Sarcoidosis Market

• The Sarcoidosis market is anticipated to grow at a significant compound annual growth rate (CAGR) during the forecast period (2025–2034). This growth in market revenue is primarily propelled by emerging therapies, advancements in diagnostic techniques, heightened awareness of the condition, and a growing number of reported cases.
• The current sarcoidosis market remains underdeveloped and less competitive, dominated by off-label treatments. The absence of recently FDA-approved therapies highlights a significant unmet need, limiting standardized care and creating potential opportunities for novel, targeted interventions in the therapeutic landscape.

 Sarcoidosis Market Insight and Trends

• The rise in sarcoidosis cases is largely attributed to better diagnostics, increased clinical awareness, and wider use of imaging tools like high-resolution CT scans. Improved disease reporting and surveillance have also contributed. 
• The current sarcoidosis market remains underdeveloped and less competitive, dominated by off-label treatments. The absence of recently FDA-approved therapies highlights a significant unmet need, limiting standardized care and creating potential opportunities for novel, targeted interventions in the therapeutic landscape.
• While the off-label drugs for sarcoidosis focus on symptomatic relief of the disorder. Challenges include broader treatment options for systemic manifestations and the development of reliable biomarkers to monitor long-term efficacy and disease progression.
• The sarcoidosis market is poised for growth as companies like aTyr Pharma’s Efzofitimod and Xentria’s XTMAB-16, among other assets are advancing through various development stages. With the anticipated approval of these therapies during the forecast period (2025–2034), the sarcoidosis therapeutic market is expected to experience significant expansion, driven by a robust CAGR.
• In March 2025, aTyr Pharma reported a fourth positive Data Safety Monitoring Board (DSMB) review for its Phase III EFZO-FIT study of efzofitimod in pulmonary sarcoidosis. The board identified no safety concerns and recommended the trial continue without changes. Topline results are expected by third quarter of 2025.
• In March 2025, Xentria reported the completion of enrollment for its Phase Ia/IIb XTMAB16 trial in pulmonary sarcoidosis, enrolling 39 patients across 4 countries. The randomized, placebo-controlled dose-ranging study surpassed initial targets. The Data and Safety Monitoring Committee (DSMC) will assess dose-response relationships to guide the next trial phase, with screening expected in fall 2025. The milestone also triggered a payment under Xentria’s partnership with Meitheal Pharmaceuticals, part of a commercialization deal.

Factors Affecting Sarcoidosis Market Growth

Rising Prevalence and Improved Disease Recognition

The global burden of sarcoidosis is increasing, particularly in North America and Europe. Improved awareness among healthcare professionals, coupled with better diagnostic capabilities, has led to a rise in reported cases. This increasing prevalence directly drives the demand for effective treatment and management options.

Advancements in Diagnostic Imaging and Biomarker Research

The development of advanced imaging modalities such as PET, HRCT, and MRI, alongside the discovery of potential biomarkers for disease activity and progression, has enhanced diagnostic accuracy. Early and precise detection encourages timely treatment initiation, driving the adoption of existing and emerging therapies.

Expanding Research in Immunopathogenesis and Targeted Therapies

Growing understanding of sarcoidosis as an immune-mediated granulomatous disease has led to the exploration of targeted therapeutic agents. Research into TNF-α inhibitors, JAK inhibitors, and anti-fibrotic drugs is creating new growth avenues and fueling innovation in the market.

Increased Clinical Trial Activity and Pipeline Advancements

The growing number of ongoing and planned clinical trials for sarcoidosis highlights strong R&D momentum. Several biotech and pharmaceutical companies are actively developing new therapeutic candidates, which is expected to expand the treatment landscape in the coming years.

Supportive Healthcare Infrastructure and Awareness Initiatives

Increasing patient advocacy, awareness programs, and supportive healthcare infrastructure in developed markets are facilitating earlier diagnosis and better disease management. Organizations like the Foundation for Sarcoidosis Research (FSR) play a key role in promoting education, research funding, and patient support, indirectly driving market growth.

DelveInsight’s comprehensive report titled “Sarcoidosis - Market Insights, Epidemiology, and Market Forecast – 2034” offers a detailed analysis of sarcoidosis. The report presents historical and projected epidemiological data covering total prevalent cases of sarcoidosis, total diagnosed prevalent cases of sarcoidosis, and gender-specific diagnosed prevalent cases of sarcoidosis. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The Sarcoidosis market report analyzes the existing treatment practices and unmet medical requirements in sarcoidosis. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Sarcoidosis Understanding: Overview, Diagnosis and Treatment

Sarcoidosis Overview

Sarcoidosis is a condition where immune cells cluster together, forming small, inflamed lumps known as granulomas. These granulomas can develop in any organ but most frequently affect the lungs and chest lymph nodes. If the condition persists, it may lead to permanent organ scarring. The inflammation that leads to these granulomas can be caused either by infections or by certain things you come into contact with in your environment.

