Orphan drugs are the type of medical products intended for prevention, diagnosis or treatment of serious, life-threatening disorders that are rare.
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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Orphan drugs are the type of medical products intended for prevention, diagnosis or treatment of serious, life-threatening disorders that are rare. These are known as orphan drugs because, under normal market conditions, the pharmaceutical industry has little interest in developing and marketing these products projected for only a small number of patients. Since the Orphan Drug Act was enacted, the global market has seen the approval of more than 600 new rare disease drugs.
The entrance of cocktail of orphan drugs in the global market has shown robust response in last few years. Some of the top selling orphan drugs include Revilimid, Opdivo, Keytruda, Rituxan, and others which are mainly indicated for the management of cancer. Outside of cancers, other top-performing orphan drugs tend to include those for rare genetic diseases, blood disorders and central nervous system diseases. Biogen’s Spinraza and Alexion’s Soliris were the first to market for their respective indications, spinal muscular atrophy and paroxysmal nocturnal hemoglobinuria. All these blockbuster drugs have sales of more than US$ 1 Billion every year, which further boosts the growth of market.
The encouraging response and associated incentives with orphan drug development has propelled the investments from pharmaceutical companies. 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. RIBA aims to foster a unique novel precision medicine environment to accelerate, de-risk, and improve the development of new orphan drugs based on the combination of large real-life data sets in rare disease with innovative big data, innovative artificial intelligence, as well as computational algorithms and expertise. The rising collaboration, partnerships, and joint ventures among the pharmaceutical companies will also boost the growth of market during the forecast period.
Despite considerable interest from pharmaceutical giants, the global market has several challenges which need to be overcome. The lack of awareness among the patient and physician regarding orphan disease treatment and high prices are coupled with these drug development are expected to act as major restraints towards the growth of the orphan drugs market. In addition, low patient enrollment and delayed diagnosis also restricts its growth in the global market. Although market have several obstacles, but it is suggested that the overall market will witness high rates which is mainly attributed to new product launches and rising orphan drug designation by US FDA and other regulatory bodies.
As per our analysis, the global orphan drug market is expected to surpass US$ 350 Billion by 2028. The rapid increase in prevalence rate of hypertension, diabetes and cardiovascular diseases is expected to accelerate the market growth in the forecast period of 2021 to 2028. Likewise, the rise in prevalence of rare diseases and increase in the healthcare expenditure are also predictable to enhance the orphan drugs market growth. Furthermore, the favorable reimbursement policies and favorable government policies are also projected to drive the market growth rate. Also, the expansion of product pipeline by launching new drugs and increase in the rate of research and development initiatives are also expected to influence the orphan drugs market growth globally.
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