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市場調查報告書

生物醫藥品的無菌製劑 (充填作業) :最佳業務實踐調查 2015年

Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015

出版商 HighTech Business Decisions 商品編碼 261635
出版日期 內容資訊 英文 550 Pages
商品交期: 最快1-2個工作天內
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生物醫藥品的無菌製劑 (充填作業) :最佳業務實踐調查 2015年 Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015
出版日期: 2015年11月30日 內容資訊: 英文 550 Pages
簡介

生物醫藥品的無菌製劑 (充填作業) 契約服務市場過去3年以17%的年複合成長率成長。該市場今後也持續擴大,預計2020年達到24億美元。

本報告提供生技藥品的無菌製劑受託製造市場相關調查分析、生物製造業、外包相關目前策略、必要的與有關服務、能力、價格政策、未來的策略等彙整資料、用戶及供應商的詳細的資料,為您概述為以下內容。

第1章 摘要整理

第2章 調查方法、定義、簡稱

第3章 無菌製劑 (充填作業) 受託製造:市場概要

  • 簡介
  • 供應商:無菌製劑受託製造企業
    • 企業的種類
    • 受託製造企業
    • 投藥形態和服務
    • 受託製造的能力
  • 客戶:製藥公司、生物科技公司
    • 客戶的產品
    • 外包的充填作業:各投藥形態
    • 客戶的未來外包前景
    • 外包的需求
  • 市場能力
  • 市場規模
    • 客戶支出為基礎市場規模預測
    • 受託製造企業的收益為基礎的市場規模預測
    • 各投藥形態、服務分類的市場規模
  • 市場成長預測
  • 無菌製劑受託製造市場趨勢
    • 產業創新與課題
    • 產業整體趨勢

第4章 製藥公司、生物科技公司:客戶分析

  • 簡介
  • 製造需求
    • 需求
    • 投藥形態
    • 臨床、商業產品
  • 製造技術
    • 藥物銷售的計劃格式
    • 新的給藥技術
    • 特殊處理必要條件
    • 收穫率損失
  • 外包策略
    • 目前公司內部製造能力、外包策略
    • 公司內部製造能力的變化
    • 核心/非核心技術的影響
    • 標準/非標準技術的影響
    • 聚焦今後5年的製造外包
  • 外包的需求
    • 外包服務
    • 充填作業CMO未接受充分服務的領域
    • 充填作業CMO可緩和的主要課題
  • 受託機關的選擇
  • 契約價格
    • 費用模式
    • 費用結構:技術轉移費用
    • 費用結構:預約費
    • 費用結構:取消費
  • 外包費用
    • 對無菌製劑 (充填作業) CMO的支付價格
    • 外包預算
    • 外包預算:各服務類型
  • 與受託機關的關係
    • 特定合約的合作夥伴
    • 優先選擇的受託機關
    • 回應預期的受託機關的主要的疑慮
    • 保證、保障、補償
    • 理想的製造網路或聯盟結構
  • 未來趨勢與預定
    • 法規必要條件的變化
    • 未來的無菌製劑的課題和障礙
    • 未來技術、營運趨勢
    • 影響無菌製劑的新產品、創新
    • 生物醫藥品的無菌製劑的未來趨勢

第5章 受託製造商

  • 簡介
  • 能力
  • 製造活動
  • 製造業務
  • 製造技術
  • 價格
  • 客戶的關係
  • 無菌製劑產業的收益與成長
  • 製造上的課題、未來趨勢

附錄A-D

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目錄

The market for biopharmaceutical contract fill-and-finish services has grown at a compound annual rate of 17% over the past three years. This market will continue to expand and reach $2.4 billion in 2020 according to HighTech Business Decisions latest report, “Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015.” On average, executives from contract manufacturing organizations expect future annual market growth of 15% per year. Driving this growth for fill-and-finish services is demand for biotechnology drugs, investment in biotechnology projects, and new service offerings. The biotechnology industry continues to rely on fill-and-finish contract manufacturing organizations to provide filling and lyophilization capacity for both its commercial- and clinical-phase drug product production.

