sarcoidosis market insight

DelveInsight’s ‘Sarcoidosis – Market Insights, Epidemiology, and Market Forecast – 2030’ report delivers an in-depth understanding of the historical and forecasted epidemiology as well as the market trends of sarcoidosis in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The sarcoidosis market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted Sarcoidosis market Size from 2018 to 2030, segmented by seven major markets. The report also covers the current Sarcoidosis treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying market potential.

Geographies Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Sarcoidosis: Disease Understanding and Treatment Algorithm

Sarcoidosis Overview

Sarcoidosis is a multisystem granulomatous inflammatory disease, with the lungs and intrathoracic lymph nodes being the most frequently affected sites. Patients typically experience fatigue, weakness, and dyspnea. Furthermore, respiratory muscle weakness, secondary to granulomatous inflammation, is associated with dyspnea and decreased quality of life (QoL).

The presentation of sarcoidosis varies considerably from mild, acute self-limiting disease to chronic disease involving several organs and causing severe symptoms and functional impairment. The condition is staged from I (least severe) to III (most severe): 55–90% of patients presenting with stage I disease, 40–70% of patients with stage II disease,  and 10–20% of patients with stage III  disease. Patients with advanced sarcoidosis may develop pulmonary hypertension for a variety of reasons. Sarcoidosis-associated pulmonary hypertension (SAPH) is a significant complication of sarcoidosis and is associated with significant morbidity and mortality. Over the past few years, increased recognition has led to more frequent identification of SAPH patients.

The diagnosis of sarcoidosis relies on the presence of noncaseating granuloma on histopathologic examination, compatible clinical presentation, and exclusion of other causes of granulomatous inflammation. There are no universally accepted measures to determine if each diagnostic criterion has been satisfied; therefore, the diagnosis of sarcoidosis is never fully secure.

Most patients with sarcoidosis do not require treatment and often make a full recovery. However, around a third of patients have more serious diseases involving different organs and require therapies that suppress the immune system. The goals of sarcoidosis management are to prevent or control organ damage, relieve symptoms, and improve the patient’s quality of life. For patients with extrapulmonary involvement, a multidisciplinary approach may be required.

Glucocorticoids (GCs) are the first-line therapy, whereas glucocorticoid-sparing agents and biologic agents are used in refractory/recurrent cases. Methotrexate is the most commonly used corticosteroid-sparing agent for corticosteroid-resistant disease or corticosteroid-intolerant patients. Other second-line agents include hydroxychloroquine, leflunomide, azathioprine, mycophenolate, and others. Third-line agents include infliximab, adalimumab, and others. Other treatment considerations include cyclophosphamide, rituximab, adrenocorticotropic hormone, pentoxifylline. Regardless of whether treatment is started, the clinician needs to organize regular follow-up to monitor remissions, flares, progression, complications, toxicity, and relapses to promptly adjust the drugs used.

Sarcoidosis Diagnosis and Treatment

It covers the details of conventional and current medical therapies and diagnoses available in the sarcoidosis market to treat the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan.

The DelveInsight Sarcoidosis Market Report gives a thorough understanding of sarcoidosis by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis. It also provides the treatment algorithms and treatment guidelines for sarcoidosis in the US, Europe, and Japan.

Sarcoidosis Epidemiology

The sarcoidosis epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the prevalent patient pool and trends, along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides historical and forecasted sarcoidosis epidemiology segmented as the prevalent cases of sarcoidosis, gender-specific cases of sarcoidosis, and age-specific cases of sarcoidosis. The report includes the prevalent scenario of sarcoidosis symptoms in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2018 to 2030.

Country-wise Sarcoidosis Epidemiology

The epidemiology segment also provides the Sarcoidosis epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The prevalent sarcoidosis population in the 7MM countries was estimated to be 249,250 cases in 2020.

