Hunter Syndrome Treatment Market is expected to reach US$ 1,417.79million by 2033 | Major Companies - Takeda Pharmaceuticals U.S.A., Inc., GC Biopharma, Denali Therapeutics.

Market Size and Growth:

The Global Hunter Syndrome Treatment Market size reached US$ 747.06 million in 2024 and is expected to reach US$ 1,417.79million by 2033, growing at a CAGR of 7.5% during the forecast period 2025-2033.

The Hunter Syndrome Treatment Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving global market.

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The Hunter Syndrome Treatment Market refers to the global industry focused on developing, manufacturing, and commercializing therapies for Hunter syndrome (MPS II), a rare genetic lysosomal storage disorder. It includes enzyme replacement therapies, gene therapies, supportive care solutions, and diagnostic services aimed at managing symptoms, slowing disease progression, and improving patient quality of life.

Recent Key Developments of United States:

✅ December 2025: Positive Phase 1/2 trial data for tividenofusp alfa (DNL310), a brain‐penetrant enzyme replacement therapy, were published in a leading medical journal, showing substantial reductions in central nervous system and peripheral biomarkers in MPS II patients and supporting its potential as a whole‐body treatment.​

✅ December 2025: A synthetic royalty funding agreement of about US$275 million was announced to support development and potential commercialization of the Hunter syndrome drug tividenofusp alfa in the US and other markets, signaling strong late‐stage investment in this asset.​

✅ December 2025: Additional Phase 1/2 results for tividenofusp alfa in Hunter syndrome were reported, reinforcing earlier findings that the therapy can cross the blood-brain barrier and normalize heparan sulfate levels in cerebrospinal fluid and urine to ranges seen in unaffected children.​

Recent Key Developments of Europe:

✅ November 2025: An updated interventional gene‐therapy study for MPS II (RGX‐121‐3102) in Europe and other regions was listed/updated in the EU clinical trials register, evaluating intracisternal administration of RGX‐121 to deliver a functional IDS gene to the central nervous system of Hunter syndrome patients.

✅ November 2025: A boy treated with a world‐first gene therapy for Hunter syndrome in Europe was reported to show marked clinical improvement, illustrating early real‐world impact of experimental CNS‐targeted gene therapy approaches in this indication.

✅ October 2025: A UK‐based clinical trial of next‐generation stem‐cell gene therapy for severe Hunter syndrome was approved, using autologous hematopoietic stem cells modified with a lentiviral vector carrying an IDS gene construct designed to cross the blood-brain barrier.

List of the Key Players in the Hunter Syndrome Treatment Market:

Takeda Pharmaceuticals U.S.A., Inc.
GC Biopharma
CANbridge Life Sciences Ltd
JCR Pharmaceuticals Co., Ltd.
REGENXBIO Inc.
Denali Therapeutics
Avrobio, Inc.
Inventiva.

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This Report Covers:

✔ Go-to-market Strategy.

✔ Neutral perspective on the market performance.

✔Development trends, competitive landscape analysis, supply side analysis, demand side analysis, year-on-year growth, competitive benchmarking, vendor identification, and other significant analysis, as well as development status.

✔Customized regional/country reports as per request and country level analysis.

✔ Potential & niche segments and regions exhibiting promising growth covered.

✔ Analysis of Market Size (historical and forecast), Total Addressable Market (TAM), Serviceable Available Market (SAM), Serviceable Obtainable Market (SOM), Market Growth, Technological Trends, Market Share, Market Dynamics, Competitive Landscape and Major Players (Innovators, Start-ups, Laggard, and Pioneer).

Segments Covered in the Hunter Syndrome Treatment Market:

By Drug: idursulfase, IZCARGO, Hunterase ICV, Others.

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Hunter Syndrome Treatment market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Hunter Syndrome Treatment Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The Global Hunter Syndrome Treatment market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Hunter Syndrome Treatment Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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