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Cystic Fibrosis-API Insights, 2015

  • April 2015
  • -
  • Delve Insight
  • -
  • 60 pages

Summary

DelveInsight’s, Cystic Fibrosis-API Insights, 2015,report provides Cystic Fibrosis drugs marketed details and API Manufacturers details across the globe along with the location. The report gives the clear idea on the United States Drug Master File (USDMF) and Europe DMF filed by worldwide countries related to the drugs falling under Cystic Fibrosis. The Report provides the India and China API Manufactures who are driving the current API Market. DelveInsight’s report also highlights the patent, patent exclusivity information and competitive landscape. The research analysis also presents the global sales forecasts data for the Cystic Fibrosis drugs till 2016.
The active pharmaceutical ingredients worldwide market is in continuous development from the recent years. There is expected to be a major impact on the global API industry, with the large number of blockbuster drugs going off patent in the coming years. It is going to affect the revenue of the API market as generic drugs occupy the market.
India and China produce a large percentage of a majority of the APIs and intermediates produced in the world currently. The USFDA and EMA have strict guidelines for API manufacturing 'Process Validation: General Principles and Practices'. While countries such as Japan and Singapore are signatories to the ICH Q7 regulation, India and China follow their national GMP guidelines. The efficiency and expertise of Asian contract manufacturers have positioned them in a very strategic space in the global pharmaceutical supply chain, with a vast majority of the APIs and intermediates being sourced from markets such as India and China.
Data Sources
The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by DelveInsight team of industry experts.Secondary sources information and data has been collected from various printable and non-printable sources like search engines, News websites, Government Websites, Trade Journals, White papers, Magazines, Trade associations, Books, Industry Portals, Industry Associations and access to available databases.
Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

• A snapshot of the global Market therapeutics scenario for Cystic Fibrosis.
• A review of the marketed products under prescription for Cystic Fibrosis, regulatory information and marketing status.
• Coverage of global patent coverage and detailed commentaries on the US patent challenges.
• Graphical representation of investigational products for patent expiry and market exclusivities across the globe.
• Product profiles for marketed products for Cystic Fibrosis with complete description of mechanism of action, therapeutic class, target, route(s) of administration and chemical details.
• Coverage of API Manufacturers for Cystic Fibrosis drugs in the United States, Europe and Asian Regions with location details.
• Coverage of Regulatory filings in the US, Europe, and Asia specifically India and China for Cystic Fibrosis drugs.
• Key discontinued Marketed products.
• Global Sales Figure from 2012-2016.

Reasons to Buy

• Evaluate the marketing status and exclusivity details of Cystic Fibrosis key products to exploit opportunities for generic drug development opportunities.
• Key players in the pharmaceutical industry.
•Strategic drivers and restraints of this market are revealed and market opportunities and challenges are identified.
• Design effective counter-strategies to gain competitive advantage by identifying the key patent expiry details and exclusivity with respect to Cystic Fibrosis.
• API intelligence over marketed drugs for Cystic Fibrosis and gaining primary intelligence over active ingredients manufacturers across the globe.
• Uncovering opportunities in the rapidly growing the US markets.

Table Of Contents

Cystic Fibrosis-API Insights, 2015
Table of Contents
• Indication Overview
• Marketed Drugs Assessment
• Marketed Details of Drugs by Application Type
• Marketed Details of Drugs (NDA) by Marketing Status
• Marketed Details of Drugs by Patent Expiration Timeline
• The Active Pharmaceutical Ingredient (API) Manufacturers Assessment
• The API Manufacturers by the United States Drug Master File (US DMF) Status
• The API Manufacturers by the US DMF Status (Drug Specific)
• Drugs Market Data and Forecasted Sales Figures (2012-2016)
• Marketed Drugs Information
• Drugs Description
• Global Active Pharmaceutical Manufacturers
• Approval Status
• Patent and Exclusivity Details
• Company Overview
• Discontinued Drugs Information

List of Tables

Cystic Fibrosis Therapeutic Market, US, Marketed Drugs by Application Type, 2015
Cystic Fibrosis Therapeutic Market, US, Marketed Drugs by Marketing Status, 2015
Cystic Fibrosis Therapeutic Market, US, (Year), 2015
Cystic Fibrosis Marketed Drugs, API Manufacturers by US DMF Status, 2015
Cystic Fibrosis Marketed Drugs, US DMF Status Drug Specific (Number), 2015
Cystic Fibrosis Therapeutic Market, Global Sales (in million USD), 2015
Cystic Fibrosis Marketed Drugs, API Manufacturers, Global, 2015
Discontinued Drugs for Cystic Fibrosis, 2015

List of Figures

Cystic Fibrosis Therapeutic Market, US, Marketed Drugs by Application Type (%), 2015
Cystic Fibrosis Therapeutic Market, US, Marketed Drugs by Marketing Status (%), 2015
Cystic Fibrosis Therapeutic Market, US, (Year), 2015
Cystic Fibrosis Marketed Drugs, API Manufacturers by US DMF Status (%), 2015
Cystic Fibrosis Marketed Drugs, US DMF Status Drug Specific (Number), 2015
Cystic Fibrosis Therapeutic Market, Global Sales (in million USD), 2015
Cystic Fibrosis Marketed Drugs, Patent/Exclusivity Expiry (Year), 2015

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Cystic Fibrosis

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