Stringent, Yet Ill-Defined, Approval Standards Make it Difficult for Companies to Bring Hospital Antibiotics to Market, According to a New Report from Decision Resources
WALTHAM, Mass., Nov. 12 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Gilead will topple GlaxoSmithKline (GSK) as the top player in the anti-infectives drug market in 2014. According to the new report entitled Commercial Outlook for Anti-Infectives: 2003-2014, GSK's fall will be due to generic erosion and a sparse anti-infectives pipeline. Gilead's rise will be due to its remarkable growth in HIV driven by its blockbuster products, Truvada and Atripla.
The report also finds that increasingly stringent, yet ill-defined, approval standards make it difficult for companies to bring hospital antibiotics to market. The FDA's heightened scrutiny of hospital antibiotics has resulted in extended review periods, cancelled advisory meetings, postponed PDUFA dates and the issuance of multiple consecutive approvable letters requesting further data.
"We believe there is discordance between the FDA's expectations and the submission data presented by drug developers," said Sylvia Eash, Ph.D., analyst at Decision Resources. "As a result, the lack of FDA guidance that clearly defines these standards has emerged as the greatest challenge for drug developers who are left to wonder how the approval process will change while their late-stage hospital antibiotic candidates await further regulatory decisions. Agents suffering from these regulatory uncertainties include J&J's Doribax, Pfizer's Zeven, Theravance's telavancin and J&J's ceftobiprole."
The report is the first of its kind from Decision Resources, outlining the entire drug market for anti-bacterials, anti-virals and anti-fungals. Each drug class is thoroughly dissected with robust data on major brands, supporting brands, late stage and early stage R&D candidates. The 251 page report also includes the therapy area rankings by company from 2003-2014, the sales by class from 2003-2014 and key events within the anti-infectives market.
In addition to the report, Commercial Outlook for Anti-Infectives: 2003-2014 will include an interactive forecast model for anti-infectives as well as a unique slide deck featuring analysis on the anti-infective franchises of the top 20 pharma companies.
About Commercial Outlook for Anti-Infectives: 2003-2014
Commercial Outlook for Anti-Infectives: 2003-2014 is part of the Pharmaview franchise from Decision Resources. Offering top-down sales numbers, complete overviews of all major drugs on the market and in late and early-stage development, this report is a must-have for any biopharmaceutical company in, or looking to break into, the anti-infectives market or any company partnering with or selling into a drug company currently in the anti-infectives market.
About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.
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For more information, contact: Elizabeth Marshall Decision Resources, Inc. 781-296-2563 [email protected]
SOURCE Decision Resources