Orphan Drug Status Approval Designation Clinical Trials Market Analysis Report 2028

Kuick’s research report gives comprehensive insights into commercial and clinical parameters related to the Orphan Drugs market

/EIN News/ — Singapore, June 25, 2022 (GLOBE NEWSWIRE) — Highlights of the Global Orphan Drugs and Clinical Trials Market Report 2028:

  • Clinical overview on more than 600 marketed orphan drugs
  • Clinical overview of over 1,300 orphan drugs in clinical trials
  • Clinical status of the designated orphan medicinal product by indication and country
  • Global market opportunity of more than 350 billion USD
  • Market exclusivity and patent protection criteria for orphan drugs
  • Sales Opportunity in the Global and Regional Orphan Drugs Market
  • Reimbursement policy for orphan drugs
  • Orphan Clinical Pipeline Overview Company, Drug Class, Formulation, Indication, Region, Priority Status, Patient Segment, Phase

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Recently, orphan drugs have become one of the flagship drugs of the pharmaceutical industry. Orphan drugs are new pharmaceutical products indicated for the prevention, diagnosis or treatment of rare diseases. These rare diseases are chronic and life-threatening, requiring appropriate long-term medication. As these diseases are rare, the development of drugs for these diseases requires considerable investment, thus increasing the overall cost of the drug. These are named orphans because pharmaceutical giants have little interest in developing these drugs, which is mainly attributed to the small target population and lack of data to conduct clinical studies.

However, increasing incentives from government agencies have enabled huge investments in this segment. Currently, more than 500 drugs have been designated orphan by regulatory agencies around the world. Additionally, about 200 of them have obtained market approval 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 entering the market, these drugs have shown high adoption rates, primarily due to their targeted nature in disease management. Apart from this, the availability of generics or biosimilars of these drugs also helps to increase the accessibility of the drugs to patients from lower socio-economic backgrounds, thereby driving the growth of the market.

The United States, followed by Europe, currently holds more than 50% of the global market share, which is mainly attributed to the high expenditure in the healthcare sector and the presence of better medical facilities. In addition, the high rates of adoption of a westernized lifestyle in these regions, coupled with the increase in the geriatric population, pose a high risk for the development of several rare chronic diseases, including diabetes, cancer, heart disease and many others. Furthermore, the presence of various leading pharmaceutical and biotechnology companies that are working to develop ideal agents to target rare diseases is another factor driving the market growth in these regions. Pharmaceutical companies involving Novartis, AstraZeneca, Pfizer, BMS, Bayer, Amgen, Johnson & Johnson, Roche, Eli Lily, Merck, etc. are currently studying the therapeutic potential of several innovative approaches and most of them are working on the development of immunotherapies and targeted therapies. .

Although the United States and Europe remain at the forefront of the global orphan drug market, emerging countries like India, China, and Japan have also taken several initiatives to boost this segment. For example, the National Initiative for Rare Diseases (NIRD) in India was jointly organized by AIIMS, ICMR, JNU and PRESIDE. Apart from this, IGIB, New Delhi has conducted a CSIR-funded project titled “Genomics for Understanding Rare Diseases India Alliance Network (GUaRDIAN)” with the aim of gathering and understanding new genetic variations to obtain translational applications by researchers. In addition, India regularly organizes seminars, awareness campaigns regarding quality compliance and orphan drugs, opportunities for orphan drugs and policy makers in collaboration with FDA of other countries.

According to the findings of our report, the global orphan drug market is expected to exceed US$350 billion by 2028, which is mainly attributed to the increasing prevalence of rare diseases associated with high demand for orphan drugs in its management. High expenditure on research and development of orphan drugs, coupled with the presence of several large-scale manufacturers, is the main driver for the growth of the market. Apart from this, several pharmaceutical companies like Amgen, Roche, Genetech have developed their assistance programs through which they can potentially reduce out-of-pocket costs to patients. For example, Genetech has developed the Hemlibra Co-pay program that helps eligible patients reduce out-of-pocket expenses during their treatment.

For More Information Related To Report Contact:
                  Neeraj Chawla
                  Research Head
                  Kuick Research

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