Insomnia Market

• The Insomnia market size in the 7MM was approximately USD 5,700 million in 2022 and is projected to increase during the forecast period (2023–2032).
• The Insomnia diagnosed prevalence has been increasing due to the increasing prevalence of lifestyle-associated disorders, besides increasing population and awareness of sleep disorders.
• Increased awareness and a better understanding of disease pathophysiology have improved diagnosis and treatment.
• Benzodiazepines and benzodiazepine receptor antagonists, so-called Z-drugs, are widely used first-line pharmacotherapy to decrease sleep latency and are approved for short-term treatment of sleep-onset insomnia. The other medications approved by the US FDA include selective histamine H1 antagonists, melatonin receptor agonists, and dual orexin receptor antagonists (DORAs) (the latest class to be approved), besides non-pharmacological interventions like cognitive behavioral therapy.
• One of the major concerns in understanding the insomnia market is frequent off-label prescribing and unrestricted use of antidepressants and other OTCs, despite a lack of clinical evidence of benefit. Further, many approved drugs have been on the market for over a decade and face the threat of generic erosion. This is evident from the gradual decline in the revenue of drugs. Most approved pharmacological treatment options are associated with adverse events, like reduced sleep quality, next-day somnolence, and increased risk of accidents/injuries
• Insomnia is associated with poor health-related quality of life, increased healthcare resource utilization reduced productivity, and substantial economic burden.
• Changes in the diagnostic criteria have improved the diagnosis of insomnia and helped in the recognition of insomnia as a disorder in its own right, along with greater operationalization and quantification of its diagnostic criteria. Significant developments in the treatment regime have led to the approval of novel class therapies such as orexin antagonists and melatonin agonists, along with CBTs, that address insomnia with associated conditions
• In 2022, the US had the largest Insomnia market size of insomnia among the 7MM countries, accounting for approximately USD 4,656 million, which is expected to increase further by 2032.
• Novel orexin receptor antagonists, suvorexant, lemborexant, and daridorexant, are the latest FDA-approved class for the treatment of insomnia. These 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, with a clear unmet need for cost-effective, long-term therapies that improve sleep quality without resulting in next-day impairment and/or dependence.
• Emerging therapies like vornorexant (TS-142) (Taisho Pharmaceutical), HETLIOZ (tasimelteon) (Vanda Pharmaceuticals), seltorexant (JNJ-42847922) (Janssen Pharmaceutical), and sunobinop (IMB-115) (Imbrium Therapeutics), have the potential to address some of these concerns maybe. The insomnia market, though, will change during the forecast period due to the expected approval of these emerging therapies leading to the entry of new players in the treatment landscape.
• Janssen Pharmaceutical’s Seltorexant (JNJ-42847922), an orexin antagonist for the treatment of individuals with MDD suffering from associated insomnia, is a niche-specific product that may address the side effects associated with DORAs.
• Vanda Pharmaceuticals’ HETLIOZ (tasimelteon), a melatonin receptor agonist, is another therapy with potential that is anticipated to enter the US market by 2024, according to DelveInsight’s analysts. This circadian regulator has the potential to improve latency to persistent sleep significantly by synchronizing an individual’s sleep/wake cycle.
• 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.
• With no curative therapy and the large side effect associated with the current treatment regime, there are opportunities for pharma players to develop therapies with improved safety and tolerability profiles, effective in improving sleep quality without next-day somnolence.

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DelveInsight’s “Insomnia – Market Insights, Epidemiology, and Market Forecast – 2032” report delivers an in-depth understanding of insomnia, historical and forecasted epidemiology, as well as the insomnia market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Insomnia market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM insomnia market size from 2019 to 2032. The report also covers current insomnia treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Insomnia Treatment Market

Insomnia is a common sleep–wake disorder characterized by 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 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 or 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 another 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 wearable actigraphic devices 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 cannot 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 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) are tools that 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; 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.

Further details related to country-based variations are provided in the report…

Insomnia Treatment

The treatment goal for insomnia is improving the patient’s ability to fall, stay, wake, and function well. According to various guidelines, insomnia is primarily treated using behavioral and psychological therapies such as Cognitive Behavioral Therapy for insomnia (CBT-I).

CBT-I is a multi-component gold standard for treating chronic insomnia, including cognitive, behavioral, and psychoeducational interventions. The first line of treatment recommended for insomnia is delivered through 4–8 sessions, typically by a clinician with specialized training in this area. Recently, the US FDA approved Pear Therapeutics, SOMRYST, the first and only digital therapeutic drug to treat chronic insomnia.

In most acute cases, to increase the effectiveness of non-pharmacological therapies, various pharmacological therapies are also recommended to ameliorate the condition.

