Sarcoidosis Market Size in the 7MM is projected to grow at a steady CAGR over the forecast period of 2026-2036

(Albany, US), October 21, 2026 – DelveInsight’s ‘Sarcoidosis Market Insights, Epidemiology and Market Forecast 2036’ report delivers an in-depth understanding of Sarcoidosis, historical and forecasted epidemiology, as well as the Sarcoidosis market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

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Key Takeaways from the Sarcoidosis Market Report

• In May 2026, Xentria presented the latest update on XTMAB-16 in pulmonary sarcoidosis. The anti-TNFα antibody showed a favorable safety and tolerability profile without unexpected TNF-inhibitor class effects. Preliminary efficacy signals suggest it may facilitate corticosteroid reduction while preserving lung function and improving patient-reported outcomes.
• In May 2026, aTyr Pharma announced the path forward for efzofitimod in pulmonary sarcoidosis, following receipt of the official meeting minutes from a Type C meeting with the US FDA. The meeting reviewed the results of the Phase III EFZO-FIT study to determine next steps for the program.
• In February 2026, Priovant Therapeutics announced positive results from the Phase II BEACON study of brepocitinib in cutaneous sarcoidosis. BEACON is the first industry-sponsored, placebo-controlled trial in the indication to read out positively.
• According to DelveInsight’s analysis, the Sarcoidosis market size was found to be [XX] million in the 7MM in 2025, and it is projected to reach [XX] million by 2036, growing at a CAGR of [XX]% during 2026-2036.
• Acthar Gel (repository corticotropin injection), approved in 1952 and marketed by Mallinckrodt Pharmaceuticals, is currently the only FDA-approved therapy specifically indicated for symptomatic pulmonary sarcoidosis, and it is expected to keep that position during the forecast period.
• Current standard of care relies primarily on corticosteroids and other immunosuppressive therapies, many used off-label, with variable efficacy and significant toxicity with long-term use. Although the pipeline has strengthened in recent years, no new therapy has yet achieved regulatory approval.
• Substantial unmet need persists, including the lack of approved disease-specific therapies, long-term dependence on corticosteroids, the absence of reliable biomarkers, and the management of extrapulmonary manifestations.
• The leading Sarcoidosis Companies include Kyorin Pharmaceutical, aTyr Pharma, Priovant Therapeutics, Molecure, Xentria, and others.
• Promising Sarcoidosis Therapies include KRP-R120 (Efzofitimod), Brepocitinib, OATD-01, XTMAB-16, and others.

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Sarcoidosis Overview

Sarcoidosis is a rare, multisystem inflammatory disease characterized by the formation of non-caseating granulomas in affected organs. Although the exact cause remains unknown, it is believed to result from an abnormal immune response triggered by environmental, infectious, or genetic factors in susceptible individuals. Sarcoidosis can affect virtually any organ, but the lungs and intrathoracic lymph nodes are involved in more than 90% of cases. Other commonly affected organs include the skin, eyes, liver, heart, and nervous system. The clinical presentation is highly variable, ranging from asymptomatic disease to chronic progressive organ dysfunction. Diagnosis is based on a combination of clinical findings, radiographic evidence, histological confirmation of non-caseating granulomas, and exclusion of alternative granulomatous disorders such as tuberculosis or fungal infections. Chest X-ray and high-resolution computed tomography (HRCT) are commonly used to assess pulmonary involvement, while pulmonary function tests help evaluate respiratory impairment, and tissue biopsy is often required for confirmation.

Sarcoidosis Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalent Cases of Sarcoidosis
• Gender-specific Diagnosed Prevalent Cases of Sarcoidosis
• Age-specific Diagnosed Prevalent Cases of Sarcoidosis
• Total Treated Cases of Sarcoidosis

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Sarcoidosis Epidemiology Key Findings

• Sarcoidosis is a multisystem granulomatous disease affecting 8–10 per 100,000 individuals in the US, with pulmonary (90%), cardiac (5–25%), renal (10%), hepatic (20%), and neurologic (5–10%) involvement.
• According to the American Lung Association, sarcoidosis is a rare disease, with approximately 27,000 new cases diagnosed annually in the US.
• Sarcoidosis most commonly occurs in individuals between the ages of 20 and 60. While it was originally recognized in younger adults, over half of cases are now diagnosed in patients over 40 years old, and women in particular tend to be older at diagnosis.
• According to secondary research data, the worldwide prevalence of sarcoidosis is about 4.7–64 per 100,000 people.
• Spontaneous remission occurs in 10 to 82% of cases, and about 10% of patients develop advanced pulmonary sarcoidosis.

