Summary

Overview
Global Hyperammonemia Market reached US$ XX billion in 2022 and is expected to reach US$ XX billion by 2030, growing with a CAGR of XX% during the forecast period 2023-2030.
The global hyperammonemia market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. The increase in urea cycle disorders is driving factor of the market.
Hyperammonemia is associated with a number of factors. The oral medication acts as the first line of defense. Drugs such as rifaximin, sodium benzoate, and others are preferred for reducing the symptoms of the disease. The increase in the launches and approvals will play a major role in elevating the market growth.
The oral medication segment accounts for the largest share of the market. Oral medications are readily available and are cost-effective Similarly, North America holds a significant position in the market share owing to the increase in healthcare expenditure, advancements in healthcare, and the approvals of the products.
Dynamics
Increase in the Prevalence of Urea Cycle Disorders will Drive the Market Growth
An increase in the prevalence of urea cycle disorders is driving market growth. For instance, according to NIH, the incidence of UCDs is estimated to be at least 1:35,000 births. Newborns can develop hyperammonemia due to a congenital urea cycle disorder (a genetic condition they're born with). Children can develop hyperammonemia.
Urea cycle disorders are inborn errors of metabolism resulting from defects in one of the enzymes or transporter molecules involved in the hepatic removal of ammonia from the bloodstream. Urea cycle disorder is a genetic condition, also known as an inborn error of metabolism, that causes ammonia to build up in the blood (hyperammonemia), which is toxic to the body. Symptoms of this condition target the brain and organ function.
Additionally, ornithine transcarbamylase deficiency is the most common of the urea cycle disorders. It is an X-linked genetic disorder that prevents the breakdown and excretion of ammonia. This accumulates ammonia, rising to toxic levels affecting the central nervous system. Thus, the increase in the number of urea cycle disorders will drive the market in the forecast period.
Side Effects Associated with the Available Treatments can Impede the Market Growth
The side effects associated with the drugs available can impede market growth. Hyperammonemia treatment consists of sodium benzoate/sodium phenylacetate IV, lactulose, and rifaximin. Potential side effects of using rifaximin may include nausea, stomach pain, and headaches.
The side effects of sodium benzoate may include nausea, headaches, and impaired mental status. Lactulose diarrhea, vomiting, muscle cramps/weakness, irregular heartbeat, mental/mood changes, and seizures. Thus, the side effects associated can hamper the market growth.
Segment Analysis
The global hyperammonemia market is segmented based on type, treatment, route of administration, distribution channel, and region.
Oral Medication Segment Holds a Significant Market Share
Hyperammonemia is a metabolic condition characterized by raised ammonia levels, a nitrogen-containing compound. Ammonia is a potent neurotoxin. Hyperammonemia most commonly presents with neurological signs and symptoms that may be acute or chronic, depending on the underlying abnormality. The first-line therapy for encephalopathy is an oral medication that includes lactulose and lactitol. These sugars decrease the production and absorption of ammonia in the intestines.
Sodium benzoate decreases the blood ammonium level by reducing glycine metabolism in the liver, kidney, and brain. Benzoate integrates with coenzyme A (CoA) to form benzoyl-CoA in hepatocyte mitochondria. Then, benzoyl-CoA transfers the benzoyl moiety of the CoA ester to glycine and produces hippurate. This process hampers glycine degradation by the ammonia-forming metabolic pathway in the liver, kidney, and brain. Thus, the above factors are holding the segment dominant in market share.
Geographical Penetration
North America is Expected to Dominate the Market Share
North America holds a significant position in the hyperammonemia market share. The increased healthcare expenditure, launches, and product approvals can expand this region's market growth. Due to the presence of major players in the region, a number of products are available for the treatment of the disease. The increase in research and technology in the region also plays a vital role in the growth of the market in the region.
The United States has one of the most developed healthcare in the world. For instance, according to the American Medical Association, health spending in the U.S. increased by 2.7% in 2021 to $4.3 trillion or $12,914 per capita. Additionally, in 2021, the U.S. healthcare system spent $603 billion on prescription drugs before accounting for rebates, of which $421 billion was on retail drugs. Spending growth on drugs was primarily due to growth in spending per prescription and, to a lesser extent, by increased utilization. Thus, the increase in the healthcare expenditure will drive the market growth.
COVID-19 Impact Analysis
The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for pharmaceutical markets worldwide, including the global hyperammonemia market. As countries grappled with lockdowns, supply chain disruptions and the manufacturing of products and drugs were halted and have significantly impacted the market.
The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting diagnosis, treatment, and the availability of drugs. Patients could not reach out to the hospitals, and there was a delay in the diagnosis and postponements of the follow-ups. As a result, many key players have halted the production and supply of the drugs.
The COVID-19 pandemic severely disrupted global supply chains, impacting the supply of the drugs to the retail stores. The focus of the companies has shifted to emergency drugs and vaccines, which has impacted the market negatively. The restrictions for non-essential drugs have declined the market growth. The stringent rules and regulations have affected the growth of the market. However, these regulations and restrictions have reduced the spread of the virus.
