Insomnia - Market Insight, Epidemiology And Market Forecast - 2032

This ‘Insomnia - Market Insights, Epidemiology, and Market Forecast-2032' report deliver 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.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, Spain) and the UK
• Japan

Study Period: 2019-2032

Insomnia Understanding and Treatment Algorithm

Insomnia Overview

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..

Insomnia Diagnosis

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.

Insomnia Treatment

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).

Insomnia Epidemiology

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.

Key Findings

• In 2021, the total diagnosed prevalent cases of insomnia were estimated to be approximately 85,968,021 cases in the 7MM. These cases are expected to increase by 2032 at a CAGR of 0.6% during the study period (2019-2032).
• Among the 7MM, the United States accounted for nearly 67% of the total diagnosed prevalent cases of insomnia in the year 2021. These cases are expected to increase further during the study period (2019-2032).
• As per analysis, in the US, there were approximately 31,564,128 cases of acute insomnia and 26,086,057 cases of chronic insomnia in 2021, which are expected to increase by 2032.
• According to estimates based on the publisher's epidemiology model of insomnia, in 2021, in EU4 and the UK, there were approximately 9,836,407 cases of acute insomnia and 13,305,555 cases of chronic insomnia, which are expected to increase by 2032.
• According to estimates based on the publisher's epidemiology model of Insomnia, the age-specific cases of insomnia in EU4 and the UK in 2021 were approximately 2,206,746, 3,715,978, 3,751,031, 3,969,639, 4,000,375, and 5,498,193 cases in the age groups 18-24, 25-34, 35-44, 45-54, 55-64, and 65+, respectively.
• In 2021, in Japan, there were approximately 2,252,023 cases of insomnia in males, and 2,923,851 cases of insomnia in females. These gender-specific cases are expected to decrease by 2032 in Japan.

Insomnia Epidemiology

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.

Insomnia Drug Chapters

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.

Insomnia Emerging Drugs

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): Vanda Pharmaceuticals

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.

Vornorexant (TS-142): Taisho Pharmaceutical

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.

List of products to be continued in the report…

Analyst Commentary

• HETLIOZ (tasimelteon), under development by Vanda Pharmaceutical, is a circadian regulator with the potential to synchronize an individual's sleep/wake cycle. With successful Phase III results, the drug is one of the best in the development pipeline for insomnia and can potentially make Vanda an important player in the insomnia market.
• JNJ-42847922 (seltorexant) by Janssen, an orexin antagonist, has the potential to change the treatment regime for individuals with MDD suffering from associated insomnia. The first of its kind to address the difficulties of this cohort, the drug is an advanced specific ORX2 molecule with a niche of its own and thus has the potential to grow in the insomnia market.
• TS-142, developed by Taisho Pharmaceutical, is a novel compound with potent antagonistic activity against orexin receptors that can potentially improve the orexin-dominated drug market for insomnia. With fast absorption and short elimination properties compared to the marketed similar class products, the drug has the potential to improve the quality of sleep and sleep maintenance, thus, creating a niche for itself in the crowded market space.

Insomnia Market Outlook

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 the publisher, the overall dynamics of the Insomnia market is anticipated to change in the coming years owing to the expected launch of emerging therapies.

Key Findings

• The market size of the Insomnia in the seven major markets was approximately USD 5,662.2 million in 2021, which is further expected to increase by 2032.
• The market size in the 7MM will increase at a CAGR of 3.7% due to increasing awareness of the disease
• Among the 7MM countries, the US accounted for the highest market size of Insomnia with approximately USD 4,606.0 million in 2021, and is likely to increase by 2032.
• Among EU4 and the UK, France accounted for the highest market share of insomnia with approximately USD 348.2 million in 2021, followed by Germany with approximately USD 130.2 million in the respective year, while Spain accounted for the lowest market with USD 80.8 million in 2021.
• Japan accounted for approximately USD 289.6 million in 2021, which is expected to increase by 2032.

The United States Market Outlook

This section provides the total Insomnia market size and market size by therapies in the United States.

EU4 and the UK Market Outlook

The total Insomnia market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Insomnia market size and market size by therapies in Japan are provided.

Insomnia Drugs Uptake

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.

Insomnia Development Activities

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.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, mergers, licensing, and patent details for Insomnia emerging therapies.

Reimbursement Scenario in Insomnia

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.

Competitive Intelligence Analysis

The publisher performs 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.

Scope of the Report

• The report covers a descriptive overview of Insomnia, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Insomnia epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Insomnia is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Insomnia market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Insomnia market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the Insomnia market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Insomnia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Insomnia. The launch of emerging therapies (therapeutic and prophylactic) will significantly impact the Insomnia market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Insomnia Report Insights

• Patient Population
• Therapeutic Approaches
• Insomnia Pipeline Analysis
• Insomnia Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies (therapeutic and prophylactic)

Insomnia Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Insomnia Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market

Insomnia Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions Answered

Market Insights:

• What was the Insomnia market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Insomnia total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Insomnia market size during the forecast period (2022-2032)?
• At what CAGR, the Insomnia market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Insomnia market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Insomnia market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of Insomnia?
• What is the historical Insomnia patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of Insomnia at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Insomnia?
• Out of the above-mentioned countries, which country would have the highest incidence population of Insomnia during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Epidemiology Insights:

• What are the current options for the treatment of Insomnia along with the approved therapy?
• What are the current treatment guidelines for the treatment of Insomnia in the US and Europe?
• What are the Insomnia marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
• How many companies are developing therapies for the treatment of Insomnia?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Insomnia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Insomnia therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Insomnia and their status?
• What are the key designations that have been granted for the emerging therapies for Insomnia?
• What is the 7MM historical and forecasted market for Insomnia?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving Insomnia.
• To understand the future market competition in the Insomnia market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Insomnia in the US, EU4 (Germany, Spain, Italy, France) and the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Insomnia market.
• To understand the future market competition in the Insomnia market