Approved Therapies for Sarcoidosis

Acthar Gel (repository corticotropin injection): Mallinckrodt Pharmaceuticals

Acthar Gel, approved in 1952, is currently the only FDA-approved therapy specifically indicated for symptomatic pulmonary sarcoidosis. It remains a unique biologic product, and no FDA-approved biosimilars or generic equivalents are currently available. The limited availability of disease-specific therapies highlights the significant unmet need for novel targeted treatments.

Sarcoidosis Pipeline Analysis

Efzofitimod (KRP-R120): Kyorin Pharmaceutical and aTyr Pharma

Efzofitimod is a novel biologic immunomodulator that targets neuropilin-2 (NRP2) to modulate activated myeloid cells, and is in clinical development for pulmonary sarcoidosis. In September 2025, the global Phase III EFZO-FIT study did not meet its primary endpoint, and subsequent statistical testing is reported as nominal findings. In May 2026, aTyr announced the path forward for the program following a Type C meeting with the US FDA. The US FDA has granted efzofitimod Orphan Drug Designation for sarcoidosis and Fast Track designation for pulmonary sarcoidosis. The European Commission and Japan’s PMDA (to Kyorin) have also granted Orphan Drug Designation for sarcoidosis.

Brepocitinib: Priovant Therapeutics

Brepocitinib is an investigational oral dual TYK2/JAK1 inhibitor being developed for several autoimmune and inflammatory diseases, including cutaneous sarcoidosis. It was evaluated in the Phase II BEACON trial, a randomized, double-blind, placebo-controlled study in adults with cutaneous sarcoidosis. Following the positive BEACON data, Priovant plans to commence a Phase III study in cutaneous sarcoidosis in 2026.

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Sarcoidosis Market Outlook

The sarcoidosis treatment landscape has evolved gradually, and significant unmet needs remain due to the limited availability of disease-specific therapies. Corticosteroids and immunosuppressive agents continue to be the mainstay of treatment, but concerns about long-term toxicity, variable efficacy, and relapse have driven the search for more targeted approaches. Emerging therapies from companies such as Kyorin Pharmaceutical and aTyr Pharma (efzofitimod), Priovant Therapeutics (brepocitinib), Molecure (OATD-01), and Xentria (XTMAB-16) span diverse mechanisms, including immunomodulatory fusion proteins, JAK/TYK2 inhibitors, chitinase inhibitors, and anti-TNFα biologics. Overall, the Sarcoidosis Therapeutics Market across the 7MM is expected to grow steadily through 2036, supported by improved diagnostic practices and a growing pipeline of targeted therapies. Agents with steroid-sparing potential, improved safety profiles, and disease-modifying capabilities may significantly reshape the treatment paradigm.

Sarcoidosis Treatment Landscape

Treatment depends on disease severity, organ involvement, and the risk of permanent organ damage. Many patients with mild or asymptomatic disease may not require immediate therapy and can be managed through regular monitoring. Corticosteroids such as prednisone remain the cornerstone and first-line option for symptomatic or progressive disease. For patients who are refractory to steroids, experience significant adverse effects, or require long-term therapy, steroid-sparing immunosuppressants such as methotrexate, azathioprine, and mycophenolate mofetil may be used. In severe or treatment-resistant cases, biologic therapies, particularly TNF-α inhibitors such as infliximab, have demonstrated clinical benefit. Key factors driving the market include high unmet need in chronic and refractory disease, growing clinical development activity, and favorable regulatory incentives for rare diseases.

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Scope of the Sarcoidosis Market Report

• Coverage- 7MM
• Study Period- 2022-2036
• Forecast Period- 2026-2036
• Sarcoidosis Companies- Kyorin Pharmaceutical, aTyr Pharma, Priovant Therapeutics, Molecure, Xentria, and others.
• Sarcoidosis Therapies- KRP-R120 (Efzofitimod), Brepocitinib, OATD-01, XTMAB-16, and others.
• Sarcoidosis Market Dynamics: Sarcoidosis market drivers and market barriers
• Sarcoidosis Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis
• Sarcoidosis Unmet Needs, KOL Views, Reimbursement

Table of Contents

1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
5. Epidemiology and Market Forecast Methodology
6. Sarcoidosis Market Overview at a Glance
7. Disease Background and Overview of Sarcoidosis
8. Epidemiology and Patient Population of Sarcoidosis
9. Patient Journey of Sarcoidosis
10. Marketed Therapies
11. Emerging Therapies
12. Sarcoidosis: 7MM Analysis
13. Unmet Needs of Sarcoidosis
14. SWOT Analysis of Sarcoidosis
15. KOL Views of Sarcoidosis
16. Market Access and Reimbursement of Sarcoidosis
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight