Hunter Syndrome Treatment Market Size, Share & Trends Report

Hunter Syndrome Treatment Market Size, Share & Trends Analysis Report By Treatment (Enzyme Replacement Therapy, Hematopoietic Stem Cell Transplant), By Region, And Segment Forecasts, 2019 - 2025

  • Published Date: Jan, 2019
  • Base Year for Estimate: 2017
  • Report ID: GVR-2-68038-743-8
  • Format: Electronic (PDF)
  • Historical Data: 2016
  • Number of Pages: 80

Industry Insights

The global Hunter syndrome treatment market size was valued at USD 782.5 million in 2017 and is projected to grow at a CAGR of 7.6% over the forecast period. Rising patient population of this medical condition, potential approval of pipeline drugs worldwide, and increasing healthcare expenses are key factors fueling market growth.

Hunter syndrome, also referred to as mucopolysaccharidosis type II (MPS II), is an inherited genetic disorder caused by the missing or malfunctioning iduronate-2-sulfatase enzyme. Patients suffering from this X-linked deficiency collect glycosaminoglycans (GAGs) in various tissues, leading to bone and joint abnormalities, loss of cardiac function, enlargement of internal organs, obstructive airway disease, mental retardation, impaired speech and hearing, and a life expectancy as low as 10 to 15 years.

U.S. Hunter syndrome treatment market

Since there are no curative therapies for Hunter syndrome, treatments mainly focus on providing symptomatic relief and management of complications associated with disease progression. Current therapeutic options include enzyme replacement therapy (ERT) and hematopoietic stem cell transplant (HSCT).

According to the National Institute of Health (NIH) 2018 report, MPS II affects around one in 160,000 males. Risk of developing this disease is far less among women, because they inherit two X chromosomes and one of them can provide a functioning gene if the other X chromosome is defective. However, in men, there is no other X chromosome to compensate for the defective one.

Treatment Insights

The treatment regime for Hunter syndrome is determined based on the severity of symptoms and varies from patient to patient. On the basis of treatment type, the global Hunter syndrome treatment market is categorized intoenzyme replacement therapy (ERT) and hematopoietic stem cell transplant (HSCT), and others,wherein, ERTs dominated the market in 2017. It is expected that enzyme replacement therapies will emerge as the leading segment in the market through the forecast period. Strong sales of ELAPRASE and potential worldwide approval of Hunterase are some of the factors responsible for its rapid growth in the treatment class.

Approximately 2,000 patients globally are candidates for enzyme replacement therapy. Shire’s ELAPRASE(idursulfase) is the single major drug for treatment of mucopolysaccharidosis type IIworldwide, with GC Pharma’s Hunterase (idursulfase beta) being approved only in South Korea as of now. The pricing of ELAPRASE is in line with other ERTs at an annual cost of around USD 450,000 per patient.

North America Hunter syndrome treatment market

The approval of ELAPRASE addressed a significant unmet need in Hunter syndrome and Shire is developing several follow-up compounds for the same. However, to significantly increase patient benefits, entry of novel therapeutic modality such as gene therapy and RNA therapeutics is in great demand. Recently, a National Institute of Neurological Disorders and Stroke (NINDS)-funded research demonstrated the termination of the material buildup in brain cells through a virus delivered gene therapy and can improve memory and learning.

Regional Insights

On the basis of region, the global market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. North America led the market by accounting for a share of close to 40.0% in 2017. This can be attributed to favorable regulations for orphan drug development, rising awareness among people concerning rare diseases, increased funding for research activities, and improved healthcare facilities.

Health insurance coverage of expensive drugs such as ELAPRASE and encouraging reimbursement policies are also influencing pharmaceutical companies to increase investment in R&D of orphan drugs. Furthermore, market growth is fueled by developing healthcare infrastructure in Asia Pacific, which provides significant opportunities for biopharmaceutical companies to penetrate this region. Asia Pacific is expected to demonstrate the fastest growth in the market, primarily due to large population in emerging countries such as India and China.

Hunter Syndrome Treatment Market Share Insights

Currently, Shire Plc. is leading the market, supported by strong sales of their marketed drug ELAPRASE for the treatment of Hunter syndrome. However, it is expected that Shire will face stiff competition from Green Cross Pharma through the forecast period. GC Pharma is emerging as a global player in the rare diseases space with its orphan drug, Hunterase, receiving approval from Korea FDA in 2012. Prior to the approval, Shire’s ELAPRASE was the only approved drug for the management of this condition.

Some of the key players operating in the MPS II market are Shire Plc.; GC Pharma.; JCR Pharmaceuticals Co Ltd.; RegenxBio Inc.; Sangamo Therapeutics, Inc.; ArmaGen Inc.; Inventiva S.A.; Denali Therapeutics Inc.; Bioasis Technologies Inc.; and Esteve. Key players are engaged in development of novel technologies, strategic planning, and alliances to achieve extensive growth and acquire a leading position in the market. For example, Shire Plc. entered into an agreement with ArmaGen in 2014, to jointly develop and commercialize the pipeline drug AGT-182 for treatment of mucopolysaccharidosis type II.

Report Scope

Attribute

Details

Base year for estimation

2017

Actual estimates/Historical data

2016

Forecast period

2018 - 2025

Market representation

Revenue in USD Million & CAGR from 2018 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America, & MEA

Country scope

U.S., Canada, U.K., Germany, Japan, China, India, Brazil, Mexico, South Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis on latest industry trends and opportunities in each of the sub-segments from 2016 to 2025. For the purpose of this study, Grand View Research has segmented the global Hunter syndrome treatment market report on the basis of treatment and region:

  • Treatment Outlook (Revenue, USD Million, 2016 - 2025)

    • Enzyme Replacement Therapy (ERT)

    • Hematopoietic Stem Cell Transplant (HSCT)

    • Others

  • Regional Outlook (Revenue, USD Million, 2016 - 2025)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • U.K.

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

      • Mexico

    • MEA

      • South Africa

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