(MENAFN- Market Press Release) November 4, 2025 4:39 am - The global Enzyme Replacement Therapy (ERT) for Fabry Disease Market is valued at USD 1,950 million in 2025 and projected to reach USD 3.7 billion by 2032, growing at a 9% CAGR.

Global Enzyme Replacement Therapy (ERT) for Fabry Disease Market to Reach USD 3.7 Billion by 2032, Growing at a CAGR of 9%

The global Enzyme Replacement Therapy (ERT) for Fabry Disease Market is projected to reach USD 1,950 million in 2025, with strong growth expected through 2032, achieving a compound annual growth rate (CAGR) of 9% to surpass USD 3.7 billion. This growth is fueled by the rising prevalence of Fabry disease, increasing adoption of biologic therapies, and continuous advancements in enzyme engineering and recombinant DNA technology. North America remains the largest market due to robust healthcare infrastructure and high diagnostic awareness, while Europe and Asia-Pacific are witnessing accelerated adoption through enhanced reimbursement frameworks and regional biopharmaceutical initiatives.

Key Segment Focus

ERT remains the primary treatment approach for Fabry disease, with recombinant enzyme formulations such as agalsidase beta and agalsidase alfa dominating the therapeutic landscape. Among application segments, hospitals and specialty clinics account for the majority of ERT administrations, supported by structured infusion programs and patient management systems. Additionally, home infusion therapy is emerging as a growing segment in developed regions, driven by patient convenience, government reimbursement support, and telemedicine integration. Pediatric and female Fabry patients are also experiencing increased treatment access due to earlier genetic screening and disease awareness campaigns.

Price Trend Analysis

Between 2024 and 2025, the average treatment cost per patient for Fabry disease ERT has shown a 2.5% year-over-year increase, mainly due to manufacturing complexities and higher biologics production costs. In the United States, therapy costs continue to rise moderately with expanding patient coverage under rare disease programs. In Germany and Japan, pricing remains more regulated, supported by government-negotiated reimbursement models and the entry of biosimilar candidates. The emergence of next-generation recombinant enzymes and improved bioprocess yields are expected to stabilize pricing over the forecast period, balancing affordability with innovation-driven value.

Key Players Overview

The market is led by a concentrated group of global biopharmaceutical innovators. Sanofi S.A. (France) and Takeda Pharmaceutical Company Limited (Japan) are the two leading players with approved ERTs-Fabrazyme and Replagal, respectively. Amicus Therapeutics (U.S.) continues to expand its footprint next-generation enzyme formulations and chaperone combination therapies. Emerging through biotechnology companies such as AVROBIO Inc. (U.S.) and Protalix BioTherapeutics (Israel) are actively developing alternative recombinant and gene therapy-based approaches, broadening the competitive landscape. Strategic partnerships, R&D collaborations, and regional distribution agreements remain central to market expansion.

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