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Fibromyalgia-Japan Drug Forecast and Market Analysis to 2023

Fibromyalgia-Japan Drug Forecast and Market Analysis to 2023

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Executive Summary

Fibromyalgia-Japan Drug Forecast and Market Analysis to 2023


The fibromyalgia market is relatively new and not yet established. Three drugs currently dominate the sales across the 7MM and form the core treatment options; Lyrica, Cymbalta and Savella are all approved in the US while only the former is approved in Japan. Since these drugs are also available in the 5EU for other indications, they are prescribed as off-label therapies. A handful of other genericized products also provide off-label usage including antidepressants, anti-epileptics, opioids and muscle relaxants. Although Lyrica, Cymbalta and Savella can provide an effective treatment regimen, there are ample opportunities for the development of alternative treatment choices which can expand the medications available to patients, providing improvement in efficacy, safety and compliance. By 2023, there will be four new entrants to the market (Lyrica CR, TNX-102 SL, DS-5565 and TD-9855). These new products will help to drive market growth and offset some of the patent expiries of the leading brands during the forecast period. Despite these advancements in the treatment landscape, fibromyalgia therapeutic sales growth are expected to be minimal.

The patents of the two branded products in the Japanese fibromyalgia market, Cymbalta and Lyrica, are expected to expire in 2018 and 2022, respectively. This will inevitably trigger the launch of cheaper generics. However, Japanese physicians prefer to prescribe branded products and this is reflected in the forecast, where generic erosion in Japan is less severe in comparison with the US and 5EU.

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Overview of Fibromyalgia 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 Fibromyalgia 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 Fibromyalgia.

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.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 7

