How are companies such as Biogen, Horizon Therapeutics, Bristol–Myers Squibb, and others influencing the CLE market?

LAS VEGAS, CALIFORNIA, UNITED STATES OF AMERICA, March 21, 2024 /EINPresswire.com/ -- The total market size of CLE in the 7MM was USD 580 million in 2022 and is projected to grow during the forecast period (2023–2032) due to an increase in the diagnosed population of CLE along with the expected launch of emerging therapies such as litifilimab (Biogen), daxdilimab (Horizon Therapeutics), and SOTYKTU (Bristol–Myers Squibb), and others.

DelveInsight’s Cutaneous Lupus Erythematosus epidemiology-based market forecast report includes a comprehensive understanding of these market drivers and how they will impact the overall CLE market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

Key Takeaways from the Cutaneous Lupus Erythematosus Market Report

As per the DelveInsight assessment, the diagnosed cases of CLE in the 7MM were approximately 823K in 2023.

As per DelveInsight’s analysis, the US accounted for around 60% of the total diagnosed prevalent cases of CLE in the 7MM in 2023.

In 2023, among gender-specific cases of CLE in the US, females accounted for a significantly higher number of cases than males.

The dynamics of the CLE market are also anticipated to change in the coming years, owing to the rise in healthcare spending in the 7MM.

CLE companies including Biogen (litifilimab), Horizon Therapeutics (daxdilimab), Bristol–Myers Squibb (SOTYKTU), and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of CLE.

Cutaneous Lupus Erythematosus Market Dynamics

The market dynamics of Cutaneous Lupus Erythematosus are evolving rapidly, driven by advancements in diagnostic technologies, increasing awareness, and expanding treatment options. With a growing patient pool worldwide, pharmaceutical companies are focusing on developing novel therapies that target specific pathways involved in the pathogenesis of CLE. This has led to a surge in research and development activities, resulting in a robust pipeline of potential drugs ranging from topical treatments to biologics.

Moreover, the demand for effective and safe treatments has intensified competition among key players in the market. This has resulted in strategic collaborations, licensing agreements, and mergers & acquisitions aimed at enhancing product portfolios and expanding market reach. Additionally, the rising prevalence of autoimmune diseases, including CLE, has fueled market growth, with healthcare systems globally focusing on improving patient outcomes and quality of life. As a result, the Cutaneous Lupus Erythematosus market is poised for significant expansion, offering immense opportunities for innovative therapies and improved patient care.

Download the report to understand which factors are driving CLE market trends @ Cutaneous Lupus Erythematosus Market Insights

Cutaneous Lupus Erythematosus Treatment Market

The primary systemic treatment for CLE involves medications such as hydroxychloroquine (HCQ), chloroquine (CQ), and quinacrine (Q), with HCQ being the preferred option. Prolonged and high-dose use of HCQ carries a risk of retinopathy, so the dosage should be determined based on the individual's body weight. Dapsone is recommended for bullous LE and is seen as a second-choice treatment for CLE that does not respond to initial therapies, with an initial low-dose regimen and monitoring for G6PD deficiency. B cell-targeted treatments such as rituximab and belimumab are being researched for their effectiveness in treating skin lesions, especially in cases where other treatments have not been successful. However, the potential serious side effects of rituximab mean that careful consideration and adherence to guidelines are crucial.

Immunosuppressants: About half of patients who do not respond to antimalarials find relief with immunosuppressants. Methotrexate becomes a treatment option for CLE (cutaneous lupus erythematosus) when antimalarials prove ineffective. Following unsuccessful attempts with topical therapies and antimalarials in CLE, a range of immunosuppressive drugs such as dapsone, oral vitamin A derivatives, oral corticosteroids, methotrexate, MMF (mycophenolate mofetil), azathioprine, cyclophosphamide, and cyclosporine can be beneficial. These medications may be used alone, alongside antimalarial therapy, or in combination.

Despite the effectiveness of current treatments, many patients still do not respond, underlining the need for new therapeutic approaches. Managing cutaneous lupus remains challenging, partly due to the diverse and often unpredictable responses seen among different subtypes of cutaneous lupus and even among patients within these subtypes. Unfortunately, challenges persist, in part due to issues with trial design and the varied nature of the disease.

Recent Developments in the Cutaneous Lupus Erythematosus 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 (DLE).

Emerging Cutaneous Lupus Erythematosus Therapies and Key Companies

Some of the drugs in the CLE pipeline include litifilimab (Biogen), daxdilimab (Horizon Therapeutics), and SOTYKTU (Bristol–Myers Squibb), and others.

Litifilimab, also known as BIIB059, was discovered and developed internally by Biogen scientists. It is a humanized IgG1 monoclonal antibody (mAb) designed to target BDCA2, with investigations underway for its potential in treating SLE and CLE. BDCA2 serves as a receptor primarily found on a specific type of human immune cells known as Plasmacytoid Dendritic Cells (pDCs). When litifilimab binds to BDCA2, it has been demonstrated to decrease the production of inflammatory molecules by pDCs, including type-I interferon (IFN-I) along with other cytokines and chemokines. These inflammatory agents are believed to have a significant role in the development of systemic and cutaneous lupus.

Biogen is currently assessing this treatment candidate in a Phase II/III trial (NCT05531565, AMETHYST) involving individuals with active subacute cutaneous lupus erythematosus and/or chronic cutaneous lupus erythematosus, with or without systemic symptoms, who have not responded well to or cannot tolerate antimalarial therapy. In October 2022, Biogen announced the first patient dosed in a crucial study of litifilimab for CLE.

