EU5, USA, and Japan Alpha Mannosidosis (Enzyme Replacement Therapy) ERT Market is Estimated to be US$ 33.73 Million in 2023, Owing to the Great Number of AM Diagnosed Patients in Europe and the United States

The EU5, USA, and Japan alpha mannosidosis enzyme replacement therapy (ERT) pharma market is expected to value US$ 100.0 Million by 2030 growing at a CAGR of 37.2% over the forecast period owing to the launch of Velmanase alfa, the one and only approved enzyme replacement therapy for alpha mannosidosis by the EMA in all the European countries. An increasing number of diagnosed patients with Type 1 and Type 2 AM in the UK, Germany, France, the United States, and other countries coupled with the availability of reimbursement policies for ultra-rare disorder drugs in the United States, Germany are expected to create lucrative opportunities for the growth of the market. In addition, there is no ERT in clinical trials or in the market for alpha mannosidosis, in the USA, there is an increase in trend for the co-insurance of the drugs and payers showing interest towards the drugs that are providing co-insurance programs. For instance, Kanuma (Sebelipase Alfa), offering a commercial co-pay program can limit out-of-pocket expenses to $5 for eligible patients with commercial insurance. Moreover, more than 70 patients in Germany are readily eligible for ERT treatment and in the UK, according to NICE, more than 30 patients are eligible for ERT and many more are yet to be diagnosed. However, a very limited number of patients for ultra-rare diseases and rejection for drug reimbursement by the HTA bodies such as NICE (, and the high cost of enzyme replacement therapy are anticipated to restrain the growth of the market over the forecast period.

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Type II segment accounted for a higher revenue share.

Based on type, EU5, USA, and Japan alpha mannosidosis therapeutics market is segmented into Type I and Type II. Type II segment accounted for the largest market share in 2022 with respect to revenue owing to the greater number of patients with AM are diagnosed with Type II AM, those who are readily eligible for ERT, and the percentage of revenue that is to be generated is pretended to be around 72.5% by 2030. More than 79% of patients in the market are diagnosed with Type II AM in 2022. Patient access schemes and other commercial agreements and focus on recognizing Type I and Type II patients by conducting awareness campaigns and benefits of early diagnosis of patients could offer lucrative opportunities over the forecast years.

Germany is expected to lead EU5, USA, and Japan Alpha Mannosidosis ERT Market

PBI's EU5, USA, and Japan Alpha Mannosidosis pharmaceuticals market report analyses the market in different countries such as Germany, the UK, Italy, France, Spain, the USA, and Japan. According to country analysis, Germany is expected to account for a larger revenue share in 2022 and the same trend is projected to follow over 2023-2030 owing to the launch or commercialization of ERT (Lamzede) in Germany and the highest number of Type I and Type II patients are readily eligible for ERT coupled with availability of reimbursement for the product in the country is expected to drive the growth of the market over the forecast period. The Germany AM ERT market is expected to create an opportunity of US$ 15.3 Mn over 2023 - 2030. Approval of Lamzede for reimbursement in the UK by NICE would offer lucrative opportunities for the product over the forecast years. The launch of the product is expected at the end of 2022 in the United States and is expected to emerge as the market leader in AM ERT market over the forecast years.

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Recent Developments in the EU5, USA, and Japan Alpha Mannosidosis ERT Market:
In February 2023, the US Food and Administration approved velmanase alfa-tycv for the treatment of non-central nervous systems manifestations of alfa-mannosidosis in adult and pediatric patients.
For instance, in April 2018, Chiesi announced that the European Commission granted the marketing authorization for Lamzede® (Velmanase alfa), the first enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha‑mannosidosis (AM), an ultra-rare progressive and debilitating disease)
In 2013, Chiesi announced that it had signed a definitive agreement with Sunstone Capital to acquire Zymenex Holding A/S and its related group of companies.

Key player profiles in the report are Chiesi Farmaceutici

Detailed Segmentation
By Alpha Mannosidosis Type
o Type I
o Type II

Countries
o EU5
• Germany
• France
• U.K
• Italy
• Spain
o Japan
o USA

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