Insomnia - 5EU Drug Forecast and Market Analysis to 2023

Insomnia - 5EU Drug Forecast and Market Analysis to 2023


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Executive Summary

Insomnia - 5EU 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.

Belsomra is anticipated to experience quick uptake as it is a first-in-class drug that is expected to address the need for a product with long-term safety and efficacy data in the 5EU. For this reason, the drug will gain a greater patient share in chronic insomnia patients, as GPs will be more confident in prescribing the drug for long-term periods. Patient share in acute patients will be gained from individuals who are not responding adequately to available treatments, as well as those who are willing to switch to a new treatment option.

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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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in 5EU from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting 5EU 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 5EU.



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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 10

2 Introduction 11

2.1 Catalyst 11

2.2 Related Reports 11

3 Disease Overview 12

3.1 Etiology and Pathophysiology 12

3.1.1 Etiology 12

3.1.2 Pathophysiology 18

3.2 Classification 19

3.3 Symptoms 22

3.4 Prognosis 22

4 Disease Management 24

4.1 Diagnosis and Treatment Overview 24

4.1.1 Clinical Evaluation 24

4.1.2 Referral 28

4.1.3 Treatment Guidelines and Leading Prescribed Drugs 28

4.1.4 Clinical Practice 30

4.2 France 34

4.3 Germany 37

4.4 Italy 40

4.5 Spain 43

4.6 UK 46

5 Competitive Assessment 50

5.1 Overview 50

5.2 Product Profiles - Major Brands 52

5.2.1 Nonbenzodiazepines 52

5.2.2 Benzodiazepines 91

5.2.3 Melatonin Receptor Agonists 96

5.2.4 Low-Dose Sedating Antidepressants 115

5.2.5 Orexin Receptor Antagonists 128

5.3 Other Therapeutic Classes 139

6 Unmet Need and Opportunity 140

6.1 Overview 140

6.2 Novel Drugs with Improved Safety Profiles 141

6.2.1 Unmet Need 141

6.2.2 Gap Analysis 143

6.2.3 Opportunity 144

6.3 Drugs That Can Be Used for Long-Term Treatment 144

6.3.1 Unmet Need 144

6.3.2 Gap Analysis 145

6.3.3 Opportunity 146

6.4 Availability of Cognitive Behavioral Therapy 146

6.4.1 Unmet Need 146

6.4.2 Gap Analysis 148

6.4.3 Opportunity 148

6.5 Drugs That Improve the Quality of Sleep 149

6.5.1 Unmet Need 149

6.5.2 Gap Analysis 150

6.5.3 Opportunity 151

6.6 Education for Primary Care Physicians 151

6.6.1 Unmet Need 151

6.6.2 Gap Analysis 152

6.6.3 Opportunity 153

7 Pipeline Assessment 154

7.1 Overview 154

7.2 Clinical Trial Mapping 154

7.2.1 Clinical Trials by Sponsor Type 154

7.3 Promising Drugs in Clinical Development 155

7.3.1 E-2006 156

7.3.2 Piromelatine 161

7.4 Promising Drugs in Early-Stage Development 166

7.5 Other Drugs in Development 168

8 Market Outlook 169

8.1 France 169

8.1.1 Forecast 169

8.1.2 Key Events 172

8.1.3 Drivers and Barriers 172

8.2 Germany 174

8.2.1 Forecast 174

8.2.2 Key Events 177

8.2.3 Drivers and Barriers 177

8.3 Italy 179

8.3.1 Forecast 179

8.3.2 Key Events 182

8.3.3 Drivers and Barriers 182

8.4 Spain 183

8.4.1 Forecast 183

8.4.2 Key Events 187

8.4.3 Drivers and Barriers 187

8.5 United Kingdom 189

8.5.1 Forecast 189

8.5.2 Key Events 192

8.5.3 Drivers and Barriers 192

9 Appendix 194

9.1 Bibliography 194

9.2 Abbreviations 228

9.3 Methodology 232

9.4 Forecasting Methodology 232

9.4.1 Diagnosed Insomnia Patients 232

