Orphan drug are novel pharmaceutical drugs which have been developed specifically to treat rare medical conditions. Rare diseases are often severe and chronic, and sometimes progressive.
Global Orphan Drugs Market & Clinical Trials Insight Report 2028 Highlights:
- Clinical Insight On More Than 600 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 drug are novel pharmaceutical drugs which have been developed specifically to treat rare medical conditions. Rare diseases are often severe and chronic, and sometimes progressive. Currently, there are about 5,000 and 8,000 rare diseases and around 7,000 for which there currently exists no effective treatment. These disease ranges from neurological disorders, infectious disease, and rare cancers to genetic syndromes. The rising incidence of rare diseases and increasing awareness among the population are the major factors which are propelling the growth of market.
In recent past, pharmaceutical companies have increasingly focused on developing drugs for rare diseases. Globally, there are more than 500 orphan drugs which have gained approval from the regulatory bodies. Globally, the market is dominated by by Herceptin, Keytruda, Blincyto, Hemlibra, Soliris, Revilimid, Opdivo and Humira. Since their entry into the market, these drugs have shown high adoption rates which is mainly due to their targeted nature in the management of disease. Apart from this, the availability of generics or bosimilars of these drugs also aid in increasing the accessibility of drugs to patients with poor socio-economic background, thus boosting the growth of market.
Among all factors, the most challenging aspect is clinical development. Our understanding of the pathophysiology of rare diseases is still relatively poor. Moreover, the lack of predictive clinical animal models, the relatively insensitive clinical endpoints, and the lack of validated biomarkers all together present huge hurdles to developing a drug for rare disease. Despite several challenges associated with the growth of market, pharmaceutical giants is actively investing in this segment, thus suggesting positive future of the market in the forthcoming years. It is analyzed that more than 1000 clinical trials globally which are evaluating the role of novel orphan therapies in wide range of application.
By therapeutic application, cancer segment held the maximum share in the market. The considerable rise in the geriatric population along with shift towards sedentary lifestyle increases the risk of developing the cancer. Moreover, the unavailability of effectively curing drugs and the rate at which conventional therapies are failing possess an unmet need for the development of targeted therapies which will boost the growth of the market. The ongoing technological advancement in cancer pharmaceuticals is expected to create opportunities for the market during the forecast period. The clinical trials and various drugs in the pipeline can further facilitate the healthy growth of the industry. Currently, more than 800 clinical trials are ongoing in cancer orphan drug segment which suggests promising future of this segment during the forecast period.
US is currently holding more than 50% share in the global orphan and is expected to continue its stronghold for a few more years. One of the major reasons for the market growth in this region is that the drug designated orphan receives seven year of patent exclusivity upon FDA approval for a specific indication, tax credits, and user fee waiver. Further, the presence of major key players in the region including Celgene, Pfizer, Bayer, Bristol Myers Squibb, Eli Lilly, Sanofi and others which actively invest in this sector also propels the growth of the market in the region.
As per our report findings, the global orphan drug market is expected to surpass US$ 350 Billion by 2028. The report covers the present ground scenario and the future growth prospects of the Orphan Drugs market for 2020-2028 along with new product launches, clinical trials, and number of drugs registered, and waiting for approval, market initiatives, high expense on research and development, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The market forecast is done on the basis of orphan drugs launched in various areas and their market presence across the globe.
For More Information Related To Report Contact:
Neeraj Chawla
Research Head
Kuick Research
+919810410366