“Over the past few years we have seen strong industry growth for outsource filland- finish services for biopharmaceuticals,” said William Downey, president of HighTech Business Decisions. “The biopharmaceutical fill-and-finish contract manufacturing organizations continue to show strong optimism about the demand for their services. On a technical side, the use of prefilled syringes continues to expand, and there continues to be strong interest in needle-free technologies. From a strategic perspective, we expect to see more industry consolidations over the next few years, new market entrants, and greater in-house fill capacity. As a result of these trends, we expect industry capacity utilization rates will remain flat.”

HighTech Business Decisions just published the results of its study in “Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015.” The findings are based on in-depth interviews and inputs from leading pharmaceutical and biotechnology companies and contract manufacturing organizations. This 550- page industry report with over 200 summary data tables and charts analyzes both the commercial and technical factors affecting this industry. The report covers current and future market size, manufacturing technologies, client outsourcing plans, contract outsource capacity, pricing, commercial terms and practices, underserved market segments, and future industry trends.

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
  • 1.4. Summary of Fill-and-Finish Contractors' Capabilities
    • 1.4.1. Dosage Forms
    • 1.4.2. Capacity Increases
    • 1.4.3. Industry and Company Growth Rates
    • 1.4.4. Contracting Business by Product Type
  • 1.5. Industry Trends and Observations

Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS

  • 2.1. Research Objectives
  • 2.2. Research Methodology
  • 2.3. Definition of Parenteral Fill-and-Finish Manufacturing
  • 2.4. Box-and-Whiskers Plot Definition
  • 2.5. Acronyms

Chapter 3: FILL-AND-FINISH CONTRACT MANUFACTURING: MARKET OVERVIEW

  • 3.1. Introduction
  • 3.2. Suppliers: The Fill-and-Finish Contract Manufacturers
    • 3.2.1. Types of Fill-and-Finish Contract Companies
    • 3.2.2. Fill-and-Finish Contract Manufacturing Companies
    • 3.2.3. Dosage Forms and Services
    • 3.2.4. Fill-and-Finish Contract Manufacturing Organizations' Capacities

Chapter 3: 3.3 The Customers: Pharmaceutical and Biotechnology Companies

  • 3.3.1. Customers' Products
  • 3.3.2. Outsourced Fill-and-Finish by Dosage Form
  • 3.3.3. Customers' Future Outsourcing Expectations
  • 3.3.4. Outsourcing Needs
  • 3.4. Market Capacity
  • 3.5. Market Size
    • 3.5.1. Estimates of Market Size Based on Customer Spending
    • 3.5.2. Estimates of Market Size Based on Contractor Revenues
    • 3.5.3. Market Size by Dosage Form and Service Categories
  • 3.6. Market Growth Forecasts
  • 3.7. Trends in the Fill-and-Finish Contract Manufacturing 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. Respondent Titles and Location
    • 4.1.2. In-House Manufacturing Sites
    • 4.1.3. Recombinant Large-Molecule Drug Products on Market
  • 4.2. Manufacturing Demand
    • 4.2.1. Manufacturing Needs
    • 4.2.2. Dosage Forms
    • 4.2.3. Clinical and Commercial Products
  • 4.3. Manufacturing Technologies
    • 4.3.1. Planned Format for Drug Launch
    • 4.3.2. New Delivery Technologies
    • 4.3.3. Special Handling Requirements
    • 4.3.4. Yield Loss

