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PharmaPoint: Fibromyalgia - Global Drug Forecast and Market Analysis to 2023

Summary

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.

Highlights

Key Questions Answered

- The fibromyalgia market is marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the fibromyalgia market?
- The late-stage fibromyalgia pipeline consists of reformulations of existing therapies, one of which has a novel route of administration, and me-too products. Which drug will have a significant impact on the fibromyalgia market? Which of these drugs will have the highest CAGR, and why?
- How will the introduction of new therapies change the fibromyalgia treatment landscape? How will the drug treatment rates change over the next five years? What are the key drivers and barriers to this change?

Key Findings

- The main driver of the expansion of the fibromyalgia market will be the introduction of four new therapies across the seven major markets.
- The biggest barrier for the introduction of new therapies will be patent expirations of the leading brands marketed for fibromyalgia, which will result in an increase of generics, and which may negatively impact revenue from branded drugs that are expected to launch in the forecast period.
- The concerns of reducing healthcare costs as part of government austerity measures, particularly in Europe, which will impede market growth. To ensure reimbursement companies will have to work closely together with payers and price their drugs competitively.

Scope

- Overview of fibromyalgia, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized fibromyalgia therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the fibromyalgia therapeutics market.
- Pipeline analysis: focus on the four late-stage pipeline drugs discussing emerging trends as well as overview of earlier phase drugs.
- Analysis of the current and future market competition in the global fibromyalgia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global fibromyalgia therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global fibromyalgia therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global fibromyalgia therapeutics market from 2013-2018.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

