PUBLISHER: DelveInsight | PRODUCT CODE: 1226671
PUBLISHER: DelveInsight | PRODUCT CODE: 1226671
DelveInsight's 'Insomnia - Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of the Insomnia, historical and forecasted epidemiology as well as the Insomnia market trends in the United States, EU4 (Germany, France, Italy, Spain) and the UK, and Japan.
The Insomnia market report provides current treatment practices, emerging drugs, market share of individual therapies, and the current and forecasted the 7MM Insomnia market size from 2019 to 2032. The Report also covers current Insomnia treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2019-2032.
Insomnia is a common sleep-wake disorder characterized by both nocturnal and diurnal symptoms. It involves a predominant complaint of dissatisfaction with sleep quality or duration. It is accompanied by difficulties initiating sleep at bedtime, frequent or prolonged awakenings, or early-morning awakening with an inability to return to sleep. According to the American Academy of Sleep Medicine, Insomnia is defined as difficulty falling or staying asleep accompanied by daytime impairments related to those sleep troubles.
According to the International Classification of Sleep Disorders 3rd edition criteria, Insomnia disorder is defined as complaints of difficulty initiating sleep (DIS), and/or difficulty maintaining sleep (DMS), and/or early morning awakenings (EMA). These nocturnal symptoms must be accompanied by daytime impairment related to sleeping difficulties.
Whereas DSM-V defines Insomnia as dissatisfaction with sleep quantity or quality, often associated with either difficulty initiating sleep or difficulty maintaining sleep. It is characterized by frequent awakenings or problems returning to sleep after awakenings. This sleep difficulty is present for at least 3 months or occurs at least 3 nights per week. The condition has been renamed Insomnia disorder.
There is no single established cause of insomnia. However, research suggests that in many people, it results from certain physiological arousal at unwanted times, disrupting standard sleep patterns. Such arousal can include a heightened heart rate, a higher body temperature, and increased levels of specific hormones like cortisol. It also often occurs along with various mental disorders.
Insomnia was previously subdivided into many different types, including primary and secondary insomnia. Recently, these categories were changed American Academy of Sleep Medicine categorizes insomnia into short-term insomnia, chronic insomnia, and other insomnia. Other previously used subtypes now under chronic insomnia included paradoxical insomnia, idiopathic insomnia, psychophysiological insomnia, and inadequate sleep hygiene, among others. These subtypes were recently removed in the new ICSD-III.
Chronic Insomnia is when a person experiences sleeping difficulties and related daytime symptoms, like fatigue and attention issues, at least 3 days per week for more than 3 months or repeatedly over the years. Short-term insomnia r involves the same sleep difficulties and symptoms as chronic, but those problems are experienced for less than 3 months and may not occur three times per week. In specific cases, a doctor may diagnose a condition called other insomnia disorder if a person has significant sleeping problems but does not meet all of the criteria for either chronic or short-term insomnia disorder.
Increasing age, female gender, medical and psychiatric disease, and shift work all independently predict the risk of developing chronic insomnia. Insomnia is more prevalent in older populations, and the elderly are prone to several concomitant risk factors, such as increased prescription drug use, somatic disorders, neurological decline, reduced exposure to outdoor light, and polyphasic sleep-wake patterns. Lack of physical activity also may play a role in the age-related increase in insomnia prevalence..
Diagnosis of insomnia is based on the subjective complaint of difficulties initiating or maintaining sleep and reports of substantial distress or daytime impairments. Currently, two modalities help with objectively measuring sleep activity: actigraphy and polysomnography. Actigraphy is a technique for measuring limb movement activity with actigraphic devices that are wearable on wrists or ankles. The data for movement activity is gathered over a period, ultimately giving patterns for wakefulness and sleep. With the patterns, general sleep parameters, including sleep latency, sleep efficiency, total sleep time, and wake after sleep onset, can be obtained. These parameters greatly aid in evaluating insomnia. Non-REM and REM sleep cycles, however, can not be gathered and need polysomnography to assess. Although polysomnography is the golden standard in measuring sleep-related disorders, it is not used routinely for diagnosing insomnia. In insomnia cases, it is usually indicated when there is suspicion that another sleep-related disorder is possible. Such conditions would include breathing disorders such as obstructive sleep apnea, central sleep apnea, or sleep-related movement disorders.