Chapter 4: 4.4 Outsourcing Strategies

  • 4.4.1. Current In-House Filling Capacity and Outsourcing Strategy
  • 4.4.2. Changes to In-House Filling Capacity
  • 4.4.3. Impact of Core/Non-Core Technology
  • 4.4.4. Impact of Standard/Non-Standard Technology
  • 4.4.5. Focus of Filling Outsourcing over Next 5 Years
  • 4.5. Outsourcing Needs
    • 4.5.1. Outsourced Services
    • 4.5.2. Areas Underserved by Fill-and-Finish CMOs
    • 4.5.3. Key Challenges a Fill-and-Finish CMO Can Help Alleviate
  • 4.6. Contractor Selection
    • 4.6.1. Essential Characteristics Sought in a F&F Contractor
    • 4.6.2. Key Components for Successful Collaboration with a Fill-and-Finish CMO
    • 4.6.3. Regional Outsourcing Preference
    • 4.6.4. Opinion of Emerging Market CMOs
  • 4.7. Contractor Pricing
    • 4.7.1. Price Models Used
    • 4.7.2. Fee Structure: Technology Transfer
    • 4.7.3. Fee Structure: Reservation
    • 4.7.4. Fee Structure: Cancelation
  • 4.8. Outsourced Spending
    • 4.8.1. Prices Paid to Fill-and-Finish CMOs
    • 4.8.2. Outsourcing Budgets
    • 4.8.3. Outsourcing Budgets by Service Category
  • 4.9. Contractor Relationships
    • 4.9.1. Identifying Contract Partners
    • 4.9.2. Preferred Contractors
    • 4.9.3. Top Concerns of Contractors Meeting Expectations
    • 4.9.4. Warranties, Guarantees and Indemnifications
    • 4.9.5. Ideal Production Network or Alliance Structure
  • 4.10. Future Trends and Expectations
    • 4.10.1. Regulatory Requirement Challenges
    • 4.10.2. Future F&F Manufacturing Challenges and Bottlenecks
    • 4.10.3. Future Technology and Operational Trends
    • 4.10.4. Future Trends in Biopharmaceutical Fill-and-Finish Contract Manufacturing

Chapter 5: FILL-AND-FINISH CONTRACT MANUFACTURERS

  • 5.1. Introduction
    • 5.1.1. Respondents' Titles and Experience
    • 5.1.2. Company Locations
    • 5.1.3. Regulatory Approval Status
    • 5.1.4. One-Stop-Shop CMO Model
  • 5.2. Capacity
    • 5.2.1. Dosage Forms
    • 5.2.2. Current Capacity for Fill-and-Finish
    • 5.2.3. Current Capacity for Lyophilization
    • 5.2.4. Capacity Expansions
  • 5.3. Manufacturing Practices
    • 5.3.1. Contracting Business by Product Type
    • 5.3.2. Current and Future Capacity Utilization
    • 5.3.3. Average Batch Size and Batches per Fill Line
    • 5.3.4. Number of Employees by Function
    • 5.3.5. Cost Reduction Plans
  • 5.4. Manufacturing Technologies
    • 5.4.1. Technology Impacts on Operations
    • 5.4.2. Average Yield Loss
    • 5.4.3. Focus of Capabilities in Next 5 Years
  • 5.5. Pricing
    • 5.5.1. Price Structures for Fill-and-Finish
    • 5.5.2. Batch Pricing
    • 5.5.3. Contractors' Technology Transfer Fees
    • 5.5.4. Contractors' Reservation Fees
    • 5.5.5. Contractors' Cancellation Fees
    • 5.5.6. Gross Profit Margin
  • 5.6. Customer Relationships
    • 5.6.1. Strengths and Weaknesses of Contract Manufacturers
    • 5.6.2. Competitive Attributes
    • 5.6.3. Warranties, Guarantees and Indemnifications
    • 5.6.4. Production Networks or Alliances
    • 5.6.5. Trade Shows

Chapter 5: 5.7 Fill-and-Finish Industry Revenues and Growth

  • 5.7.1. Opportunities for Growth in the Fill-and-Finish Industry
  • 5.7.2. Industry and Company Growth Rates
  • 5.7.3. Current and Expected Revenue Categories
  • 5.7.4. Revenues from Industry Segments
  • 5.7.5. Revenues from World Regions
  • 5.8. Challenges and Future Trends for F&F Manufacturing
    • 5.8.1. Most Significant Challenges/Threats
    • 5.8.2. Regulatory Requirement Challenges
    • 5.8.3. Potential Growth Areas
    • 5.8.4. Trends for the Future of F&F Contract Manufacturing

