Hunter Syndrome Treatment Market to Grow at CAGR of 5.43% through 2030

Advanced enzyme replacement therapies (ERTs) and gene therapy revolution are expected to drive the Global Hunter Syndrome Treatment Market growth in the forecast period, 2026-2030.

According to TechSci Research report, “Hunter Syndrome Treatment Market – Global Industry Size, Share, Trends, Competition, Forecast & Opportunities, 2020-2030F”, the Global Hunter Syndrome Treatment Market stood at USD 1.34 Billion in 2024 and is expected to reach USD 1.55 Billion by 2030 with a CAGR of 5.43% during the forecast period.

The emergence of gene therapy represents a transformative shift in the treatment of Hunter syndrome, offering a potential one-time curative option instead of lifelong management strategies. Hunter syndrome, caused by mutations in the IDS gene, results in deficient or nonfunctional iduronate-2-sulfatase, leading to the accumulation of glycosaminoglycans (GAGs) in various tissues. Traditional treatments, such as enzyme replacement therapy (ERT), only mitigate symptoms without addressing the underlying genetic defect. Gene therapy seeks to correct this by introducing a functional copy of the IDS gene into the patient's cells, enabling sustained enzyme production and reducing GAG buildup. Preclinical studies have demonstrated promising results, showing that gene therapy can effectively deliver the necessary genetic material, restore enzyme function, and slow disease progression in animal models. Early-phase clinical trials have further validated its potential, with reports of improved biochemical markers and reduced GAG accumulation in treated patients. A major advantage of gene therapy lies in its potential to offer long-term benefits with a single administration, minimizing the burden of frequent infusions associated with ERT.

However, challenges remain in ensuring the precise targeting of gene delivery vectors, optimizing dosage, and assessing long-term safety and efficacy. Immune system responses to viral vectors used for gene delivery could pose potential obstacles. Despite these challenges, ongoing advancements in gene-editing technologies, such as CRISPR and adeno-associated virus (AAV)-mediated gene transfer, continue to refine the approach. If gene therapy proves successful in larger clinical trials, it could redefine the standard of care for Hunter syndrome, reducing reliance on symptomatic management and significantly improving patient outcomes. The regulatory landscape is also evolving to accommodate these advancements, with accelerated approval pathways expediting research efforts. Gene therapy thus holds immense promise in shifting Hunter syndrome treatment from palliative approaches to a potential cure.

Enzyme replacement therapy (ERT) has been the cornerstone of Hunter syndrome treatment, helping to compensate for the missing or deficient iduronate-2-sulfatase enzyme. While existing ERTs, such as idursulfase (Elaprase), have significantly improved patient outcomes by reducing glycosaminoglycan (GAG) accumulation, they come with notable limitations, including frequent intravenous infusions and limited blood-brain barrier penetration. Consequently, ongoing research is focused on enhancing ERT formulations to improve their efficacy, reduce side effects, and provide longer-lasting benefits.

One of the key advancements in ERT is the development of fusion proteins or enzyme modifications that enhance cellular uptake and extend enzyme half-life, reducing the frequency of infusions. These next-generation ERTs aim to improve patient adherence and quality of life. Research efforts are exploring enzyme modifications that enhance central nervous system (CNS) penetration. Since Hunter syndrome also affects cognitive functions, effective delivery of therapeutic enzymes to the brain remains a critical goal. Intrathecal or intracerebroventricular administration methods are being investigated to bypass the blood-brain barrier and deliver enzymes directly to the CNS. Another innovation involves recombinant enzyme engineering to enhance stability and activity. These advancements aim to maximize enzyme bioavailability while minimizing immune responses that may reduce treatment effectiveness. Clinical trials evaluating second-generation ERTs have shown promising preliminary results, demonstrating improved biochemical and clinical outcomes.

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The Global Hunter Syndrome Treatment Market is segmented into treatment, end user, regional distribution, and company.

