Insomnia - US Drug Forecast and Market Analysis to 2023

Insomnia - US Drug Forecast and Market Analysis to 2023


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Executive Summary

Insomnia - US Drug Forecast and Market Analysis to 2023

Summary

Insomnia is the most common sleep disorder and is believed to affect approximately 35% of the global population. The condition can be defined as patient-reported difficultly with sleep initiation or sleep maintenance which can include frequent awakenings, difficulty returning to sleep after awakenings, or awakening too early with inability to return to sleep. Cases of insomnia can be classified on the basis of etiology into primary and secondary (or comorbid) subtypes. The insomnia market is widely genericized creating a competitive environment for new products. As such, the treatment algorithm centers on the generically available nonbenzodiazepines and low-dose sedating antidepressants, despite the launch of numerous novel agents. The value of the insomnia market is set to further decline following the loss of exclusivity for Sunovion/Dainippon Sumitomo's Lunesta, the top selling insomnia drug, in April 2014. However, GlobalData expects the launch of two pipeline products from a novel class of drugs to provide growth in the insomnia market as they may address some of the unmet need.

GlobalData expects Belsomra to be the top-selling insomnia product in the US in 2023, generating sales of approximately USD358.9m. This is largely due to Belsomra being first-in-class with the potential to address some unmet need in the insomnia market due to its safety profile. In addition, all other key brands will face generic competition at the end of the forecast period in the US, leading to significant erosion of sales.

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Scope

Overview of Insomnia including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the US from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting the US Insomnia market.

Reasons to buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for Insomnia.

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2013-2023 in the US.



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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 8

2 Introduction 9

2.1 Catalyst 9

2.2 Related Reports 9

3 Disease Overview 10

3.1 Etiology and Pathophysiology 10

3.1.1 Etiology 10

3.1.2 Pathophysiology 16

3.2 Classification 17

3.3 Symptoms 20

3.4 Prognosis 20

4 Disease Management 22

4.1 Diagnosis and Treatment Overview 22

4.1.1 Clinical Evaluation 22

4.1.2 Referral 26

4.1.3 Treatment Guidelines and Leading Prescribed Drugs 26

4.1.4 Clinical Practice 28

4.2 US 32

5 Competitive Assessment 36

5.1 Overview 36

5.2 Product Profiles - Major Brands 38

5.2.1 Nonbenzodiazepines 38

5.2.2 Benzodiazepines 77

5.2.3 Melatonin Receptor Agonists 82

5.2.4 Low-Dose Sedating Antidepressants 101

5.2.5 Orexin Receptor Antagonists 114

5.3 Other Therapeutic Classes 125

6 Unmet Need and Opportunity 126

6.1 Overview 126

6.2 Novel Drugs with Improved Safety Profiles 127

6.2.1 Unmet Need 127

6.2.2 Gap Analysis 129

6.2.3 Opportunity 130

6.3 Drugs That Can Be Used for Long-Term Treatment 130

6.3.1 Unmet Need 130

6.3.2 Gap Analysis 131

6.3.3 Opportunity 132

6.4 Availability of Cognitive Behavioral Therapy 132

6.4.1 Unmet Need 132

6.4.2 Gap Analysis 134

6.4.3 Opportunity 134

6.5 Drugs That Improve the Quality of Sleep 135

6.5.1 Unmet Need 135

6.5.2 Gap Analysis 136

6.5.3 Opportunity 137

6.6 Education for Primary Care Physicians 137

6.6.1 Unmet Need 137

6.6.2 Gap Analysis 138

6.6.3 Opportunity 139

7 Pipeline Assessment 140

7.1 Overview 140

7.2 Clinical Trial Mapping 140

7.2.1 Clinical Trials by Sponsor Type 140

7.3 Promising Drugs in Clinical Development 141

7.3.1 E-2006 142

7.3.2 Piromelatine 147

7.4 Promising Drugs in Early-Stage Development 152

7.5 Other Drugs in Development 154

8 Market Outlook 155

8.1 United States 155

8.1.1 Forecast 155

8.1.2 Key Events 158

8.1.3 Drivers and Barriers 158

9 Appendix 161

9.1 Bibliography 161

9.2 Abbreviations 195

9.3 Methodology 199

9.4 Forecasting Methodology 199

9.4.1 Diagnosed Insomnia Patients 199

9.4.2 Percent Drug-Treated Patients 200

9.4.3 Drugs Included in Each Therapeutic Class 200

9.4.4 Launch and Patent Expiry Dates 201

9.4.5 General Pricing Assumptions 202

9.4.6 Individual Drug Assumptions 203

9.4.7 Generic Erosion 216

9.4.8 Pricing of Pipeline Agents 217

9.5 Primary Research - KOLs Interviewed for this Report 218

9.6 Primary Research - Prescriber Survey 220

9.7 About the Authors 221

9.7.1 Analyst 221

9.7.2 Therapy Area Director 221

9.7.3 Epidemiologist 222

9.7.4 Global Head of Healthcare 222

9.8 About GlobalData 223

9.9 Disclaimer 223

1.2 List of Figures

Figure 1: The ''3P'' Model of Insomnia 12

Figure 2: Insomnia Diagnosis Algorithm 23

Figure 3: Chronic Insomnia Treatment Algorithm 31

Figure 4: Belsomra's Development in Insomnia 118

Figure 5: Insomnia Therapeutics - Sponsor Type, 2015 141

Figure 6: Insomnia - Phase II-III Pipeline, 2015 142

Figure 7: Clinical and Commercial Positioning of E-2006 145

Figure 8: Clinical and Commercial Positioning of Piromelatine 151

Figure 9: Sales for Insomnia in the United States by Drug Class, 2013-2023 157

1.1 List of Tables

Table 1: ICSD-2 Classification of Sleep Disorders and Subtypes of Insomnia 11

Table 2: Comorbid Psychiatric Disorders, Medical Disorders, Medications, and Substances that Can Cause Insomnia 14

