Hyperammonemia Treatment Market

Hyperammonemia Treatment Market Snapshot (2023 to 2033)

Expected to hold a valuation of USD 1,318.05 Million in 2023, the hyperammonemia treatment market is forecast to register a CAGR of 4.77% during the 2023 to 2033 assessment period. By the end of the said decade, the market worth of hyperammonemia treatment is likely to touch USD 2,100 Million.

A rising number of pipeline products for the treatment of hyperammonemia is anticipated to fuel the growth of the market in near future. For instance, on September 17, 2019, Kaleido Biosciences, a clinical-stage healthcare company, initiated a phase 2 clinical trial study to evaluate the efficacy and safety of KB195 in subjects with urea cycle disorder with severe symptoms. These studies and trials will help in driving the market growth of Hyperammonemia.

Additionally, the presence of better healthcare services and a growing number of innovative diagnostic approaches are likely to aid in the expansion of the market in the coming years. On the contrary, the impact of the novel coronavirus on this market has been negative as production was brought to a standstill, and so did the research and development procedure. Nevertheless, growing consumer awareness about such diseases and the rising support from various national governments in terms of reimbursement policies are likely to create new growth prospects in the coming years.

The Hyperammonemia treatment market is anticipated to offer lucrative opportunities in the near future due to the focus of major market players on inorganic growth strategies such as acquisitions, partnerships, and agreements to strengthen product portfolios and presence in the global market.

Report Attribute	Details
Expected Market Value (2023)	USD 1,318.05 Million
Anticipated Forecast Value (2033)	USD 2,100 Million
Projected Growth Rate (2023 to 2033)	CAGR 4.77%

2018 to 2022 Hyperammonemia Treatment Demand Analysis vs. Forecast 2023 to 2033

The hyperammonemia treatment market grossed a valuation of USD 1,188.9 Million in 2022, trailing at a CAGR of 3.5%. Rising research and development activities by academic institutes in gene therapy for the treatment of Hyperammonemia are augmenting the growth.

Owing to these factors, the Hyperammonemia treatment market is projected to record a valuation of USD 2,100 Million with a CAGR of 4.77% during the forecast period.

Which are Some Prominent Drivers of the Hyperammonemia treatment market?

High investments in Research and Development bolstering Market Growth

Research & development initiatives undertaken by research & academic institutes supported by pharmaceutical companies as well as governments are estimated to drive the global Hyperammonemia treatment market. Furthermore, the existence of well-established players, the rise in investments in research and development by pharmaceutical giants, and an association of pharmaceutical and biotech companies with research institutes will drive the global Hyperammonemia treatment market.

Additionally, research and development studies highlighting the genetic characterization of Hyperammonemia treatment will help market players align their product development, contributing to market expansion. In October 2021, Boehringer Ingelheim and Thoeris GmbH announced a collaboration and license agreement to investigate novel first-in-class therapies for patients with Hyperammonemia treatment (UCDs). Such partnership will help players leverage their expertise and expand their product offerings, thus propelling the market growth.

What are the Challenges Projected to be Faced by the Market?

Complications from long-term therapy to restrain product demand

The growing need for alternative diagnosis & treatment options, the absence of skilled personnel, and the dearth of reimbursement policies are some of the factors challenging market growth.

Moreover, due to long-term therapy, patients may suffer from some complications, like fussiness, sleepiness or sluggishness, low body temperature, vomiting, problems with posture, seizures, and others. Thus, such complications of long-term therapy are anticipated to hamper market growth over the forecast period. Additionally, the high cost of therapeutics is also expected to hinder market growth.

Region-Wise Insights

How is North America expected to perform in the Market for Hyperammonemia Treatment?

North American region is expected to hold a dominant position in the global Hyperammonemia treatment market over the forecast period, due to rising research and development by academic institutes in gene therapy for the treatment of Hyperammonemia. This region dominated the market in 2022 and is anticipated to retain its dominance in the coming years due to increasing research and development by academic institutes in gene therapy for the treatment of Hyperammonemia treatment.

Also, owing to the well-developed health care system, rising awareness among the masses, a coalition of pharmaceutical and biotech companies with research institutes, and acceptance of the latest techniques in these nations are expected to fuel the Hyperammonemia treatment market growth till 2033.

The United States in this region is expected to hold a significant share of around 48% during the forecast period. There is a high burden of UCDs on the United States healthcare system, generating demand for its diagnostics and therapeutics, thus, driving the market growth. Furthermore, the Hyperammonemia treatment market is projected to expand rapidly in the next few years due to a well-developed healthcare system, appropriate reimbursement scenarios, and acceptance of the latest techniques in this region.

For instance, in March 2019, the University of Calgary Cumming School of Medicine (CSM) and Alberta Health Services (AHS) collaboratively initiated a clinical trial study on treatment of Hyperammonemia treatment with the help of gene therapy. The clinical trial study was conducted at Clinical Trials Unit (CTU) at the Foothills Medical Centre (FMC), a hospital in Canada. Thus, developments in gene therapy will strengthen the market growth.

How is South Asia expected to Shape Up in the Hyperammonemia Treatment Market?

The South Asian market is projected to register a steady revenue CAGR of 4.2% during the forecast period. There are various factors driving the market in South Asia for the treatment of hyperammonemia, including the presence of well-established companies, growth in Research and Development spending by pharmaceutical industry giants, and partnerships between pharmaceutical and biotech firms and research institutes.

Category wise Insights

By Treatment, which Category is anticipated to Retain the Maximum Market Share?

