 ページ情報 英文 300+ Pages; 220+ Charts & Tables
納期: 即日から翌営業日
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生物医薬品製造受託:ベストプラクティスと価格設定の分析 Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2019
出版日: 2019年08月31日 ページ情報: 英文 300+ Pages; 220+ Charts & Tables
概要

当レポートでは、生物医薬品製造受託の慣習および価格動向を調査し、哺乳類細胞培養、微生物培養、その他サービスに対する料金体系、実際の価格の推移と予測、注文者のアウトソーシング戦略と請負業者の選定に関する考察、請負業者による事業戦略、注文者・請負者の両サイドからの契約の慣習・好み、契約の改善・ベストプラクティスに関する考察などをまとめています。

第1章 エグゼクティブサマリー

第2章 調査方法・定義・略語

第3章 業界価格動向

  • イントロダクション
    • 承認・上市済みバイオ医薬品
    • 臨床試験中のバイオ医薬品
    • 商業生産向けにライセンスされたCMO工場で製造されている製品
  • 産業価格の動向
    • 近年の産業価格の推移
    • CMOによる今後の薬価設定の変更
    • 大きく価格変動したサービス
    • 製造コストへの影響因子
  • 利益幅
    • 請負業者の総利益目標

第4章 アウトソーシング戦略と請負業者の選定

  • アウトソーシング戦略
    • 製造予算:社内 vs アウトソース
    • アウトソーシング予算:プロセス開発 vs 製造
    • ユーザーのアウトソーシング戦略
    • ユーザーのアウトソーシング戦略の将来における変化
  • 請負業者の関係性
    • ユーザーの現在の請負業者
    • 新規・別の請負業者に関する計画
  • 請負業者の選定
    • 請負業者との初回の接触
    • プロジェクトの提案のために接触したCMOの数
    • CMOの選定における意思決定者
    • 意思決定プロセスにおける価格の重要性
    • 哺乳類細胞株開発のアウトソーシング
    • CMOが期待する技術サポート
    • CMOとの共同作業の機会
    • 低いベース価格と高い成功報酬に関する考察
  • 請負業者のロケーション
    • CMOの選定に影響を及ぼす地理的位置付け
    • アジアベースのCMOの検証
    • 中国市場における中国のCMOの利用
  • 技術・サービスの動向
    • 独自の発現系の利用
    • 独自の発現系への好まれる決済モデル
    • GMP製造価格へのエンジニアリングランの算入
    • 製品ポートフォリオの変化・必要とされる新技術

第5章 請負業者の事業戦略と顧客タイプ

  • 事業戦略
  • 顧客基盤
  • 技術・サービスの動向

第6章 委託契約:期待/好み

  • 価格モデル:ユーザーの期待
  • 請負業者による価格設定の慣習と好み

第7章 支払い済み価格と価格の推移

  • プロセス開発価格
  • FTEレート
  • 請負業者の価格モデル
  • 請負業者のレート:短期 vs 長期
  • 価格:バッチ・週・グラムあたり
  • 特別分析:グラムあたりの価格の比較
  • 特別分析:バッチ・週・リットルあたりの価格
  • 付加サービスへの一般的な価格

第8章 請負契約の改善・最終考察

  • 製造契約交渉
  • ユーザーの展望:問題への備え
  • 請負業者の展望:問題への備え
  • 最終考察
目次

‘Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2019 ’ provides an analysis of the biopharmaceutical contract manufacturing market's best practices in pricing and contract agreements. The research was specifically designed to understand price structures and actual prices, payment terms, and contractual agreements. In-depth data collected from both pharmaceutical and biotechnology company respondents as well as contract manufacturing organizations allowed for an objective analysis of individual pricing practices while respondent names remain anonymous.

We thank the 37 respondents from pharmaceutical, biotechnology, and contract manufacturing companies who took the time to share their insights, opinions, and pricing practices with us. We thank our sponsoring companies, who supported this project with their ideas, suggested topics, and funding for this project.

