Hunter Syndrome Market Size in the 7MM was USD 376.62 Million in 2017

"The increase in market size is a direct consequence of increasing awareness and increasing diagnosed prevalent population of Hunter Syndrome in the 7MM"

The Hunter Syndrome market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Hunter Syndrome market size from 2019 to 2032. The report also covers current Hunter Syndrome treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Key takeaways from the Hunter Syndrome Market Research Report

• The Hunter Syndrome market is expected to experience a positive growth in the coming years, owing to the advancements in research and development. The key driver for the surge in Hunter Syndrome market size is the rise in the number of the prevalent cases for Hunter Syndrome and the rise in awareness of the disease.

• According to DelveInsight's analysis, Hunter Syndrome rarely affects females.

• The leading Hunter Syndrome Companies includes Takeda, JCR Pharmaceuticals, Green Cross Corporation/GC Pharma, Denali Therapeutics, Regenxbio, Sangamo Therapeutics, and others.

• Promising Hunter Syndrome Pipeline Therapies includes ELAPRASE (idursulfase), HUNTERASE, HMI-203, DNL310, RGX-121, and others.

To discover which therapies are expected to grab the major Hunter Syndrome Market share, click here for Hunter Syndrome Market Research Report @ https://www.delveinsight.com/sample-request/hunter-syndrome-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Recent Developmental Activities in the Hunter Syndrome Treatment Landscape

• In October 2007, Shire received approval from Japan's Ministry of Health, Labour and Welfare for Elaprase, a human enzyme replacement therapy for the treatment of Hunter syndrome, sale and marketing in Japan. As part of an agreement with Genzyme Corporation, Genzyme was accounted to manage sales and distribution of Elaprase in Japan as well as certain other countries in the Asia Pacific region.

• In January 2007, the European Commission granted a marketing authorization valid throughout the European Union for Elaprase to treat patients with Hunter syndrome.

• In July 2006, the US FDA granted marketing approval for Elaprase, a human enzyme replacement therapy for the treatment of Hunter syndrome, also known as MPS II.

• In January 2012, Hunterase was approved by the Korean Food & Drug Administration (KFDA) for the treatment of Hunter Syndrome in Korea. It is currently in phase II stage of clinical development for patients with Hunter Syndrome in the United States. However, GC Pharma has entered into a licensing agreement with Clinigen K.K. to commercialize Hunterase in Japan. Also, as per clinicaltrials.gov the drug is in phase III stage of clinical development.

Hunter Syndrome Overview

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 glycosaminoglycan's (GAG).

Hunter Syndrome Epidemiology Segmentation in the 7MM

• Total Hunter Syndrome Diagnosed Prevalent Population

• Hunter Syndrome Severity-Based Diagnosed Population

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Hunter Syndrome Marketed Drugs


• Elaprase (idursulfase): Takeda

Elaprase with an active pharmaceutical ingredient idursulfase, is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Hunter syndrome (MPS II), which was manufactured by the Shire, but after its acquisition in January 2019, the drug belonged to Takeda. It is known to improve walking capacity in patients 5 years and older with MPS II. Also, it is important to note that Elaprase is the first and only treatment approved for people suffering from Hunter syndrome. It has been designed to replace the natural enzyme, increasing the catabolism of certain accumulated glycosaminoglycans (GAG)-which abnormally accumulate in multiple tissue types in patients with Hunter syndrome. It is generally available as a sterile, aqueous clear to slightly-opalescent colorless solution for intravenous infusion.

Hunter Syndrome Emerging Drugs Profile

• JR-141: JCR Pharmaceuticals
JR-141 is an anti-human transferrin receptor (J-Brain Cargo) antibody fused IDS (iduronate-2-sulfatase), which is expected to cross the blood-brain barrier (BBB). It consists of intact human IDS and anti-human transferrin receptor (hTfR) antibody, which is being developed by JCR Pharmaceuticals. Transferrin is a protein that crosses BBB through a mechanism of receptor-mediated transcytosis, which is utilized in the delivery of JR-141 to the brain. JR-141 is distributed in the brain parenchyma of hTfR knock-in cells after intravenous administration. Additionally, intravenous administration of human IDS fused with anti-mouse TfR antibody has reduced GAG accumulations in both the peripheral tissues and the brains of MPS II patients, leading to significant improvements of neurocognitive deficits. In addition, after administration of JR-141, the heparin sulfate concentrations in the cerebrospinal fluid (CSF) decreases in parallel with those in the brain, indicating that GAGs in CSF can be used as an important biomarker of the pathophysiological activities of neuropathic MPS II.

