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SummaryThis 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.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.Reasons to buyThis 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 ContentsChapter 1: Executive Summary 1Chapter 2: Objectives and Methodology 3Methodology 3Chapter 3: Recent Trends in Injectables NDA/BLA Approvals 5Injectables approvals overview 5NDA/BLA approvals of injectable products 6Injectable NDA/BLA approvals by sponsor type 10Processing and packaging characteristics 12Contract manufacturing of injectable NDA/BLA approvals 15European biosimilar approvals 18Cytotoxic drug approvals 19CMOs winning NDA/BLA approvals 20What it means 21Chapter 4: Injectables Pipeline 24Pipeline Overview 24Biosimilars 27Cytotoxic and High Potency Pipeline 28Pipeline Ownership 29Pipeline by Route of Administration 31Unit volumes 32What it means 35Chapter 5: Demand Forecast for CMO Capacity 36Forecasting new standard potency approvals 37Model Results: Standard Potency Therapeutic Products 41Forecasting new cytotoxic approvals 44Model Results: Cytotoxic Products 45Chapter 6: CMO Industry Capacity analysis 47Injectables CMO Capacity Overview 47Injectables capacity 48Cytotoxic Injectables Capacity 52Injectables Capacity Expansions 53What it means 55Chapter 7: Supply-Demand Balance and Implications 57Standard Potency Supply-Demand Balance 57Standard Potency NME capacity 60Cytotoxic Capacity Supply-Demand Balance 62What It Means 63Appendix 1 64Injectables CMOs Manufacturing NDAs /BLAs and Biosimilars Approved 2012 - November 2017 641.1 List of TablesTable 2.1 Abbreviations Used in this Report 4Table 3.1: Injectable NDA/BLA approvals by sponsor type 2012‒2017 10Table 3.2: Packaging of New NDA/BLA Approvals 14Table 3.3: Manufacturing Source of NDA Approvals by Approval and Company Type 2012‒2017 16Table 4.1: Unit Volume Categories Used in Demand Model 33Table 4.2: Products Used to Calibrate Demand Model 33Table 5.1: Modeling Assumptions for Standard Potency Products 39Table 5.2: Modeling Assumptions for Cytotoxic Products 44Table 6.1: Preferred Injectable CMOs for Capacity Analysis 49Table 6.2: Cytotoxic Injectable CMOs for Capacity Analysis 52Table 6.2: Injectable CMO Capacity Expansions 541.2 List of FiguresFigure 3.1: FDA injectables NDA/BLA approvals 2012‒2016 6Figure 3.10: Manufacturing of BLA Approvals for Global Bio/Pharma 2012‒2017 17Figure 3.11: Manufacturing of EU-approved biosimilars 2006-2017 19Figure 3.12: CMOs manufacturing