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  5. > Kidney Disease-API Insights, 2014

Kidney Disease-API Insights, 2014

  • November 2014
  • -
  • Delve Insight

Summary

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.

DelveInsight’s, Kidney Disease -API Insights, 2014 Report describes the current therapeutics that are propelling the pharmaceutical markets worldwide. The report gives the clear idea on the United States Drug Master File (USDMF) and Europe DMF filed by worldwide countries related to the Kidney Disease. It also provides the India and China API Manufactures who are driving the current API Market. The report also highlights the patent and patent exclusivity information. The research analysis also presents the global sales forecasts data till 2015.

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 Kidney Disease.
- A review of the marketed products under prescription for Kidney Disease, 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 Kidney Disease with complete description of mechanism of action, therapeutic class, target, route(s) of administration and chemical details.
- Coverage of API Manufacturers for Kidney Disease 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 Kidney Disease drugs.
- Key discontinued Marketed products.
- Global Sales Figure from 2011-2015.

Reasons to Buy
- Evaluate the marketing status and exclusivity details of Kidney Disease 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 Kidney Disease.
- API intelligence over marketed drugs for Kidney Disease and gaining primary intelligence over active ingredients manufacturers across the globe.
- Uncovering opportunities in the rapidly growing the US markets.

Table Of Contents

Kidney Disease-API Insights, 2014
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 (2011-2015)
- Marketed Drugs Information
- Drugs Description
- Global Active Pharmaceutical Manufacturers
- Approval Status
- Patent and Exclusivity Details
- Company Overview
- Discontinued Drugs Information

List of Tables
Kidney Disease Therapeutic Market, US, Marketed Drugs by Application Type, 2014
Kidney Disease Therapeutic Market, US, Marketed Drugs by Marketing Status, 2014
Kidney Disease Therapeutic Market, US, (Year), 2014
Kidney Disease Marketed Drugs, API Manufacturers by US DMF Status, 2014
Kidney Disease Marketed Drugs, US DMF Status Drug Specific (Number), 2014
Kidney Disease Therapeutic Market, Global Sales (in million USD), 2014
Kidney Disease Marketed Drugs, API Manufacturers, Global, 2014
Discontinued Drugs for Kidney Disease, 2014

List of Figures
Kidney Disease Therapeutic Market, US, Marketed Drugs by Application Type (%), 2014
Kidney Disease Therapeutic Market, US, Marketed Drugs by Marketing Status (%), 2014
Kidney Disease Therapeutic Market, US, (Year), 2014
Kidney Disease Marketed Drugs, API Manufacturers by US DMF Status (%), 2014
Kidney Disease Marketed Drugs, US DMF Status Drug Specific (Number), 2014
Kidney Disease Therapeutic Market, Global Sales (in million USD), 2014
Kidney Disease Marketed Drugs, Patent/Exclusivity Expiry (Year), 2014

Companies Mentioned
Shire LLC
Pharmacia and Upjohn, Inc.
Genzyme Corporation
Baxter Healthcare Corporation
Pfizer Inc.
Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care AG and Co. KGaA
Aton Pharma, Inc.
Sandoz Inc.
B. Braun Medical Inc.

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