Facioscapulohumeral Muscular Dystrophy Market Size in the 7MM is projected to grow at a significant CAGR by 2034, estimates DelveInsight

DelveInsight's "Facioscapulohumeral Muscular Dystrophy Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of facioscapulohumeral muscular dystrophy, historical and forecasted epidemiology as well as the facioscapulohumeral muscular dystrophy market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Facioscapulohumeral Muscular Dystrophy Market Report

* On January 29, 2026- Hoffmann-La Roche conducted a Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Pharmacodynamics, Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7204239 in Participants With Facioscapulohumeral Muscular Dystrophy.
* On January 20, 2026- Avidity Biosciences Inc . announced a study consists of a Screening Period of up to 6 weeks and 72-week Treatment Period. The anticipated duration is approximately 78 weeks. Participants will be randomized to receive an intravenous infusion of either del-brax or placebo at the clinical study site every 6 weeks for a total of 13 doses. The final dose will occur at Week 72, followed by a final assessment at Week 78. After completion of the Week 78 visit, eligible participants will have the option to enroll into an open label extension (OLE) study, pending regulatory approval. Participants who decline participation in the OLE will be followed for a period of 12 weeks for safety.
* Among the seven major markets, DelveInsight's consultant estimates that the maximum number of cases belong to FSHD1. There were approximately 95% prevalent cases of FSHD1, compared to FSHD2, in 2023.
* The Facioscapulohumeral Muscular Dystrophy gender-specific cases were slightly more in males than females in the United States in 2023. Approximately 70% of the total prevalent FSHD cases fall within the Ricci severity score (4-10).
* The United States accounted for approximately 40% of total Facioscapulohumeral Muscular Dystrophy Prevalence Cases recorded in the seven major markets.
* Based on the age-specific prevalence, it has been shown that the 50 years and above age group had the highest Facioscapulohumeral Muscular Dystrophy Prevalence across the seven major markets.
* Among the EU4 and the UK, Germany recorded the highest number of Facioscapulohumeral Muscular Dystrophy Prevalent Cases in 2023.
* The leading Facioscapulohumeral Muscular Dystrophy Companies such as Fulcrum Therapeutics, GSK, Roche and others.
* Promising Facioscapulohumeral Muscular Dystrophy Therapies such as EPI-321, ATYR1940, RO7204239, Losmapimod oral tablet, AOC 1020, MYO-029 and others.

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Facioscapulohumeral Muscular Dystrophy Epidemiology Segmentation in the 7MM

* Total Prevalent Cases of FSHD
* Total Diagnosed Prevalent Cases of FSHD
* Type-specific Diagnosed Prevalent Cases of FSHD
* Gender-specific Diagnosed Prevalent Cases of FSHD
* Age-specific Diagnosed Prevalent Cases of FSHD
* Severity-specific Diagnosed Prevalent Cases of FSHD
* Total Treated Cases of FSHD

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Facioscapulohumeral Muscular Dystrophy Emerging Drugs

* Losmapimod: Fulcrum Therapeutics/GSK

Losmapimod is an investigational, selective p38/ mitogen-activated protein kinase (MAPK) inhibitor. Utilizing its internal product engine, Fulcrum discovered that inhibition of p38/ reduced expression of the DUX4 gene in muscle cells derived from patients with FSHD. Currently, the molecule is in Phase III trial (NCT05397470) to treat patients with genetically confirmed diagnoses of FSHD 1 or FSHD 2. Fulcrum anticipates reporting top-line data from the REACH Phase III clinical trial assessing losmapimod in FSHD Patients in the fourth quarter of 2024.

* GYM329 (RO7204239/RG 6237): Roche

GYM329 is an investigational anti-myostatin antibody designed to target skeletal muscles, potentially increasing their size and growth. Currently, it is being investigated under Phase II trial in participants with FSHD. Moreover, this trial is expected to be completed May 2025. The company expects to start the regulatory submissions after 2027.

Facioscapulohumeral Muscular Dystrophy Treatment Landscape

The mainstay of management is care directed at the symptomatic impairments to maximize functional abilities and improve patients' QoL. In cases of severe pathology, physical therapy alone may not be enough to correct functional limitations. Assistive devices are, therefore, useful and can be tailored to each patient's specific needs. Foot drop can be partially corrected using ankle-foot orthoses or in combination with knee-ankle-foot orthoses. Surgical scapular fixation might be offered cautiously to selected patients after careful consideration of the overall muscle impairment in the involved arm, assessment of potential gain in the range of motion by manual fixation of the scapula, the patient's rate of disease progression, and the potential adverse consequences of surgery and prolonged postsurgical bracing.

