Numerous collaborative research
programs across North America and Europe is owing to growth of orphan drugs
market
Regional segmentation of Orphan
Drugs Market by Coherent Market Insights comprises of North America, Latin
America, Europe, Asia Pacific, Middle East, and Africa. North America dominates
the market globally due to factors such as established regulatory and
reimbursement framework and incentives given by U.S. Food and Drug Administration
(FDA) for research and development in orphan drugs sector. The various
collaborative research programs across United States and Europe provides
research data on rare diseases to manufacturers, patients and health experts
which gives timely medical care, thus boost the orphan drug market. Whereas the
prevalence of genetic diseases and growth of population are some factors which
might allow the orphan drugs manufacturers to invest in the Asia Pacific
region.
The drugs which are developed for
treatment of rare diseases and conditions are referred to as orphan drugs. The
rare diseases such as Tourette syndrome, Huntington’s disease, muscular
dystrophy, myoclonus, and ALS (Lou Gehrig’s disease) are some of those diseases
for treatment of which adequate drugs have not been developed, and hence these
diseases are treated by orphan drugs. Orphan drugs are developed by the
pharmaceutical companies for public health need, and the sales generated by
this drugs are very minimal when compared to normal drugs.
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The orphan diseases manifest in
patient populations representing 6-8% of the global population. Symptoms of
some orphan diseases may appear at birth or in childhood including cystic
fibrosis, infantile spinal muscular atrophy, familial adenomatous polyposis
(FAP), and some others.
Developing novel indications for
designated orphan drugs is expected to drive the orphan drugs market
There are around 5,000 rare
diseases listed globally and 80% of those are to genetic origins. The
probability of getting infected by these diseases in adults is 50%.The need for
the development of orphan drugs which will treat such diseases and proactive
initiatives undertaken by government and regulatory authorities are the major
factors driving the orphan drugs market. For instance, the authorities of U.S.
FDA for orphan drug development department are providing the incentives to
healthcare and biotechnology industries in order to enhance their research and
development in orphan drugs. There are few drugs that have been withdrawn from
the market due to certain risk developed over prolong administration of these
drugs. However, these drugs have shown good results for treatment of those
diseases which in particular do not have any standard drug, owing to drive the
orphan drugs market. For instance, thalidomide used as a hypnotic drug was
withdrawn from market when teratogenic risk was discovered, however, this drug
has shown prominent result in treating leprosy.
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Developing orphan drugs that are
used to treat rare diseases do not have a high profit margin for the
manufacturers and prolong timeline for product development and manufacturing,
uncertain and expensive, are the factors hindering the growth of orphan drugs
market. However, the untapped emerging market and development of novel
indications for designated orphan drugs is expected to create various
opportunities in the orphan drugs industry.
The increasing prevalence of rare
cancer in patients owing to oncological diseases segment to dominate in the
orphan drugs market
Initiatives taken by government
to increase the investment in orphan drugs development driving the growth of
orphan drugs market.
Key players operating the orphan
drugs market are Acorda Therapeutics, Actelion Pharmaceuticals Ltd., Amgen,
Alexion Pharmaceuticals, Baxter international, Bayer healthcare
pharmaceuticals, Biomarin Pharmaceuticals, Novartis, F.Hoffmann-La Roche AG,
Johnson and Johnson and many others. The increase in investments, and some
initiatives taken by government helping the orphan drug manufacturers. For
instance, U.S. government provides 50% of tax credit on the research and
development expenses spent on the orphan drugs development by manufacturers.
However the high cost of the orphan drugs and generation of small sales from it
is amongst those factors which is lowering the interest of companies for
market.
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