Numerous collaborative researchprograms across North America and Europe is owing to growth of orphan drugsmarket
Regional segmentation of OrphanDrugs Market by Coherent Market Insights comprises of North America, LatinAmerica, Europe, Asia Pacific, Middle East, and Africa. North America dominatesthe market globally due to factors such as established regulatory andreimbursement framework and incentives given by U.S. Food and Drug Administration(FDA) for research and development in orphan drugs sector. The variouscollaborative research programs across United States and Europe providesresearch data on rare diseases to manufacturers, patients and health expertswhich gives timely medical care, thus boost the orphan drug market. Whereas theprevalence of genetic diseases and growth of population are some factors whichmight allow the orphan drugs manufacturers to invest in the Asia Pacificregion.
The drugs which are developed fortreatment of rare diseases and conditions are referred to as orphan drugs. Therare diseases such as Tourette syndrome, Huntington’s disease, musculardystrophy, myoclonus, and ALS (Lou Gehrig’s disease) are some of those diseasesfor treatment of which adequate drugs have not been developed, and hence thesediseases are treated by orphan drugs. Orphan drugs are developed by thepharmaceutical companies for public health need, and the sales generated bythis drugs are very minimal when compared to normal drugs.
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The orphan diseases manifest inpatient populations representing 6-8% of the global population. Symptoms ofsome orphan diseases may appear at birth or in childhood including cysticfibrosis, infantile spinal muscular atrophy, familial adenomatous polyposis(FAP), and some others.
Developing novel indications fordesignated orphan drugs is expected to drive the orphan drugs market
There are around 5,000 rarediseases listed globally and 80% of those are to genetic origins. Theprobability of getting infected by these diseases in adults is 50%.The need forthe development of orphan drugs which will treat such diseases and proactiveinitiatives undertaken by government and regulatory authorities are the majorfactors driving the orphan drugs market. For instance, the authorities of U.S.FDA for orphan drug development department are providing the incentives tohealthcare and biotechnology industries in order to enhance their research anddevelopment in orphan drugs. There are few drugs that have been withdrawn fromthe market due to certain risk developed over prolong administration of thesedrugs. However, these drugs have shown good results for treatment of thosediseases which in particular do not have any standard drug, owing to drive theorphan drugs market. For instance, thalidomide used as a hypnotic drug waswithdrawn from market when teratogenic risk was discovered, however, this drughas shown prominent result in treating leprosy.
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Developing orphan drugs that areused to treat rare diseases do not have a high profit margin for themanufacturers and prolong timeline for product development and manufacturing,uncertain and expensive, are the factors hindering the growth of orphan drugsmarket. However, the untapped emerging market and development of novelindications for designated orphan drugs is expected to create variousopportunities in the orphan drugs industry.
The increasing prevalence of rarecancer in patients owing to oncological diseases segment to dominate in theorphan drugs market
Initiatives taken by governmentto increase the investment in orphan drugs development driving the growth oforphan drugs market.
Key players operating the orphandrugs market are Acorda Therapeutics, Actelion Pharmaceuticals Ltd., Amgen,Alexion Pharmaceuticals, Baxter international, Bayer healthcarepharmaceuticals, Biomarin Pharmaceuticals, Novartis, F.Hoffmann-La Roche AG,Johnson and Johnson and many others. The increase in investments, and someinitiatives taken by government helping the orphan drug manufacturers. Forinstance, U.S. government provides 50% of tax credit on the research anddevelopment expenses spent on the orphan drugs development by manufacturers.However the high cost of the orphan drugs and generation of small sales from itis amongst those factors which is lowering the interest of companies formarket.
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