Cutaneous Lupus Erythematosus - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

• The treatment of Cutaneous lupus erythematosusis centered upon formulating a regimen of topical and systemic therapies designed to reduce disease activity and minimize cosmetic damage. Sun avoidance and sunscreen are important preventative measures proven to minimize Cutaneous lupus erythematosusexacerbations.
• Cutaneous lupus erythematosusrequires long-term disease monitoring due to its chronic and relapsing course.
• Patient education on the risk factors, protective measures, and the necessity of a long-term follow-up is a basis for a better treatment outcome.
• The pathogenesis of cutaneous lupus erythematosus is multifactorial, with an interplay between genetic and environmental factors. Immune dysregulation and aberrant cell signaling pathways through cytokine cascades are also implicated
• 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).
• Diagnosis of these diseases 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 exclude systemic disease.
• Presentation of Overlapping clinical symptoms among cutaneous lupus erythematosus subtypes and with other skin diseases like cancer etc., led to a lower diagnosis rate.
• Advancements in research and development, coupled with the relay of scientific information about disease pathophysiology and the introduction of new diagnostic techniques, present an optimistic future in terms of cutaneous lupus erythematosus diagnosis.
• In 2022, the total market size of Cutaneous lupus erythematosusin the 7MM and China was ~USD 580 million, expected to reach ~USD 1,260 million by 2032. In the total Cutaneous lupus erythematosusmarket size, the United States accounted for the highest market size in 2022, followed by China.
• Off-label and generic therapies constitute almost a share of the cutaneous lupus erythematosus market, providing an opportunity to gain a first-mover advantage.
• As of now, no drug has been specifically approved for CLE. It is due to the challenges associated with trials on lupus. High placebo response rates due to background therapies make interpreting trial endpoints difficult.
• Among emerging drugs, BDCA2 protein inhibitors, dendritic cell inhibitors, and TYK2 kinase inhibitors will be expanding the treatment landscape of CLE.
• Out of these emerging therapies, Biogen's litifilimab and Bristol Myers Squibb deucravacitinib will be the leading drugs in the Cutaneous lupus erythematosusmarket in our forecast period.
• Litifilimab, developed by Biogen, is a humanized IgG1 monoclonal antibody targeting BDCA2 and is being investigated for the potential treatment of SLE and CLE. Currently, it is being developed in Phase II/III trials to treat CLE. The estimates it will garner sales of approximately USD 175 million in the 7MM and China by 2032.
• Approved targeted therapies are needed for an hour to cater to treatment for the growing diagnosed prevalent pool of cutaneous lupus erythematosus.
• Emerging therapies such as Biogen's litifilimab (BIIB059), Horizon Therapeutics's daxdilimab (VIB7734), Bristol-Myers Squibb's SOTYKTU (deucravacitinib) have the potential to create a significant positive shift in the cutaneous lupus erythematosus market size in our forecast period.

This “Cutaneous Lupus Erythematosus - Market Insights, Epidemiology and Market Forecast - 2032 report delivers an in-depth understanding of the Cutaneous Lupus Erythematosus, historical and forecasted epidemiology as well as the Cutaneous Lupus Erythematosus market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, Japan, and China. The Cutaneous Lupus Erythematosus market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM and China Cutaneous Lupus Erythematosus market size from 2019 to 2032. 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 potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the UK
• Japan
• China

Study Period: 2019-2032

Cutaneous Lupus Erythematosus Disease Understanding and Treatment Algorithm

Cutaneous Lupus Erythematosus Overview

Cutaneous Lupus Erythematosus (CLE) 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. About the skin, there are lupus-specific skin lesions and non-specific skin lesions. Cutaneous Lupus Erythematosus and severe systemic LE are on one end of the spectrum. Both of them can occur together and separately.

There are three broad types of cutaneous lupus: Acute, Subacute, and Chronic Cutaneous Lupus Erythematosus. The prototypical example of acute cutaneous lupus is the malar rash. Subacute cutaneous lupus (SCLE) usually involves rashes in sun-exposed areas, and this generally does not lead to scarring. Chronic cutaneous lupus can be subdivided into several cutaneous findings, including discoid, tumidus, profundus, and chilblains. The hallmark condition of chronic cutaneous lupus is discoid lupus erythematosus (DLE).

