Orphan Drugs Market : Value Chain, Dynamics and Key Players 2020

The Orphan Drugs Market report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

The global orphan drugs market was worth $132.61 billion in 2019. It is expected to grow at a compound annual growth rate (CAGR) of 7.86% and reach $179.49 billion by 2023.

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The report presents the market competitive landscape and a corresponding detailed analysis of the major vendor/key players in the market. Top Companies in the Global Orphan Drugs Market: Bristol-Myers Squibb Company; Celgene Corporation; F. Hoffmann-La Roche Ltd; Amgen; Biogen and others.

Industry News:

5th March 2020: A new analysis from GlobalData has claimed that the number of orphan drug designations (ODD) being handed out by both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) is declining. The company has revealed that over the last six years, the numbers have slowed down despite the visible benefits of such designations in speeding these drugs through development and to patients. Quentin Horgan, pharma analyst at the firm explains that the EMA had a "much greater" decline in unique drugs awarded ODDs than the FDA - with the EU-based organisation showing a 49% decrease between 2014 and 2019, while the FDA only had an 8% decrease across the same time period.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 16, 2014-- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the fields of cancer metabolism and inborn errors of metabolism (IEMs), today announced that the U.S. Food and Drug Administration (FDA) has granted the company orphan drug designation for AG-221 for treatment of patients with acute myelogenous leukemia (AML). AG-221 is an oral, first-in-class IDH2 mutant inhibitor being evaluated in a Phase 1 clinical trial in patients with advanced hematologic malignancies that carry an IDH2 mutation.
The FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation provides to Agios and its collaborator Celgene certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

Market Overview:

The orphan drugs market covered in this report are segmented by therapy area into oncology, blood, central nervous system, endocrine, cardiovascular, respiratory, immunomodulatory. They are also segmented by distribution channel into hospital pharmacy, retail pharmacy, and online sales.

The rising prevalence of rare diseases is a key factor driving the growth of the orphan drugs market. Any disease that affects a small percentage of the population is a rare disease. Rare disease treatments often require a cold chain, a supply chain regulated by temperature that is not readily accessible in all countries. Orphan diseases or rare diseases occurs rarely among the people (i.e. 7 out of 10,000). However, globally, the prevalence of rare diseases is increasing in recent years. In 2017, there were 7,000 identified rare diseases, including hemophilia, Gaucher disease, Hunter syndrome and many types of rare cancer. Some cases of aplastic anemia, caused by damage to stem cells in the bone marrow that are diagnosed in around 500 to 1,000 individuals in the USA each year, are inherited. Thus, the rising prevalence of rare diseases is driving the growth of the orphan drugs market.

Lack of supportive government policies hinders the orphan drugs market. Due to the lack of relevant policies for orphan drug, certain drugs do not receive any special recognition or priorities for approval by regulatory authority. Medgenome Labs Ltd., global research partner in accelerating insights into complex genetic diseases, pointed out that companies manufacturing orphan drugs frequently drop out in foreign markets due to a lack of government funding. For example, orphan medical products (OMPs) in India, due to lack of proper regulations and clear guidelines, do not obtain tax cuts or exemptions from customs duties. Therefore, lack of supportive government policies limits the growth of the orphan drugs market.

Approval of biological orphan drugs for multiple indication act as a key trend driving the growth of the orphan drugs market. The biological drugs are used for treating rare diseases such as cancer with fewer side effects that have a high prevalence rate in the developed world. For Instance, in 2018, in order to launch the company's biological orphan drug development program Cardax, Inc. announced that it has been engaged with biological orphan drug expert Frederick D. Sancilio, Ph.D. For the development of commercial products, the companies are focused on obtaining biological orphan drugs to increase their revenue.

In November 2019, Bristol-Myers Squibb, a biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines, acquired Celgene for an undisclosed amount. Through this acquisition, Celgene shareholders received for each share, 1 share of Bristol-Myers Squibb common stock, $50.00 in cash without interest and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a payment of $9.00 in cash if certain future regulatory milestones are achieved. Celgene, a biopharmaceutical company positioned to address the needs of the patients with serious diseases.

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Regional Analysis For Orphan Drugs Market:

For comprehensive understanding of market dynamics, the global Orphan Drugs market is analyzed across key geographies namely:
North America (United States, Canada and Mexico)
Europe (Germany, France, UK, Russia and Italy)
Asia-Pacific (China, Japan, Korea, India and Southeast Asia)
South America (Brazil, Argentina, Colombia)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.

Orphan Drugs Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger and acquisitions along with trending innovation and business policies are reviewed in the report. The report contains basic, secondary and advanced information pertaining to the Market global status and trend, market size, share, growth, trends analysis, segment and forecasts from 2020-2023.

Following are major Table of Content of Orphan Drugs Market:

- Global Market Overview, Drivers, Restraints and Opportunities, Segmentation overview
- Global Market competition by top Players
- Analysis by Regions
- Consumption by Regions
- Consumption, By Types, Revenue and Market share by Types
- Consumption, By Applications, Market share (%) and Growth Rate by Applications
- Complete profiling and analysis of Players
- Industrial Chain, Sourcing Strategy and Downstream Buyers
- Marketing Strategy Analysis, Distributors/Traders
- Global Market Effect Factors Analysis
- Global Market Forecast
- Global Market Research Findings and Conclusion, Appendix, methodology and data source

Finally, all aspects of the Global Market are quantitatively as well qualitatively assessed to study the Global as well as regional market comparatively. This market study presents critical information and factual data about the market providing an overall statistical study of this market on the basis of market drivers, limitations and its future prospects. The report supplies the international economic competition with the assistance of Porter's Five Forces Analysis and SWOT Analysis.

We Offer Customization On Report Based On Specific Client Requirement:

- Free country Level analysis for any 5 countries of your choice.
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