Insomnia - Japan Drug Forecast and Market Analysis to 2023

Insomnia - Japan Drug Forecast and Market Analysis to 2023


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Executive Summary

Insomnia - Japan 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 estimates the drug sales for insomnia in 2013 were approximately USD380.4m in Japan. Aside from some year-to-year fluctuation, the value of the insomnia market in Japan is expected to follow a growth trend over the 10-year forecast period, reaching USD432.4m by 2023. This growth can be attributed to the launch of the orexin receptor antagonists Belsomra and E-2006, and the continued uptake of Lunesta and Rozerem prior to their respective patent expiries.

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

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

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



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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 Japan 32

5 Competitive Assessment 35

5.1 Overview 35

5.2 Product Profiles - Major Brands 37

5.2.1 Nonbenzodiazepines 37

5.2.2 Benzodiazepines 76

5.2.3 Melatonin Receptor Agonists 81

5.2.4 Low-Dose Sedating Antidepressants 100

5.2.5 Orexin Receptor Antagonists 113

5.3 Other Therapeutic Classes 124

6 Unmet Need and Opportunity 125

6.1 Overview 125

6.2 Novel Drugs with Improved Safety Profiles 126

6.2.1 Unmet Need 126

6.2.2 Gap Analysis 128

6.2.3 Opportunity 129

6.3 Drugs That Can Be Used for Long-Term Treatment 129

6.3.1 Unmet Need 129

6.3.2 Gap Analysis 130

6.3.3 Opportunity 131

6.4 Availability of Cognitive Behavioral Therapy 131

6.4.1 Unmet Need 131

6.4.2 Gap Analysis 133

6.4.3 Opportunity 133

6.5 Drugs That Improve the Quality of Sleep 134

6.5.1 Unmet Need 134

6.5.2 Gap Analysis 135

6.5.3 Opportunity 136

6.6 Education for Primary Care Physicians 136

6.6.1 Unmet Need 136

6.6.2 Gap Analysis 137

6.6.3 Opportunity 138

7 Pipeline Assessment 139

7.1 Overview 139

7.2 Clinical Trial Mapping 139

7.2.1 Clinical Trials by Sponsor Type 139

7.3 Promising Drugs in Clinical Development 140

7.3.1 E-2006 141

7.3.2 Piromelatine 146

7.4 Promising Drugs in Early-Stage Development 151

7.5 Other Drugs in Development 153

8 Market Outlook 154

8.1 Japan 154

8.1.1 Forecast 154

8.1.2 Key Events 157

8.1.3 Drivers and Barriers 157

9 Appendix 159

9.1 Bibliography 159

9.2 Abbreviations 193

9.3 Methodology 197

9.4 Forecasting Methodology 197

9.4.1 Diagnosed Insomnia Patients 197

9.4.2 Percent Drug-Treated Patients 198

9.4.3 Drugs Included in Each Therapeutic Class 198

9.4.4 Launch and Patent Expiry Dates 199

9.4.5 General Pricing Assumptions 200

9.4.6 Individual Drug Assumptions 201

9.4.7 Generic Erosion 214

9.4.8 Pricing of Pipeline Agents 215

9.5 Primary Research - KOLs Interviewed for this Report 216

9.6 Primary Research - Prescriber Survey 218

9.7 About the Authors 219

9.7.1 Analyst 219

9.7.2 Therapy Area Director 219

9.7.3 Epidemiologist 220

9.7.4 Global Head of Healthcare 220

9.8 About GlobalData 221

9.9 Disclaimer 221

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 117

Figure 5: Insomnia Therapeutics - Sponsor Type, 2015 140

Figure 6: Insomnia - Phase II-III Pipeline, 2015 141

Figure 7: Clinical and Commercial Positioning of E-2006 144

Figure 8: Clinical and Commercial Positioning of Piromelatine 150

Figure 9: Sales for Insomnia in Japan by Drug Class, 2013-2023 156

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 - Japan 34

Table 9: Leading Treatments for Insomnia, 2015 37

Table 10: Product Profile - Ambien/Ambien CR 40

Table 11: Ambien/Ambien CR SWOT Analysis, 2015 44

Table 12: Global Sales Forecast (USDm) for Ambien, 2013-2023 45

Table 13: Global Sales Forecasts (USDm) for Ambien CR, 2013-2023 45

