PHENOBARBITAL MARKET ANALYSIS

Global Phenobarbital Market size is estimated to be valued at US$ 1.58 billion in 2023 and is expected to reach US$ 2.23 billion by 2030, by exhibiting a compound annual growth rate (CAGR) of 5% from 2023 to 2030.

Global phenobarbital market is driven by its widespread use as an anticonvulsant medication for the treatment of various seizure disorders. Phenobarbital is considered a first-line treatment for epilepsy, particularly in developing countries such as India, China, etc. where it remains an affordable and accessible option. Increasing prevalence of epilepsy and other seizure disorders, and the growing demand for effective anticonvulsant medications is expected to drive the market growth of the global phenobarbital market.

Phenobarbital Market Regional Insights

• North America: North America is the largest market for phenobarbital, which accounted for a market share of over 33.5% in 2022. In North America, including the U.S. and Canada, the phenobarbital market is influenced by a well-developed healthcare system and a higher prevalence of epilepsy. For instance, on February 13, 2023, according to the Centers for Disease Control and Prevention (CDC), around 1.2% of people in the U.S. have active epilepsy.
• Europe: Europe is the second-largest market for phenobarbital, which accounted for a market share of over 26.1% in 2022. In Europe, the phenobarbital market is influenced by variations in healthcare systems and regulations across different countries. Some European countries may have more restricted use of phenobarbital, while others may still consider it as a viable treatment option for certain patients with epilepsy.
• Asia Pacific: Asia Pacific is the fastest-growing market for phenobarbital, which accounted for a market share of over 20.3% in 2022. The Asia Pacific region, including countries like India and China, has a higher prevalence of epilepsy and limited access to newer antiepileptic drugs due to cost and availability. Phenobarbital remains an important and commonly prescribed anticonvulsant in this region due to its affordability and established efficacy.

Figure 1. Global Phenobarbital Market Share (%), By Region, 2023

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Analysts’ Views on Global Phenobarbital Market:

The phenobarbital market holds a strong potential for growth over the next five years. Rising prevalence of epilepsy is a key driver as phenobarbital remains one of the most commonly prescribed anti-seizure medications. An increasing elderly population is expected to drive the demand for phenobarbital as older adults are more susceptible to seizures. However, strict regulations regarding the use of phenobarbital are expected to hamper the market growth. Many countries have tightened restrictions on phenobarbital prescription due to its high addiction potential.

North America dominates the phenobarbital market and is expected to remain the largest regional market. Increasing incidence of traumatic brain injuries from accidents is a major factor driving the higher phenobarbital consumption in the region. Meanwhile, Asia Pacific presents lucrative opportunities owing to its massive patient population and improving access to healthcare. Countries like India and China with their healthcare initiatives are boosting the regional demand for phenobarbital.

On the product side, generic formulations witnesses rising demand since they are more cost effective than branded drugs. Research into developing analogue drugs with lower side effects also creates potential opportunities. Investments into improving agriculture and production techniques could help overcome restraints which are associated with limited raw material supplies. Development of easy-to-administer alternative delivery forms may further help in the market growth.

Global Phenobarbital Market Drivers:

• Increasing prevalence of epilepsy: The prevalence of epilepsy is on the rise globally which is directly boosting the demand for anti-epileptic drugs such as phenobarbital. For instance, on February 9 2023, according to recent statistics by the World Health Organization, around 50 Mn people worldwide suffer from epilepsy with nearly 80% of them living in developing countries. The economic burden of this neurological disorder on healthcare systems and families is massive. Moreover, since the risk of epilepsy rises with age, more individuals are receiving treatment for the condition due to an ageing population and improved detection rates, particularly in low- and middle-income countries. Phenobarbital remains a very important and effective therapeutic option recommended as a first line treatment by doctors in developing countries due to its low price and availability in generic form. It has demonstrated great efficacy in controlling seizures for several types of epilepsy, when it is used appropriately under medical supervision. As more epilepsy patients get diagnosed and seek medication every year, phenobarbital dispensing will continue rising proportionately across Africa, Asia and Latin America thus driving the market revenues over the forecast period. Initiatives by non-profit organizations to spread awareness about epilepsy treatment in rural communities will further aid the growth momentum of phenobarbital demand.

