Narcolepsy Drugs Market

Global Industry Analysis (2018 – 2021) – Growth Trends and Market Forecast (2022 – 2026)

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Rising Prevalence, and Awareness to Boost Demand for Narcolepsy Drugs

As per the Narcolepsy Network, narcolepsy roughly affects one in every 2000 people in the US. Roughly 70% of the patients experience cataplexy (a sudden loss of muscle strength) that can cause slurred speech, and affect other body parts as well. Many patients also face difficulty functioning at workplaces, as well as in social situations. As per Narcolepsy UK, at least 25,000 people in the UK are suffering from narcolepsy whereas ~75% are misdiagnosed.

Narcolepsy is a debilitating ailment that can exert a significant emotional, social, and financial toll on patients. The condition, characterised by numerous symptoms, including excessive daytime sleepiness (EDS), automatic behaviors (walking or eating, in a semiconscious way), cataplexy, hallucinations, and sleep paralysis, involves the symptoms first appearing between the age group of 7 and 25. Narcolepsy is a chronic neurological disorder, where patient’s ability to regulate sleep-wake cycles diminishes over the period of time. The symptoms frequently change over time, and are often cyclical (e.g., seasonal) in nature, especially with respect to sleep patterns.

Other related symptoms, viz. weight gain, insomnia, depression, and mood fluctuations have a significant impact on a patient’s quality of life. Screening tests like polysomnogram (sleep study), hypocretin level measurement, and multiple sleep latency test (MSLT) are typically employed to diagnose narcolepsy. The awareness around narcolepsy is on the rise recently, mostly because of the campaigns from patient advocacy groups, and welfare associations, viz. Narcolepsy Network Inc., European Narcolepsy Network, American Sleep Association, and Wake Up Narcolepsy. This remains a strong factor supporting the growth of the global narcolepsy drugs market.

Type 1 Narcolepsy (with Cataplexy) Dominates Global Narcolepsy Drugs Market

Narcolepsy has two main types based on the presence of cataplexy, type 1 (narcolepsy with cataplexy), and type 2 (narcolepsy without cataplexy). There is also a condition known as secondary narcolepsy, resulting out of the hypothalamus injury. As per the study of the National Sleep Foundation, almost 60-70% of narcoleptic patients suffer from type 1 narcolepsy. Moreover, cataplexy is the confirming symptom for the conclusive diagnosis of narcolepsy, although it is rarely the first symptom of narcolepsy. Some patients, even when treated, may develop cataplexy as a new symptom over the time. On the other hand, type 2 narcolepsy is the fastest growing segment during the forecast period, attributable to the rapid increase in public awareness regarding the disease.

Stimulants, and Selective Serotonin are Widely Available Medications

Narcolepsy has no complete cure; however, drug therapies are employed to improve the patients’ quality of life. There are two approved drug classes for narcolepsy treatment, including stimulants such as modafinil, amodafonil, antidepressents, and tricuclicals, and selective serotonin that includes nor-adrenegic reuptake inhibitors, and sodium oxybate. Sodium oxybate is a preferred prescription drug for narcolepsy. It is also anticipated to exhibit robust growth rate during the forecast period due to the high treatment costs, and favourable reimbursement policies. Xyrem is a drug approved by FDA for use in cataplexy, and associated EDS. The American Academy of Sleep Medicine (ASSM) has recommended Xyrem as gold standard for narcolepsy with EDS, and cataplexy. It can be reimbursed under Medicare, and Medicaid. Moreover, manufacturers extend assistance programmes for patients without insurance coverage. Stimulants will lose on market share owing to patent expiration of Provigil, and Nuvigil. A few other stimulants, and antidepressants are also used as off-label narcolepsy drugs. Lifestyle modifications such as diet control, exercise, and regular napping can also help patients manage disease symptoms. The US Food and Drug Administration (FDA)-approved drugs are not available yet, specifically for the pediatric narcolepsy treatment.

Growing Research Activities around Narcolepsy Treatment

In the US, the National Institute of Neurological Disorders and Stroke (NINDS) along with several other National Institutes of Health (NIH) facilities, and centres support research on narcolepsy, and other sleep disorders through grants to medical institutions across the country. Moreover, National Heart, Lung, and Blood Institute manages the National Center on Sleep Disorders Research (NCSDR), which provides coordination to Federal government sleep research activities, and educates the public, and healthcare professionals about sleep disorders. NINDS-sponsored researchers are conducting studies devoted to clarifying the range of genetic -HLA genes and non-HLA genes, and environmental factors that may cause narcolepsy.  Other investigators are using animal models to better understand hypocretin, and other chemicals such as glutamate that may play a key role in regulating sleep, and wakefulness. Scientists have also demonstrated the presence of unusual activity of the immune system in people with narcolepsy. The NINDS continues to support investigations into the basic biology of sleep such as examining the brain mechanisms involved in generating, and regulating REM sleep and other sleep behaviors.

Developed Countries Hold a Majority of Market; Asia Pacific to Register Solid Demand Growth

Currently, North America dominates the global narcolepsy drugs market, followed by Europe. The NINDS estimates that around 200,000 people in the US alone are living with narcolepsy. The growing demand for sleep disorder treatment in the US, and Canada, coupled with high healthcare expenditure, is expected to fuel the market growth in North America. Moreover, favourable reimbursement policies, and strong clinical pipeline are the other factors to boost the revenue growth in this region. In Europe, the H1N1 influenza pandemic had resulted in heightening prevalence of sleep-related disorders.

Asia Pacific, on the other hand, is anticipated to witness lucrative growth over the forecast period. Shift-work sleep disorder, and increased stress levels are expected to expand the patient base in Asia Pacific. These factors may contribute to the growing demand for drugs in these economies. Constantly improving healthcare reimbursement policies are expected to boost demand further over the forecast period. In addition, increasing living standards have spurred regional demand. The region is set to exhibit lucrative growth during the forecast period on account of growing awareness about narcolepsy, and consistently growing healthcare expenditure. While populous economies like India, and China will facilitate further market growth in the region, Japan already has high narcolepsy prevalence.

Key Market Players Prioritise R&D, and Collaborative Activities to Strengthen Market Positioning

Key companies in the narcolepsy drugs market are exploring collaborative opportunities as a part of strategic expansions. In January 2020, Adare Pharmaceuticals, and NLS Pharmaceutics partnered to develop the treatment of narcolepsy, and attention deficit hyperactivity disorder (ADHD). In January 2019, Takeda acquired Provigil from Shire. In addition, companies are supporting patients through out-of-pocket co-pays, & free products for eligible patients. For instance, Jazz Pharmaceuticals plc has initiated Patient Assistance Programs for those without insurance coverage for narcolepsy drug therapies. Besides, BIOPROJET, Addrenex Pharmaceuticals, Arena Pharmaceuticals, Inc., GrayMark Healtcare Inc., Graymark Healthcare, Inc., Mylan N.V., Teva Pharmaceutical Industries Ltd., Novartis AG, Shire, Shionogi Inc., and Ligand Pharmaceuticals, Inc. are some of the prominent companies steering the competition in the global narcolepsy drugs market.

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