Table 14: Product Profile - Intermezzo 48

Table 15: Pivotal Trials of Intermezzo in Insomnia 49

Table 16: Intermezzo SWOT Analysis, 2015 51

Table 17: Global Sales Forecast (USDm) for Intermezzo, 2013-2023 52

Table 18: Product Profile - Zolpimist 54

Table 19: Zolpimist SWOT Analysis, 2015 56

Table 20: Global Sales Forecast (USDm) for Zolpimist, 2013-2023 57

Table 21: Product Profile - Edluar 59

Table 22: Edluar SWOT Analysis, 2015 61

Table 23: Global Sales Forecast (USDm) for Edluar, 2013-2023 62

Table 24: Product Profile - Lunesta 64

Table 25: Adverse Events at ?2% Incidence in Lunesta Clinical Trials 67

Table 26: Lunesta SWOT Analysis, 2015 68

Table 27: Global Sales Forecast (USDm) for Lunesta, 2013-2023 69

Table 28: Product Profile - Sonata 71

Table 29: Adverse Events at ?2% Incidence in Sonata Trials 74

Table 30: Sonata SWOT Analysis, 2015 75

Table 31: Global Sales Forecast (USDm) for Sonata, 2013-2023 76

Table 32: Benzodiazepine SWOT Analysis, 2015 80

Table 33: Global Sales Forecasts (USDm) for the Benzodiazepines, 2013-2023 81

Table 34: Product Profile - Hetlioz 83

Table 35: Results of a Phase III clinical trial of Hetlioz in Transient Insomnia 84

Table 36: Results of a Phase III clinical trial of Hetlioz in Chronic Insomnia 85

Table 37: Adverse Events Observed in Clinical Trials of Hetlioz 86

Table 38: Hetlioz SWOT Analysis, 2015 86

Table 39: Product Profile - Rozerem 89

Table 40: Incidence (%) of Adverse Events in Rozerem's Clinical Trials 91

Table 41: Rozerem SWOT Analysis, 2015 92

Table 42: Global Sales Forecast (USDm) for Rozerem, 2013-2023 93

Table 43: Product Profile - Circadin 95

Table 44: Frequency of Adverse Reactions Observed in Clinical Trials of Circadin 98

Table 45: Circadin SWOT Analysis, 2015 99

Table 46: Global Sales Forecast (USDm) for Circadin, 2013-2023 100

Table 47: Product Profile - Silenor 102

Table 48: Objective Sleep Efficacy Measures of Silenor in Chronic Primary Insomnia 104

Table 49: Objective Sleep Efficacy Measures of Silenor in Elderly Chronic Primary Insomnia Patients 105

Table 50: Subjective Sleep Efficacy Measures of Silenor in Elderly Chronic Primary Insomnia Patients 106

Table 51: Incidence (%) of Adverse Events in Silenor Trials 107

Table 52: Silenor SWOT Analysis, 2015 107

Table 53: Global Sales Forecasts (USDm) for Silenor, 2013-2023 108

Table 54: Low-Dose Sedating Antidepressants SWOT Analysis, 2015 112

Table 55: Global Sales Forecast (USDm) for Low-Dose Sedating Antidepressants, 2013-2023 113

Table 56: Product Profile - Belsomra 116

Table 57: Pooled Sleep Efficacy Measures from Two Phase III Trials of Belsomra in Primary Insomnia 118

Table 58: Belsomra Pooled Adverse Events at ?2% Incidence in the First 3 Months of Phase III Clinical Trials 120

Table 59: Belsomra SWOT Analysis, 2015 122

Table 60: Global Sales Forecast (USD) for Belsomra, 2013-2023 123

Table 61: Summary of Minor Therapeutic Classes, 2015 124

Table 62: Unmet Needs and Opportunities in Insomnia 126

Table 63: Product Profile - E-2006 142

Table 64: Sleep Efficacy Measures from a Phase I Trial of E-2006 in Primary Insomnia Patients 143

Table 65: E-2006 SWOT Analysis, 2015 145

Table 66: Global Sales Forecast (USD) for E-2006, 2013-2023 146

Table 67: Product Profile - Piromelatine 148

Table 68: Piromelatine SWOT Analysis, 2015 151

Table 69: Drugs in Development, 2015 153

Table 70: Sales Forecast (USDm) for Insomnia in Japan, 2013-2023 155

Table 71: Key Events Impacting Sales for Insomnia in Japan, 2013-2023 157

Table 72: Insomnia Market in Japan - Drivers and Barriers, 2013-2023 157

Table 73: Key Launch Dates 199

Table 74: Key Patent Expiries 199

Table 75: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 218

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