Top Dose CMOs by Number of NDA and BLA Approvals (07/2010)
This report measures success in the CMO industry by the number of regulatory approvals gained. The PharmSource team found that 200 of the 487 products receiving FDA approval (NDA and BLA) during the period 2005-2010 involved a contract dose manufacturer.
The analysis suggests that we should see more industry consolidation in the coming years. Consider the fact that more than 60% of CMOs listed in the PharmSource ADVANTAGE database claim FDA compliance received no new FDA approvals in the period, while most CMOs that did receive an approval received only one. The report contains a list of the 72 CMOs receiving FDA approvals and the number of approvals received by dosage form.
For more information, please download an executive summary of this Special Report.
The Market for Contract Analytical and Development Services (11/2009)
This report, The Market for Contract Analytical and Development Services, presents the findings of our extensive effort to model expenditures on GMP analytical development and testing in both the clinical and commercial phases and to understand the factors that will drive outsourcing of analytical activities over the next five years.
The heart of the study is our model of spending for CMC development, including API process development, formulation, CTM manufacture and associated analytical testing. We have constructed a model driven by the new product pipeline and the outsourcing behavior of the major end-customer segments. A separate model breaks down spending for analytical testing of commercial products.
For more information, please download a PDF brochure and order form for this Special Report.
Demand and Supply for Contract Manufacturing of Injectable Drugs (07/2009)
This extensive study, Demand and Supply for Contract Manufacturing of Injectable Drugs, estimates the demand for contract injectable manufacturing through 2015 and analyzes the relationship between supply and demand for these services over the 2008-2015 period. It provides invaluable information regarding latest trends and plans for outsourcing of commercially approved injectable products by the major pharmaceutical and biopharmaceutical companies.
The study presents a demand model focusing on the status of projects in the pipeline, the survival rate of projects from phase to phase and formulation requirements. Projections are presented for key processing capabilities, including aseptic fill, lyophilized vials and prefilled devices such as syringes, cartridges and proprietary devices. The study analyzes the current capacity and planned additions to capacity of contract manufacturers, as well as the plans by major sponsors to increase or divest in-house capacity.
Cell Culture Manufacturing Capacity: Trends & Outlook Through 2013 (12/2008)
This proprietary report, Cell Culture Manufacturing Capacity: Trends and Outlook Through 2013, was researched and published exclusively by PharmSource and BioProcess Technology Consultants. It provides expert insights for contract biomanufacturing executives, bio/pharma sourcing executives and investors seeking access to the quantitative analysis and projections needed for critical strategic decision-making and planning.
For more information, please download a PDF brochure and order form for this Special Report.
Injectable CTM Manufacturing Market Report (10/2008)
It wasn’t so long ago that capacity for manufacturing Phase I/II clinical trial materials (CTM) for injectable products seemed to be in short supply. Five years ago, a relative handful of CROs and CMOs were manufacturing clinical batches of injectables, and many of these were suspect from the standpoint of expertise and GMP compliance.
PharmSource’s experts completed an analysis of the supply/demand balance for injectable CTM manufacturing. We interviewed several injectable CTM manufacturers to understand typical client requirements as well as key manufacturing practices, then applied our knowledge to the development pipeline and supply base to calculate the supply/demand balance.
For more information, please download an executive summary of this Special Report.
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