Glycerol Phenylbutyrate-based Treatment is expected to Gain Maximum Momentum

Glycerol phenylbutyrate (Ravicti) is an adjunctive therapy for the chronic management of patients with Hyperammonemia. ‘Ravicti’ is the first licensed oral liquid of phenylbutyrate and shares the same mechanism of action and metabolic pathway as sodium phenylbutyrate.

Ravicti provides an alternative option in a formulation that may reduce the substantial treatment burden and unpleasant taste and odor associated with sodium phenylbutyrate which will propel the growth of this segment. This segment is expected to account for 35.5% segment share by end of the forecast period.

Which Distribution Channel will generate Maximum Hyperammonemia Treatment Drug Sales?

Hospital Pharmacies to be the Primary POC for availing Treatment Solutions

Future Market Insights expected the hospital pharmacy segments to hold the largest share of 48% in the hyperammonemia treatment market. This is mainly due to the increasing number of patients suffering from conditions that are treated in hospitals equipped with advanced infrastructure and adequate facilities. Moreover, the growing number of hospitals along with adequate reimbursement policies is also contributing to the segment’s growth.

Start-ups in Hyperammonemia Treatment Market

• Founded in 2006, Hyperion Therapeutics is a USA-based company that developed ‘Ravicti’, a drug for the treatment of both Hyperammonemia treatment (UCD) and hepatic encephalopathy (HE). The company was acquired by Horizon Pharma on March 30, 2015. It received a total funding of USD 148 million.
• Founded in 2015, Archimedes is a US-based bioengineering start-up that is treating rare metabolic disease treatment paradigms through point-of-care diagnostic devices. The company is focused on Hyperammonemia treatment (UCD), phenylketonuria (PKU), and maple syrup-urine disease (MSUD). The company is supporting the development of precision medicine by providing physicians and caregivers the data they need to optimize medication and diet for patients with rare diseases. The company is based on a portfolio of patent-pending diagnostic technologies that enable the detection of aminoacidopathy disorders. This company is not funded yet.

Market Competition

The market is fragmented and moderately competitive. The strategies like mergers and acquisitions adopted by major market players will boost the market growth. The major players in the market are Bausch Health Companies, Inc, Recordati Rare Diseases Inc., Lucane Pharma SA, Acer Therapeutics, Ultragenyx Pharmaceutical Inc, Aeglea BioTherapeutics, Arcturus Therapeutics Holdings Inc., Orpharma Pty Ltd, Abbott Laboratories, Selecta Biosciences, Inc.

Some recent developments in this industry are:

• In January 2021, Acer Therapeutics and Relief Therapeutics Holding AG entered into a collaboration and license agreement for the worldwide development and commercialization of acer-001, a sodium Phenylbutyrate drug conjugate for the treatment of urea cycle disorders.
• In July 2022, Versantis AG revealed that the USA Food and Drug Administration (FDA) designated its major product candidate VS-01, an ammonia clearance enhancer, a rare pediatric disease designation for the treatment of Hyperammonemia.
• In October 2021, according to Acer Therapeutics Inc. and its collaboration partner, Relief Therapeutics, the USA Food and Drug Administration (FDA) accepted the submission of the New Drug Application (NDA) for the drug ACER-001 (sodium phenylbutyrate) for the treatment of patients with Hyperammonemia disorder.
• In January 2021, Recordati Rare Diseases Inc. received the USA Food and Drug Administration (FDA) approval for CARBAGLU for the treatment of acute hyperammonemia.

Report Scope

Report Attribute	Details
Market Value in 2023	USD 1,318.05 Million
Market Value in 2033	USD 2,100 Million
Growth Rate	CAGR of 4.77% from 2023 to 2033
Base Year for Estimation	2022
Historical Data	2018 to 2022
Forecast Period	2023 to 2033
Quantitative Units	Revenue in USD Million and CAGR from 2023 to 2033
Report Coverage	Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis
Segments Covered	Treatment, Route of administration, Distribution Channel, Region.
Regions Covered	North America; Latin America; Europe; South Asia; East Asia; Oceania; Middle East & Africa.
Key Countries Profiled	USA, Canada, Brazil, Mexico, Germany, United Kingdom, France, Spain, Italy, India, Malaysia, Singapore, Thailand, China, Japan, South Korea, Australia, New Zealand, GCC Countries, South Africa, Israel.
Key Companies Profiled	Bausch Health Companies Inc.; Recordati Rare Diseases Inc.; Lucane Pharma SA; Acer Therapeutics; Ultragenyx Pharmaceutical Inc.; Aeglea BioTherapeutics; Arcturus Therapeutics Holdings Inc.; Orpharma Pty Ltd; Abbott Laboratories; Selecta Biosciences, Inc.
Customization	Available Upon Request

Key Segments Profiled in the Hyperammonemia Treatment Market Industry Survey

By Treatment Type:

• Amino Acid Supplements
• Sodium Phenylbutyrate
• Glycerol Phenylbutyrate
• Sodium Benzoate
• Others

By Route of Administration:

• Oral
• Injectable

By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

Frequently Asked Questions

How Big is the Global Hyperammonemia Treatment Market?

The global demand may generate USD 1,318.05 million revenue in 2023.

What is the Advancement Rate for Adoption of Hyperammonemia Treatment Services?

Adoption of hyperammonemia treatment is poised to witness 4.77% CAGR through 2033.

Which Segment of Hyperammonemia Treatment Market Garners Higher Revenue?

The Ravicti segment is forecasted to have almost 35.5% of the market share by 2033.

What will be the Size of Hyperammonemia Treatment Market in the United States?

The country could retain its top position of capturing 48% of the global market.

What is the Scope of Growth for Hyperammonemia Treatment Market in South Asia?

It is currently the most lucrative market that could exhibit 4.2% CAGR through 2033.