Hunter Syndrome Treatment Market Analysis & Forecast to 2024-2034

The global hunter syndrome treatment market size was estimated to be USD 1.00 billion in 2023 and is expected to reach at USD 2.49 billion by 2034 with a CAGR of 8.65% during the forecast period 2024-2034. The increasing prevalence of Hunter syndrome, a heightened emphasis on research & development initiatives by companies to introduce new products, a growing adoption of diverse strategies such as collaborations and partnerships by market players to develop effective drugs & treatment alternatives, a rise in awareness concerning Hunter syndrome, a substantial investment by key market players, a surge in the number of clinical trial procedures, and an increase in regulatory authorities' approvals of novel therapies for Hunter syndrome are some of the key factors boosting the market growth.

An increase in regulatory authorities' approvals of novel therapies for Hunter syndrome is predicted to boost the market growth during the forecast period. Hunter syndrome is a rare genetic disorder inherited due to the absence or dysfunction of the enzyme iduronate-2-sulfatase. This deficiency leads to an inadequate breakdown of sugar molecules in the body. The accumulation of these molecules in organs and tissues over time can result in significant damage, impacting both physical and mental development and abilities. This disorder belongs to a category of inherited metabolic conditions referred to as mucopolysaccharidosis (MPS). Consequently, regulatory authorities are increasingly approving novel therapies for the treatment of Hunter syndrome due to its growing prevalence. For instance, in May 2023, REGENXBIO Inc. has disclosed that the U.S. Food and Drug Administration (FDA) bestowed the Regenerative Medicine Advanced Therapy (RMAT) designation upon RGX-121. This investigational AAV Therapeutic is designed as a one-time treatment for Mucopolysaccharidosis Type II (MPS II), commonly referred to as Hunter syndrome.

By treatment type, enzyme replacement therapy was the highest revenue-grossing segment in the global hunter syndrome treatment market in 2023 owing to the increasing accessibility of enzyme replacement therapies, the effectiveness & safety profile of innovative enzyme drugs, a rising awareness, less stringent regulations for rare diseases, and a growing effort by companies to develop products for enzyme replacement therapy. Additionally, Hematopoietic Stem Cell Transplant (HSCT) is predicted to grow at the fastest CAGR during the forecast period owing to the rising number of clinical trials incorporating hematopoietic stem cell transplant (HSCT) and an increasing emphasis on creating new therapeutic alternatives for Hunter syndrome treatment. For instance, in February 2022, Information on the HMI-203 gene therapy candidate, which is designed to treat Hunter syndrome (MPS II), was released by Homology Medicines, Inc. This data was presented during the phase I dose-escalation clinical study conducted in adults with Hunter syndrome at the Annual WorldSymposium Meeting.

By route of administration, intravenous was the highest revenue-grossing segment in the global hunter syndrome treatment market in 2023 owing to the rising utilization of intravenous administration of Elaprase and the increasing approvals of new drug products. For instance, in July 2022, Avrobio introduced AVR-RD-05, a gene therapy that has gained orphan drug designation from the USFDA to treat mucopolysaccharidosis type II. Additionally, intracerebroventricular (ICV)/ intrathecal is predicted to grow at the fastest CAGR during the forecast period owing to the growing acceptance of Hunterase and the increasing launch of new products.

By end-user, hospitals was the highest revenue-grossing segment in the global hunter syndrome treatment market in 2023 owing to the treatments for Hunter syndrome are frequently administered in hospital settings under the supervision of trained medical professionals, increase in the number of patients with Hunter syndrome seeking medical attention in hospitals and rise in the number of clinical trial procedures. For instance, in August 2023, Denali Therapeutics Inc. released interim findings from the continuous open-label, single-arm Phase 1/2 investigation of DNL310 (ETV:IDS) in children diagnosed with MPS II (Hunter syndrome). DNL310, an experimental enzyme replacement therapy, is engineered to penetrate the blood-brain barrier and target the behavioral, cognitive, and physical symptoms associated with MPS II. Additionally, diagnostic centers is predicted to grow at the fastest CAGR during the forecast period owing to the increasing number of diagnostic centers, the elevated provision of specialized care for individuals with Hunter syndrome, a heightened focus from national government agencies on treating patients in advanced healthcare settings.

North America region is anticipated for the highest revenue share during the forecast period owing to the increasing awareness about rare diseases, the existence of robust healthcare infrastructure, favorable regulations promoting the development of orphan drugs, a heightened emphasis from major players on conducting clinical trials to assess the safety and efficacy of enzyme drugs and therapies for individuals with Hunter syndrome, a rising emphasis from companies on creating advanced products, and an increase in product launches and approvals. For instance, in August 2022, REGENXBIO Inc. declared its intention to submit a Biologics License Application (BLA) in 2024 through the FDA's expedited approval route for RGX-121, targeting the treatment of mucopolysaccharidosis Type II (MPS II). Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increasing awareness among patients regarding new treatment alternatives, the involvement of prominent biopharmaceutical companies in clinical stages, rising efforts by major players to secure approval for their innovative therapies, and a rising introduction of new treatment options. For instance, in September 2023, CANbridge Pharmaceuticals has announced the forthcoming launch of Hunterase (CAN101), an enzyme replacement therapy designed to treat Hunter syndrome, in Beijing, China.

Report Scope:

• Base Year: 2023
• Forecast Period: 2024-2034

Study Coverage

• Market Forecast by Type, Material, Product, and End-user
• Market Forecast for 5 Regions and 17+ Countries
• North America (U.S. and Canada)
• Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
• Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
• Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
• MEA (South Africa, GCC, Rest of MEA)
• Exhaustive Company Profiles of Top 10+ Major Market Players
• 20% Free Customization Available to Meet Your Exact Requirement.

Segmentation: Hunter Syndrome Treatment Market Report 2023 - 2034

Hunter Syndrome Treatment Market Analysis & Forecast by Treatment Type 2023 - 2034 (Revenue USD Bn)

• Hematopoietic Stem Cell Transplant (HSCT)
• Enzyme Replacement Therapy (ERT)
• Others

Hunter Syndrome Treatment Market Analysis & Forecast by Route Of Administration 2023 - 2034 (Revenue USD Bn)

• Intracerebroventricular (ICV)/ Intrathecal
• Intravenous

Hunter Syndrome Treatment Market Analysis & Forecast by End-user 2023 - 2034 (Revenue USD Bn)

• Diagnostic Centers
• Hospitals
• Others

Hunter Syndrome Treatment Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)

• North America
• U.S.
• Canada
• Europe
• Germany
• France
• UK
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• Japan
• India
• Australia
• South Korea
• Rest of APAC
• Latin America
• Brazil
• Mexico
• Argentina
• Rest of LATAM
• Middle East & Africa
• South Africa
• GCC
• Rest of MEA