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Global Orphan Drugs Market Report -----------------------------------------
2016
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Executive Summary A rare disease is the one that occurs uncommonly or rarely in the general population. However, there exists no clear definition for
categorizing “rare diseases” and is usually defined on the basis of the prevalence, and some other factors including the severity of disease and availability of treatment options. Rare diseases are often serious, chronic and progressive. Orphan drugs are medicinal products intended for the diagnosis, prevention or treatment of rare diseases. These drugs are referred to be “orphan” as under normal conditions because these drugs are not cost effective to be developed by the pharmaceuticals industry, intended for a small number of patients suffering from rare conditions.
Increasing sales of prescription drugs, substantial benefits for new entrants in rare disease drug market, increased spending on medicines, rising healthcare expenditure and improving economic conditions of nations are some of the significant factors driving growth of the Orphan drugs market. However, the growth of the market is hindered by certain challenges including tougher regulatory approvals, limitation on charging higher prices and no approved drugs for several rare diseases including Polychethemia Vera (PV).
The global orphan drugs market is expected to see numerous developments including approval of several Ultra-Rare drugs, increasing scope of Gene therapy, development of drugs for rare blood disease, higher success prospects for Hematology compared to Solid Tumors, attractive pricing option for orphan drug competitors and striking opportunities in developing orphan drugs.
The report, “Global Orphan Drugs Market” analyzes the current prevailing condition of the market along with its future scope of development. The global market along with specific market of the U.S., Canada, Europe and Japan, is being discussed in the report. The major trends, growth drivers as well as issues being faced by the industry are being presented in this report. The major players in the industry are being profiled, along with their key financials and strategies for growth.
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The development of orphan drugs has become an important and attractive research and development strategy of many pharmaceutical companies, as it most commonly generates greater profitability due to the recent development drivers…
The global market for orphan drugs was estimated to have reached US$... billion in the year 2015, increasing from US$.. billion in the previous fiscal year recording an annual growth of …% for the year.
For the year 2014, …% share of the overall orphan drugs market was held by biological orphan drugs followed by non-biological orphan drugs that held rest of the ..% share.
The average cost per person for an orphan and non-orphan drug was nearly US$... thousand and US$... thousand respectively for the year 2014, increasing from US$... thousand and US$.. thousand respectively in the previous fiscal year.
The median cost of orphan drugs per patient reached US$.. thousand in the year 2014, increasing from US$.. thousand in the previous fiscal.
Global Orphan Drugs Market by Type (2014)
Global Orphan Drugs Market (2010-2015E)
The U.S. Prescription Pain Market Share by Product Value (2014)
2010 2011 2012 2013 2014 2015E
US$
Billio
n
Revenue Annual Growth
Biological Non-biological
2010 2011 2012 2013 2014
US$
Thou
sand
Orphan Drugs Non-orphan Drugs
The significant factors driving growth include governmental financial incentives including tax credits, shorter clinical trial times with smaller trial sizes, higher rate of regulatory success and longer exclusivity periods…
The total incidence for NHL reached … thousand in the major economies increasing from … thousand recording an annual growth of …%.
The total spending on branded orphan drugs in the U.S. was estimated to have reached US$... billion in the year 2014, increasing from US$... billion in the previous fiscal year.
The prevalence of LEMS (Lambert-Eaton Myasthenic Syndrome) in the U.S. was estimated to have reached … in the year 2015, with a further expectation of reaching …by the end of year 2020.
The market for Firdapse drug for the treatment of LEMS in the U.S. is expected to start with sales worth US$.. million in 2016, and reach US$.. million by the end of 2022.
The U.S. Orphan Drugs Spending (2009-2014E)
Non-Hodgkin’s Lymphoma (NHL) Incidence by Country (2014)
Prevalence of LEMS in the U.S. (2015-2020E)
2010 2011 2012 2013 2014
Num
ber o
f Pat
ient
s ('0
00)
The U.S. France Germany Italy Spain The UK
2009 2010 2011 2012 2013 2014E
US$
Billio
n
Spending % of Total Drug Expenditure2015 2016 2017 2018 2019 2020
The orphan drug spending in the U.S. will rise aided by increasing approvals for orphan drugs by health ministry, improved medical insurance coverage and reimbursements for the treatment of rare diseases.
The spending on branded orphan drugs in Canada was estimated to reach US$.. million in the year 2014, increasing from US$... million in the previous fiscal year.
The orphan drug spending in Canada was anticipated to have reached US$.. million in the year 2015, recording an annual growth of .. % with a further expectation of reaching US$.. million by the end of year 2018.
The orphan drug designations per year in Japan reached .., increasing from .. in the previous fiscal year.
In Europe, Non-Hodgkin’s Lymphoma was expected to be the most common indication with .. orphan designations followed by Leukemia, acute myeloid (AML) with and Cystic Fibrosis (CF) with .. And .. designations.
Japanese Orphan Drug Designation per Year (2009-2014)
Canadian Orphan Drug Spending (2009-2014E)
Orphan Drug Designation in the EU by Indication (2014)
2009 2010 2011 2012 2013 2014
Num
ber o
f Des
ignat
ions
2009 2010 2011 2012 2013 2014E
US$
Millio
n
Spending % of Total Drug Expenditure
Graft vs host disease (GvHD)Leukaemia, chronic lymphocytic (CLL)
Renal cell carcinoma (RCC)Multiple myeloma
Ovarian cancerPancreatic cancer
GliomaCystic fibrosis (CF)
Leukaemia, acute myeloid (AML)Non-Hodgkin lymphoma (NHL)
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