Across decades, various classes have been approved by the US FDA for the treatment of insomnia, that 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 classes approved by the US FDA include selective histamines antagonists, melatonin receptor agonists, such as ramelteon, and orexin receptor antagonists, such as suvorexant, lemborexant, and daridorexant.

Dual orexin receptor antagonists (DORAs), the latest entrants in the treatment landscape, changed this treatment paradigm of Z-drug or a benzodiazepine associated with some significant side effects, including drowsiness the next morning, impacting the quality of life. The three approved products in this class include BELSOMRA, DAYVIGO, and QUVIVIQ.

Merck’s BELSOMRA (suvorexant) is the first entrant in the US (2014) market, followed by Eisai’s DAYVIGO (lemborexant). The most recent product to be marketed in the US and Europe is Idorsia, Syneos Health, and Mochida Pharmaceutical’s QUVIVIQ (daridorexant), a dual orexin receptor antagonist.

Insomnia Epidemiology

As the market is derived using a patient-based model, the insomnia epidemiology chapter 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 in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

• In 2022, the total insomnia diagnosed prevalent cases were estimated to be approximately 86,512,557 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 67.2% of the total insomnia diagnosed prevalent cases in 2022. These cases are expected to increase further during the study period (2019–2032).
• As per DelveInsight analysis, there were approximately 31,830,445 cases of acute insomnia in the US and 26,306,153 cases of chronic insomnia in 2022, which are expected to increase by 2032.
• According to estimates based on DelveInsight’s epidemiology model of insomnia, in 2022, in EU4 and the UK, there were approximately 9,869,071 cases of acute insomnia and 13,342,330 cases of chronic insomnia, which are expected to increase by 2032.
• According to estimates based on DelveInsight’s epidemiology model of Insomnia, the age-specific cases of insomnia in EU4 and the UK in 2022 were approximately 2,214,257, 3,728,920, 3,763,699, 3,981,128, 4,011,010, and 5,512,387 cases in the age groups 18-24, 25-34, 35-44, 45-54, 55-64, and 65+, respectively.
• In 2022, in Japan, there were approximately 2,247,099 cases of insomnia in males and 2,917,458 cases of insomnia in females. These gender-specific cases are expected to decrease in Japan by 2032.

Read Epidemiology Report- Insomnia Epidemiology Report

Insomnia Drug Chapters

The drug chapter segment of the insomnia report encloses a detailed analysis of insomnia-marketed drugs and late-stage (Phase III and Phase II) Insomnia Pipeline Drugs. It also helps understand the insomnia clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Insomnia Emerging Drugs

• HETLIOZ (tasimelteon): Vanda Pharmaceuticals

HETLIOZ (tasimelteon), also known as VEC-162, 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 the 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.

• Seltorexant (JNJ-42847922): Janssen Pharmaceutical

Seltorexant, with the code name JNJ-42847922, is a selective orexin-2 receptor antagonist 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. This system promotes arousal (wakefulness) and is hypothesized to play a role in excessive arousal, which occurs in subsets of patients with mood disorders and has clinical utility in treating such patients.

Seltorexant is the most advanced specific ORX2 molecule in clinical development, with antagonistic activity when binding to its receptor. Seltorexant is currently in Phase III development for the adjunctive treatment for MDD with insomnia symptoms by Janssen. It also develops the drug for treating probable Alzheimer’s with clinically significant agitation or aggression.

• Vornorexant (TS-142): Taisho Pharmaceutical

TS-142, 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.

Orexins are neuropeptides that are important in maintaining wakefulness and regulating the sleep–wake cycle. There are two types of orexin receptors; OX2 has a role in sleep regulation, while OX1 acts synergistically with OX2 to regulate rapid eye movement sleep.

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.

Note: Detailed emerging therapies assessment will be provided in the final report.

Insomnia Drug Class Insights

Insomnia is directional and co-occurs with psychiatric or physical conditions, where it is the cause and symptom both. It is clinically diagnosed when the impact on sleep quantity or quality is persistent and is there for at least three nights per week for at least three months, and occurs despite an adequate opportunity to sleep, with a negative impact on daytime functioning. 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, stay, wake, and function well. Pharmacotherapy remains an important component of insomnia management.

Benzodiazepines, promote sleep and reduce anxiety by binding to gamma-aminobutyric acid-A (GABA-A) receptors in the brain, low levels of which lead to trouble falling asleep. But since these have a risk for dependency, they are not recommended for long-term use. The Z-drugs have a similar hypnotic effect as benzodiazepines, as they also raise the GABA levels in the brain. Though more efficacious than BZDs, these are also associated with significant side effects, including drowsiness the next morning, impacting the quality of life. Melatonin receptor agonists, like ramelteon, which is approved for treating insomnia characterized by difficulty falling asleep, selectively bind to the brain’s MT1 and MT2 melatonin receptors. They work to create a manageable circadian rhythm or sleep-wake cycle.