PharmaPoint: Fibromyalgia - Global Drug Forecast and Market Analysis to 2023
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 19
2.1 Catalyst 19
2.2 Related Reports 20
2.3 Upcoming Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 23
3.2 Classification 27
3.3 Symptoms 28
3.4 Quality of Life 28
4 Epidemiology 29
4.1 Disease Background 29
4.2 Risk Factors and Comorbidities 29
4.3 Global Trends 31
4.3.1 US 33
4.3.2 5EU 33
4.3.3 Japan 33
4.4 Forecast Methodology 34
4.4.1 Sources Used 34
4.4.2 Sources Not Used 38
4.4.3 Forecast Assumptions and Methods - Total Prevalent Cases of Fibromyalgia 39
4.4.4 Forecast Assumptions and Methods - Fibromyalgia Pain Severity 41
4.5 Epidemiological Forecast for Fibromyalgia (2013-2023) 42
4.5.1 Total Prevalent Cases of Fibromyalgia 42
4.5.2 Age-Specific Total Prevalent Cases of Fibromyalgia 44
4.5.3 Sex-Specific Total Prevalent Cases of Fibromyalgia 46
4.5.4 Age-Standardized Total Prevalence of Fibromyalgia 48
4.5.5 Total Prevalent Cases of Fibromyalgia by Pain Severity 50
4.6 Discussion 51
4.6.1 Epidemiological Forecast Insight 51
4.6.2 Limitations of the Analysis 53
4.6.3 Strengths of the Analysis 53
5 Disease Management 55
5.1 Diagnosis and Treatment Overview 55
5.1.1 Diagnosis 55
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 57
5.1.3 Clinical Practice 59
5.2 US 61
5.3 France 63
5.4 Germany 65
5.5 Italy 67
5.6 Spain 69
5.7 UK 71
5.8 Japan 73
6 Competitive Assessment 75
6.1 Overview 75
6.2 Product Profiles 76
6.2.1 Cymbalta (duloxetine) 76
6.2.2 Savella (milnacipran) 80
6.2.3 Lyrica (pregabalin) 85
6.2.4 Neurontin (gabapentin) 90
6.2.5 Other Antidepressants 94
6.2.6 Opioids 101
6.2.7 Cyclobenzaprine 106
7 Unmet Need and Opportunity 110
7.1 Overview 110
7.2 More Effective and Well-Tolerated Therapies 111
7.2.1 Unmet Need 111
7.2.2 Gap Analysis 113
7.2.3 Opportunity 113
7.3 Increased Drug Approvals 113
7.3.1 Unmet Need 113
7.3.2 Gap Analysis 114
7.3.3 Opportunity 115
7.4 Increased Physician/Patient Awareness and Earlier Diagnosis 115
7.4.1 Unmet Need 115
7.4.2 Gap Analysis 116
7.4.3 Opportunity 116
7.5 Diagnostic Tools 117
7.5.1 Unmet Need 117
7.5.2 Gap Analysis 118
7.5.3 Opportunity 118
8 Pipeline Assessment 119
8.1 Overview 119
8.2 Clinical Trial Mapping 119
8.2.1 Clinical Trials by Class of Therapy 119
8.3 Promising Drugs in Clinical Development 120
8.3.1 Lyrica CR (pregabalin) 123
8.3.2 DS-5565 (mirogabalin) 129
8.3.3 TNX-102 SL (cyclobenzaprine) 135
8.3.4 TD-9855 143
8.4 Other Drugs in Development 148
9 Current and Future Players 149
9.1 Overview 149
9.2 Trends in Corporate Strategy 152
9.3 Company Profiles 153
9.3.1 Pfizer 153
9.3.2 Eli Lilly 156
9.3.3 Forest Laboratories (Actavis) 160
9.3.4 Daiichi Sankyo 163
9.3.5 Tonix Pharmaceuticals 166
9.3.6 Theravance Biopharma 169
10 Market Outlook 172
10.1 Global Markets 172
10.1.1 Forecast 172
10.1.2 Drivers and Barriers - Global Issues 176
10.2 United States 177
10.2.1 Forecast 177
10.2.2 Key Events 181
10.2.3 Drivers and Barriers 181
10.3 5EU 182
10.3.1 Forecast 182
10.3.2 Key Events 187
10.3.3 Drivers and Barriers 187
10.4 Japan 189
10.4.1 Forecast 189
10.4.2 Key Events 192
10.4.3 Drivers and Barriers 192
11 Appendix 194
11.1 Bibliography 194
11.2 Abbreviations 203
11.3 Methodology 208
11.4 Forecasting Methodology 208
11.4.1 Diagnosed Fibromyalgia Patients 209
11.4.2 Percentage of Drug-Treated Patients 209
11.4.3 Drugs Included in Each Therapeutic Class 209
11.4.4 Launch and Patent Expiry Dates 209
11.4.5 General Pricing Assumptions 210
11.4.6 Individual Drug Assumptions 211
11.4.7 Generic Erosion 214
11.4.8 Pricing of Pipeline Agents 214
11.5 Primary Research - KOLs Interviewed for This Report 215
11.6 Primary Research - Prescriber Survey 216
11.7 About the Authors 217
11.7.1 Analyst 217
11.7.2 Therapy Area Director 217
11.7.3 Epidemiologist 218
11.7.4 Global Head of Healthcare 218
11.8 About GlobalData 219
11.9 Disclaimer 219

