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市場調查報告書

生物製藥代工:最佳業務實踐和價格設定分析 (2016年)

Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2016

出版商 HighTech Business Decisions 商品編碼 206945
出版日期 內容資訊 英文 350 Pages; 225+ Charts & Tables
商品交期: 最快1-2個工作天內
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生物製藥代工:最佳業務實踐和價格設定分析 (2016年) Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2016
出版日期: 2016年08月25日 內容資訊: 英文 350 Pages; 225+ Charts & Tables
簡介

本報告提供生物製藥代工的慣例及價格趨勢調查,提供您哺乳類細胞培養,微生物培養,其他服務的收費系統,實際的價格變化與預測,定購者的外包策略和承包商的選擇相關考察,承包商的產業策略,定購者·承包者的兩方的契約慣例·喜好,並彙整契約的改善·最佳業務實踐等相關考察資料。

第1章 摘要整理

第2章 調查方法·定義·簡稱

第3章 產業價格趨勢

  • 簡介
    • 核准·已上市生物醫藥品
    • 臨床試驗中的生物醫藥品
    • 核准商業生產用的CMO工廠所製造的產品
  • 產業價格趨勢
    • 近幾年產業價格的轉變
    • CMO今後的藥價設定變更
    • 價格大幅變動的服務
    • 製造成本的因素
  • 利益幅度
    • 承包商的毛利目標

第4章 外包策略和承包商的選擇

  • 外包策略
    • 製造預算:公司內部 vs 外包
    • 外包預算:製程發展 vs 製造
    • 用戶的外包策略
    • 用戶的外包策略未來變化
  • 承包商的關係性
    • 用戶的目前承包商
    • 新·其他承包商相關計劃
  • 承包商的選擇
    • 與承包商的初期接觸
    • 為了計劃提案而接觸的CMO數
    • CMO選擇的決策者
    • 決策流程中價格的重要性
    • 哺乳類細胞株開發的外包
    • CMO期待的技術支援
    • 跟CMO共同工作的機會
    • 低基礎價格與高成功報酬相關考察
  • 承包商的定位
    • 地理地位影響CMO的選擇
    • 亞洲為準的CMO檢驗
    • 中國市場上中國CMO的利用
  • 技術·服務趨勢
    • 利用獨家表現系統
    • 對獨家表現系統的偏好之付款模式
    • engineering run對GMP製造價格算入
    • 產品系列的變化·必要的新技術

第5章 承包商的產業策略和客戶類型

  • 產業策略
  • 基本客群
  • 技術·服務趨勢

第6章 委託契約:期待/喜好

  • 定價模式:用戶的期待
  • 承包商的價格設定慣例和偏好

第7章 支付完成價格和價格的轉變

  • 製程發展價格
  • FTE比率
  • 承包商的定價模式
  • 承包商的比率:短期 vs 長期
  • 每價格:批次式·周·克
  • 每特別分析:克的價格比較
  • 每特別分析:批次式·周·公升的價格
  • 補充服務的一般價格

第8章 承包契約的改善·最後考察

  • 製造契約談判
  • 對用戶的展望:問題的準備
  • 對承包商的展望:問題的準備
  • 最後考察

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目錄

This 350-page report details both the prices paid by biotechnology companies and prices charged by biopharmaceutical contract manufacturing organizations for large-molecule drug substance production, using both mammalian cell culture and microbial fermentation technologies, at specific bioreactor tank sizes. In addition, this report documents current prices for other services offered by the contract manufacturing organizations, including cell banking, cell-line development, process development, technology transfer, and regulatory support.

William Downey, president of HighTech Business Decisions, explained, “According to the biotechnology and contract manufacturing executives, overall contract manufacturing prices have shown a moderate increase over the past two years as industry supply and demand come into balance. Furthermore, contract manufacturing organizations see higher demand, greater capacity-especially disposable bioreactors, and added regulatory and quality requirements will affect industry pricing. Going forward, most biotechnology executives expect to pay higher prices for production, analytical and development services, and stability and release testing.”