Currently, the drug is in phase III stage of clinical development for patients with Hunter Syndrome in Japan and is in phase II preparation in Brazil. JCR Pharmaceuticals has received Orphan Drug Designation from both the FDA and the EMA and is expecting to file for marketing approval of JR-141 in 2020 in Japan. However, the company intends to initiate trial of JR-141 in the US and Europe as well in near future.

• TAK-609/SHP609/HGT-2310: Takeda
SHP-609 is an investigational formulation of idursulfase administered intrathecally for the treatment of pediatric patients with Hunter syndrome and cognitive impairment. In clinical trials, SHP609 is administered to patients using an intrathecal drug delivery device. SHP609 is administered directly into the cerebrospinal fluid as a means of delivering the drug to the central nervous system.

According to the clinicaltrials.gov, the drug is in phase II/III stage of clinical development for patients with Hunter Syndrome and cognitive impairment, and the Shire is conducting the trial. However, in January 2019, Shire was acquired by Takeda, which has included the drug by the name TAK-609 in its pipeline in phase II clinical developmental trial.

• GC1111 (Hunterase): Green Cross Corporation/GC Pharma
Green Cross's Hunterase drug eases the symptoms of Hunter Syndrome, which is caused by deficiency or absence of the enzyme iduronate-2-sulfatase (IDS), by injecting cell-culture-produced enzyme. This drug reduces the levels of mucopolysaccharidosis excreted through the urine by about 30-40% following treatment. It also leads to an average increase in the 6 min walking distance. Hunterase has shown potentially better safety levels, including proportionately fewer occurrences of adverse drug reactions compared to the reference drug.

GC Pharma aspires toward increasing Hunterase's global market share to over 50%, thereby shifting the paradigm on Hunter syndrome treatment. The company also intends to continue to invest in treatments for various other rare diseases, including Fabry disease, to ensure effective treatment and better quality of life for struggling people in Korea and around the world. The company has also submitted a New Drug Application to gain marketing approval for Hunterase in China.

• 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.

Denali is planning to initiate a phase I/II stage clinical development of DNL310 for patients with Hunter Syndrome in June 2020.

• RGX-121: Regenxbio
RGX-121 is being developed as a novel, one-time, treatment for MPS II, which is directly administered intra-cisternally into the CNS. It includes the NAV AAV9 vector encoding for human IDS (iduronate-2-sulfatase). Delivery of the enzyme that is deficient within cells in the CNS could provide a permanent source of secreted IDS beyond the blood-brain barrier, allowing long-term cross-correction of cells throughout the CNS. This strategy could also provide rapid IDS delivery to the brain, potentially preventing the progression of cognitive deficits that otherwise occurs in MPS II patients.

• SB-913: Sangamo Therapeutics
SB-913, a zinc finger nuclease (ZFN) in vivo genome editing product candidate for the treatment of patients with MPS II in development by Sangamo Therapeutics. It is an investigational product candidate, which is designed to insert a normal copy of the IDS gene into a precise location in the DNA of liver cells. The goal of SB-913 treatment is to enable a patient's liver to produce a continuous supply of functional IDS enzyme.

To learn more about the Hunter Syndrome FDA-approved drugs, click here for Hunter Syndrome Treatment Market @ https://www.delveinsight.com/sample-request/hunter-syndrome-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Scope of the Hunter Syndrome Market Research Report

• Coverage- 7MM

• Hunter Syndrome Companies- Takeda, JCR Pharmaceuticals, Green Cross Corporation/GC Pharma, Denali Therapeutics, Regenxbio, Sangamo Therapeutics, and others.

• Hunter Syndrome Pipeline Therapies- ELAPRASE (idursulfase), HUNTERASE, HMI-203, DNL310, RGX-121, and others.

• Hunter Syndrome Market Dynamics: Hunter Syndrome Market Drivers and Barriers

• Hunter Syndrome Market Access and Reimbursement, Unmet Needs

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Table of Content
1. Key Insights
2. Hunter Syndrome Market Overview at a Glance
3. Disease Background and Overview: Hunter Syndrome
4. Diagnostic Algorithm for Hunter Syndrome
5. 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. KOL Reviews
13. Case Reports
14. Hunter Syndrome Market Drivers
15. Hunter Syndrome Market Barriers
16. Hunter Syndrome SWOT Analysis
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

To read more about the Hunter Syndrome Market Dynamics of the report, click here for Hunter Syndrome Market Barriers and Drivers @ https://www.delveinsight.com/sample-request/hunter-syndrome-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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