Orphan drugs are novel drugs which are dedicated to treat the disease conditions that are rare as well as life-threatening to small percentage of patient population at global level.
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
Orphan drugs are novel drugs which are dedicated to treat the disease conditions that are rare as well as life-threatening to small percentage of patient population at global level. At present, there are about 6,000 rare diseases for which there is no effective treatment available. The orphan drug developers’ focus on identifying and studying potential treatments to serve the unmet need of patients living with rare diseases, and the current landscape offers a wide variety of incentives, government support, and regulatory agency assistance to encourage orphan drug development.
With the passage of orphan drug development act in 1980s, more than 5000 medicines have been granted orphan drug designation by regulatory bodies and about 800 drugs have been commercially available in the market. The entrance of these drugs in the market has revolutionized the paradigm treatment of several diseases. Further, these laws also provided several financial incentives, market exclusivity, patent protection, high price allotment, and government grants, which have resulted in favorable economic environment for the development of novel orphan drugs.
As per report findings, it is analyzed that the overall cost of the development of orphan drugs is much higher than the drugs that are considered to be working against some of the common diseases such as cardiovascular diseases due to the less availability of the participants for the clinical trials and less drug numbers in the market. In addition, the understanding of the pathophysiology of rare diseases is still very poor and there is lack of validated biomarkers, which further restrain the growth of market. However, the advancement in genomic fingerprinting and introduction of novel technologies for drug development process has further encouraged pharmaceutical companies to develop novel orphan drugs.
The entry of several small and big pharmaceutical giants in the global orphan drugs market is helping in speeding up the clinical trials and research activities in this sector. The companies are competing in the market for new product launches and to maintain their presence in the market. The key players in the market include Pfizer, Roche, Sanofi, Eli Lilly, Novartis, Biogen, Teva Pharmaceuticals, Merck, and several others which have developed a robust pipeline of orphan drugs. Currently, more than 1000 orphan drugs are present in clinical trials, which are expected to enter the market during forecast period.
In the last few years, it can be observed that there has been an increase in the number of opportunities that are associated with the orphan drug makers as the drug makers involved in the market are focusing on expanding the drug policies and specifically product range for each and every rare disease conditions. The forthcoming years of the orphan drug market is estimated to observe increase in the research and development as well as overall business operations and outreach, increase in the patient rights, increase in orphan drug competition, healthcare solutions getting delivered by orphan drugs and increase in the number of investors at a splendid rate. In addition to all the above-mentioned parameters, increase in the number of drugs developed for rare blood diseases and uncured diseases are estimated to explore the global market growth towards bright future.
US is estimated to dominate the market which is mainly attributed to rising prevalence of rare diseases in recent years and the increasing support from US government. The US FDA offers several benefits such as fact track approval, protocol assistance, waiver of fees and marketing exclusivity to manufacturers, facilitating the development and commercialization of diagnostic tools and treatment devoted to rare diseases. Furthermore, there has been rise in development of orphan biological drugs indicated for the treatment of various cancers and blood disorders, which further propel the market growth.
Contact:
Neeraj Chawla
Research Head
Kuick Research
+919810410366