Novel orexin receptor antagonists, suvorexant, lemborexant, and daridorexant, are FDA approved for the treatment of insomnia. Orexin receptor antagonists have potential advantages over benzodiazepines and other hypnotics, including limited cognitive impairment and the ability to quickly arouse patients from sleep with adequate stimulation.

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, increased risk of motor vehicle accidents and falls, workplace impairment, and costly workspace accidents and errors.

CBT-I is recommended as a first-line treatment for chronic insomnia disorder by the American Academy of Sleep Medicine (AASM), the American College of Physicians (ACP), and the European Sleep Research Society (ESRS). It is a non-pharmacological treatment of insomnia delivered throughout 4–8 sessions, typically by a clinician with specialized training in this area. It has improved several sleep outcomes, including sleep time, efficiency, and onset latency. However, there are barriers to CBT-I treatment, such as lack of access to sleep therapists or other trained providers and cost restraints.

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.

Benzodiazepines and non-benzodiazepines are associated with significant side effects, including drowsiness the next morning, impacting the quality of life. Melatonin receptor agonists, like ramelteon, are approved for the treatment of insomnia characterized by difficulty falling asleep. Though helpful in falling asleep initially, these are not recommended for those who wake up in the middle of the night and have trouble getting back to sleep. Further, even though they are considered safe than benzodiazepines and Z-drugs, they can still cause daytime drowsiness and affect coordination.

Another major conflict is that though approved therapies in these classes have been on the market for over a decade, they now face the threat of generic erosion. This is evident from the gradual decline in the revenue of drugs like Takeda’s ROZEREM, Currax Pharmaceuticals’ SILENOR, Sanofi’s AMBIEN, Neurim Pharmaceuticals, and Lundbeck’s CIRCADIN.

Dual orexin receptor antagonists (DORAs), the latest entrants in the treatment landscape, have three approved products: BELSOMRA, DAYVIGO, and QUVIVIQ. Merck’s BELSOMRA (suvorexant) is the first entrant in the US (2014) market, followed by Eisai’s DAYVIGO (lemborexant). The former has been on the market for 7 years but failed to catch up with patients. BELSOMRA’s first-to-market advantage in the US has not translated into big annual sales. Both have faced difficulties in gaining market share along with warning labels regarding next-day residual effects and abuse potential, among other safety risks.

The most recent product to be marketed in the US and Europe is Idorsia, Syneos Health, and Mochida Pharmaceutical’s QUVIVIQ (daridorexant), a dual orexin receptor antagonist. Idorsia has also become the first drug maker in the EU to claim approval for a drug for chronic insomnia in DORA class, ahead of rivals Merck and Eisai, giving it a first-mover advantage and a chance to make a breakthrough in the region.

The current market has been segmented into different commonly used therapeutic classes based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. Benzodiazepines, non-benzodiazepines, melatonin receptor agonists, other antidepressants, BELSOMRA, DAYVIGO, and QUVIVIQ are the major drugs covered in the forecast model.

Key players Taisho Pharmaceutical’s Vornorexant (TS-142), Vanda Pharmaceuticals’ HETLIOZ (tasimelteon), Janssen Pharmaceutical’s Seltorexant (JNJ-42847922), and Imbrium Therapeutics’ Sunobinop (IMB-115) are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of insomnia.

• The total Insomnia market size in the 7MM was USD 5,759 million in 2022 and is projected to increase during the forecast period (2023–2032).
• The Insomnia market size in the US will increase at a CAGR of 3.8% during the study period due to increasing awareness of the disease and the launch of the emerging therapy, the market size was approximately USD 4,656 million in 2022.
• The total insomnia market size in EU4 and the UK was calculated to be approximately USD 771 million in 2022, which was nearly 13.4% of the total market revenue for the 7MM.
• According to DelveInsight’s estimates, among EU4 and the UK, France accounted for the highest market with approximately USD 350 million in 2022, followed by Germany with approximately USD 130 million in the respective year, while Spain accounted for the lowest market in 2022.
• According to DelveInsight’s analysis, in the US, non-benzodiazepines have the highest market share among all the therapies, in 2022, with a revenue of approximately USD 1,785 million, followed by other antidepressants and benzodiazepines, respectively.
• In 2022, the Insomnia market size in Japan was nearly 5.8% of the total market size in the 7MM, with a revenue of approximately USD 333 million.
• Janssen Pharmaceutical’s Seltorexant (JNJ-42847922), for the treatment of individuals with MDD suffering from associated insomnia, with an anticipated entry in 2025, is expected to generate a revenue of approximately USD 3.9 million in its entry year. With a niche patient pool, the drug is predicted to have a slow-medium uptake during the forecast period.