Sarcoidosis Drug Chapters

The drug chapter segment of the Sarcoidosis report encloses the detailed analysis of sarcoidosis marketed drugs and late stage (Phase-III, Phase-II/III, Phase-II, and Phase-I/II) pipeline drugs. It also helps to understand the sarcoidosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Acthar Gel, a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides, is approved to treat active sarcoidosis in the United States, being used off-label in Europe. The US expert panel consensus statement, developed by 12 independent physicians with expertise in treating patients with sarcoidosis, advised a starting dose of 40 units of Acthar Gel twice a week for most patients with less severe disease. The panel also recommends that Acthar Gel be continued at an individualized maintenance dose for most patients who respond to the therapy, particularly those with advanced sarcoidosis or who fail to respond to most treatments. Recently, new treatment guidelines for sarcoidosis from the European Respiratory Society (ERS) also include Acthar Gel (repository corticotropin injection) therapy in the clinical management of certain patients with pulmonary sarcoidosis. The treatment guidelines are the first ERS-issued evidence-based clinical practice recommendations to guide physicians treating sarcoidosis patients, including Acthar Gel.

However, Acthar Gel is rarely used in clinical practice because it lacks clinical data to support its efficacy. Other disadvantages of Acthar Gel include its high cost and inconvenience of the parenteral route. The investigators do not recommend using this medication for the management of sarcoidosis.  Moreover, Acthar gel is soon likely to face tough competition due to the recent approval of the ANI Pharma lead candidate, i.e., Purified Cortrophin Gel. Purified Cortrophin Gel (Repository Corticotropin Injection USP) is a purified adrenocorticotropic hormone (ACTH) previously approved in the US for multiple indications, including multiple sclerosis (MS), rheumatoid arthritis (RA), and nephrotic syndrome (NS). The company anticipates a full product commercial launch by 2022.

Products detail in the report…

Sarcoidosis Emerging Drugs

ATYR1923 is a potential first-in-class disease-modifying therapy for patients with severe inflammatory lung diseases. It works by selectively modulating Neuropilin-2 (NRP2) to downregulate the innate and adaptive immune responses in uncontrolled inflammatory disease states to resolve inflammation and prevent subsequent fibrosis. Clinical proof-of-concept for ATYR1923 was recently established in a Phase Ib/IIa multiple-ascending dose, placebo-controlled study in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose-response and trends of the benefit of ATYR1923 compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms, and inflammatory biomarkers (aTyr Pharma, 2021a).

Another key asset, Selexipag (Uptravi), is a selective prostacyclin receptor agonist discovered by Nippon Shinyaku and licensed to Actelion Pharmaceuticals Ltd outside Japan. The drug was approved for the treatment of PAH (WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. In addition, its use is indicated in adults with WHO functional class II to III PAH in the US and EU. The drug is presently being studied in a Phase II study that aims to investigate selexipag to treat patients with another form of pulmonary hypertension called sarcoidosis-associated pulmonary hypertension (Actelion, 2021).

Products detail in the report…

Sarcoidosis Market Outlook

The sarcoidosis market outlook of the report builds a detailed comprehension of the historical, current, and forecasted Sarcoidosis market trends by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of Sarcoidosis market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the Sarcoidosis market in the 7MM is expected to change in the study period 2018–2030.

Presently, unmet needs in treatment for sarcoidosis are significant, with around 30% of patients having chronic progressive disease, unresponsive to steroid treatment. Also, there is no clear-cut PAH-specific therapy with proven efficacy or approval for treating SAPH. Thus, there is an increased demand for disease-modifying therapies to cater to the needs of patients.

Key Findings

This section includes a glimpse of the sarcoidosis market in the 7MM. The market size of sarcoidosis in the seven major markets was USD 499.5 million in 2020.

The United States: Market Outlook

This section provides the total sarcoidosis market size and market size by therapies of sarcoidosis in the United States.

The United States accounts for the highest market size of sarcoidosis compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

Relapse is common during tapering or after discontinuation of glucocorticoids, occurring in as many as 30% of patients. Treatment of relapse is with dose escalation of the glucocorticoids, with tapering similar to the first episode. In addition, with relapse, most experts will also recommend disease-modifying antirheumatic drugs (DMARDs) for their corticosteroid-sparing effect because these patients tend to be corticosteroid dependent and are at a higher risk for the development of glucocorticoid toxicity.

Methotrexate is the most frequently used and well-studied DMARD for pulmonary sarcoidosis. The usual dose is between 10 and 25 mg weekly, either orally or intramuscularly. Methotrexate has a slow onset of action, and maximal efficacy will not be observed until at least 2 to 3 months after initiation of the therapy. Less commonly used DMARDs with less evidence to support their efficacy include azathioprine, leflunomide, mycophenolate, and chloroquine/hydroxychloroquine.