9.4.2 Percent Drug-Treated Patients 233

9.4.3 Drugs Included in Each Therapeutic Class 233

9.4.4 Launch and Patent Expiry Dates 234

9.4.5 General Pricing Assumptions 235

9.4.6 Individual Drug Assumptions 236

9.4.7 Generic Erosion 249

9.4.8 Pricing of Pipeline Agents 250

9.5 Primary Research - KOLs Interviewed for this Report 251

9.6 Primary Research - Prescriber Survey 253

9.7 About the Authors 254

9.7.1 Analyst 254

9.7.2 Therapy Area Director 254

9.7.3 Epidemiologist 255

9.7.4 Global Head of Healthcare 255

9.8 About GlobalData 256

9.9 Disclaimer 256

1.2 List of Figures

Figure 1: The ''3P'' Model of Insomnia 14

Figure 2: Insomnia Diagnosis Algorithm 25

Figure 3: Chronic Insomnia Treatment Algorithm 33

Figure 4: Belsomra's Development in Insomnia 132

Figure 5: Insomnia Therapeutics - Sponsor Type, 2015 155

Figure 6: Insomnia - Phase II-III Pipeline, 2015 156

Figure 7: Clinical and Commercial Positioning of E-2006 159

Figure 8: Clinical and Commercial Positioning of Piromelatine 165

Figure 9: Sales for Insomnia in France by Drug Class, 2013-2023 171

Figure 10: Sales for Insomnia in Germany by Drug Class, 2013-2023 176

Figure 11: Sales for Insomnia in Italy by Drug Class, 2013-2023 181

Figure 12: Sales for Insomnia in Spain by Drug Class, 2013-2023 186

Figure 13: Sales for Insomnia in the UK by Drug Class, 2013-2023 191

1.1 List of Tables

Table 1: ICSD-2 Classification of Sleep Disorders and Subtypes of Insomnia 13

Table 2: Comorbid Psychiatric Disorders, Medical Disorders, Medications, and Substances that Can Cause Insomnia 16

Table 3: The Three Main Classifications of Insomnia Disorders 20

Table 4: Symptoms of Insomnia 22

Table 5: Examples of Patient Questionnaires Used in the Diagnosis of Insomnia 26

Table 6: Treatment Guidelines for Insomnia 29

Table 7: Most Prescribed Drugs for Insomnia by Class in the Global Markets, 2013 30

Table 8: Country Profile - France 37

Table 9: Country Profile - Germany 40

Table 10: Country Profile - Italy 43

Table 11: Country Profile - Spain 46

Table 12: Country Profile - UK 49

Table 13: Leading Treatments for Insomnia, 2015 52

Table 14: Product Profile - Ambien/Ambien CR 55

Table 15: Ambien/Ambien CR SWOT Analysis, 2015 59

Table 16: Global Sales Forecast (USDm) for Ambien, 2013-2023 60

Table 17: Global Sales Forecasts (USDm) for Ambien CR, 2013-2023 60

Table 18: Product Profile - Intermezzo 63

Table 19: Pivotal Trials of Intermezzo in Insomnia 64

Table 20: Intermezzo SWOT Analysis, 2015 66

Table 21: Global Sales Forecast (USDm) for Intermezzo, 2013-2023 67

Table 22: Product Profile - Zolpimist 69

Table 23: Zolpimist SWOT Analysis, 2015 71

Table 24: Global Sales Forecast (USDm) for Zolpimist, 2013-2023 72

Table 25: Product Profile - Edluar 74

Table 26: Edluar SWOT Analysis, 2015 76

Table 27: Global Sales Forecast (USDm) for Edluar, 2013-2023 77

Table 28: Product Profile - Lunesta 79

Table 29: Adverse Events at ?2% Incidence in Lunesta Clinical Trials 82

Table 30: Lunesta SWOT Analysis, 2015 83

Table 31: Global Sales Forecast (USDm) for Lunesta, 2013-2023 84

Table 32: Product Profile - Sonata 86

Table 33: Adverse Events at ?2% Incidence in Sonata Trials 89

Table 34: Sonata SWOT Analysis, 2015 90

Table 35: Global Sales Forecast (USDm) for Sonata, 2013-2023 91

Table 36: Benzodiazepine SWOT Analysis, 2015 95

Table 37: Global Sales Forecasts (USDm) for the Benzodiazepines, 2013-2023 96

Table 38: Product Profile - Hetlioz 98

Table 39: Results of a Phase III clinical trial of Hetlioz in Transient Insomnia 99