Appendix A: Write-Ups of Interviews with 26 Pharmaceutical and Biotechnology Company BioManufacturing Directors Worldwide, Unnamed and Edited for Confidentiality

Appendix B: Directory of Biopharmaceutical Fill-and-Finish Contract Manufacturers

Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company Respondents

Appendix D: Interview Guide for Biopharmaceutical Fill-and-Finish Contract Manufacturers

LIST OF TABLES

Chapter 1

  • 1.2-1. Biopharmaceutical Fill-and-Finish Contract Manufacturing Industry Capacity Estimate in Units
  • 1.3-1. Respondents Capacity by Segment
  • 1.3-2. Outsource Decision Criterion
  • 1.4-1. Fill Line Expansion Plans
  • 1.5-1. Industry Trends and Challenges

Chapter 2

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

Chapter 3

  • 3.2-1. Rating of Respondents' Fill-and-Finish Contract Manufacturers
  • 3.2-2. CMO Revenue Mix by Service Category: 2015
  • 3.2-3. Biopharmaceutical F&F Contract Manufacturing Industry Capacity Estimates in Units
  • 3.3-1. Estimates of Needs for Outsourced Volumes for the Respondent Group
  • 3.4-1. Biopharmaceutical F&F Outsourced Manufacturing Capacity Utilization
  • 3.5-1. Worldwide 2015 Market Size for Biopharmaceutical Fill-and-Finish Contract Manufacturing: Estimates Based on Customer Spending: US$
  • 3.5-2. Worldwide 2015 Market Size for Biopharmaceutical Fill-and-Finish Contract Manufacturing: Estimates Based on Contractors' Revenues: US$
  • 3.5-3. Market Size by Dosage Forms: US$
  • 3.5-4. Market Size by Service Category: US$
  • 3.7-1. Observations on Biopharmaceutical Fill-and-Finish Contract Manufacturing Industry Trends: Manufacturing Trends

Chapter 4

  • 4.1-1. Titles of Pharmaceutical and Biotechnology Company Respondents
  • 4.1-2. Location of In-House Fill-and-Finish Manufacturing Sites
  • 4.1-3. Number of Recombinant Large-Molecule Drug Products on Market

Chapter 4

  • 4.2-1. Respondents' Current and Expected Capacity Needs for Outsourced Product - Vials (Lyophilized)
  • 4.2-2. Respondents' Current and Expected Capacity Needs for Outsourced Product - Vials (Not Lyophilized)
  • 4.2-3. Respondents' Current and Expected Capacity Needs for Outsourced Products - Syringes (Lyophilized)
  • 4.2-4. Respondents' Current and Expected Capacity Needs for Outsourced Products - Syringes (Not Lyophilized)
  • 4.2-5. Respondents' Current and Expected Capacity Needs for Outsourced Products - Cartridge (Not Lyophilized)
  • 4.2-6. Number of Outsourced Products by Phase by Year
  • 4.2-7. Average Outsourcing Percentage by Dosage Form
  • 4.2-8. Number of Biopharmaceutical Products Filled by Dosage Form
  • 4.2-9. Types of Respondents' Biopharmaceutical Products by Dosage Form
  • 4.3-1. Delivery Technologies Under Investigation
  • 4.3-2. Cause for Fill-and-Finish Yield Losses
  • 4.4-1. Respondent Capacity by Segment
  • 4.4-2. Outsource Decision Criterion - Respondents with In-House Capacity
  • 4.4-3. Outsource Decision Criterion - Respondents with No In-House Capacity
  • 4.4-4. Impact of Core Technology on Outsourcing Decision
  • 4.4-5. Focus of Fill-and-Finish Outsourcing Efforts in Next 5 Years
  • 4.5-1. Outsourcing of Fill-and-Finish Related Services
  • 4.5-2. Number of Products Currently and Planned to Outsource by Service
  • 4.5-3. Areas Underserved by Fill-and-Finish CMOs
  • 4.5-4. Challenges Fill-and-Finish CMOs can Help Alleviate
  • 4.6-1. Ranked Characteristics of a Good Service Level at F&F Contractor
  • 4.6-2. Rationale for Number ‘1' Ranked Good Service Characteristic
  • 4.6-3. Key Component for Successful Collaboration
  • 4.6-4. Regional Outsourcing Preferences
  • 4.6-5. Observations and Influences on Opinion about Emerging-Market CMOs
  • 4.7-1. Price Model Used for Fill-and-Finish Services by Respondent Type
  • 4.7-2. Average Technology Transfer Fees Paid by Dosage Form
  • 4.8-1. Price Per-Batch by Dosage Form by Product Phase
  • 4.8-2. Examples of Other Services and Material Charges
  • 4.8-3. Fill-and-Finish Outsourcing Budgets by Respondent Type: 2015, 2017, 2020
  • 4.8-4. Simple Average: Percentage of F&F Outsourcing Budget by Service
  • 4.8-5. Weighted Average: Percentage of F&F Outsourcing Budget by Service

