Hunter Syndrome Market

Key Highlights

• As per 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 National Organization for Rare Disorders.

• The Hunter syndrome epidemiology covered in the report provides historical as well as forecasted Hunter syndrome epidemiology [segmented as Total Diagnosed Prevalent Population of Hunter Syndrome, and Severity-based Diagnosed Prevalent Population of Hunter Syndrome] in the 7MM covering the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

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DelveInsight’s “Hunter Syndrome – Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of the Hunter syndrome, historical and forecasted epidemiology as well as the Hunter syndrome market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Hunter syndrome market report provides current treatment practices, emerging drugs, Hunter syndrome market share of the individual therapies, and current and forecasted market size from 2019 to 2032, segmented by seven major markets. The report also covers current Hunter syndrome treatment practices/algorithms and Hunter Syndrome unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, Spain) and the United Kingdom
• Japan

Study period: 2019–2032

Hunter Syndrome Market: Understanding and Treatment Algorithm

The DelveInsight’s Hunter syndrome market report gives a thorough understanding of Hunter syndrome by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment. Hunter syndrome is also known as Mucopolysaccharidosis type II (MPS II). It 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. It is a rare, X-linked disorder caused due to a deficiency of the lysosomal enzyme iduronate-2-sulfatase, which plays a major role in the catabolism of glycosaminoglycans (GAG).

It is a cause of mutations in the IDS gene locus. The father of an affected male will not have the disease, nor will he be hemizygous for the IDS pathogenic variant; therefore, the father does not require any further evaluation or testing. In a family with more than one affected individual, the mother of an affected male is an obligate heterozygote (carrier). On rare occasion, heterozygous females manifest findings of MPS II. This result from skewed inactivation of the normal paternally inherited X chromosome and expression of the maternally inherited mutated IDS allele.

Hunter syndrome Diagnosis

A urine sample can be checked for the deficient enzyme or for excess amounts of the complex sugar molecules associated with this disorder. A genetic analysis can confirm the diagnosis.

Hunter syndrome Treatment

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 cell 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.

Hunter Syndrome Epidemiology

The Hunter syndrome epidemiology section provides insights into historical and current Hunter syndrome patient pool and forecasted trends for seven individual major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Hunter syndrome report also provides the diagnosed patient pool, their trends and assumptions undertaken.

Key findings

• As per 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 National Organization for Rare Disorders.

• The Hunter syndrome epidemiology covered in the report provides historical as well as forecasted Hunter syndrome epidemiology [segmented as Total Diagnosed Prevalent Population of Hunter Syndrome, and Severity-based Diagnosed Prevalent Population of Hunter Syndrome] in the 7MM covering the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.

Country-wise Hunter Syndrome Epidemiology

The epidemiology segment also provides the Hunter syndrome epidemiology data and findings across the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

Hunter Syndrome Drug Chapters

The drug chapter segment of the Hunter syndrome report encloses the detailed analysis of Hunter syndrome marketed drugs and late-stage (Phase III and Phase II) Hunter syndrome pipeline drugs. It also helps understand the Hunter syndrome clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Hunter Syndrome Marketed Drugs

ELAPRASE (idursulfase): Takeda Pharmaceutical

It is now a decade since ERT with intravenous idursulfase (ELAPRASE), a recombinant form of human iduronate 2-sulfatase, has been approved in the United States, European Union and in Japan at a weekly dose of 0.5 mg/kg for the treatment of MPS II patients who are five years and older. The approval was mainly based on the results from a first trial on individuals with the slowly progressive form of the disease. Recently, a 3.5-year independent study determined that long-term use of ERT is similarly effective in young (age 1.6–12 years at the start of ERT) and older individuals (age 12–27 years at the start of ERT).

Note: Detailed current therapies assessment will be provided in the full report of Hunter syndrome.

Hunter Syndrome Emerging Drugs

The report details the emerging Hunter syndrome therapies under the late and mid-stage of development for Hunter syndrome treatment.

DNL310: Denali Therapeutics

DNL310 is a recombinant form of the iduronate 2-sulfatase (IDS) enzyme engineered to cross the BBB using Denali’s proprietary Enzyme Transport Vehicle technology. DNL310 is intravenously administered and intended to improve overall clinical manifestations of Hunter syndrome, including both peripheral and neurological symptoms, which are not adequately addressed by currently approved therapies. The company initiated a phase I/II stage clinical development of DNL310 for patients with Hunter Syndrome in July 2020. In January 2020, Denali also announced that it submitted an IND for DNL310 for Hunter syndrome, a bio-therapeutic product candidate engineered to cross the BBB enabled by the Transport Vehicle technology. In June 2019, the company received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation from the US FDA for DNL310 for the treatment of MPS II. Moreover, in March 2021, the company announced Fast Track Designation granted by the US FDA to ETV: IDS (DNL310) for the treatment of patients with MPS II.

Note: Detailed emerging therapies assessment will be provided in the full report of Hunter syndrome.

Hunter Syndrome Market Outlook

The Hunter syndrome market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Hunter syndrome market trends by analyzing the impact of current therapies on the market, Hunter Syndrome unmet needs, and demand for better technology.

This segment gives a thorough detail of the Hunter syndrome market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need for the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

Key players such as Takeda Pharmaceutical, and Denali Therapeutics along with few others are involved in developing therapies for Hunter syndrome.

