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Bio/Pharmaceutical Outsourcing Report
 
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CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition
 
This report is the 8th edition of our long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs.  
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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.  
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Recent Trends in Injectables NDA/BLA Approvals and Outsourcing
 
As biologics and self-injected products become a large share of the new product mix, biopharma companies and CMOs have become intensely interested in trends in injectables manufacturing and outsourcing. This report analyzes injectable NDA and BLA approvals during the 2012-2017 period and describes the key developments relating to packaging, lyophilization, outsourcing and the performance of the CMO industry.  
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Contract Manufacturing Industry Outlook
 
The CDMO industry enjoyed strong performance in 2017 thanks to robust funding for emerging biopharma companies that fed R&D spending. The industry’s performance has fed a boom in M&A activity but most deals are still tactical in scale and scope. The industry needs some very big deals to create large scale CMOs that can be truly strategic partners to global biopharma companies.  
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What’s Next for the CDMO Business?
 
Jim Miller's presentation at Contract Pharma 2017 in New Brunswick, NJ.  
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Contract Dose Manufacturing Industry by the Numbers: Composition, Size, Market Share and Outlook – 2017 Edition
 
Growth of the CMO industry is expected to continue to slow relative to overall industry growth. This is primarily a consequence of a decline in unit volume per product, while outsourcing propensity has remained stable for a decade.  
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M&A in the CMC Services Industry: Implications and Outlook
 
M&A is reshaping the bio/pharmaceutical contract development services industry. Established CMOs and CROs are pursuing acquisitions to drive scale and broaden their offerings, while private equity are anxious to either gain a presence in the industry or cash in on investments already made.  
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CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2017 Edition
 
This report analyzes the performance of the drug product CMO industry using NDA approvals as the primary indicator of performance. CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs.  
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Follow the Money: The Outlook for Outsourced Spending on Early Development Services
 
Demand for development services to support Phase 1 and Phase 2 clinical trials is driving double-digit growth for CROs and CDMOs. Demand for clinical manufacturing services is actually outstripping industry capacity and leading to delays in getting clinical trial materials needed for studies. This report exams the link between external funding sources and early drug development, and addresses the outlook for continued funding over the next two years.  
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Bio/Pharma CapEx Trends 2016
 
This Trend Report analyzes recent trends in capital spending by bio/pharmaceutical companies and assesses the implications for the CMO industry. It tracks spending by major segments of the bio/pharma industry, with detailed information on investments by global and generic biopharma companies.  
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Contract Manufacturing Market Opportunities for Antibody Drug Conjugates
 
This expert trend report is an indispensable resource for understanding the technical developments in the Antibody Drug Conjugate (ADC) sector and the scale of the commercial opportunities and risks for CMOs. The CDMO sector is investing significant resources to expand its capabilities in the ADC arena. More than 20 companies are active in the sector although, to date, no single company has demonstrated proficiency across all four elements of the ADC supply chain: large molecule manufacture, drug conjugation, the toxic payload, and fill/ finish of the conjugate.  
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Catching a Wave: How Much Will CMOs Benefit From Biosimilars?
 
Regulatory developments in the United States, coupled with impending patent expiry, have paved the way for the introduction of biosimilars of increasing technical complexity. In the European Union, 20 first wave biosimilars, consisting of growth hormones and relatively simple recombinant proteins, have already been approved. Of those first wave biosimilars, 30% have been outsourced to dose manufacturers, and 10% to API manufacturers.  
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Opportunity Knocks: In-Licensed Drug Products Can Signal Outsourcing Opportunity
 
Of the more than 230 New Molecular Entities (NMEs) approved between 2003-2013, over one-third were in-licensed by the sponsor receiving the approval. A significant difference in manufacturing status emerged between products originally discovered in-house and those in-licensed from external partners. During this period 66% of in-licensed NMEs were either outsourced completely or partially, compared to 44% for internally discovered candidates.  
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The Demand and Supply for Contract Manufacturing of Cytotoxic Injectable Drugs Through 2019
 
This report presents a detailed analysis of CMO industry capacity and the projected demand in the next five years and beyond. The research is based on an expert analysis of cytotoxic injectable drugs in the pipeline, including antibody drug conjugates (ADC)s.  
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The Demand and Supply for Contract Manufacturing of Conventional Injectable Drugs Through 2019
 
This report provides an important expert quantitative analysis on the latest trends and plans for outsourcing commercially approved injectable products. The model and assumptions are fully explained so you can understand how the analysis was driven and how conclusions were reached.  
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