Scleroderma – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Scleroderma Market Outlook

Thelansis’s “Scleroderma Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Scleroderma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Scleroderma Overview

Scleroderma, a connective tissue disorder, primarily manifests as thickened and hardened skin. There are two main types: localized and systemic, also known as systemic sclerosis. In localized scleroderma, the condition primarily affects the skin and may also impact muscles and bones. The exact causes of scleroderma remain unclear, but some evidence suggests genetic and environmental factors play a role in its development. Silica and specific organic solvents are recognized risk factors for systemic scleroderma. These factors trigger an immune system response, damaging blood vessels and tissues and forming scar tissue and excess collagen accumulation. Raynaud's phenomenon (RP) is often the initial symptom of scleroderma, sometimes appearing years before other signs of the disease. It is a visible expression of a systemic vascular issue fundamental to scleroderma's development. Three primary mechanisms contribute to scleroderma development: vascular anomalies, excess fibrosis, and autoimmune processes. Abnormal interactions between endothelial cells, fibroblasts, and lymphocytes (B and T) lead to microcirculatory vascular involvement. This results in the production of endothelin by endothelial cells, causing vasoconstriction and fibroblast activation. Additionally, fibroblasts and activated endothelial cells produce reactive oxygen species, accelerating vascular remodeling and the obliteration of small vessels. Activated fibroblasts quickly transform into myofibroblasts, which have an increased ability to synthesize collagen. Several other conditions exhibit skin changes similar to scleroderma, including Scleredema (scleredema diabeticorum and scleredema of Buschke), Eosinophilic fasciitis, Eosinophilia-myalgia syndrome, and Nephrogenic systemic fibrosis. The life expectancy of systemic sclerosis patients depends on the extent and severity of internal organ involvement. Compared to healthy individuals of the same age, those with SSc have a 3.5 times higher mortality rate. Survival rates for SSc patients are approximately 75-80% after five years, 55% after ten years, 35-40% after 15 years, and 25-30% after 20 years. Risk factors for higher mortality include older age at diagnosis, male gender, diffuse skin involvement, and organ involvement (such as pulmonary, cardiac, or renal). Systemic scleroderma's skin hardening and musculoskeletal effects, especially in the hands, can lead to functional disabilities. Oral restrictions can affect food intake and dental care. Linear scleroderma of the limbs, especially when it affects underlying bones, can also cause functional issues and potential aesthetic concerns in cases of "en coup de sabre" linear scleroderma. Treatment for scleroderma aims to alleviate symptoms and slow disease progression, although there is no single proven agent to modify the course of the disease.

• Scleroderma is a rare disease, with an estimated prevalence of 276-300 cases per million in the United States.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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