[Geneva, 27^th June 2025] – Clearview Market Insights (CVMI) projects that the global carglumic acid market will grow from USD 610 million in 2024 to USD 1.19 billion by 2031, reflecting a CAGR of 9.7%. Rising newborn screening initiatives and increasing awareness of urea cycle disorders are driving demand.

Carglumic acid is a life-saving therapy for patients with NAGS deficiency. As genetic diagnostics become more common, demand for orphan treatments continues to grow,” said Dr. Thomas Kleiber, metabolic disorders analyst at CVMI.

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Key Market Highlights

• 2024 Market Size: USD 610 million
• 2031 Forecast: USD 1.19 billion
• CAGR: 9.7% (2024–2031)

Growth Catalysts

• Expansion of Newborn Screening Programs: Mainly in North America and Europe
• Favorable regulatory landscape: orphan drug incentives and fast-track approvals.
• Patient Advocacy Impact: Boosting diagnosis rates via awareness campaigns

Segment Insights

• Primary application: NAGS deficiency treatment makes up 70% of current use.
• Distribution Channel Trend: Specialty pharmacies lead, with online channels experiencing growth
• Top Region: North America leads with a strong rare disease infrastructure, followed by Europe.

Competitive Landscape (2024)

• Recordati – 87%: Carbaglu® dominates globally
• Others – 13%: Pipeline development and early regional entries

Outlook to 2031

The future of the carglumic acid market will concentrate on affordability solutions, increased participation in clinical trials, and collaborations in genetic therapy. Growth in Asia-Pacific and Latin America will rely on newborn screening programs and healthcare funding initiatives.

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Clearview Market Insights is a leading market research and consulting firm providing in-depth industry analysis and strategic recommendations for businesses worldwide.

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