This report provides the reader with over 225 detailed charts and tables covering industry trends, prices, and selected contract terms such as reservation and cancellation fees, change orders, price models and arrangements. In addition to production prices, this report also documents FTE rates paid and charged by major functional areas.

Table of Contents

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. Changes in CMO Pricing in Next Two Years
  • 1.4. Outsourcing Strategies and Contractor Selection
    • 1.4.1. Users' Outsourcing Strategies
    • 1.4.2. Importance of Price in Decision-Making Process
    • 1.4.3. Technical Support Expected from CMO
    • 1.4.4. Use of China CMO for Chinese Market
  • 1.5. Contractors' Business Strategies and Customer Types
    • 1.5.1. Contractors' Client Segments
    • 1.5.2. Importance of Price in Clients' Decision-Making Process
    • 1.5.3. Provisions for Inflation in Contracts
    • 1.5.4. CMOs' Management of Development Risk
  • 1.6. Contract Agreement: Expectations and Preferences
    • 1.6.1. Preferred Pricing Models
    • 1.6.2. Premium Paid for Earliest Capacity Availability
    • 1.6.3. Typical Pricing Model for Development Services
  • 1.7. Prices Paid and Prices Charged
    • 1.7.1. Contractors' Pricing Models
    • 1.7.2. Pricing: Per-Batch, Per-Week, and Per-Gram
  • 1.8. Improving Contract Agreements and Solving Problems
    • 1.8.1. Users' Perspective: Negotiation Challenges
    • 1.8.2. Contractors' Perspective: Negotiation Challenges
    • 1.8.3. Contractors' Cancellation Fees for GMP Runs
    • 1.8.4. Users' Tolerance of CMO Rescheduling
    • 1.8.5. Final Observations

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

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
    • 3.1.4. Product Produced in CMO Facility Licensed for Commercial Production
  • 3.2. Industry Pricing Trends
    • 3.2.1. Recent Industry Price Changes
    • 3.2.2. Changes in CMO Pricing in the Next Two Years
    • 3.2.3. Services Where Prices Have Changed the Most
    • 3.2.4. Key Factors Affecting Manufacturing Costs
  • 3.3. Profit Margins
    • 3.3.1. Contractors' Target Gross Profit Margins

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' Future Changes to Outsourcing Strategy
  • 4.2. Contractor Relationships
    • 4.2.1. Users' Current Contractors
    • 4.2.2. Plans for New or Different Contractors
  • 4.3. Contractor Selection
    • 4.3.1. Initial Contact with Contractors
    • 4.3.2. Number of CMOs Contacted for Proposals for Project
    • 4.3.3. Decision Maker for CMO Selection
    • 4.3.4. Importance of Price in Decision-Making Process
    • 4.3.5. Outsourcing of Mammalian Cell-Line Development
    • 4.3.6. Technical Support Expected from CMO
    • 4.3.7. Co-Work Opportunities with CMO
    • 4.3.8. Consideration of Low Base Price with Bonuses Tied to Targets
  • 4.4. Contractor Location
    • 4.4.1. Geographic Location Impact on CMO Selection
    • 4.4.2. Consideration of Asia-Based CMO
    • 4.4.3. Use of China CMO for Chinese Market
  • 4.5. Technology and Service Trends
    • 4.5.1. Use of Proprietary Expression Systems
    • 4.5.2. Preferred Payment Model for Proprietary Expression Systems
    • 4.5.3. Inclusion of Engineering Runs in GMP Production Price
    • 4.5.4. Changes in Product Portfolio and New Technologies Needed

5. Contractors' Business Strategies/Customer Types

  • 5.1. Business Strategies
    • 5.1.1. CMO Focus or Business Strategy
    • 5.1.2. Importance of Price in Clients' Decision-Making Process
    • 5.1.3. Provisions for Inflation in Contracts
    • 5.1.4. CMOs' Management of Development Risk
  • 5.2. Customer Base
    • 5.2.1. Fee-for-Service versus Partnership Contracts
    • 5.2.2. Domestic versus International Clients
    • 5.2.3. Contractors' Client Segments
  • 5.3. Technology and Service Trends
    • 5.3.1. Inclusion of Engineering Runs in GMP Production
    • 5.3.2. Number of Runs in a Campaign
    • 5.3.3. Provisions for Raw and Consumable Materials
    • 5.3.4. Material Pass-Through Costs
    • 5.3.5. Charging for Product Support/Project Management
    • 5.3.6. Electronic Documentation

