Rising Demand For Gene Therapies Driving The Growth Of The Market Due To Increasing Prevalence Of Genetic Disorders: A Significant Driver Propelling The Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market In 2025

The Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market Report by The Business Research Company delivers a detailed market assessment, covering size projections from 2025 to 2034. This report explores crucial market trends, major drivers and market segmentation by [key segment categories].

What Is the Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market Size and Projected Growth Rate?
The market for ornithine transcarbamylase deficiency (OTC deficiency) has seen robust growth in recent years. Its size is expected to expand from $0.83 billion in 2024 to $0.89 billion in 2025, experiencing a compound annual growth rate (CAGR) of 7.1%. The factors that contributed to this growth in past years include an increase in knowledge and awareness about rare metabolic conditions, advancements in genetic testing and diagnosis, enhanced newborn screening initiatives, and a significant rise in the prevalence of genetic testing for rare diseases.

The market size of Ornithine Transcarbamylase Deficiency (OTC deficiency) is projected to witness robust growth in the coming years, expanding to $1.16 billion by 2029 at a Compound Annual Growth Rate (CAGR) of 6.8%. A variety of factors, such as increasing diagnosis and awareness, a rise in urea cycle disorders incidence, a heightened focus on treating rare diseases, an increase in research and clinical trials, and enhanced patient access to treatments are all contributing to the growth during the forecasted period. The period is also likely to register significant trends such as progress in gene therapies and gene editing technologies, the formulation of enzyme replacement therapies, joint venture research initiatives and partnerships, technological enhancements in diagnostic tools, and government subsidies and incentives for orphan drugs.

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What Are the Major Segments in the Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market?
The ornithine transcarbamylase deficiency (OTC deficiency) market covered in this report is segmented -

1) By Product Type: DTX-301, SEL-313, SHP-641, PRX-OTC
2) By Treatment Type: Gene Therapy, Liver Transplant, Dietary Management, Other Treatement Type
3) By Diagnosis: Genetic Testing, Ammonia Level Testing
4) By End-User: Hospitals, Specialty Clinics, Research Institutes, Other End Users

Subsegmentss:

1) By DTX-301: Adeno-Associated Virus (AAV)-Based Gene Therapy, Intravenous Dosing Formulation
2) By SEL-313: Immune Tolerance-Inducing Therapy, Enzyme Replacement Therapy (ERT) Combination
3) By SHP-641: Small Molecule Therapy, mRNA-Based Therapeutic Approach
4) By PRX-OTC: Recombinant Enzyme Replacement Therapy, Protein Engineering-Based Therapy

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What Are The Driving Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market Evolution?
The escalating need for gene therapies is anticipated to fuel the expansion of the ornithine transcarbamylase deficiency market in the future. Gene therapy encompasses a therapeutic procedure or method that adjusts or manipulates an individual's genetic matter to diagnose or thwart diseases. The escalating need for gene therapies is ascribed to the upward trend in genetic disorders because these conditions often have restricted therapy alternatives. Gene therapy proposes a potential solution to deal with the principal cause instead of just controlling the symptoms. The potential of gene therapies is displayed through ornithine transcarbamylase deficiency by rectifying the genetic anomaly that disturbs the urea cycle, thereby enabling a targeted therapy to resume metabolic activity and avert the build-up of harmful ammonia. For example, the American Society of Gene & Cell Therapy, a US-based association for gene and cell therapy, reported in January 2024, that in Q4 2023, the quantity of gene therapies in Phase III grew by 10% from the preceding quarter, signifying the first growth since Q3 2022. Consequently, the escalating need for gene therapies is spurring the growth of the ornithine transcarbamylase deficiency market.

Which Firms Dominate The Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market Segments?
Major companies operating in the ornithine transcarbamylase deficiency (OTC deficiency) market are Thermo Fisher Scientific, Novartis AG, GlaxoSmithKline plc, Roche Holding AG, Eli Lilly and Company, Amgen Inc., Merck & Co. Inc, Biogen Idec, Bausch Health Companies Inc, Alexion Pharmaceuticals, Sobi, BioMarin Pharmaceutical Inc, Glenmark Pharmaceuticals Ltd., Nutricia, Vertex Pharmaceuticals Incorporated, Ultragenyx Pharmaceutical Inc, Arcturus Therapeutics, Regenxbio, OrphanPacific Inc, Ucyclyd Pharma Inc.

What Trends Are Expected to Dominate the Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market in the Next 5 Years?
Leading corporations operating in the market for ornithine transcarbamylase deficiency (OTC Deficiency) are making strides in producing innovative treatments like mRNA therapeutics to increase the success rate of treatments and tackle the genetic root of OTC deficiency. mRNA therapeutics represent a category of remedies using messenger RNA (mRNA) to direct cells in the creation of specific proteins aimed at therapy. Such remedies utilise the innate protein synthesis mechanisms of the body to manage diseases, encompassing genetic disorders, infectious diseases, and cancer types. For example, in June 2023, Arcturus Therapeutics Holdings Inc., a US-based firm specialising in biotechnology, received a Fast Track Designation from the U.S. Food and Drug Administration (FDA) for ARCT-810, their mRNA therapy candidate formulated for ornithine transcarbamylase (OTC) deficiency. The objective of this designation is to quicken the developmental and review process of this drug, potentially resulting in benefits like higher frequency of FDA meetings and expedited review. ARCT-810 aims to empower OTC deficient patients, suffering from a urea cycle disorder, to generate a functioning OTC enzyme in their liver cells, addressing the root cause and potentially enhancing their overall life quality.

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Which Is The Largest Region In The Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market?
North America was the largest region in the ornithine transcarbamylase deficiency (OTC Deficiency) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the ornithine transcarbamylase deficiency (OTC deficiency) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

Frequently Asked Questions:
1. What Is the Market Size and Growth Rate of the Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market?
2. What is the CAGR expected in the Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market?
3. What Are the Key Innovations Transforming the Ornithine Transcarbamylase Deficiency (OTC Deficiency) Industry?
4. Which Region Is Leading the Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market?

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