Chapter 4

  • 4.9-1. Search Modes for Fill-and-Finish Contractors
  • 4.9-2. Rating of Respondents' Fill-and-Finish Contract Manufacturers
  • 4.9-3. Top Concerns of Fill-and-Finish Contractors Meeting Expectations
  • 4.9-4. Warranties, Guarantees and Indemnifications Negotiated by Respondents
  • 4.9-5. Proposed Models and Arrangements with a CMO
  • 4.10-1. Regulatory Requirements That Present the Greatest Challenges
  • 4.10-2. Challenges and Bottlenecks Facing Fill-and-Finish Manufacturing
  • 4.10-3. Technology Trends in Drug Presentations
  • 4.10-4. Technology Trends at CMOs
  • 4.10-5. Operational and Business Trends in Fill-and-Finish Contract Manufacturing
  • 4.10-6. Future Trends in Biopharmaceutical Fill-and-Finish Contract Manufacturing

Chapter 5

  • 5.1-1. Titles of Fill-and-Finish Contractor Respondents
  • 5.1-2. Fill-and-Finish Contractors: Headquarter Locations
  • 5.1-3. Regulatory Agency Approvals
  • 5.1-4. Relevance of Being a One-Stop-Shop
  • 5.2-1. Average Batch Size per Fill Line and Contractor
  • 5.2-2. Fill Capacity by Batch Size at Respondents' Facilities in 2015
  • 5.2-3. Lyophilizer Capacity by Shelf Space at Respondents' Facilities in 2015
  • 5.2-4. Lyophilizer Capacity by Batch Size at Respondents' Facilities in 2015
  • 5.2-5. Fill Line Expansion Plans
  • 5.2-6. Lyophilizer Expansion Plans
  • 5.3-1. Percent of Contracting Business by Product Type: 2015 and 2017
  • 5.3-2. Capacity Utilization Rate: Fill Line
  • 5.3-3. Capacity Utilization Rate: Lyophilization
  • 5.3-4. Number of Batches Ran per Fill Line
  • 5.3-5. Batch Size Ran by Fill Line
  • 5.3-6. Number of Employees by Function
  • 5.3-7. Plans to Reduce Fill-and-Finish Manufacturing Costs
  • 5.4-1. Technology Impacts on Fill-and-Finish Operations
  • 5.4-2. Sources of Product Yield Loss
  • 5.4-3. Focus of Manufacturing Capabilities
  • 5.5-1. Pricing Methods for Clinical and Commercial Phase
  • 5.5-2. Calculation Methods of Technology Transfer Fees
  • 5.5-3. Contractors' Cancellation Fees: Average Percentage of Total Project Fee
  • 5.5-4. Gross Profit Margin

