Carglumic Acid Market Size Worth $281.81 Million by 2033: The Brainy Insights

The global Carglumic Acid market is anticipated to grow from USD 138.27 million to USD 281.81 million in 10 years. The market is likely to experience growth due to rising government initiatives and awareness campaigns addressing various metabolic disorders, particularly in the management and treatment of hyperammonemia disease. Carglumic acid, a crucial medication for lowering ammonia concentrations in the bloodstream, is projected to drive the growth of the carglumic acid market during the forecast years. Additionally, established industry leaders' increased focus on research and development to create innovative orphan drugs is expected to propel the global carglumic acid market.


Newark, March 05, 2024 (GLOBE NEWSWIRE) -- The Brainy Insights estimates that the USD 138.27 million in 2023 global Carglumic Acid market will reach USD 281.81 million by 2033. Integrating carglumic acid treatment with digital health solutions like remote monitoring and telehealth can enhance patient management. These technological advancements offer opportunities to improve adherence, monitor outcomes, and streamline healthcare delivery. Furthermore, expanding and optimizing patient assistance programs for carglumic acid can improve patient access. Initiatives such as financial assistance, co-pay support, and educational resources contribute to market growth. Also, investing in awareness campaigns and educational initiatives for healthcare professionals, patients, and caregivers can contribute to early diagnosis and treatment. Increased awareness fosters a supportive environment for carglumic acid market growth. In addition, implementing tailored marketing strategies highlighting the unique benefits of carglumic acid for treating urea cycle disorders can enhance market positioning. This aspect includes targeted promotional efforts towards healthcare providers and patient communities. Exploring innovations in drug delivery systems for carglumic acid can also improve administration convenience and patient adherence. Enhanced formulations or alternative delivery methods can contribute to market differentiation. Besides, active participation in global rare disease initiatives and collaborations can provide opportunities for advocacy, research, and improved access to carglumic acid. Engaging with international networks supports a more comprehensive approach to rare disease management.

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Key Insight of the global Carglumic Acid market

Asia Pacific is expected to witness the highest market growth over the forecast period.

The Asia Pacific region has a large and diverse population. The genetic diversity in this region may contribute to a higher prevalence of rare genetic disorders, including urea cycle disorders, driving the demand for carglumic acid. Also, there is an increasing focus on healthcare awareness and improvements in diagnostic capabilities in many Asia-Pacific countries. This factor has led to better recognition and diagnosis of rare diseases, creating a conducive environment for the adoption of carglumic acid. Furthermore, many governments in the Asia Pacific region are experiencing economic growth, leading to increased healthcare expenditure. This spending increase supports advancements in healthcare infrastructure, research, and access to innovative treatments, including carglumic acid. Additionally, many nations in the Asia Pacific region are undertaking initiatives to address rare diseases. Policies and support programs for research, development, and access to treatments contribute to the expected growth of the carglumic acid market. Most importantly, the pharmaceutical markets in countries like China and India are rapidly growing. This evolution is driven by increased investments in research and development, making these markets attractive for introducing and expanding carglumic acid. The biotechnology sector in the Asia Pacific region is also expanding, focusing on developing innovative therapies for various medical conditions. This growth presents opportunities for the development and commercialization of carglumic acid.

In 2023, the dispersible tablets segment held the largest market share at 54.29% and a market revenue of 75.10 million.

The dosage form segment is split into orally disintegrating tablets, dispersible tablets and others. In 2023, the dispersible tablets segment held the largest market share at 54.29% and a market revenue of 75.10 million.

In 2023, the hospital pharmacies segment dominated the market with the largest share of 60.13% and revenue of 83.14 million.

The distribution channel segment is divided into hospital pharmacies, retail pharmacies and online pharmacies. In 2023, the hospital pharmacies segment dominated the market with the largest share of 60.13% and revenue of 83.14 million.

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Advancement in market

In January 2021: Recordati Rare Diseases Inc. has disclosed that the FDA has authorised a new indication for CARBAGLU (carglumic acid) tablets 200mg. This approval expands the usage of CARBAGLU as adjunctive therapy, in addition to standard care, for treating acute hyperammonemia associated with PA (propionic acidemia) or MMA (methylmalonic academia) in pediatric and adult patients. CARBAGLU stands out as the first and only FDA-authorised medication for addressing acute hyperammonemia related to PA and MMA. Additionally, it is approved as a maintenance therapy for addressing chronic hyperammonemia resulting from NAGS deficiency. This latest approval underscores the versatility of CARBAGLU in addressing acute hyperammonemia in a broader spectrum of metabolic disorders, further advancing its role in rare disease treatment.