1.1 List of Tables
Table 1: Risk Factors and Comorbidities for Fibromyalgia 30
Table 2: Comparison of the ACR Criteria for Fibromyalgia Classification 32
Table 3: 7MM, Sources of Total Prevalence Data Used to Forecast the Total Prevalent Cases of Fibromyalgia 34
Table 4: 7MM, Sources of Fibromyalgia Pain Severity Data Used to Forecast the Total Prevalent Cases of Fibromyalgia Segmented by Pain Severity 35
Table 5: 7MM, Total Prevalent Cases of Fibromyalgia, Ages ?10 Years, Both Sexes, N, Selected Years 2013-2023 43
Table 6: 7MM, Age-Specific Total Prevalent Cases of Fibromyalgia, Both Sexes, N (Row %), 2013 45
Table 7: 7MM, Sex-Specific Total Prevalent Cases of Fibromyalgia, Ages ?10 Years, N (Row %), 2013 47
Table 8: 7MM Total Prevalent Cases of Fibromyalgia, N (%), by Pain Severity, Both Sexes, Ages ?10 Years, 2013 50
Table 9: Treatment Guidelines for Fibromyalgia 58
Table 10: Most Commonly Prescribed Drugs for Fibromyalgia by Class in the Global Markets, 2014 59
Table 11: Diagnosis and Treatment of Fibromyalgia, Country Profile - US 62
Table 12: Diagnosis and Treatment of Fibromyalgia, Country Profile - France 64
Table 13: Diagnosis and Treatment of Fibromyalgia, Country Profile - Germany 66
Table 14: Diagnosis and Treatment of Fibromyalgia, Country Profile - Italy 68
Table 15: Diagnosis and Treatment of Fibromyalgia, Country Profile - Spain 70
Table 16: Diagnosis and Treatment of Fibromyalgia, Country Profile - UK 72
Table 17: Diagnosis and Treatment of Fibromyalgia, Country Profile - Japan 74
Table 18: Leading Branded Drug Treatments for Fibromyalgia in the 7MM, 2014 76
Table 19: Product Profile - Cymbalta 77
Table 20: Cymbalta SWOT Analysis, 2014 79
Table 21: Global Sales Forecasts ($m) for Cymbalta, 2013-2023 80
Table 22: Product Profile - Savella 81
Table 23: Savella SWOT Analysis, 2014 84
Table 24: Global Sales Forecasts ($m) for Savella, 2013-2023 85
Table 25: Product Profile - Lyrica 86
Table 26: Lyrica SWOT Analysis, 2014 89
Table 27: Global Sales Forecasts ($m) for Lyrica, 2013-2023 90
Table 28: Product Profile - Neurontin 91
Table 29: Neurontin SWOT Analysis, 2014 92
Table 30: Global Sales Forecasts ($m) for Gabapentin, 2013-2023 93
Table 31: Product Profile - Other Antidepressants Frequently Used in the Treatment of Fibromyalgia 96
Table 32: Other Antidepressants Used in the Treatment of Fibromyalgia, SWOT Analysis, 2014 100
Table 33: Global Sales Forecasts ($m) for Other Antidepressants, 2013-2023 101
Table 34: Product Profile - Opioids 103
Table 35: Opioids SWOT Analysis, 2014 105
Table 36: Global Sales Forecasts ($m) for Opioids, 2013-2023 106
Table 37: Product Profile - Cyclobenzaprine 107
Table 38: Cyclobenzaprine SWOT Analysis, 2014 109
Table 39: Global Sales Forecasts ($m) for Cyclobenzaprine, 2013-2023 109
Table 40: Unmet Need and Opportunity in Fibromyalgia 111
Table 41: Comparison of Therapeutic Classes in Development for Fibromyalgia, 2014 122
Table 42: Product Profile - Lyrica CR (pregabalin) 124
Table 43: Lyrica CR SWOT Analysis, 2014 128
Table 44: Global Sales Forecasts ($m) for Lyrica CR, 2013-2023 129
Table 45: Product Profile - DS-5565 (mirogabalin) 130
Table 46: DS-5565 SWOT Analysis, 2014 134
Table 47: Global Sales Forecasts ($m) for DS-5565, 2013-2023 135
Table 48: Product Profile - TNX-102 SL (Cyclobenzaprine) 137
Table 49: SWOT Analysis TNX-102 SL, 2014 142
Table 50: Global Sales Forecasts ($m) for TNX-102 SL, 2013-2023 143
Table 51: Product Profile - TD-9855 144
Table 52: TD-9855 SWOT Analysis, 2014 147
Table 53: Global Sales Forecasts ($m) for TD-9855, 2013-2023 148
Table 54: Drugs in Development for Fibromyalgia, 2014 148
Table 55: Key Companies in the Fibromyalgia Market in the 7MM, 2014 150
Table 56: Pfizer's Fibromyalgia Portfolio Assessment, 2014 154
Table 57: Eli Lilly's Fibromyalgia Portfolio Assessment, 2014 157
Table 58: Forest Laboratories' (Actavis) Fibromyalgia Portfolio Assessment, 2014 160
Table 59: Daiichi Sankyo's Fibromyalgia Portfolio Assessment, 2014 163
Table 60: Tonix Pharmaceutical's Fibromyalgia Portfolio Assessment, 2014 166
Table 61: Theravance Biopharma's Fibromyalgia Portfolio Assessment, 2014 170
Table 62: Global Sales Forecasts ($m) for Fibromyalgia, 2013-2023 174
Table 63: Global Fibromyalgia Market - Drivers and Barriers, 2013-2023 176
Table 64: Sales Forecasts ($m) for Fibromyalgia in the US, 2013-2023 179
Table 65: Key Events Impacting Sales for Fibromyalgia in the US, 2013-2023 181
Table 66: Fibromyalgia Market in the US - Drivers and Barriers, 2013-2023 181
Table 67: Sales Forecasts ($m) for Fibromyalgia in the 5EU, 2013-2023 184
Table 68: Key Events Impacting Sales for Fibromyalgia in the 5EU, 2013-2023 187
Table 69: Fibromyalgia Market in the 5EU - Drivers and Barriers, 2013-2023 187
Table 70: Sales Forecasts ($m) for Fibromyalgia in Japan, 2013-2023 190
Table 71: Key Events Impacting Sales for Fibromyalgia in the US, 2013-2023 192
Table 72: Fibromyalgia Market - Drivers and Barriers, 2013-2023 192
Table 73: Key Launch Dates for Fibromyalgia Drugs in the 7MM 209
Table 74: Key Patent Expiries for the Marketed Drugs Indicated for Fibromyalgia 210
Table 75: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 216