Cutaneous Lupus Erythematosus Diagnosis

To properly diagnose cutaneous manifestations of Lupus Erythematosus, the physician must first correctly classify the subtype and exclude systemic involvement of the disease. Cutaneous Lupus Erythematosus diagnosis should be based on the findings of patient history, clinical exam, laboratory studies, serology, histology, and direct immunofluorescence (DIF) exam of skin biopsies. Serology is routinely obtained at baseline to assess systemic involvement as well as guidance among the subsets of Cutaneous Lupus Erythematosus.

The histopathological picture for diagnosing Cutaneous Lupus Erythematosus is the golden standard combined with clinical and serological pictures. A biopsy cannot confidently discriminate between the three main subsets of Cutaneous Lupus Erythematosus since these will all show interface dermatitis.

A serological test of ANA and extractable nuclear antigens (ENAs) should be performed at baseline to assess possible systemic involvement. A routine blood and biochemistry test, including a urinalysis for proteinuria, should be performed. A visual check should also be performed before starting medication if antimalarial are considered.

Diagnosing Acute Cutaneous Lupus Erythematosus requires proper sub-type classification through a combination of physical examination, laboratory studies, histology, and antibody serology. Also, direct immunofluorescence and photo-provocation may confirm the diagnosis in some specific cases to exclude systemic disease.

In the case of Sub-acute Cutaneous Lupus Erythematosus, diagnosis is mainly based on clinical features and confirmed by histopathology. Severe systemic disease is less common in these patients. Also, for all the different Cutaneous Lupus Erythematosus sub-types, a very detailed skin examination continues to be fundamental to properly diagnose all the cutaneous manifestations of LE and differentiate other skin conditions with skin biopsies.

Further details related to country-based variations are provided in the report.

Cutaneous Lupus Erythematosus Treatment

According to current guidelines, management of cutaneous lupus erythematosus involves a combination of topical and systemic drugs, fairly similar for the different subtypes. Although consensus over the treatment and guidelines has succeeded over the years, no specific drugs have been approved by the Food and Drug Administration (FDA). Most of the medications for Cutaneous lupus erythematosushave been adapted from SLE treatment, but the existing literature is limited to small studies, and evidence often lacks. As drugs that have proven effective in systemic disease may not be effective in cutaneous disease, the treatment of refractory cutaneous lupus erythematosus is particularly challenging, as it is difficult to achieve a consensus on the appropriate progression of treatment beyond first- and second-line treatment options.

The available current treatments are immunosuppressants, with possible side effects; a thoughtful approach is mandatory to select the most appropriate drug better. General recommendations include sun protection, smoking cessation, vitamin D implementation, withdrawal of photosensitizing drugs, and avoidance of isomorphic trigger factors. Female patients are also recommended to avoid hormonal contraception containing estrogen and estrogen replacement therapies. These measures are crucial to prevent refractory cutaneous lupus erythematosus. Studies on the photo-protective habits of lupus patients have shown an increased frequency of sunscreen utilization over the years. However, not all patients with cutaneous lupus erythematosus use daily sun protection; not all apply the right dose, and not all re-apply sunscreen during the day.

Accordingly, active smoking has been associated with cutaneous lupus erythematosus severity, with a lower risk of long-term cutaneous lupus erythematosus remission. Although it is known that it decreases the efficacy of systemic treatment, the impact of tobacco on the efficacy of antimalarial may be caused by an increase in the severity of the disease more than by resistance in smokers.

Cutaneous Lupus Erythematosus Epidemiology

As the market is derived using the patient-based model, the Cutaneous Lupus Erythematosus epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, 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, and Total Treated Cases of Cutaneous Lupus Erythematosus in the 7MM and China covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, Japan, and China from 2019 to 2032. The total diagnosed prevalent cases of Cutaneous Lupus Erythematosus in the 7MM and China comprised approximately 1,467,900 cases in 2022 and are projected to increase during the forecasted period.

• The total diagnosed prevalent cases of Cutaneous Lupus Erythematosus in the United States were around 452,000 cases in 2022.
• Among the EU4 countries, the UK accounted for the largest number of Cutaneous Lupus Erythematosus cases, followed by France, whereas Spain accounted for the lowest number of cases in 2022.
• According to the publisher's estimates, Japan had around 19,055 and 46,652 diagnosed prevalent male and female cases, respectively, in 2022. These cases are projected to increase during the forecasted period.
• In China, the total diagnosed prevalent cases of Cutaneous lupus erythematosusby severity were 352,375, 250,728, and 74,541 in mild, moderate, and severe, respectively, in 2022, which are likely to increase during the forecasted period.
• It has been observed that the prevalence of Cutaneous lupus erythematosusis higher in CCLE (~73%) compared to SCLE (18%) and ACLE (15%) in the 7MM and China.
• In the 7MM and China, the total treated cases of Cutaneous lupus erythematosuswere ~888,700 in 2022, which are likely to increase to ~1,226,800 cases, respectively, by 2032.

