Cutaneous Lupus Erythematosus Market

• The Cutaneous Lupus Erythematosus Market Size in the 7MM was around USD 500 million in 2023.
• The United States accounts for the largest Cutaneous Lupus Erythematosus Market Size (around USD 400 million), in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.

Cutaneous Lupus Erythematosus Market & Epidemiology Insights

• Cutaneous Lupus Erythematosus, a chronic autoimmune disease affecting the skin, an estimated 10% of all lupus cases are cutameous.
• The United States accounts for the largest number of Cutaneous Lupus Erythematosus diagnosed prevalent cases (around 500,000), in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among the diagnosed patient pool, cutaneous lupus erythematosus is more significant in females (~64%) than in males (~36%).
• Approximately 70% of the diagnosed patient pool receive treatment. The Cutaneous Lupus Erythematosus treatment is centered upon formulating a regimen of topical and systemic therapies based on the severity. More than 30% of cutaneous lupus erythematosus are moderate-to-severe requiring biologics, and systemic immunomodulators apart from the standard therapies.
• Currently, the FDA has approved only two medications for the treatment of Cutaneous Lupus Erythematosus: hydroxychloroquine and glucocorticoids.
• Among emerging drug classes, BDCA2 protein inhibitors, dendritic cell inhibitors, and TYK2 kinase inhibitors will be expanding the treatment landscape of Cutaneous Lupus Erythematosus.
• Biogen’s litifilimab and Bristol Myers Squibb deucravacitinib are expected to be the leading drugs in the Cutaneous Lupus Erythematosus market during the forecast period (2024-2034). Both the drugs are anticipated to garner ~25% of the total sales in the coming decade.
• Other companies (Horizon Therapeutics, Gilead Sciences, Merck KGaA, and others) are also developing treatment for cutaneous lupus erytheramtosus in order to launch effective therapies in the market.
• In January 2023, Horizon Therapeutics announced the first patient enrolled in a Phase II trial in patients with moderate-to-severe primary discoid lupus erythematosus.

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DelveInsight's “Cutaneous Lupus Erythematosus Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Cutaneous Lupus Erythematosus, historical and forecasted epidemiology as well as the Cutaneous Lupus Erythematosus market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Cutaneous Lupus Erythematosus Treatment Market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Cutaneous Lupus Erythematosus market size from 2020 to 2034. The report also covers current Cutaneous Lupus Erythematosus treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Cutaneous Lupus Erythematosus Disease Understanding

Cutaneous Lupus Erythematosus Overview

Cutaneous Lupus Erythematosus is a chronic, autoimmune disease affecting the skin, which belongs to the family of lupus erythematosus, where the symptoms are restricted to the skin. Lupus Erythematosus (LE) is a chronic, autoimmune disease that affects multiple body organs and systems with a broad spectrum of symptoms. It is categorized into three main entities: acute cutaneous lupus erythematosus (ACLE), subacute CLE, and chronic cutaneous lupus erythematosus (CCLE). CCLE encompasses discoid LE (DLE), LE profundus (LEP), chilblain LE (CHLE), and LE tumidus (LET). Cutaneous Lupus Erythematosus Diagnosis requires proper classification of the subtype through a combination of a physical exam, laboratory studies, histology, antibody serology, and occasionally direct immunofluorescence while ensuring to exclusion of systemic disease.

Cutaneous Lupus Erythematosus Treatment

Cutaneous Lupus Erythematosus treatment consists of patient education on proper sun protection along with appropriate topical and systemic agents. Cutaneous Lupus Erythematosus treatment should begin with topical therapies, including steroids and/or calcineurin inhibitors. Systemic agents are indicated in widespread, scarring, or treatment-refractory disease cases. Topical corticosteroids remain the first-line treatment of all cutaneous lupus erythematosus subtypes, both in localized and widespread form.

Cutaneous Lupus Erythematosus Epidemiology

The Cutaneous Lupus Erythematosus epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Cutaneous Lupus Erythematosus epidemiology is segmented with detailed insights into total diagnosed prevalent cases of Cutaneous Lupus Erythematosus,  diagnosed prevalent cases of Cutaneous Lupus Erythematosus by gender, diagnosed prevalent cases of Cutaneous Lupus Erythematosus by type, diagnosed prevalent cases of Cutaneous Lupus Erythematosus by severity, total treated cases of Cutaneous Lupus Erythematosus.