Table of Contents

Chapter 1: EXECUTIVE SUMMARY

  • 1.1. Introduction
  • 1.2. Participants' Locations
  • 1.3. Industry Pricing Trends
    • 1.3.1. Recent Industry Pricing Changes
    • 1.3.2. Expected Price Change over the Next Two Years
  • 1.4. Outsourcing Strategies and Contractor Selection
    • 1.4.1. Significance of Price in Contractor Selection
    • 1.4.2. Important Attributes Sought in Long-Term Client-CMO Relationship
    • 1.4.3. Benefit- or Risk-Sharing Agreements
    • 1.4.4. Capital Equipment Arrangements
  • 1.5. Contractors' Business Strategies and Customer Types
    • 1.5.1. Tier Pricing for Strategic Customers
    • 1.5.2. Annual Price Adjustment Policies
    • 1.5.3. Small-Scale Commercialization Trends
    • 1.5.4. Key Factors Affecting Manufacturing Costs
  • 1.6. Contract Agreement: Expectations and Preferences
    • 1.6.1. Users' Preferred Pricing Models
    • 1.6.2. Users' Preferred Payment Terms for Proprietary Cell Line
    • 1.6.3. Contractors' Rescheduling Incentives
  • 1.7. Prices Paid and Prices Charged
    • 1.7.1. Contractors' Pricing Models
    • 1.7.2. Per-Batch Prices: Mammalian and Microbial
    • 1.7.3. Price Per-Gram Analysis: 2019 Versus 2016
  • 1.8. Improving Contract Agreements and Solving Problems
    • 1.8.1. Users' Perspective: Unacceptable Contract Terms
    • 1.8.2. The Effect of Large Capacity Additions
    • 1.8.3. Commoditization of Biopharmaceutical Manufacturing
    • 1.8.4. Users' Final Observations

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: INDUSTRY PRICING TRENDS

  • 3.1. Introduction
    • 3.1.1. Participants' Locations and Job Titles
    • 3.1.2. Approved Biopharmaceutical Products on Market
    • 3.1.3. Number of Biopharmaceuticals in Clinical Trials
  • 3.2. Industry Pricing Trends
    • 3.2.1. Recent Industry Price Changes
    • 3.2.2. Services with the Greatest Price Change
    • 3.2.3. Contractor Average Annual Price Increase: Past Five Years
    • 3.2.4. Expected Price Changes over the Next Two Years
  • 3.3. Estimates: Profit Margins
    • 3.3.1. Contractors' Target Gross Profit Margins

Chapter 4: OUTSOURCING STRATEGIES/CONTRACTOR SELECTION

  • 4.1. Outsourcing Strategies
    • 4.1.1. Manufacturing Budgets: In-House versus Outsourced
    • 4.1.2. Outsourcing Budgets: Process Development versus Manufacturing
    • 4.1.3. Users' Outsourcing Strategies
    • 4.1.4. Users' Regional Supply Strategy
    • 4.1.5. Users' Current Contractors
    • 4.1.6. Major Concerns with CMOs
  • 4.2. Engaging and Selecting a Contractor
    • 4.2.1. Top CMO Selection Criteria
    • 4.2.2. Stage and Trigger of Initial CMO Contact
    • 4.2.3. Timing of RFP Bid
    • 4.2.4. RFP to Technology Transfer Timeline
    • 4.2.5. Number of CMOs Contacted for Project Proposals
    • 4.2.6. RFP Review Process
    • 4.2.7. Final Contract Negotiation
    • 4.2.8. Decision Maker for CMO Selection
    • 4.2.9. Significance of Price in CMO Selection
    • 4.2.10. Important Attributes Sought in Long-Term Client-CMO Relationship
  • 4.3. CMO Location
    • 4.3.1. Geographic Location's Effect on CMO Selection for Process Development
    • 4.3.2. Consideration of Western-CMO in China to Target Chinese Market
    • 4.3.3. Interest in Using Non-Western-CMO in APAC Region to Target EU/US Market
  • 4.4. Technology and Service Trends
    • 4.4.1. Value of One-Stop-Shop CMO
    • 4.4.2. Benefit- or Risk-Sharing Agreements
    • 4.4.3. Capital Equipment Arrangements
    • 4.4.4. Capacity Shift to SUBs for Small-Scale Production

