Orphan Drugs Market Overview:
The market for orphan drugs is expected to register a CAGR of 11.5% over the forecast period. Factors responsible for the growth of this market include market exclusivity for orphan drug developers, increasing the incidence of rare diseases, and favorable public policies.
The market is anticipated to register an increased CAGR during the forecast period as the incidence of rare diseases among the global population has risen in the latest years. To tackle this issue, both developing and developed countries have formulated laws promoting the development of rare disease drugs, as well as ensuring that these drugs are readily available to patients. Currently, the average approval time for non-orphan drugs is around 13 months, and the same for orphan drugs is much lesser at around 10 months. Similar policies have been introduced by the European Union for the growth of these drugs and these policies have been enforced separately by European governments in their nations. Some of these are Italy s 5% AIFA Fund, Belgium s Special Solidarity Fund, and France s Temporary Authorization for use. Even Asia-Pacific countries have also followed comparable measures with nations such as Japan, South Korea, and Taiwan with projects such as the Revised Orphan Drug Regulations and Orphan Drug Guidelines 2003. These projects provided both the patient and the pharmaceutical companies tax credits and subsidies. These policies have developed in the market studied in numerous nations around the globe, which has been increasing at a good pace in the latest years.
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Scope of the Report:
Orphan drugs can be defined as a molecule intended to treat a rare disease. As the name indicates, the rare disease has a low prevalence rate and has been described differently across geographic places.
Key Market Trends:
Biological Orphan Drug is having the largest share over the forecast period.
Biological orphan drugs can register the largest market share in the drug segment type and are anticipated to develop at a good rate during the forecast period. This high market share is due to the higher costs of biological medicines compared to non-biological medicines. The latest trend of approval of biological orphan drugs for various indications has led in the development and has been an encouraging factor for new and established market players to enter this market. Another reason is that for a long time the biological drugs have been used to treat chronic conditions. The most focused orphan disease, i.e. cancer, which has a greater prevalence rate in the developed world, has been efficiently handled with fewer side effects by biological drugs.
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North America is dominating the market growth
North America currently dominates the orphan drug market and is anticipated to remain its stronghold for a few more years. The United States maintains the largest market share in the North American region. One reason for market growth is that a drug-assigned orphan drug status in the United States gets seven years of marketing exclusivity upon FDA approval for a particular indication, tax credits, and user fee waiver. The new indication approvals have risen significantly since 2013.
Competitive Landscape:
The market for orphan drugs is moderately competitive and consists of quite a few significant players. In terms of market share, some of the key players presently dominate the market. With the rising number of diseases and a growing amount of cases each year, a few smaller players are entering the market and holding a significant share. Some of the market s significant players are Teva Pharmaceutical, Celgene, Merck & Co. Inc., Bristol-Myers Squibb Company, and F. Hoffmann-La Roche AG, among others.
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Table of Content Covers the Topics mentioned below
- Introduction
- Research Methodology
- Market Analysis
- Market Dynamics
- Market – by Drugs Type
- Global Market – by Top Selling Drugs
- Orphan Drugs Industry – by Disease Type
- Orphan Drugs Market – by Phase
- Orphan Drugs Market – by Geography
- Orphan Drugs Market – Company Profiles
- Market Competitive Landscape
- Market Insights
- Appendix
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