Chapter 5

  • 5.6-1. Contract Manufacturers' Strengths and Weaknesses
  • 5.6-2. Contractor Competitive Advantage
  • 5.6-3. Warranties, Guarantees and Indemnifications Accepted by F&F CMOs
  • 5.6-4. Desired Arrangements with Clients
  • 5.6-5. Trade Shows Named by Fill-and-Finish Contractors
  • 5.6-6. Trade Shows for Best Quality Leads
  • 5.6-7. Trade Shows for Best Technical Information
  • 5.7-1. Opportunities for Growth in the Fill-and-Finish Industry
  • 5.7-2. Annual Growth Rates: Industry Estimate versus Company Forecast
  • 5.7-3. Revenue by Service Category: 2015
  • 5.7-4. Revenue Change Expected by Service Category: 2015 to 2017
  • 5.7-5. Customer Mix
  • 5.7-6. Geographic Mix
  • 5.8-1. Future Challenges to Business Operations
  • 5.8.2. Current Regulatory Challenges
  • 5.8.3. Potential Fill-and-Finish Manufacturing Growth Areas
  • 5.8.4. Future Technology Trends
  • 5.8.5. Future Business Trends

LIST OF FIGURES

Chapter 1

  • 1.2-A: Size of Worldwide Biopharmaceutical Fill-and-Finish Contract Manufacturing Industry in US$B
  • 1.3-A: Respondents' 82 Biopharmaceutical Products by Phase
  • 1.3-B: Number of Products Outsourced by Dosage Form: 2015-2020
  • 1.3-C: Simple Average Percentages of Expected Overall Outsourced Budget
  • 1.4-A: Dosage Forms Produced by Number of Contractor Respondents
  • 1.4-B: Percent of Fill Lines Available among Contractor Respondents for Various Dosage Forms
  • 1.4-C: Annual Growth Rates: Industry Estimate versus Company Forecast
  • 1.4-D: Percent of Contracting Business by Product Type: 2015 and 2017

Chapter 2

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

Chapter 3

  • 3.2-A: Dosage Forms Produced by Number of Contractor Respondents
  • 3.2-B: Percent of Fill Lines Available among Contractor Respondents for Various Dosage Forms
  • 3.3-A: Respondents' 82 Biopharmaceutical Products by Phase
  • 3.3-B: Percent of Products Outsourced: 2015
  • 3.3-C: Simple Average Percentages of Expected Overall Outsourcing Budget
  • 3.3-D: Number of Products Outsourced by Dosage Form: 2015-2020
  • 3.3-E: Estimates of Needs for Outsourced Batches for the Worldwide Industry
  • 3.6-A: Size of the Worldwide Biopharmaceutical Fill-and-Finish Contract Manufacturing Market in US$B

Chapter 4

  • 4.1-A: In-House Fill-and-Finish Manufacturing Capability
  • 4.2-A: Summation of Outsourced Units Required - Vials
  • 4.2-B: Summation of Outsourced Units Required - Syringes
  • 4.2-C: Percentage of Products Outsourced - 2015
  • 4.2-D: Number of Respondents' Products Produced by Dosage Form
  • 4.2-E: Respondents' 82 Biopharmaceutical Products by Phase
  • 4.2-F: Respondents' 82 Biopharmaceutical Products by Company Type
  • 4.3-A: Format Used for Drug Product Launch
  • 4.3-B: Investigation of New Delivery Technologies
  • 4.3-C: Needle-Based versus Needle-Free Delivery Technologies Under Investigation

