The Orphan Drugs Market is developing exponentially owing to the growing investment in research and development and unmet needs for rare diseases are the key factor driving the orphan drugs Market.
Currently, these orphan drugs are representing 35% of the total new drug approvals in the industry. The orphan drugs are disorders that affects a small percentage of the population. A pharmaceutical product aimed at rare diseases or disorders is known as an orphan drug. The major driving factor for the growth are extensive exclusivity, low marketing cost, legislative and tax benefits, government support leading to economic, and new technology development such as DNA recombinant, gene mapping, and hybridoma.
The Orphan Drug Act of 1983 has been financially incentivised through US law for the development of orphan drugs. As per the National Organization for Rare Disorders (NORD) established an act which anticipate that approximately 30 million Americans suffer from 7,000 different types of rare diseases.
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Almost half of the rare diseases are genetic in nature, with 50% of children being affected. There are an estimated 350 million people worldwide and 30 million in Europe suffering from rare diseases. Approved drug treatment for about 5% of rare diseases are available that accounts to only 326 new drugs being approved by the FDA and are supplied in the market. Prior to the incorporation of Orphan Drug Act, 38 drugs from orphan category were already approved.
Extensive post market surveillance, costly clinical trials, competition from generics and biosimilars, and safety concern are certain factors that intimidates the growth of this market. The limitation of distribution and commercialization channels are due to the differential availability of the product in the developed and developing countries due to social and economic factors.
Orphan Drugs Market – Industry Updates
Jan, 2017 Acucela Inc. received orphan drug FDA approval for emixustat for treatment of Stargardt disease. This approval is anticpated to be essential for the treatment of this genetic disease.
Nov, 2015 Ocata Therapeutics was acquired by Astellas Pharma to expand its product portfolio for treatment of retinal disorders such as age-related macular degeneration and Stargardt disease
June, 2015 Johns Hopkins University and Bayer Healthcare agreed to sign a five year collaboration agreement for developing treatment for diabetic macular edema, retinal vein occlusion, Stargardt’s disease, geographic atrophy, and age-related macular degeneration
March, 2014 Santen Pharmaceuticals contracted a pact with TRACON pharmaceuticals for the development and commercialization of Tracon’s anti-VEGF product TRC105, an orphan drug class for the treatment of various eye related disorder
April, 2012 Baush & Lomb acquired Ista Pharmaceuticals for expanding its customer base and gaining pipline drugs for the treatment of Stargardt disease.
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Orphan Drugs Market – Regional Analysis
The global orphan drugs market is segmented into four major regions including
And Africa region.
Globally, the Americas region is considered to be the largest market for orphan drugs. Factors such as the increasing government incentives, and high product demand are expected to promote market growth in the US region, which is reflected to be the highest revenue-generating region in the Americas.
The European regions is the second-largest market for Global orphan drugs. The upcoming market for orphan drugs is predicted to be subjugated by the developed regions with developing regions acting as a support pillar for its growth.
Asia Pacific will be the fastest growing regional market and is likely to be the key to the future. Middle East & Africa is expected to have limited but steady growth in the market.
Orphan Drugs Market – Company Analysis
This market is highly fragmented and is dominated by five major vendors including F. Hoffmann La Roche AG, Celgene Corporation, Bristol-Mayer Squibb Company, Novartis AG, and Pfizer Inc. as these are supposed to have extensive product portfolios. Factors such as the stringent rules and regulations, patent expiry of branded drugs, decreased R&D productivity, and high regulatory barriers are some significant challenges to the vendors during the forecast period.
Table of Contents:
1.2 Scope of Study
1.3 Research Objective
1.4 Assumptions & Limitations
1.5 Market Structure
2 Research Methodology
2.1 Research Process
2.2 Primary Research
2.3 Secondary Research
3 Market Dynamics
List Of Tables:
TABLE 1 GLOBAL ORPHAN DRUGS MARKET, 2013-2022 (USD MILLION)
TABLE 2 GLOBAL ORPHAN DRUGS MARKET, BY APPLICATION, 2013-2022 (USD MILLION)
TABLE 3 GLOBAL ORPHAN DRUGS MARKET, BY PHARMACOLOGICAL CLASS, 2013-2022 (USD MILLION)
TABLE 4 GLOBAL ORPHAN DRUGS MARKET, BY TECHNOLOGY, 2013-2022 (USD MILLION)
TABLE 5 GLOBAL ORPHAN DRUGS MARKET, BY SOURCE, 2013-2022 (USD MILLION)
TABLE 6 GLOBAL ORPHAN DRUGS MARKET, BY REGION, 2013-2022 (USD MILLION)
List Of Figures:
FIGURE 1 RESEARCH PROCESS
FIGURE 2 PORTERS FIVE FORCES MODEL
FIGURE 3 GLOBAL ORPHAN DRUGS MARKET, BY APPLICATION
FIGURE 4 GLOBAL ORPHAN DRUGS MARKET, BY PHARMACOLOGICAL CLASS
FIGURE 5 GLOBAL ORPHAN DRUGS MARKET, BY TEHCNOLOGY
FIGURE 6 GLOBAL ORPHAN DRUGS MARKET, BY SOURCE
FIGURE 7 GLOBAL ORPHAN DRUGS MARKET, BY REGION
FIGURE 8 GLOBAL ORPHAN DRUGS MARKET: COMPANY SHARE ANALYSIS, 2015 (%)
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