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

 Published On: Feb, 2018 |    No of Pages: 70 |  Published By: GlobalData | Format: PDF
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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 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.

1 Table of Contents
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

1.1 List of Tables
Table 2.1 Abbreviations Used in this Report 4
Table 3.1: Injectable NDA/BLA approvals by sponsor type 2012‒2017 10
Table 3.2: Packaging of New NDA/BLA Approvals 14
Table 3.3: Manufacturing Source of NDA Approvals by Approval and Company Type 2012‒2017 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

1.2 List of Figures
Figure 3.1: FDA injectables NDA/BLA approvals 2012‒2016 6
Figure 3.10: Manufacturing of BLA Approvals for Global Bio/Pharma 2012‒2017 17
Figure 3.11: Manufacturing of EU-approved biosimilars 2006-2017 19
Figure 3.12: CMOs manufacturing

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