Based on the treatment category, the Enzyme Replacement Therapy (ERT) sector is the fastest-growing segment in the Hunter Syndrome Treatment Market during the projected period. This growth is fueled by factors such as the increasing availability of enzyme replacement therapies, rising awareness, and more favorable regulations for rare diseases. ERT has become a key treatment for various rare conditions, involving the replacement of deficient enzymes with functional recombinant versions through intravenous administration.

For Hunter Syndrome (Mucopolysaccharidosis type II), ERT is the primary treatment, effectively managing symptoms like hepatomegaly and splenomegaly. The intravenous administration of human recombinant iduronate 2-sulphatase is considered the standard of care for patients, driving demand for ERT and fueling the market's rapid expansion.

Moreover, the continuous development of new ERT products by various companies is expected to increase the availability of treatments, further accelerating the sector's growth. For instance, in March 2021, the Ministry of Health, Labour and Welfare (MHLW) approved IZCARGO (pabinafusp alfa 10 mL, intravenous drip infusion) for treating MPS II in Japan, a significant milestone in expanding ERT options and contributing to the segment's fast-paced growth.

Based on the region, Europe hold the second-largest share in the Global Hunter Syndrome Treatment Market, following North America. The region’s strong position is driven by well-established healthcare infrastructure, favorable reimbursement policies, and advanced research in rare disease treatments. Countries such as Germany, France, the United Kingdom, and Italy play a pivotal role in shaping the market due to their high healthcare expenditures and growing focus on orphan diseases.

One of the key factors contributing to Europe’s dominance is the widespread availability of Enzyme Replacement Therapy (ERT). The region has a strong presence of biopharmaceutical companies engaged in developing and distributing treatments for Hunter syndrome. European regulatory agencies, including the European Medicines Agency (EMA), have implemented policies that support orphan drug development and accelerated approval pathways, ensuring faster access to innovative therapies. Europe also benefits from extensive newborn screening programs in several countries, which help in early diagnosis and timely intervention. Government and non-profit organizations are actively involved in raising awareness and funding research initiatives aimed at improving Hunter syndrome treatments.

Major companies operating in Global Hunter Syndrome Treatment Market are:

• Takeda Pharmaceutical Co Ltd
• F Hoffmann-La Roche AG
• Abbott Laboratories Inc
• Johnson & Johnson
• GSK PLC
• Bayer AG
• Novartis AG
• Pfizer Inc
• Zimmer Biomet Holdings Inc
• Sangamo Therapeutics, Inc.

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“Innovations in drug delivery systems are poised to revolutionize Hunter syndrome treatment by improving the efficiency, accessibility, and convenience of therapeutic administration. Traditional treatment options, such as intravenous enzyme replacement therapy (ERT), require frequent hospital visits, which can be burdensome for patients and caregivers. As a result, researchers are actively developing novel drug delivery mechanisms to enhance patient adherence, reduce systemic side effects, and optimize therapeutic efficacy. One promising approach is the development of extended-release formulations that allow for sustained drug release over longer periods. These formulations could significantly reduce the frequency of ERT infusions, making treatment more manageable for patients. Subcutaneous delivery of ERT is under investigation as a less invasive alternative to intravenous administration, potentially enabling at-home administration and improving patient compliance. Non-invasive drug delivery methods are also gaining traction. Researchers are exploring oral, nasal, and transdermal delivery systems that could replace or supplement traditional infusions. Oral enzyme formulations, if successfully developed, could provide a breakthrough by simplifying treatment regimens.,” said Mr. Karan Chechi, Research Director of TechSci Research, a research-based management consulting firm.

“Hunter Syndrome Treatment Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented    By Treatment (Enzyme Replacement Therapy, Hematopoietic Stem Cell Transplant), By End User (Hospitals & Clinics, Ambulatory Care Centers, Others), By Region and Competition, 2020-2030F”, has evaluated the future growth potential of Global Hunter Syndrome Treatment Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Global Hunter Syndrome Treatment Market.

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