Insomnia Drugs Uptake

This section focuses on the uptake rate of potential Insomnia drugs expected to be launched in the market during 2019–2032. For example, Vanda Pharmaceuticals’ HETLIOZ (tasimelteon), a melatonin receptor agonist, is expected to enter the US market by 2024 and is projected to have a slow-medium uptake during the forecast period.

Further detailed analysis of emerging therapies drug uptake in the report…

Insomnia Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes Insomnia companies involved in developing targeted therapeutics.

Read Pipeline Report- Insomnia Pipeline 2023 Report (Updated)

Pipeline Development Activities

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

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on insomnia evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Texas Health Science Center, Johns Hopkins University, Harvard Medical School, King’s College in London, Fondation Fondamental in Créteil, and the University of Shizuoka were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or insomnia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in insomnia trials, efficacy scores are analyzed based on their ability to improve sleep onset as measured by LPS and the change in WASO.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Insomnia Market Access and Reimbursement

The US FDA has approved an array of prescription medications for Insomnia treatment, including BZD and non-BZD drugs, the melatonin agonist ramelteon, the sedating antidepressant doxepin, and the orexin receptor antagonist suvorexant. In addition, several agents approved for other indications, such as the antidepressants trazodone and mirtazapine, are used in this setting. Over-the-counter alternative therapies include antihistamines, melatonin, and valerian and kava herbal products.

SILENOR (doxepin) savings program aims to reduce the out-of-pocket cost to as little as USD 25, requiring a minimum of 30 tablet prescriptions. Patients with a high copay or prescription plan based on an annual deductible may have additional responsibility. The maximum benefit depends upon the patient’s prescription plan and purchased product quantity. The card is valid only in the US and is not valid if the prescription is paid/partially paid by Medicaid, Medicare, or Federal or State healthcare programs. DAYVIGO (lemborexant) may be covered by commercial insurance companies, Medicare, and Medicaid. Coverage may vary significantly by the insurance company, specific health insurance plan, and patient. Insurance companies can base coverage decisions on formal policies or make decisions on a case-by-case basis. Medicare is a federal health insurance program for people 65 or older, certain younger people with disabilities, and people with end-stage renal disease. Part D covers prescription drugs one gets at a pharmacy and takes home, including DAYVIGO. One’s healthcare provider can help understand how Medicare may cover DAYVIGO.

QUVIVIQ 360 is a comprehensive program designed to help patients with insurance coverage support, seamlessly applied savings, and ongoing education.

Provisions for pharmaceutical chargebacks (primarily reimbursements to wholesalers in the US for honoring contracted prices and legislated discounts to third parties) closely approximate actual amounts incurred, as these deductions are generally settled within 2–5 weeks of incurring the liability.

The Insomnia market report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Insomnia Market Report Scope

• The report covers a segment of key events, an executive summary, and a descriptive overview of Insomnia, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Insomnia market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The patient-based Insomnia Market forecasting report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM insomnia market.

Insomnia Market Report Insights

• Patient-based Insomnia Market Forecasting
• Therapeutic Approaches
• Insomnia Pipeline Drugs Analysis
• Insomnia Market Size and Trends
• Existing and Future Market Opportunity

Insomnia Market Report Key Strengths

• 10 Years Insomnia Market Forecast
• The 7MM Coverage
• Insomnia Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Insomnia Market Forecast Assumptions

Insomnia Market Report Assessment

• Current Insomnia Treatment Practices
• Insomnia Unmet Needs
• Insomnia Pipeline Drugs Profiles
• Insomnia Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Insomnia Treatment Market Insights

• What was the total Insomnia market size, the Insomnia market size by therapies, and market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• How will Seltorexant and HETLIOZ (tasimelteon) affect the treatment paradigm of insomnia?
• How will QUVIVIQ (daridorexant) compete with other similar class products and off-label therapies?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Insomnia Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Insomnia? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Insomnia?
• What is the historical and forecasted insomnia patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent insomnia population during the forecast period (2023–2032)?
• What factors are contributing to the growth of insomnia cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Insomnia? What are the current guidelines for treating insomnia in the US, Europe, and Japan?
• How many companies are developing therapies for the treatment of Insomnia?
• How many emerging therapies are in the mid-stage and late stage of development for treating Insomnia?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and Insomnia Market forecasted?

Reasons to Buy

• The Patient-based Insomnia Market Forecasting report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Insomnia market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for insomnia, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the Insomnia unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

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