Cutaneous Lupus Erythematosus Drug Chapters

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

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 Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus. BDCA2 is a receptor predominantly expressed on a subset of human immune cells called pDCs. The binding of litifilimab to BDCA2 has been shown to reduce the production of pro-inflammatory molecules by pDCs.

The drug is being evaluated in Phase II/III (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. The study is anticipated to be complete by July 2026.

The drug is expected to launch by 2027 for Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) and would have first mover advantage. Moreover, it is expected to cater to the major cutaneous lupus erythematosus patient pool. A subgroup of patients with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy are included in undergoing clinical trials. The overall drug could fetch the maximum market share in the cutaneous lupus erythematosus market space.

SOTYKTU (deucravacitinib): Bristol-Myers Squibb

SOTYKTU (deucravacitinib) is a selective, allosteric inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. It is in the Phase II trial (NCT04857034) in participants with active discoid and/or subacute cutaneous lupus erythematosus with or without SLE that is not well-controlled with SOC. The drug is expected to be the second largest market share getter in the cutaneous lupus erythematosus treatment market space.

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

Drug Class Insights

Antimalarials mainly dominate the existing Cutaneous Lupus Erythematosus treatment. Other classes (off-label), such as glucocorticoids, systemic immunomodulators (MTX, Belimumab, and others), biologics (rituximab, IVIG), etc., have an impressive presence.

Moreover, the upcoming treatment landscape is poised to expand further after new classes emerge, such as biologics, tyrosine kinase inhibitors, and other agents.

Cutaneous Lupus Erythematosus Market Outlook

Cutaneous Lupus Erythematosus treatment in the US is entering a new era with changing dynamics. Apart from antimalarial, no targeted drugs have been approved by the US FDA to treat Cutaneous Lupus Erythematosus. The current treatment approach is concentrated on symptomatic management of the disease burden with off-label therapies and considering recommended general protective agents.

It is worth mentioning that the 2021 British Association of Dermatologists Guidelines for the Management of People with Cutaneous Lupus Erythematosus presently recommends the treatment for moderate-severe Cutaneous Lupus Erythematosus includes starting treatment with topical glucocorticoids and calcineurin inhibitors for the mild Cutaneous Lupus Erythematosus. For moderate-severe Cutaneous Lupus Erythematosus patients, recommended therapies include systemic glucocorticoids, systemic immunomodulators, biologics, and others. Moreover, antimalarials will be added as approved treatment agents.

The current market has been segmented into different commonly used drugs based on the prevailing treatment pattern across the 7MM and China, presenting minor variations in the overall prescription pattern. Glucocorticoids, Immunomodulators, biologics, etc., are the major drugs covered in the forecast model.

The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, there are a few roadblocks regarding the timely diagnosis and treatment of these patients; for instance, generics dominate a major share of the market being used as off-label therapy. These factors often become a hindrance when adopting newer therapies.

Key players, such as new therapies, are in development for cutaneous lupus erythematosus, including Biogen (litifilimab), Horizon Therapeutics (daxdilimab), and Bristol-Myers Squibb (deucravacitinib).

• The total market size of cutaneous lupus erythematosus in the 7MM and China is approximately USD 580 million in 2022 and is projected to increase during the forecast period (2023-2032).
• The market size in the 7MM and China will increase at a CAGR of 7.2% due to the increasing treated pool of the cutaneous lupus erythematosus and the launch of the emerging therapy.
• Among EU4 countries, the UK accounts for the maximum market size in 2022, while Spain occupied the bottom of the ladder in 2022.
• By 2032, among all the emerging therapies, the highest revenue is expected to be generated by litifilimab followed by deucravacitinib in the 7MM and China.

Cutaneous Lupus Erythematosus Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in 2019-2032. For example, for litifilimab, the company runs trials across the US and Europe. We expect the drug uptake to be medium with a probability-adjusted peak share of 6.4%; years to the peak is expected to be 7 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report.

Cutaneous Lupus Erythematosus Pipeline Development Activities

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

Pipeline Development Activities

The report covers detailed information on collaborations, acquisition and merger, licensing, and patent details for Cutaneous Lupus Erythematosus emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on Cutaneous Lupus Erythematosus evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, drug uptake along with challenges related to accessibility, including medical/scientific writers, medical oncologists and professors, pediatric rheumatologists, lupus foundation, and others.

