Nexviazyme Market Report 2025: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

This Nexviazyme market report delivers an in-depth analysis of the market’s key characteristics, including size, growth potential, and segmentation. It provides a detailed breakdown of the market across major regions and leading countries, highlighting historical data and future growth projections. The report also examines the competitive landscape, market share insights, emerging trends, and strategic developments shaping the market.

The growth observed in the historic period can be attributed to several factors, including the rising global prevalence of Pompe disease, increasing investments in the rare disease treatment sector, expanded patient access to innovative therapies due to improvements in healthcare infrastructure, FDA approval of Nexviazyme for late-onset Pompe disease, and positive clinical trial results demonstrating its efficacy in improving respiratory function and mobility.

Market growth during the forecast period can be attributed to factors such as the increasing global demand for enzyme replacement therapies, growing government support for rare disease treatments, the expansion of healthcare systems in emerging markets, rising research and development investments in gene therapies and related treatments, and increased healthcare spending in developed economies. Key trends expected to shape the forecast period include a shift toward more targeted and efficient enzyme therapies, the growth of gene therapy research as a complement to enzyme therapies, greater use of digital health technologies for treatment monitoring, the development of combination therapies for Pompe disease, and advancements in biopharmaceutical manufacturing to improve production efficiency.

The growing prevalence of Pompe disease is expected to drive the expansion of the Nexviazyme market. Pompe disease is a rare genetic disorder caused by a deficiency of the enzyme acid alpha-glucosidase, leading to the accumulation of glycogen in muscles. This results in progressive muscle weakness and respiratory problems. The increasing number of Pompe disease cases can be linked to improvements in diagnostic technologies, such as genetic screening and newborn screening programs. Nexviazyme is an enzyme replacement therapy used to treat late-onset Pompe disease, helping reduce glycogen buildup in muscles, enhancing respiratory function, and improving mobility. For example, in December 2024, a report from the International Brain Research Organization stated that the global birth prevalence of Pompe disease was 2 cases per 100,000 live births, with infantile-onset Pompe disease at 1 cases per 100,000 live births and late-onset Pompe disease at 2.4 cases per 100,000 live births. As a result, the increasing prevalence of Pompe disease is driving the growth of the Nexviazyme market.

A key trend in the Nexviazyme market is the development of new treatment options for patients aged one year and older with late-onset Pompe disease. Nexviazyme, an enzyme replacement therapy, targets the mannose-6-phosphate (M6P) receptor to enhance the cellular uptake of the enzyme, helping treat this progressive muscle disorder. For example, the Food and Drug Administration (FDA) approved Nexviazyme for patients aged one year and older with late-onset Pompe disease. Clinical trials demonstrated its ability to improve respiratory function and walking distance, positioning it as a transformative therapy for rare diseases.

In May 2023, Sanofi, a France-based pharmaceutical company, entered into an exclusive license agreement with Maze Therapeutics to further the development of its glycogen synthase 1 (GYS1) program and its lead candidate, MZE001, for Pompe disease. This collaboration could significantly improve patient outcomes by addressing the root causes of glycogen accumulation and potentially enhancing the overall efficacy of treatments. Maze Therapeutics, a US-based biotechnology company, focuses on developing precision medicines for rare genetic disorders.

The key company operating in the nexviazyme market is Sanofi S.A.

North America was the largest region in the nexviazyme market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in nexviazyme report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the nexviazyme market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Nexviazyme is a medication designed for the treatment of Pompe disease, a rare genetic disorder that affects muscle and respiratory function. It is a biologic therapy developed to address the underlying cause of the disease by replacing the missing or deficient enzyme, acid alpha-glucosidase (GAA). This helps improve muscle strength and respiratory function in affected patients.

The main indications for Nexviazyme are infantile-onset Pompe disease and late-onset Pompe disease. Infantile-onset Pompe disease is a rare genetic disorder that typically appears in infants within the first few months of life. Nexviazyme is distributed through hospital pharmacies, retail pharmacies, and online pharmacies, and is used by various end users, including adults, pediatrics, and geriatrics.

The nexviazyme market research report is one of a series of new reports that provides nexviazyme market statistics, including nexviazyme industry global market size, regional shares, competitors with a nexviazyme market share, detailed nexviazyme market segments, market trends and opportunities, and any further data you may need to thrive in the nexviazyme industry. This nexviazyme market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The nexviazyme market consists of sales of nexviazyme Infusion pumps and intravenous (IV) tubing. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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