DelveInsight’s “Hunter Syndrome Market Insights, Epidemiology, and Market Forecast 2032” report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the Hunter Syndrome market size, share, trends, and growth opportunities in the seven major markets (7MM) (i.e., the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom and Japan).
The report covers emerging Hunter Syndrome drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2019 to 2032. It also evaluates the current Hunter Syndrome treatment practice/algorithm, key drivers & barriers impacting the market growth, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Hunter Syndrome: An Overview
Hunter syndrome, also known as mucopolysaccharidosis type II (MPS II), is a condition that affects many different parts of the body and mainly affects males. It is a progressive disorder, but the rate of progression varies among affected individuals.
In patients with mucopolysaccharidosis II, glycosaminoglycan’s accumulate within tissues and organs, contributing to the signs and symptoms of the disease. Mucopolysaccharidosis II affects multiple organs and physiologic systems and has a variable age of onset and variable rate of progression. Common presenting features include excess urinary glycosaminoglycan excretion, facial dysmorphism, organomegaly, joint stiffness and contractures, pulmonary dysfunction, myocardial enlargement and valvular dysfunction, and neurologic involvement. In patients with neurologic involvement, intelligence is impaired, and death usually occurs in the second decade of life, whereas those patients with minimal or no neurologic involvement may survive into adulthood with normal intellectual development.
There are two types of MPS II, called severe and mild types. While both types affect many different organs and tissues, people with severe MPS II also experience a decline in intellectual function and a more rapid disease progression. Individuals with severe form begin to lose basic functional skills (developmentally regress) between the ages of 6 and 8. The life expectancy of these individuals is 10–20 years. Individuals with mild MPS II also have a shortened lifespan, but they typically live into adulthood, and their intelligence is not affected. Heart disease and airway obstruction are major causes of death in people with both types of MPS II.
Hunter Syndrome Market Key Facts
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The Hunter Syndrome Market is expected to strengthen as awareness of the disease increases and more effective interventions are being developed.
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As per the National Institute of Health, MPS II is a progressively debilitating disorder that primarily affects males, affecting different parts of the body. MPS II occurs in approximately 1 in 100,000–1 in 170,000 males in a population. Similar findings have been quoted by the National MPS Society and the National Organization for Rare Disorders.
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Bradley et al. conducted a pilot systematic evidence review to establish methodology utility in rare genetic diseases. They found that with context to Hunter Syndrome, affected individuals are almost always male, whereas females are the symptomatic carriers. MPS II has been recognized in 0.3–1.3 per 100,000 live-born males as mainly white populations.
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As per DelveInsight’s estimates, the total diagnosed prevalent population of Hunter Syndrome in the 7MM was around 1,200 cases in 2022. In the case of Hunter Syndrome patients in the United States, the diagnosed prevalent cases were found to be around 500 cases in 2022, which are expected to rise during the study period 2019–2032.
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As per DelveInsight in EU4 and the UK, the diagnosed prevalence of Hunter Syndrome was maximum in Germany with around 80 cases, followed by the United Kingdom. While, the least number of cases were found in Spain, in 2022.
The market outlook section of the report helps to build a detailed comprehension of the historical, current, and forecasted market size by analyzing the impact of current and emerging Hunter Syndrome pipeline therapies. It also thoroughly assesses the Hunter Syndrome market drivers & barriers, unmet needs, and emerging technologies set to impact the market dynamics.
The report gives complete details of the market trend for each marketed Hunter Syndrome drug and mid & late-stage pipeline therapies by evaluating their impact based on the annual cost of therapy, their Mechanism of Action (MOA), Route of Administration (ROA), molecule types, competition with other therapies, brand value, and their impact on the market.
Hunter Syndrome Epidemiology Assessment
The epidemiology section provides insights into the historical, current, and forecasted Hunter Syndrome epidemiology trends in the seven major countries (7MM) from 2019 to 2032. It helps to recognize the causes of current and forecasted Hunter Syndrome epidemiology trends by exploring numerous studies and research. The epidemiology section also provides a detailed analysis of diagnosed and prevalent patient pools, future trends, and views of key opinion leaders.
