SODIUM PHENYLBUTYRATE MARKET ANALYSIS

The Global Sodium Phenylbutyrate Market size is projected to reach US$ 3.02 Bn by 2030, from US$ 1.92 Bn in 2023, at a CAGR of 6.7% during the forecast period. Sodium phenylbutyrate is a nitrogen-binding drug used to treat urea cycle disorders (UCDs) and maple syrup urine disease (MSUD). UCDs are a group of inherited disorders that affect the body's ability to break down ammonia. MSUD is a rare genetic disorder that causes the body to produce high levels of ammonia.

The growth of the sodium phenylbutyrate market is driven by the increasing incidence of UCDs and MSUD. According to the Centers for Disease Control and Prevention (CDC), the estimated incidence of UCDs is 1 in 8,500 births. Additionally, rising awareness about the benefits of sodium phenylbutyrate for the treatment of UCDs and MSUD is also driving the growth of the market.

Sodium Phenylbutyrate Market Regional Insights

• North America is the leading market for sodium phenylbutyrate, with a share of 35% in 2022. The high prevalence of UCDs and MSUD in North America and the presence of a large number of key players in the region are the major factors driving the growth of the market in North America.
• Europe is the second-largest market for sodium phenylbutyrate, with a share of 25% in 2022. The rising awareness about the benefits of sodium phenylbutyrate for the treatment of UCDs and MSUD and the increasing number of product approvals in Europe are the major factors driving the growth of the market in the region.
• Asia Pacific is expected to grow at the highest CAGR during the forecast period, with a share of 20% in 2022. The growth of the market in Asia Pacific is driven by the rising awareness about UCDs and MSUD, the increasing number of product approvals, and the presence of a large number of key players in the region.

Figure 1. Global Sodium Phenylbutyrate Market Share (%), by Region, 2023

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Sodium Phenylbutyrate Market Drivers

• Increasing prevalence of urea cycle disorders (UCDs): Sodium phenylbutyrate is commonly used in the treatment of urea cycle disorders, a group of rare genetic disorders that affect the body's ability to remove waste nitrogen. The rising prevalence of UCDs worldwide is driving the demand for sodium phenylbutyrate as a therapeutic option.
• Growing awareness and diagnosis of rare diseases: There has been an increasing focus on the diagnosis and treatment of rare diseases, including urea cycle disorders. Improved awareness and diagnostic capabilities have led to an increase in the number of patients being diagnosed with UCDs, thereby driving the demand for sodium phenylbutyrate.
• Expansion of orphan drug development: Sodium phenylbutyrate is classified as an orphan drug, meaning it is used to treat rare diseases. Governments and regulatory agencies worldwide have implemented supportive policies and incentives to encourage the development and commercialization of orphan drugs. This has facilitated the growth of the sodium phenylbutyrate market.
• Advancements in pharmaceutical research and development: Continuous advancements in pharmaceutical research and development have led to the development of more effective and innovative drugs. This includes the development of sodium phenylbutyrate formulations with improved efficacy, safety, and patient compliance, which contribute to the market growth.

Sodium Phenylbutyrate Market Opportunities

• Expansion into emerging markets: There are significant opportunities for sodium phenylbutyrate manufacturers to expand their presence in emerging markets. Developing regions, such as Asia Pacific and Latin America, are experiencing rapid urbanization, improved healthcare infrastructure, and increasing awareness of rare diseases. As a result, there is a growing demand for effective treatments like sodium phenylbutyrate in these regions.
• Development of combination therapies: Sodium phenylbutyrate has shown potential as an adjuvant therapy in combination with other medications for the treatment of certain diseases. Research is underway to explore the synergistic effects of sodium phenylbutyrate with other drugs, such as histone deacetylase inhibitors, in various indications, including cancer. The development of combination therapies can open new avenues for sodium phenylbutyrate applications and expand its market potential.
• Expansion of indications: Although sodium phenylbutyrate is primarily used in the treatment of urea cycle disorders, there is ongoing research exploring its efficacy in other diseases. Preclinical and clinical studies are investigating the use of sodium phenylbutyrate in conditions like neurodegenerative disorders, cancer, and metabolic diseases. Successful outcomes in these studies can lead to the expansion of indications for sodium phenylbutyrate, broadening its market opportunities.
• Increasing focus on precision medicine: Precision medicine aims to deliver personalized treatments based on individual characteristics, including genetic makeup and disease profiles. Sodium phenylbutyrate aligns with the principles of precision medicine, as it is used to treat specific genetic disorders. As the field of precision medicine advances, there will be growing opportunities for sodium phenylbutyrate to be integrated into personalized treatment approaches.

