Hunter Syndrome Market

Market Overview:

The 7 major Hunter syndrome markets reached a value of US$ 702.2 Million in 2023. Looking forward, IMARC Group expects the 7MM to reach US$ 1,152.5 Million by 2034, exhibiting a growth rate (CAGR) of 4.61% during 2024-2034.

The Hunter syndrome market has been comprehensively analyzed in IMARC's new report titled "Hunter Syndrome Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Hunter syndrome refers to a rare genetic disorder that affects the body's ability to break down and recycle certain complex sugars called glycosaminoglycans (GAGs). It is identified as an X-linked recessive disorder and occurs predominantly in males. Hunter syndrome is mainly caused by a deficiency in iduronate-2-sulfatase (I2S) enzyme, resulting in the accumulation of GAGs in cells and tissues throughout the body. The indications of this ailment vary in severity and primarily include stiff joints, thickening of facial features, delayed appearance of teeth, a larger than normal head, a broad chest, a short neck, hearing loss, wide spaces between teeth, an enlarged spleen and liver, delayed growth, white deposits on the skin, etc. The diagnosis of Hunter syndrome is typically based on a combination of the patient's underlying symptoms, medical history, and physical examination. A blood workup that measures the activity of the enzyme I2S is also recommended to validate a diagnosis. The healthcare provider may further perform various diagnostic tests and procedures, such as urine analysis, genetic testing, X-rays, etc., to determine the exact cause of the indications and rule out other health conditions among patients.

The rising incidences of genetic disorders on account of gene abnormalities, DNA changes, and chromosomal damage are primarily driving the Hunter syndrome market. Furthermore, the growing male population, who are more susceptible to single X chromosome gene alteration, is also augmenting the market growth. Apart from this, the widespread adoption of enzyme replacement therapy with idursulfase, that aims to replace the deficient lysosomal enzyme, thereby reducing the GAGs concentration in the body and providing symptom relief, is further creating a positive outlook for the market. Additionally, the inflating application of prenatal diagnostic techniques, including amniotic fluid and chorionic villus sampling, since they can identify the gene mutation and provide early disease detection in the fetus, is also propelling the market growth. Moreover, the emerging popularity of developmental and occupational therapy to support the management of the underlying symptoms as well as improve social skills and cognitive abilities in patients is acting as another significant growth-inducing factor. Besides this, the increasing utilization of gene editing therapy for correcting faulty gene mutations, restoring the function of the IDS enzyme, and slowing the progression of the illness is expected to drive the Hunter syndrome market in the coming years. 

IMARC Group's new report provides an exhaustive analysis of the Hunter syndrome market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for Hunter syndrome and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the Hunter syndrome market in any manner.

Recent Developments:

• In February 2024, REGENXBIO Inc. reported topline results from the Phase I/II/III CAMPSIITE trial study of RGX-121 for the management of patients up to 5 years old suffering from Mucopolysaccharidosis Type II (MPS II), also called Hunter syndrome, demonstrating that the pivotal phase of the clinical trial met its primary endpoint with statistical significance.
• In August 2023, Denali Therapeutics Inc. released additional interim data from its ongoing open-label, single-arm Phase 1/2 study of DNL310 in children with Hunter syndrome. The interim Phase 1/2 results comprised new biomarker and safety data from additional patients receiving up to two years of DNL310 treatment, as well as previously published clinical outcomes data for participants receiving one year of treatment.

Key Highlights:

• Hunter syndrome is one of the most frequent MPS, accounting for one in every 170,000 male live births.
• This condition affects only males.
• A few uncommon occurrences have been recorded in carrier females as a result of chromosomal rearrangement or inactivation of the typical X-chromosome-expressing gene.
• It affects roughly 500 boys in the United States and less than 2,000 worldwide.
• Research in the United Kingdom found a frequency among men of approximately one in 130,000 male live births.

Drugs:

ELAPRASE (idursulfase) is a prescription drug for Hunter syndrome (Mucopolysaccharidosis II, MPS II) that was approved by the FDA in 2006. ELAPRASE is classified as enzyme replacement therapy since it contains a formulation of the enzyme iduronate-2-sulfatase (I2S), which is absent or impaired in persons with Hunter syndrome. ELAPRASE is a purified version of the I2S enzyme created using recombinant DNA technology in a human cell line.

DNL310 is an investigational iduronate-2-sulfatase (IDS) fusion protein designed to cure both the cognitive and physical symptoms of MPS II with a weekly IV infusion. DNL310 Phase 1/2 interim data indicate that biochemical correction restores cellular and neural health, perhaps leading to better clinical outcomes.

RGX-121 is an investigational, one-time gene treatment that uses the NAV AAV9 vector to deliver the IDS, which encodes the iduronate-2-sulfatase enzyme. The RGX-121 produced protein is structurally identical to normal I2S. RGX-121 is delivered to the central nervous system via intracisternal or intracerebroventricular routes.

Time Period of the Study

• Base Year: 2023
• Historical Period: 2018-2023
• Market Forecast: 2024-2034

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
   

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the Hunter syndrome market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the Hunter syndrome market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current Hunter syndrome marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance
   

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the Hunter syndrome market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
• What was the country-wise size of the Hunter syndrome market across the seven major markets in 2023 and what will it look like in 2034?
• What is the growth rate of the Hunter syndrome market across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?
   

Epidemiology Insights

• What is the number of prevalent cases (2018-2034) of Hunter syndrome across the seven major markets?
• What is the number of prevalent cases (2018-2034) of Hunter syndrome by age across the seven major markets?
• What is the number of prevalent cases (2018-2034) of Hunter syndrome by gender across the seven major markets?
• How many patients are diagnosed (2018-2034) with Hunter syndrome across the seven major markets?
• What is the size of the Hunter syndrome patient pool (2018-2023) across the seven major markets?
• What would be the forecasted patient pool (2024-2034) across the seven major markets?
• What are the key factors driving the epidemiological trend of Hunter syndrome?
• What will be the growth rate of patients across the seven major markets?
   

Hunter Syndrome: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for Hunter syndrome drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the Hunter syndrome market?
• What are the key regulatory events related to the Hunter syndrome market?
• What is the structure of clinical trial landscape by status related to the Hunter syndrome market?
• What is the structure of clinical trial landscape by phase related to the Hunter syndrome market?
• What is the structure of clinical trial landscape by route of administration related to the Hunter syndrome market?