Questionnaires such as the Insomnia Severity Index (ISI) and the Pittsburgh Sleep Quality Index (PSQI) is a tools to aid in the diagnosis of insomnia. The Insomnia Severity Index consists of seven questions with a score of 1-4. The maximum score is 28, and the higher the score, the worse insomnia. A score of greater than 14 indicates clinical insomnia. The questionnaire can be self-administered by patients and brought in for evaluation by the provider.
The PSQI was developed to help differentiate between different sleep-related disorders. It consists of 19 questions and measures different domains of sleep (quality, latency, duration, efficacy, medication use, daytime symptoms, and disturbances) over a month.
The goal of therapy for insomnia is to improve the patient's ability to fall asleep, stay asleep, wake and function well. According to various guidelines, insomnia is primarily treated using behavioral and psychological therapies such as CBT-I. CBT-I is recommended as a first-line treatment for chronic insomnia. Recently the US FDA approved SOMRYST, the first and only prescription digital therapeutic indicated to treat chronic insomnia. It is intended to improve insomnia symptoms by providing neurobehavioral intervention to adults 22 years of age and older with chronic insomnia.
However, due to limitations in the large-scale adoption of such treatments, pharmacotherapy remains an important component of insomnia management. The pharmacotherapies classes approved by the US FDA for the treatment of insomnia include the recently approved novel orexin receptor antagonists (suvorexant, lemborexant, and daridorexant), besides, benzodiazepines (temazepam, triazolam, estazolam, flurazepam, and quazepam), non-benzodiazepines (zolpidem, eszopiclone, zaleplon, or zolpidem tartrate), melatonin receptor agonists (ramelteon), and other antidepressants (including selective histamine H1 antagonists).
The approved products in these classes include LUNESTA (eszopiclone), AMBIEN (zolpidem tartrate), SONATA (zaleplon), HALCION (triazolam), PROSOM (estazolam), RESTORIL (temazepam), DORAL (quazepam), DALMENE (flurazepam), ZOLPIMIST (zolpidem tartrate), SILENOR (doxepin), ROZEREM (ramelteon), DAYVIGO (lemborexant), QUVIVIQ (daridorexant), BELSOMRA (suvorexant), CIRCADIN, and SLENYTO.
Most of these have been in the insomnia market for over a decade now and majority of them already have their generics in the market except orexin receptor antagonists, a novel class that includes Merck's BELSOMRA, Eisai's DAYVIGO, and the recent entrant Idorsia, Syneos Health, and Mochida Pharmaceutical's QUVIVIQ (daridorexant).
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Insomnia, Type-specific Cases of Insomnia, Gender-specific Cases of Insomnia, and Age-specific Cases of Insomnia scenario of Insomnia in the 7MM covering the United States, EU4 (Germany, France, Italy, Spain) and the UK, and Japan from 2019 to 2032.
The epidemiology segment also provides the Insomnia epidemiology data and findings across the United States, EU4 (Germany, France, Italy, Spain) and the UK, and Japan.
The drug chapter segment of the Insomnia report encloses a detailed analysis of Insomnia marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Insomnia clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.
The potential drugs that are expected to launch in the forecasted period include Vornorexant (TS-142), HETLIOZ (tasimelteon), Seltorexant (JNJ-42847922), Sunobinop (IMB-115).