1.2 List of Figures
Figure 1: 7MM, Total Prevalent Cases of Fibromyalgia Ages ?10 Years, Both Sexes, N, 2013-2023 44
Figure 2: 7MM, Age-Specific Total Prevalent Cases of Fibromyalgia, Both Sexes, N, 2013 46
Figure 3: 7MM, Sex-Specific Total Prevalent Cases of Fibromyalgia, Ages ?10 Years, N, 2013 48
Figure 4: 7MM, Age-Standardized Total Prevalence of Fibromyalgia (%), Ages ?10 Years, by Sex, 2013 49
Figure 5: 7MM Total Prevalent Cases of Fibromyalgia (N), by Pain Severity, Both Sexes, Ages ?10 Years, 2013 51
Figure 6: Fibromyalgia Tender Points 56
Figure 7: Fibromyalgia Therapeutics - Class of Therapy, 2014 120
Figure 8: Fibromyalgia - Phase II-III Pipeline, 2014 121
Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in Fibromyalgia, 2013-2023 122
Figure 10: Clinical and Commercial Positioning of Lyrica CR 127
Figure 11: Clinical and Commercial Positioning of DS-5565 133
Figure 12: Clinical and Commercial Positioning of TNX-102 SL 141
Figure 13: Clinical and Commercial Positioning of TD-9855 147
Figure 14: Global Sales of Branded Products for Fibromyalgia by Company, 2013-2023 151
Figure 15: Company Portfolio Gap Analysis in Fibromyalgia, 2013-2023 152
Figure 16: Pfizer's SWOT Analysis in Fibromyalgia, 2013-2023 156
Figure 17: Eli Lilly SWOT Analysis in Fibromyalgia, 2013-2023 159
Figure 18: Forest Laboratories (Actavis) SWOT Analysis in Fibromyalgia, 2013-2023 162
Figure 19: Daiichi Sankyo SWOT Analysis in Fibromyalgia, 2013-2023 165
Figure 20: Tonix Pharmaceuticals SWOT Analysis in Fibromyalgia, 2013-2023 168
Figure 21: Theravance Biopharma SWOT Analysis in Fibromyalgia, 2013-2023 171
Figure 22: Global Sales for Fibromyalgia by Region, 2013-2023 175
Figure 23: Sales for Fibromyalgia in the US by Drug Class, 2013-2023 180
Figure 24: Sales for Fibromyalgia in the 5EU by Drug Class, 2013-2023 185
Figure 25: Sales for Fibromyalgia in the 5EU by Country, 2013-2023 186
Figure 26: Sales for Fibromyalgia in Japan by Drug Class, 2013-2023 191

Companies Mentioned
Pfizer
Eli Lilly
Forest Laboratories (Actavis)
Daiichi Sankyo
Tonix Pharmaceuticals
Theravance Biopharma

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