 Global Phenobarbital Market Opportunities:

• Increasing prevalence of neonatal seizures: Seizures in newborn babies commonly known as neonatal seizures are another major application area which is expected to drive for higher sales of phenobarbital. On March 15 2023, according to UpToDate, Inc., an information services company, the incidence of neonatal seizures ranges from 1.5 to 5.5 per 1000 newborns and may be even higher in premature infants. Timely and effective treatment of neonatal seizures is critical to prevent long term neurodevelopmental impairments in children. Phenobarbital is a first-line anticonvulsant prescribed internationally to terminate acute seizure episodes in newborns and control prolonged seizure activity. Its tolerability profile, flexibility of dosage forms, and affordability make it a drug of choice amongst neonatologists.

 Global Phenobarbital Market Trends:

• Shift towards individualized treatment approaches: Treatment techniques for epilepsy and seizure disorders are becoming more individualised and personalised, including the use of phenobarbital. Healthcare providers are increasingly tailoring treatment regimens based on factors such as patient age, seizure type, comorbidities, and response to therapy. This approach allows for optimized treatment outcomes and minimization of side effects, thus driving the demand for phenobarbital as part of personalized treatment strategies.

Global Phenobarbital Market Restraints:

• Availability of alternative anti-epileptic drugs: The availability of alternative anti-epileptic drugs with improved safety profiles and fewer side effects poses a restraint to the global phenobarbital market. Newer medications with different mechanisms of action and targeted indications have been developed, offering more options for managing epilepsy and seizure disorders. Healthcare providers may prefer to prescribe these newer drugs over phenobarbital, especially in cases where minimizing side effects or drug interactions is a priority. For instance, in March 2022, UCB, a biopharmaceutical company, announced that FINTEPLA (fenfluramine) oral solution CIV was approved in the U.S., by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older.
• Adverse effects and safety Concerns: Phenobarbital is associated with various side effects, including sedation, cognitive impairment, dizziness, and behavioral changes. These adverse effects may impact patient compliance and quality of life, particularly in situations where the medication interferes with daily activities or cognitive function. Safety concerns related to the potential serious hypersensitivity reactions need to be considered, which may help in cautious prescribing or monitoring practices. For instance, according to National Center for Biotechnology Information (NCBI), complications associated with phenobarbital use are coma, decreased effort to breathe, and low blood pressure. The more common adverse effects include incoordination, impaired balance, and drowsiness.

Counterbalances: The key market players should focus on minimizing the adverse effects associated with the usage of phenobarbital and keep on inventing for newer drugs to have a competitive edge in the market with the alternative anti-epileptic drugs in the market.

Recent Developments

New product launches

• On January 25 2023, Sun Pharmaceutical Industries Ltd., a multinational pharmaceutical company, launched the SEZABY (phenobarbital sodium) in the U.S. for the treatment of neonatal seizures.

Agreements

• In November 2022, Sun Pharmaceutical Industries Ltd., a multinational pharmaceutical company, and Sun Pharma Advanced Research Company Ltd. (SPARC), a clinical stage bio-pharmaceutical company, announced the signing of a licensing agreement for commercialization of benzyl alcohol and propylene glycol-free phenobarbital sodium powder for injection in the U.S.

Figure 2. Global Phenobarbital Market Share (%), By Indication, 2023

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Top companies in Phenobarbital Market

• Sanofi
• Pfizer Inc.
• Novartis AG
• Lundbeck A/S
• Teva Pharmaceutical Industries Ltd.
• Sun Pharmaceutical Industries Ltd.
• Hikma Pharmaceuticals
• Cipla Ltd.
• Par Pharmaceutical.

Definition: Phenobarbital is a medication which belongs to the class of barbiturates. It is primarily used as an anti-epileptic drug to control and prevent seizures in various forms of epilepsy. Phenobarbital works by slowing down the activity in the brain and nervous system, thereby reducing the occurrence of seizures. It is also sometimes used as a sedative or for the treatment of withdrawal symptoms associated with alcohol or drug dependence.