Market Dynamics

Driver: Expanding healthcare infrastructure.

Expanding healthcare infrastructure involves establishing and reinforcing medical facilities, including hospitals, clinics, and diagnostic centres. In developing regions, where healthcare services may have been limited in the past, these developments foster a more comprehensive and accessible healthcare system. The increased availability of diagnostic facilities allows for timely and accurate identification of various medical conditions, including rare diseases like hyperammonemia. Moreover, improving healthcare systems enables more efficient management and treatment of rare diseases. Patients with hyperammonemia can receive prompt, effective care with better-trained healthcare professionals and upgraded medical facilities. This factor not only improves patient outcomes but also contributes to the overall effectiveness of the healthcare system. In hyperammonemia, a rare disorder characterized by elevated ammonia levels in the blood, the demand for specific treatments like carglumic acid is rising. Carglumic acid is a pharmaceutical agent known for its effectiveness in managing hyperammonemia by aiding in removing excess ammonia from the body. As healthcare infrastructure expands, the awareness and understanding of rare diseases, including hyperammonemia, increase among healthcare providers. Consequently, there is a heightened demand for specialized medications like carglumic acid to address the specific needs of patients with rare metabolic disorders.

Restraint: Limited awareness and diagnosis.

One notable impediment in the widespread adoption of carglumic acid as a treatment option is the restricted awareness surrounding urea cycle disorders (UCDs) and the consequential underdiagnosis of these rare diseases. This lack of awareness and underdiagnosis poses a significant challenge, as it often results in patients needing to be correctly identified and diagnosed with UCDs. Consequently, this underdiagnosis contributes to a deficient demand for carglumic acid, a specific treatment designed to address the metabolic abnormalities associated with these disorders.

Opportunity: Innovation in drug delivery systems.

Innovations in drug delivery systems have the potential to significantly improve both the convenience and effectiveness of administering carglumic acid, a medication used in the treatment of urea cycle disorders. These advancements encompass the development of extended-release formulations and alternative delivery methods, providing patients with enhanced options for managing their condition. These innovations not only enhance the convenience of carglumic acid administration but also contribute to the overall effectiveness of treatment. Tailoring drug delivery systems to individual patient needs can improve therapeutic outcomes, reduce side effects, and enhance quality of life. Additionally, these advancements may expand the range of patients who can benefit from carglumic acid, addressing specific challenges associated with traditional medication administration.

Challenge: Stigma associated with rare diseases.

The stigma surrounding rare diseases arises from a lack of awareness and understanding within society. Individuals with rare diseases may face misconceptions, prejudice, or societal judgment due to the unfamiliarity of their conditions. This lack of attention can lead to delayed diagnosis as patients may be hesitant to seek medical attention or may encounter healthcare professionals unfamiliar with the specificities of rare diseases. Furthermore, the rarity of these conditions may result in isolation for affected individuals and their families. The feeling of being 'different' or 'alone' can contribute to delayed reporting of symptoms, avoidance of seeking medical help, and, subsequently, delayed diagnosis. This social isolation can be exacerbated by a lack of support groups or resources for individuals with rare diseases, further impeding the dissemination of information and awareness. In addition, the social challenges associated with rare diseases may include difficulties accessing appropriate healthcare services. Limited knowledge about rare diseases among healthcare providers may lead to misdiagnosis or a failure to consider less common conditions. This lack of understanding can delay the initiation of suitable treatments, such as carglumic acid, specifically designed to address the metabolic abnormalities associated with urea cycle disorders.

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Some of the major players operating in the global Carglumic Acid market are:

• Apothecon Pharmaceuticals Pvt. Ltd.
• Biophore India Pharmaceuticals Pvt. Ltd.
• Civentichem LLC
• Dipharma
• Eton Pharmaceuticals
• Manus Aktteva Biopharma LLP
• Recordati Rare Diseases Inc.
• Nuray Chemicals
• Novitium Pharma LLC
• Rhyme Organics and Chemicals Ltd.
• Suven Life Sciences Limited

Key Segments cover in the market:

By Dosage Form

• Orally Disintegrating Tablets
• Dispersible Tablets
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America (U.S., Canada, Mexico)
• Europe (Germany, France, the UK, Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America)
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

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About the report:

The market is analyzed based on value (USD Million). All the segments have been analyzed worldwide, regional, and country basis. The study includes the analysis of more than 30 countries for each part. The report analyses driving factors, opportunities, restraints, and challenges to gain critical market insight. The study includes Porter's five forces model, attractiveness analysis, Product analysis, supply, and demand analysis, competitor position grid analysis, distribution, and marketing channels analysis.

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