(PharmaNewsWire.Com, October 22, 2019 ) Market Overview • Narcolepsy is a rare sleep disorder associated with uncontrollable sleepiness and frequent daytime sleeping. The condition is characterized by several symptoms, including excessive daytime sleepiness (EDS), cataplexy, automatic behaviors, hallucinations, and sleep paralysis. Narcolepsy has no cure, but drug therapies and lifestyle changes can often help improve symptoms.
Market Dynamics • The global narcolepsy therapeutics market is growing due to several factors such as rising prevalence of narcolepsy, growing narcolepsy awareness programs, increasing research & development for new drugs and treatment for narcolepsy. • The narcolepsy affects 0.03 to 0.16% of general population with incidence 1/2,000 globally. The American Academy of Sleep Medicine's International Classification of Sleep Disorders has classified two forms of narcolepsy: narcolepsy with cataplexy (also called narcolepsy type 1 (NT1)) and narcolepsy without cataplexy (also known as narcolepsy type 2 (NT2)). The NT1 is most commonly caused by a deficiency of central nervous system (CNS) hypocretin (hcrt also called orexin) in the hypothalamus. The prevalence for narcolepsy type 1 is 25 to 50 per 100,000 people and 20 to 34 per 100,000 people for narcolepsy type 2. • This growth of the market is also driven by the robust pipeline portfolio. There are currently few approved therapies available for narcolepsy. Some of the approved drugs for narcolepsy are: Xyrem (sodium oxybate), amphetamine, Nuvigil (amodafonil), Provigil (modafinil), and methylphenidate. The majority of the drugs are also used off-label for narcolepsy, including stimulants, depressants, and antidepressants. In October 2018, the Food and Drug Administration has cleared Xyrem (sodium oxybate) oral solution to treat cataplexy and excessive daytime sleepiness in patients ages 7-17 with narcolepsy. The two highest selling drugs are expected to be Avadel’s/ Sodium oxybate ER and Jazz Pharmaceutical’s/JZP-258, which both address some of the unmet needs in the market. • However, the market growth is hindered by the adverse effects and risks associated with narcolepsy drugs and delayed diagnosis.
Market Segmentation • On the basis of disease type, the narcolepsy therapeutics market is segmented into daytime extreme sleepiness (DES), cataplexy, and others. Among these, the daytime extreme sleepiness (DES) accounted for the largest market share in 2018, due to rising prevalence of narcolepsy and other sleep disorders. Daytime extreme sleepiness is one of the most common sleep-related patient symptoms affecting an estimated 20% of the population. Obstructive sleep apnea is a particularly significant cause of excessive daytime sleepiness. An estimated 26 to 32% of adults are at risk of or have obstructive sleep apnea, and the prevalence is expected to increase during the forecast period. About 20% of adults in the United States report a level of daytime sleepiness sufficient to interfere with daily activities, and excessive daytime sleepiness is the leading symptom of patients presenting to sleep clinics. On the other hand, the cataplexy segment is expected grow at the fastest CAGR during the forecast period (2019-2026), as patients suffering from cataplexy tend to lose muscle control and majority of the narcolepsy patients have this symptom. The cataplexy is a common type of narcolepsy disorder, which affects nearly around 0.02% to 0.05% of the population globally. • By therapeutics type, the narcolepsy Therapeutics market is segmented into central nervous system stimulants, sodium oxybate, tricyclic antidepressants, selective serotonin reuptake inhibitor, and others. Among these, the sodium oxybate segment held the largest market share in 2018, as these drugs are highly effective to treat daytime extreme sleepiness and cataplexy. Sodium oxybate (Xyrem) is the sodium salt of gamma-hydroxybutyrate (GHB), a naturally occurring substance in the brain. Sodium oxybate is quite different from the other medications used to treat narcolepsy as it is a sedating liquid taken at bedtime instead of a usual pill taken during the day. Its effects last only a few hours, a second dose is taken three to four hours later. These two doses produce deep sleep through much of the night, and after several weeks of regular use, sodium oxybate usually improves daytime sleepiness and cataplexy. On the other hand, the selective serotonin reuptake inhibitor segment is expected grow at the fastest CAGR during the forecast period (2019-2026), due to rising R&D activities for the development of these type of drugs by the major players in the market.
Geographical Analysis • North America holds the dominant market share for narcolepsy therapeutics in 2018, and it is expected to maintain the growth over the forecast period, due to the factors, such as rising prevalence of narcolepsy and other sleep disorders, robust pipeline product for the treatment of narcolepsy by manufactures, and rising awareness towards this sleep disorder. In the United States, around 1 among the 2000 patients are affected with narcolepsy disorder. The prevalence in North America is around 0.07%. Thus, the growing measures in therapeutics for diagnosis and treatment of narcolepsy lead to the growth of the market in North America region during the forecast period (2019-2026). For instance, on August 15th 2019, the US FDA has approved pitolisant (Wakix, Harmony Biosciences) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy.
Competitive Landscape • The narcolepsy therapeutics market is highly competitive with presence of large number of players including Jazz Pharmaceutical plc, Arena Pharmaceutical, Inc., Ligand Pharmaceuticals Inc., Bioprojet Pharma, Novartis, Teva Pharmaceutical Industries Ltd., Shinogi Inc., Takeda Pharmaceutical Company, Addrenex Pharmaceuticals, , among othersShire Plc
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