HETLIOZ (tasimelteon), also known as VEC-162, being developed by Vanda Pharmaceuticals, is a melatonin receptor agonist of the human MT1 and MT2 receptors, with greater specificity for MT2. The drug is a circadian regulator that can reset the master body clock in the suprachiasmatic nucleus (SCN) located in the hypothalamus. HETLIOZ is approved to treat the non-24-h sleep-wake disorder (non-24) and nighttime sleep disturbances in Smith-Magenis syndrome (SMS). It is also developing tasimelteon for treating jet lag disorder, delayed sleep phase disorder, sleep disturbances in autism spectrum disorder, and pediatric non-24. Vanda Pharmaceuticals plans to submit a supplemental new drug application (sNDA) for HETLIOZ to treat insomnia.
TS-142 (vornorexant), a vornorexant, also known by the code, ORN-0829, being developed by Taisho Pharmaceutical, is an orexin receptor antagonist under development for the treatment of insomnia. It is a dual orexin OX1 and OX2 receptor antagonist (DORA) with a relatively short elimination half-life of approximately 6 h. Taisho Pharmaceutical is currently conducting Phase III trials of TS-142 in Japan for the treatment of insomnia and is also developing the drug overseas. Taisho is also evaluating the drug for hepatic impairment and obstructive sleep apnea-hypopnea.
Seltorexant (JNJ-42847922): Janssen Pharmaceutical
Seltorexant, with the code name JNJ-42847922, is a selective orexin-2 receptor antagonist being developed by Janssen Pharmaceutical as adjunctive therapy for major depressive disorder (MDD) and the treatment of insomnia disorder. The orexin system in the brain controls several key functions, including metabolism, stress response, and wakefulness. Seltorexant is the most advanced specific ORX2 molecule in clinical development, with antagonistic activity when binding to its receptor. It is currently in Phase III development for the adjunctive treatment for MDD with insomnia symptoms by Janssen. It is also developing the drug for treating probable Alzheimer's with clinically significant agitation or aggression.
Insomnia is the most commonly reported sleep-wake disorder and remains undertreated in many patients. It is characterized by difficulty falling asleep, staying asleep, or both, which can lead to daytime consequences such as fatigue, difficulty concentrating, and irritability. It is associated with an elevated risk of several comorbidities.
In the last decade, the diagnostic criteria for insomnia underwent some major changes with the decision to remove the distinction between primary and secondary insomnia, with the lack of evidence that treating the primary disorder would relieve insomnia accordingly, for example, in cases of insomnia associated with depression, being the main reason for this change. With the introduction of DSM-V criteria, insomnia associated with the comorbid condition was considered. Based on this, even ICSD-3 guidelines for insomnia were introduced. According to the study by Olufsen et al. (2020), which examined the impact of the changes in the diagnostic criteria for insomnia on the association between insomnia, anxiety, and depression, the new diagnostic criteria for insomnia strengthened the association between insomnia, anxiety, and depression.
Once diagnosed with insomnia disorder, treatment options are often insufficient. The goal of therapy for insomnia is to improve the patient's ability to fall asleep, stay asleep, wake and function well. According to various guidelines, insomnia is primarily treated using behavioral and psychological therapies such as CBT-I. Various pharmacological therapies, such as benzodiazepines or a combination of psychologic and pharmacologic therapies, are also recommended to ameliorate the condition. CBT-I is recommended as a first-line treatment for chronic insomnia disorder. However, there are barriers to CBT-I treatment, such as lack of access to sleep therapists or other trained providers, cost restraints, insurance coverage, patient unwillingness to participate actively, and patient adherence issues. Recently, the US FDA approved SOMRYST, the first and only digital therapeutic drug to treat chronic insomnia. It is intended to improve insomnia symptoms by providing neurobehavioral intervention to adults aged 22 and older with chronic insomnia.
Since numerous system, clinician, and patient barriers to psychologic therapies persist, limiting the large-scale adoption of such treatments, pharmacotherapy remains an important component of insomnia management.
