Urea Cycle Disorders Treatment Market: Rising Growth Potential, Forecasted at USD 1,650 Million by 2030 with a CAGR of 3.5%

The global urea cycle disorders treatment market size was valued at USD 1,250 million in 2021 and is projected to reach around USD 1,650 million in 2030 exhibiting a CAGR of 3.5% in the forecasted period. 

The increasing prevalence of urea cycle disorders and the growing number of pipeline products. Product approvals, launches, and strategic initiatives by important market players are anticipated to contribute to market growth. Furthermore, research and development studies underlining the genetic description of urea cycle disorders will benefit market players align their product development supporting to market growth. On the other hand, the high cost of therapeutics can be a restraint in the growth of this market.

The increasing prevalence of urea cycle disorders is anticipated to upsurge the demand for treatment preferences for urea cycle disorders (UCD), which is estimated to drive the growth of global urea cycle disorders treatment market throughout the forecasted period. As per the Urea Cycle Disorders Consortium (UCDC), a section of the Rare Diseases Clinical Research Network (RDCRN), united prevalence of urea cycle disorders is nearby 1 in 30,000 people in the U.S in 2017.

Recently, nations have faced an enormous threat of COVID-19. As per the World Health Organization (WHO), coronavirus is an infectious disease, and most people diseased with the COVID-19 virus will experience mild to moderate respiratory illness. The occurrence of the COVID-19 pandemic damaged the world economy and the healthcare system. The item “Longitudinal Metabolomics Reveals Ornithine Cycle Dysregulation Correlates with Inflammation and Coagulation in COVID-19 Severe Patients,” issued in December 2021, recognized that the ornithine cycle dysregulation is significantly interrelated with swelling and coagulation in severe patients, which may be a possible machinery of COVID-19 pathogenicity. Consequently, the COVID-19 medicines hindered the urea cycle, aiming to a lack of certain enzymes. Therefore, there is a growing demand for its therapeutics, contributing to market growth.

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Key Companies Insights
The market for urea cycle disorders treatment is moderately competitive. With the rising applications of urea cycle disorders treatment, new players are planning to enter the market. The companies are also involved in events like joint ventures, partnerships, acquisitions, mergers, and collaborations. These activities aid in growing the effect of the players in the Urea cycle disorders treatment market, ultimately boosting the market growth. Some of the key companies working in the global Urea cycle disorders treatment market include:
• Bausch Health Companies Inc.
• Recordati Rare Diseases
• Eurocept Pharmaceuticals Holding (Lucane Pharma SA)
• Acer Therapeutics
• Ultragenyx Pharmaceutical
• Aeglea BioTherapeutics
• Arcturus Therapeutics, Inc.
• Orpharma Pty Ltd.
• Selecta Biosciences, Inc.
• Abbott Laboratories
• Mead Johnson & Company, LLC
• Other players

Some of the Recent Developments:
• In February 2022, Relief Therapeutics Holding SA and Acer Therapeutics, were issued a new patent from the United States Patent and Trademark Office (USPTO) for certain claims related to ACER-001 (sodium phenylbutyrate) related to ACER-001’s multi-particulate dosage formulation for oral management as a possible treatment for Urea Cycle Disorders (UCDs) and Maple Syrup Urine Disease (MSUD).
• In January 2022, Acer Therapeutics Inc. and Relief Therapeutics Holding SA declared the approval of four ACER-001 abstracts for poster presentations in Orlando, Florida, and in Las Vegas, Nevada.

Segments
By Treatment Type
• Amino Acid Supplements
• Sodium Phenylbutyrate
• Glycerol Phenylbutyrate
• Sodium Benzoate
• Others

By Enzyme Deficiency Type
• Ornithine Transcarbamylas (OTC)
• Argininosuccinate Synthetase (citrullinemia) (AS)
• Arginase (AG)
• Argininosuccinate Lyase (AL)
• Carbamoyl Phosphate Synthase (CPS1)
• N-acetylglutamate Synthase (NAGS)

By Route of Administration
• Oral
• Injectable

By Geography
• North America
o U.S.
o Canada
o Mexico
• Europe
o U.K.
o Germany
o France
o Italy
o Spain
o Russia
• Asia-Pacific
o Japan
o China
o India
o Australia
o South Korea
o ASEAN
• Latin America
o Brazil
o Argentina
o Colombia
• MEA
o South Africa
o Saudi Arabia
o UAE
o Egypt

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Though, the production of these drugs was hindered owing to the momentary lockdown in the manufacturing plants, dearth of skilled labour, and increasing cases of COVID-19 inside the manufacturing plants, which has led to outages, thus, hampering the market. Hence, the above factors indicate that COVID-19 considerably impacted the market.

Enzyme Deficiency Type Insights
Ornithine transcarbamylase segment is projected to account for the major market share through the forecasted period. Ornithine transcarbamylase deficiency is an extremely prevalent urea cycle disorder. It is an X-linked genetic disorder that inhibits the breakdown and excretion of ammonia. It allows ammonia to accumulate, escalating to toxic levels where it affects the central nervous system.

The factors such as product approvals, intensifying research and development, and calculated initiatives accepted by major market players are anticipated to back to the substantial growth of the market. For instance, in July 2021, Arcturus Therapeutics Holdings Inc. got approval from the UK Health Research Authority to start a Phase II clinical study for ARCT-810, a new mRNA-based therapeutic candidate for Ornithine Transcarbamylase (OTC) Deficiency. Moreover, in April 2020, the company recognized two clinical trials for its flagship asset ARCT-810. The Company’s Investigational New Drug (IND) application for a Phase Ib study in patients with OTC deficiency was certified to proceed by the United States Food and Drug Administration (FDA), and a further Clinical Trial Application (CTA) for a Phase I study in strong volunteers was accepted by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). Consequently, with rising product approvals and research and development activities, the segment is anticipated to present effective therapeutics to boost the market’s growth.

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Key Questions Answered in the Report:
● What will be the development pace of market? What is the growth rate of the global market?
● Who are the key manufacturers in the market space? Who are the world’s leading manufacturers?
● What are sales, revenue, and price analysis of the top manufacturers of market?
● Who are the distributors, traders, and dealers of market? What are the key factors driving the Global market?
● What are the market opportunities and threats faced by the vendors in the industries?
● What are deals, incomes, and value examinations by types and applications of the market?

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