Las Vegas – – September 11, 2026 -- The sarcoidosis treatment market across the seven major markets is projected to expand steadily through 2036, driven by a pipeline of seven late- and mid-stage drug candidates targeting a disease that affects an estimated 150,000 to 200,000 patients annually in the United States alone, according to a new market report from DelveInsight.
United States dominates a treatment landscape with one approved drug
The US accounted for the largest sarcoidosis treatment market size among the seven major markets in 2025, ahead of the EU4 nations (Germany, France, Italy, Spain), the United Kingdom and Japan. Roughly 27,000 new sarcoidosis cases are diagnosed annually in the US, yet Acthar Gel (repository corticotropin injection) remains the only FDA-approved therapy specifically indicated for symptomatic pulmonary sarcoidosis, leaving corticosteroids and immunosuppressants as the default standard of care despite long-term toxicity risks.
aTyr Pharma advances efzofitimod toward a global Phase 3 sarcoidosis trial
Kyorin Pharmaceutical and aTyr Pharma's efzofitimod (KRP-R120), a biologic immunomodulator derived from a tRNA synthetase, has secured Orphan Drug Designation in the US, Europe and Japan, plus US Fast Track Designation for pulmonary sarcoidosis. aTyr has submitted a protocol to the FDA for a global Phase 3 trial in pulmonary sarcoidosis, following a subgroup analysis from the Phase 3 EFZO-FIT trial presented at the WASOG Congress in Porto, Portugal, on July 15-17, 2026. The drug targets activated myeloid cells via neuropilin-2 to resolve inflammation without broad immunosuppression.
Priovant plans Phase 3 trial for cutaneous sarcoidosis drug brepocitinib in 2026
Priovant Therapeutics' oral TYK2/JAK1 inhibitor brepocitinib produced encouraging results in the Phase 2 BEACON trial for cutaneous sarcoidosis, prompting the company to plan a Phase 3 study launch in 2026. Molecure's OATD-01, a first-in-class chitinase inhibitor, is targeting granulomatous inflammation and fibrotic processes, while Xentria's XTMAB-16 reported a favorable safety and tolerability profile in pulmonary sarcoidosis patients in May 2026, without unexpected TNF-inhibitor class effects.
Additional candidates from OrphAI, MindMaze and Foresee round out the pipeline
Other programs in development include LAM-001 from OrphAI Therapeutics and Quince Therapeutics, RLF-100 from MindMaze Therapeutics, and Aderamastat (FP-025) from Foresee Pharmaceuticals. DelveInsight's Aparna Thakur said efzofitimod is expected to achieve significant commercial uptake following potential approval, citing its steroid-sparing profile as an attractive option for chronic pulmonary sarcoidosis patients.