Biologic agents are considered third-line therapy for patients with refractory disease that does not respond to glucocorticoids and DMARDs or for those who cannot tolerate these agents. They are reserved for later use for several reasons, including the higher cost, potential adverse effects, mode of administration, and lack of approval by the Food and Drug Administration due to the lack of unequivocal evidence of their efficacy in clinical trials. The most commonly prescribed class of biologic agents is tumor necrosis factor α (TNF-α) inhibitor; infliximab is the TNF-α inhibitor with the most robust data. Adalimumab is another TNF-α inhibitor with some data to support its efficacy, although the evidence was based on case series and open-label studies.

EU-5 Countries: Market Outlook

The total Sarcoidosis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are also mentioned.

Japan Market Outlook

The total Sarcoidosis market size and market size by therapies of Sarcoidosis in Japan are also mentioned.

Sarcoidosis Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2018–2030. The analysis covers Sarcoidosis market uptake by drugs, patient uptake by therapies, and sales of each drug. 

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allow the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Sarcoidosis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, and Phase I/II stage. It also analyses the key players involved in developing targeted therapeutics for sarcoidosis.

Major players include aTyr Pharmaceuticals and Johnson and Johnson/Nippon Shinyaku, whose key products are expected to launch in the US market by 20XX.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for sarcoidosis emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the sarcoidosis domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Sarcoidosis market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform a Competitive and Market Intelligence analysis of the Sarcoidosis market using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of sarcoidosis, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies
• Comprehensive insight is provided into the sarcoidosis epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for sarcoidosis is provided, along with the assessment of new therapies, which will impact the current treatment landscape.
• A detailed review of the Sarcoidosis market; historical and forecasted, is included in the report, covering drug outreach in the 7MM
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global Sarcoidosis market

Report Highlights

• In the coming years, the Sarcoidosis market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Sarcoidosis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for sarcoidosis. The launch of emerging therapies will significantly impact the Sarcoidosis market.
• A better understanding of disease pathogenesis will also contribute to developing novel therapeutics for sarcoidosis.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competitor, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Sarcoidosis Report Insights

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

Sarcoidosis Report Key Strengths

• 10-year Forecast
• 7MM Coverage
• Sarcoidosis Epidemiology Segmentation
• Key Competitors
• Highly Analyzed Market
• Drugs Uptake

Sarcoidosis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the market share (%) distribution in 2018, and how would it look in 2030?
• What would be the sarcoidosis total market size and market size by therapies across the 7MM during the forecast period (2018–2030)?
• What are the key findings pertaining to the market across 7MM, and which country will have the largest Sarcoidosis market Size during the forecast period (2018–2030)?
• At what CAGR is the sarcoidosis market expected to grow in the 7MM during the forecast period (2018–2030)?
• What would be the sarcoidosis market outlook across the 7MM during the forecast period (2018–2030)?
• What would be the Sarcoidosis market growth till 2030 and the resultant market Size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of sarcoidosis?
• What is the historical patient pool of sarcoidosis in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of sarcoidosis in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What will be the growth opportunities in the 7MM concerning the patient population pertaining to sarcoidosis?
• Out of all 7MM countries, which country would have the highest prevalence of sarcoidosis during the forecast period (2018–2030)?
• At what CAGR the population is expected to grow in the 7MM during the forecast period (2018–2030)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of sarcoidosis?
• What are the current treatment guidelines for treating sarcoidosis in the USA, Europe, and Japan?
• What are the sarcoidosis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of sarcoidosis?
• How many therapies are developed by each company for the treatment of sarcoidosis?
• How many emerging therapies are in the mid-stage and late stages of development to treat sarcoidosis?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Sarcoidosis therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for sarcoidosis and its status?
• Which key designations have been granted for the emerging therapies for sarcoidosis?
• What are the global historical and forecasted markets for sarcoidosis?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Sarcoidosis market
• To understand the future market competition in the Sarcoidosis market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Sarcoidosis in the US, Europe (Germany, Spain, Italy, France, and 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.
• Organize sales and marketing efforts by identifying the best opportunities for the Sarcoidosis market.
• To understand the future market competition in the Sarcoidosis market.