Hunter Syndrome Therapeutics Market Size in the 7MM is expected to grow by 2034, estimated DelveInsight

DelveInsight's "Hunter Syndrome Market Insight, Epidemiology, and Market Forecast - 2034" report delivers an in-depth analysis of Hunter Syndrome epidemiology, market, and clinical development in Hunter Syndrome. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the hunter syndrome market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Key Takeaways from the Hunter Syndrome Market Report

* The total number of Hunter Syndrome Diagnosed Prevalent Cases in the 7MM was nearly 1,200 cases in 2023 and is projected to increase during the forecasted period.
* The total number of Hunter Syndrome Diagnosed Prevalent Cases in EU4 and the UK for hunter syndrome was estimated to be nearly 350 cases in 2023. Germany had the highest prevalent cases followed by the UK.
* MPS II typically affects only males, with symptoms becoming apparent at approximately 2-4 years of age.
* It is estimated that about two-third of MPS II patients develop cognitive impairment with onset of symptoms between 1 to 3 years of age in the neuronopathic form.
* Patients with MPS II are often classified as severe MPS II or mild MPS II. Severe form accounts for 65-70% of the cases. However, it slightly varies from country to country.
* The leading Hunter Syndrome Companies such as Homology Medicine, Denali Therapeutics, Regenxbio, Takeda, JCR Pharmaceuticals, GC Pharma, Regenxbio, Sangamo Therapeutics, ArmaGen , and others
* Promising Hunter Syndrome Therapies such as HMI-203, DNL310, RGX-121, SHP-609/ TAK-60 , and others

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Hunter Syndrome Epidemiology

* Total Hunter Syndrome Diagnosed Prevalent Cases
* Hunter Syndrome Severity-specific Cases

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Hunter Syndrome Marketed Drugs

* ELAPRASE (idursulfase): Takeda Pharmaceuticals

ELAPRASE is the first enzyme replacement therapy to be approved for people suffering from Hunter syndrome and it was launched in the US in July 2006 and in 2007 in the EU and Japan. ELAPRASE has been shown to improve walking capacity in patients 5 years and older. In patients 16 months to 5 years of age, no data are available to demonstrate improvement in disease-related symptoms or long term clinical outcome; however, treatment with ELAPRASE has reduced spleen volume similarly to that of adults and children 5 years of age and older. The safety and efficacy of ELAPRASE have not been established in pediatric patients less than 16 months of age.

* IZCARGO: JCR Pharmaceuticals

IZCARGO is the world's first biological drug applied with the brain drug delivery technology J-Brain Cargo., which utilizes the transferrin receptor-mediated Fe/transferrin transport to the brain and was launched in Japan to treat patients with all forms of MPS II. In March 2021, JCR received approval in Japan for IZCARGO (10 mL, intravenous drip infusion), the first enzyme replacement therapy capable of crossing the blood-brain barrier. Sales of IZCARGO increased more than 10% year-on-year and progressing well. The revenue reached from JPY 1,070 million in Q1 2022 to JPY 1,372 in Q1 2024.

Hunter Syndrome Emerging Drugs

* Tividenofusp alfa (DNL310): Denali Therapeutics

Tividenofusp alfa (DNL310) is a fusion protein composed of IDS fused to Denali's proprietary Enzyme Transport Vehicle (ETV), which is engineered to cross the BBB via receptor-mediated transcytosis into the brain and to enable broad delivery of IDS into cells and tissues throughout the body with the goal of addressing the behavioral, cognitive, and physical manifestations of MPS II. In March 2021, the US Food and Drug Administration granted Fast Track Designation to DNL310 for the treatment of patients with MPS II. In May 2022, the European Medicines Agency granted DNL310 Priority Medicines designation.

* RGX-121: Regenxbio

RGX121 is an investigational adeno-associated Virus (AAV) therapeutic for the treatment of MPS II. RGX121 is designed to use the NAV AAV9 vector to deliver the human IDS gene to cells in the Central Nervous System (CNS). RGX-121 is the only product in late-stage development with the potential to address neurocognitive development in patients diagnosed under the age of 2 years. In May 2023, RGX-121 received Regenerative Medicine Advanced Therapy (RMAT) designation. Moreover, the drug has also received Orphan Drug Designation (ODD, 2015), Rare Pediatric Drug Designation (RPDD, 2016), and Fast Track Drug Designation (FTD, 2018) from the US FDA. In October 2017, the EMA granted ODD to REGENXBIO for recombinant adeno-associated viral vector serotype 9 containing the human IDS gene.

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Hunter Syndrome Market Outlook

The Hunter Syndrome Market is mainly dominated by ERT, along with a few major emerging products in the pipeline that are also based on the same principle of iduronate 2-sulfatase (I2S) ERT. The only approved therapy with idursulfase is ELAPRASE. However, one of the major drawbacks of ELAPRASE is its inability to cross the blood-brain barrier (BBB), which affects the product's efficacy.

Hunter Syndrome Treatment Market

The current Hunter syndrome treatment involves patients receiving infusion of the IDS enzyme, usually once a week. These infusions can help break down the accumulated glycosaminoglycans and can help alleviate symptoms and slow disease progression. However, the enzyme does not cross the blood-brain barrier, so the treatment does not help with cognitive or developmental symptoms.

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Scope of the Hunter Syndrome Market Report

* Coverage- 7MM
* Study Period- 2020-2034
* Hunter Syndrome Companies- Homology Medicine, Denali Therapeutics, Regenxbio, Takeda, JCR Pharmaceuticals, GC Pharma, Regenxbio, Sangamo Therapeutics, ArmaGen, and others
* Hunter Syndrome Therapies- HMI-203, DNL310, RGX-121, SHP-609/ TAK-60, and others
* Hunter Syndrome Market Dynamics: Hunter Syndrome Market Drivers and Barriers
* Hunter Syndrome Market Access and Reimbursement, Unmet Needs and Future Perspectives

Table of Content

1. Key Insights

2. Hunter Syndrome Market Overview at a Glance

3. Hunter Syndrome Market Disease Background and Overview: Hunter Syndrome

4. Diagnostic Algorithm for Hunter Syndrome

5. Hunter Syndrome Epidemiology and Patient Population

6. Country-Wise Epidemiology of Hunter Syndrome

7. Hunter Syndrome Treatment

8. Recognized Establishments

9. Hunter Syndrome Unmet Needs

10. Hunter Syndrome Marketed Profile

11. Hunter Syndrome: 7 Major Market Analysis

12. Hunter Syndrome KOL Reviews

13. Case Reports

14. Hunter Syndrome Market Drivers

15. Hunter Syndrome Market Barriers

16. SWOT Analysis

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About Us

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