2 Introduction 8

2.1 Catalyst 8

2.2 Related Reports 8

2.3 Upcoming Related Reports 9

3 Disease Overview 10

3.1 Etiology and Pathophysiology 10

3.1.1 Etiology 10

3.1.2 Pathophysiology 12

3.2 Classification 16

3.3 Symptoms 16

3.4 Quality of Life 17

4 Disease Management 18

4.1 Diagnosis and Treatment Overview 18

4.1.1 Diagnosis 18

4.1.2 Treatment Guidelines and Leading Prescribed Drugs 20

4.1.3 Clinical Practice 22

4.2 Japan 24

5 Competitive Assessment 26

5.1 Overview 26

5.2 Product Profiles 27

5.2.1 Cymbalta (duloxetine) 27

5.2.2 Savella (milnacipran) 31

5.2.3 Lyrica (pregabalin) 36

5.2.4 Neurontin (gabapentin) 41

5.2.5 Other Antidepressants 44

5.2.6 Opioids 52

5.2.7 Cyclobenzaprine 57

6 Unmet Need and Opportunity 61

6.1 Overview 61

6.2 More Effective and Well-Tolerated Therapies 62

6.2.1 Unmet Need 62

6.2.2 Gap Analysis 64

6.2.3 Opportunity 64

6.3 Increased Drug Approvals 64

6.3.1 Unmet Need 64

6.3.2 Gap Analysis 65

6.3.3 Opportunity 66

6.4 Increased Physician/Patient Awareness and Earlier Diagnosis 66

6.4.1 Unmet Need 66

6.4.2 Gap Analysis 67

6.4.3 Opportunity 67

6.5 Diagnostic Tools 68

6.5.1 Unmet Need 68

6.5.2 Gap Analysis 69

6.5.3 Opportunity 69

7 Pipeline Assessment 70

7.1 Overview 70

7.2 Clinical Trial Mapping 70

7.2.1 Clinical Trials by Class of Therapy 70

7.3 Promising Drugs in Clinical Development 71

7.3.1 Lyrica CR (pregabalin) 74

7.3.2 DS-5565 (mirogabalin) 80

7.3.3 TNX-102 SL (cyclobenzaprine) 86

7.3.4 TD-9855 94

7.4 Other Drugs in Development 99

8 Market Outlook 100

8.1 Japan 100

8.1.1 Forecast 100

8.1.2 Key Events 103

8.1.3 Drivers and Barriers 103

9 Appendix 105

9.1 Bibliography 105

9.2 Abbreviations 115

9.3 Methodology 120

9.4 Forecasting Methodology 120

9.4.1 Diagnosed Fibromyalgia Patients 120

9.4.2 Percentage of Drug-Treated Patients 121

9.4.3 Drugs Included in Each Therapeutic Class 121

9.4.4 Launch and Patent Expiry Dates 121

9.4.5 General Pricing Assumptions 122

9.4.6 Individual Drug Assumptions 123

9.4.7 Generic Erosion 126

9.4.8 Pricing of Pipeline Agents 126

9.5 Primary Research-KOLs Interviewed for This Report 128

9.6 Primary Research-Prescriber Survey 129

9.7 About the Authors 130

9.7.1 Analyst 130

9.7.2 Therapy Area Director 130

9.7.3 Epidemiologist 131

9.7.4 Global Head of Healthcare 131

9.8 About GlobalData 132

9.9 Disclaimer 132

1.2 List of Figures

Figure 1: Fibromyalgia Tender Points 19

Figure 2: Fibromyalgia Therapeutics-Class of Therapy, 2014 71

Figure 3: Fibromyalgia-Phase II-III Pipeline, 2014 72

Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Fibromyalgia, 2013-2023 73

Figure 5: Clinical and Commercial Positioning of Lyrica CR 78

Figure 6: Clinical and Commercial Positioning of DS-5565 84

Figure 7: Clinical and Commercial Positioning of TNX-102 SL 92

Figure 8: Clinical and Commercial Positioning of TD-9855 98

Figure 9: Sales for Fibromyalgia in Japan by Drug Class, 2013-2023 102

1.1 List of Tables

Table 1: Treatment Guidelines for Fibromyalgia 21

Table 2: Most Commonly Prescribed Drugs for Fibromyalgia by Class in the Global Markets, 2014 22

Table 3: Diagnosis and Treatment of Fibromyalgia, Country Profile-Japan 25

Table 4: Leading Branded Drug Treatments for Fibromyalgia in the 7MM, 2014 27

Table 5: Product Profile-Cymbalta 28

Table 6: Cymbalta SWOT Analysis, 2014 30

Table 7: Global Sales Forecasts (USD m) for Cymbalta, 2013-2023 31

Table 8: Product Profile-Savella 32

Table 9: Savella SWOT Analysis, 2014 35

Table 10: Global Sales Forecasts (USD m) for Savella, 2013-2023 36

Table 11: Product Profile-Lyrica 37

Table 12: Lyrica SWOT Analysis, 2014 40

Table 13: Global Sales Forecasts (USD m) for Lyrica, 2013-2023 41

Table 14: Product Profile-Neurontin 42

Table 15: Neurontin SWOT Analysis, 2014 43

Table 16: Global Sales Forecasts (USD m) for Gabapentin, 2013-2023 44

Table 17: Product Profile-Other Antidepressants Frequently Used in the Treatment of Fibromyalgia 47

Table 18: Other Antidepressants Used in the Treatment of Fibromyalgia, SWOT Analysis, 2014 51

Table 19: Global Sales Forecasts (USD m) for Other Antidepressants, 2013-2023 52

Table 20: Product Profile-Opioids 54

Table 21: Opioids SWOT Analysis, 2014 56

Table 22: Global Sales Forecasts (USD m) for Opioids, 2013-2023 57

Table 23: Product Profile-Cyclobenzaprine 58

Table 24: Cyclobenzaprine SWOT Analysis, 2014 60

Table 25: Global Sales Forecasts (USD m) for Cyclobenzaprine, 2013-2023 60

Table 26: Unmet Need and Opportunity in Fibromyalgia 62

Table 27: Comparison of Therapeutic Classes in Development for Fibromyalgia, 2014 73

Table 28: Product Profile-Lyrica CR (pregabalin) 75

Table 29: Lyrica CR SWOT Analysis, 2014 79

Table 30: Global Sales Forecasts (USD m) for Lyrica CR, 2013-2023 80

Table 31: Product Profile-DS-5565 (mirogabalin) 81

Table 32: DS-5565 SWOT Analysis, 2014 85

Table 33: Global Sales Forecasts (USD m) for DS-5565, 2013-2023 86

Table 34: Product Profile-TNX-102 SL (Cyclobenzaprine) 88

Table 35: SWOT Analysis TNX-102 SL, 2014 93

Table 36: Global Sales Forecasts (USD m) for TNX-102 SL, 2013-2023 94

Table 37: Product Profile-TD-9855 95

Table 38: TD-9855 SWOT Analysis, 2014 98

Table 39: Global Sales Forecasts (USD m) for TD-9855, 2013-2023 99

Table 40: Drugs in Development for Fibromyalgia, 2014 99

Table 41: Sales Forecasts (USD m) for Fibromyalgia in Japan, 2013-2023 101

Table 42: Key Events Impacting Sales for Fibromyalgia in the US, 2013-2023 103

Table 43: Fibromyalgia Market-Drivers and Barriers, 2013-2023 103

Table 44: Key Launch Dates for Fibromyalgia Drugs in the 7MM 121

Table 45: Key Patent Expiries for the Marketed Drugs Indicated for Fibromyalgia 122

Table 46: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 129

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