Number Of Commercially Available Orphan Drugs In Market Is Expected Increase 25% By 2028 Says Kuick Research.
Number Of Commercially Available Orphan Drugs In Market Is Expected Increase 25% By 2028 Says Kuick Research
Global Orphan Drugs Market & Clinical Trials Insight Report 2028 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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Rare disease is any disease that affects a small percentage of total population. There are approximately 7,000 rare diseases affecting 25 to 30 million Americans and 400 million worldwide. Orphan drugs are the drugs which are associated with the treatment or diagnostic of rare diseases. Rare diseases can include infectious diseases, birth defects, genetic disorders, and cancers. Although more than 500 orphan drugs have been approved by regulatory bodies, a large number of rare diseases remain without effective treatment. The increasing incidences of rare diseases associated with the unmet need of orphan drugs have propelled the further research and development in this sector.
Hundreds of new rare-disease treatments have entered the market over the past few decades, and orphan drug development has become a highly profitable industry. The development of orphan drugs is associated with several advantages which encourage the pharmaceutical companies to invest in this sector. There is a lack of competitors or strong competitive headwinds in the space. Another benefit is the long term protection periods offered by authorities and have faster approval time.
The regulatory bodies are rapidly granting orphan drug designation to the new drugs which are indicated for rare diseases, which will expedite the drug development and provide several incentives to the company for boosting clinical trials. In 2022, several drugs have been granted orphan designation by US FDA. Aptorum Group Limited received orphan designation for SACT-1, a repurposed small molecule compound for the treatment of patients with Neuroblastoma. In addition, MT-601, an investigational T-cell immunotherapy, for treatment of advanced or metastatic pancreatic adenocarcinoma was also granted orphan designation. Furthermore, Eureka Therapeutics received orphan drug designation to ET140203 and ECT204 for the treatment of hepatocellular carcinoma. These rising trends will have a positive impact on the growth of global orphan drug market.
The amount of interest and investment in rare diseases and orphan drugs has grown tremendously in recent years, leading to continuous innovation in a space that was once largely overlooked. Pharmaceutical companies believe that partnerships or collaboration between players that have complementary strengths, knowledge bases, and goals can be the keys to success. For instance in 2022, Centogene and Insilico Medicine announced a research and development collaboration to accelerate the discovery of novel therapeutic targets for Niemann-Pick disease type C. Further, Centogene and Molecular Health collaborated to initiate the Real-life data and Innovative Bioinformatic Algorithms (RIBA) project – starting with Epilepsy as the first indication. The major key players in the market include Noavrtis, Amgen, Roche, Celegene, Abbott Laboratories, Teva Pharamceutical, Sanofi, Merck, and others.
Despite their promising results, many challenges remain which restrict the growth of market including high cost, lack of awareness, and limited patients for clinical trial. However, rising government initiatives and increasing awareness about rare diseases will drive the market during the forecast period. Organizations around the world people are observing February 28, 2019, as the annual Rare Disease Day. The main objective of Rare Disease Day is to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives. The increasing awareness about rare diseases and availability of orphan drugs will also have a positive impact on the growth of market.
As per our report findings, the global orphan drug market will surpass US$ 350 Billion by 2028. The report provides detailed information regarding the top selling orphan drugs in the market. Furthermore, the report exhibits dynamic factors including segments, sub-segments, regional marketplaces, competition, dominant key players, and market forecasts. In addition, the market includes recent collaborations, mergers, acquisitions, and partnerships along with regulatory frameworks across different regions impacting the market trajectory. Recent technological advances and innovations influencing the global market are included in the report.
Contact:
Neeraj Chawla
Research Head
Kuick Research
+919810410366