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

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


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 GlobalData Pharmaceutical Intelligence Center with our 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.


- 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.

Reasons to buy

This 70-page report gives important, expert insight you wont 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.

Chapter 1: Executive Summary 1
Chapter 2: Objectives and Methodology 3
Methodology 3
Chapter 3: Recent Trends in Injectables NDA/BLA Approvals 5
Injectables approvals overview 5
NDA/BLA approvals of injectable products 6
Injectable NDA/BLA approvals by sponsor type 10
Processing and packaging characteristics 12
Contract manufacturing of injectable NDA/BLA approvals 15
European biosimilar approvals 18
Cytotoxic drug approvals 19
CMOs winning NDA/BLA approvals 20
What it means 21
Chapter 4: Injectables Pipeline 24
Pipeline Overview 24
Biosimilars 27
Cytotoxic and High Potency Pipeline 28
Pipeline Ownership 29
Pipeline by Route of Administration 31
Unit volumes 32
What it means 35
Chapter 5: Demand Forecast for CMO Capacity 36
Forecasting new standard potency approvals 37
Model Results: Standard Potency Therapeutic Products 41
Forecasting new cytotoxic approvals 44
Model Results: Cytotoxic Products 45
Chapter 6: CMO Industry Capacity analysis 47
Injectables CMO Capacity Overview 47
Injectables capacity 48
Cytotoxic Injectables Capacity 52
Injectables Capacity Expansions 53
What it means 55
Chapter 7: Supply-Demand Balance and Implications 57
Standard Potency Supply-Demand Balance 57
Standard Potency NME capacity 60
Cytotoxic Capacity Supply-Demand Balance 62
What It Means 63
Appendix 1 64
Injectables CMOs Manufacturing NDAs /BLAs and Biosimilars Approved 2012 - November 2017 64

List Of Tables

1.1 List of Tables
Table 2.1 Abbreviations Used in this Report 4
Table 3.1: Injectable NDA/BLA approvals by sponsor type 20122017 10
Table 3.2: Packaging of New NDA/BLA Approvals 14
Table 3.3: Manufacturing Source of NDA Approvals by Approval and Company Type 20122017 16
Table 4.1: Unit Volume Categories Used in Demand Model 33
Table 4.2: Products Used to Calibrate Demand Model 33
Table 5.1: Modeling Assumptions for Standard Potency Products 39
Table 5.2: Modeling Assumptions for Cytotoxic Products 44
Table 6.1: Preferred Injectable CMOs for Capacity Analysis 49
Table 6.2: Cytotoxic Injectable CMOs for Capacity Analysis 52
Table 6.2: Injectable CMO Capacity Expansions 54

List Of Figures

1.2 List of Figures
Figure 3.1: FDA injectables NDA/BLA approvals 20122016 6
Figure 3.10: Manufacturing of BLA Approvals for Global Bio/Pharma 20122017 17
Figure 3.11: Manufacturing of EU-approved biosimilars 2006-2017 19
Figure 3.12: CMOs manufacturing NMEs approved 20122017 20
Figure 3.13: CMOs manufacturing Non-NMEs approved 20122017 21
Figure 3.2: Injectables share of all NDA/BLA approvals 7
Figure 3.3: Injectables NDA/BLA approvals by API type 8
Figure 3.4: Injectable NME approvals receiving special consideration 9
Figure 3.5: Injectables NME approvals by sponsor type 11
Figure 3.6: Injectables Non-NME approvals by sponsor type 12
Figure 3.7: Lyophilized injectable NME approvals 13
Figure 3.8: Packaging of Products Delivered Subcutaneous or Intramuscular 14
Figure 3.9: Contract Manufactured NDA Approvals 2006-2017 15
Figure 4.1: Injectable NME Pipeline by Nature of API and Development Phase 24
Figure 4.2: Pipeline by Indication Category 27
Figure 4.3: Pipeline Candidates Requiring Special Handling 28
Figure 4.4: Breakdown of Cytotoxic Pipeline by Phase 29
Figure 4.5: Injectables Pipeline by Sponsor Type 29
Figure 4.6: Breakdown of Traditional Injectable NME Pipeline by Sponsor 30
Figure 4.7: Pipeline by Mode of Administration 31
Figure 4.8: Pipeline by Expected Product Unit Volume (in millions of units) 34
Figure 5.1: Projected Demand for CMO Standard Potency Prefilled Device Capacity 42
Figure 5.2: Projected Demand for CMO Standard Potency Aseptic Vial Fill Capacity 42
Figure 5.3: Projected Demand for CMO Standard Potency Capacity by Product Type 42
Figure 5.4: Projected Demand for CMO Standard Potency Lyophilization Capacity 43
Figure 5.5: Projected Demand for CMO Cytotoxic Vial Capacity 45
Figure 5.6: Projected Demand for CMO Cytotoxic Lyophilization Capacity 46
Figure 6.1: Current and Planned CMO Capacity 2017-2023 50
Figure 6.1: Injectable CMO Universe 47
Figure 6.3: Distribution of CMO Aseptic Vial Fill Capacity 50
Figure 6.4: Distribution of CMO Lyophilization Capacity 51
Figure 6.5: Distribution of CMO Prefilled Syringe Capacity 51
Figure 6.6: Cytotoxic Vial Fill Capacity 52
Figure 6.7: Cytotoxic Lyophilization Capacity 53
Figure 7.1 Aseptic Vial Fill and Prefilled Syringe Supply/Demand Balance in 2023 57
Figure 7.2 Lyophilization Supply/Demand Balance in 2023 58
Figure 7.3 Composition of Incremental Aseptic Vial Fill Demand in 2023 59
Figure 7.4 Composition of Incremental Lyophilization Demand in 2023 59
Figure 7.5 Cytotoxic Aseptic Vial Fill Supply/Demand Balance in 2023 62
Figure 7.6 Cytotoxic Lyophilization Supply/Demand Balance in 2023 62

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Reports Details

Published Date : Feb 2018
No. of Pages :70
Country :Global
Category :Pharmaceuticals and Healthcare
Publisher :GlobalData
Report Delivery By :Email
Report Delivery Time :12 to 24 hours after placing the order.

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