Duchenne Muscular Dystrophy Market Report 2034: Epidemiology, Pipeline Therapies, and Recent Regulatory Approvals by DelveInsight | Featuring Sarepta Therapeutics, PTC Therapeutics, Nippon Shinyaku, S

The Duchenne Muscular Dystrophy market size in the 7MM was around USD 2,150 million in 2023. The market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, the expected market launch of one-time gene therapies, and raised awareness.
DelveInsight's report, "Duchenne Muscular Dystrophy Market Insights, Epidemiology, and Market Forecast-2034," provides a comprehensive analysis of Duchenne Muscular Dystrophy (DMD). It covers historical and projected epidemiology, as well as market trends across key regions, including the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.

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Some of the key facts of the Duchenne Muscular Dystrophy Market Report:

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The Duchenne Muscular Dystrophy (DMD) market is projected to experience significant growth at a robust CAGR during the forecast period of 2020-2034.

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On November 6, 2024, Cumberland Pharmaceuticals Inc. announced that the U.S. FDA granted Ifetroban both Orphan Drug Designation and Rare Pediatric Disease Designation for treating cardiomyopathy associated with DMD. The company is conducting the FIGHT DMD Trademark trial, a Phase II multicenter, double-blind, placebo-controlled study evaluating the pharmacokinetics, safety, and efficacy of once-daily oral Ifetroban in DMD patients, with results expected later this year.

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In November 2024, Genethon, a leading gene therapy research organization founded by AFM-Telethon, reported promising outcomes from the Phase 1/2 dose-escalation portion of its international Phase 1/2/3 trial for GNT0004, a gene therapy for DMD. These results were presented at the ASGCT Breakthroughs in Muscular Dystrophy conference in Chicago on November 19-20, 2024. Building on this success, Genethon plans to initiate pivotal trials in Europe in Q2 2025, followed by the U.S. shortly thereafter.

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In September 2024, Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage biotech company developing transformative therapies for genetically driven muscle disorders, announced positive findings from its ongoing Phase 1/2 DELIVER trial. The study, investigating DYNE-251 in DMD patients eligible for exon 51 skipping, demonstrated increased dystrophin expression and functional improvements across multiple patient cohorts.

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The DMD market in the seven major markets (7MM) was valued at approximately USD 2,150 million in 2023. Market growth is expected to accelerate due to wider adoption of existing therapies, the anticipated launch of one-time gene therapies, and increased disease awareness.

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Key therapeutic strategies for DMD include gene replacement or other mutation-specific genetic therapies to restore dystrophin production, membrane stabilization and upregulation of compensatory proteins, as well as approaches to reduce inflammation and enhance muscle regeneration.

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Currently approved DMD treatments in the U.S. include EMFLAZA (deflazacort), VYONDYS 53 (golodirsen), EXONDYS 51 (eteplirsen), AMONDYS 45 (casimersen), VILTEPSO (viltolarsen), and ELEVIDYS (delandistrogene moxeparvovec). In January 2024, Santhera Pharmaceuticals launched AGAMREE (vamorolone) in Germany for DMD patients aged four and above, marking its entry into the commercial biopharma space. ELEVIDYS, the first FDA-approved gene therapy for DMD, received accelerated approval in June 2023, though Sarepta's therapy faces scrutiny from ICER over surrogate endpoints, potentially delaying full approval.

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In the EU4 and the UK, steroid therapies remain standard of care, complemented by TRANSLARNA (ataluren) for patients with nonsense mutations. In Japan, VILTEPSO (viltolarsen) is the sole approved therapy.

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Emerging therapies from companies including Santhera Pharmaceuticals/ReveraGen BioPharma (Vamorolone), Taiho Pharmaceutical (TAS-205), FibroGen (Pamrevlumab), Capricor (CAP-1002), Italfarmaco (Givinostat), Antisense Therapeutics (ATL1102), and Sarepta Therapeutics (SRP-5051) are expected to significantly expand the market. Coupled with rising DMD prevalence, these treatments will likely drive growth in the U.S., followed by the EU4, UK, and Japan.

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In 2023, the U.S. had the highest prevalence of DMD, with around 17,200 cases. Within the EU4 and UK, the UK reported the most cases, while Spain had the fewest. In the U.S., the 5-9-year age group represented the largest share of cases in 2023, followed by the 10-14-year cohort. Most individuals with DMD are non-ambulatory.

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Key Companies in DMD: Sarepta Therapeutics, PTC Therapeutics, Nippon Shinyaku, Santhera Pharmaceuticals/ReveraGen BioPharma, Taiho Pharmaceutical, FibroGen, Capricor, Daiichi Sankyo, Italfarmaco, Antisense Therapeutics, Solid Biosciences, among others.

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Key Therapies: ITF2357 (givinostat), VYONDYS 53, ELEVIDYS (delandistrogene moxeparvovec), and more.

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The DMD market is poised for substantial growth due to increasing disease prevalence, heightened awareness, and the launch of multiple pipeline therapies, which are expected to transform the market landscape during the forecast period.

Duchenne Muscular Dystrophy Overview

Duchenne Muscular Dystrophy (DMD) is the most prevalent form of muscular dystrophy in children, marked by progressive muscle weakness and degeneration. This genetic disorder arises from the absence of dystrophin, a protein critical for maintaining the structural integrity of muscle cells. Symptoms usually appear between ages 3 and 5, predominantly in boys, although rare cases have been observed in girls.

Genetic testing for DMD mutations using a blood sample is essential, even when a muscle biopsy initially confirms the absence of dystrophin protein. The results of genetic testing play a key role in clinical decision-making, including genetic counseling, prenatal diagnosis, and the evaluation of mutation-specific therapeutic options.