Chapter 5: CONTRACTORS' BUSINESS STRATEGIES/CUSTOMER TYPES

  • 5.1. Business Strategies
    • 5.1.1. Contractors' Focus or Business Strategy
    • 5.1.2. Tier Pricing for Strategic Clients
    • 5.1.3. Annual Price Adjustment Policies
    • 5.1.4. Client Interest in One-Stop-Shop
    • 5.1.5. One-Stop-Shop Contracts in Effect
    • 5.1.6. Leveraging Process Analytical Development Team with Prospective Clients
  • 5.2. Customer Base
    • 5.2.1. Fee-for-Service versus Partnership Contracts
    • 5.2.2. Domestic versus Export Clients
    • 5.2.3. Contractors' Client Segments
  • 5.3. Technology and Service Trends
    • 5.3.1. Small-Scale Commercialization Trends
    • 5.3.2. Volume Shift for Microbial Fermentation
    • 5.3.3. Key Factors Affecting Manufacturing Costs

Chapter 6: CONTRACT AGREEMENT: EXPECTATIONS/PREFERENCES

  • 6.1. Users' Expectations of Pricing Models
    • 6.1.1. Expectations of Core Charges: Users versus Contractors
    • 6.1.2. Preferred Pricing Models
    • 6.1.3. Preferred Pricing Structure for API
    • 6.1.4. Preferred Pricing Model for Commercial Supply
    • 6.1.5. Preferred Payment Terms for Proprietary Cell Line
    • 6.1.6. Services Users Will Pay a Premium for Speed or Early Capacity
    • 6.1.7. CMO-Purchased Material Markup
  • 6.2. Contractors' Pricing Practices and Preferences
    • 6.2.1. Premium Paid by Clients for Early Capacity Availability
    • 6.2.2. Client Capital Equipment Investment
    • 6.2.3. Rescheduling Incentives
    • 6.2.4. Typical Cell- or Gene-Therapy Contract Terms
    • 6.2.5. Dedicated Suite Pricing Model
    • 6.2.6. Typical Dedicated Suite Reservation Fees

Chapter 7: PRICES PAID AND PRICES CHARGED

  • 7.1. Hourly Rates
  • 7.2. Contractors' Pricing Models
  • 7.3. Contractor and User Production Prices
    • 7.3.1. GMP Production Batches
    • 7.3.2. Per-Batch Pricing: Contractor versus User Averages
    • 7.3.3. Per-Batch Pricing: Contractor and User Distributions
    • 7.3.4. GMP Batch Pricing: Stainless Steel versus Single-Use Bioreactor
    • 7.3.5. GMP Batch Pricing: Microbial Refolding
    • 7.3.6. Contractors' GMP Batch Pricing: Multiple Batch Discounts
  • 7.4. Price Per-Gram: 2019 versus 2016
  • 7.5. Raw Material and Other Service Charges
    • 7.5.1. Raw Materials and Consumables Cost
    • 7.5.2. Typical Charges for Other Mammalian Cell Culture Services
    • 7.5.3. Typical Charges for Other Microbial Fermentation Services
  • 7.6. Viral Vector Therapy Pricing

Chapter 8: IMPROVING CONTRACT AGREEMENTS AND FINAL OBSERVATIONS

  • 8.1. Users' Contract Agreements
    • 8.1.1. Users' Perspective: Unacceptable Contract Terms
    • 8.1.2. Users' Opinions on Reasonable Cancellation Fees
  • 8.2. Contractors' Contract and Operational Changes
    • 8.2.1. Typical RFP Timelines
    • 8.2.2. RFP Response: Rough Estimate versus Detailed Proposal
    • 8.2.3. Down Payment at Contract Signing
    • 8.2.4. Contractors' Reservation Fees for GMP Runs
    • 8.2.5. Contractors' Cancellation Fees for GMP Runs
    • 8.2.6. Unutilized Reserved Capacity
    • 8.2.7. Pass-Through Cost Estimates
    • 8.2.8. Itemizing Pass-Through Costs
    • 8.2.9. Markup on Pass-Through Items
  • 8.3. Future Observations
    • 8.3.1. The Effect of Large Production Capacity Additions
    • 8.3.2. Commoditization of Biopharmaceutical Manufacturing
    • 8.3.3. Venture Capital Funding Shift to Novel Products
    • 8.3.4. Contractors' Areas of Future Growth
    • 8.3.5. Users' Perspective: Other Observations
    • 8.3.6. Contractors' Perspective: Other Observations