Chapter 4

  • 4.3-D: Respondents' Special Handling Requirements
  • 4.3-E: Distribution of Percent of Products with Special Handling Needs
  • 4.3-F: Special Handling Needs Required
  • 4.3-G: Handling Needs for Typical Biologics
  • 4.3-H: Distribution of Average Fill-and-Finish Yield Losses
  • 4.4-A: Distribution of Respondents with In-House Capacity
  • 4.4-B: Changes to In-House Filling Capacity
  • 4.4-C: Core Technology's Impact on Outsourcing Decisions
  • 4.4-D: Standard Technology's Impact on Outsourcing Decisions
  • 4.6-A: Number ‘1' Ranked Good Service Characteristics
  • 4.6-B: Most Important Good Service Characteristics by Weighted Ranking
  • 4.6-C: Changing Opinion about Emerging-Market CMOs
  • 4.7-A: Different Price Model Used for Commercial Products
  • 4.7-B: Average Technology Transfer Fees Paid by Respondent Type
  • 4.7-C: Payment of Reservation Fee
  • 4.7-D: When Cancellation Charges are First Expected to be Incurred
  • 4.7-E: Cancellation Fees: Average Percentages of the Total Contract Fee
  • 4.8-A: Average Per-Batch Price by Clinical Phase
  • 4.8-B: Unit Price versus Batch Size: Non-Lyophilization
  • 4.8-C: Unit Price versus Batch Size: Lyophilization
  • 4.8-D: Price per Batch by SafeBridge® Level: Vials
  • 4.8-E: Price per Batch by SafeBridge® Level: Prefilled Syringes
  • 4.8-F: Average Fill-and-Finish Outsourcing Budgets by Respondent Type
  • 4.8-G: Simple Average: Percentage of F&F Outsourcing Budget by Service: 2015
  • 4.8-H: Weighted Average: Percentage of F&F Outsourcing Budget by Service 2015
  • 4.9-A: Search Modes for Fill-and-Finish CMOs
  • 4.9-B: Warranties, Guarantees and Indemnifications
  • 4.9-C: Negotiation of Contractor's Final Product Quality and Consequential Damages
  • 4.9-D: Preference for Production Networks or Alliances
  • 4.9-E: Preferred Characteristics of Production Networks or Alliances

Chapter 5

  • 5.1-A: Number of Years Fill-and-Finish Services Offered
  • 5.1-B: One-Stop-Shop CMO Model
  • 5.2-A: Dosage Forms Produced by Percent of Contractors Respondents
  • 5.2-B: Percent of Fill Lines Available among Contractor Respondents for Various Dosage Forms
  • 5.2-C: Comparison of Percent of Dosage Forms Produced by Contractor Type
  • 5.2-D: Capacity Expansion Plans
  • 5.2-E: Dosage Forms Being Added

Chapter 5

  • 5.3-A: Percent of Contracting Business by Product Type: 2015 and 2017
  • 5.3-B: Fill Line Capacity Utilization Rate
  • 5.3-C: Lyophilization Capacity Utilization Rates
  • 5.3-D: Average Number of Employees by Function
  • 5.3-E: Plans to Reduce Fill-and-Finish Manufacturing Costs
  • 5.4-A: Average Yield Loss
  • 5.5-A: Pricing Methods
  • 5.5-B: Use of Different Pricing Methods Based on Product Phase
  • 5.5-C: Dosage Form
  • 5.5-D: Batch Size
  • 5.5-E: Batch Pricing
  • 5.5-F: Technology Transfer Fee Charged
  • 5.5-G: Reservation Fee Charged
  • 5.5-H: When Cancellation Fees Are First Charged
  • 5.5-I: Average Targeted and Achieved Gross Profit Margins
  • 5.6-A: Warranties, Guarantees and Indemnifications Accepted by F&F CMOs
  • 5.6-B: Comparison of CMO and Pharma Respondents “Always” Negotiation Term
  • 5.6-C: Plans for Production Network or Alliances with Clients
  • 5.7-A: Average Annual Growth Rates: Industry Estimate versus Company Forecast
  • 5.7-B: Service Revenue by Contractor Type: 2015
  • 5.7-C: Revenue Contribution from Customer Groups by Contractor Type
  • 5.7-D: Percentage of Business from the World Regions by Contractor Type
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