A new market study, titled “PharmSource: Demand and Supply for Contract Manufacturing of Injectable Drugs Through 2023”, has been featured on WiseGuyReports.
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.
Nearly 35% of new approvals were packaged in a prefilled device (syringe, cartridge or auto-injector) during the 2012-2017 period. All biologics delivered by the subcutaneous route of administration were launched in a prefilled device. Lyophilization of biologics has declined as formulations and cold chain logistics have improved.
The propensity to outsource dose manufacturing of an injectable drug is primarily a function of bio/pharma company type and API type. Small and mid-size biopharma companies are highly likely to outsource manufacturing. Global bio/pharma companies are least likely to outsource their manufacturing overall, and their propensity to outsource has declined.
Planned and announced capacity additions will increase the amount of aseptic vial filling capacity and lyophilization capacity by 10%-15% by 2023. A small number of CMOs will account for much of the increased capacity.
Despite the apparent adequacy of current capacity, we expect injectables CMOs to add capacity, especially for lyophilization but even for prefilled syringes. CMO executives will make investment decisions based on their own prospects, and customer demands will drive them to add capacity for fear of losing customers to competitors.
Bio/pharmaceutical companies should readily find adequate capacity for their new products but would be well-advised to perform thorough due diligence to ensure that their chosen CMOs have the financial stability and depth of operational experience to meet their requirements long-term.
– 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.
Table of Content
Chapter 1: Executive Summary 1
Chapter 2: Objectives and 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
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
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