LIST OF TABLES

Chapter 1

  • 1.3-1: Expected Annual Price Changes by Respondent Group
  • 1.4-1: Other Important Factors in Decision-Making Process
  • 1.4-2: Important Attributes for a Long-Term or Commercial Relationship
  • 1.5-1: Tier Pricing Offering by CMO Segment
  • 1.5-2: Factors Affecting Manufacturing Costs
  • 1.6-1: Pricing Model Usage Frequency by Percentage of Users
  • 1.6-2: Preferred Pricing Model by Project Phase
  • 1.6-3: Proprietary Cell Line Payment Preferences
  • 1.7-1: Contractor' Preferred Pricing Models by Project Phase
  • 1.8-1: Unacceptable Contract Terms
  • 1.8-2: Effect of Increased Capacity on Pricing
  • 1.8-3: Other Effects of Increased Capacity
  • 1.8-4: Areas of Commoditization
  • 1.8-5: Barriers to Commoditization
  • 1.8-6: Additional User Observations about Pricing and Contract Agreements

Chapter 2

  • 2.2-1: Market Research Steps
  • 2.5-1: Acronyms

Chapter 3

  • 3.1-1: Titles of Respondents Listed Alphabetically
  • 3.2-1: Changing Prices
  • 3.2-2: Products or Services with Greatest Price Change
  • 3.2-3: Five-Year Average Annual Price Increases by CMO Segment
  • 3.2-4: Expected Annual Price Changes by Respondent Group
  • 3.3-1: Contractors' Target Gross Profit Margins

Chapter 4

  • 4.1-1: Regional Supply Strategies
  • 4.1-2: Contract Manufacturers Used by Respondents
  • 4.1-3: Concerns with Drug Product Manufacturing
  • 4.2-1: Essential Characteristics for Choosing a CMO-Clinical
  • 4.2-2: Essential Characteristics for Choosing a CMO-Commercial
  • 4.2-3: Triggers for Outreach to a CMO
  • 4.2-4: RFP to Technology Transfer Timelines
  • 4.2-5: Criteria Used for Ranking
  • 4.2-6: Management Level for CMO Selection
  • 4.2-7: Change in Decision Maker for CMO Selection as Project Progresses
  • 4.2-8: Other Important Factors in Decision-Making Process
  • 4.2-9: Important Attributes for a Long-Term or Commercial Relationship

Chapter 4

  • 4.3-1: Use of Western-CMO in China by User Segment
  • 4.3-2: Use of Non-Western-CMO in APAC Region by User Segment
  • 4.3-3: Acceptable Countries for Non-Western-CMO Consideration
  • 4.3-4: Reasons for Not Considering a Non-Western-CMO in APAC Region
  • 4.4-1: Value of One-Stop-Shop CMO by User Segment
  • 4.4-2: Advantages and Disadvantages of Using a One-Stop-Shop CMO

Chapter 5

  • 5.1-1: Tier Pricing Offering by Contractor Segment
  • 5.1-2: Client One-Stop-Shop Interest by Contractor Segment
  • 5.1-3: Ways to Leverage Process Analytical Development Team
  • 5.2-1: Client Mix: Fee-for-Service versus Partnership Contracts
  • 5.2-2: Contractors' Client Base by Segment
  • 5.3-1: Factors Affecting Manufacturing Costs

