Major players in the orphan drugs market are Bristol-Myers Squibb Company, Celgene Corporation, F. Hoffmann-La Roche Ltd, Amgen, Biogen, Bayer, Novartis AG, GlaxoSmithKline plc, Johnson & Johnson and AbbVie Inc.
The global orphan drugs market is expected to grow from $135.2 billion in 2020 to $141.91 billion in 2021 at a compound annual growth rate (CAGR) of 5%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $183.27 billion in 2025 at a CAGR of 7%.
The orphan drugs market consists of sales of orphan drugs and related services that are used to treat rare diseases. An orphan drug is a pharmaceutical drug developed to treat patients suffering from rare diseases and would not make profit if developed commercially.
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, by drug type into biological, non-biological and by diesease type into oncology, hematology, neurology, cardiovascular, others.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
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.
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.
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. According to the study published in European Journal of Human Genetics in 2019, there are 300 million cases of rare diseases and approximately 4% of total population is affected by rare disease at any point in time. Thus, the rising prevalence of rare diseases is driving 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.
The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
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