DelveInsight’s “Insomnia Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Insomnia, historical and forecasted epidemiology as well as the Insomnia market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.
To Know in detail about the Insomnia market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Insomnia Market Forecast
Some of the key facts of the Insomnia Market Report:
The Insomnia market size is anticipated to grow with a significant CAGR during the study period (2020-2034).
The diagnosed prevalence of insomnia has steadily increased, driven by factors such as stress, demanding lifestyles, greater awareness, and advancements in sleep medicine and personalized therapies. In 2023, the estimated number of diagnosed insomnia cases across the 7MM was approximately 87 million.
Insomnia is a significant health concern in the United States, where its prevalence has been rising in recent years. According to DelveInsight’s estimates, the US accounted for 67% of all insomnia cases in the 7MM in 2023, followed by France, Japan, and Germany.
DelveInsight’s analysis also highlights that insomnia is more prevalent among females in the 7MM, with women accounting for 58% of cases compared to 42% in men.
The insomnia market faces several challenges, including high treatment costs, market saturation, complex drug development, and patient non-compliance. Key unmet needs in insomnia management include the development of long-term solutions with minimal side effects, therapies that address the root causes of insomnia, and more personalized treatment options.
In 2023, the insomnia market across the 7MM was valued at approximately USD 5.84 billion, with expectations for significant growth, projected at a compound annual growth rate (CAGR) of 3.9% by 2034. The market is expected to expand further with the anticipated introduction of emerging therapies, such as Seltorexant, TS-142, and others.
In July 2024, the European Medicines Agency’s CHMP approved an extension for SLENYTO to treat insomnia in children with neurogenetic disorders (NGDs). Initially approved in 2018 for autism spectrum disorder and Smith-Magenis Syndrome, SLENYTO is now set to become the sole medication for insomnia in children aged 2-18 with NGDs and aberrant melatonin secretion, addressing a critical need for effective treatment in this pediatric population.
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
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.
Key Insomnia Companies: Vanda Pharmaceuticals, Janssen Pharmaceutical, Taisho Pharmaceutical, Neurim Pharmaceuticals, Imbrium Therapeutics, Defined Research, and others
Key Insomnia Therapies: HETLIOZ (tasimelteon), Seltorexant (JNJ-42847922), Vornorexant (TS-142), Piromelatine (Neu-P11), Sunobinop (IMB-115), Defined CBD (cannabidiol), and others
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.
The Insomnia market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Insomnia pipeline products will significantly revolutionize the Insomnia market dynamics.
Insomnia Overview
Insomnia is a common sleep-wake disorder characterized by dissatisfaction with the quality or duration of sleep. Individuals with insomnia often experience difficulty falling asleep, frequent awakenings during the night, or early-morning wakefulness with an inability to fall back asleep. According to the American Academy of Sleep Medicine, insomnia is defined as difficulty initiating or maintaining sleep, resulting in daytime impairment. The International Classification of Sleep Disorders (ICSD-3) classifies it by challenges in falling asleep, staying asleep, or waking up too early, along with associated daytime dysfunction. The DSM-V refers to it as *Insomnia Disorder*, describing it as dissatisfaction with sleep quantity or quality, with symptoms occurring at least three times a week for a duration of three months or more.
While no single cause has been identified, insomnia is often associated with physiological arousal, such as an elevated heart rate and increased cortisol levels, which can disrupt sleep. Insomnia can be classified into two types: short-term and chronic. Chronic insomnia is defined by persistent symptoms lasting three months or more. Various factors contribute to the risk of developing insomnia, including age, gender, underlying medical and psychiatric conditions, and lifestyle factors such as shift work.
The diagnosis of insomnia is primarily based on subjective reports from patients about difficulties in initiating or maintaining sleep, as well as the resulting daytime impairments. Objective assessments often include actigraphy, which tracks limb movements using wearable devices to provide data on sleep patterns such as latency (the time it takes to fall asleep) and sleep efficiency. For more detailed analysis, including Non-REM and REM sleep cycles, polysomnography is used, although it is not typically employed for routine insomnia diagnosis unless another sleep disorder, such as sleep apnea, is suspected. Additional diagnostic tools include the Insomnia Severity Index (ISI), a scale that measures the severity of insomnia, and the Pittsburgh Sleep Quality Index (PSQI), a 19-question survey that evaluates various aspects of sleep over a one-month period.