Chapter 6

  • 6.1-1: Pricing Model Usage Frequency by Percentage of Users
  • 6.1-2: Preferred Pricing Model by Project Phase
  • 6.1-3: Proprietary Cell Line Payment Preferences
  • 6.1-4: Premiums for Shorter Timelines
  • 6.1-5: Pass-Through Costs Payment Terms
  • 6.2-1: Contractors' Opinions on Quick-Turn Premiums
  • 6.2-2: Examples of Cell- or Gene-Therapy Contract Terms
  • 6.2-3: Suite Time Fee Variables
  • 6.2-4: Dedicated Suite Reservation Fee

Chapter 7

  • 7.1-1: Average Hourly Rates
  • 7.1-2: Hourly Rate with Highest Percentage Mentions by Activity
  • 7.2-1: Contractors' Preferred Pricing Models by Project Phase
  • 7.3-1: Average Number of Batches per Project by Tank Size
  • 7.4-1: Number of Users' Products Included in the Analysis
  • 7.5-1: Pass-Through Consumable and Raw Material Prices Paid
  • 7.5-2: Prices Paid or Charged for Additional Services: Mammalian Cell Culture
  • 7.5-3: Prices Paid or Charged for Additional Services: Microbial Fermentation

Chapter 8

  • 8.1-1: Unacceptable Contract Terms
  • 8.1-2: Users: Reasonable Cancellation Fees
  • 8.2-1: RFP Timelines
  • 8.2-2: Contractors: Cancellation Fees
  • 8.2-3: Itemizing Pass-Through Costs by CMO Segments
  • 8.2-4: Pass-Through Cost Items Subject to Markup
  • 8.3-1: Effect of Increased Capacity on Pricing
  • 8.3-2: Other Effects of Increased Capacity
  • 8.3-3: Areas of Commoditization
  • 8.3-4: Barriers to Commoditization
  • 8.3-5: Product Categories Receiving VC Funding
  • 8.3-6: VC Funding Effects on Contract Manufacturing
  • 8.3-7: Contractors Future Areas of Growth and Development
  • 8.3-8: Additional User Observations about Pricing and Contract Agreements
  • 8.3-9: Additional Contractor Observations

LIST OF FIGURES

Chapter 1

  • 1.2-A: Location of Study Participants
  • 1.3-A: Past Two Years Price Change Observations
  • 1.3-B: Expected Annual Price Increases
  • 1.3-C: Price Changes by Service Segment over the Next Two Years
  • 1.4-A: Importance of Price in CMO Selection
  • 1.4-B: Importance of Price for Commercial Supply
  • 1.4-C: Benefit- or Risk-Sharing Arrangement
  • 1.4-D: Willingness to Pay for Capital Equipment at CMO
  • 1.4-E: Reasons for Users Installing Capital Equipment at CMOs
  • 1.4-F: Stipulated Conditions of Capital Purchase
  • 1.5-A: Tier Pricing Offering
  • 1.5-B: Contract Inflation Provisions
  • 1.5-C: Commercialization at Smaller Scales
  • 1.5-D: Relative Margins by Scale
  • 1.5-E: Managing Cost Factors
  • 1.6-A: Pricing Model Usage Frequency by Number of Users
  • 1.6-B: Users' Preferred Pricing Model by Project Phase
  • 1.6-C: Proprietary Cell Line Preferred Payment Terms
  • 1.6-D: Proprietary Cell Line Preferred Payment Terms by User Segment
  • 1.6-E: Incentive Availability for Client Rescheduling
  • 1.7-A: Contractors: Pricing Models Based on Mix of Contracts
  • 1.7-B: Contractors' Preferred Pricing Models by Project Phase
  • 1.7-C: Per-Batch Pricing: Average Prices Charged and Paid: Mammalian
  • 1.7-D: Per-Batch Pricing: Average Prices Charged and Paid: Microbial
  • 1.7-E: Per-Gram Pricing: Fee Per Gram by Project Volumes: Mammalian
  • 1.7-F: Per-Gram Pricing: Fee Per Gram by Project Volumes: Microbial
  • 1.8-A: Effect of Expected Capacity Increase on Pricing
  • 1.8-B: Commoditization in the Biopharmaceutical Manufacturing Industry