• The total diagnosed prevalent cases of Cutaneous Lupus Erythematosus in the 7MM comprised ~8,00,000 cases in 2023 and are projected to increase during the forecast period.
• According to the findings, approximately two-thirds of people with lupus will develop some type of skin disease Cutaneous Lupus Erythematosus, and about 2% of Systemic Lupus Erythematosus cases eventually develop Cutaneous Lupus Erythematosus every year.
• It has been observed that the prevalence of chronic Cutaneous Lupus Erythematosus is higher among the diagnosed population when compared to othe types in the 7MM. The chronic Cutaneous Lupus Erythematosus accounted for ~340,000 cases in the US in 2023.
• Among EU4 and the UK, the UK accounted for the highest number of diagnosed prevalent cases followed by France and Spain accounted for the lowest number of cases with ~40,000 cases.
• On the severity basis, mild cases were most common among the Cutaneous Lupus Erythematosus suffering patients.

Cutaneous Lupus Erythematosus Epidemiology Segmentation

• Total Diagnosed Prevalent Cases of Cutaneous Lupus Erythematosus in the 7MM
• Prevalent cases of Cutaneous Lupus Erythematosus by Gender in the 7MM
• Prevalent Cases of Cutaneous Lupus Erythematosus by Type in the 7MM
• Prevalent Cases of Cutaneous Lupus Erythematosus by Severity in the 7MM
• Total Treated Cases of Cutaneous Lupus Erythematosus in the 7MM

Recent Developments In The Cutaneous Lupus Erythematosus Treatment Market

• On October 16, 2024, Cullinan Therapeutics received FDA clearance for its Investigational New Drug (IND) application for CLN-978, allowing it to proceed with a global Phase 1 clinical trial in patients with moderate to severe systemic lupus erythematosus (SLE).

Cutaneous Lupus Erythematosus Drug Analysis

The drug chapter segment of the Cutaneous Lupus Erythematosus drugs market report encloses a detailed analysis of Cutaneous Lupus Erythematosus marketed drugs and late-stage (Phase III and Phase II) Cutaneous Lupus Erythematosus pipeline drugs. It also deep dives into the pivotal Cutaneous Lupus Erythematosus clinical trials details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Cutaneous Lupus Erythematosus Emerging Drugs

• Litifilimab: Biogen

Litifilimab (known as BIIB059), discovered and developed in-house by Biogen scientists, is a humanized IgG1 monoclonal antibody targeting BDCA2 and is being investigated for the potential treatment of SLE and CLE. BDCA2 is a receptor predominantly expressed on a subset of human immune cells called plasmacytoid dendritic cells (pDCs). The binding of litifilimab to BDCA2 has been shown to reduce the production of pro-inflammatory molecules by pDCs, including type-I interferon (IFN-I) as well as other cytokines and chemokines.

The company is evaluating the candidate in the Phase II/III trial (NCT05531565, AMETHYST) in participants with active subacute cutaneous lupus erythematosus and/or chronic cutaneous lupus erythematosus with or without systemic manifestations and who are refractory and/or intolerant to antimalarial therapy.

• Daxdilimab: Horizon Therapeutics/ Amgen

Daxdilimab (HZN-7734), formerly known as VIB7734, is an anti-ILT7 human monoclonal antibody that depletes certain dendritic cells. Depleting these cells may interrupt the cycle of inflammation that causes tissue damage in various autoimmune conditions. Horizon also investigates daxdilimab in Systemic Lupus Erythematosus, DLE, and alopecia areata and plans to investigate it in dermatomyositis and lupus nephritis.

 The company is evaluating the candidate in the Phase II trial (NCT05591222; RECAST DLE) in moderate-to-severely active primary DLE who are refractory to SOC

Cutaneous Lupus Erythematosus Market Outlook

Key Cutaneous Lupus Erythematosus Companies, such as Biogen, Horizon Therapeutics/ Amgen, Bristol-Myers Squibb, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Cutaneous Lupus Erythematosus.

