Alpha-mannosidosis Treatment Market to Reach USD 31.3 Billion by 2031, Europe Largest Market, North America Fastest Growing | DataM Intelligence

Leander, Texas - The Global Alpha-mannosidosis Market reached approximately US$12.65 billion in 2023 and is expected to grow to about US$31.3 billion by 2031, with a CAGR of around 16.5% during the forecast period of 2024 to 2031.

This significant growth is driven by increasing research investments, rising awareness of the rare hereditary disease alpha-mannosidosis, and advancements in treatment options such as enzyme replacement therapies. Additionally, the expanding patient pool and enhanced diagnostic methods contribute to market expansion.

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United States: Key Industry Developments
✅ March 2025: Sobi expanded its partnership with Ionis Pharmaceuticals to commercialize olezarsen, enhancing treatment availability beyond the US for lysosomal storage disorders including alpha-mannosidosis.

✅ January 2025: REGENXBIO entered a $110 million collaboration with Nippon Shinyaku to advance RGX-121 and related gene therapies targeting lysosomal storage diseases, including alpha-mannosidosis.

✅ February 2023 (relevant for 2025 context): Chiesi Global Rare Diseases' Lamzede (velmanase alfa), the first FDA-approved enzyme replacement therapy for alpha-mannosidosis, remains a key therapy, administered intravenously to treat enzyme deficiency symptoms in patients.

Japan: Key Industry Developments
✅ January 2025: Nippon Shinyaku partnered with REGENXBIO to develop and commercialize gene therapies for lysosomal storage disorders like alpha-mannosidosis, aiming to introduce innovative treatments in Japan.

✅ 2025 (early year emphasis): Kyowa Kirin completed acquisition of Orchard Therapeutics, reinforcing its position in rare disease gene therapy which may accelerate alpha-mannosidosis treatment research in Japan.

Key Merges and Acquisitions (2025):
✅ Kyowa Kirin completed its acquisition of Orchard Therapeutics in January 2024, securing a rare-disease gene therapy platform with commercial expertise from Lenmeldy, enhancing its position in the Alpha-mannosidosis treatment space.

✅ Sobi expanded its collaboration with Ionis Pharmaceuticals in March 2025 to deepen its rare disease reach, including olezarsen commercialization beyond the US, strengthening its pipeline and market footprint.

✅ REGENXBIO entered a $110 million collaboration with Nippon Shinyaku in January 2025 for RGX-121 and related lysosomal storage disorder gene therapies, including therapies relevant to alpha-mannosidosis, to enhance its commercial and development capabilities.

Market Segmentation Analysis:
-By Indication: Type I, Type II, Type III
Type I leads with the highest market share, attributed to its higher prevalence and demand for treatment in earlier diagnosed patients. Types II and III constitute smaller shares due to lower incidence rates.

-By Treatment: Bone Marrow Transplant (BMT), Enzyme Replacement Therapy (ERT), Gene Therapy, Others
ERT dominates with approximately 82.4% market share in 2024, benefiting from velmanase alfa's first-to-market position. Gene Therapy is the fastest growing segment, forecasted to expand at a CAGR of about 18.4% through 2030, signaling future disruption. BMT and Others hold smaller shares.

-By End User: Hospitals, Specialty Clinics, Others
Hospitals hold the largest share among end users because of the intensive care required for alpha-mannosidosis treatment, followed by specialty clinics. Other end users contribute a relatively minor share.

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Growth Drivers:
-Increasing awareness and diagnosis rates of alpha-mannosidosis, aided by advanced diagnostic tools and genetic screening programs.

-Advancements in enzyme replacement therapy (ERT), which remains the dominant treatment approach with improved efficacy and reduced side effects.

-Growing research and development efforts focused on innovative therapies like gene therapy, offering potential long-term solutions.

-Supportive government policies and initiatives aimed at orphan drug development and access, including incentives for rare disease treatments.

-Rising prevalence of rare genetic and lysosomal storage disorders, expanding the patient pool needing specialized treatments.

-Enhanced involvement of pharmaceutical companies investing in clinical research, strategic partnerships, and market penetration strategies.

Regional Insights:
-North America: North America is the largest market overall. The U.S. holds a significant share, attributed to advanced healthcare infrastructure, high healthcare spending, a focus on orphan drug development (supported by legislation like the Orphan Drugs Act), and the FDA's 2024 approval of the enzyme replacement therapy (ERT) Lamzede. The region is also the fastest growing, projected to expand at a 15.7% CAGR through 2030, driven by expanding newborn screening initiatives and a high number of clinical trials.

-Europe: Europe held the largest revenue share in 2024, accounting for approximately 41.3%. The market benefits from well-established healthcare systems and earlier reimbursement pathways for ERTs. However, the market is fragmented due to variations in healthcare funding models across countries, leading to a "patchwork" of market access scenarios. Germany, the UK, and France are key markets.

-Asia-Pacific: The Asia-Pacific region is the fastest-growing market. This growth is fueled by increasing awareness of rare genetic diseases, improving healthcare infrastructure, rising disposable incomes, and government initiatives to boost crop yields (not directly relevant, this seems like a snippet from another report), and the implementation of newborn screening programs. China and India show significant potential for market expansion.

-Latin America: This region represents an emerging market with steady growth potential, driven by rising demand for advanced medical devices and a growing middle class.

-Middle East & Africa: This region accounts for a smaller share of the global market but is anticipated to grow due to increasing healthcare investments, new hospital construction, and growing awareness of rare diseases.

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Key Players:
CHIESI Farmaceutici S.p.A. | Zymenex

Key Highlights (Top 5 Key Players) for Alpha-mannosidosis Treatment Market:
-Chiesi Farmaceutici S.p.A. reported rare disease segment revenues of approximately USD 540 million (about €540M in 2023), driven by its Lamzede enzyme replacement therapy and a growing focus on alpha-mannosidosis treatment, contributing significantly to the overall €3 billion (around USD 3.2 billion) group sales.

-Zymenex, a pioneer in enzyme replacement therapies for alpha-mannosidosis, has shown significant growth in market revenue with a strong position in this niche segment, though exact revenue figures are less publicly detailed.

-Sanofi Genzyme is identified as a key player with a notable share in the alpha-mannosidosis treatments market, benefiting from its expertise in rare diseases and a broad portfolio in enzyme replacement therapies.

-Pfizer holds a competitive position in the alpha-mannosidosis treatment sphere, leveraging its pharmaceutical scale and R&D investments into rare genetic disorders.

-Amgen is also among key companies competing in this market, focusing on innovative therapies for rare diseases including alpha-mannosidosis.

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