By Type
• Acute Hyperammonemia
• Chronic Hyperammonemia
By Treatment
• Intravenous infusion
• Oral Medication
o Lactulose
o Lactitol
• Dietary supplements
o L-carnitine
o L-ornithine-L-aspartate
o Arginine
By Route of Administration
• Intravenous
• Oral
By Distribution Channel
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o South Korea
o Rest of Asia-Pacific
• Middle East and Africa
Key Developments
• On December 22, 2022, the Food and Drug Administration (FDA) approved Olpruva (sodium phenylbutyrate) as an oral suspension for the treatment of patients with urea cycle disorders (UCDs). Olpruva, a nitrogen-binding agent, is indicated as adjunctive therapy to standard of care, including dietary management, for the chronic management of adult and pediatric patients weighing 20kg or greater and with a body surface area of 1.2m2 or greater, with UCDs involving deficiencies of carbamyl phosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase.
• On January 26, 2021, Recordati Rare Diseases Inc. stated that the U.S. Food and Drug Administration (FDA) has approved a new indication for CARBAGLU (carglumic acid) tablets 200mg as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic academia (MMA) in pediatric and adult patients. CARBAGLU is the first and only FDA-approved medication for treating acute hyperammonemia due to PA and MMA. The FDA initially approved CARBAGLU for N acetylglutamate synthase (NAGS) deficiency, another rare metabolic disorder, as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency and maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
Competitive Landscape
The major global players in the market include Bausch Health Companies Inc., Recordati Rare Diseases Inc., Medunik USA, Pfizer Inc., Manus Aktteva Biopharma LLP, Wellona Pharma, Merck KGaA, Biobrick Pharma, Asterisk Laboratories Pvt. Ltd, and Orpharma Pty Ltd among others.
Why Purchase the Report?
• To visualize the global hyperammonemia market segmentation based on type, treatment, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of hyperammonemia market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global hyperammonemia market report would provide approximately 61 tables, 58 figures, and 186 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Type
3.2. Snippet by Treatment
3.3. Snippet by Route of Administration
3.4. Snippet by Distribution Channel
3.5. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Increase in the prevalence of urea cycle disorders
4.1.1.2. XX
4.1.2. Restraints
4.1.2.1. Side effects associated with the available treatments
4.1.3. Opportunity
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Russia-Ukraine War Impact Analysis
5.6. DMI Opinion
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID
6.1.2. Scenario During COVID
6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion
7. By Type
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
7.1.2. Market Attractiveness Index, By Type
7.2. Acute Hyperammonemia*
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Chronic Hyperammonemia
8. By Treatment
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
8.1.2. Market Attractiveness Index, By Treatment
8.2. Intravenous infusion*
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Oral Medication
8.3.1. Lactulose
8.3.2. Lactitol
8.4. Dietary supplements
8.4.1. L-carnitine
8.4.2. L-ornithine-L-aspartate
8.4.3. Arginine
9. By Route of Administration
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
9.1.2. Market Attractiveness Index, By Route of Administration
9.2. Intravenous *
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.2.3. Oral
10. By Distribution Channel
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
10.1.2. Market Attractiveness Index, By Distribution Channel
10.2. Hospital Pharmacies *
10.2.1. Introduction
10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Retail Pharmacies
10.3.1. Online Pharmacies
11. By Region
11.1. Introduction
11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
11.1.2. Market Attractiveness Index, By Region
11.2. North America
11.2.1. Introduction
11.2.2. Key Region-Specific Dynamics
11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.2.7.1. U.S.
11.2.7.2. Canada
11.2.7.3. Mexico
11.3. Europe
11.3.1. Introduction
11.3.2. Key Region-Specific Dynamics
11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.3.7.1. Germany
11.3.7.2. UK
11.3.7.3. France
11.3.7.4. Italy
11.3.7.5. Russia
11.3.7.6. Rest of Europe
11.4. South America
11.4.1. Introduction
11.4.2. Key Region-Specific Dynamics
11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.4.7.1. Brazil
11.4.7.2. Argentina
11.4.7.3. Rest of South America
11.5. Asia-Pacific
11.5.1. Introduction
11.5.2. Key Region-Specific Dynamics
11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11.5.7.1. China
11.5.7.2. India
11.5.7.3. Japan
11.5.7.4. Australia
11.5.7.5. Rest of Asia-Pacific
11.6. Middle East and Africa
11.6.1. Introduction
11.6.2. Key Region-Specific Dynamics
11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
12. Competitive Landscape
12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis
13. Company Profiles
13.1. Bausch Health Companies Inc.*
13.1.1. Company Overview
13.1.2. Product Portfolio and Description
13.1.3. Financial Overview
13.1.4. Key Developments
13.2. Recordati Rare Diseases Inc.
13.3. Medunik USA
13.4. Pfizer Inc.
13.5. Manus Aktteva Biopharma LLP
13.6. Wellona Pharma
13.7. Merck KGaA
13.8. Biobrick Pharma
13.9. Asterisk Laboratories Pvt. Ltd
13.10. Orpharma Pty Ltd
LIST NOT EXHAUSTIVE
14. Appendix
14.1. About Us and Services
14.2. Contact Us