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. Services Users are Willing to Pay a Premium for Speed
    • 6.1.4. Mammalian Cell-Line Development Pricing and Time Expectation
    • 6.1.5. Markups of CMO Purchased Materials
    • 6.1.6. Users' Management of Development Risk
  • 6.2. Contractors' Pricing Practices and Preferences
    • 6.2.1. Services Clients Willing to Pay Premium for Speed
    • 6.2.2. Typical Pricing Model for Development Services
    • 6.2.3. Charging for Pre-Production Services
    • 6.2.4. Typical Charge for IND Submission Services
    • 6.2.5. Long-Term Supply Agreement with Clients
    • 6.2.6. Price Reduction Provisions from Process Improvements

7. Prices Paid and Prices Charged

  • 7.1. Process Development Prices
    • 7.1.1. Process Development Prices and Time Estimates: Mammalian
    • 7.1.2. Process Development Prices and Time Estimates: Microbial
    • 7.1.3. FTE Rates for Process Development
  • 7.2. FTE Rates
  • 7.3. Contractors' Pricing Models
  • 7.4. Contractors' Short-Term versus Long-Term Rates
    • 7.4.1. Contractors' Batch Pricing: Single versus Multiple Batches
    • 7.4.2. Contractors' Batch Pricing: Stainless Steel versus Single-Use
    • 7.4.3. Batch Pricing: Microbial Refolding
  • 7.5. Pricing: Per-Batch, Per-Week, and Per-Gram
    • 7.5.1. Per-Batch Pricing: Contractor versus User Averages
    • 7.5.2. Time-in-Facility Pricing: Contractor versus User Averages
    • 7.5.3. Price-Per-Gram: Contractor versus User Averages
  • 7.6. Special Analysis: Price Per-Gram 2016 versus 2013
  • 7.7. Special Analysis: Price Per-Batch or Per-Week, Per-Liter
  • 7.8. Typical Charges for Additional Services
    • 7.8.1. Typical Charges for Mammalian Cell Culture Services
    • 7.8.2. Typical Charges for Microbial Fermentation Services

8. Improving Contract Agreements and Final Observations

  • 8.1. Contract Negotiations for Production
    • 8.1.1. Users' Perspective: Negotiation Challenges
    • 8.1.2. Contractors' Perspective: Negotiation Challenges
  • 8.2. Users' Perspective: Preparing for Problems
    • 8.2.1. Users' Experience with Cancellation Fees for GMP Runs
    • 8.2.2. Users' Cancellation Fees for Development/Non-GMP Batches
    • 8.2.3. Users' Frequency of Change Orders
  • 8.3. Contractors' Perspectives: Preparing for Problems
    • 8.3.1. Contractors' Reservation Fees For GMP Runs
    • 8.3.2. Contractors' Reservation Fees for Development/Non-GMP Batches
    • 8.3.3. Contractors' Cancellation Fees for GMP Runs
    • 8.3.4. Contractors' Cancellation Fees for Development/Non-GMP Batches
    • 8.3.5. Flexibility in Rescheduling Manufacturing Campaigns
    • 8.3.6. Users' Tolerance of CMO Rescheduling
  • 8.4. Final Observations
    • 8.4.1. Concerns Regarding Capital Expenditures or Supply Capability
    • 8.4.2. Changes in Commercial Contract Terms Due to Capacity Concerns
    • 8.4.3. Commoditization of Biopharmaceutical Manufacturing
    • 8.4.4. Market Challenges: CMOs
    • 8.4.5. Users' Perspective: Other Observations
    • 8.4.6. Contractors' Perspective: Other Observations
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