Singapore, May 18, 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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Orphan drugs are novel pharmaceutical products which are specified for the diagnosis, prevention, and treatment of various rare disorders or diseases. Rare diseases generally have low prevalence rate in comparison to other disease, and hence have small market. Although more than 500 orphan drugs have been approved by regulatory bodies, a large number of rare diseases remain without effective treatment. The increasing incidences of rare diseases associated with the unmet need of orphan drugs have propelled the further research and development in this sector.
Currently, the global orphan drug market is mainly dominated by rare cancers. In last few years, the prevalence of cancers have increased drastically which is mainly due to increase in geriatric population, increased smoking and alcohol consumption, exposure to carcinogens, limited physical activity and poor nutrition. The increase in target patient base increases the demand of orphan drugs in the management of rare cancer, thus propelling the growth in the orphan drugs market. Apart from cancer, neurology and cardiovascular sector also contributes for significant share in the overall market.
Several challenges hamper the growth of orphan drug market. Finding eligible patients for clinical trials in orphan medicines is one of the biggest challenges in the market. Moreover, effective recruitment in rare diseases requires clear understanding about the biology of the disease. In addition to this, making therapy accessible to most patients requires marketing access via public or private reimbursement policies. However, reimbursement of orphan drugs is quite challenging which restricts the growth of market. Apart from this, the price of orphan drugs per treatment cycle can be very high. Therefore, the affordability of these orphan drugs has become a major issue for payers which impact the growth of the market.
Despite several limitations, there has been up surge in the research and development activities in this domain. As the awareness regarding the progression and diagnosis of rare diseases is increasing among individuals, several pharmaceutical companies have developed robust pipeline of orphan drugs. The pharmaceutical company’s pipeline is highly crowded with next generation therapeutics such as bispecific antibodies, chimeric antigen receptor T cell therapy, gene therapies and others which have been granted orphan drug designations.
US is currently holding the maximum share in global market owing to large target population and surge in awareness about diagnosis of orphan diseases. Apart from this, government in US also took initiatives to promote the development and adoption of orphan drugs in the region. For instance, national institute of health (NIH) supports research to improve the health of people with rare diseases. Around 27 institutes and centers at the NIH fund medical research for rare diseases. One of these centers, National Center for advancing translational sciences (NCATS), focuses on getting new cure and treatment to all patients quickly. In addition, presence of majority of pharmaceutical
As per our report findings, the global orphan drug market is expected to surpass US$ 350 Billion by 2028. The rise in patients suffering from rare disease globally and surge in demand of potential treatment is the major driving factor to the market. In addition, rising research and development activities and new product launches in the market are also expected to propel the growth of market during the forecast period. Other factors, including improvements in the healthcare infrastructure, along with extensive research and development (R&D) activities, are expected to drive the market further. The major key players in the market include Noavrtis, Amgen, Celegene, Abbott Laboratories, Teva Pharamceutical, Bristol Myers Squibb, Sanofi, Merck, and others. The continuous invest by these companies will also have positive impact on the growth of market.
