The global scleroderma therapeutics market size is expected to reach USD 3.44 billion by 2030, registering a CAGR of 5.0% from 2025 to 2030, according to a new report 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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The immunosuppressors segment accounted for the largest share of 27.4% in 2024, 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
The U.S. market accounted for 90.6% share of the North America scleroderma therapeutics market in 2024. 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
Grand View Research has segmented the global scleroderma therapeutics market on the basis of drug class, indication, and region:
Scleroderma Therapeutics Drug Class Outlook (Revenue, USD Million, 2018 - 2030)
Immunosuppressors
Phosphodiesterase 5 inhibitors - PHA
Endothelin Receptor Antagonists
Prostacyclin Analogues
Calcium Channel Blockers
Analgesics
Others
Scleroderma Therapeutics Indication Outlook (Revenue, USD Million, 2018 - 2030)
Systemic Scleroderma
Morphea
Linear
Localized Scleroderma
Diffuse Systemic Sclerosis
Limited Cutaneous Systemic Sclerosis Syndrome
Scleroderma Therapeutics Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
Australia
South Korea
Thailand
Latin America
Brazil
Argentina
Middle East & Africa
South Africa
Saudi Arabia
UAE
Kuwait
List of Key Players in the Scleroderma Therapeutics Market
F. Hoffman La-Roche Ltd
Bristol-Myers Squibb Company
Bayer AG
Boehringer Ingelheim International GmbH
Emerald Health Pharmaceuticals
Sanofi
Cytori Therapeutics Inc.
Chemomab
Corbus Pharmaceuticals Holdings, Inc.
Calliditas Therapeutics AB.
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