More Than 400 Orphan Designated Drugs Are Commercially Available And 1300 Are In Clinical Trials says Kuick Research
Delhi, Nov. 23, 2021 (GLOBE NEWSWIRE) — Global Orphan Drugs Clinical Trials Insight Report Highlights:
- Clinical Insight On More Than 400 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: > 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 refer to the pharmaceuticals which are used for the diagnosis, prevention, and treatment of rare medical disorders. Rare diseases differ from usual disease as their prevalence rate is very low and hence appeal to very small patient population. These drugs are developed to treat patients suffering from very rare diseases for which no treatment option is available. Scientists have identified several rare diseases including lymphoma, leukemia, cystic fibrosis, and others for which a wide range of orphan drugs have been approved by regulatory bodies.
The orphan drug share of new products approvals has increased dramatically over the last 20 years. To date, around 500 orphan designated drugs have entered the market which is indicated for the management of numerous oncological, metabolic, hematologic, immunologic, infectious, and neural diseases. Presently, oncology orphan drugs occupy the majority of share in the market. Almost 200 rare cancers have been identified which all together represent more than 20% 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. Moreover, the advancements in the science and technology and better understanding of cancer has allowed further segmentation of cancer types in smaller subgroups.
The spiraling cost of drug development in association with stringent regulations, coupled with low return on investment often discourage the pharmaceutical sector from developing drugs for extremely small patient population. Apart from this, finding eligible patients for clinical trials in orphan medicines is one of the biggest challenges in the market. Furthermore, there is lack of knowledge about the biology of rare diseases which further hampers the research and development activities in this field. Despite this, several pharmaceutical companies in US such as Pfizer, Novartis, GlaxoSmithKline, AbbVie, Amgen, Roche, Merck, Jazz Pharmaceuticals, Sanofi and several others have developed strategic collaborations or joint ventures to boost the research and development in this sector. The major key players also compete to increase their revenue in the global market.
Since the awareness and understanding surrounding rare diseases has increased, a number of biopharmaceutical companies are investing in this segment. In addition, there has been rising support from government in terms of developing reimbursement policies and patent exclusivity. At present, incentives for drug development by government authorities in various countries are encouraging pharmaceutical companies to develop orphan drugs. For instance, National Institute of Health (NIH) supports research to improve orphan drugs including fast track approval, waiver of fees, protocol assistance and marketing exclusivity. Furthermore in Japan, government incentives include financial subsides for up to 50% of expenses for clinical and non-clinical research, 10 year marketing rights, and reduction in tax.
As per our report findings, the global orphan drug market is expected to reach US$ 350 Billion by 2028. The emergence of new pharmaceutical drug manufacturers and the implementation of favorable government policies to inhibit the spread of contagious diseases are also contributing to the market growth. Additionally, various product innovations, such as the development of biological orphan drugs, are acting as other growth-inducing factors. These drugs can treat diseases, such as cancer, and reverse the damage caused to the stem cells, which is facilitating their overall demand significantly. Other factors, including improvements in the healthcare infrastructure, along with extensive research and development activities, are expected to drive the market further.
CONTACT: Neeraj Chawla Research Head firstname.lastname@example.org +919810410366
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