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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 (2016年)

Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2016

発行 HighTech Business Decisions 商品コード 206945
出版日 ページ情報 英文 350 Pages; 225+ 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 (2016年) Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2016
出版日: 2016年08月25日 ページ情報: 英文 350 Pages; 225+ 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

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目次

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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