Idursulfase Sales Forecast Summary

Key Factors Driving Idursulfase Growth

Market Share Gains and New Patient Starts

• Idursulfase (Elaprase) is the established standard-of-care enzyme replacement therapy (ERT) for Mucopolysaccharidosis type II (MPS II, Hunter syndrome), maintaining a dominant share in this ultra-rare lysosomal storage disorder market.
• New patient starts are driven by improved newborn screening, early genetic diagnosis, and increased disease awareness among pediatric metabolic specialists.
• Takeda’s (formerly Shire) long-standing commercial presence and strong engagement with rare disease centers and patient advocacy groups continue to support sustained adoption globally.

Expansion Across Key Indications

• Primary indication – MPS II (Hunter syndrome): Elaprase is approved for the long-term treatment of patients with MPS II, targeting the underlying enzyme deficiency (iduronate-2-sulfatase).
• Ongoing clinical research focuses on earlier initiation of therapy and long-term outcome optimization, particularly in pediatric patients, which may improve disease stabilization.
• While Idursulfase remains limited to MPS II, its success has encouraged broader development of enzyme replacement strategies across lysosomal storage disorders, reinforcing its role as a reference therapy.

Geographic Expansion

• United States and Europe: Core commercial markets with long-standing regulatory approvals and well-established reimbursement frameworks.
• Asia-Pacific: Increasing uptake driven by government-supported rare disease programs, improved diagnostic infrastructure, and rising healthcare investments, particularly in countries like Japan, China, and South Korea.
• Emerging markets: Gradual expansion supported by Takeda’s global rare disease footprint and strategic distribution partnerships.

New Indication Approvals

• Idursulfase holds full regulatory approval for MPS II across major global markets.
• No additional disease indications have been approved, as its use remains highly specific to Hunter syndrome. Future regulatory focus is primarily on improving access and early treatment, rather than label expansion.

Strong MPS II Treatment Momentum

• Long-term studies demonstrate improvements in pulmonary function, mobility, and quality of life, particularly in somatic manifestations of MPS II.
• Real-world registry data confirms sustained clinical benefit and manageable safety profile with chronic intravenous administration.
• Increasing evidence supports earlier treatment initiation as a key driver of better long-term outcomes, reinforcing the importance of early diagnosis.

Competitive Differentiation and Market Trends

• First-in-class ERT for MPS II: Elaprase remains the only widely approved enzyme replacement therapy for Hunter syndrome.
• Proven long-term safety: Over 15 years of clinical use has built strong clinician confidence.
• Rare disease trends: Expansion of newborn screening programs, personalized medicine approaches, and orphan drug incentives continues to support long-term market stability.
• Growing interest in gene therapy and CNS-targeted treatments is reshaping the future landscape, but Idursulfase remains the backbone of current MPS II management.

Idursulfase Recent Developments

• Idursulfase have largely focused on next-generation therapies and lifecycle management strategies. Takeda and other industry players have emphasized the limitations of standard Idursulfase in treating neurological symptoms, driving investment into brain-penetrant variants and gene therapies (such as Idursulfase beta and JR-141). Takeda has also continued to support global patient registries and long-term outcome studies, reinforcing Elaprase’s role as the benchmark therapy for MPS II and the primary comparator for emerging advanced treatments.

“Idursulfase Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of Idursulfase for approved indication like Mucopolysaccharidosis II in the 7MM. A detailed picture of Idursulfase’s existing usage in anticipated entry and performance in approved indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the Idursulfase for approved indications. The Idursulfase market report provides insights about Idursulfase’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Idursulfase performance, future market assessments inclusive of the Idursulfase market forecast analysis for approved indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Idursulfase sales forecasts, along with factors driving its market.

Idursulfase Drug Summary

Idursulfase is a purified recombinant form of human iduronate-2-sulfatase, a lysosomal enzyme produced via recombinant DNA technology in a human cell line and administered intravenously weekly as Elaprase by Takeda to treat mucopolysaccharidosis II (MPS II, Hunter syndrome), an X-linked lysosomal storage disorder primarily affecting males. It hydrolyzes the 2-O-sulfate groups from terminal iduronate residues in glycosaminoglycans (GAGs) dermatan sulfate and heparan sulfate, reducing their pathologic accumulation in lysosomes that causes cellular engorgement, organomegaly, skeletal abnormalities, and cardiopulmonary dysfunction. FDA-approved in 2006 for patients aged 5 years and older (with later extensions), Idursulfase improves walking distance, forced vital capacity, and GAG clearance through mannose-6-phosphate receptor-mediated uptake into cells, though it does not cross the blood-brain barrier or cure the underlying genetic deficiency. The report provides Idursulfase’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Idursulfase Market Report 

The report provides insights into:

• A comprehensive product overview including the Idursulfase MoA, description, dosage and administration, research and development activities in approved indication like Mucopolysaccharidosis II.
• Elaborated details on Idursulfase regulatory milestones and other development activities have been provided in Idursulfase market report.
• The report also highlights Idursulfase‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved indications across the United States, Europe, and Japan. 
• The Idursulfase market report also covers the patents information, generic entry and impact on cost cut.
• The Idursulfase market report contains current and forecasted Idursulfase sales for approved indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Idursulfase market report also features the SWOT analysis with analyst views for Idursulfase in approved indications.

Methodology

The Idursulfase market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Idursulfase Analytical Perspective by DelveInsight

In-depth Idursulfase Market Assessment

This Idursulfase sales market forecast report provides a detailed market assessment of Idursulfase for approved indication like Mucopolysaccharidosis II in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Idursulfase sales data uptil 2034.

Idursulfase Clinical Assessment

The Idursulfase market report provides the clinical trials information of Idursulfase for approved indications covering trial interventions, trial conditions, trial status, start and completion dates.

Idursulfase Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Idursulfase Market Potential & Revenue Forecast

• Projected market size for the Idursulfase and its key indications
• Estimated Idursulfase sales potential (Idursulfase peak sales forecasts)
• Idursulfase Pricing strategies and reimbursement landscape

Idursulfase Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• Idursulfase Market positioning compared to existing treatments
• Idursulfase Strengths & weaknesses relative to competitors

Idursulfase Regulatory & Commercial Milestones

• Idursulfase Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

Idursulfase Clinical Differentiation

• Idursulfase Efficacy & safety advantages over existing drugs
• Idursulfase Unique selling points

Idursulfase Market Report Highlights 

• In the coming years, the Idursulfase market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The Idursulfase companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Idursulfase’s dominance.
• Other emerging products for Mucopolysaccharidosis II are expected to give tough market competition to Idursulfase and launch of late-stage emerging therapies in the near future will significantly impact the market. 
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Idursulfase in approved indications.
• Analyse Idursulfase cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Idursulfase sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Idursulfase in approved indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of Idursulfase? How strong is Idursulfase’s clinical and commercial performance?
• What is Idursulfase’s clinical trial status in each individual indications such as Mucopolysaccharidosis II and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Idursulfase Manufacturers?
• What are the key designations that have been granted to Idursulfase for approved indications? How are they going to impact Idursulfase’s penetration in various geographies?
• What is the current and forecasted Idursulfase market scenario for approved indications? What are the key assumptions behind the forecast? 
• What are the current and forecasted sales of Idursulfase in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?  
• What are the other emerging products available and how are these giving competition to Idursulfase for approved indications?
• Which are the late-stage emerging therapies under development for the treatment of approved indications?
• How cost-effective is Idursulfase? What is the duration of therapy and what are the geographical variations in cost per patient?