Orphan Drug Status Approval Designation Clinical Trials Market Insight Report 2028

·4 min read
KuicK Research
KuicK Research

Kuick Research Report Gives Comprehensive Insights On Commercial & Clinical Parameters Related To Orphan Drug Market

Singapore, June 25, 2022 (GLOBE NEWSWIRE) -- Global Orphan Drugs Market & Clinical Trials Insight Report 2028 Highlights:

  • Clinical Insight On More Than 600 Marketed Orphan Drugs

  • Clinical Insight On More Than 1300 Orphan Drugs in Clinical Trials

  • Orphan Designated Drug Clinical Status by Indication & Country

  • Global Market Opportunity More Than USD 350 Billion

  • Market Exclusivity & Patent Protection Criteria for Orphan Drugs

  • Global & Regional Orphan Drug Market Sales Opportunity

  • Orphan Drug Reimbursement Policy

  • Orphan Clinical Pipeline Overview Company, Drug Class, Formulation, Indication, Region, Priority Status, Patient Segment, Phase

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Recently, orphan drugs have emerged as one of the blockbuster drugs for the pharmaceutical industry. Orphan drugs are novel pharmaceuticals which are indicated for the prevention, diagnosis, or treatment of rare diseases. These rare diseases are chronic and life-threatening which requires proper long-term medications. As these diseases are rare, therefore the drug development of these diseases requires considerable amount of investment, thus increasing the overall cost of the drug. These are named orphan as pharmaceutical giants have little interest in the development of these drugs which is mainly attributed to small target population and lack of data for conducting clinical studies.

However, the rising incentives by government bodies have enabled huge investments in this segment. Presently, more than 500 drugs have been designated orphan designation by regulatory bodies worldwide. Further, about 200 of them have gained approval in the market for the management of rare diseases. The global orphan drug market is mainly dominated by Herceptin, Keytruda, Blincyto, 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. Apart from this, the availability of generics or biosimilars of these drugs also aid in increasing the accessibility of drugs to patients with poor socio-economic background, thus boosting the growth of market.

US followed by Europe is currently holding more than 50% share in the global market which is mainly attributed to the high spending on healthcare sector and the presence of better medical facilities. In addition, the high adoption rates to westernized lifestyle in these regions associated with increase in geriatric population possess high risk for the development of several rare chronic disorders including diabetes, cancer, heart diseases and several others. Further, presence of various leading pharmaceutical and biotechnological companies which are working for the development of ideal agents for targeting the rare diseases is another factor driving the growth of market in these regions. 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.

Although US and Europe remain at front foot in the global orphan drugs market, emerging countries like India, China, Japan has also taken several initiatives to boost this segment. For instance, The National Initiative for Rare Diseases (NIRD) in India was organized jointly by AIIMS, ICMR, JNU and PRESIDE. Apart from this, IGIB, New Delhi has conducted project funded by CSIR, titled “Genomics for Understanding Rare Diseases India Alliance Network (GUaRDIAN),” for the purpose to bring together and understanding novel genetic variations to achieve translational applications by researchers. Further, India conducts regular seminars, awareness campaigns regarding quality compliance and orphan drugs, opportunities for orphan drugs, and strategy maker in collaboration with FDA of other countries.
As per our report findings, the global orphan drug market is expected to surpass US$ 350 Billion by 2028 which is mainly attributed to increase in prevalence of rare diseases associated with high demand for the orphan drugs in its management. The high spending on research and development of orphan drugs, coupled with the presence of several large scale manufacturers are the major factoring driving the growth of market. Apart from this, several pharmaceutical companies like Amgen, Roche, Genetech have developed their assistance programs through which their potentially lower down the out-of pocket cost from the patients. For instance, Genetech has developed Hemlibra Co-pay program which helps eligible patients to reduce their out-of pocket cost in their course of treatment.

CONTACT: For More Information Related To Report Contact: Neeraj Chawla Research Head Kuick Research neeraj@kuickresearch.com +919810410366

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