The Duchenne Muscular Dystrophy report provides an in-depth analysis of the disease, covering its pathophysiology, diagnostic approaches, and comprehensive treatment strategies. It also illustrates a real-world patient journey, tracing the progression from initial symptom onset to diagnosis and the full course of treatment.

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Duchenne Muscular Dystrophy Epidemiology

The epidemiology section offers an analysis of past, present, and projected trends in the seven major markets (7MM) from 2020 to 2034. It highlights the factors driving these trends by examining multiple studies and insights from key opinion leaders. Additionally, this section provides a detailed assessment of the diagnosed patient population and anticipated future developments.

Duchenne Muscular Dystrophy Epidemiology Segmentation:

The Duchenne Muscular Dystrophy market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Diagnosed Prevalence of Duchenne Muscular Dystrophy in Adults

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Diagnosed Prevalence of Duchenne Muscular Dystrophy in Pediatrics

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Diagnosed Prevalence of Duchenne Muscular Dystrophy by Types

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Diagnosed Prevalence of Duchenne Muscular Dystrophy by Location

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Diagnosed Prevalence of Duchenne Muscular Dystrophy by Severity

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Duchenne Muscular Dystrophy Marketed Drugs

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ELEVIDYS (delandistrogene moxeparvovec): Sarepta Therapeutics

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VYONDYS 53: Sarepta Therapeutics

Duchenne Muscular Dystrophy Emerging Drugs

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ITF2357 (givinostat): Italfarmaco

Duchenne Muscular Dystrophy Therapies: ITF2357 (givinostat), VYONDYS 53, ELEVIDYS (delandistrogene moxeparvovec), and others

Duchenne Muscular Dystrophy Key Companies: Sarepta Therapeutics, PTC Therapeutics, Nippon Shinyaku, Santhera Pharmaceuticals/ReveraGen BioPharma, Taiho Pharmaceutical, FibroGen, Capricor, Daiichi Sankyo, Italfarmaco, Antisense Therapeutics, Solid Biosciences, and others

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Duchenne Muscular Dystrophy Market Outlook

Medical management of Duchenne Muscular Dystrophy (DMD) involves a comprehensive approach, including cardiac and respiratory care, nutrition, exercise, bracing, and spinal management. Current treatment strategies combine standard care with emerging therapies such as gene and cell-based interventions, membrane stabilization, upregulation of cytoskeletal proteins, and modulation of secondary pathways. Supportive care and psychosocial management are also key components of patient care.

In the EU4 and the UK, steroid therapies are the mainstay, supplemented by TRANSLARNA (ataluren) for patients with nonsense mutations. In Japan, VILTEPSO (viltolarsen) remains the only approved therapy.

Sarepta Therapeutics currently leads the market with three approved treatments and two pipeline candidates, though competition is intensifying from companies like Pfizer, AbbVie, and Italfarmaco. Regulatory approval processes differ across the seven major markets (7MM), with variations reflecting differing standards among agencies such as the EMA and FDA.

Scope of the Duchenne Muscular Dystrophy Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Duchenne Muscular Dystrophy Companies: Sarepta Therapeutics, PTC Therapeutics, Nippon Shinyaku, Santhera Pharmaceuticals/ReveraGen BioPharma, Taiho Pharmaceutical, FibroGen, Capricor, Daiichi Sankyo, Italfarmaco, Antisense Therapeutics, Solid Biosciences, and others

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Key Duchenne Muscular Dystrophy Therapies: ITF2357 (givinostat), VYONDYS 53, ELEVIDYS (delandistrogene moxeparvovec), and others

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Duchenne Muscular Dystrophy Therapeutic Assessment: Duchenne Muscular Dystrophy current marketed and Duchenne Muscular Dystrophy emerging therapies

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Duchenne Muscular Dystrophy Market Dynamics: Duchenne Muscular Dystrophy market drivers and Duchenne Muscular Dystrophy market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Duchenne Muscular Dystrophy Unmet Needs, KOL's views, Analyst's views, Duchenne Muscular Dystrophy Market Access and Reimbursement

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Table of Contents

1. Duchenne Muscular Dystrophy Market Report Introduction

2. Executive Summary for Duchenne Muscular Dystrophy

3. SWOT analysis of Duchenne Muscular Dystrophy

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

5. Duchenne Muscular Dystrophy Market Overview at a Glance

6. Duchenne Muscular Dystrophy Disease Background and Overview

7. Duchenne Muscular Dystrophy Epidemiology and Patient Population

8. Country-Specific Patient Population of Duchenne Muscular Dystrophy

9. Duchenne Muscular Dystrophy Current Treatment and Medical Practices

10. Duchenne Muscular Dystrophy Unmet Needs

11. Duchenne Muscular Dystrophy Emerging Therapies

12. Duchenne Muscular Dystrophy Market Outlook

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

14. Duchenne Muscular Dystrophy Market Access and Reimbursement of Therapies

15. Duchenne Muscular Dystrophy Market Drivers

16. Duchenne Muscular Dystrophy Market Barriers

17. Duchenne Muscular Dystrophy Appendix

18. Duchenne Muscular Dystrophy Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

Related Reports:

Duchenne Muscular Dystrophy Pipeline

"Duchenne Muscular Dystrophy Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Duchenne Muscular Dystrophy market. A detailed picture of the Duchenne Muscular Dystrophy pipeline landscape is provided, which includes the disease overview and Duchenne Muscular Dystrophy treatment guidelines.

Duchenne Muscular Dystrophy Epidemiology

DelveInsight's 'Duchenne Muscular Dystrophy Epidemiology Forecast to 2034' report delivers an in-depth understanding of the disease, historical and forecasted Duchenne Muscular Dystrophy epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

About DelveInsight

DelveInsight is a leading Healthcare 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.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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