Global Orphan Drugs Clinical Trials Insight Report Highlights:
- Clinical Insight On More Than 400 Marketed Orphan Drugs
- Clinical Insight On More Than 1300 Orphan Drugs in Clinical Trials
- Orphan Designated Drug Clinical Status by Indication & Country
- Global Market Opportunity More Than USD 350 Billion
- Market Exclusivity & Patent Protection Criteria for Orphan Drugs
- Global & Regional Orphan Drug Market Sales Opportunity
- Orphan Drug Reimbursement Policy
- Orphan Clinical Pipeline Overview Company, Drug Class, Formulation, Indication, Region, Priority Status, Patient Segment, Phase
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Orphan drugs are medicinal products intended for diagnosis, prevention or treatment of life threatening or very serious diseases or disorders that are rare. These drugs are called “orphan” because under normal market conditions the pharmaceutical industry has little interest in developing and marketing products intended for only a small number of patients. It is analyzed that there are more than 7000 rare diseases globally and for which no treatment options are available. The rising prevalence of rare diseases has gained the interest of researchers for the development of novel orphan drugs in their management.
As of now, about 500 orphan drugs have been approved globally which are used in the management of wide range of rare diseases including several cancers, Pompe disease, fabry disease, cystic fibrosis, spinal muscular atrophy, and several others. The market for orphan drug is mainly dominated by cancer orphan drugs which are mainly due to rising prevalence of cancer. Moreover, different types of rare cancers have been discovered over the past few years, which call for an immediate need to implement the administration of complex orphan drugs. The extensive research and development activities will drive the oncology segment during the forecast period.
In last few years, orphan drugs have become the pharmaceutical industry’s favorite children, and are on the leading edge of the specialty trend. Orphan drug designations (ODD) have gained considerable interest from the pharmaceutical industry which is mainly due to the benefits of the enhanced regulatory processes, tax benefits, and extended market exclusivity associated with the development of orphan drugs. For instance, in Europe, orphan drug designation provides market exclusivity of ten years for the approved product, whilst in the US it’s seven years. Other benefits include reduced or wavered regulatory fees, and in the US, the opportunity for tax credits and subsidies for clinical trials in the rare disease space.
These and other benefits have resulted in an increased interest in orphan drug development and have encouraged and incentivized companies to develop treatments for rare indications. As per our analysis, there are more than 1300 orphan drugs in clinical pipeline which are expected to enter the market during the forecast period. Our report, Global Orphan drug market provides comprehensive and in-depth analysis on the ongoing clinical trials in the market and also provides commercial information on more than 400 commercially available orphan drugs.
As rare diseases are often poorly understood, and primary care physicians and specialists can easily confuse their symptoms with other diseases. In addition, the high cost of treatment and lack of market potential also restricts pharmaceutical giants to invest in this sector. Recently, orphan drug manufacturers have effectively lead the market by proactively engaging in physician, payer, and patient education. Apart from this, the companies have adopted strategic alliances including collaboration, merger, acquisitions, or partnerships to maintain their position in the market. The major companies in the market includes such as Pfizer, Novartis, GlaxoSmithKline, AbbVie, Amgen, Roche, Merck, Jazz Pharmaceuticals, Sanofi, and others.
As per our report analysis, it is estimated that global orphan drugs market will surpass US$ 350 Billion by 2028. The demand for the orphan drugs has increased significantly owing to surge in prevalence of rare diseases. In addition, the rise in awareness among the populace regarding rare diseases, increase in research and development investment, and drug development drive the market growth.US will remain strong throughout the forecast period which is mainly due to rising support from government. In addition, this region is likely to witness the highest number of FDA approvals for the orphan drug development, encouraging companies to develop new orphan drugs. Besides US, Europe is also anticipated to witness considerable growth owing to the incentivization of orphan drug manufacturing.