The pharmacotherapies classes approved by the US FDA for the treatment of insomnia include benzodiazepines (temazepam, triazolam, estazolam, flurazepam, and quazepam), non-benzodiazepines (also called "Z-drugs") (zolpidem, eszopiclone, zaleplon, or zolpidem tartrate), both of which are used as first-line pharmacotherapy. The additional medications approved by the US FDA include selective histamines H1 antagonists, melatonin receptor agonists, such as ramelteon, and orexin receptor antagonists, such as suvorexant, lemborexant, and daridorexant. The most recent product to be marketed in US and Europe is Idorsia, Syneos Health, and Mochida Pharmaceutical's QUVIVIQ (daridorexant), a dual orexin receptor antagonist. The drug is also being developed in Japan for the treatment of insomnia.
Benzodiazepine receptor antagonists, so-called Z-drugs, bind to benzodiazepine receptors, resulting in an agonist effect on GABA. These agents decrease sleep latency and are approved for short-term treatment of sleep-onset insomnia. But, these cause drowsiness and dizziness and have an additive effect with other central nervous system (CNS) depressants besides complex sleep-related behaviors.
Drugs of the benzodiazepine class bind to benzodiazepine receptors on the postsynaptic GABA neuron, thereby enhancing GABA's inhibitive effect. Despite demonstrated efficacy with increasing objective measures such as total sleep duration, long-term use of BZDs is discouraged due to the potential for tolerance and dependence.
Histamine receptor antagonists promote wakefulness by activating H1 receptors in the cerebral cortex, but these are not recommended for chronic insomnia as they can cause CNS depression, resulting in sedation as well as anticholinergic effects. Melatonin receptors have agonist activity at the melatonin MT1 and MT2 receptors and are used to treat insomnia.
Most of these have been in the insomnia market for over a decade and have their generics except orexin receptor antagonists, a novel class that includes Merck's BELSOMRA, Eisai's DAYVIGO, and the recent entrant QUVIVIQ (daridorexant). Orexin receptor antagonists have potential advantages over benzodiazepines and other hypnotics, including limited cognitive impairment and the ability to arouse patients from sleep with adequate stimulation quickly. However, one major potential limitation to using orexin receptor antagonists is their cost.
Despite all the advances made over the last few decades with treatment modalities, insomnia is still a common disease that needs cost-effective treatment without side effects upon long-term usage. There is a clear unmet need for cost-effective, long-term insomnia therapies that improve sleep quality without resulting in next-day impairment and/or dependence. Various therapies that are expected to enter the market during the forecast period include Vornorexant (TS-142) (Taisho Pharmaceutical), HETLIOZ (tasimelteon) (Vanda Pharmaceuticals), Seltorexant (JNJ-42847922) (Janssen Pharmaceutical), and Sunobinop (IMB-115) (Imbrium Therapeutics), have the potential to maybe address some of these concerns. However, the pipeline is modest, with nothing novel and out of the box, caution is needed and one needs to have a wait-and-watch stance. The insomnia market though will have some change during the forecast period (2022-2032) due to the expected approval of these emerging therapies leading to the entry of new players in the treatment landscape. According to DelveInsight, the overall dynamics of the Insomnia market is anticipated to change in the coming years owing to the expected launch of emerging therapies.
This section provides the total Insomnia market size and market size by therapies in the United States.
The total Insomnia market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The total Insomnia market size and market size by therapies in Japan are provided.
This section focuses on the rate of uptake of the potential drugs recently launched in the Insomnia market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Insomnia market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, and the reasons behind the maximal use of new drugs and allow, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The report provides insights into different therapeutic candidates in the phase II, and phase III stages and also analyzes key players involved in developing targeted therapeutics.
The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for Insomnia emerging therapies.
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
We perform competitive and market Intelligence analysis of the Insomnia market by using various competitive intelligence tools that include-SWOT analysis, Attribute analysis, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.