Sodium Phenylbutyrate Market Trends

• Increasing research and development activities: There is a significant focus on research and development activities related to sodium phenylbutyrate. This includes efforts to develop new formulations, optimize dosing regimens, explore combination therapies, and investigate additional indications for sodium phenylbutyrate. The aim is to enhance the therapeutic outcomes, improve patient compliance, and expand the market potential of sodium phenylbutyrate.
• Rise in strategic collaborations and partnerships: Collaborations and partnerships between pharmaceutical companies, research institutions, and healthcare organizations are becoming increasingly common. These collaborations help in sharing expertise, resources, and data to accelerate drug development and commercialization. In the sodium phenylbutyrate market, such collaborations facilitate clinical trials, expand market reach, and enhance product offerings.
• Growing demand for orphan drugs: Orphan drugs, including sodium phenylbutyrate, are medications used to treat rare diseases. There is a rising demand for orphan drugs globally, driven by increasing awareness, improved diagnosis rates, and supportive regulations and incentives. The sodium phenylbutyrate market is benefiting from this trend, as it is a key treatment option for urea cycle disorders, which are classified as rare diseases.
• Emphasis on patient-centric approaches: There is a growing focus on patient-centric approaches in healthcare, and this trend is also influencing the sodium phenylbutyrate market. Patient advocacy groups, regulatory agencies, and healthcare providers are prioritizing patient preferences, needs, and experiences. This includes personalized medicine approaches, patient support programs, and initiatives to improve medication access and affordability for sodium phenylbutyrate.

Sodium Phenylbutyrate Market Restraints

• Limited awareness and under diagnosis: The general public and medical professionals continue to be unaware of rare diseases and their treatments, such as urea cycle disorders, despite efforts to raise awareness of these conditions. This leads to under diagnosis and delays in initiating appropriate treatment with sodium phenylbutyrate. Limited awareness and under diagnosis act as a restraint on the market's growth potential.
• High treatment costs: The cost of sodium phenylbutyrate treatment can be high, especially for individuals without adequate insurance coverage or in regions with limited healthcare resources. The high treatment costs may restrict access to sodium phenylbutyrate for patients, particularly in developing countries or for those without sufficient financial means, thus posing a restraint on market growth.
• Stringent regulatory requirements: The regulatory approval process for sodium phenylbutyrate and other orphan drugs can be complex and time-consuming. Meeting the stringent regulatory requirements, including demonstrating safety and efficacy through rigorous clinical trials, can pose challenges and delay market entry. These regulatory barriers act as restraints on the timely availability and commercialization of sodium phenylbutyrate.
• Side effects and safety concerns: While sodium phenylbutyrate is generally well-tolerated, it can still cause side effects, including gastrointestinal disturbances, neurotoxicity, and metabolic abnormalities. Safety concerns associated with sodium phenylbutyrate may limit its use in certain patient populations or require close monitoring, thereby affecting market acceptance and uptake.

Analyst view:

The global sodium phenylbutyrate market is expected to witness steady growth over the forecast period owing to the increasing prevalence of urea cycle disorders. Rising awareness about the availability of treatment options and government support initiatives are further expected to drive the market. However, stringent regulatory approvals and high research and developments costs associated with drug development may hamper market growth. North America is expected to dominate the global sodium phenylbutyrate market during the forecast period. This is attributed to the presence of major market players and availability of advanced healthcare facilities in the region. The growing patient population and newborn screening programs are also contributing to the regional market growth. Europe is anticipated to be the second largest market for sodium phenylbutyrate due to rising healthcare expenditure. The sodium phenylbutyrate market in Asia Pacific is expected to grow at a high rate over the next few years. Improving healthcare infrastructure, rising medical tourism, and increasing healthcare spending are some key factors likely to offer lucrative opportunities for market players in the coming years. Key players are investing in R&D activities to develop enhanced formulations in order to gain a competitive edge in the emerging APAC market. In terms of product form, the tablets segment currently dominates the sodium phenylbutyrate market. However, the oral powder formulation is anticipated to witness higher demand in the coming years.

Recent Developments

New product launches

• In 2020, Hikma Pharmaceuticals is a British multinational pharmaceutical company launched a generic version of sodium phenylbutyrate tablets in the U.S. This generic version is available in 500 mg and 1000 mg strengths.
• In 2021, Acella Pharmaceuticals launched a generic version of sodium phenylbutyrate powder for oral suspension in the U.S. This generic version is available in a 0.94 gram/gram strength.

Acquisition and partnerships

• In 2021, Hikma Pharmaceuticals is a British multinational pharmaceutical company acquired the rights to market sodium phenylbutyrate in the U.S from Salix Pharmaceuticals.
• In 2022, Alvogen acquired the rights to market sodium phenylbutyrate in Europe from Orphan Europe.
• In 2022, CSL Behring entered into a partnership with Oryzon Genomics to develop and commercialize sodium phenylbutyrate for the treatment of urea cycle disorders.

Figure 2. Global Sodium Phenylbutyrate Market Share (%), By application, 2023

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Top companies in Sodium Phenylbutyrate Market

• Horizon Therapeutics plc
• Ammonett Pharma LLC
• Medison Pharma Ltd.
• Modern Dietetics Inc.
• Synageva BioPharma Corp.
• Medison Pharma Ltd.
• Swedish Orphan Biovitrum AB (Sobi)
• Entera Health, Inc.
• Dipharma Francis S.r.l.
• Ucyclyd Pharma, Inc.

Definition: The sodium phenylbutyrate market refers to the global business sector involving the production, distribution, and sale of sodium phenylbutyrate, a medication used primarily to treat urea cycle disorders. This market includes various stakeholders such as manufacturers, distributors, healthcare providers, research institutions, and patients. The size and growth of this market are influenced by factors such as the prevalence of urea cycle disorders, the drug's effectiveness and safety profile, pricing and reimbursement policies, and the activities of key market players.