Global Orphan Drug Rare Disease Market Clinical Trials Forecast 2028

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

For Report Sample Contact neeraj@kuickresearch.com

An orphan drug is a pharmaceutical product which is utilized in the diagnosis, prevention, and treatment of rare and serious diseases. These diseases are distinct from other diseases in that they have a very low prevalence rate relative to other diseases, and so are purchased by a very tiny patient population. In past decade, rare diseases have gained interest in the pharmaceutical market as government provide incentives for pharmaceutical and biotechnology companies to develop new drugs indicated for the treatment of rare diseases. The increased interest is also a result of scientific and technological advances in genetic, molecular, and biochemical researches to reveal the pathophysiology of rare diseases.

Currently, multiple of orphan drugs have entered the global market which are indicated for wide range of rare diseases including ALS (Lou Gehrig’s disease), Huntington’s disease, muscular dystrophy, Tourette syndrome, and myoclonus, and several others. Increasing demand for orphan drugs due to increasing prevalence of life-threatening or serious diseases or disorders that are rare is expected to boost growth of the global orphan drugs market over the forecast period. As per our analysis, there are about 7,000 rare diseases globally which require unmet medical needs, which will drive the research and development in this sector.

The global orphan drug market is eminently competitive and fragmented in nature. There are several players in the market and a pool of new players is expected to enter the market during the forecast period. The prominent players in the market include GlaxoSmith Kline, Pfizer, Novartis, Celegene, Eli Lilly, Merck, and Takeda Pharmaceuticals. These leading players are focusing on gaining stronger foothold by investing in research and development in drug development area and rapid product launches in the market. For instance, US FDA recently granted orphan drug designation to CT120 for the management of acute lymphoblastic leukemia. CT120 is fully human CD19/CD22 dual-targeted chimeric antigen receptor (CAR)-T cell therapy developed by IASO Biotherapeutics.

High cost of orphan drugs, risks associated with orphan drugs and prolong timeline for product development is expected to hamper growth of the global orphan drugs market. Nonetheless, regardless of the constraints restraining the growth of market, the rising research and development by the leading players and governments initiatives to support the development of drugs is projected to expand the global orphan drugs market in the upcoming years. For instance, Europe Union has implemented some policies including Italy’s AIFA 5% Fund, Belgium’s Special Solidarity Fund, and France’s Temporary Authorization to boost their development. In addition, Asia-pacific countries including China, Japan, South Korea, and Taiwan provide incentives such as tax credits and subsidies to both the patients as well as the pharmaceutical companies. These policies in various countries around the world have evolved the market in last few years.

The global orphan drug market is expected to surpass US$ 350 Billion by 2028. This is mainly attributed to large number of clinical trials, rising geriatric population, and increasing investment in this sector. US currently dominate the market for orphan drugs and is expected to continue its stronghold for a few more years. One of the reasons for market growth is that in the United States, a drug designated orphan drug status receives seven years of marketing exclusivity upon FDA approval for a specific indication, tax credits, and user fee waiver. In addition, rise in prevalence of rare diseases and increasing awareness among the population will also boost the growth of market in this region. Moreover, Asia Pacific is expected to witness robust growth in the global orphan drugs market due to increasing prevalence of genetic diseases and increasing population in this region.

Contact:

Neeraj Chawla
Research Head
Kuick Research
neeraj@kuickresearch.com
+919810410366

Delhi
India

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This release was published on openPR.