• The Cutaneous Lupus Erythematosus Market Size in the seven major markets was around USD 500 million in 2023.
• The United States accounts for the largest Cutaneous Lupus Erythematosus Market Size (around USD 400 million), in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• Among EU4 and the UK, the United Kingdom accounts for the highest Cutaneous Lupus Erythematosus Market Size.
• Spain accounts for the smallest Cutaneous Lupus Erythematosus Market Size in the 7MM.
• Japan holds the third-largest Cutaneous Lupus Erythematosus Market Size among the 7MM and is projected to increase during the forecast period (2024–2034).
• By 2034, among all the emerging therapies, the highest revenue is expected to be generated by litifilimab followed by deucravacitinib in the 7MM

Cutaneous Lupus Erythematosus Drugs Uptake

This section focuses on the uptake rate of potential Cutaneous Lupus Erythematosus drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Cutaneous Lupus Erythematosus Pipeline Development Activities

The Cutaneous Lupus Erythematosus pipeline report provides insights into different Cutaneous Lupus Erythematosus clinical trials within Phase III and Phase II stages. It also analyzes key Cutaneous Lupus Erythematosus Companies involved in developing targeted therapeutics.

Cutaneous Lupus Erythematosus Pipeline Development Activities

The Cutaneous Lupus Erythematosus clinical trials analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Cutaneous Lupus Erythematosus emerging therapies.

KOL Views on Cutaneous Lupus Erythematosus Market Report

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility. DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Cutaneous Lupus Erythematosus. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Cutaneous Lupus Erythematosus Report Qualitative Analysis

We perform Qualitative and Cutaneous Lupus Erythematosus Drugs Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Cutaneous Lupus Erythematosus Treatment Market Access and Reimbursement

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children’s Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), third-party organizations that provide services, and educational programs to aid patients are also present.

The Cutaneous Lupus Erythematosus drugs market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Cutaneous Lupus Erythematosus Therapeutics Market Report

• The Cutaneous Lupus Erythematosus therapeutics market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country-specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current Cutaneous Lupus Erythematosus treatment market landscape.
• A detailed review of the Cutaneous Lupus Erythematosus drugs market, historical and forecasted Cutaneous Lupus Erythematosus treatment market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Cutaneous Lupus Erythematosus treatment market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Cutaneous Lupus Erythematosus Drugs Market.

Cutaneous Lupus Erythematosus Treatment Market Report Insights

• Patient-based Cutaneous Lupus Erythematosus Market Forecasting
• Cutaneous Lupus Erythematosus Therapeutic Approaches
• Cutaneous Lupus Erythematosus Pipeline Analysis
• Cutaneous Lupus Erythematosus Market Size and Trends
• Existing and future Cutaneous Lupus Erythematosus Drugs Market Opportunity

Cutaneous Lupus Erythematosus Treatment Market Report Key Strengths

• 10 Years Cutaneous Lupus Erythematosus Market Forecast
• 7MM Coverage
• Cutaneous Lupus Erythematosus Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Cutaneous Lupus Erythematosus Drugs Uptake
• Key Cutaneous Lupus Erythematosus Market Forecast Assumptions

Cutaneous Lupus Erythematosus Treatment Market Report Assessment

• Current Cutaneous Lupus Erythematosus Treatment Market Practices
• Cutaneous Lupus Erythematosus Unmet Needs
• Cutaneous Lupus Erythematosus Pipeline Product Profiles
• Cutaneous Lupus Erythematosus Drugs Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Cutaneous Lupus Erythematosus Market Drivers
• Cutaneous Lupus Erythematosus Market Barriers

FAQs

• What is the growth rate of the 7MM Cutaneous Lupus Erythematosus treatment market?
• What was the Cutaneous Lupus Erythematosus market size, the Cutaneous Lupus Erythematosus market size by therapies, Cutaneous Lupus Erythematosus market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Cutaneous Lupus Erythematosus?
• How many Cutaneous Lupus Erythematosus Companies are developing therapies for the Cutaneous Lupus Erythematosus treatment?
• What are the recent novel therapies, targets, Cutaneous Lupus Erythematosus Mechanisms of Action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to Buy Cutaneous Lupus Erythematosus Market Forecast Report

• The Cutaneous Lupus Erythematosus Drugs Market Report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Cutaneous Lupus Erythematosus Treatment Market.
• Insights on patient burden/disease Cutaneous Lupus Erythematosus Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing Cutaneous Lupus Erythematosus Drugs Market opportunities 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 approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the Cutaneous Lupus Erythematosus Drugs Market will help devise strategies to help get 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 expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives 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.

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