Daxdilimab (HZN-7734), previously referred to as VIB7734, is a human monoclonal antibody targeting ILT7 that aims to reduce specific dendritic cells. The reduction of these cells could potentially disrupt the inflammatory process responsible for tissue damage in various autoimmune disorders. Horizon is also exploring the effects of daxdilimab in conditions such as SLE, DLE, and alopecia areata, with plans to further investigate its impact on dermatomyositis and lupus nephritis.

The company is currently conducting a Phase II trial (NCT05591222) involving patients with moderate-to-severe primary discoid lupus erythematosus. This trial is actively recruiting participants, and the primary completion date is expected to be in July 2024.

SOTYKTU (deucravacitinib) is an allosteric inhibitor that selectively targets tyrosine kinase 2 (TYK2), a component of the Janus kinase (JAK) family. This medication is undergoing assessments in worldwide clinical trials across various immune-related conditions such as psoriasis, psoriatic arthritis, active discoid and/or subacute cutaneous lupus erythematosus (CLE), and inflammatory bowel diseases. Currently, deucravacitinib is in Phase II clinical trials for the treatment of discoid lupus erythematosus.

The anticipated launch of these emerging therapies for CLE are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the CLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about drugs for CLE in development @ Cutaneous Lupus Erythematosus Clinical Trials

Cutaneous Lupus Erythematosus: Overview

Cutaneous lupus erythematosus (CLE) is a form of lupus erythematosus, an autoimmune condition primarily impacting the skin. CLE specifically focuses on skin tissues, leading to a variety of distinct symptoms and presentations. While the exact cause of CLE isn't entirely clear, it is thought to result from a complex mix of genetic predisposition, environmental triggers, and dysfunction within the immune system.

Symptoms of cutaneous lupus erythematosus can vary widely, often depending on the specific subtype, which includes discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), and tumid lupus erythematosus (TLE). Common signs include skin rashes, lesions, and heightened sensitivity to sunlight. The classic butterfly-shaped rash on the cheeks and nose, known as a malar rash, is frequently linked with lupus. Diagnosis of cutaneous lupus erythematosus entails a blend of clinical assessment, review of medical history, and laboratory examinations. Dermatologists and rheumatologists often work together in this diagnostic process. Skin biopsies of affected areas can uncover specific histopathological characteristics that aid in distinguishing CLE from other skin conditions. Additionally, blood tests such as antinuclear antibody (ANA) testing can confirm the diagnosis and help rule out systemic involvement.

Cutaneous Lupus Erythematosus Epidemiology Segmentation

The CLE epidemiology section provides insights into the historical and current CLE patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders.

The CLE market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:

Total Diagnosed Prevalent Cases
Total Prevalent Cases of CLE by Gender
Total Prevalent Cases of CLE by Type
Total Treated Cases
Total Prevalent Cases of CLE by Severity

Scope of the Cutaneous Lupus Erythematosus Market Report

Cutaneous Lupus Erythematosus Therapeutic Assessment: Cutaneous Lupus Erythematosus current marketed and emerging therapies
Cutaneous Lupus Erythematosus Key Companies: Biogen, Horizon Therapeutics, Bristol-Myers Squibb, Gilead Sciences, Daiichi Sankyo, Inc., EMD Serono, Hoth Therapeutics, Zylo Therapeutics, Sanofi, Merck KGaA, Kyowa Kirin Co., Ltd., Priothera Ltd., Centessa Pharmaceuticals, Horizon Therapeutics, and others
Cutaneous Lupus Erythematosus Pipeline Therapies: Litifilimab, Daxdilimab, SOTYKTU (deucravacitinib), Edecesertib, DS-7011a, Enpatoran, and others
Cutaneous Lupus Erythematosus Market Dynamics: Attribute Analysis of Emerging Cutaneous Lupus Erythematosus Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL’s views, Analyst’s views, Cutaneous Lupus Erythematosus Market Access and Reimbursement

Table of Contents

1.
Cutaneous Lupus Erythematosus Market Key Insights
2.
Cutaneous Lupus Erythematosus Market Report Introduction
3.
Cutaneous Lupus Erythematosus Market Overview at a Glance
4.
Cutaneous Lupus Erythematosus Market Executive Summary
5.
Disease Background and Overview
6.
Cutaneous Lupus Erythematosus Treatment and Management
7.
Cutaneous Lupus Erythematosus Epidemiology and Patient Population
8.
Patient Journey
9.
Cutaneous Lupus Erythematosus Marketed Drugs
10.
Cutaneous Lupus Erythematosus Emerging Drugs
11.
Seven Major Cutaneous Lupus Erythematosus Market Analysis
12.
Cutaneous Lupus Erythematosus Market Outlook
13.
Potential of Current and Emerging Therapies
14.
KOL Views
15.
Unmet Needs
16.
SWOT Analysis
17.
Appendix
18.
DelveInsight Capabilities
19.
Disclaimer
20.
About DelveInsight

Related Reports

Cutaneous Lupus Erythematosus Pipeline Report

Cutaneous Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key CLE companies, including Hoth Therapeutics, Zylo Therapeutics, Sanofi, Gilead Sciences, Bristol-Myers Squibb, Merck KGaA, Kyowa Kirin Co., Ltd., Priothera Ltd., Centessa Pharmaceuticals, Horizon Therapeutics, among others.

About DelveInsight

DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

DelveInsight’s healthcare consulting services leverage our extensive industry expertise, market research capabilities, and data analytics to provide clients with practical, data-driven solutions. The consultants work closely with clients to understand their unique needs and challenges and to develop tailored solutions that meet their specific requirements. DelveInsight’s consulting services cover a range of areas, including market access, commercial strategy, product development, and regulatory affairs in the healthcare domain.

Shruti Thakur
DelveInsight Business Research LLP
+ 14699457679
www.delveinsight.com

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