Mucopolysaccharidosis Treatment Market Surges Across USA, Europe, APAC, and Saudi Arabia with Strong Growth Outlook Toward 2035

The global mucopolysaccharidosis (MPS) treatment market is entering a phase of sustained expansion, supported by improved diagnostic detection, enhanced clinical guidelines, and ongoing biotechnology advancements. The market is projected to reach USD 5,014.5 million by 2035, up from an estimated USD 2,826.6 million in 2025, at a CAGR of 5.9%. This represents continued growth from 2024, where the market valuation reached USD 2,669.1 million with a year-on-year rise of 5.8%.

MPS is a rare genetic disorder characterized by deficiencies in specific lysosomal enzymes, leading to progressive organ and tissue damage. Current treatment approaches include enzyme replacement therapy (ERT), hematopoietic stem cell transplantation (HSCT), supportive clinical management, and emerging gene therapy candidates. ERT continues to dominate treatment usage, holding approximately 56.4% market share in 2025.

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Demand Drivers and Technological Advancements

Increasing newborn screening and early diagnostic awareness are key contributors fueling treatment adoption. Advances in biotechnology continue to enhance enzyme delivery efficiency, reduce infusion frequency, and expand therapeutic indications. Gene therapy research, particularly targeted at curative enzyme expression correction, is expected to redefine long-term care strategies.

Supportive care strategies, including surgical interventions and physical therapy, further aid in disease progression management, contributing to the sustained need for specialized clinical treatment infrastructure.

Regional Outlook: USA, Europe, APAC, and Saudi Arabia

United States

The United States leads global market growth with a projected CAGR of 7.4% through 2035. Regulatory incentives like orphan drug designation, fast-track approvals, and commercialization support programs are expanding treatment availability and accelerating drug development pipelines.

Europe

Europe continues to invest in collaborative R&D and clinical trial networks. Germany is projected to grow at 7.1% CAGR, while the United Kingdom is progressing rapidly through strategic alliances between research hospitals and academic gene therapy centers.

Asia-Pacific

Japan is positioned as a key innovation hub, growing at 6.3% CAGR, driven by rapid product launches and government-backed rare disease funding. China and India are improving diagnostic coverage, gradually expanding treatment access across regional healthcare systems.

Middle East and Saudi Arabia

Saudi Arabia and GCC nations are expanding genetic screening programs and specialized pediatric rare disease centers. Government reforms and cross-border clinical collaborations are expected to improve access and build long-term treatment infrastructure.

Strategic Market Developments and Investment Momentum

Pharmaceutical leaders are adopting strategic acquisitions to expand rare disease drug pipelines. In February 2024, REGENXBIO Inc. reported significant positive data in its RGX-121 Phase I/II/III program in pediatric MPS II patients. In January 2024, Kyowa Kirin Co., Ltd. acquired Orchard Therapeutics to accelerate its gene therapy portfolio, strengthening market competitiveness.

These developments highlight the industry’s transition toward long-acting and potentially curative treatment modalities, particularly gene and combination therapies.

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Cost Challenges and Access Barriers

Despite advancements, the high cost of lifelong ERT and gene therapy treatments presents a significant challenge, particularly in lower-income regions. Access limitations impact early diagnosis rates, treatment adherence, and clinical outcomes. Reimbursement reform and managed access programs will play a critical role in expanding equitable treatment availability globally.

End-User and Competitive Landscape

Hospitals remain the primary treatment centers, expected to represent over 53% market share by 2035 due to the complexity of infusion-based therapy administration and the need for interdisciplinary clinical care teams.

Tier-one companies, including Sanofi S.A., BioMarin Pharmaceutical Inc., Takeda Pharmaceutical Company Limited, and Sumitomo Pharma Co., Ltd., collectively hold approximately 68.6% market share. Tier-two innovators such as Ultragenyx Pharmaceutical Inc. and Sarepta Therapeutics continue advancing targeted clinical development in next-generation ERT and gene therapy.

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