The Report Covers the Hunter Syndrome Epidemiology, Segmented as –
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Total Diagnosed Prevalent Population of Hunter Syndrome
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Severity-based Diagnosed Prevalent Population of Hunter Syndrome
Hunter Syndrome Drugs Uptake and Pipeline Development Activities
The drug uptake section focuses on the uptake rate of potential drugs recently launched in the Hunter Syndrome market or expected to be launched during the study period. The analysis covers the Hunter Syndrome market uptake by drugs, patient uptake by therapies, and sales of each drug. Moreover, the therapeutics assessment section helps understand the market dynamics by drug sales, the most rapid drug uptake, and the reasons behind the maximal use of particular drugs. Additionally, it compares the Hunter Syndrome drugs based on their sale and market share.
The report also covers the Hunter Syndrome pipeline development activities. It provides valuable insights about different therapeutic candidates in various stages and the key Hunter Syndrome companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
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Clinical, Commercial, and Regulatory Developments in the Hunter Syndrome Therapeutics Market
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In August 2023, Denali Therapeutics announced new, additional positive interim data from the Phase I/II study of DNL310 in children with Hunter syndrome.
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In May 2023, REGENXBIO received FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RGX-121 gene therapy for hunter syndrome.
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In April 2023, JCR Pharmaceuticals and Sumitomo Pharma entered into a co-promotion agreement for IZCARGO in Japan.
Hunter Syndrome Therapeutics Analysis
Treatments aimed at providing replacement of I2S in Hunter syndrome have been reported, including fibroblast transplantation, serum or plasma infusion, white blood cell infusions, and human amnion membrane implantation. These treatments have been tested in single patients or in small series of patients, and no evidence of clinical benefit has been reported. Other methods include hematopoietic stem cel transplantation (HSCT) and enzyme-replacement therapy (ERT) with recombinant human I2S. Only recombinant human I2S has been tested in randomized clinical trials.
There is only one FDA-approved drug used for treating patients with Hunter Syndrome, namely, ELAPRASE (idursulfase), which was essentially developed by Shire, which was later acquired by Takeda. Moreover, in January 2021, GC Pharma received Japan manufacturing and marketing approval for HUNTERASE ICV (intracerebroventricular) Injection 15 mg (generic name: idursulfase-beta (recombinant)) as a treatment for Hunter syndrome and is also the world’s first and only drug for the treatment of central nervous system symptoms of mucopolysaccharidosis type II. JCR Pharmaceuticals’ IZCARGO (pabinafusp Alfa) is another therapy approved for Hunter Syndrome in Japan.
Several major pharma and biotech companies are developing therapies for Hunter Syndrome. Currently, Denali Therapeutics is leading the therapeutics market with its Hunter Syndrome drug candidates in the most advanced stage of clinical development.
Hunter Syndrome Companies Actively Working in the Therapeutics Market Include
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AVROBIO
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Capsida Biotherapeutics
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GENERIUM Pharmaceuticals
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Denali Therapeutics
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REGENXBIO
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ArmaGen Technologies
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Homology Medicines
And Many Others
Emerging and Marketed Hunter Syndrome Therapies Covered in the Report Include:
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DNL310: Denali Therapeutics Inc
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RGX-121: Regenxbio Inc.
And Many More
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Table of Content (TOC)
1. Key Insights
2. Executive Summary
3. Hunter Syndrome Competitive Intelligence Analysis
4. Hunter Syndrome Market Overview at a Glance
5. Hunter Syndrome Disease Background and Overview
6. Hunter Syndrome Patient Journey
7. Hunter Syndrome Patient Population and Epidemiology Trends (In the US, EU5, and Japan)
8. Hunter Syndrome Treatment Algorithm, Current Treatment, and Medical Practices
9. Hunter Syndrome Unmet Needs
10. Key Endpoints of Hunter Syndrome Treatment
11. Hunter Syndrome Marketed Therapies
12. Hunter Syndrome Emerging Drugs and Latest Therapeutic Advances
13. Hunter Syndrome Seven Major Market Analysis
14. Attribute Analysis
15. Hunter Syndrome Market Outlook (In US, EU5, and Japan)
16. Hunter Syndrome Companies Active in the Market
17. Hunter Syndrome Access and Reimbursement Overview
18. KOL Views on the Hunter Syndrome Market
19. Hunter Syndrome Market Drivers
20. Hunter Syndrome Market Barriers
21. Appendix
22. DelveInsight Capabilities
23. Disclaimer
*The Table of Contents (TOC) is not exhaustive; the final content may vary. Refer to the sample report for the complete table of contents.
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About DelveInsight
DelveInsight is a leading 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.
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