This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM and China. Centers such as MD Anderson Cancer Center, Texas from UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, MD Anderson Cancer Center, etc., were contacted. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Cutaneous Lupus Erythematosus market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, administration frequency, administration route, 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 Cutaneous Lupus Erythematosus, one of the most important primary outcome measures is the Cutaneous lupus disease area and severity index (CLASI), which measures mainly disease activity and disease-induced damage. Additionally, cutaneous lupus activity-investigator global assessment (CLA-IGA) is also another measure, like many other outcome measures.

Both EMA and the FDA believe the endpoint in Phase II/III clinical trials should be tailored to the drug in question, and the benefit should outweigh the risk, allowing subsequent drug development. Given that Cutaneous lupus disease area and severity index (CLASI) is the preferred primary endpoint for Phase III clinical trials. Thus, Phase II trials should look for an early signal of finite treatment efficacy. A decrease in Cutaneous lupus disease area and severity index (CLASI) was proposed as a clinically meaningful endpoint for Phase II trials.

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 route of administration, order of entry and designation, 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.

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.

HAS uses the ratings of ASMR for improvement in existing therapies and SMR for a new drug. An ASMR rating is assigned based on the drug's improvement of medical benefit compared to the current standard of care. ASMR I, II, and III mean faster market access with price notification instead of negotiation and consistent price all over Europe, ASMR IV means that the drug is to be priced equal to the comparator, and ASMR V rating means that the drug is to be priced lower than the comparator. However, an SMR rating is given on the product's medical benefit to determine whether the drug should be reimbursed. A 65-100%, 30%, 15%, and 0% reimbursement is given to drugs with SMR ratings of important, moderate, mild, and insufficient, respectively.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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 Report

• The report covers a segment of key events, an executive summary, descriptive overview of Cutaneous Lupus Erythematosus, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Cutaneous Lupus Erythematosus market, historical and forecasted market size, and market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM and China drug outreach.
• The 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 shape and drive the 7MM and China Cutaneous Lupus Erythematosus market.

Cutaneous Lupus Erythematosus Report Insights

• Patient Population
• Therapeutic Approaches
• Cutaneous Lupus Erythematosus Pipeline Analysis
• Cutaneous Lupus Erythematosus Market size and Trends
• Existing and Future Market Opportunities

Cutaneous Lupus Erythematosus Report Key Strengths

• Ten Years Patient-based Forecast
• The 7MM and China coverage
• Cutaneous Lupus Erythematosus Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Cutaneous Lupus Erythematosus Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market insights

• What was the Cutaneous Lupus Erythematosus total market size, the market size by therapies, and market share (%) distribution in 2019, and what would it all look like by 2032? What are the contributing factors for this growth?
• How will interferon as a class affect the treatment paradigm in Cutaneous Lupus Erythematosus?
• What kind of uptake will litifilimab witness in Cutaneous Lupus Erythematosus patients in the coming years?
• How will emerging drugs compete with existing therapies in the market?
• Which class is going to be the largest contributor by 2032?
• 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?

Epidemiology insights

• What are the disease risk, burden, and unmet needs of Cutaneous Lupus Erythematosus? What growth opportunities will be across the 7MM and China for the Cutaneous Lupus Erythematosus patient population?
• What is the historical and forecasted Cutaneous Lupus Erythematosus patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, Japan, and China?
• Why do only limited patients appear with symptoms? Why is the current year diagnosis rate not high?
• What factors are affecting the increase in the diagnosis of symptomatic cases?

Current treatment scenario, marketed drugs, and emerging therapies

• What are the current options to treat Cutaneous Lupus Erythematosus? What are the current guidelines for treating Cutaneous Lupus Erythematosus in the US and Europe?
• How many companies are developing therapies to treat Cutaneous Lupus Erythematosus?
• How many emerging therapies are in the mid-stage and late stage of development for treating Cutaneous Lupus Erythematosus?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What key designations have been granted for the emerging therapies for Cutaneous Lupus Erythematosus?
• What is the cost burden of therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM and China historical and forecasted markets of Cutaneous Lupus Erythematosus?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Cutaneous Lupus Erythematosus market.
• Insights on patient burden/disease diagnosis 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 approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, Japan, and China.
• Identifying strong upcoming players in the market will help devise strategies that will 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 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 need of the existing market so that the upcoming players can strengthen their development and launch strategy.