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PharmSource: Demand and Supply for Contract Manufacturing of Injectable Drugs Through 2023
Summary
This report is the 6th edition of our long-running analysis of the injectables CMO industry. It provides an expert quantitative analysis on the latest trends and plans for outsourcing commercially approved injectable products. It combines the rich data resources of PharmSource and the author's Pharmaceutical Intelligence Center with 20 years’ experience in analyzing the injectables CMO industry to provide the most definitive, trustworthy source of strategic insight on this topic in the bio/pharmaceutical realm.
Scope
This 70-page report gives important, expert insight you won’t find in any other source. Over 25 tables and graphs throughout the report illustrate major points and trends.
This report is required reading for:
Summary
This report is the 6th edition of our long-running analysis of the injectables CMO industry. It provides an expert quantitative analysis on the latest trends and plans for outsourcing commercially approved injectable products. It combines the rich data resources of PharmSource and the author's Pharmaceutical Intelligence Center with 20 years’ experience in analyzing the injectables CMO industry to provide the most definitive, trustworthy source of strategic insight on this topic in the bio/pharmaceutical realm.
Scope
- The report is based on the most recent data on industry capacity, the injectables pipeline and the behaviors of the key biopharmaceutical industry actors.
- The model and assumptions are fully explained so you can understand how the analysis was driven and how conclusions were reached.
This 70-page report gives important, expert insight you won’t find in any other source. Over 25 tables and graphs throughout the report illustrate major points and trends.
This report is required reading for:
- CMO executives who must have deep understanding of the injectables marketplace to make strategic planning and investment decisions.
- Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
- Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.
Note: Product cover images may vary from those shown
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Chapter 1: Executive Summary
Chapter 2: Objectives and Methodology
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
Chapter 2: Objectives and Methodology
- Methodology
- 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
- Pipeline Overview
- Biosimilars
- Cytotoxic and High Potency Pipeline
- Pipeline Ownership
- Pipeline by Route of Administration
- Unit volumes
- What it means
- Forecasting new standard potency approvals
- Model Results: Standard Potency Therapeutic Products
- Forecasting new cytotoxic approvals
- Model Results: Cytotoxic Products
- Injectables CMO Capacity Overview
- Injectables capacity
- Cytotoxic Injectables Capacity
- Injectables Capacity Expansions
- What it means
- 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
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
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