Table 40: Results of a Phase III clinical trial of Hetlioz in Chronic Insomnia 100

Table 41: Adverse Events Observed in Clinical Trials of Hetlioz 101

Table 42: Hetlioz SWOT Analysis, 2015 101

Table 43: Product Profile - Rozerem 104

Table 44: Incidence (%) of Adverse Events in Rozerem's Clinical Trials 106

Table 45: Rozerem SWOT Analysis, 2015 107

Table 46: Global Sales Forecast (USDm) for Rozerem, 2013-2023 108

Table 47: Product Profile - Circadin 110

Table 48: Frequency of Adverse Reactions Observed in Clinical Trials of Circadin 113

Table 49: Circadin SWOT Analysis, 2015 114

Table 50: Global Sales Forecast (USDm) for Circadin, 2013-2023 115

Table 51: Product Profile - Silenor 117

Table 52: Objective Sleep Efficacy Measures of Silenor in Chronic Primary Insomnia 119

Table 53: Objective Sleep Efficacy Measures of Silenor in Elderly Chronic Primary Insomnia Patients 120

Table 54: Subjective Sleep Efficacy Measures of Silenor in Elderly Chronic Primary Insomnia Patients 121

Table 55: Incidence (%) of Adverse Events in Silenor Trials 122

Table 56: Silenor SWOT Analysis, 2015 122

Table 57: Global Sales Forecasts (USDm) for Silenor, 2013-2023 123

Table 58: Low-Dose Sedating Antidepressants SWOT Analysis, 2015 127

Table 59: Global Sales Forecast (USDm) for Low-Dose Sedating Antidepressants, 2013-2023 128

Table 60: Product Profile - Belsomra 131

Table 61: Pooled Sleep Efficacy Measures from Two Phase III Trials of Belsomra in Primary Insomnia 133

Table 62: Belsomra Pooled Adverse Events at ?2% Incidence in the First 3 Months of Phase III Clinical Trials 135

Table 63: Belsomra SWOT Analysis, 2015 137

Table 64: Global Sales Forecast (USD) for Belsomra, 2013-2023 138

Table 65: Summary of Minor Therapeutic Classes, 2015 139

Table 66: Unmet Needs and Opportunities in Insomnia 141

Table 67: Product Profile - E-2006 157

Table 68: Sleep Efficacy Measures from a Phase I Trial of E-2006 in Primary Insomnia Patients 158

Table 69: E-2006 SWOT Analysis, 2015 160

Table 70: Global Sales Forecast (USD) for E-2006, 2013-2023 161

Table 71: Product Profile - Piromelatine 163

Table 72: Piromelatine SWOT Analysis, 2015 166

Table 73: Drugs in Development, 2015 168

Table 74: Sales Forecasts (USDm) for Insomnia in France, 2013-2023 170

Table 75: Key Events Impacting Sales for Insomnia in France, 2013-2023 172

Table 76: Insomnia Market in France - Drivers and Barriers, 2013-2023 172

Table 77: Sales Forecast (USDm) for Insomnia in Germany, 2013-2023 175

Table 78: Key Events Impacting Sales for Insomnia in Germany, 2013-2023 177

Table 79: Insomnia Market in Germany - Drivers and Barriers, 2013-2023 177

Table 80: Sales Forecast (USDm) for Insomnia in Italy, 2013-2023 180

Table 81: Key Events Impacting Sales for Insomnia in Italy, 2013-2023 182

Table 82: Insomnia Market in Italy - Drivers and Barriers, 2013-2023 182

Table 83: Sales Forecast (USDm) for Insomnia in Spain, 2013-2023 185

Table 84: Key Events Impacting Sales for Insomnia in Spain, 2013-2023 187

Table 85: Insomnia Market in Spain - Drivers and Barriers, 2013-2023 187

Table 86: Sales Forecast (USDm) for Insomnia in the UK, 2013-2023 190

Table 87: Key Events Impacting Sales for Insomnia in the UK, 2013-2023 192

Table 88: Insomnia Market in the UK - Drivers and Barriers, 2013-2023 192

Table 89: Key Launch Dates 234

Table 90: Key Patent Expiries 234

Table 91: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 253

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