Sarcoidosis Diagnosis and Treatment Overview 

Sarcoidosis is identified through clinical assessment and imaging techniques. Symptoms differ among patients, but commonly include a persistent dry cough, fatigue, and shortness of breath. Other signs may involve red, painful skin nodules, blurred vision due to uveitis, hoarseness, and swollen lymph nodes in the neck or underarms. In some cases, joint pain, neurological symptoms like seizures or hearing loss, and complications such as cardiomyopathy or liver enlargement may occur.

Treatment primarily targets symptom control and disease management. Oral glucocorticoids are typically prescribed at 0.3–0.6 mg/kg for 4–6 weeks, with possible extension if symptoms persist. For steroid-intolerant patients, alternatives like methotrexate, azathioprine, infliximab, or leflunomide are used. New therapies are being developed to address the disease at its source and improve patient quality of life. Timely diagnosis, ongoing monitoring, and a multidisciplinary approach are crucial for effective care and slowing disease progression.

Sarcoidosis Epidemiology

The epidemiology section of the sarcoidosis market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalent of sarcoidosis. Additionally, the Sarcoidosis market report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings in Sarcoidosis Epidemiological Landscape

• As per the secondary research, prevalence of sarcoidosis is nearly 60 cases per 100,000 in US.
• As per a study conducted in Italy reported a prevalence rate of 49 cases per 100,000 people for sarcoidosis. This figure reflects the disease burden within the population and contributes to understanding regional epidemiological patterns for more targeted healthcare planning.
• The prevalence of sarcoidosis in Japan is estimated to be 3 per 100,000.
• In the US, sarcoidosis is more commonly observed in females than in males, with the highest prevalence consistently reported among women. This gender difference suggests a potential influence of hormonal, genetic, or immunological factors in disease susceptibility and progression.
• The epidemiology of sarcoidosis is expected to change during the forecast period (2025–2034).

Sarcoidosis Market Outlook

The current treatment approach focuses on reducing inflammation and managing symptoms. Corticosteroids, particularly oral prednisone, are the first-line therapy. For patients with chronic or steroid-resistant disease, immunosuppressants such as methotrexate, azathioprine, or mycophenolate mofetil may be used. In refractory cases, biologics like infliximab or adalimumab, which target TNF-α, are considered. Treatment is tailored based on organ involvement, disease severity, and progression. Observation without treatment is an option in mild cases that may resolve spontaneously within a few years. 

The sarcoidosis therapeutics market is further expected to increase by the major drivers, such as the rising prevalent population, technological advancements, and upcoming therapies in the forecast period [2025–2034].

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the sarcoidosis market in the 7MM is expected to change significantly during the study period 2020–2034.

Sarcoidosis Drug Chapters 

Emerging Sarcoidosis Drugs

The sarcoidosis market is expected to experience gradual changes, mainly due to the limited availability of emerging therapies in this area. Key Sarcoidosis Companies, including, aTyr Pharma’s Efzofitimod, and Xentria’s XTMAB-16, among others, have demonstrated a keen interest in this condition and are actively pursuing the development of potential treatments.

Efzofitimod: aTyr Pharma

Efzofitimod is an innovative immunomodulatory therapy designed to regulate immune responses in inflammatory diseases. As a fusion protein targeting neuropilin-2 (NRP2) signaling, it aims to restore immune balance without causing widespread immunosuppression. Currently being evaluated for pulmonary sarcoidosis, efzofitimod has demonstrated potential in reducing inflammation and supporting lung function. By selectively modulating immune activity, it presents a promising approach for managing chronic inflammatory conditions while minimizing systemic effects. 

The drug is currently active in Phase III clinical trials for sarcoidosis.

XTMAB-16: Xentria

XTMAB-16 is an intravenous monoclonal antibody designed to block tumor necrosis factor-alpha (TNF-α), a cytokine involved in granuloma formation-a key feature of sarcoidosis. Initially considered a biosimilar to infliximab, it functions by suppressing TNF-α activity. Although the disease can resolve naturally within 12 to 36 months after symptoms begin, around 25% of patients may develop a chronic form. Involvement of organs through inflammation or fibrosis can lead to both physical and mental health issues. The drug’s regulatory designation underscores the critical need for new treatment options for sarcoidosis, a serious inflammatory condition. The drug is currently active in Phase II

In December 2020, the US FDA granted Orphan Drug Designation (ODD) to XTMAB-16 for treating sarcoidosis. 