Chapter 2

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

Chapter 3

  • 3.1-A: Location of Study Participants
  • 3.1-B: Respondents with Biopharmaceutical Products on the Market
  • 3.1-C: Respondents with Biopharmaceuticals in Clinical Trials
  • 3.1-D: Number of Biopharmaceuticals in Clinical Trials
  • 3.2-A: Past Two Years Price Change Observations
  • 3.2-B: Distribution of Five-Year Annual Price Increases
  • 3.2-C: Expected Annual Price Increases (Users and Contractors)
  • 3.2-D: Price Changes by Service Segment over the Next Two Years
  • 3.3-A: Contractors' Target Gross Profit Margins by Phase: 2019 and 2022

Chapter 4

  • 4.1-A: Outsource versus In-House Manufacturing
  • 4.1-B: Manufacturing Budgets: Outsourced versus In-House
  • 4.1-C: Percentage of Budget Spent on Outsourcing
  • 4.1-D: Change in Proportion of Manufacturing Budget for Outsourced Production
  • 4.1-E: Outsourcing Budgets: Process Development versus Manufacturing
  • 4.1-F: Level of Outsource Spending for Process Development and Manufacturing
  • 4.1-G: Change in Outsourcing Spending for Process Development and Manufacturing
  • 4.1-H: Summary of Outsourcing Strategies
  • 4.1-I: Regional Supply Strategy
  • 4.2-A: Initial Contact with CMO
  • 4.2-B: Average Time RFP Sent in Advance of GMP Material Requirements
  • 4.2-C: Examples of RFP Timelines
  • 4.2-D: Number of CMOs that Users Seek Proposals From
  • 4.2-E: General Process Used to Review Proposals
  • 4.2-F: Number of CMOs in Final Contract Negotiation
  • 4.2-G: Change in Decision Maker for CMO Selection as Project Progresses
  • 4.2-H: Importance of Price in CMO Selection
  • 4.2-I: Importance of Price for Commercial Supply
  • 4.3-A: Effect of Geographic Location on CMO Selection
  • 4.3-B: Reasons for Proximity Importance
  • 4.3-C: Use of Western-CMO in China to Target Chinese Market
  • 4.3-D: Price Expectation: Western CMO in China versus Western-Region CMO
  • 4.3-E: Price Expectation: Western CMO in China versus Local Chinese CMO
  • 4.3-F: Using Non-Western-CMO in APAC Region to Target EU/US Market
  • 4.3-G: Price Expectation: Non-Western-CMO in APAC vs. Western-Region CMO
  • 4.4-A: Value of One-Stop-Shop CMO
  • 4.4-B: Benefit- or Risk-Sharing Arrangement
  • 4.4-C: Willingness to Pay for Capital Equipment at CMO
  • 4.4-D: Reasons for Users Installing Capital Equipment at CMOs
  • 4.4-E: Stipulated Conditions of Capital Purchase
  • 4.4-F: Capacity Shift to SUBs for Small-Scale Production
  • 4.4-G: Price Difference: Disposables versus Stainless Steel Bioreactors

Chapter 5

  • 5.1-A: Phase-Based Business Focus
  • 5.1-B: Tier Pricing Offering
  • 5.1-C: Contract Inflation Provisions
  • 5.1-D: Clients' Interest in One-Stop-Shop
  • 5.1-E: One-Stop-Shop Contract Practices
  • 5.1-F: Using Process Analytical Development Team to Win Clients
  • 5.2-A: Fee-for-Service versus Partnership Contracts
  • 5.2-B: Percentage of Domestic Clients
  • 5.2-C: Contractors' Client Base by Segment

Chapter 5

  • 5.3-A: Commercialization at Smaller Scales
  • 5.3-B: Relative Margins by Scale
  • 5.3-C: Shift in Microbial Fermentation Volumes
  • 5.3-D: Shift to Smaller or Larger Microbial Fermentation Volumes
  • 5.3-E: Managing Cost Factors

