Global Orphan Drugs Market
- Synopsis
According to a new report by Market Research Future, the
global market for orphan drugs is estimated to reach USD 200 billion by the end
of 2022. The market is estimated to expand at 11.56 % CAGR over the assessment
period (2017-2022) owing to the unmet requirement for rare diseases. Orphan
drugs are generally used for treating rare disorders and diseases that affect a
small percentage of the population.
There are approximately 30 million in Europe, 30 million
people in the US, and 350 million people worldwide who suffer from 7,000 types
of rare diseases and disorders among which four-fifths of the rare diseases are
genetic and 50 % of the crowd affected being children. Only 5 % of the rare
diseases had approved drug treatment with 326 new drugs being approved by FDA
and brought to the market.
Global Orphans Drug Market Segmentation
Globally, the market for orphan drugs has been segmented on
the basis of application, pharmacological class, source, technology, and
region.
The market has been segmented into enzyme replacement,
protein replacement, and gene chromosome expression based on pharmacological
class.
The market has been segmented into oncology, blood-related
disorders, neurology, nephrology, and infectious diseases based on
applications. Among these, oncology is predicted to dominate the market owing
to the increasing drug approvals for treating rare cancers.
The market has been segmented into Transgenic, DNA
recombination, and gene expression based on technology.
The market has also been segmented into biological orphan
drug and non-biological orphan drug based on source. Among these, biological
orphan drug leads the market in terms of revenue and is predicted to maintain
its dominance over the assessment period owing to the high efficacy of biologic
products for treating diseases.
Future
Drivers and Constraints Affecting the Market
Growing investment in R&D, unmet requirement for rare
diseases, economic, legislative, and tax benefits offered by the government,
high ROI, development of latest technologies like hybridoma, gene mapping, and
DNA recombinant, extensive exclusivity, and faster uptake and low marketing
cost are some of the major factors driving the market over the forecast period.
There has been a growing demand for drugs for rare diseases such as Yellow
Fever, Von Willebrand Disease, Aarskog Syndrome, Waardenburg Syndrome, diabetic
macular edema, Abetalipoproteinemia, Autism spectrum disorder (ASD), Yellow
Nail syndrome, Asperger syndrome, Von Hippel-Lindau Disease, and others which
is contributing towards the growth of the market. Moreover, FDA free waivers,
R&D grants by the government, favorable reimbursement policy along with
premium pricing owing to the low competition also contribute the market
growth.
Global Orphan Drugs Market - Competition Analysis
The key players operating the market for orphan drugs are
Alexion Pharmaceuticals Inc., Bayer AG, Sanofi, Celgene Corporation, Novartis AG,
Biogen Idec Limited, Hoffmann- La Roche, Takeda Pharmaceuticals Company
Limited, Bristol-Myers Squibb, Vertex Pharmaceuticals Inc. Johnson &
Johnson, and others.
Meanwhile, high cost of development, extensive post-market
surveillance, costly clinical trials, monopolized and unitary market, concern
over safety, competition from biosimilars and generics are some of the
restraining factors inhibiting the growth of the market over the forecast
period. Moreover, active distribution and commercialization can be hindered by
differential availability of developing and developed countries, owing to
socio-economic factors.
The FDA has granted orphan drug designation to Surface
Oncology's lead investigational candidate SRF231 which is a potential treatment
for patients suffering from multiple myeloma. The SRF231 is a human monoclonal
antibody therapeutic targeting CD47, a protein overexpressed on cancer cells to
prevent them from being eliminated and engulfed by macrophage-mediated
phagocytosis.
North
America to Dominate the Market
Geographically, the market for orphan drugs has been spanned
across regions such as North America, Europe, Asia Pacific, Middle East and
Africa.
North America has been estimated to hold the largest market
share owing to well-established healthcare infrastructure, favorable
regulations for drug approval for rare diseases, initiatives by
non-governmental and governmental agencies to increase awareness related to use
of orphan drugs, and drug exclusivity status received by orphan drugs.
Moreover, US contributes substantially to the market which calls for strong
R&D for development of orphan drugs.
Major
Table of Content:
1 Introduction
2
Research Methodology
3 Market Dynamics
4 Market Factor Analysis
5 Global Orphan Drugs Market, By Application
6 Global Orphan Drugs Market, By Pharmacological Class
7 Global Orphan Drugs Market, By Technology
8 Global Orphan Drugs Market,
By Source
9 Global Orphan Drugs Market, By Regions
10 Company Landscape
11 Company Profile
12 Appendix
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