According to DelveInsight, the Hunter syndrome market in 7MM is expected to witness a major change in the study period 2019–2032.

Key findings

This section includes a glimpse of the Hunter syndrome market in 7MM.

The United States: Hunter Syndrome Market Outlook

This section provides the total Hunter syndrome market size and market size by therapies in the United States.

EU4 and the UK: Hunter Syndrome Market Outlook

The total Hunter syndrome market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan: Hunter Syndrome Market Outlook

The total Hunter syndrome market size and market size by therapies in Japan is also mentioned.

Analyst Commentary

• The pipeline of lumbosacral radicular pain is very robust, many potential therapies are being investigated for the treatment of Hunter syndrome, and it is safe to predict that the treatment space will experience a significant impact on the market during the forecast period.
• The expected introduction of emerging therapies with improved efficacy, more awareness initiatives programs, and further improvement in the diagnosis rate, are likely to boost the growth of the Hunter syndrome in the 7MM. Aside from that, the market size of Hunter syndrome may flourish due to increased research and development, label-expansion of approved therapies into other epilepsy in this field.
• The market growth of Hunter syndrome may offset by failures and/or discontinuation of the emerging therapies, unaffordable pricing, market access and reimbursement issues, and a scarcity of healthcare specialists

Hunter Syndrome Drug Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Hunter syndrome market or expected to get launched in the market during the study period 2019–2032. The analysis covers Hunter syndrome market uptake by drugs, patient uptake by therapies, and sales of each drug.

This will help in understanding the Hunter syndrome drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size, which again will be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

Hunter Syndrome Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Hunter syndrome key players involved in developing targeted therapeutics.

Hunter syndrome Clinical Trial Development Activities

The report covers detailed information on collaborations, acquisitions, and mergers, licensing patent details, and other information for Hunter syndrome emerging therapies.

Hunter Syndrome Reimbursement Scenario

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL Views

To keep up with current epidemiology and market trends, we take KOLs and SMEs' opinions working in the Hunter syndrome domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies and treatment patterns along with Hunter syndrome market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform competitive and market intelligence analysis of the Hunter syndrome market by using various competitive intelligence tools that include – SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Hunter Syndrome Market Report Scope

• Descriptive overview of Hunter syndrome, disease overview, patient journeys, treatment algorithms, diagnosis, and currently available therapies
• Comprehensive insight into the Hunter syndrome epidemiology and forecasts in the 7MM
• An all-inclusive account of both the current and emerging therapies for Hunter syndrome, along with the assessment of new therapies, expected to have an impact on the current treatment landscape
• Exhaustive analysis of the Hunter syndrome market; historical and forecasted covering drug outreach in the 7MM
• Trends shaping and driving the global Hunter syndrome market

Hunter Syndrome Market Report Highlights

• In the coming years, the Hunter syndrome market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market
• The companies and academics are working to assess challenges and seek opportunities that could influence Hunter syndrome R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition
• Major players are involved in developing Hunter syndrome therapies. The launch of emerging therapies will significantly impact the Hunter syndrome market
• A better understanding of Hunter syndrome pathogenesis will also contribute to the development of novel therapeutics for Hunter syndrome
• Our in-depth analysis of the Hunter syndrome pipeline assets across different stages of development (Phase III and Phase II), emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities

Hunter Syndrome Report Insights

• Patient-Based Hunter Syndrome Market Forecasting
• Therapeutic approaches
• Hunter syndrome pipeline analysis
• Hunter syndrome market size and trends
• Hunter syndrome market opportunities
• Impact of upcoming therapies

Hunter Syndrome Report Key Strengths

• 11 years forecast
• 7MM coverage
• Hunter syndrome epidemiology segmentation
• Key cross competition
• KOL views
• Hunter syndrome drugs uptake

Hunter Syndrome Report Assessment

• Current treatment practices
• Hunter Syndrome Unmet needs
• Hunter syndrome pipeline product profiles
• Hunter syndrome market attractiveness

Key Questions

Hunter syndrome market insights:

• What would be the Hunter syndrome market growth till 2032, and what will be the resultant market size in 2032?
• What was the Hunter syndrome drug class share (in percentage) distribution in 2019, and how would it look in 2032?
• What would be the Hunter syndrome total market size and market size by therapies across the 7MM during the forecast period (2019–2032)?
• What are the key findings of the market across 7MM, and which country will have the largest Hunter syndrome market size during the forecast period (2019–2032)
• How would the unmet needs affect the Hunter syndrome market dynamics and subsequent analysis of the associated trends?

Hunter Syndrome Epidemiology Insights:

• What are the disease risk, burden, and regional/ethnic differences of Hunter syndrome?
• What is the historical and forecasted Hunter syndrome patient pool in 7MM, and where can one observe the highest patient population and growth opportunities?
• What are the key factors driving the epidemiology trends for seven major markets covering the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current treatment guidelines and treatment options, in addition to approved therapies for Hunter syndrome in the US, Europe, and Japan?
• What are the key collaborations (Industry–Industry, Industry-Academia), mergers and acquisitions, and licensing activities related to Hunter syndrome therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hunter syndrome and its status, along with the challenges faced?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Hunter syndrome market
• Organize sales and marketing efforts by identifying the best opportunities for Hunter syndrome in the US, EU4 (Germany, France, Italy, Spain) and the UK, and Japan
• Identification of strong upcoming players in the market that will help devise strategies that will help in getting ahead of competitors