Chapter 6

  • 6.1-A: Activity Types Expected to be Included in Batch Pricing
  • 6.1-B: Activity Types Expected to be Charged as Separate Item
  • 6.1-C: Pricing Model Usage Frequency by Number of Users
  • 6.1-D: Users' Preferred Pricing Model by Project Phase
  • 6.1-E: API Preferred Price Structure
  • 6.1-F: Commercial Supply Preferred Price Model
  • 6.1-G: Commercial Supply Preferred Price Model by User Segment
  • 6.1-H: Proprietary Cell Line Preferred Payment Terms
  • 6.1-I: Proprietary Cell Line Preferred Payment Terms by User Segment
  • 6.1-J: Willingness to Pay Premium for Speed or Earliest Capacity Availability
  • 6.1-K: Distribution of Average Premium for Speed or Earliest Capacity Availability
  • 6.1-L: Pass-Through Items Subject to Markup
  • 6.1-M: Distribution of Raw Materials and Consumables Markups
  • 6.1-N: Distribution of Resins Markups
  • 6.1-O: Distribution of Services Markups
  • 6.1-P: Pass-Through Cost Payment Timing Drivers
  • 6.1-Q: Comparison of CMO Markups Charged for Purchased Materials
  • 6.2-A: Incentive Availability for Client Rescheduling
  • 6.2-B: Dedicated Suite Offering

Chapter 7

  • 7.1-A: Hourly Rates for Process Development
  • 7.1-B: Hourly Rates for Manufacturing Staff
  • 7.1-C: Hourly Rates for QC Staff
  • 7.1-D: Hourly Rates for Project Management Staff
  • 7.1-E: Hourly Rates for Regulatory Support Staff
  • 7.1-F: Hourly Rates for Analytical Development Staff
  • 7.2-A: Contractors: Pricing Models Based on Mix of Contracts
  • 7.2-B: Contractors' Preferred Pricing Models by Project Phase
  • 7.3-A: Per-Batch Pricing: Average Prices Charged and Paid: Mammalian
  • 7.3-B: Per-Batch Pricing: Average Prices Charged and Paid: Microbial
  • 7.3-C: Box-and-Whiskers Plot Explanation
  • 7.3-D: Per-Batch Pricing: Fee Per-Batch by Tank Size Category: Mammalian
  • 7.3-E: Per-Batch Pricing: Fee Per-Batch by Tank Size Category: Microbial
  • 7.3-F: Per-Batch Pricing: Stainless Steel versus Single-Use Project: Mammalian
  • 7.3-G: Per-Batch Pricing: No Refolding versus Refolding: Microbial
  • 7.3-H: Multiple Batch Discounts

Chapter 7

  • 7.4-A: Per-Gram Pricing: Fee Per-Gram by Project Volumes: Mammalian
  • 7.4-B: Per-Gram Pricing: Fee Per-Gram by Project Volumes: Microbial
  • 7.6-A: Viral Vector Batch Pricing Distribution by Process Type
  • 7.6-B: Viral Vector Batch Pricing Distribution by Respondent and Process Type

Chapter 8

  • 8.1-A: Users' Opinion on Reasonable Cancellation Fees for GMP Runs
  • 8.2-A: Examples of RFP Timelines
  • 8.2-B: Distribution of Down Payment at Contract Signing
  • 8.2-C: Charging Reservation Fees for GMP Runs
  • 8.2-D: Distribution of Average Reservation Fees Charges
  • 8.2-E: Time Slot Guarantee and Reservation Fee Payment Terms
  • 8.2-F: Contractors: Cancellation Fees for GMP Runs
  • 8.2-G: Contractors: Distribution of Cancellation Fees for GMP Runs
  • 8.2-H: Comparison of Contractor and User Cancellation Fees
  • 8.2-I: Percent of Time Reserved Capacity Unutilized
  • 8.2-J: Deliberately Blocked Capacity
  • 8.2-K: Estimate Timing of Pass-Through Costs and Lead Times
  • 8.2-L: Average Markup Charge for Pass-Through Costs
  • 8.3-A: Effect of Expected Capacity Increase on Pricing
  • 8.3-B: Commoditization in the Biopharmaceutical Manufacturing Industry
  • 8.3-C: VC Funding Shift to Novel Products
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