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Facioscapulohumeral Muscular Dystrophy Drugs Uptake and Pipeline Development Activities

The Drug Uptake section offers a detailed analysis of the adoption trends of newly launched and upcoming therapies for facioscapulohumeral muscular dystrophy throughout the study period. It evaluates patient adoption rates, market penetration, and the commercial performance of each therapy, providing a clear understanding of the factors driving or hindering the market acceptance of these treatments. The Therapeutics Assessment further highlights the facioscapulohumeral muscular dystrophy drugs, demonstrating the most rapid uptake. It examines the underlying drivers contributing to their swift adoption and compares the market share of these therapies to identify those gaining significant traction.

Facioscapulohumeral Muscular Dystrophy Market Outlook

The Facioscapulohumeral Muscular Dystrophy Market is poised for steady growth over the forecast period (2024-2034), largely driven by the anticipated entry of novel therapies and increased R&D activities. Key players such as Fulcrum Therapeutics (in collaboration with GSK) and Roche are actively evaluating their lead candidates-losmapimod and RO7204239/GYM-329/RG-6237, respectively-in various stages of clinical development, targeting the underlying mechanisms of FSHD. The market expansion is supported by several factors, including a better understanding of disease biology, improved diagnostics, greater adoption of advanced therapies, and supportive regulatory initiatives. The approval and launch of first-in-class or best-in-class therapies with favorable clinical profiles are expected to significantly enhance patient outcomes and reshape the treatment landscape for FSHD in the coming decade.

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Scope of the Facioscapulohumeral Muscular Dystrophy Market Report

* Coverage- 7MM
* Study Period- 2020-2034
* Facioscapulohumeral Muscular Dystrophy Companies- Fulcrum Therapeutics, GSK, Roche and others.
* Facioscapulohumeral Muscular Dystrophy Therapies such as EPI-321, ATYR1940, RO7204239, Losmapimod oral tablet, AOC 1020, MYO-029 and others.
* Facioscapulohumeral Muscular Dystrophy Therapeutic Assessment: Facioscapulohumeral Muscular Dystrophy currently marketed, and Facioscapulohumeral Muscular Dystrophy emerging therapies.
* Facioscapulohumeral Muscular Dystrophy Market Dynamics: Facioscapulohumeral Muscular Dystrophy market drivers and Facioscapulohumeral Muscular Dystrophy market barriers.
* Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies.
* Facioscapulohumeral Muscular Dystrophy Unmet Needs, KOL's views, Analyst's views, Facioscapulohumeral Muscular Dystrophy Market Access and Reimbursement.

Table of Contents

1. Facioscapulohumeral Muscular Dystrophy Market Report Introduction

2. Executive Summary for Facioscapulohumeral Muscular Dystrophy

3. SWOT analysis of Facioscapulohumeral Muscular Dystrophy

4. Facioscapulohumeral Muscular Dystrophy Patient Share (%) Overview at a Glance

5. Facioscapulohumeral Muscular Dystrophy Market Overview at a Glance

6. Facioscapulohumeral Muscular Dystrophy Disease Background and Overview

7. Facioscapulohumeral Muscular Dystrophy Epidemiology and Patient Population

8. Country-Specific Patient Population of Facioscapulohumeral Muscular Dystrophy

9. Facioscapulohumeral Muscular Dystrophy Current Treatment and Medical Practices

10. Facioscapulohumeral Muscular Dystrophy Unmet Needs

11. Facioscapulohumeral Muscular Dystrophy Emerging Therapies

12. Facioscapulohumeral Muscular Dystrophy Market Outlook

13. Country-Wise Facioscapulohumeral Muscular Dystrophy Market Analysis (2020-2034)

14. Facioscapulohumeral Muscular Dystrophy Market Access and Reimbursement of Therapies

15. Facioscapulohumeral Muscular Dystrophy Market Drivers

16. Facioscapulohumeral Muscular Dystrophy Market Barriers

17. Facioscapulohumeral Muscular Dystrophy Appendix

18. Facioscapulohumeral Muscular Dystrophy Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

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