The Hunter syndrome treatment market was valued at an estimated market size of USD 942 million in 2020, and it is expected to reach USD 1,265 million by 2026, registering a CAGR of nearly 5.2% during the forecast period, 2021-2026.
The COVID-19 pandemic has resulted in decreased public mobility, as well as impacted the diagnostic industries. Several diagnostic procedures and therapy that are non-emergent were put on hold to avoid the transmission of the novel coronavirus.
As per the National MPS Society, Hunter syndrome is a rare condition that affects 1 in 100,000 to 1 in 170,000, primarily males. It is the absence of enzyme iduronate sulfatase in patients, which is essential to break down the mucopolysaccharides dermatan and heparan sulphate. These materials are stored in the body’s cells, causing progressive damage.
The market growth is attributed to increasing government initiatives, the introduction of novel therapies, and robust pipelines. In addition, growing awareness about Hunter syndrome and the availability of therapeutic options may propel the revenue growth of the market.
In 2018, Shire PLC, with International MPS Network and National MPS Society, launched the #FlyforMPS campaign to raise awareness about MPS (mucopolysaccharide) diseases, and this disease is affecting at least one in 25000 births in the United States. Moreover, a report was published by the National Institute of Health in 2018 that states that globally, Hunter syndrome disease is affecting 1 in 160,000 males, making it a rare disease. Thus, increasing R&D expenditure, approval of novel therapies, several initiatives by market players, and technological advancements in terms of adopting new technologies for the treatment of this type of rare disease are likely to fuel the growth of the overall market.
Key Market Trends
The Enzyme Replacement Therapy (ERT) Segment is Estimated to Witness Healthy Growth in the Future
The enzyme replacement therapy segment is estimated to witness notable growth in the future attributed to increasing awareness, rising availability of enzyme replacement therapy, and less stringent guidelines.
Enzyme replacement therapy (ERT) is a standard of care for several types of rare diseases. ERT consists of replacing the deficient or absent enzyme with a functional recombinant version through intravenous administration. In addition, several products in ERT sales have been significantly increased, which results in the segment growth. For example, Idursulfase manufactured by Shire PLC is used for the treatment of Hunter disease. In addition, idursulfase beta by Clinigen Group PLC will fulfill the unmet need for this type of disease.
Furthermore, in 2017, Shire PLC announced top-line results from its Phase II/III clinical trial evaluating SHP609, previously known as HGT-2310. It is an investigational formulation of idursulfase administered intrathecally for a new potential indication for the treatment of pediatric patients with Hunter syndrome (mucopolysaccharidosis II or MPS II) and cognitive impairment.
As per a 2020 European study, titled 'Mucopolysaccharidosis Type II: One Hundred Years of Research, Diagnosis, and Treatment', the incidence rate of Hunter syndrome ranges from 0.38 per 100,000 live newborns in Brazil to 1.09 per 100,000 live newborns in Portugal and European countries, generally present a lower incidence than East Asian countries, whereas MPS II incidence accounts for about 50% of all mucopolysaccharidoses.
Thus, the growing adoption of these therapies by the target patient pool and growing product approvals may trigger the growth of enzyme replacement therapy.
North America is Expected to Hold a Significant Share in the Forecast Period
North America holds a significant market share due to rising awareness regarding rare diseases, favorable regulations for orphan drug development, growing healthcare expenditure, and favorable reimbursement policies. In 2018, US healthcare accounted for 17.9% of the GDP. The United States is one of the major destinations for all the recent advancements in the field of medicine.
Furthermore, well-established healthcare infrastructure, increasing adoption of novel therapies, and technological advancements are also expected to fuel the Hunter syndrome market in this region. For instance, in December 2019, REGENXBIO Inc., a US-based company, announced interim data from the first cohort of the ongoing Phase I/II trial of RGX-121 for the treatment of Mucopolysaccharidosis Type II (Hunter syndrome). It is an investigational one-time gene therapy designed to deliver the gene that encodes the iduronate-2-sulfatase enzyme direct to the central nervous system (CNS) using the AAV9 vector.
The Hunter syndrome market is moderately competitive and consists of several major players. Some of the companies currently dominating the market are REGENXBIO Inc., Takeda Pharmaceutical Company Limited, Clinigen Group PLC, JCR Pharmaceuticals, ArmaGen, Sangamo Therapeutics, Denali Therapeutics Inc., Bioasis Technologies Inc., Inventiva, etc. Additionally, the key players have been involved in various strategic alliances, along with the launch of advanced products, to secure their positions in the global market. For instance, in October 2020, AVROBIO Inc. announced an exclusive, worldwide license agreement and a collaborative research funding agreement with The University of Manchester for investigational lentiviral gene therapy for mucopolysaccharidosis type II (MPS II), or Hunter syndrome, a rare and deadly lysosomal disorder that primarily affects young boys.
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1.2 Scope of the Study
4.2 Market Drivers
4.2.1 Increasing Government Initiatives
4.2.2 Introduction of Novel Therapies
4.2.3 Robust Pipelines
4.3 Market Restraints
4.3.1 High Treatment Costs
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5.1.1 Enzyme Replacement Therapy (ERT)
5.1.2 Hematopoietic Stem Cell Transplant (HSCT)
5.1.3 Other Treatment Types
5.2 By End User
5.2.2 Diagnostic Centers
5.2.3 Other End Users
5.3.1 North America
188.8.131.52 United States
184.108.40.206 United Kingdom
220.127.116.11 Rest of Europe
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.3.4 Rest of the World
6.1.1 REGENXBIO Inc.
6.1.2 Takeda Pharmaceutical Company Limited (Shire)
6.1.3 Clinigen Group PLC
6.1.4 JCR Pharmaceuticals
6.1.6 Sangamo Therapeutics
6.1.7 Denali Therapeutics Inc.
6.1.8 Bioasis Technologies Inc.
6.1.10 GC Pharma (Green Cross Holdings)
6.1.12 Avrobio Inc.
6.1.13 CANbridge Life Sciences Ltd
A selection of companies mentioned in this report includes:
- REGENXBIO Inc.
- Takeda Pharmaceutical Company Limited (Shire)
- Clinigen Group PLC
- JCR Pharmaceuticals
- Sangamo Therapeutics
- Denali Therapeutics Inc.
- Bioasis Technologies Inc.
- GC Pharma (Green Cross Holdings)
- Avrobio Inc.
- CANbridge Life Sciences Ltd