InsightAce Analytic Pvt. Ltd. has announced the publication of a market research report titled “Global Orphan Drugs Market by (Drug Type (Biological, Non-Biological), Top Selling Drug (Revlimid, Rituxan, Copaxone, Opdivo, Keytruda, Imbruvica, Avonex, Sensipar, Soliris and Other Top Selling Drugs), Therapeutic Area (Oncology, Blood, Central Nervous System, Endocrine, Cardiovascular, Respiratory, Immunomodulatory and Other Disease Types)) – Market Outlook and Industry Analysis 2030”

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An orphan drug is a pharmaceutical product that is used to treat a rare disease or condition.  In the United States, an estimated 30 million people suffer from rare (orphan) diseases or disorders; nevertheless, the availability of innovative therapies for these diseases and ailments has historically been limited in comparison to more prevalent conditions. This is primarily due to the financial risks associated with recouping medication research expenses.

One of the most significant obstacles for firms developing medications for rare diseases is that sponsors are unlikely to recoup their research, development, and approval costs from the orphan drug product due to the small number of the target population. As a result, the FDA has established a variety of incentives to make orphan medication research more financially feasible for firms. The Orphan Pharma Act included new tax exemptions and other economic incentives to increase drug producers’ interest in these specialized markets.

Market Dynamics:

The market’s growth is attributed to the increasing incidence of rare illnesses and the current trend toward the approval of orphan biological medicines for diverse indications. Government incentives for drug development and help from the FDA and EU Commission under specific protocols give an additional push to firms, further accelerating the market growth. Numerous pharmaceutical and biotechnology companies are taking advantage of incentives offered by global regulatory bodies to develop orphan drugs and address these patients’ vast unmet needs, and the potential to deliver life-changing therapies is becoming a reality with the advancement of technologies and manufacturing capabilities.

The Covid-19 pandemic has had an adverse effect on market growth. Patients with rare diseases faced barriers to diagnosis and treatment as a result of the pandemic. Companies reported an effect on their routine R&D procedures, emphasizing challenges with trial start and the review/approval process. The management of ongoing clinical trials focusing on uncommon illnesses was complicated by the inability to conduct on-site monitoring visits and enroll/retain patients. As a result, corporations have evolved numerous alternate tactics for continuing clinical studies, such as remote monitoring and enrollment, to enable these trials to continue.

During the projected period, North America is expected to lead the global orphan drugs market.  Orphan-drug status in the United States confers several benefits, including tax credits, a provision for seven years of exclusive marketing rights following approval, an exemption of prescription-drug user fees, annual grant funding to cover the cost of qualified clinical testing, and clinical research design assistance from the Food and Drug Administration (FDA).

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The following key companies are engaged in the Orphan Drugs market:

Bristol-Myers Squibb Company, Celgene Corporation, F. Hoffmann-La Roche Ltd, Amgen, Biogen, Bayer, Novartis AG, GlaxoSmithKline plc, Johnson & Johnson, AbbVie Inc, Eli Lilly and Company, Alexion, Pharmaceuticals, Shire, Novo Nordisk, AstraZeneca, Eisai, Daiichi Sankyo, Merck, Teva, Pharmaceutical Industries, Actelion Pharmaceuticals Ltd., Aegerion Pharmaceuticals Players among others.

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