The systemic sclerosis (SSc) market across the seven major markets (7MM*) is forecast to witness steady growth, increasing from $2.9 billion in 2025 to $5.4 billion in 2035 at a compound annual growth rate (CAGR) of 6.4%, according to GlobalData, a leading intelligence and productivity platform.
GlobalData’s latest report, “Systemic Sclerosis: Disease Analysis Report and Forecast 2025–35,” reveals that the anticipated growth is mainly driven by the uptake of Boehringer Ingelheim’s (BI’s) Jascayd (nerandomilast), which was launched in the US in 2025 for the treatment of progressive pulmonary fibrosis (PPF) and in the five major European markets (5EU**) and Japan in 2026.
Connor Daniels, Healthcare Analyst at GlobalData, comments: “Jascayd is also expected to receive a broader SSc label in 2032. Further market growth is expected to come from Merck & Co.’s Winrevair (sotatercept) in SSc-associated pulmonary arterial hypertension (PAH) and three late-stage pipeline agents. By 2035, Jascayd is expected to be the top-selling SSc product with $1.6 billion in sales, while pipeline agents are forecast to generate $834 million.”
In 2025, the SSc market was dominated by BI’s Ofev (nintedanib), the first therapy approved for SSc-associated interstitial lung disease (SSc-ILD), and by biologics such as rituximab and tocilizumab, which together accounted for two-thirds of 7MM sales. AstraZeneca’s Saphnelo (anifrolumab) is expected to be the first pipeline agent to launch in the US in Q3 2028, followed by GSK’s Benlysta (belimumab) in Q2 2031.
Daniels adds: “SSc continues to be treated on an organ-by-organ basis, with mycophenolate mofetil (MMF) remaining the cornerstone first-line therapy for skin and lung fibrosis despite being used off-label in the US and 5EU.”
The most significant unmet need identified by key opinion leaders (KOLs) interviewed by GlobalData was the lack of disease-modifying therapies for gastrointestinal (GI) involvement, which affects up to 90% of patients and is the third leading cause of SSc-related death. KOLs also highlighted the lack of therapies that reverse established fibrosis and the need for predictive biomarkers to identify patients at risk of progression. Until treatments target its underlying causes, SSc will remain a disease that is managed rather than modified.
The late-stage pipeline consists of five assets with novel mechanisms of action, all of which have received US FDA orphan drug designation: Saphnelo, which targets the type I interferon receptor; Benlysta, which targets B-lymphocyte stimulator in SSc-ILD; Amgen and Tanabe Pharma’s Uplizna (inebilizumab), expected to launch in Japan in 2028; the Jascayd label expansion; and Bristol-Myers Squibb’s CAR-T therapy zolacabtagene autoleucel. The latter could offer the first potentially curative option, but its Phase III trial was paused in August 2026 following three deaths in Novartis’ rapcabtagene autoleucel program, and it is not expected to launch within the forecast period.
Daniels concludes: “The SSc market will be constrained by nintedanib generics entering the 5EU and Japan in 2026 and the US in 2029, which are expected to more than halve kinase inhibitor sales from $982 million to $458 million by 2035. Low-cost generic immunosuppressants and biosimilars of tocilizumab and rituximab will also pressure pricing, and GlobalData anticipates that payers will restrict high-priced pipeline therapies to patients who have failed to respond to the low-cost standard of care.”
*7MM- the US, France, Germany, Italy, Spain, the UK, and Japan
**5EU -France, Germany, Italy, Spain, and the UK
