The global carglumic acid market size was estimated to be USD 139.4 million in 2023 and is expected to reach USD 309.2 million by 2034 with a CAGR of 7.51% during the forecast period 2024-2034. Rising prevalence of urea cycle disorders, expanding applications beyond UCDs, increasing disposable income and improved healthcare infrastructure, orphan drug status and limited competition, technological advancements and product development, growing focus on personalized medicine and early diagnosis, and strategic partnerships and collaborations will drive the market growth.
The uncommon hereditary metabolic diseases known as UCDS impair the body's capacity to metabolize ammonia, a hazardous waste product. Demand has grown since carglumic acid is an essential therapy for several UCDs, most notably N-acetylglutamate synthase deficiency (NAGS deficiency). Increased diagnoses of UCD instances are fueled by rising awareness and better diagnostics, which further propels market expansion. For instance, Recordati claims that Recardio and Recartio Plus, their new ARBs, would be available in Europe starting in May 2023. Carglumic acid is the active component in these medications.
By dosage form, the dispersible tablets segment accounted for the highest revenue-grossing segment in the global carglumic acid market in 2023 and is predicted to grow at the fastest CAGR during the forecast period owing to the increasing preference among healthcare professionals and patients for this convenient and easily administrable dosage form. The dispersible tablets offer improved patient compliance, ease of consumption, and efficient absorption, driving their adoption for the treatment of hyperammonemia, thereby contributing significantly to the overall market expansion. For instance, in October 2022, Dipharma Francis and a top Chinese pharmaceutical business form a strategic alliance for the provision of carglumic acid. It is anticipated that this collaboration would increase Dipharma's market share in Asia.
By distribution channel, the hospital pharmacies segment accounted for the highest revenue-grossing segment in the global carglumic acid market in 2023 and is predicted to grow at the fastest CAGR during the forecast period owing to the increasing prevalence of hyperammonemia cases requiring immediate medical attention, coupled with the crucial role played by hospital pharmacies in the distribution and administration of specialized medications. The close collaboration between healthcare professionals and hospital pharmacies ensures prompt access to Carglumic Acid for patients in need, driving the segment's financial performance. For instance, in July 2023, Lucane Pharma is granted a new patent for a creative method of producing carglumic acid. It is anticipated that this patent would solidify Lucane's standing as the drug's top producer.
North American region is anticipated to have the highest revenue share during the forecast period owing to the well-established healthcare infrastructure, increased awareness of metabolic disorders, and a growing number of diagnosed cases of hyperammonemia. Additionally, favorable reimbursement policies, advanced research and development activities, and a proactive regulatory environment contribute to the region's dominance in the Carglumic Acid market. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the increasing awareness of rare genetic disorders, a rising incidence of metabolic diseases, and efforts to enhance healthcare infrastructure. Additionally, expanding healthcare expenditure, improving access to medical treatments, and a growing emphasis on early disease diagnosis contribute to the significant market potential in the Asia Pacific. For instance, in June 2022, Sigma-Aldrich increases the amount of carglumic acid it can produce at its German plant. It is anticipated that this expansion would satisfy the medication's rising demand.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
The uncommon hereditary metabolic diseases known as UCDS impair the body's capacity to metabolize ammonia, a hazardous waste product. Demand has grown since carglumic acid is an essential therapy for several UCDs, most notably N-acetylglutamate synthase deficiency (NAGS deficiency). Increased diagnoses of UCD instances are fueled by rising awareness and better diagnostics, which further propels market expansion. For instance, Recordati claims that Recardio and Recartio Plus, their new ARBs, would be available in Europe starting in May 2023. Carglumic acid is the active component in these medications.
By dosage form, the dispersible tablets segment accounted for the highest revenue-grossing segment in the global carglumic acid market in 2023 and is predicted to grow at the fastest CAGR during the forecast period owing to the increasing preference among healthcare professionals and patients for this convenient and easily administrable dosage form. The dispersible tablets offer improved patient compliance, ease of consumption, and efficient absorption, driving their adoption for the treatment of hyperammonemia, thereby contributing significantly to the overall market expansion. For instance, in October 2022, Dipharma Francis and a top Chinese pharmaceutical business form a strategic alliance for the provision of carglumic acid. It is anticipated that this collaboration would increase Dipharma's market share in Asia.
By distribution channel, the hospital pharmacies segment accounted for the highest revenue-grossing segment in the global carglumic acid market in 2023 and is predicted to grow at the fastest CAGR during the forecast period owing to the increasing prevalence of hyperammonemia cases requiring immediate medical attention, coupled with the crucial role played by hospital pharmacies in the distribution and administration of specialized medications. The close collaboration between healthcare professionals and hospital pharmacies ensures prompt access to Carglumic Acid for patients in need, driving the segment's financial performance. For instance, in July 2023, Lucane Pharma is granted a new patent for a creative method of producing carglumic acid. It is anticipated that this patent would solidify Lucane's standing as the drug's top producer.
North American region is anticipated to have the highest revenue share during the forecast period owing to the well-established healthcare infrastructure, increased awareness of metabolic disorders, and a growing number of diagnosed cases of hyperammonemia. Additionally, favorable reimbursement policies, advanced research and development activities, and a proactive regulatory environment contribute to the region's dominance in the Carglumic Acid market. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the increasing awareness of rare genetic disorders, a rising incidence of metabolic diseases, and efforts to enhance healthcare infrastructure. Additionally, expanding healthcare expenditure, improving access to medical treatments, and a growing emphasis on early disease diagnosis contribute to the significant market potential in the Asia Pacific. For instance, in June 2022, Sigma-Aldrich increases the amount of carglumic acid it can produce at its German plant. It is anticipated that this expansion would satisfy the medication's rising demand.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Dosage Form, and Distribution Channel
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of the Top 10+ Major Market Players
- 20% Free Customization Available to Meet Your Exact Requirement.
Segmentation: Carglumic Acid Market Report 2023 - 2034
Carglumic Acid Market Analysis & Forecast by Dosage Form 2023 - 2034 (Revenue USD Mn)
- Orally Disintegrating Tablets
- Dispersible Tablets
- Other Dosage Forms
Carglumic Acid Market Analysis & Forecast by Distribution Channel 2023 - 2034 (Revenue USD Mn)
- Hospital Pharmacies
- Retail Pharmacies
- E-commerce Channels
Carglumic Acid Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Mn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Carglumic Acid Market: Dosage Form Estimates & Trend Analysis
8. Carglumic Acid Market: Distribution Channel Estimates & Trend Analysis
9. Regional Market Analysis
10. North America Carglumic Acid Market
11. Europe Global Carglumic Acid Market
12. Asia Pacific Global Carglumic Acid Market
13. Latin America Global Carglumic Acid Market
14. MEA Global Carglumic Acid Market
15. Competitor Analysis
16. Company Profiles
Companies Mentioned
- Recordati S.p.A.
- Dipharma Francis S.r.l.
- Lucane Pharma
- Sigma-Aldrich (Merck KGaA)
- Novartis AG
- Rare Disease Therapeutics Inc.
- Beijing Continent Pharmaceuticals Co. Ltd.
- United States Pharmacopeia (USP)
- Aceto Corporation
- Hangzhou Hyper Chemicals Limited
- MedChemExpress
- AlliChem LLC
- TCI America
- Tokyo Chemical Industry Co. Ltd. (TCI)
- VIO Chemicals.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | March 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 139.4 Million |
| Forecasted Market Value ( USD | $ 309.2 Million |
| Compound Annual Growth Rate | 7.5% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
