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Global Markets for Orphan Drugs, Focus on Non-Biologics

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Jun 10,2013 : Bharat Book Bureau presents the new report, on 'Global Markets for Orphan Drugs - Focus on Non-Biologics' This report explores present and future strategies and regulations within the orphan drug market, advances in the market, the setbacks, the current situation and the needs of the market.


A detailed analysis of the structure of the orphan drug industry has been conducted. Revenues are broken down by region drug type (i.e., biological and nonbiological), active ingredient and area of medical application. Sales figures are estimated for the five-year period from 2012 through 2017.

Applications for orphan drugs are also discussed in the report, with an emphasis on the usage of the drugs in various disease segments. The report also covers significant patents and their allotments in each category.


Extensive research in the field of orphan drugs has resulted in therapeutic treatments for a number of rare diseases. Most of the big pharmaceutical companies have now begun to explore the advantages of orphan drugs as a major source of profit and a steady market.

R&D spending, competition and new technologies are increasing. Advances, new product launches and assistance from regulatory bodies are positively impacting the growth of the market for orphan drugs in the near term. This study examines these factors.


This study focuses on the manufacturers and users of orphan drugs and its market growth. Pharmaceutical biotechnical companies, research institutes and physicians will find this study to be of interest.


The scope of this study includes orphan drugs in pharmaceutical markets worldwide. BCC analyzes each market and its applications, regulatory environment, technology, market projections and market shares. Technological issues include the latest trends and developments. The emerging market for orphan drugs includes countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.


Both primary and secondary research methodologies were used in preparing this study. BCC conducted a comprehensive literature search, which included technical newsletters and journals and many other sources. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions and market trends.


Many companies were surveyed to obtain data for this study. Included were manufacturers and end users of orphan drugs within the therapeutic categories examined and various disease sector industries. Data were gathered from various industry sources. BCC spoke with officials within the industry, consulted newsletters, company literature, product literature and a host of technical articles, journals, indexes and abstracts. Exhaustive investigations of databases by key terminology were completed. In addition, data were compiled from current financial, trade and government sources.


This report provides:

An overview of orphan drug criteria, the history of the Orphan Drug Act and its influence and advantages inherent in orphan drug designation and future growth trends; this report focuses on non-biologics.
Analyses of global market trends, with data from 2010 to 2012, and projections of compound annual growth rates (CAGRs) through 2017.
Detailed discussion of successful orphan products.
Detailed analysis of blockbuster orphan drugs.
The rising influence of pharmacogenomics in the orphan drug market.
A discussion of specific rare diseases for which orphan drugs exist.
Analyses of the most promising therapeutic areas in the industry and leading orphan drugs in these areas.
An outline of legislation and regulation, including public and private agencies involved in support and development.
Technology trends analysis within the orphan drug market.
Comprehensive company profiles of major players in the industry.

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