The global treatment market for Fabry disease will expand in value from $683 million in 2014 to approximately $1.25 billion by 2024, driven primarily by rising physician awareness of the condition and consequently higher diagnosis rates, according to research and consulting firm GlobalData.
The company’s latest report states that this value increase, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, UK, and Japan, represents a moderate Compound Annual Growth Rate (CAGR) of 6.3%.
Valentina Gburcik, PhD, GlobalData’s Director of Cardiovascular and Metabolic Disorders, says that alongside increasing diagnosed cases, the market entry of the first pharmacological chaperone for the treatment of Fabry disease, namely Amicus’ migalastat, will also boost growth.
Gburcik comments: “Migalastat is anticipated to launch in the US and five European countries (5EU) in 2017, before entering the Japanese market in 2020. The patient share for migalastat is not only expected to be captured from existing patients receiving enzyme replacement therapy (ERT), but also treatment-naïve patients that have not previously been considered suitable for ERT, including children, and adults with late-onset, less severe cases of Fabry disease.”
GlobalData forecasts migalastat to garner sales of $165 million across the 7MM by the end of the forecast period, but further growth will be hindered by the drug only being available to Fabry disease patients with mutations amenable to the drug.
As a consequence, ERT will remain the standard of care, with sales of Genzyme’s Fabrazyme and Shire’s Replagal reaching $678 million and $396 million, respectively, in 2024.
Gburcik continues: “Of the two ERTs, Fabrazyme will be the market leader, which is attributed to the fact that Fabrazyme is the only therapy approved in the US.”
“As Fabry disease is a rare, life-threatening condition with debilitating symptoms, ERT has a positive reimbursement status in the 5EU and Japan, and is normally covered by insurance plans in the US. Despite its high price tag, GlobalData believes that ERT will continue to be prescribed and reimbursed as a treatment for Fabry patients,” the director concludes.