North America Duchenne muscular dystrophy (DMD) treatment market Size to Reach US$ 8.84 billion by 2033 - Exclusive Report by DataM Intelligence

The North America Duchenne muscular dystrophy (DMD) treatment market was valued at US$ 2.06 billion in 2024 and is projected to reach US$ 8.84 billion by 2033, expanding at a CAGR of 20.2% during the forecast period 2025-2033.

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Market Drivers:
➠ Rising Prevalence of DMD
The growing number of diagnosed cases and improved genetic screening are expanding the patient pool, fueling demand for effective therapies.

➠ Advancements in Gene and Cell Therapies
Breakthroughs in exon-skipping drugs, CRISPR-based research, and gene replacement therapies are accelerating treatment adoption in the region.

➠ Strong Regulatory Framework and Orphan Drug Incentives
U.S. FDA designations such as Fast Track, Breakthrough Therapy, and Orphan Drug status provide pharmaceutical companies with accelerated pathways, encouraging innovation.

➠ High Healthcare Spending and Insurance Coverage
Robust healthcare expenditure, coupled with reimbursement for high-cost therapies, makes North America a favorable market for novel DMD treatments.

➠ Active Research Collaborations and Clinical Trials
Academic institutions, biotech firms, and patient advocacy groups play a key role in driving clinical research and expanding treatment accessibility across the region.

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Market Segments:
By Treatment Type (Exon-Skipping Therapies, Gene Therapies, Corticosteroids, Others)
By Route of Administration (Oral, Intravenous)

Latest clinical / regulatory developments (2025):

✅ Avidity's del-zota (delpacibart zotadirsen) - FDA Breakthrough Therapy designation (July 2025)
Avidity's exon-44-skipping AOC candidate showed statistically significant increases in exon skipping and dystrophin in EXPLORE44 (Phase 1/2); the FDA granted Breakthrough Therapy designation and Avidity is preparing materials for an accelerated approval filing targeted by year-end 2025.

✅ Dyne Therapeutics' DYNE-251 - FDA Breakthrough Therapy designation (Aug 4, 2025)
Dyne announced Breakthrough Therapy designation for DYNE-251 based on encouraging DELIVER study results showing sustained functional improvements.
Mergers, acquisitions, partnerships and financing activity 2025

✅ Novartis reportedly considering acquisition of Avidity (news reports, Aug 6, 2025 - exploratory stage)
Media coverage in Aug 2025 reported that Novartis was weighing a takeover of Avidity (Avidity's del-zota and other muscle-disease programs make it an attractive target); this was reported as preliminary/rumored.

✅ Sarepta ↔ Arrowhead commercial / financing actions (2025)
Sarepta and Arrowhead have had major commercial/strategic transactions in the past year (large licensing/milestone deals and Sarepta's later sales of Arrowhead stake to shore up cash were reported in 2025). These moves affect balance sheets and strategic focus for companies operating in the DMD / RNA therapeutics space.

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Product launches / near-launch candidates & regulatory plans (2025):

✅ Del-zota (Avidity) - on track for regulatory filing / potential U.S. launch (BLA materials planned for submission by end-2025)
Breakthrough designation and positive EXPLORE44 data put del-zota in the "near-launch" category if FDA accelerated approval pathways progress favorably.

✅ DYNE-251 (Dyne Therapeutics) - Breakthrough designation (accelerated development path)
Breakthrough designation moves DYNE-251 into a prioritized regulatory pathway; not yet an approved launch but a candidate with potentially accelerated review.

✅ Elevidys (Sarepta) - previously approved gene therapy but regulatory status in flux in 2025
Elevidys remains the only gene therapy previously approved for some DMD patients; however, 2025 brought intense regulatory and safety scrutiny that affected availability and commercialization plans. (Not a 2025 new launch, but a major market product whose availability changed in 2025).

Market Key Players:
Key players are Sarepta Therapeutics, Inc., ITF Therapeutics LLC, NS Pharma, Inc., Catalyst Pharmaceuticals, Inc., and PTC Therapeutics. Emerging players in the market include F. Hoffmann-La Roche Ltd, Capricor Therapeutics, Inc., REGENXBIO Inc., Solid Biosciences Inc., Wave Life Sciences and Genethon.

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