PharmSource: Demand and Supply for Contract Manufacturing of Injectable Drugs Through 2023

Chapter 1: Executive Summary

Chapter 2: Objectives and Methodology

• Methodology

Chapter 3: Recent Trends in Injectables NDA/BLA Approvals

• Injectables approvals overview
• NDA/BLA approvals of injectable products
• Injectable NDA/BLA approvals by sponsor type
• Processing and packaging characteristics
• Contract manufacturing of injectable NDA/BLA approvals
• European biosimilar approvals
• Cytotoxic drug approvals
• CMOs winning NDA/BLA approvals
• What it means

Chapter 4: Injectables Pipeline

• Pipeline Overview
• Biosimilars
• Cytotoxic and High Potency Pipeline
• Pipeline Ownership
• Pipeline by Route of Administration
• Unit volumes
• What it means

Chapter 5: Demand Forecast for CMO Capacity

• Forecasting new standard potency approvals
• Model Results: Standard Potency Therapeutic Products
• Forecasting new cytotoxic approvals
• Model Results: Cytotoxic Products

Chapter 6: CMO Industry Capacity analysis

• Injectables CMO Capacity Overview
• Injectables capacity
• Cytotoxic Injectables Capacity
• Injectables Capacity Expansions
• What it means

Chapter 7: Supply-Demand Balance and Implications

• Standard Potency Supply-Demand Balance
• Standard Potency NME capacity
• Cytotoxic Capacity Supply-Demand Balance
• What It Means
• Appendix 1
• Injectables CMOs Manufacturing NDAs /BLAs and Biosimilars Approved 2012 - November 2017

List of Tables
Table 2.1 Abbreviations Used in this Report
Table 3.1: Injectable NDA/BLA approvals by sponsor type 2012?2017
Table 3.2: Packaging of New NDA/BLA Approvals
Table 3.3: Manufacturing Source of NDA Approvals by Approval and Company Type 2012?2017
Table 4.1: Unit Volume Categories Used in Demand Model
Table 4.2: Products Used to Calibrate Demand Model
Table 5.1: Modeling Assumptions for Standard Potency Products
Table 5.2: Modeling Assumptions for Cytotoxic Products
Table 6.1: Preferred Injectable CMOs for Capacity Analysis
Table 6.2: Cytotoxic Injectable CMOs for Capacity Analysis
Table 6.2: Injectable CMO Capacity Expansions

List of Figures
Figure 3.1: FDA injectables NDA/BLA approvals 2012?2016
Figure 3.10: Manufacturing of BLA Approvals for Global Bio/Pharma 2012?2017
Figure 3.11: Manufacturing of EU-approved biosimilars 2006-2017
Figure 3.12: CMOs manufacturing NMEs approved 2012?2017
Figure 3.13: CMOs manufacturing Non-NMEs approved 2012?2017
Figure 3.2: Injectables share of all NDA/BLA approvals
Figure 3.3: Injectables NDA/BLA approvals by API type
Figure 3.4: Injectable NME approvals receiving special consideration
Figure 3.5: Injectables NME approvals by sponsor type
Figure 3.6: Injectables Non-NME approvals by sponsor type
Figure 3.7: Lyophilized injectable NME approvals
Figure 3.8: Packaging of Products Delivered Subcutaneous or Intramuscular
Figure 3.9: Contract Manufactured NDA Approvals 2006-2017
Figure 4.1: Injectable NME Pipeline by Nature of API and Development Phase
Figure 4.2: Pipeline by Indication Category
Figure 4.3: Pipeline Candidates Requiring Special Handling
Figure 4.4: Breakdown of Cytotoxic Pipeline by Phase
Figure 4.5: Injectables Pipeline by Sponsor Type
Figure 4.6: Breakdown of Traditional Injectable NME Pipeline by Sponsor
Figure 4.7: Pipeline by Mode of Administration
Figure 4.8: Pipeline by Expected Product Unit Volume (in millions of units)
Figure 5.1: Projected Demand for CMO Standard Potency Prefilled Device Capacity
Figure 5.2: Projected Demand for CMO Standard Potency Aseptic Vial Fill Capacity
Figure 5.3: Projected Demand for CMO Standard Potency Capacity by Product Type
Figure 5.4: Projected Demand for CMO Standard Potency Lyophilization Capacity
Figure 5.5: Projected Demand for CMO Cytotoxic Vial Capacity
Figure 5.6: Projected Demand for CMO Cytotoxic Lyophilization Capacity
Figure 6.1: Current and Planned CMO Capacity 2017-2023
Figure 6.1: Injectable CMO Universe
Figure 6.3: Distribution of CMO Aseptic Vial Fill Capacity
Figure 6.4: Distribution of CMO Lyophilization Capacity
Figure 6.5: Distribution of CMO Prefilled Syringe Capacity
Figure 6.6: Cytotoxic Vial Fill Capacity
Figure 6.7: Cytotoxic Lyophilization Capacity
Figure 7.1 Aseptic Vial Fill and Prefilled Syringe Supply/Demand Balance in 2023
Figure 7.2 Lyophilization Supply/Demand Balance in 2023
Figure 7.3 Composition of Incremental Aseptic Vial Fill Demand in 2023
Figure 7.4 Composition of Incremental Lyophilization Demand in 2023
Figure 7.5 Cytotoxic Aseptic Vial Fill Supply/Demand Balance in 2023
Figure 7.6 Cytotoxic Lyophilization Supply/Demand Balance in 2023