Despite advancements in diagnostic methods, several gaps remain in the accurate diagnosis of insomnia. Current tools, while effective, often lack the sensitivity needed to differentiate between primary insomnia and secondary sleep disorders, which can lead to misdiagnosis. Actigraphy and polysomnography, though useful, can be expensive and cumbersome, limiting their widespread use. There is also a need for more reliable biomarkers or objective measures that can complement subjective reports and enhance diagnostic precision. Furthermore, existing questionnaires like the ISI and PSQI may not fully capture the broader impact of insomnia on daily functioning. To address these challenges, more refined diagnostic methods that incorporate both advanced sleep monitoring technologies and personalized approaches could improve accuracy and ultimately support better treatment outcomes.
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Insomnia Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
In 2023, the total diagnosed prevalence of insomnia in the United States was approximately 58.6 million cases, with projections indicating a continued increase during the forecast period.
Among the EU4 countries and the UK, France represented the largest share of diagnosed insomnia cases, accounting for 43% of the total, while Spain reported the lowest prevalence at just 11%. This disparity underscores France’s dominant role in the regional insomnia landscape, in contrast to Spain’s relatively small case load.
DelveInsight estimates show that insomnia is more prevalent among females than males in the US. Specifically, there were approximately 32.7 million cases in females, compared to 25.9 million in males, reflecting a clear gender disparity in the condition’s prevalence.
Age-specific data in Japan for 2023 revealed that individuals aged 65 and older had the highest prevalence of diagnosed insomnia, with nearly 2.2 million cases, while those in the 18–24 age group had the lowest prevalence, at approximately 292,000 cases.
In the EU4 and the UK, the diagnosed prevalence of insomnia in 2023 totaled around 23.3 million cases. Of these, nearly 9.9 million cases were classified as acute insomnia, while 13.4 million were categorized as chronic insomnia.
Insomnia Epidemiology Segmentation:
The Insomnia market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
Total Prevalence of Insomnia
Prevalent Cases of Insomnia by severity
Gender-specific Prevalence of Insomnia
Diagnosed Cases of Episodic and Chronic Insomnia
Insomnia Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Insomnia market or expected to get launched during the study period. The analysis covers Insomnia market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Insomnia Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
Insomnia Key Companies
Vanda Pharmaceuticals, Janssen Pharmaceutical, Taisho Pharmaceutical, Neurim Pharmaceuticals, Imbrium Therapeutics, Defined Research
Insomnia Therapies
HETLIOZ (tasimelteon), Seltorexant (JNJ-42847922), Vornorexant (TS-142), Piromelatine (Neu-P11), Sunobinop (IMB-115), Defined CBD (cannabidiol)
Discover more about therapies set to grab major Insomnia market share @ Insomnia Treatment Landscape
Insomnia Market Insights:
In 2023, the market size for insomnia in the United States was approximately USD 4,734 million, with projections indicating a robust compound annual growth rate (CAGR) of 4.1% during the forecast period.
In the EU4 and the UK, the insomnia market was valued at around USD 774 million in 2023, and it is expected to grow at a CAGR of 3.1%.
Among the EU countries, France represented the largest market for insomnia, with a market size of approximately USD 352 million in 2023, while Spain had the smallest market, at about USD 82 million.
The introduction of emerging therapies, such as Seltorexant (JNJ-42847922) and TS-142, is anticipated to drive market dynamics, potentially reshaping the insomnia treatment landscape in the coming years.
Insomnia Market
Insomnia, the most common sleep-wake disorder, is often underdiagnosed and inadequately treated. It is characterized by difficulty falling or staying asleep, which leads to daytime impairment such as fatigue, concentration issues, and irritability. Insomnia is also associated with an increased risk of comorbid conditions, accidents, and reduced workplace productivity. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the first-line treatment by leading sleep organizations, but access to trained therapists and the high cost of therapy pose significant barriers, leaving pharmacological options as a key part of treatment.