In November 2023, the company reported that XTMAB-16 received ODD from EMA as the first patient was enrolled for this disease.

Note: Detailed emerging therapies assessment will be provided in the final report.

Sarcoidosis Market Segmentation

DelveInsight’s  ‘Sarcoidosis Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a detailed outlook of the current and future sarcoidosis market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies. 

Sarcoidosis Market Size by Countries

The sarcoidosis market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2025, the United States held a significant share of the overall 7MM (Seven Major Markets) sarcoidosis market, primarily attributed to the country’s higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Sarcoidosis Market Size by Therapies

Sarcoidosis Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034. 

Note: Detailed market segment assessment will be provided in the final report.

Sarcoidosis Drugs Uptake

This section focuses on the sales uptake of potential sarcoidosis drugs that have recently been launched or are anticipated to be launched in the sarcoidosis market between 2020 and 2034. It estimates the market penetration of sarcoidosis drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the Sarcoidosis market.

The emerging sarcoidosis therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the sarcoidosis market.

Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on Sarcoidosis.

Sarcoidosis Market Access and Reimbursement

DelveInsight’s ‘Sarcoidosis Market Insights, Epidemiology, and Market Forecast – 2034’ report provides a descriptive overview of the market access and reimbursement scenario of sarcoidosis.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments. 

Latest KOL Views on Sarcoidosis

To keep up with current sarcoidosis market trends and fill gaps in secondary findings, we interview KOLs and SMEs’ working in the sarcoidosis domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or sarcoidosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the sarcoidosis unmet needs.

What KOLs are saying on Sarcoidosis Patient Trends?

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Boston Children’s Hospital, US, Rutgers New Jersey Medical School, US, Hospices Civils de Lyon, Laboratoire de Neurobiologie Gillet-Mérieux, Bron, France, Neurology Service, Sant Joan de Déu Hospital, Barcelona, Spain and Department of Pediatrics, Jichi Medical University, Tochigi, Japan, among others.

"Sarcoidosis is a chronic multisystem inflammatory disorder of unknown etiology that is characterized by the formation of granulomas- clumps of inflammatory cells- in one or more grown organs in the body." 

"While treatment options for sarcoidosis have improved in recent years, the complexity of the disease demands a personalized approach to therapy. Research into novel treatments, such as gene therapy and enzyme replacement therapy, is progressing, but these therapies need further validation. Early diagnosis is key to improving outcomes, and efforts should be made to integrate advanced genetic screening into routine clinical practice." 

"Sarcoidosis poses significant diagnostic and treatment challenges in Japan, especially in the face of rare genetic disorders, where patients often experience debilitating neurological symptoms. While there are emerging treatment options, such as enzyme replacement therapy and miglustat, they remain largely symptomatic. There is an urgent need for more research into disease-modifying therapies and a greater emphasis on early detection to improve long-term patient outcomes."

Note: Detailed assessment of KOL Views will be provided in the full report on sarcoidosis.

Sarcoidosis Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the sarcoidosis. Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Sarcoidosis Clinical Trials Analysis

The Sarcoidosis market report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for sarcoidosis. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Sarcoidosis Pipeline Development Activities

The Sarcoidosis market report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging sarcoidosis therapies.

Sarcoidosis Market Report Insights

• Sarcoidosis Patient Population
• Therapeutic Approaches
• Sarcoidosis Pipeline Analysis
• Sarcoidosis Market Size and Trends
• Sarcoidosis Market Opportunities
• Impact of Upcoming Therapies

Sarcoidosis Market Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Sarcoidosis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Sarcoidosis Market
• Sarcoidosis Drugs Uptake

Sarcoidosis Market Report Assessment

• Sarcoidosis Current Treatment Practices
• Unmet Needs
• Sarcoidosis Product Profiles
• Sarcoidosis Market Attractiveness

Key Questions Answered in the Sarcoidosis Report

• How common is sarcoidosis?
• What are the key findings of sarcoidosis epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020–2034)?
• What are the currently available treatments for sarcoidosis?
• What are the disease risk, burden, and unmet needs of sarcoidosis?
• At what CAGR is the sarcoidosis market and its epidemiology is expected to grow in the 7MM during the forecast period (2025–2034)?
• How would the unmet needs impact the sarcoidosis market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of sarcoidosis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025–2034)?
• How many companies are currently developing therapies for the treatment of sarcoidosis?

Reasons to buy Sarcoidosis Report

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the sarcoidosis Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.