The global scleroderma therapeutics market size is expected to reach over USD 2.6 billion by 2026 registering a CAGR of 6.0%, according to a new study by Grand View Research, Inc. The market growth is credited to the availability of various therapies used off-label, such as small molecule therapies including branded, generics, and OTC drugs.
The mix of several indications and drug classes engenders a fragmented market with multiple players. Roche is the dominant company with biologic immunosuppressants, Actemra/RoActemra, Cellcept, and Rituxan contributing majorly to the company’s share. Pfizer and Eli Lilly are the key companies in the market. Over the forecast period, new entrants including Boehringer Ingelheim, Corbus Pharmaceuticals, and Fibrocell will marginally displace the share of established firms in this market.
The on-label market is in the development phase. Supplemental indication approval is one of the most common strategies adopted by market participants. For example, riociguat by Bayer was previously used for PAH and currently, it is under clinical trials for the treatment of SSc-related digital ulcers. There are several other pharmaceutical companies following suit as this strategy favors the pharmaceutical industry in offsetting high development costs and in reaping larger benefits from one molecule already developed and present in the market.
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Further key findings from the study suggest:
- The immunosuppressants segment held the largest market share in 2018 and is likely to maintain the dominance throughout the forecast years
- High preference for immunosuppressants owing to the favorable reimbursement scenario associated with this drug class supports its dominant market share
- Systemic scleroderma indication segment accounted for the major market share and will expand further due to use of high-priced immunosuppressants
- U.S. held the majority of the share in 2018. Expected label expansions and expected launch of first-in-class therapies coupled with an evolving reimbursement landscape for orphan drugs support continual scleroderma therapeutics market growth
- Europe trails with a lower share as compared to the U.S. majorly due to higher use of generics and biosimilars for off-label treatment of scleroderma
- Some of the key companies are F. Hoffman La-Roche Ltd.; Bristol-Myers Squibb Company; Celgene Corp.; arGentis Pharmaceuticals, LLC; Bayer AG; Boehringer Ingelheim International GmbH; Akashi Therapeutics; Prometic Life Sciences, Inc.; Emerald Health Pharmaceuticals; Kadmon Holdings, Inc.; Seattle Genetics, Inc.; Cytori Therapeutics, Inc.; Fibrocell Science, Inc.; Chemomab; Corbus Pharmaceuticals Holdings, Inc.; and Genkyotex SA