In the United States, approved pharmacotherapies for insomnia include benzodiazepines and non-benzodiazepines (Z-drugs). Other treatment options include selective histamine H1 antagonists, melatonin receptor agonists like ramelteon, and orexin receptor antagonists such as suvorexant and lemborexant. A recent addition to the insomnia treatment arsenal is QUVIVIQ, developed by Idorsia, which is also being investigated for approval in Japan.
While benzodiazepines and Z-drugs are effective, they are often associated with significant side effects, such as next-day drowsiness and potential dependency. Melatonin receptor agonists are generally more effective for sleep initiation but less effective for maintaining sleep. Meanwhile, many existing insomnia drugs are experiencing revenue declines due to generic competition. Dual Orexin Receptor Antagonists (DORAs) like BELSOMRA and DAYVIGO have faced challenges in gaining widespread adoption, but the recent approval of QUVIVIQ in Europe positions Idorsia for a potential breakthrough in the insomnia treatment market.
The current insomnia market is segmented by therapeutic class, reflecting minor variations in prescribing patterns across the 7MM (US, EU4, and Japan). Major drugs in the forecast model include benzodiazepines, non-benzodiazepines, melatonin receptor agonists, other antidepressants, BELSOMRA, DAYVIGO, and QUVIVIQ.
The launch of emerging therapies such as Seltorexant (JNJ-42847922), TS-142, and others is expected to positively impact the market. The approval of these new treatments could significantly alter market dynamics, though their success rates and adoption remain uncertain.
Scope of the Insomnia Market Report
Study Period: 2020–2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Insomnia Companies: Dana-Farber Cancer Institute, Huabo Biopharm Co., Ltd., Beijing Scitech-Mq Pharmaceuticals, Oxford BioMedica, Hutchison Medipharma Limited, Takeda, Amgen, Novartis, AVEO Pharmaceuticals, Inc., Merck Sharp & Dohme LLC, Pfizer, Calithera Biosciences, Inc, AbbVie, Bristol-Myers Squibb, Abbott, SCRI Development Innovations, LLC, Astellas Pharma Inc, and others
Key Insomnia Therapies: Bevacizumab, HB0025, ST-1898 tablets, Trovax, fruquintinib+sintilimab, Cabozantinib, AMG 102, Pazopanib, tivozanib (AV-951), Belzutifan, Temsirolimus (CCI-779), CB-839, ABT-869, Nivolumab, ABT-510/Thrombospondin-1 mimetic, bevacizumab, CP-461, and others
Insomnia Therapeutic Assessment: Insomnia current marketed and Insomnia emerging therapies
Insomnia Market Dynamics: Insomnia market drivers and Insomnia market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
Insomnia Unmet Needs, KOL’s views, Analyst’s views, Insomnia Market Access and Reimbursement
To know more about Insomnia companies working in the treatment market, visit @ Insomnia Clinical Trials and Therapeutic Assessment
Table of Contents
1. Insomnia Market Report Introduction
2. Executive Summary for Insomnia
3. SWOT analysis of Insomnia
4. Insomnia Patient Share (%) Overview at a Glance
5. Insomnia Market Overview at a Glance
6. Insomnia Disease Background and Overview
7. Insomnia Epidemiology and Patient Population
8. Country-Specific Patient Population of Insomnia
9. Insomnia Current Treatment and Medical Practices
10. Insomnia Unmet Needs
11. Insomnia Emerging Therapies
12. Insomnia Market Outlook
13. Country-Wise Insomnia Market Analysis (2020–2034)
14. Insomnia Market Access and Reimbursement of Therapies
15. Insomnia Market Drivers
16. Insomnia Market Barriers
17. Insomnia Appendix
18. Insomnia Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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DelveInsight’s ‘Insomnia Epidemiology Forecast to 2034’ report delivers an in-depth understanding of the disease, historical and forecasted Insomnia epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
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