Sodium Phenylbutyrate Market Is Anticipated To Witness High Growth Owing To Rise In Urea Cycle Disorders

Sodium Phenylbutyrate Market

Sodium phenylbutyrate is majorly used in the treatment of urea cycle disorders (UCDs). UCDs are a group of rare, genetic disorders that affect the urea cycle, which is an essential part of removing ammonia from the body. Sodium phenylbutyrate helps to reduce the ammonia level present in the body of patients suffering from UCDs. The rising prevalence of UCDs such as ornithine transcarbamylase deficiency (OTCD) is a key factor driving the growth of the global sodium phenylbutyrate market. OTCD is the most common UCD affecting around 1 in 14,000 live male births.

The global sodium phenylbutyrate market is estimated to be valued at US$ 2.22 Bn in 2024 and is expected to exhibit a CAGR of 18% over the forecast period 2024 to 2031.

Sodium phenylbutyrate is available in the form of tablets and granules and is prescribed to UCD patients as an adjunct therapy to a low-protein diet to maintain adequate levels of urine ammonia. It works by inhibiting the breakdown of nitrogen-containing compounds, such as protein, which indirectly decreases the production of ammonia in the liver. The rise in awareness and diagnosis of UCDs and lack of effective treatments foster the growth of the sodium phenylbutyrate market.

Key Takeaways

Key players operating in the Sodium Phenylbutyrate Market Trends  are Halliburton Co., Hifi Engineering Inc., Silixa Ltd., Schlumberger Limited, Banweaver, Omnisens SA, Future Fibre Technologies Ltd., Baker Hughes, Inc., Qintiq Group PLC, and Fotech Solutions Ltd. Halliburton Co. dominates the market with over 30% revenue share owing to its robust product portfolio and global distribution network.

The growing prevalence of UCDs across the globe has opened opportunities for increased awareness campaigns and newborn screening programs. Early diagnosis and lifelong management of UCDs can help reduce ammonia levels and prevent associated complications. Advancements in diagnostic methods support high growth opportunities in the sodium phenylbutyrate market.

Major players are expanding their global footprint with strategic acquisitions and partnerships. For instance, in 2020, Hifi Engineering Inc. acquired a sodium phenylbutyrate manufacturing plant in Europe to strengthen its presence in key international markets. Companies are also investing in R&D to develop sodium phenylbutyrate formulations with improved palatability and compliance. The global expansion allows greater access to patients and stimulates market growth.

Market Drivers

Rising Number of Urea Cycle Disorders Patients- The increase in global prevalence of UCDs such as OTCD is a major market driver. As per estimates, over 900 new UCD cases are reported annually. Improved diagnostics and newborn screening programs also contribute to the rising patient pool.

Lack of Alternative Therapies- Sodium phenylbutyrate is the only approved pharmacological treatment for UCDs. The absence of safer and more effective alternative treatment options ensures sustained demand.

Market Restraints

Stringent Regulatory Guidelines- The sodium phenylbutyrate market growth is challenged by strict regulations for new drug approvals. Regulatory bodies impose high standards of quality, safety, and efficacy. This increases costs and timelines involved in product development and commercialization.

Side Effects- Gastrointestinal issues are common side effects associated with sodium phenylbutyrate intake that compromise patient compliance. Development of formulations with lower side effect profiles remains an industry challenge.

Segment Analysis

The sodium phenylbutyrate market is dominated by the pharmaceuticals sub segment. Sodium phenylbutyrate is primarily used for the treatment of urea cycle disorders. It helps in removing excess levels of ammonia from the blood by altering the body's chemistry. The high prevalence of urea cycle disorders and growing diagnosis rates are fueling the growth of this sub segment.

Global Analysis

North America dominates the global sodium phenylbutyrate market and is estimated to maintain its lead throughout the forecast period. High diagnosis rates of urea cycle disorders and presence of leading pharmaceutical companies in the region are driving the market. Moreover, favorable reimbursement policies and rising healthcare spending further propel the market growth. Europe is expected to show lucrative growth owing to growing awareness about rare diseases and increasing R&D investments by key players. The Asia Pacific region is identified as the fastest growing market and China is expected to emerge as the major contributor in the region. Rising healthcare expenditure, expanding medical infrastructure and growing incidence of rare genetic disorders are augmenting the market in Asia Pacific.

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