Facioscapulohumeral Muscular Dystrophy (FSHD) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Facioscapulohumeral Muscular Dystrophy (FSHD) Market Outlook

Thelansis’s “Facioscapulohumeral Muscular Dystrophy (FSHD) 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 Facioscapulohumeral Muscular Dystrophy treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Facioscapulohumeral Muscular Dystrophy (FSHD) Overview

Facioscapulohumeral muscular dystrophy (FSHD) stands out as a genetic muscle disorder with a primary impact on facial, shoulder, and upper arm muscles. This condition is categorized into type 1 (FSHD1) and type 2 (FSHD2), presenting identical signs and symptoms but differing in their genetic origins. Initially, FSHD manifests as facial, shoulder girdle, and arm muscle weakness. Facial weakness may lead to restricted lip movements, causing challenges like whistling, using a straw, or puckering the lips. Notably, individuals with FSHD may acquire a distinctive "mask-like" facial appearance. Upper facial weakness can also result in an inability to close the eyes during sleep. FSHD1 is attributed explicitly to abnormal expression of the DUX4 gene, found on chromosome 4 in the D4Z4 region. The DNA in this region usually undergoes hypermethylation and contains 11-100 repeated DNA segments. Notably, each pregnancy involving an affected parent carries a 50% risk of passing on the abnormal gene to the offspring, irrespective of gender.

• In terms of prevalence, FSHD affects an estimated 5 to 11 cases per 100,000 population in the USA. A substantial majority, around 95%, are classified as FSHD1, with the remaining 5% falling under FSHD2.

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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