Table 3: The Three Main Classifications of Insomnia Disorders 18

Table 4: Symptoms of Insomnia 20

Table 5: Examples of Patient Questionnaires Used in the Diagnosis of Insomnia 24

Table 6: Treatment Guidelines for Insomnia 27

Table 7: Most Prescribed Drugs for Insomnia by Class in the Global Markets, 2013 28

Table 8: Country Profile - US 35

Table 9: Leading Treatments for Insomnia, 2015 38

Table 10: Product Profile - Ambien/Ambien CR 41

Table 11: Ambien/Ambien CR SWOT Analysis, 2015 45

Table 12: Global Sales Forecast (USDm) for Ambien, 2013-2023 46

Table 13: Global Sales Forecasts (USDm) for Ambien CR, 2013-2023 46

Table 14: Product Profile - Intermezzo 49

Table 15: Pivotal Trials of Intermezzo in Insomnia 50

Table 16: Intermezzo SWOT Analysis, 2015 52

Table 17: Global Sales Forecast (USDm) for Intermezzo, 2013-2023 53

Table 18: Product Profile - Zolpimist 55

Table 19: Zolpimist SWOT Analysis, 2015 57

Table 20: Global Sales Forecast (USDm) for Zolpimist, 2013-2023 58

Table 21: Product Profile - Edluar 60

Table 22: Edluar SWOT Analysis, 2015 62

Table 23: Global Sales Forecast (USDm) for Edluar, 2013-2023 63

Table 24: Product Profile - Lunesta 65

Table 25: Adverse Events at ?2% Incidence in Lunesta Clinical Trials 68

Table 26: Lunesta SWOT Analysis, 2015 69

Table 27: Global Sales Forecast (USDm) for Lunesta, 2013-2023 70

Table 28: Product Profile - Sonata 72

Table 29: Adverse Events at ?2% Incidence in Sonata Trials 75

Table 30: Sonata SWOT Analysis, 2015 76

Table 31: Global Sales Forecast (USDm) for Sonata, 2013-2023 77

Table 32: Benzodiazepine SWOT Analysis, 2015 81

Table 33: Global Sales Forecasts (USDm) for the Benzodiazepines, 2013-2023 82

Table 34: Product Profile - Hetlioz 84

Table 35: Results of a Phase III clinical trial of Hetlioz in Transient Insomnia 85

Table 36: Results of a Phase III clinical trial of Hetlioz in Chronic Insomnia 86

Table 37: Adverse Events Observed in Clinical Trials of Hetlioz 87

Table 38: Hetlioz SWOT Analysis, 2015 87

Table 39: Product Profile - Rozerem 90

Table 40: Incidence (%) of Adverse Events in Rozerem's Clinical Trials 92

Table 41: Rozerem SWOT Analysis, 2015 93

Table 42: Global Sales Forecast (USDm) for Rozerem, 2013-2023 94

Table 43: Product Profile - Circadin 96

Table 44: Frequency of Adverse Reactions Observed in Clinical Trials of Circadin 99

Table 45: Circadin SWOT Analysis, 2015 100

Table 46: Global Sales Forecast (USDm) for Circadin, 2013-2023 101

Table 47: Product Profile - Silenor 103

Table 48: Objective Sleep Efficacy Measures of Silenor in Chronic Primary Insomnia 105

Table 49: Objective Sleep Efficacy Measures of Silenor in Elderly Chronic Primary Insomnia Patients 106

Table 50: Subjective Sleep Efficacy Measures of Silenor in Elderly Chronic Primary Insomnia Patients 107

Table 51: Incidence (%) of Adverse Events in Silenor Trials 108

Table 52: Silenor SWOT Analysis, 2015 108

Table 53: Global Sales Forecasts (USDm) for Silenor, 2013-2023 109

Table 54: Low-Dose Sedating Antidepressants SWOT Analysis, 2015 113

Table 55: Global Sales Forecast (USDm) for Low-Dose Sedating Antidepressants, 2013-2023 114

Table 56: Product Profile - Belsomra 117

Table 57: Pooled Sleep Efficacy Measures from Two Phase III Trials of Belsomra in Primary Insomnia 119

Table 58: Belsomra Pooled Adverse Events at ?2% Incidence in the First 3 Months of Phase III Clinical Trials 121

Table 59: Belsomra SWOT Analysis, 2015 123

Table 60: Global Sales Forecast (USD) for Belsomra, 2013-2023 124

Table 61: Summary of Minor Therapeutic Classes, 2015 125

Table 62: Unmet Needs and Opportunities in Insomnia 127

Table 63: Product Profile - E-2006 143

Table 64: Sleep Efficacy Measures from a Phase I Trial of E-2006 in Primary Insomnia Patients 144

Table 65: E-2006 SWOT Analysis, 2015 146

Table 66: Global Sales Forecast (USD) for E-2006, 2013-2023 147

Table 67: Product Profile - Piromelatine 149

Table 68: Piromelatine SWOT Analysis, 2015 152

Table 69: Drugs in Development, 2015 154

Table 70: Sales Forecast (USDm) for Insomnia in the United States, 2013-2023 156

Table 71: Key Events Impacting Sales for Insomnia in the US, 2013-2023 158

Table 72: Insomnia Market in the US - Drivers and Barriers, 2013-2023 158

Table 73: Key Launch Dates 201

Table 74: Key Patent Expiries 201

Table 75: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 220

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