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Published: Mar 18, 2022
Global Orphan Drugs Market & Clinical Trials Insight Report 2028 Highlights:
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Orphan drugs are the novel class of pharmaceutical drugs which are indicated for the diagnosis, prevention, and treatment of rare medical disorders. These drugs are manufactured to meet a specific public health requirement and usually have a limited market as they are approved for small group of patients. The most commonly reported rare diseases are Primary immunodeficiency disorders, Lysosomal storage disorders (Gaucher’s disease, Mucopolysaccharidoses, Pompe disease, fabry disease etc.) small molecule inborn errors of metabolism (Maple Syrup urine disease, organic acidemias etc.), Cystic Fibrosis, osteogenesis imperfecta, cancer, certain forms of muscular dystrophies and spinal muscular atrophy, etc.
Since the passage of orphan drug act, about 600 orphan drugs have been approved globally for wide range of therapeutic indications. Currently, the market is dominated by Herceptin, Keytruda, Trikafta, Imbruvica, Jakafi, Hemlibra, Soliris, Revilimid, Opdivo and Humira. Since their entry into the market, these drugs have shown high adoption rates which is mainly due to their targeted nature in the management of disease. By therapeutic indication, rare cancers held the maximum share in the market which is mainly due to large number of product approval. Almost 200 rare cancers have been identified which all together represent 22% of all cancer incidences. It has been suggested that except for 5 major tumors including breast, lung, colorectal, prostate, and bladder cancers, all others are classified as rare.
Despite the increasing focus given to the development and marketing of rare disease therapeutics, certain limitations restrict the growth of market. One of the critical factors restraining the growth of market is high cost associated with these drugs. Such high cost of treatment has significantly limited the widespread adoption of these product offerings, especially in emerging countries. Apart from this, such high cost of treatments is also a concern for developed countries where majority of drugs are not adequately reimbursed, thus significantly increasing the patient’s out of pocket cost.
However, the presence of well-established pharmaceutical sector along with the increasing involvement of the local as well as multinational companies is also indicating towards the future dominance of this sector in the global market. The pharmaceutical companies involving Novartis, AstraZeneca, Pfizer, BMS, Bayer, Amgen, Johnson & Johnson, Roche, Eli Lily, Merck etc. are currently investigating the therapeutic potential of several novel approaches and most of them are working to develop immunotherapies and targeted therapies for rare diseases.
As per our report findings, the global orphan drug market is expected to surpass US$ 350 Billion by 2028. Factors such as high incidence of rare disorders, a large number of rare disorders registries, and the presence of substantial research and development facilities for rare diseases are the main driving factors in the market. The market is also driven by the increasing awareness among the masses regarding the benefits of orphan drugs and the implementation of favorable government policies to inhibit the spread of contagious diseases are also contributing to market growth. Furthermore, presence of several incentives by regulatory bodies including patent exclusivity, research grants, tax credits, and protocol assistance also urges the pharmaceutical companies to invest in this sector.
The Global Orphan Drugs Market report provides a holistic evaluation of the market for the forecast period (2020–2028). The report comprises of various segments as well an analysis of the trends and factors that are playing a substantial role in the market. These factors; the market dynamics, involves the drivers, restraints, opportunities and challenges through which the impact of these factors in the market are outlined. The report also provide geographical analysis of various regions including US, Europe, China, Taiwan, South Korea, Brazil, Middle East, and others.
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